Oral Nigella sativa seed capsules × Increased complete clearance or expulsion of adult kidney stones

Required evidence, verification status and materials actually read
Item	AVerification status	BReading scope	CReview item	DCurrent findings	EWhy unverified	FRequired materials and conditions	GFurther research
1	Partly verified	Full text not readStored summary read	N01 · Evidence conditionWhich black-seed preparation and stone question are selected?Required	The original effect description concerns increased complete clearance or expulsion of adult kidney stones; the selected endpoint is complete disappearance on ultrasound. R01	Information retained in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.	Adult kidney stones, ground-seed capsules, placebo, 10 weeks and complete ultrasound disappearance	Material needed: Original trial question, endpoint definitions and eligibility criteria This records needed materials; no new research was executed.
2	Partly verified	Full text not readStored summary read	N02 · Evidence conditionWhat seed formulation is the 500 mg capsule?Required	The retained intervention description specifies Nigella sativa L. seeds and ground-seed 500 mg capsules. R01	Information retained in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.	Nigella sativa L. seeds, ground-seed 500 mg capsules, composition and quality	Material needed: Product composition, raw-material/batch analyses, manufacture and quality material This records needed materials; no new research was executed.
3	Partly verified	Full text not readStored summary read	N03 · Evidence conditionAre seeds, fixed oil, extracts and thymoquinone the same intervention?Required	The original product description states that seed powder, fixed oil, aqueous extracts, ethanolic topical preparations, purified thymoquinone and combinations are not interchangeable. R01	Information retained in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.	Distinguish the original formulation from fixed oil, aqueous extracts, topical preparations, purified constituents and combinations	Material needed: Formulation-specific composition and original trials directly addressing the same question This records needed materials; no new research was executed.
4	Partly verified	Full text not readStored summary read	N04 · Evidence conditionWhat was the actual exposure to 500 mg, 2 times daily?Required	The original dose is 500 mg, 2 times daily. R01	Information retained in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.	Dose per 1 administration, frequency, use records, constituent quantification and adherence	Material needed: Administration procedures, product content and use diaries This records needed materials; no new research was executed.
5	Partly verified	Full text not readStored summary read	N05 · Evidence conditionWhat was the actual schedule for 10 weeks of treatment and ultrasound follow-up?Required	The retained duration is 10 weeks of treatment and ultrasound follow-up. R01	Information retained in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.	Treatment start/end, ultrasound visits, discontinuation and subsequent follow-up	Material needed: Treatment/ultrasound visit schedules and discontinuation/follow-up material This records needed materials; no new research was executed.
6	Partly verified	Full text not readStored summary read	N06 · Evidence conditionWhich adults and which kidney stones were studied?Required	The retained population is limited to adults with kidney stones. R01	Information retained in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.	Adults, kidney-stone diagnosis, inclusion/exclusion and baseline conditions	Material needed: Participant eligibility/baseline tables and diagnostic criteria This records needed materials; no new research was executed.
7	Partly verified	Full text not readStored summary read	N07 · Evidence conditionWhat were stone size, location, composition and number?Required	The original explanation describes limited reporting of stone location and spontaneous-passage influences. It cautions against extending results to every size, composition and location. R01	Information retained in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.	Baseline size/location/composition by group, single/multiple stones and likelihood of passage	Material needed: Baseline stone characteristics, imaging tables and composition material This records needed materials; no new research was executed.
8	Partly verified	Full text not readStored summary read	N08 · Evidence conditionWhat was actually compared with matched placebo?Required	The retained comparison is matched placebo and the design description is a randomized, triple-blind, placebo trial. R01	Information retained in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.	Placebo composition/appearance, common management and masking conditions	Material needed: Placebo composition and common treatment/management tables This records needed materials; no new research was executed.
9	Unverified	Full text not readStored summary read	N09 · Evidence conditionHow did hydration, diet, drugs and procedures differ?Required	The original explanation mentions limited reporting of hydration, stone location and spontaneous-passage influences. R01	Information retained in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.	Hydration/diet, stone medication/standard management, additional procedures and group differences	Material needed: Hydration/diet/concomitant-treatment, procedure and change records This records needed materials; no new research was executed.
10	Partly verified	Full text not readStored summary read	N10 · Evidence conditionHow do complete ultrasound disappearance and actual expulsion differ?Required	The retained principal endpoint is complete disappearance of stones on ultrasound. The original effect description uses both disappearance and expulsion. R01	Information retained in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.	Ultrasound disappearance, confirmation of actual expulsion, operational definitions and correspondence	Material needed: Definitions of complete disappearance/expulsion, confirmation of expulsion and original imaging-assessment material This records needed materials; no new research was executed.
11	Unverified	Full text not readStored summary read	N11 · Evidence conditionWhat does dissolution in the study title establish?Supplementary; required if extending to dissolution mechanisms	The article title includes kidney stone dissolution, but the retained verdict selects complete ultrasound disappearance. R01	Information retained in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.	Distinguish imaging disappearance, expulsion and chemical dissolution/mechanisms	Material needed: Original trial endpoints/measurements and stone-composition/expulsion material This records needed materials; no new research was executed.
12	Unverified	Full text not readStored summary read	N12 · Evidence conditionAre complete-disappearance events and size reduction the same outcome?Required	The retained endpoint is complete ultrasound disappearance; size reduction is separate, and the original explanation also states that these outcomes should not be mixed. R01	Information retained in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.	Size units, measurement/timing, between-group change and separation from complete disappearance	Material needed: Separate size-reduction result tables, imaging measurements and denominators This records needed materials; no new research was executed.
13	Unverified	Full text not readStored summary read	N13 · Evidence conditionWhich assessment procedures determined ultrasound disappearance?Required	The original text describes ultrasound assessment of stone status and limited reporting of imaging-assessment procedures. R01	Information retained in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.	Imaging equipment, sensitivity, assessors/masking, agreement and confirmation of disappearance	Material needed: Ultrasound SOPs, masking/assessment procedures and original images This records needed materials; no new research was executed.
14	Partly verified	Full text not readStored summary read	N14 · Evidence conditionHow do 60 randomized participants differ from analysis groups?Required	The retained participant record states 60 randomized; percentage-based analysis approximately 27 versus 26. R01	Information retained in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.	Randomization and arm-specific allocation, analysis, completion and endpoint denominators	Material needed: CONSORT flow and arm-specific allocation/analysis tables This records needed materials; no new research was executed.
15	Partly verified	Full text not readStored summary read	N15 · Evidence conditionHow were the approximately 27 and 26 analysis participants recorded?Required	The original explanation states that 44.4% and 15.3% came from small analysis groups of approximately 27 and 26. The original participant record also states percentage-based analysis approximately 27 versus 26. R01	Information retained in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.	Reported percentages, historical reconstruction, original denominators, rounding and units	Material needed: Original event/denominator tables, flow and original rounding/calculation records This records needed materials; no new research was executed.
16	Partly verified	Full text not readStored summary read	N16 · Evidence conditionAre 12/27 versus 4/26 original counts or reconstructions?Required	The result labels 12/27 versus 4/26 as reconstructed, while the reader answer presents approximately 12/27 versus 4/26. R01	Information retained in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.	Original event counts, reconstructed counts, approximation labels, denominators and group correspondence	Material needed: Original frequency tables and historical reconstruction records This records needed materials; no new research was executed.
17	Partly verified	Full text not readStored summary read	N17 · Evidence conditionWhich endpoint do the reported 44.4% versus 15.3% describe?Required	The original result and reader answer report complete disappearance of 44.4% versus 15.3%. R01	Information retained in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.	Complete-disappearance percentages, group correspondence, timing, units and denominators	Material needed: Complete-disappearance result tables, group denominators and definitions This records needed materials; no new research was executed.
18	Partly verified	Full text not readStored summary read	N18 · Evidence conditionWhat are the sources of RD 29.1 percentage points, RR 2.89 and the CI?Required	The original result reports RD 29.1 percentage points and RR 2.89 (95% CI 1.07 to 7.82) with reconstructed counts. Its note explicitly identifies a Codex reconstruction rather than adjusted paper estimates. R01	Information retained in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.	Original estimates versus reconstructed risk differences/RRs/CIs, effect of interest and adjustment	Material needed: Original effect tables and historical calculation-event records This records needed materials; no new research was executed.
19	Partly verified	Full text not readStored summary read	N19 · Evidence conditionWhat uncertainty remains with few events and a wide interval?Required	The original reader answer describes small absolute event counts and the need to reproduce imaging/spontaneous-passage conditions. The historical RR CI is 1.07 to 7.82. R01	Information retained in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.	Intervals for the effect of interest, direct events/denominators and clinical importance	Material needed: Original counts/effects and sample-size/clinical-importance plans This records needed materials; no new research was executed.
20	Unverified	Full text not readStored summary read	N20 · Evidence conditionWhat was the 1st endpoint in the prospective trial plan?Required	The retained intervention record labels complete ultrasound disappearance as the primary endpoint; the registration identifier is unconfirmed. R01	Information retained in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.	Registration, protocol, SAP and original endpoint/timing/analysis hierarchy	Material needed: Registration/protocol/SAP and change histories This records needed materials; no new research was executed.
21	Unverified	Full text not readStored summary read	N21 · Evidence conditionHow were sequence generation, concealment and baseline balance handled?Required	The original design is described as a randomized, triple-blind, placebo trial, with 60 randomized participants. R01	Information retained in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.	Random sequence/concealment, allocation and baseline stone/participant balance	Material needed: Allocation procedures and baseline tables This records needed materials; no new research was executed.
22	Unverified	Full text not readStored summary read	N22 · Evidence conditionWhich roles remained masked?Required	The original design description states triple blinding. R01	Information retained in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.	Participants, personnel and assessors, product distinguishability and maintenance of masking	Material needed: Placebo/preparations, role-specific masking and assessment procedures This records needed materials; no new research was executed.
23	Unverified	Full text not readStored summary read	N23 · Evidence conditionHow were actual use, discontinuation and additional treatment handled?Required	The original record specifies 500 mg, 2 times daily, 10 weeks of treatment and comparison with placebo. R01	Information retained in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.	Use diaries, nonadherence/discontinuation, additional treatment and the effect targeted in analysis	Material needed: Use diaries, deviation/procedure records and analysis plans This records needed materials; no new research was executed.
24	Unverified	Full text not readStored summary read	N24 · Evidence conditionWho among the 60 randomized participants was omitted from analysis?Required	The original participant record combines 60 randomized with percentage-based analysis of approximately 27/26. R01	Information retained in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.	Group-specific flow, withdrawal/missingness, ITT/PP, original denominators and handling	Material needed: Group-specific flow, analysis definitions and missing-data handling This records needed materials; no new research was executed.
25	Unverified	Full text not readStored summary read	N25 · Evidence conditionWhen and for whom was complete disappearance assessed?Required	The recorded duration is 10 weeks of treatment and ultrasound follow-up. R01	Information retained in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.	Clearance-assessment timing, interim/end visits, cumulative/single-visit events and denominators	Material needed: Visit-specific clearance tables, event timing and follow-up/denominators This records needed materials; no new research was executed.
26	Unverified	Full text not readStored summary read	N26 · Evidence conditionHow were event units for people and stones defined?Required	The original reader answer explains 12/27 and 4/26 in the context of participant denominators. R01	Information retained in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.	People/stones, multiple stones, complete-clearance criteria and group denominators	Material needed: Person/stone definitions and multiple-stone/denominator tables This records needed materials; no new research was executed.
27	Unverified	Full text not readStored summary read	N27 · Evidence conditionHow were spontaneous passage and intervention effects distinguished?Required	The original explanation describes limited reporting of hydration, stone location and spontaneous-passage influences. R01	Information retained in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.	Hydration/location/size, spontaneous passage, comparison conditions and assessment/timing	Material needed: Baseline stones, hydration/common management and expulsion/adjustment material This records needed materials; no new research was executed.
28	Unverified	Full text not readStored summary read	N28 · Evidence conditionHow were analyses of clearance, size and expulsion specified in advance?Required	The original endpoint description separates complete disappearance from size reduction; the registration identifier is unconfirmed. R01	Information retained in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.	Planned endpoints, analyses/timing, multiple comparisons and reporting changes	Material needed: Plans/registration and result tables for all analyses/times This records needed materials; no new research was executed.
29	Unverified	Full text not readStored summary read	N29 · Evidence conditionDoes a clearance signal establish replacement of standard care or effects on symptoms/kidney function?Supplementary; required if extending to treatment replacement or additional effects	The original advertising-boundary text states that replacement of surgery/standard care cannot be claimed for stones of every size, composition and location. R01	Information retained in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.	Standard treatment/procedures, pain/infection/obstruction, kidney function and patient-important outcomes	Material needed: Patient-important outcomes and standard-care coadministration/procedure material This records needed materials; no new research was executed.
30	Partly verified	Full text not readStored summary read	N30 · Evidence conditionWhich original report do the current summary and citation identify?Required	The original citation is Ardakani Movaghati MR et al., Phytother Res.2019, PMID30873671, DOI10.1002/ptr.6331. R01	Information retained in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.	Evidence/citation, PMID/DOI and study-report families	Material needed: Article/registration and lists of reports from the same trial This records needed materials; no new research was executed.
31	Partly verified	Full text not readStored summary read	N31 · Evidence conditionHas the small-sample signal been repeated in other independent material?Required	The original rationale lists independent research as a strength while noting a single small sample, denominator reconstruction and imaging limitations. The original R1/I2 axes are retained. R01	Information retained in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.	Teams/trial families, the same formulation/conditions and independent replication	Material needed: Original trials addressing the same formulation/question and imaging/expulsion conditions This records needed materials; no new research was executed.
32	Unverified	Full text not readStored summary read	N32 · Evidence conditionWhat was the actual role of Mashhad University support?Required	The original funding record states support from Mashhad University. R01	Information retained in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.	Funding/product support, affiliations, COI and support roles	Material needed: Original funding/COI, author-affiliation and product-support disclosures This records needed materials; no new research was executed.
33	Partly verified	Full text not readStored summary read	N33 · Evidence conditionWere the PubMed link, original article and registration read?Required	The clinical material read was the entire stored JSON summary. The PubMed URL is recorded as in the original citation. R01	Information retained in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.	Stored JSON, external abstracts/full text, registration/plans and acquisition/reading	Material needed: Original text, registration/plans and supplementary material corresponding to the citation This records needed materials; no new research was executed.
34	Partly verified	Full text not readStored summary read	N34 · Evidence conditionWhat dates are 2026-09-08 and the correction date?Required	The original evidence date is 2026-09-08, the correction date is 2026-09-14 and the bibliography is from 2019. R01	Information retained in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.	Roles of the original evidence date, correction/bibliography and current preparation date	Material needed: Original search, receipt, publication and correction records This records needed materials; no new research was executed.
35	Partly verified	Full text not readStored summary read	N35 · Evidence conditionAre generic English wording and the 1-field correction retained?Required	The English reader answer gives approximately 12/27 and 4/26 and historical RR/CI. Generic explanations remain for English funding, endpoint and result fields, while the English participant explanation describes preservation without actual denominators. The correction records replacement of 1 field. R01	Information retained in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.	Korean/English numbers, generic explanations and before/after correction events	Material needed: Complete before/after correction originals and English result/denominator correspondence This records needed materials; no new research was executed.
36	Partly verified	Full text not readStored summary read	N36 · Evidence conditionWhat roles do C56 and historical Codex reconstruction/cross-checks have here?Required	The original C56, Caution, B/H/R1/I2/E+/B2/C0 axes and historical independent Codex cross-check/reconstruction wording are preserved in the original copy. R01	Information retained in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.	Separate grade, score, caution label, axes, verdict decisions, historical calculation and current preparation	Material needed: Original verdict/reconstruction events and separately authorized subsequent corrections This records needed materials; no new research was executed.
37	Partly verified	Full text not readStored summary read	N37 · Evidence conditionFrom which denominators were actual adverse events for this formulation collected?Required	The original safety text states that small trials do not exclude rare adverse events or long-term safety concerns. R01	Information retained in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.	Event definitions/collection, group event/person counts, harm denominators and discontinuation/missingness	Material needed: Original adverse-event/discontinuation tables and group-specific collection/denominators This records needed materials; no new research was executed.
38	Unverified	Full text not readStored summary read	N38 · Evidence conditionWhat are the onset/recovery and concomitant-condition/treatment limits for harms?Required	The original text records the oral 10-week exposure and general cautionary wording. R01	Information retained in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.	Event timing, discontinuation/re-exposure, baseline conditions/concomitant drugs and alternative causes	Material needed: Individual event timing, concomitant treatment/baseline conditions and causal material This records needed materials; no new research was executed.
39	Unverified	Full text not readStored summary read	N39 · Evidence conditionAre drugs mentioned in cautions actual interaction events?Supplementary; required for concomitant-use harms	The retained safety explanation preserves cautionary wording to consult a clinician while taking relevant drugs. R01	Information retained in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.	Glucose-lowering, blood-pressure, anticoagulant, antiseizure and immunomodulatory drugs, exposures/events and alternatives	Material needed: Drug-specific exposure/formulation and original interaction material This records needed materials; no new research was executed.
40	Partly verified	Full text not readStored summary read	N40 · Evidence conditionWhat remains unknown about rare/long-term safety and vulnerable groups?Supplementary; required for long-term or vulnerable-population safety	The original text describes constituent differences between products/extraction methods, cautions for vulnerable groups/perioperative use and the inability of small trials to exclude rare/long-term harms. R01	Information retained in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.	Duration/formulation, pregnancy/breastfeeding, children, liver/kidney disease, perioperative use and rare harms	Material needed: Long-term/rare, formulation-specific and population-specific harm material This records needed materials; no new research was executed.
41	Unverified	Full text not readStored summary read	N41 · Evidence conditionIs the same formulation/event recorded in independent material?Supplementary; required for repeated-harm claims	The retained text preserves general cautionary wording and does not present an actual unique-case list. R01	Information retained in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.	Unique harm cases, report families and matching formulation/exposure/event	Material needed: Unique cases/report families and actual formulation/exposure material This records needed materials; no new research was executed.
42	Partly verified	Full text not readStored summary read	N42 · Evidence conditionHow are unread material and subsequent changes connected?Required	The stored JSON summary is used for preparation and only the original PubMed link is connected. External material was unread, with no access attempt. R01	Information retained in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.	Stored summary, external articles/registration/denominators/imaging, complete pre-change originals and condition/evidence events	Material needed: User-provided or separately authorized original material and corrections This records needed materials; no new research was executed.

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42 itemsWhat the statuses mean

Assessment scope

Stored-material review date: Not recorded
Original evidence cut-off: 2026-09-08
Scope actually checked: Existing review summaries and stored records of methodological application. Full papers, supplements, registrations, plans and original data were not read.
What the dates mean: The date 2026-09-08 in material items is the original evidence date, not a date of external reading in this work. The date 2026-10-06 is the original production date. Original review and verification dates are unrecorded; production timestamps are not presented as completed-content-review dates.
Population: The population is adults with kidney stones. Age ranges, diagnostic and eligibility criteria, stone characteristics, baseline kidney function and inclusion/exclusion of obstruction or infection remain unverified. Applicability to every stone size, composition and location is not assumed.
Ingredient, formulation and route: The intervention is oral Nigella sativa L. ground-seed capsules containing 500 mg. Cultivar, manufacture, excipients, constituent quantification and batch quality remain unverified. Fixed oil, aqueous extracts, topical preparations, purified thymoquinone and combinations are not treated as interchangeable.
Dose: The retained dose is 500 mg, 2 times daily. Actual use, adherence, constituent content, administration times, missed doses and adjustments remain unverified. No new daily total, cumulative dose or optimal dose is calculated or converted into personal dosing instructions.
Comparator: The record describes comparison with matched placebo. Placebo composition and appearance, matching administration procedures, hydration and diet, concomitant drugs, standard management and additional procedures remain unverified.
Measured outcome: The endpoint selected in the retained verdict is complete disappearance of stones on ultrasound. Direct confirmation of expulsion, the correspondence of imaging disappearance with passage or dissolution, and prospective endpoint hierarchy remain unverified. It is not substituted for size reduction, symptoms, kidney function or avoidance of procedures.
Duration: The original record describes 10 weeks of treatment and ultrasound follow-up. Interim visits, exact clearance-assessment timing, whether events were cumulative, follow-up after discontinuation and subsequent recurrence remain unverified. Long-term effects or safety are not established.
Questions outside this scope: The selected question concerns complete ultrasound disappearance in a comparison of oral ground-seed capsules and matched placebo in adults with kidney stones. It is not extended to actual expulsion, size reduction, chemical dissolution, other formulations, success rates for every stone or replacement of standard care.; The existing C·56 points·Caution and B/H/R1/I2/E+/B2/C0 are retained. Historical independent Codex cross-check wording does not establish completed content review or new certification of efficacy, safety or independent replication here.; The original record of 60 randomized participants remains distinct from approximately 27 versus 26 in percentage-based analysis groups. Arm-specific randomized counts, original analysis and completion denominators, withdrawals and missing-data handling remain unverified. No new total, denominator reconstruction, ITT/PP set or harm denominator is created.; The reported complete-disappearance percentages are 44.4% versus 15.3%. The historical Codex reconstruction of 12/27 versus 4/26, RD 29.1 percentage points and RR 2.89 (95% CI 1.07 to 7.82) is retained as an existing record. The accuracy of approximate denominators and counts remains unverified; they are not presented as adjusted paper estimates or new calculations in this work.; A stone no longer visible on ultrasound remains distinct from confirmed expulsion, size reduction and chemical dissolution. Gaps in imaging equipment, assessment, masking, detection limits, analysis units, spontaneous passage and hydration conditions remain.; The original description as a randomized, triple-blind, placebo trial is retained. It does not establish verified details of sequence generation, concealment, baseline balance, role-specific masking, registration or prospective analysis hierarchy.; The original record of support from Mashhad University is retained. Product provision, author roles, conflicts and support roles remain unverified. General cautionary wording is not converted into actual adverse-event counts, interactions, contraindications, overall safety or new certification of independence.; PMID30873671, DOI10.1002/ptr.6331, the 2019 bibliography, the original evidence date 2026-09-08 and the correction date 2026-09-14 for 1 English-placeholder field are retained. The date 2026-10-06 is the original production date. Unconfirmed registration identifiers are not interpreted as nonregistration, and identifiers or historical generic descriptions are not promoted to current external reading.

Evidence and sources

The links below lead to the sources. A link alone does not mean the original source was read or its latest publication status verified.

R01 · Ardakani Movaghati et al. 2019 · Report of black-seed capsules and kidney-stone disappearance

PubMed

Material type: Retained description as a randomized, triple-blind, placebo trial; detailed procedures not externally verified
Materials actually read: Summary read; external abstracts/full text, registration and plans unread, with no access attempt
Findings recorded in the stored summary: Reported complete disappearance 44.4% versus 15.3%; historical reconstruction 12/27 versus 4/26, RD 29.1 percentage points, RR 2.89 (95% CI 1.07 to 7.82)
Record level: Reported percentages remain distinct from historical Codex reconstructions. Direct correspondence with original counts, denominators, timing and adjusted estimates remains unverified. Imaging disappearance is not substituted for direct expulsion, size change or chemical dissolution.
Study overlap and independent replication: Only the retained connection between the trial summary and citation is maintained. Other reports or recitations of the same trial remain distinct from independent replication; no new unique-trial, participant or event totals or independent-replication count are established.

Public availability, access and reading status by material
Material	Public availability	Access status	Actually read	Notes
Stored existing review summary	Existing stored summary acquired	Stored summary	Summary read	The stored summary was read for preparation. This does not establish acquisition or content reading of the original trial full text. Existing bibliography is linked; external articles, registration, protocols, analysis plans and additional material are unread. A retained URL or identifier alone does not establish full-text acquisition, content reading or absence of material. The date 2026-09-08 in material items is the original evidence date, not a date of external reading in this work. The date 2026-10-06 is the original production date. Original review and verification dates are unrecorded; production timestamps are not presented as completed-content-review dates.
External article identity link	Original bibliography link only; external content unread	Unread; access not attempted	Not read	Only the existing PubMed citation URL is linked. External content reading and access or click testing were not performed. Existing bibliography is linked; external articles, registration, protocols, analysis plans and additional material are unread. A retained URL or identifier alone does not establish full-text acquisition, content reading or absence of material. The date 2026-09-08 in material items is the original evidence date, not a date of external reading in this work. The date 2026-10-06 is the original production date. Original review and verification dates are unrecorded; production timestamps are not presented as completed-content-review dates.
External full text	Original bibliography link only; external content unread	Unread; access not attempted	Not read	A bibliographic identity URL does not establish full-text acquisition, download or reading. Existing bibliography is linked; external articles, registration, protocols, analysis plans and additional material are unread. A retained URL or identifier alone does not establish full-text acquisition, content reading or absence of material. The date 2026-09-08 in material items is the original evidence date, not a date of external reading in this work. The date 2026-10-06 is the original production date. Original review and verification dates are unrecorded; production timestamps are not presented as completed-content-review dates.
Additional material needed	Needed material; existence and public availability unverified	Unread; access not attempted	Not read	The original registration identity is unconfirmed. Registration identifiers, public availability and protocol or analysis-plan contents are not inferred. Existing bibliography is linked; external articles, registration, protocols, analysis plans and additional material are unread. A retained URL or identifier alone does not establish full-text acquisition, content reading or absence of material. The date 2026-09-08 in material items is the original evidence date, not a date of external reading in this work. The date 2026-10-06 is the original production date. Original review and verification dates are unrecorded; production timestamps are not presented as completed-content-review dates.
Additional material needed	Needed material; existence and public availability unverified	Unread; access not attempted	Not read	The 60 randomized participants remain distinct from historical approximate 27/26 denominators and reconstructed counts. No additional reconstruction or pooling was performed. Existing bibliography is linked; external articles, registration, protocols, analysis plans and additional material are unread. A retained URL or identifier alone does not establish full-text acquisition, content reading or absence of material. The date 2026-09-08 in material items is the original evidence date, not a date of external reading in this work. The date 2026-10-06 is the original production date. Original review and verification dates are unrecorded; production timestamps are not presented as completed-content-review dates.
Additional material needed	Needed material; existence and public availability unverified	Unread; access not attempted	Not read	The correspondence of imaging disappearance with direct expulsion, size change and dissolution remains unverified. Existing bibliography is linked; external articles, registration, protocols, analysis plans and additional material are unread. A retained URL or identifier alone does not establish full-text acquisition, content reading or absence of material. The date 2026-09-08 in material items is the original evidence date, not a date of external reading in this work. The date 2026-10-06 is the original production date. Original review and verification dates are unrecorded; production timestamps are not presented as completed-content-review dates.
Additional material needed	Needed material; existence and public availability unverified	Unread; access not attempted	Not read	Direct material on product specifications, constituent quantification, placebo, actual use and adherence remains unverified. Existing bibliography is linked; external articles, registration, protocols, analysis plans and additional material are unread. A retained URL or identifier alone does not establish full-text acquisition, content reading or absence of material. The date 2026-09-08 in material items is the original evidence date, not a date of external reading in this work. The date 2026-10-06 is the original production date. Original review and verification dates are unrecorded; production timestamps are not presented as completed-content-review dates.
Additional material needed	Needed material; existence and public availability unverified	Unread; access not attempted	Not read	Details of baseline stones, hydration and diet, concomitant treatment, spontaneous passage and alternative explanations in the groups remain unverified. Existing bibliography is linked; external articles, registration, protocols, analysis plans and additional material are unread. A retained URL or identifier alone does not establish full-text acquisition, content reading or absence of material. The date 2026-09-08 in material items is the original evidence date, not a date of external reading in this work. The date 2026-10-06 is the original production date. Original review and verification dates are unrecorded; production timestamps are not presented as completed-content-review dates.
Additional material needed	Needed material; existence and public availability unverified	Unread; access not attempted	Not read	General cautionary wording is not converted into actual event counts, harm denominators or confirmation of causality. Existing bibliography is linked; external articles, registration, protocols, analysis plans and additional material are unread. A retained URL or identifier alone does not establish full-text acquisition, content reading or absence of material. The date 2026-09-08 in material items is the original evidence date, not a date of external reading in this work. The date 2026-10-06 is the original production date. Original review and verification dates are unrecorded; production timestamps are not presented as completed-content-review dates.
Additional material needed	Needed material; existence and public availability unverified	Unread; access not attempted	Not read	Support roles beyond the record of Mashhad University support, product provision, author roles and conflicts remain unverified. Existing bibliography is linked; external articles, registration, protocols, analysis plans and additional material are unread. A retained URL or identifier alone does not establish full-text acquisition, content reading or absence of material. The date 2026-09-08 in material items is the original evidence date, not a date of external reading in this work. The date 2026-10-06 is the original production date. Original review and verification dates are unrecorded; production timestamps are not presented as completed-content-review dates.

Report counts versus independent study counts

Only the retained connection between the trial summary and citation is maintained. Other reports or recitations of the same trial remain distinct from independent replication; no new unique-trial, participant or event totals or independent-replication count are established.

Review criteria

Version 1.0 · Criteria record date 2026-10-06. These are Chamgap's own application conditions, informed by the referenced methods. They do not constitute official assessment-tool certification or a new efficacy score.

N01 · Which black-seed preparation and stone question are selected?

Required materials and conditions: Adult kidney stones, ground-seed capsules, placebo, 10 weeks and complete ultrasound disappearance
Conditions for verification: Original records on Adult kidney stones, ground-seed capsules, placebo, 10 weeks and complete ultrasound disappearance must link to the relevant report, analysis unit, timing and denominator, distinguishing recorded information from what remains unverified.
Requirement and applicability: Required
Application exceptions: Ultrasound disappearance, actual expulsion, size reduction and dissolution mechanisms remain distinct. Randomized counts and historically reconstructed denominators or effects are not converted into confirmed paper values or harm denominators, or extended to other formulations, every stone, replacement of standard care or overall safety.
Why this condition is needed: Material on Adult kidney stones, ground-seed capsules, placebo, 10 weeks and complete ultrasound disappearance is needed to connect adult kidney stones to formulation, population, comparison, exposure, imaging, denominators, the effect of interest or harms.
Referenced methods: Existing principles distinguish the question, formulation, population, denominators, imaging disappearance, actual expulsion, size change, support and harms in the retained comparison of ground-seed capsules and placebo in adults with kidney stones.

N02 · What seed formulation is the 500 mg capsule?

Required materials and conditions: Nigella sativa L. seeds, ground-seed 500 mg capsules, composition and quality
Conditions for verification: Original records on Nigella sativa L. seeds, ground-seed 500 mg capsules, composition and quality must link to the relevant report, analysis unit, timing and denominator, distinguishing recorded information from what remains unverified.
Requirement and applicability: Required
Application exceptions: Ultrasound disappearance, actual expulsion, size reduction and dissolution mechanisms remain distinct. Randomized counts and historically reconstructed denominators or effects are not converted into confirmed paper values or harm denominators, or extended to other formulations, every stone, replacement of standard care or overall safety.
Why this condition is needed: Material on Nigella sativa L. seeds, ground-seed 500 mg capsules, composition and quality is needed to connect adult kidney stones to formulation, population, comparison, exposure, imaging, denominators, the effect of interest or harms.
Referenced methods: Existing principles distinguish the question, formulation, population, denominators, imaging disappearance, actual expulsion, size change, support and harms in the retained comparison of ground-seed capsules and placebo in adults with kidney stones.

N03 · Are seeds, fixed oil, extracts and thymoquinone the same intervention?

Required materials and conditions: Distinguish the original formulation from fixed oil, aqueous extracts, topical preparations, purified constituents and combinations
Conditions for verification: Original records on Distinguish the original formulation from fixed oil, aqueous extracts, topical preparations, purified constituents and combinations must link to the relevant report, analysis unit, timing and denominator, distinguishing recorded information from what remains unverified.
Requirement and applicability: Required
Application exceptions: Ultrasound disappearance, actual expulsion, size reduction and dissolution mechanisms remain distinct. Randomized counts and historically reconstructed denominators or effects are not converted into confirmed paper values or harm denominators, or extended to other formulations, every stone, replacement of standard care or overall safety.
Why this condition is needed: Material on Distinguish the original formulation from fixed oil, aqueous extracts, topical preparations, purified constituents and combinations is needed to connect adult kidney stones to formulation, population, comparison, exposure, imaging, denominators, the effect of interest or harms.
Referenced methods: Existing principles distinguish the question, formulation, population, denominators, imaging disappearance, actual expulsion, size change, support and harms in the retained comparison of ground-seed capsules and placebo in adults with kidney stones.

N04 · What was the actual exposure to 500 mg, 2 times daily?

Required materials and conditions: Dose per 1 administration, frequency, use records, constituent quantification and adherence
Conditions for verification: Original records on Dose per 1 administration, frequency, use records, constituent quantification and adherence must link to the relevant report, analysis unit, timing and denominator, distinguishing recorded information from what remains unverified.
Requirement and applicability: Required
Application exceptions: Ultrasound disappearance, actual expulsion, size reduction and dissolution mechanisms remain distinct. Randomized counts and historically reconstructed denominators or effects are not converted into confirmed paper values or harm denominators, or extended to other formulations, every stone, replacement of standard care or overall safety.
Why this condition is needed: Material on Dose per 1 administration, frequency, use records, constituent quantification and adherence is needed to connect adult kidney stones to formulation, population, comparison, exposure, imaging, denominators, the effect of interest or harms.
Referenced methods: Existing principles distinguish the question, formulation, population, denominators, imaging disappearance, actual expulsion, size change, support and harms in the retained comparison of ground-seed capsules and placebo in adults with kidney stones.

N05 · What was the actual schedule for 10 weeks of treatment and ultrasound follow-up?

Required materials and conditions: Treatment start/end, ultrasound visits, discontinuation and subsequent follow-up
Conditions for verification: Original records on Treatment start/end, ultrasound visits, discontinuation and subsequent follow-up must link to the relevant report, analysis unit, timing and denominator, distinguishing recorded information from what remains unverified.
Requirement and applicability: Required
Application exceptions: Ultrasound disappearance, actual expulsion, size reduction and dissolution mechanisms remain distinct. Randomized counts and historically reconstructed denominators or effects are not converted into confirmed paper values or harm denominators, or extended to other formulations, every stone, replacement of standard care or overall safety.
Why this condition is needed: Material on Treatment start/end, ultrasound visits, discontinuation and subsequent follow-up is needed to connect adult kidney stones to formulation, population, comparison, exposure, imaging, denominators, the effect of interest or harms.
Referenced methods: Existing principles distinguish the question, formulation, population, denominators, imaging disappearance, actual expulsion, size change, support and harms in the retained comparison of ground-seed capsules and placebo in adults with kidney stones.

N06 · Which adults and which kidney stones were studied?

Required materials and conditions: Adults, kidney-stone diagnosis, inclusion/exclusion and baseline conditions
Conditions for verification: Original records on Adults, kidney-stone diagnosis, inclusion/exclusion and baseline conditions must link to the relevant report, analysis unit, timing and denominator, distinguishing recorded information from what remains unverified.
Requirement and applicability: Required
Application exceptions: Ultrasound disappearance, actual expulsion, size reduction and dissolution mechanisms remain distinct. Randomized counts and historically reconstructed denominators or effects are not converted into confirmed paper values or harm denominators, or extended to other formulations, every stone, replacement of standard care or overall safety.
Why this condition is needed: Material on Adults, kidney-stone diagnosis, inclusion/exclusion and baseline conditions is needed to connect adult kidney stones to formulation, population, comparison, exposure, imaging, denominators, the effect of interest or harms.
Referenced methods: Existing principles distinguish the question, formulation, population, denominators, imaging disappearance, actual expulsion, size change, support and harms in the retained comparison of ground-seed capsules and placebo in adults with kidney stones.

N07 · What were stone size, location, composition and number?

Required materials and conditions: Baseline size/location/composition by group, single/multiple stones and likelihood of passage
Conditions for verification: Original records on Baseline size/location/composition by group, single/multiple stones and likelihood of passage must link to the relevant report, analysis unit, timing and denominator, distinguishing recorded information from what remains unverified.
Requirement and applicability: Required
Application exceptions: Ultrasound disappearance, actual expulsion, size reduction and dissolution mechanisms remain distinct. Randomized counts and historically reconstructed denominators or effects are not converted into confirmed paper values or harm denominators, or extended to other formulations, every stone, replacement of standard care or overall safety.
Why this condition is needed: Material on Baseline size/location/composition by group, single/multiple stones and likelihood of passage is needed to connect adult kidney stones to formulation, population, comparison, exposure, imaging, denominators, the effect of interest or harms.
Referenced methods: Existing principles distinguish the question, formulation, population, denominators, imaging disappearance, actual expulsion, size change, support and harms in the retained comparison of ground-seed capsules and placebo in adults with kidney stones.

N08 · What was actually compared with matched placebo?

Required materials and conditions: Placebo composition/appearance, common management and masking conditions
Conditions for verification: Original records on Placebo composition/appearance, common management and masking conditions must link to the relevant report, analysis unit, timing and denominator, distinguishing recorded information from what remains unverified.
Requirement and applicability: Required
Application exceptions: Ultrasound disappearance, actual expulsion, size reduction and dissolution mechanisms remain distinct. Randomized counts and historically reconstructed denominators or effects are not converted into confirmed paper values or harm denominators, or extended to other formulations, every stone, replacement of standard care or overall safety.
Why this condition is needed: Material on Placebo composition/appearance, common management and masking conditions is needed to connect adult kidney stones to formulation, population, comparison, exposure, imaging, denominators, the effect of interest or harms.
Referenced methods: Existing principles distinguish the question, formulation, population, denominators, imaging disappearance, actual expulsion, size change, support and harms in the retained comparison of ground-seed capsules and placebo in adults with kidney stones.

N09 · How did hydration, diet, drugs and procedures differ?

Required materials and conditions: Hydration/diet, stone medication/standard management, additional procedures and group differences
Conditions for verification: Original records on Hydration/diet, stone medication/standard management, additional procedures and group differences must link to the relevant report, analysis unit, timing and denominator, distinguishing recorded information from what remains unverified.
Requirement and applicability: Required
Application exceptions: Ultrasound disappearance, actual expulsion, size reduction and dissolution mechanisms remain distinct. Randomized counts and historically reconstructed denominators or effects are not converted into confirmed paper values or harm denominators, or extended to other formulations, every stone, replacement of standard care or overall safety.
Why this condition is needed: Material on Hydration/diet, stone medication/standard management, additional procedures and group differences is needed to connect adult kidney stones to formulation, population, comparison, exposure, imaging, denominators, the effect of interest or harms.
Referenced methods: Existing principles distinguish the question, formulation, population, denominators, imaging disappearance, actual expulsion, size change, support and harms in the retained comparison of ground-seed capsules and placebo in adults with kidney stones.

N10 · How do complete ultrasound disappearance and actual expulsion differ?

Required materials and conditions: Ultrasound disappearance, confirmation of actual expulsion, operational definitions and correspondence
Conditions for verification: Original records on Ultrasound disappearance, confirmation of actual expulsion, operational definitions and correspondence must link to the relevant report, analysis unit, timing and denominator, distinguishing recorded information from what remains unverified.
Requirement and applicability: Required
Application exceptions: Ultrasound disappearance, actual expulsion, size reduction and dissolution mechanisms remain distinct. Randomized counts and historically reconstructed denominators or effects are not converted into confirmed paper values or harm denominators, or extended to other formulations, every stone, replacement of standard care or overall safety.
Why this condition is needed: Material on Ultrasound disappearance, confirmation of actual expulsion, operational definitions and correspondence is needed to connect adult kidney stones to formulation, population, comparison, exposure, imaging, denominators, the effect of interest or harms.
Referenced methods: Existing principles distinguish the question, formulation, population, denominators, imaging disappearance, actual expulsion, size change, support and harms in the retained comparison of ground-seed capsules and placebo in adults with kidney stones.

N11 · What does dissolution in the study title establish?

Required materials and conditions: Distinguish imaging disappearance, expulsion and chemical dissolution/mechanisms
Conditions for verification: Original records on Distinguish imaging disappearance, expulsion and chemical dissolution/mechanisms must link to the relevant report, analysis unit, timing and denominator, distinguishing recorded information from what remains unverified.
Requirement and applicability: Supplementary; required if extending to dissolution mechanisms
Application exceptions: Ultrasound disappearance, actual expulsion, size reduction and dissolution mechanisms remain distinct. Randomized counts and historically reconstructed denominators or effects are not converted into confirmed paper values or harm denominators, or extended to other formulations, every stone, replacement of standard care or overall safety.
Why this condition is needed: Material on Distinguish imaging disappearance, expulsion and chemical dissolution/mechanisms is needed to connect adult kidney stones to formulation, population, comparison, exposure, imaging, denominators, the effect of interest or harms.
Referenced methods: Existing principles distinguish the question, formulation, population, denominators, imaging disappearance, actual expulsion, size change, support and harms in the retained comparison of ground-seed capsules and placebo in adults with kidney stones.

N12 · Are complete-disappearance events and size reduction the same outcome?

Required materials and conditions: Size units, measurement/timing, between-group change and separation from complete disappearance
Conditions for verification: Original records on Size units, measurement/timing, between-group change and separation from complete disappearance must link to the relevant report, analysis unit, timing and denominator, distinguishing recorded information from what remains unverified.
Requirement and applicability: Required
Application exceptions: Ultrasound disappearance, actual expulsion, size reduction and dissolution mechanisms remain distinct. Randomized counts and historically reconstructed denominators or effects are not converted into confirmed paper values or harm denominators, or extended to other formulations, every stone, replacement of standard care or overall safety.
Why this condition is needed: Material on Size units, measurement/timing, between-group change and separation from complete disappearance is needed to connect adult kidney stones to formulation, population, comparison, exposure, imaging, denominators, the effect of interest or harms.
Referenced methods: Existing principles distinguish the question, formulation, population, denominators, imaging disappearance, actual expulsion, size change, support and harms in the retained comparison of ground-seed capsules and placebo in adults with kidney stones.

N13 · Which assessment procedures determined ultrasound disappearance?

Required materials and conditions: Imaging equipment, sensitivity, assessors/masking, agreement and confirmation of disappearance
Conditions for verification: Original records on Imaging equipment, sensitivity, assessors/masking, agreement and confirmation of disappearance must link to the relevant report, analysis unit, timing and denominator, distinguishing recorded information from what remains unverified.
Requirement and applicability: Required
Application exceptions: Ultrasound disappearance, actual expulsion, size reduction and dissolution mechanisms remain distinct. Randomized counts and historically reconstructed denominators or effects are not converted into confirmed paper values or harm denominators, or extended to other formulations, every stone, replacement of standard care or overall safety.
Why this condition is needed: Material on Imaging equipment, sensitivity, assessors/masking, agreement and confirmation of disappearance is needed to connect adult kidney stones to formulation, population, comparison, exposure, imaging, denominators, the effect of interest or harms.
Referenced methods: Existing principles distinguish the question, formulation, population, denominators, imaging disappearance, actual expulsion, size change, support and harms in the retained comparison of ground-seed capsules and placebo in adults with kidney stones.

N14 · How do 60 randomized participants differ from analysis groups?

Required materials and conditions: Randomization and arm-specific allocation, analysis, completion and endpoint denominators
Conditions for verification: Original records on Randomization and arm-specific allocation, analysis, completion and endpoint denominators must link to the relevant report, analysis unit, timing and denominator, distinguishing recorded information from what remains unverified.
Requirement and applicability: Required
Application exceptions: Ultrasound disappearance, actual expulsion, size reduction and dissolution mechanisms remain distinct. Randomized counts and historically reconstructed denominators or effects are not converted into confirmed paper values or harm denominators, or extended to other formulations, every stone, replacement of standard care or overall safety.
Why this condition is needed: Material on Randomization and arm-specific allocation, analysis, completion and endpoint denominators is needed to connect adult kidney stones to formulation, population, comparison, exposure, imaging, denominators, the effect of interest or harms.
Referenced methods: Existing principles distinguish the question, formulation, population, denominators, imaging disappearance, actual expulsion, size change, support and harms in the retained comparison of ground-seed capsules and placebo in adults with kidney stones.

N15 · How were the approximately 27 and 26 analysis participants recorded?

Required materials and conditions: Reported percentages, historical reconstruction, original denominators, rounding and units
Conditions for verification: Original records on Reported percentages, historical reconstruction, original denominators, rounding and units must link to the relevant report, analysis unit, timing and denominator, distinguishing recorded information from what remains unverified.
Requirement and applicability: Required
Application exceptions: Ultrasound disappearance, actual expulsion, size reduction and dissolution mechanisms remain distinct. Randomized counts and historically reconstructed denominators or effects are not converted into confirmed paper values or harm denominators, or extended to other formulations, every stone, replacement of standard care or overall safety.
Why this condition is needed: Material on Reported percentages, historical reconstruction, original denominators, rounding and units is needed to connect adult kidney stones to formulation, population, comparison, exposure, imaging, denominators, the effect of interest or harms.
Referenced methods: Existing principles distinguish the question, formulation, population, denominators, imaging disappearance, actual expulsion, size change, support and harms in the retained comparison of ground-seed capsules and placebo in adults with kidney stones.

N16 · Are 12/27 versus 4/26 original counts or reconstructions?

Required materials and conditions: Original event counts, reconstructed counts, approximation labels, denominators and group correspondence
Conditions for verification: Original records on Original event counts, reconstructed counts, approximation labels, denominators and group correspondence must link to the relevant report, analysis unit, timing and denominator, distinguishing recorded information from what remains unverified.
Requirement and applicability: Required
Application exceptions: Ultrasound disappearance, actual expulsion, size reduction and dissolution mechanisms remain distinct. Randomized counts and historically reconstructed denominators or effects are not converted into confirmed paper values or harm denominators, or extended to other formulations, every stone, replacement of standard care or overall safety.
Why this condition is needed: Material on Original event counts, reconstructed counts, approximation labels, denominators and group correspondence is needed to connect adult kidney stones to formulation, population, comparison, exposure, imaging, denominators, the effect of interest or harms.
Referenced methods: Existing principles distinguish the question, formulation, population, denominators, imaging disappearance, actual expulsion, size change, support and harms in the retained comparison of ground-seed capsules and placebo in adults with kidney stones.

N17 · Which endpoint do the reported 44.4% versus 15.3% describe?

Required materials and conditions: Complete-disappearance percentages, group correspondence, timing, units and denominators
Conditions for verification: Original records on Complete-disappearance percentages, group correspondence, timing, units and denominators must link to the relevant report, analysis unit, timing and denominator, distinguishing recorded information from what remains unverified.
Requirement and applicability: Required
Application exceptions: Ultrasound disappearance, actual expulsion, size reduction and dissolution mechanisms remain distinct. Randomized counts and historically reconstructed denominators or effects are not converted into confirmed paper values or harm denominators, or extended to other formulations, every stone, replacement of standard care or overall safety.
Why this condition is needed: Material on Complete-disappearance percentages, group correspondence, timing, units and denominators is needed to connect adult kidney stones to formulation, population, comparison, exposure, imaging, denominators, the effect of interest or harms.
Referenced methods: Existing principles distinguish the question, formulation, population, denominators, imaging disappearance, actual expulsion, size change, support and harms in the retained comparison of ground-seed capsules and placebo in adults with kidney stones.

N18 · What are the sources of RD 29.1 percentage points, RR 2.89 and the CI?

Required materials and conditions: Original estimates versus reconstructed risk differences/RRs/CIs, effect of interest and adjustment
Conditions for verification: Original records on Original estimates versus reconstructed risk differences/RRs/CIs, effect of interest and adjustment must link to the relevant report, analysis unit, timing and denominator, distinguishing recorded information from what remains unverified.
Requirement and applicability: Required
Application exceptions: Ultrasound disappearance, actual expulsion, size reduction and dissolution mechanisms remain distinct. Randomized counts and historically reconstructed denominators or effects are not converted into confirmed paper values or harm denominators, or extended to other formulations, every stone, replacement of standard care or overall safety.
Why this condition is needed: Material on Original estimates versus reconstructed risk differences/RRs/CIs, effect of interest and adjustment is needed to connect adult kidney stones to formulation, population, comparison, exposure, imaging, denominators, the effect of interest or harms.
Referenced methods: Existing principles distinguish the question, formulation, population, denominators, imaging disappearance, actual expulsion, size change, support and harms in the retained comparison of ground-seed capsules and placebo in adults with kidney stones.

N19 · What uncertainty remains with few events and a wide interval?

Required materials and conditions: Intervals for the effect of interest, direct events/denominators and clinical importance
Conditions for verification: Original records on Intervals for the effect of interest, direct events/denominators and clinical importance must link to the relevant report, analysis unit, timing and denominator, distinguishing recorded information from what remains unverified.
Requirement and applicability: Required
Application exceptions: Ultrasound disappearance, actual expulsion, size reduction and dissolution mechanisms remain distinct. Randomized counts and historically reconstructed denominators or effects are not converted into confirmed paper values or harm denominators, or extended to other formulations, every stone, replacement of standard care or overall safety.
Why this condition is needed: Material on Intervals for the effect of interest, direct events/denominators and clinical importance is needed to connect adult kidney stones to formulation, population, comparison, exposure, imaging, denominators, the effect of interest or harms.
Referenced methods: Existing principles distinguish the question, formulation, population, denominators, imaging disappearance, actual expulsion, size change, support and harms in the retained comparison of ground-seed capsules and placebo in adults with kidney stones.

N20 · What was the 1st endpoint in the prospective trial plan?

Required materials and conditions: Registration, protocol, SAP and original endpoint/timing/analysis hierarchy
Conditions for verification: Original records on Registration, protocol, SAP and original endpoint/timing/analysis hierarchy must link to the relevant report, analysis unit, timing and denominator, distinguishing recorded information from what remains unverified.
Requirement and applicability: Required
Application exceptions: Ultrasound disappearance, actual expulsion, size reduction and dissolution mechanisms remain distinct. Randomized counts and historically reconstructed denominators or effects are not converted into confirmed paper values or harm denominators, or extended to other formulations, every stone, replacement of standard care or overall safety.
Why this condition is needed: Material on Registration, protocol, SAP and original endpoint/timing/analysis hierarchy is needed to connect adult kidney stones to formulation, population, comparison, exposure, imaging, denominators, the effect of interest or harms.
Referenced methods: Existing principles distinguish the question, formulation, population, denominators, imaging disappearance, actual expulsion, size change, support and harms in the retained comparison of ground-seed capsules and placebo in adults with kidney stones.

N21 · How were sequence generation, concealment and baseline balance handled?

Required materials and conditions: Random sequence/concealment, allocation and baseline stone/participant balance
Conditions for verification: Original records on Random sequence/concealment, allocation and baseline stone/participant balance must link to the relevant report, analysis unit, timing and denominator, distinguishing recorded information from what remains unverified.
Requirement and applicability: Required
Application exceptions: Ultrasound disappearance, actual expulsion, size reduction and dissolution mechanisms remain distinct. Randomized counts and historically reconstructed denominators or effects are not converted into confirmed paper values or harm denominators, or extended to other formulations, every stone, replacement of standard care or overall safety.
Why this condition is needed: Material on Random sequence/concealment, allocation and baseline stone/participant balance is needed to connect adult kidney stones to formulation, population, comparison, exposure, imaging, denominators, the effect of interest or harms.
Referenced methods: Existing principles distinguish the question, formulation, population, denominators, imaging disappearance, actual expulsion, size change, support and harms in the retained comparison of ground-seed capsules and placebo in adults with kidney stones.

N22 · Which roles remained masked?

Required materials and conditions: Participants, personnel and assessors, product distinguishability and maintenance of masking
Conditions for verification: Original records on Participants, personnel and assessors, product distinguishability and maintenance of masking must link to the relevant report, analysis unit, timing and denominator, distinguishing recorded information from what remains unverified.
Requirement and applicability: Required
Application exceptions: Ultrasound disappearance, actual expulsion, size reduction and dissolution mechanisms remain distinct. Randomized counts and historically reconstructed denominators or effects are not converted into confirmed paper values or harm denominators, or extended to other formulations, every stone, replacement of standard care or overall safety.
Why this condition is needed: Material on Participants, personnel and assessors, product distinguishability and maintenance of masking is needed to connect adult kidney stones to formulation, population, comparison, exposure, imaging, denominators, the effect of interest or harms.
Referenced methods: Existing principles distinguish the question, formulation, population, denominators, imaging disappearance, actual expulsion, size change, support and harms in the retained comparison of ground-seed capsules and placebo in adults with kidney stones.

N23 · How were actual use, discontinuation and additional treatment handled?

Required materials and conditions: Use diaries, nonadherence/discontinuation, additional treatment and the effect targeted in analysis
Conditions for verification: Original records on Use diaries, nonadherence/discontinuation, additional treatment and the effect targeted in analysis must link to the relevant report, analysis unit, timing and denominator, distinguishing recorded information from what remains unverified.
Requirement and applicability: Required
Application exceptions: Ultrasound disappearance, actual expulsion, size reduction and dissolution mechanisms remain distinct. Randomized counts and historically reconstructed denominators or effects are not converted into confirmed paper values or harm denominators, or extended to other formulations, every stone, replacement of standard care or overall safety.
Why this condition is needed: Material on Use diaries, nonadherence/discontinuation, additional treatment and the effect targeted in analysis is needed to connect adult kidney stones to formulation, population, comparison, exposure, imaging, denominators, the effect of interest or harms.
Referenced methods: Existing principles distinguish the question, formulation, population, denominators, imaging disappearance, actual expulsion, size change, support and harms in the retained comparison of ground-seed capsules and placebo in adults with kidney stones.

N24 · Who among the 60 randomized participants was omitted from analysis?

Required materials and conditions: Group-specific flow, withdrawal/missingness, ITT/PP, original denominators and handling
Conditions for verification: Original records on Group-specific flow, withdrawal/missingness, ITT/PP, original denominators and handling must link to the relevant report, analysis unit, timing and denominator, distinguishing recorded information from what remains unverified.
Requirement and applicability: Required
Application exceptions: Ultrasound disappearance, actual expulsion, size reduction and dissolution mechanisms remain distinct. Randomized counts and historically reconstructed denominators or effects are not converted into confirmed paper values or harm denominators, or extended to other formulations, every stone, replacement of standard care or overall safety.
Why this condition is needed: Material on Group-specific flow, withdrawal/missingness, ITT/PP, original denominators and handling is needed to connect adult kidney stones to formulation, population, comparison, exposure, imaging, denominators, the effect of interest or harms.
Referenced methods: Existing principles distinguish the question, formulation, population, denominators, imaging disappearance, actual expulsion, size change, support and harms in the retained comparison of ground-seed capsules and placebo in adults with kidney stones.

N25 · When and for whom was complete disappearance assessed?

Required materials and conditions: Clearance-assessment timing, interim/end visits, cumulative/single-visit events and denominators
Conditions for verification: Original records on Clearance-assessment timing, interim/end visits, cumulative/single-visit events and denominators must link to the relevant report, analysis unit, timing and denominator, distinguishing recorded information from what remains unverified.
Requirement and applicability: Required
Application exceptions: Ultrasound disappearance, actual expulsion, size reduction and dissolution mechanisms remain distinct. Randomized counts and historically reconstructed denominators or effects are not converted into confirmed paper values or harm denominators, or extended to other formulations, every stone, replacement of standard care or overall safety.
Why this condition is needed: Material on Clearance-assessment timing, interim/end visits, cumulative/single-visit events and denominators is needed to connect adult kidney stones to formulation, population, comparison, exposure, imaging, denominators, the effect of interest or harms.
Referenced methods: Existing principles distinguish the question, formulation, population, denominators, imaging disappearance, actual expulsion, size change, support and harms in the retained comparison of ground-seed capsules and placebo in adults with kidney stones.

N26 · How were event units for people and stones defined?

Required materials and conditions: People/stones, multiple stones, complete-clearance criteria and group denominators
Conditions for verification: Original records on People/stones, multiple stones, complete-clearance criteria and group denominators must link to the relevant report, analysis unit, timing and denominator, distinguishing recorded information from what remains unverified.
Requirement and applicability: Required
Application exceptions: Ultrasound disappearance, actual expulsion, size reduction and dissolution mechanisms remain distinct. Randomized counts and historically reconstructed denominators or effects are not converted into confirmed paper values or harm denominators, or extended to other formulations, every stone, replacement of standard care or overall safety.
Why this condition is needed: Material on People/stones, multiple stones, complete-clearance criteria and group denominators is needed to connect adult kidney stones to formulation, population, comparison, exposure, imaging, denominators, the effect of interest or harms.
Referenced methods: Existing principles distinguish the question, formulation, population, denominators, imaging disappearance, actual expulsion, size change, support and harms in the retained comparison of ground-seed capsules and placebo in adults with kidney stones.

N27 · How were spontaneous passage and intervention effects distinguished?

Required materials and conditions: Hydration/location/size, spontaneous passage, comparison conditions and assessment/timing
Conditions for verification: Original records on Hydration/location/size, spontaneous passage, comparison conditions and assessment/timing must link to the relevant report, analysis unit, timing and denominator, distinguishing recorded information from what remains unverified.
Requirement and applicability: Required
Application exceptions: Ultrasound disappearance, actual expulsion, size reduction and dissolution mechanisms remain distinct. Randomized counts and historically reconstructed denominators or effects are not converted into confirmed paper values or harm denominators, or extended to other formulations, every stone, replacement of standard care or overall safety.
Why this condition is needed: Material on Hydration/location/size, spontaneous passage, comparison conditions and assessment/timing is needed to connect adult kidney stones to formulation, population, comparison, exposure, imaging, denominators, the effect of interest or harms.
Referenced methods: Existing principles distinguish the question, formulation, population, denominators, imaging disappearance, actual expulsion, size change, support and harms in the retained comparison of ground-seed capsules and placebo in adults with kidney stones.

N28 · How were analyses of clearance, size and expulsion specified in advance?

Required materials and conditions: Planned endpoints, analyses/timing, multiple comparisons and reporting changes
Conditions for verification: Original records on Planned endpoints, analyses/timing, multiple comparisons and reporting changes must link to the relevant report, analysis unit, timing and denominator, distinguishing recorded information from what remains unverified.
Requirement and applicability: Required
Application exceptions: Ultrasound disappearance, actual expulsion, size reduction and dissolution mechanisms remain distinct. Randomized counts and historically reconstructed denominators or effects are not converted into confirmed paper values or harm denominators, or extended to other formulations, every stone, replacement of standard care or overall safety.
Why this condition is needed: Material on Planned endpoints, analyses/timing, multiple comparisons and reporting changes is needed to connect adult kidney stones to formulation, population, comparison, exposure, imaging, denominators, the effect of interest or harms.
Referenced methods: Existing principles distinguish the question, formulation, population, denominators, imaging disappearance, actual expulsion, size change, support and harms in the retained comparison of ground-seed capsules and placebo in adults with kidney stones.

N29 · Does a clearance signal establish replacement of standard care or effects on symptoms/kidney function?

Required materials and conditions: Standard treatment/procedures, pain/infection/obstruction, kidney function and patient-important outcomes
Conditions for verification: Original records on Standard treatment/procedures, pain/infection/obstruction, kidney function and patient-important outcomes must link to the relevant report, analysis unit, timing and denominator, distinguishing recorded information from what remains unverified.
Requirement and applicability: Supplementary; required if extending to treatment replacement or additional effects
Application exceptions: Ultrasound disappearance, actual expulsion, size reduction and dissolution mechanisms remain distinct. Randomized counts and historically reconstructed denominators or effects are not converted into confirmed paper values or harm denominators, or extended to other formulations, every stone, replacement of standard care or overall safety.
Why this condition is needed: Material on Standard treatment/procedures, pain/infection/obstruction, kidney function and patient-important outcomes is needed to connect adult kidney stones to formulation, population, comparison, exposure, imaging, denominators, the effect of interest or harms.
Referenced methods: Existing principles distinguish the question, formulation, population, denominators, imaging disappearance, actual expulsion, size change, support and harms in the retained comparison of ground-seed capsules and placebo in adults with kidney stones.

N30 · Which original report do the current summary and citation identify?

Required materials and conditions: Evidence/citation, PMID/DOI and study-report families
Conditions for verification: Original records on Evidence/citation, PMID/DOI and study-report families must link to the relevant report, analysis unit, timing and denominator, distinguishing recorded information from what remains unverified.
Requirement and applicability: Required
Application exceptions: Ultrasound disappearance, actual expulsion, size reduction and dissolution mechanisms remain distinct. Randomized counts and historically reconstructed denominators or effects are not converted into confirmed paper values or harm denominators, or extended to other formulations, every stone, replacement of standard care or overall safety.
Why this condition is needed: Material on Evidence/citation, PMID/DOI and study-report families is needed to connect adult kidney stones to formulation, population, comparison, exposure, imaging, denominators, the effect of interest or harms.
Referenced methods: Existing principles distinguish the question, formulation, population, denominators, imaging disappearance, actual expulsion, size change, support and harms in the retained comparison of ground-seed capsules and placebo in adults with kidney stones.

N31 · Has the small-sample signal been repeated in other independent material?

Required materials and conditions: Teams/trial families, the same formulation/conditions and independent replication
Conditions for verification: Original records on Teams/trial families, the same formulation/conditions and independent replication must link to the relevant report, analysis unit, timing and denominator, distinguishing recorded information from what remains unverified.
Requirement and applicability: Required
Application exceptions: Ultrasound disappearance, actual expulsion, size reduction and dissolution mechanisms remain distinct. Randomized counts and historically reconstructed denominators or effects are not converted into confirmed paper values or harm denominators, or extended to other formulations, every stone, replacement of standard care or overall safety.
Why this condition is needed: Material on Teams/trial families, the same formulation/conditions and independent replication is needed to connect adult kidney stones to formulation, population, comparison, exposure, imaging, denominators, the effect of interest or harms.
Referenced methods: Existing principles distinguish the question, formulation, population, denominators, imaging disappearance, actual expulsion, size change, support and harms in the retained comparison of ground-seed capsules and placebo in adults with kidney stones.

N32 · What was the actual role of Mashhad University support?

Required materials and conditions: Funding/product support, affiliations, COI and support roles
Conditions for verification: Original records on Funding/product support, affiliations, COI and support roles must link to the relevant report, analysis unit, timing and denominator, distinguishing recorded information from what remains unverified.
Requirement and applicability: Required
Application exceptions: Ultrasound disappearance, actual expulsion, size reduction and dissolution mechanisms remain distinct. Randomized counts and historically reconstructed denominators or effects are not converted into confirmed paper values or harm denominators, or extended to other formulations, every stone, replacement of standard care or overall safety.
Why this condition is needed: Material on Funding/product support, affiliations, COI and support roles is needed to connect adult kidney stones to formulation, population, comparison, exposure, imaging, denominators, the effect of interest or harms.
Referenced methods: Existing principles distinguish the question, formulation, population, denominators, imaging disappearance, actual expulsion, size change, support and harms in the retained comparison of ground-seed capsules and placebo in adults with kidney stones.

N33 · Were the PubMed link, original article and registration read?

Required materials and conditions: Stored JSON, external abstracts/full text, registration/plans and acquisition/reading
Conditions for verification: Original records on Stored JSON, external abstracts/full text, registration/plans and acquisition/reading must link to the relevant report, analysis unit, timing and denominator, distinguishing recorded information from what remains unverified.
Requirement and applicability: Required
Application exceptions: Ultrasound disappearance, actual expulsion, size reduction and dissolution mechanisms remain distinct. Randomized counts and historically reconstructed denominators or effects are not converted into confirmed paper values or harm denominators, or extended to other formulations, every stone, replacement of standard care or overall safety.
Why this condition is needed: Material on Stored JSON, external abstracts/full text, registration/plans and acquisition/reading is needed to connect adult kidney stones to formulation, population, comparison, exposure, imaging, denominators, the effect of interest or harms.
Referenced methods: Existing principles distinguish the question, formulation, population, denominators, imaging disappearance, actual expulsion, size change, support and harms in the retained comparison of ground-seed capsules and placebo in adults with kidney stones.

N34 · What dates are 2026-09-08 and the correction date?

Required materials and conditions: Roles of the original evidence date, correction/bibliography and current preparation date
Conditions for verification: Original records on Roles of the original evidence date, correction/bibliography and current preparation date must link to the relevant report, analysis unit, timing and denominator, distinguishing recorded information from what remains unverified.
Requirement and applicability: Required
Application exceptions: Ultrasound disappearance, actual expulsion, size reduction and dissolution mechanisms remain distinct. Randomized counts and historically reconstructed denominators or effects are not converted into confirmed paper values or harm denominators, or extended to other formulations, every stone, replacement of standard care or overall safety.
Why this condition is needed: Material on Roles of the original evidence date, correction/bibliography and current preparation date is needed to connect adult kidney stones to formulation, population, comparison, exposure, imaging, denominators, the effect of interest or harms.
Referenced methods: Existing principles distinguish the question, formulation, population, denominators, imaging disappearance, actual expulsion, size change, support and harms in the retained comparison of ground-seed capsules and placebo in adults with kidney stones.

N35 · Are generic English wording and the 1-field correction retained?

Required materials and conditions: Korean/English numbers, generic explanations and before/after correction events
Conditions for verification: Original records on Korean/English numbers, generic explanations and before/after correction events must link to the relevant report, analysis unit, timing and denominator, distinguishing recorded information from what remains unverified.
Requirement and applicability: Required
Application exceptions: Ultrasound disappearance, actual expulsion, size reduction and dissolution mechanisms remain distinct. Randomized counts and historically reconstructed denominators or effects are not converted into confirmed paper values or harm denominators, or extended to other formulations, every stone, replacement of standard care or overall safety.
Why this condition is needed: Material on Korean/English numbers, generic explanations and before/after correction events is needed to connect adult kidney stones to formulation, population, comparison, exposure, imaging, denominators, the effect of interest or harms.
Referenced methods: Existing principles distinguish the question, formulation, population, denominators, imaging disappearance, actual expulsion, size change, support and harms in the retained comparison of ground-seed capsules and placebo in adults with kidney stones.

N36 · What roles do C56 and historical Codex reconstruction/cross-checks have here?

Required materials and conditions: Separate grade, score, caution label, axes, verdict decisions, historical calculation and current preparation
Conditions for verification: Original records on Separate grade, score, caution label, axes, verdict decisions, historical calculation and current preparation must link to the relevant report, analysis unit, timing and denominator, distinguishing recorded information from what remains unverified.
Requirement and applicability: Required
Application exceptions: Ultrasound disappearance, actual expulsion, size reduction and dissolution mechanisms remain distinct. Randomized counts and historically reconstructed denominators or effects are not converted into confirmed paper values or harm denominators, or extended to other formulations, every stone, replacement of standard care or overall safety.
Why this condition is needed: Material on Separate grade, score, caution label, axes, verdict decisions, historical calculation and current preparation is needed to connect adult kidney stones to formulation, population, comparison, exposure, imaging, denominators, the effect of interest or harms.
Referenced methods: Existing principles distinguish the question, formulation, population, denominators, imaging disappearance, actual expulsion, size change, support and harms in the retained comparison of ground-seed capsules and placebo in adults with kidney stones.

N37 · From which denominators were actual adverse events for this formulation collected?

Required materials and conditions: Event definitions/collection, group event/person counts, harm denominators and discontinuation/missingness
Conditions for verification: Original records on Event definitions/collection, group event/person counts, harm denominators and discontinuation/missingness must link to the relevant report, analysis unit, timing and denominator, distinguishing recorded information from what remains unverified.
Requirement and applicability: Required
Application exceptions: Ultrasound disappearance, actual expulsion, size reduction and dissolution mechanisms remain distinct. Randomized counts and historically reconstructed denominators or effects are not converted into confirmed paper values or harm denominators, or extended to other formulations, every stone, replacement of standard care or overall safety.
Why this condition is needed: Material on Event definitions/collection, group event/person counts, harm denominators and discontinuation/missingness is needed to connect adult kidney stones to formulation, population, comparison, exposure, imaging, denominators, the effect of interest or harms.
Referenced methods: Existing principles distinguish the question, formulation, population, denominators, imaging disappearance, actual expulsion, size change, support and harms in the retained comparison of ground-seed capsules and placebo in adults with kidney stones.

N38 · What are the onset/recovery and concomitant-condition/treatment limits for harms?

Required materials and conditions: Event timing, discontinuation/re-exposure, baseline conditions/concomitant drugs and alternative causes
Conditions for verification: Original records on Event timing, discontinuation/re-exposure, baseline conditions/concomitant drugs and alternative causes must link to the relevant report, analysis unit, timing and denominator, distinguishing recorded information from what remains unverified.
Requirement and applicability: Required
Application exceptions: Ultrasound disappearance, actual expulsion, size reduction and dissolution mechanisms remain distinct. Randomized counts and historically reconstructed denominators or effects are not converted into confirmed paper values or harm denominators, or extended to other formulations, every stone, replacement of standard care or overall safety.
Why this condition is needed: Material on Event timing, discontinuation/re-exposure, baseline conditions/concomitant drugs and alternative causes is needed to connect adult kidney stones to formulation, population, comparison, exposure, imaging, denominators, the effect of interest or harms.
Referenced methods: Existing principles distinguish the question, formulation, population, denominators, imaging disappearance, actual expulsion, size change, support and harms in the retained comparison of ground-seed capsules and placebo in adults with kidney stones.

N39 · Are drugs mentioned in cautions actual interaction events?

Required materials and conditions: Glucose-lowering, blood-pressure, anticoagulant, antiseizure and immunomodulatory drugs, exposures/events and alternatives
Conditions for verification: Original records on Glucose-lowering, blood-pressure, anticoagulant, antiseizure and immunomodulatory drugs, exposures/events and alternatives must link to the relevant report, analysis unit, timing and denominator, distinguishing recorded information from what remains unverified.
Requirement and applicability: Supplementary; required for concomitant-use harms
Application exceptions: Ultrasound disappearance, actual expulsion, size reduction and dissolution mechanisms remain distinct. Randomized counts and historically reconstructed denominators or effects are not converted into confirmed paper values or harm denominators, or extended to other formulations, every stone, replacement of standard care or overall safety.
Why this condition is needed: Material on Glucose-lowering, blood-pressure, anticoagulant, antiseizure and immunomodulatory drugs, exposures/events and alternatives is needed to connect adult kidney stones to formulation, population, comparison, exposure, imaging, denominators, the effect of interest or harms.
Referenced methods: Existing principles distinguish the question, formulation, population, denominators, imaging disappearance, actual expulsion, size change, support and harms in the retained comparison of ground-seed capsules and placebo in adults with kidney stones.

N40 · What remains unknown about rare/long-term safety and vulnerable groups?

Required materials and conditions: Duration/formulation, pregnancy/breastfeeding, children, liver/kidney disease, perioperative use and rare harms
Conditions for verification: Original records on Duration/formulation, pregnancy/breastfeeding, children, liver/kidney disease, perioperative use and rare harms must link to the relevant report, analysis unit, timing and denominator, distinguishing recorded information from what remains unverified.
Requirement and applicability: Supplementary; required for long-term or vulnerable-population safety
Application exceptions: Ultrasound disappearance, actual expulsion, size reduction and dissolution mechanisms remain distinct. Randomized counts and historically reconstructed denominators or effects are not converted into confirmed paper values or harm denominators, or extended to other formulations, every stone, replacement of standard care or overall safety.
Why this condition is needed: Material on Duration/formulation, pregnancy/breastfeeding, children, liver/kidney disease, perioperative use and rare harms is needed to connect adult kidney stones to formulation, population, comparison, exposure, imaging, denominators, the effect of interest or harms.
Referenced methods: Existing principles distinguish the question, formulation, population, denominators, imaging disappearance, actual expulsion, size change, support and harms in the retained comparison of ground-seed capsules and placebo in adults with kidney stones.

N41 · Is the same formulation/event recorded in independent material?

Required materials and conditions: Unique harm cases, report families and matching formulation/exposure/event
Conditions for verification: Original records on Unique harm cases, report families and matching formulation/exposure/event must link to the relevant report, analysis unit, timing and denominator, distinguishing recorded information from what remains unverified.
Requirement and applicability: Supplementary; required for repeated-harm claims
Application exceptions: Ultrasound disappearance, actual expulsion, size reduction and dissolution mechanisms remain distinct. Randomized counts and historically reconstructed denominators or effects are not converted into confirmed paper values or harm denominators, or extended to other formulations, every stone, replacement of standard care or overall safety.
Why this condition is needed: Material on Unique harm cases, report families and matching formulation/exposure/event is needed to connect adult kidney stones to formulation, population, comparison, exposure, imaging, denominators, the effect of interest or harms.
Referenced methods: Existing principles distinguish the question, formulation, population, denominators, imaging disappearance, actual expulsion, size change, support and harms in the retained comparison of ground-seed capsules and placebo in adults with kidney stones.

N42 · How are unread material and subsequent changes connected?

Required materials and conditions: Stored summary, external articles/registration/denominators/imaging, complete pre-change originals and condition/evidence events
Conditions for verification: Original records on Stored summary, external articles/registration/denominators/imaging, complete pre-change originals and condition/evidence events must link to the relevant report, analysis unit, timing and denominator, distinguishing recorded information from what remains unverified.
Requirement and applicability: Required
Application exceptions: Ultrasound disappearance, actual expulsion, size reduction and dissolution mechanisms remain distinct. Randomized counts and historically reconstructed denominators or effects are not converted into confirmed paper values or harm denominators, or extended to other formulations, every stone, replacement of standard care or overall safety.
Why this condition is needed: Material on Stored summary, external articles/registration/denominators/imaging, complete pre-change originals and condition/evidence events is needed to connect adult kidney stones to formulation, population, comparison, exposure, imaging, denominators, the effect of interest or harms.
Referenced methods: Existing principles distinguish the question, formulation, population, denominators, imaging disappearance, actual expulsion, size change, support and harms in the retained comparison of ground-seed capsules and placebo in adults with kidney stones.

Referenced methods and the sections actually reviewed

M03 · Cochrane Handbook 6.5 (2024), chapter updated 2023-08

Official methodology · §3.1, §3.2.1–3.2.3, MECIR C5/C7/C13

Referenced principle: Clearly record the question, eligibility conditions and reasons for changes, and distinguish variations in interventions.
Extent of review: Existing methodological links were reused for production. External originals were not reread and methodological content was not reassessed.

M04 · Cochrane Handbook 6.5.1 (2025), chapter updated 2025-03

Official methodology · §4.5, §4.6.1–4.6.3, MECIR C42

Referenced principle: Distinguish studies from reports and link them; do not omit a study solely because results are unreported.
Extent of review: Existing methodological links were reused for production. External originals were not reread and methodological content was not reassessed.

M08 · Cochrane Handbook 6.5 (2024), chapter updated 2019-10

Official methodology · §8.1–8.2.3, Table 8.2.a

Referenced principle: Define the outcome and effect of interest, then examine randomization, deviations, missing data, measurement and selective reporting.
Extent of review: Existing methodological links were reused for production. External originals were not reread and methodological content was not reassessed.

M15 · Cochrane Handbook 6.5 (2024), chapter updated 2023-08

Official methodology · §15.2.4, §15.3.1–15.3.3

Referenced principle: Distinguish effect estimates, intervals, importance and applicability. Sample size alone does not determine precision.
Extent of review: Existing methodological links were reused for production. External originals were not reread and methodological content was not reassessed.

M19 · Cochrane Handbook 6.5 (2024), chapter updated 2019-10

Official methodology · §19.1.2, §19.2.1–19.2.4

Referenced principle: Harm questions may require different designs, populations and follow-up from efficacy questions. Case reports do not establish incidence rates.
Extent of review: Existing methodological links were reused for production. External originals were not reread and methodological content was not reassessed.

What the statuses mean

Partly verified: Partial information from the stored summary is linked; detailed originals and content review remain incomplete.
Unverified: Required details cannot be established within the preserved scope. This does not establish absence of effects or studies, or safety.
Review incomplete: Review of existing content remains incomplete.
Met: This state is used only within the relevant conditions after material verification and content review. It was not automatically assigned in this work.
Not reported: Unreported within material actually read. Unread external material is not relabeled as unreported.
Inaccessible: This means actual access failure. External access was not attempted in this work, so this state was not assigned.
Not applicable: Used only with an application exception and reason based on the question scope.
Conflicting data: This requires actual comparison of materials; no new conflict judgment was made in this work.
Insufficient evidence for the conditions: This indicates gaps in additional material for the selected conditions. Unread material as a whole is not converted into an efficacy grade.

Change history

2026-10-24 · Public page/material version 1.0

The public view and materials were prepared from the existing 42 items. No new clinical search, verification-state change or scoring was performed.

The stored-material review date (Not recorded) and original evidence cut-off (2026-09-08) were retained unchanged.

Researcher downloads

These materials provide the same evidence, scope and verification status as this page.

View all item details

N01 · Which black-seed preparation and stone question are selected?

Current findings: The original effect description concerns increased complete clearance or expulsion of adult kidney stones; the selected endpoint is complete disappearance on ultrasound.
Verification status: Partly verified
Materials actually read: The retained Korean and English summaries and bibliography were read. External articles, registration, plans and additional material remain unread, with no access attempt.
Why unverified: Information retained in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.
Reason for missing information: Definitions and correspondence of disappearance and expulsion, and the separate question boundary, still require existing-content review. No separate additional claims are recorded.
Required materials and conditions: Adult kidney stones, ground-seed capsules, placebo, 10 weeks and complete ultrasound disappearance
Materials to obtain first: Original trial question, endpoint definitions and eligibility criteria
Further research: Material needed: Original trial question, endpoint definitions and eligibility criteria This records needed materials; no new research was executed.
Remaining uncertainty: Gaps remain in original denominators, allocation and masking, imaging assessment, the correspondence of disappearance and expulsion, conditions for spontaneous passage, missing data, prospective analyses, support roles and harms. Historical reconstructions are not presented as new calculations or adjusted estimates from the paper.
Conditions for verification: Original records on Adult kidney stones, ground-seed capsules, placebo, 10 weeks and complete ultrasound disappearance must link to the relevant report, analysis unit, timing and denominator, distinguishing recorded information from what remains unverified.
Why this condition is needed: Material on Adult kidney stones, ground-seed capsules, placebo, 10 weeks and complete ultrasound disappearance is needed to connect adult kidney stones to formulation, population, comparison, exposure, imaging, denominators, the effect of interest or harms.
Application exceptions: Ultrasound disappearance, actual expulsion, size reduction and dissolution mechanisms remain distinct. Randomized counts and historically reconstructed denominators or effects are not converted into confirmed paper values or harm denominators, or extended to other formulations, every stone, replacement of standard care or overall safety.
Referenced methods: Existing principles distinguish the question, formulation, population, denominators, imaging disappearance, actual expulsion, size change, support and harms in the retained comparison of ground-seed capsules and placebo in adults with kidney stones.

Related sources R01

N02 · What seed formulation is the 500 mg capsule?

Current findings: The retained intervention description specifies Nigella sativa L. seeds and ground-seed 500 mg capsules.
Verification status: Partly verified
Materials actually read: The retained Korean and English summaries and bibliography were read. External articles, registration, plans and additional material remain unread, with no access attempt.
Why unverified: Information retained in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.
Reason for missing information: Cultivar and raw-material confirmation, manufacture and excipients, constituent quantification and batch quality remain unverified.
Required materials and conditions: Nigella sativa L. seeds, ground-seed 500 mg capsules, composition and quality
Materials to obtain first: Product composition, raw-material/batch analyses, manufacture and quality material
Further research: Material needed: Product composition, raw-material/batch analyses, manufacture and quality material This records needed materials; no new research was executed.
Remaining uncertainty: Gaps remain in original denominators, allocation and masking, imaging assessment, the correspondence of disappearance and expulsion, conditions for spontaneous passage, missing data, prospective analyses, support roles and harms. Historical reconstructions are not presented as new calculations or adjusted estimates from the paper.
Conditions for verification: Original records on Nigella sativa L. seeds, ground-seed 500 mg capsules, composition and quality must link to the relevant report, analysis unit, timing and denominator, distinguishing recorded information from what remains unverified.
Why this condition is needed: Material on Nigella sativa L. seeds, ground-seed 500 mg capsules, composition and quality is needed to connect adult kidney stones to formulation, population, comparison, exposure, imaging, denominators, the effect of interest or harms.
Application exceptions: Ultrasound disappearance, actual expulsion, size reduction and dissolution mechanisms remain distinct. Randomized counts and historically reconstructed denominators or effects are not converted into confirmed paper values or harm denominators, or extended to other formulations, every stone, replacement of standard care or overall safety.
Referenced methods: Existing principles distinguish the question, formulation, population, denominators, imaging disappearance, actual expulsion, size change, support and harms in the retained comparison of ground-seed capsules and placebo in adults with kidney stones.

Related sources R01

N03 · Are seeds, fixed oil, extracts and thymoquinone the same intervention?

Current findings: The original product description states that seed powder, fixed oil, aqueous extracts, ethanolic topical preparations, purified thymoquinone and combinations are not interchangeable.
Verification status: Partly verified
Materials actually read: The retained Korean and English summaries and bibliography were read. External articles, registration, plans and additional material remain unread, with no access attempt.
Why unverified: Information retained in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.
Reason for missing information: Direct stone-clearance effects and constituent equivalence for other formulations or products remain unverified.
Required materials and conditions: Distinguish the original formulation from fixed oil, aqueous extracts, topical preparations, purified constituents and combinations
Materials to obtain first: Formulation-specific composition and original trials directly addressing the same question
Further research: Material needed: Formulation-specific composition and original trials directly addressing the same question This records needed materials; no new research was executed.
Remaining uncertainty: Gaps remain in original denominators, allocation and masking, imaging assessment, the correspondence of disappearance and expulsion, conditions for spontaneous passage, missing data, prospective analyses, support roles and harms. Historical reconstructions are not presented as new calculations or adjusted estimates from the paper.
Conditions for verification: Original records on Distinguish the original formulation from fixed oil, aqueous extracts, topical preparations, purified constituents and combinations must link to the relevant report, analysis unit, timing and denominator, distinguishing recorded information from what remains unverified.
Why this condition is needed: Material on Distinguish the original formulation from fixed oil, aqueous extracts, topical preparations, purified constituents and combinations is needed to connect adult kidney stones to formulation, population, comparison, exposure, imaging, denominators, the effect of interest or harms.
Application exceptions: Ultrasound disappearance, actual expulsion, size reduction and dissolution mechanisms remain distinct. Randomized counts and historically reconstructed denominators or effects are not converted into confirmed paper values or harm denominators, or extended to other formulations, every stone, replacement of standard care or overall safety.
Referenced methods: Existing principles distinguish the question, formulation, population, denominators, imaging disappearance, actual expulsion, size change, support and harms in the retained comparison of ground-seed capsules and placebo in adults with kidney stones.

Related sources R01

N04 · What was the actual exposure to 500 mg, 2 times daily?

Current findings: The original dose is 500 mg, 2 times daily.
Verification status: Partly verified
Materials actually read: The retained Korean and English summaries and bibliography were read. External articles, registration, plans and additional material remain unread, with no access attempt.
Why unverified: Information retained in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.
Reason for missing information: Constituent content, actual use, adherence, timing, missed doses and excess use remain unverified.
Required materials and conditions: Dose per 1 administration, frequency, use records, constituent quantification and adherence
Materials to obtain first: Administration procedures, product content and use diaries
Further research: Material needed: Administration procedures, product content and use diaries This records needed materials; no new research was executed.
Remaining uncertainty: Gaps remain in original denominators, allocation and masking, imaging assessment, the correspondence of disappearance and expulsion, conditions for spontaneous passage, missing data, prospective analyses, support roles and harms. Historical reconstructions are not presented as new calculations or adjusted estimates from the paper.
Conditions for verification: Original records on Dose per 1 administration, frequency, use records, constituent quantification and adherence must link to the relevant report, analysis unit, timing and denominator, distinguishing recorded information from what remains unverified.
Why this condition is needed: Material on Dose per 1 administration, frequency, use records, constituent quantification and adherence is needed to connect adult kidney stones to formulation, population, comparison, exposure, imaging, denominators, the effect of interest or harms.
Application exceptions: Ultrasound disappearance, actual expulsion, size reduction and dissolution mechanisms remain distinct. Randomized counts and historically reconstructed denominators or effects are not converted into confirmed paper values or harm denominators, or extended to other formulations, every stone, replacement of standard care or overall safety.
Referenced methods: Existing principles distinguish the question, formulation, population, denominators, imaging disappearance, actual expulsion, size change, support and harms in the retained comparison of ground-seed capsules and placebo in adults with kidney stones.

Related sources R01

N05 · What was the actual schedule for 10 weeks of treatment and ultrasound follow-up?

Current findings: The retained duration is 10 weeks of treatment and ultrasound follow-up.
Verification status: Partly verified
Materials actually read: The retained Korean and English summaries and bibliography were read. External articles, registration, plans and additional material remain unread, with no access attempt.
Why unverified: Information retained in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.
Reason for missing information: Interim visits, event dates, follow-up after discontinuation and recurrence beyond 10 weeks remain unverified.
Required materials and conditions: Treatment start/end, ultrasound visits, discontinuation and subsequent follow-up
Materials to obtain first: Treatment/ultrasound visit schedules and discontinuation/follow-up material
Further research: Material needed: Treatment/ultrasound visit schedules and discontinuation/follow-up material This records needed materials; no new research was executed.
Remaining uncertainty: Gaps remain in original denominators, allocation and masking, imaging assessment, the correspondence of disappearance and expulsion, conditions for spontaneous passage, missing data, prospective analyses, support roles and harms. Historical reconstructions are not presented as new calculations or adjusted estimates from the paper.
Conditions for verification: Original records on Treatment start/end, ultrasound visits, discontinuation and subsequent follow-up must link to the relevant report, analysis unit, timing and denominator, distinguishing recorded information from what remains unverified.
Why this condition is needed: Material on Treatment start/end, ultrasound visits, discontinuation and subsequent follow-up is needed to connect adult kidney stones to formulation, population, comparison, exposure, imaging, denominators, the effect of interest or harms.
Application exceptions: Ultrasound disappearance, actual expulsion, size reduction and dissolution mechanisms remain distinct. Randomized counts and historically reconstructed denominators or effects are not converted into confirmed paper values or harm denominators, or extended to other formulations, every stone, replacement of standard care or overall safety.
Referenced methods: Existing principles distinguish the question, formulation, population, denominators, imaging disappearance, actual expulsion, size change, support and harms in the retained comparison of ground-seed capsules and placebo in adults with kidney stones.

Related sources R01

N06 · Which adults and which kidney stones were studied?

Current findings: The retained population is limited to adults with kidney stones.
Verification status: Partly verified
Materials actually read: The retained Korean and English summaries and bibliography were read. External articles, registration, plans and additional material remain unread, with no access attempt.
Why unverified: Information retained in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.
Reason for missing information: Age range, diagnostic and eligibility criteria, kidney function, obstruction/infection and inclusion/exclusion of baseline conditions remain unverified.
Required materials and conditions: Adults, kidney-stone diagnosis, inclusion/exclusion and baseline conditions
Materials to obtain first: Participant eligibility/baseline tables and diagnostic criteria
Further research: Material needed: Participant eligibility/baseline tables and diagnostic criteria This records needed materials; no new research was executed.
Remaining uncertainty: Gaps remain in original denominators, allocation and masking, imaging assessment, the correspondence of disappearance and expulsion, conditions for spontaneous passage, missing data, prospective analyses, support roles and harms. Historical reconstructions are not presented as new calculations or adjusted estimates from the paper.
Conditions for verification: Original records on Adults, kidney-stone diagnosis, inclusion/exclusion and baseline conditions must link to the relevant report, analysis unit, timing and denominator, distinguishing recorded information from what remains unverified.
Why this condition is needed: Material on Adults, kidney-stone diagnosis, inclusion/exclusion and baseline conditions is needed to connect adult kidney stones to formulation, population, comparison, exposure, imaging, denominators, the effect of interest or harms.
Application exceptions: Ultrasound disappearance, actual expulsion, size reduction and dissolution mechanisms remain distinct. Randomized counts and historically reconstructed denominators or effects are not converted into confirmed paper values or harm denominators, or extended to other formulations, every stone, replacement of standard care or overall safety.
Referenced methods: Existing principles distinguish the question, formulation, population, denominators, imaging disappearance, actual expulsion, size change, support and harms in the retained comparison of ground-seed capsules and placebo in adults with kidney stones.

Related sources R01

N07 · What were stone size, location, composition and number?

Current findings: The original explanation describes limited reporting of stone location and spontaneous-passage influences. It cautions against extending results to every size, composition and location.
Verification status: Partly verified
Materials actually read: The retained Korean and English summaries and bibliography were read. External articles, registration, plans and additional material remain unread, with no access attempt.
Why unverified: Information retained in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.
Reason for missing information: Group-specific size distributions, location, composition, counts and disease duration remain unverified.
Required materials and conditions: Baseline size/location/composition by group, single/multiple stones and likelihood of passage
Materials to obtain first: Baseline stone characteristics, imaging tables and composition material
Further research: Material needed: Baseline stone characteristics, imaging tables and composition material This records needed materials; no new research was executed.
Remaining uncertainty: Gaps remain in original denominators, allocation and masking, imaging assessment, the correspondence of disappearance and expulsion, conditions for spontaneous passage, missing data, prospective analyses, support roles and harms. Historical reconstructions are not presented as new calculations or adjusted estimates from the paper.
Conditions for verification: Original records on Baseline size/location/composition by group, single/multiple stones and likelihood of passage must link to the relevant report, analysis unit, timing and denominator, distinguishing recorded information from what remains unverified.
Why this condition is needed: Material on Baseline size/location/composition by group, single/multiple stones and likelihood of passage is needed to connect adult kidney stones to formulation, population, comparison, exposure, imaging, denominators, the effect of interest or harms.
Application exceptions: Ultrasound disappearance, actual expulsion, size reduction and dissolution mechanisms remain distinct. Randomized counts and historically reconstructed denominators or effects are not converted into confirmed paper values or harm denominators, or extended to other formulations, every stone, replacement of standard care or overall safety.
Referenced methods: Existing principles distinguish the question, formulation, population, denominators, imaging disappearance, actual expulsion, size change, support and harms in the retained comparison of ground-seed capsules and placebo in adults with kidney stones.

Related sources R01

N08 · What was actually compared with matched placebo?

Current findings: The retained comparison is matched placebo and the design description is a randomized, triple-blind, placebo trial.
Verification status: Partly verified
Materials actually read: The retained Korean and English summaries and bibliography were read. External articles, registration, plans and additional material remain unread, with no access attempt.
Why unverified: Information retained in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.
Reason for missing information: Placebo constituents/appearance, common management and matching treatment/administration procedures remain unverified.
Required materials and conditions: Placebo composition/appearance, common management and masking conditions
Materials to obtain first: Placebo composition and common treatment/management tables
Further research: Material needed: Placebo composition and common treatment/management tables This records needed materials; no new research was executed.
Remaining uncertainty: Gaps remain in original denominators, allocation and masking, imaging assessment, the correspondence of disappearance and expulsion, conditions for spontaneous passage, missing data, prospective analyses, support roles and harms. Historical reconstructions are not presented as new calculations or adjusted estimates from the paper.
Conditions for verification: Original records on Placebo composition/appearance, common management and masking conditions must link to the relevant report, analysis unit, timing and denominator, distinguishing recorded information from what remains unverified.
Why this condition is needed: Material on Placebo composition/appearance, common management and masking conditions is needed to connect adult kidney stones to formulation, population, comparison, exposure, imaging, denominators, the effect of interest or harms.
Application exceptions: Ultrasound disappearance, actual expulsion, size reduction and dissolution mechanisms remain distinct. Randomized counts and historically reconstructed denominators or effects are not converted into confirmed paper values or harm denominators, or extended to other formulations, every stone, replacement of standard care or overall safety.
Referenced methods: Existing principles distinguish the question, formulation, population, denominators, imaging disappearance, actual expulsion, size change, support and harms in the retained comparison of ground-seed capsules and placebo in adults with kidney stones.

Related sources R01

N09 · How did hydration, diet, drugs and procedures differ?

Current findings: The original explanation mentions limited reporting of hydration, stone location and spontaneous-passage influences.
Verification status: Unverified
Materials actually read: The retained Korean and English summaries and bibliography were read. External articles, registration, plans and additional material remain unread, with no access attempt.
Why unverified: Information retained in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.
Reason for missing information: Group-specific hydration/diet, concomitant drugs, standard treatment/procedures, changes and adherence remain unverified.
Required materials and conditions: Hydration/diet, stone medication/standard management, additional procedures and group differences
Materials to obtain first: Hydration/diet/concomitant-treatment, procedure and change records
Further research: Material needed: Hydration/diet/concomitant-treatment, procedure and change records This records needed materials; no new research was executed.
Remaining uncertainty: Gaps remain in original denominators, allocation and masking, imaging assessment, the correspondence of disappearance and expulsion, conditions for spontaneous passage, missing data, prospective analyses, support roles and harms. Historical reconstructions are not presented as new calculations or adjusted estimates from the paper.
Conditions for verification: Original records on Hydration/diet, stone medication/standard management, additional procedures and group differences must link to the relevant report, analysis unit, timing and denominator, distinguishing recorded information from what remains unverified.
Why this condition is needed: Material on Hydration/diet, stone medication/standard management, additional procedures and group differences is needed to connect adult kidney stones to formulation, population, comparison, exposure, imaging, denominators, the effect of interest or harms.
Application exceptions: Ultrasound disappearance, actual expulsion, size reduction and dissolution mechanisms remain distinct. Randomized counts and historically reconstructed denominators or effects are not converted into confirmed paper values or harm denominators, or extended to other formulations, every stone, replacement of standard care or overall safety.
Referenced methods: Existing principles distinguish the question, formulation, population, denominators, imaging disappearance, actual expulsion, size change, support and harms in the retained comparison of ground-seed capsules and placebo in adults with kidney stones.

Related sources R01

N10 · How do complete ultrasound disappearance and actual expulsion differ?

Current findings: The retained principal endpoint is complete disappearance of stones on ultrasound. The original effect description uses both disappearance and expulsion.
Verification status: Partly verified
Materials actually read: The retained Korean and English summaries and bibliography were read. External articles, registration, plans and additional material remain unread, with no access attempt.
Why unverified: Information retained in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.
Reason for missing information: Direct capture of expulsion, correspondence between imaging disappearance and expulsion, and adjudication rules remain unverified.
Required materials and conditions: Ultrasound disappearance, confirmation of actual expulsion, operational definitions and correspondence
Materials to obtain first: Definitions of complete disappearance/expulsion, confirmation of expulsion and original imaging-assessment material
Further research: Material needed: Definitions of complete disappearance/expulsion, confirmation of expulsion and original imaging-assessment material This records needed materials; no new research was executed.
Remaining uncertainty: Gaps remain in original denominators, allocation and masking, imaging assessment, the correspondence of disappearance and expulsion, conditions for spontaneous passage, missing data, prospective analyses, support roles and harms. Historical reconstructions are not presented as new calculations or adjusted estimates from the paper.
Conditions for verification: Original records on Ultrasound disappearance, confirmation of actual expulsion, operational definitions and correspondence must link to the relevant report, analysis unit, timing and denominator, distinguishing recorded information from what remains unverified.
Why this condition is needed: Material on Ultrasound disappearance, confirmation of actual expulsion, operational definitions and correspondence is needed to connect adult kidney stones to formulation, population, comparison, exposure, imaging, denominators, the effect of interest or harms.
Application exceptions: Ultrasound disappearance, actual expulsion, size reduction and dissolution mechanisms remain distinct. Randomized counts and historically reconstructed denominators or effects are not converted into confirmed paper values or harm denominators, or extended to other formulations, every stone, replacement of standard care or overall safety.
Referenced methods: Existing principles distinguish the question, formulation, population, denominators, imaging disappearance, actual expulsion, size change, support and harms in the retained comparison of ground-seed capsules and placebo in adults with kidney stones.

Related sources R01

N11 · What does dissolution in the study title establish?

Current findings: The article title includes kidney stone dissolution, but the retained verdict selects complete ultrasound disappearance.
Verification status: Unverified
Materials actually read: The retained Korean and English summaries and bibliography were read. External articles, registration, plans and additional material remain unread, with no access attempt.
Why unverified: Information retained in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.
Reason for missing information: Changes in stone composition, dissolution mechanisms, routes of expulsion and correspondence between actual dissolution and disappearance remain unverified.
Required materials and conditions: Distinguish imaging disappearance, expulsion and chemical dissolution/mechanisms
Materials to obtain first: Original trial endpoints/measurements and stone-composition/expulsion material
Further research: Material needed: Original trial endpoints/measurements and stone-composition/expulsion material This records needed materials; no new research was executed.
Remaining uncertainty: Gaps remain in original denominators, allocation and masking, imaging assessment, the correspondence of disappearance and expulsion, conditions for spontaneous passage, missing data, prospective analyses, support roles and harms. Historical reconstructions are not presented as new calculations or adjusted estimates from the paper.
Conditions for verification: Original records on Distinguish imaging disappearance, expulsion and chemical dissolution/mechanisms must link to the relevant report, analysis unit, timing and denominator, distinguishing recorded information from what remains unverified.
Why this condition is needed: Material on Distinguish imaging disappearance, expulsion and chemical dissolution/mechanisms is needed to connect adult kidney stones to formulation, population, comparison, exposure, imaging, denominators, the effect of interest or harms.
Application exceptions: Ultrasound disappearance, actual expulsion, size reduction and dissolution mechanisms remain distinct. Randomized counts and historically reconstructed denominators or effects are not converted into confirmed paper values or harm denominators, or extended to other formulations, every stone, replacement of standard care or overall safety.
Referenced methods: Existing principles distinguish the question, formulation, population, denominators, imaging disappearance, actual expulsion, size change, support and harms in the retained comparison of ground-seed capsules and placebo in adults with kidney stones.

Related sources R01

N12 · Are complete-disappearance events and size reduction the same outcome?

Current findings: The retained endpoint is complete ultrasound disappearance; size reduction is separate, and the original explanation also states that these outcomes should not be mixed.
Verification status: Unverified
Materials actually read: The retained Korean and English summaries and bibliography were read. External articles, registration, plans and additional material remain unread, with no access attempt.
Why unverified: Information retained in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.
Reason for missing information: Numerical size changes, denominators, between-group effects, confidence intervals and measurement timing remain unverified.
Required materials and conditions: Size units, measurement/timing, between-group change and separation from complete disappearance
Materials to obtain first: Separate size-reduction result tables, imaging measurements and denominators
Further research: Material needed: Separate size-reduction result tables, imaging measurements and denominators This records needed materials; no new research was executed.
Remaining uncertainty: Gaps remain in original denominators, allocation and masking, imaging assessment, the correspondence of disappearance and expulsion, conditions for spontaneous passage, missing data, prospective analyses, support roles and harms. Historical reconstructions are not presented as new calculations or adjusted estimates from the paper.
Conditions for verification: Original records on Size units, measurement/timing, between-group change and separation from complete disappearance must link to the relevant report, analysis unit, timing and denominator, distinguishing recorded information from what remains unverified.
Why this condition is needed: Material on Size units, measurement/timing, between-group change and separation from complete disappearance is needed to connect adult kidney stones to formulation, population, comparison, exposure, imaging, denominators, the effect of interest or harms.
Application exceptions: Ultrasound disappearance, actual expulsion, size reduction and dissolution mechanisms remain distinct. Randomized counts and historically reconstructed denominators or effects are not converted into confirmed paper values or harm denominators, or extended to other formulations, every stone, replacement of standard care or overall safety.
Referenced methods: Existing principles distinguish the question, formulation, population, denominators, imaging disappearance, actual expulsion, size change, support and harms in the retained comparison of ground-seed capsules and placebo in adults with kidney stones.

Related sources R01

N13 · Which assessment procedures determined ultrasound disappearance?

Current findings: The original text describes ultrasound assessment of stone status and limited reporting of imaging-assessment procedures.
Verification status: Unverified
Materials actually read: The retained Korean and English summaries and bibliography were read. External articles, registration, plans and additional material remain unread, with no access attempt.
Why unverified: Information retained in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.
Reason for missing information: Equipment/acquisition, detection limits, assessors, agreement, confirmation and misclassification remain unverified.
Required materials and conditions: Imaging equipment, sensitivity, assessors/masking, agreement and confirmation of disappearance
Materials to obtain first: Ultrasound SOPs, masking/assessment procedures and original images
Further research: Material needed: Ultrasound SOPs, masking/assessment procedures and original images This records needed materials; no new research was executed.
Remaining uncertainty: Gaps remain in original denominators, allocation and masking, imaging assessment, the correspondence of disappearance and expulsion, conditions for spontaneous passage, missing data, prospective analyses, support roles and harms. Historical reconstructions are not presented as new calculations or adjusted estimates from the paper.
Conditions for verification: Original records on Imaging equipment, sensitivity, assessors/masking, agreement and confirmation of disappearance must link to the relevant report, analysis unit, timing and denominator, distinguishing recorded information from what remains unverified.
Why this condition is needed: Material on Imaging equipment, sensitivity, assessors/masking, agreement and confirmation of disappearance is needed to connect adult kidney stones to formulation, population, comparison, exposure, imaging, denominators, the effect of interest or harms.
Application exceptions: Ultrasound disappearance, actual expulsion, size reduction and dissolution mechanisms remain distinct. Randomized counts and historically reconstructed denominators or effects are not converted into confirmed paper values or harm denominators, or extended to other formulations, every stone, replacement of standard care or overall safety.
Referenced methods: Existing principles distinguish the question, formulation, population, denominators, imaging disappearance, actual expulsion, size change, support and harms in the retained comparison of ground-seed capsules and placebo in adults with kidney stones.

Related sources R01

N14 · How do 60 randomized participants differ from analysis groups?

Current findings: The retained participant record states 60 randomized; percentage-based analysis approximately 27 versus 26.
Verification status: Partly verified
Materials actually read: The retained Korean and English summaries and bibliography were read. External articles, registration, plans and additional material remain unread, with no access attempt.
Why unverified: Information retained in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.
Reason for missing information: Arm-specific allocation, originally reported analysis/completion counts, withdrawals and analysis-population definitions remain unverified.
Required materials and conditions: Randomization and arm-specific allocation, analysis, completion and endpoint denominators
Materials to obtain first: CONSORT flow and arm-specific allocation/analysis tables
Further research: Material needed: CONSORT flow and arm-specific allocation/analysis tables This records needed materials; no new research was executed.
Remaining uncertainty: Gaps remain in original denominators, allocation and masking, imaging assessment, the correspondence of disappearance and expulsion, conditions for spontaneous passage, missing data, prospective analyses, support roles and harms. Historical reconstructions are not presented as new calculations or adjusted estimates from the paper.
Conditions for verification: Original records on Randomization and arm-specific allocation, analysis, completion and endpoint denominators must link to the relevant report, analysis unit, timing and denominator, distinguishing recorded information from what remains unverified.
Why this condition is needed: Material on Randomization and arm-specific allocation, analysis, completion and endpoint denominators is needed to connect adult kidney stones to formulation, population, comparison, exposure, imaging, denominators, the effect of interest or harms.
Application exceptions: Ultrasound disappearance, actual expulsion, size reduction and dissolution mechanisms remain distinct. Randomized counts and historically reconstructed denominators or effects are not converted into confirmed paper values or harm denominators, or extended to other formulations, every stone, replacement of standard care or overall safety.
Referenced methods: Existing principles distinguish the question, formulation, population, denominators, imaging disappearance, actual expulsion, size change, support and harms in the retained comparison of ground-seed capsules and placebo in adults with kidney stones.

Related sources R01

N15 · How were the approximately 27 and 26 analysis participants recorded?

Current findings: The original explanation states that 44.4% and 15.3% came from small analysis groups of approximately 27 and 26. The original participant record also states percentage-based analysis approximately 27 versus 26.
Verification status: Partly verified
Materials actually read: The retained Korean and English summaries and bibliography were read. External articles, registration, plans and additional material remain unread, with no access attempt.
Why unverified: Information retained in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.
Reason for missing information: Direct paper denominators/exclusion rules, original rounding material and analysis units remain unverified.
Required materials and conditions: Reported percentages, historical reconstruction, original denominators, rounding and units
Materials to obtain first: Original event/denominator tables, flow and original rounding/calculation records
Further research: Material needed: Original event/denominator tables, flow and original rounding/calculation records This records needed materials; no new research was executed.
Remaining uncertainty: Gaps remain in original denominators, allocation and masking, imaging assessment, the correspondence of disappearance and expulsion, conditions for spontaneous passage, missing data, prospective analyses, support roles and harms. Historical reconstructions are not presented as new calculations or adjusted estimates from the paper.
Conditions for verification: Original records on Reported percentages, historical reconstruction, original denominators, rounding and units must link to the relevant report, analysis unit, timing and denominator, distinguishing recorded information from what remains unverified.
Why this condition is needed: Material on Reported percentages, historical reconstruction, original denominators, rounding and units is needed to connect adult kidney stones to formulation, population, comparison, exposure, imaging, denominators, the effect of interest or harms.
Application exceptions: Ultrasound disappearance, actual expulsion, size reduction and dissolution mechanisms remain distinct. Randomized counts and historically reconstructed denominators or effects are not converted into confirmed paper values or harm denominators, or extended to other formulations, every stone, replacement of standard care or overall safety.
Referenced methods: Existing principles distinguish the question, formulation, population, denominators, imaging disappearance, actual expulsion, size change, support and harms in the retained comparison of ground-seed capsules and placebo in adults with kidney stones.

Related sources R01

N16 · Are 12/27 versus 4/26 original counts or reconstructions?

Current findings: The result labels 12/27 versus 4/26 as reconstructed, while the reader answer presents approximately 12/27 versus 4/26.
Verification status: Partly verified
Materials actually read: The retained Korean and English summaries and bibliography were read. External articles, registration, plans and additional material remain unread, with no access attempt.
Why unverified: Information retained in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.
Reason for missing information: Direct paper event counts, denominators, group correspondence and assumptions/accuracy of reconstruction remain unverified because external material was unread.
Required materials and conditions: Original event counts, reconstructed counts, approximation labels, denominators and group correspondence
Materials to obtain first: Original frequency tables and historical reconstruction records
Further research: Material needed: Original frequency tables and historical reconstruction records This records needed materials; no new research was executed.
Remaining uncertainty: Gaps remain in original denominators, allocation and masking, imaging assessment, the correspondence of disappearance and expulsion, conditions for spontaneous passage, missing data, prospective analyses, support roles and harms. Historical reconstructions are not presented as new calculations or adjusted estimates from the paper.
Conditions for verification: Original records on Original event counts, reconstructed counts, approximation labels, denominators and group correspondence must link to the relevant report, analysis unit, timing and denominator, distinguishing recorded information from what remains unverified.
Why this condition is needed: Material on Original event counts, reconstructed counts, approximation labels, denominators and group correspondence is needed to connect adult kidney stones to formulation, population, comparison, exposure, imaging, denominators, the effect of interest or harms.
Application exceptions: Ultrasound disappearance, actual expulsion, size reduction and dissolution mechanisms remain distinct. Randomized counts and historically reconstructed denominators or effects are not converted into confirmed paper values or harm denominators, or extended to other formulations, every stone, replacement of standard care or overall safety.
Referenced methods: Existing principles distinguish the question, formulation, population, denominators, imaging disappearance, actual expulsion, size change, support and harms in the retained comparison of ground-seed capsules and placebo in adults with kidney stones.

Related sources R01

N17 · Which endpoint do the reported 44.4% versus 15.3% describe?

Current findings: The original result and reader answer report complete disappearance of 44.4% versus 15.3%.
Verification status: Partly verified
Materials actually read: The retained Korean and English summaries and bibliography were read. External articles, registration, plans and additional material remain unread, with no access attempt.
Why unverified: Information retained in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.
Reason for missing information: Direct values/rounding in the original table, units/denominators and timing definitions remain unverified because external material was unread.
Required materials and conditions: Complete-disappearance percentages, group correspondence, timing, units and denominators
Materials to obtain first: Complete-disappearance result tables, group denominators and definitions
Further research: Material needed: Complete-disappearance result tables, group denominators and definitions This records needed materials; no new research was executed.
Remaining uncertainty: Gaps remain in original denominators, allocation and masking, imaging assessment, the correspondence of disappearance and expulsion, conditions for spontaneous passage, missing data, prospective analyses, support roles and harms. Historical reconstructions are not presented as new calculations or adjusted estimates from the paper.
Conditions for verification: Original records on Complete-disappearance percentages, group correspondence, timing, units and denominators must link to the relevant report, analysis unit, timing and denominator, distinguishing recorded information from what remains unverified.
Why this condition is needed: Material on Complete-disappearance percentages, group correspondence, timing, units and denominators is needed to connect adult kidney stones to formulation, population, comparison, exposure, imaging, denominators, the effect of interest or harms.
Application exceptions: Ultrasound disappearance, actual expulsion, size reduction and dissolution mechanisms remain distinct. Randomized counts and historically reconstructed denominators or effects are not converted into confirmed paper values or harm denominators, or extended to other formulations, every stone, replacement of standard care or overall safety.
Referenced methods: Existing principles distinguish the question, formulation, population, denominators, imaging disappearance, actual expulsion, size change, support and harms in the retained comparison of ground-seed capsules and placebo in adults with kidney stones.

Related sources R01

N18 · What are the sources of RD 29.1 percentage points, RR 2.89 and the CI?

Current findings: The original result reports RD 29.1 percentage points and RR 2.89 (95% CI 1.07 to 7.82) with reconstructed counts. Its note explicitly identifies a Codex reconstruction rather than adjusted paper estimates.
Verification status: Partly verified
Materials actually read: The retained Korean and English summaries and bibliography were read. External articles, registration, plans and additional material remain unread, with no access attempt.
Why unverified: Information retained in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.
Reason for missing information: Direct correspondence with adjusted/unadjusted paper estimates, calculation methods and original denominators remains unverified.
Required materials and conditions: Original estimates versus reconstructed risk differences/RRs/CIs, effect of interest and adjustment
Materials to obtain first: Original effect tables and historical calculation-event records
Further research: Material needed: Original effect tables and historical calculation-event records This records needed materials; no new research was executed.
Remaining uncertainty: Gaps remain in original denominators, allocation and masking, imaging assessment, the correspondence of disappearance and expulsion, conditions for spontaneous passage, missing data, prospective analyses, support roles and harms. Historical reconstructions are not presented as new calculations or adjusted estimates from the paper.
Conditions for verification: Original records on Original estimates versus reconstructed risk differences/RRs/CIs, effect of interest and adjustment must link to the relevant report, analysis unit, timing and denominator, distinguishing recorded information from what remains unverified.
Why this condition is needed: Material on Original estimates versus reconstructed risk differences/RRs/CIs, effect of interest and adjustment is needed to connect adult kidney stones to formulation, population, comparison, exposure, imaging, denominators, the effect of interest or harms.
Application exceptions: Ultrasound disappearance, actual expulsion, size reduction and dissolution mechanisms remain distinct. Randomized counts and historically reconstructed denominators or effects are not converted into confirmed paper values or harm denominators, or extended to other formulations, every stone, replacement of standard care or overall safety.
Referenced methods: Existing principles distinguish the question, formulation, population, denominators, imaging disappearance, actual expulsion, size change, support and harms in the retained comparison of ground-seed capsules and placebo in adults with kidney stones.

Related sources R01

N19 · What uncertainty remains with few events and a wide interval?

Current findings: The original reader answer describes small absolute event counts and the need to reproduce imaging/spontaneous-passage conditions. The historical RR CI is 1.07 to 7.82.
Verification status: Partly verified
Materials actually read: The retained Korean and English summaries and bibliography were read. External articles, registration, plans and additional material remain unread, with no access attempt.
Why unverified: Information retained in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.
Reason for missing information: Original denominators/CIs, prespecified important differences, planned sample size and population-specific precision remain unverified.
Required materials and conditions: Intervals for the effect of interest, direct events/denominators and clinical importance
Materials to obtain first: Original counts/effects and sample-size/clinical-importance plans
Further research: Material needed: Original counts/effects and sample-size/clinical-importance plans This records needed materials; no new research was executed.
Remaining uncertainty: Gaps remain in original denominators, allocation and masking, imaging assessment, the correspondence of disappearance and expulsion, conditions for spontaneous passage, missing data, prospective analyses, support roles and harms. Historical reconstructions are not presented as new calculations or adjusted estimates from the paper.
Conditions for verification: Original records on Intervals for the effect of interest, direct events/denominators and clinical importance must link to the relevant report, analysis unit, timing and denominator, distinguishing recorded information from what remains unverified.
Why this condition is needed: Material on Intervals for the effect of interest, direct events/denominators and clinical importance is needed to connect adult kidney stones to formulation, population, comparison, exposure, imaging, denominators, the effect of interest or harms.
Application exceptions: Ultrasound disappearance, actual expulsion, size reduction and dissolution mechanisms remain distinct. Randomized counts and historically reconstructed denominators or effects are not converted into confirmed paper values or harm denominators, or extended to other formulations, every stone, replacement of standard care or overall safety.
Referenced methods: Existing principles distinguish the question, formulation, population, denominators, imaging disappearance, actual expulsion, size change, support and harms in the retained comparison of ground-seed capsules and placebo in adults with kidney stones.

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N20 · What was the 1st endpoint in the prospective trial plan?

Current findings: The retained intervention record labels complete ultrasound disappearance as the primary endpoint; the registration identifier is unconfirmed.
Verification status: Unverified
Materials actually read: The retained Korean and English summaries and bibliography were read. External articles, registration, plans and additional material remain unread, with no access attempt.
Why unverified: Information retained in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.
Reason for missing information: External registration/plans, the 1st endpoint hierarchy, changes and analysis selection remain unverified.
Required materials and conditions: Registration, protocol, SAP and original endpoint/timing/analysis hierarchy
Materials to obtain first: Registration/protocol/SAP and change histories
Further research: Material needed: Registration/protocol/SAP and change histories This records needed materials; no new research was executed.
Remaining uncertainty: Gaps remain in original denominators, allocation and masking, imaging assessment, the correspondence of disappearance and expulsion, conditions for spontaneous passage, missing data, prospective analyses, support roles and harms. Historical reconstructions are not presented as new calculations or adjusted estimates from the paper.
Conditions for verification: Original records on Registration, protocol, SAP and original endpoint/timing/analysis hierarchy must link to the relevant report, analysis unit, timing and denominator, distinguishing recorded information from what remains unverified.
Why this condition is needed: Material on Registration, protocol, SAP and original endpoint/timing/analysis hierarchy is needed to connect adult kidney stones to formulation, population, comparison, exposure, imaging, denominators, the effect of interest or harms.
Application exceptions: Ultrasound disappearance, actual expulsion, size reduction and dissolution mechanisms remain distinct. Randomized counts and historically reconstructed denominators or effects are not converted into confirmed paper values or harm denominators, or extended to other formulations, every stone, replacement of standard care or overall safety.
Referenced methods: Existing principles distinguish the question, formulation, population, denominators, imaging disappearance, actual expulsion, size change, support and harms in the retained comparison of ground-seed capsules and placebo in adults with kidney stones.

Related sources R01

N21 · How were sequence generation, concealment and baseline balance handled?

Current findings: The original design is described as a randomized, triple-blind, placebo trial, with 60 randomized participants.
Verification status: Unverified
Materials actually read: The retained Korean and English summaries and bibliography were read. External articles, registration, plans and additional material remain unread, with no access attempt.
Why unverified: Information retained in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.
Reason for missing information: Allocation sequence, concealment and group-specific baseline stone, hydration and participant balance remain unverified.
Required materials and conditions: Random sequence/concealment, allocation and baseline stone/participant balance
Materials to obtain first: Allocation procedures and baseline tables
Further research: Material needed: Allocation procedures and baseline tables This records needed materials; no new research was executed.
Remaining uncertainty: Gaps remain in original denominators, allocation and masking, imaging assessment, the correspondence of disappearance and expulsion, conditions for spontaneous passage, missing data, prospective analyses, support roles and harms. Historical reconstructions are not presented as new calculations or adjusted estimates from the paper.
Conditions for verification: Original records on Random sequence/concealment, allocation and baseline stone/participant balance must link to the relevant report, analysis unit, timing and denominator, distinguishing recorded information from what remains unverified.
Why this condition is needed: Material on Random sequence/concealment, allocation and baseline stone/participant balance is needed to connect adult kidney stones to formulation, population, comparison, exposure, imaging, denominators, the effect of interest or harms.
Application exceptions: Ultrasound disappearance, actual expulsion, size reduction and dissolution mechanisms remain distinct. Randomized counts and historically reconstructed denominators or effects are not converted into confirmed paper values or harm denominators, or extended to other formulations, every stone, replacement of standard care or overall safety.
Referenced methods: Existing principles distinguish the question, formulation, population, denominators, imaging disappearance, actual expulsion, size change, support and harms in the retained comparison of ground-seed capsules and placebo in adults with kidney stones.

Related sources R01

N22 · Which roles remained masked?

Current findings: The original design description states triple blinding.
Verification status: Unverified
Materials actually read: The retained Korean and English summaries and bibliography were read. External articles, registration, plans and additional material remain unread, with no access attempt.
Why unverified: Information retained in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.
Reason for missing information: Who was masked, product distinguishability, imaging-assessment masking and maintenance/unmasking remain unverified.
Required materials and conditions: Participants, personnel and assessors, product distinguishability and maintenance of masking
Materials to obtain first: Placebo/preparations, role-specific masking and assessment procedures
Further research: Material needed: Placebo/preparations, role-specific masking and assessment procedures This records needed materials; no new research was executed.
Remaining uncertainty: Gaps remain in original denominators, allocation and masking, imaging assessment, the correspondence of disappearance and expulsion, conditions for spontaneous passage, missing data, prospective analyses, support roles and harms. Historical reconstructions are not presented as new calculations or adjusted estimates from the paper.
Conditions for verification: Original records on Participants, personnel and assessors, product distinguishability and maintenance of masking must link to the relevant report, analysis unit, timing and denominator, distinguishing recorded information from what remains unverified.
Why this condition is needed: Material on Participants, personnel and assessors, product distinguishability and maintenance of masking is needed to connect adult kidney stones to formulation, population, comparison, exposure, imaging, denominators, the effect of interest or harms.
Application exceptions: Ultrasound disappearance, actual expulsion, size reduction and dissolution mechanisms remain distinct. Randomized counts and historically reconstructed denominators or effects are not converted into confirmed paper values or harm denominators, or extended to other formulations, every stone, replacement of standard care or overall safety.
Referenced methods: Existing principles distinguish the question, formulation, population, denominators, imaging disappearance, actual expulsion, size change, support and harms in the retained comparison of ground-seed capsules and placebo in adults with kidney stones.

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N23 · How were actual use, discontinuation and additional treatment handled?

Current findings: The original record specifies 500 mg, 2 times daily, 10 weeks of treatment and comparison with placebo.
Verification status: Unverified
Materials actually read: The retained Korean and English summaries and bibliography were read. External articles, registration, plans and additional material remain unread, with no access attempt.
Why unverified: Information retained in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.
Reason for missing information: Adherence, discontinuation/crossover, additional treatment/procedures and handling of deviations remain unverified.
Required materials and conditions: Use diaries, nonadherence/discontinuation, additional treatment and the effect targeted in analysis
Materials to obtain first: Use diaries, deviation/procedure records and analysis plans
Further research: Material needed: Use diaries, deviation/procedure records and analysis plans This records needed materials; no new research was executed.
Remaining uncertainty: Gaps remain in original denominators, allocation and masking, imaging assessment, the correspondence of disappearance and expulsion, conditions for spontaneous passage, missing data, prospective analyses, support roles and harms. Historical reconstructions are not presented as new calculations or adjusted estimates from the paper.
Conditions for verification: Original records on Use diaries, nonadherence/discontinuation, additional treatment and the effect targeted in analysis must link to the relevant report, analysis unit, timing and denominator, distinguishing recorded information from what remains unverified.
Why this condition is needed: Material on Use diaries, nonadherence/discontinuation, additional treatment and the effect targeted in analysis is needed to connect adult kidney stones to formulation, population, comparison, exposure, imaging, denominators, the effect of interest or harms.
Application exceptions: Ultrasound disappearance, actual expulsion, size reduction and dissolution mechanisms remain distinct. Randomized counts and historically reconstructed denominators or effects are not converted into confirmed paper values or harm denominators, or extended to other formulations, every stone, replacement of standard care or overall safety.
Referenced methods: Existing principles distinguish the question, formulation, population, denominators, imaging disappearance, actual expulsion, size change, support and harms in the retained comparison of ground-seed capsules and placebo in adults with kidney stones.

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N24 · Who among the 60 randomized participants was omitted from analysis?

Current findings: The original participant record combines 60 randomized with percentage-based analysis of approximately 27/26.
Verification status: Unverified
Materials actually read: The retained Korean and English summaries and bibliography were read. External articles, registration, plans and additional material remain unread, with no access attempt.
Why unverified: Information retained in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.
Reason for missing information: Missing counts/reasons, group-specific withdrawals, ITT/PP, missing measurements and sensitivity analyses remain unverified.
Required materials and conditions: Group-specific flow, withdrawal/missingness, ITT/PP, original denominators and handling
Materials to obtain first: Group-specific flow, analysis definitions and missing-data handling
Further research: Material needed: Group-specific flow, analysis definitions and missing-data handling This records needed materials; no new research was executed.
Remaining uncertainty: Gaps remain in original denominators, allocation and masking, imaging assessment, the correspondence of disappearance and expulsion, conditions for spontaneous passage, missing data, prospective analyses, support roles and harms. Historical reconstructions are not presented as new calculations or adjusted estimates from the paper.
Conditions for verification: Original records on Group-specific flow, withdrawal/missingness, ITT/PP, original denominators and handling must link to the relevant report, analysis unit, timing and denominator, distinguishing recorded information from what remains unverified.
Why this condition is needed: Material on Group-specific flow, withdrawal/missingness, ITT/PP, original denominators and handling is needed to connect adult kidney stones to formulation, population, comparison, exposure, imaging, denominators, the effect of interest or harms.
Application exceptions: Ultrasound disappearance, actual expulsion, size reduction and dissolution mechanisms remain distinct. Randomized counts and historically reconstructed denominators or effects are not converted into confirmed paper values or harm denominators, or extended to other formulations, every stone, replacement of standard care or overall safety.
Referenced methods: Existing principles distinguish the question, formulation, population, denominators, imaging disappearance, actual expulsion, size change, support and harms in the retained comparison of ground-seed capsules and placebo in adults with kidney stones.

Related sources R01

N25 · When and for whom was complete disappearance assessed?

Current findings: The recorded duration is 10 weeks of treatment and ultrasound follow-up.
Verification status: Unverified
Materials actually read: The retained Korean and English summaries and bibliography were read. External articles, registration, plans and additional material remain unread, with no access attempt.
Why unverified: Information retained in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.
Reason for missing information: The exact assessment visit for reported percentages, cumulative events versus final visit, recurrence after interim clearance and endpoint denominators remain unverified.
Required materials and conditions: Clearance-assessment timing, interim/end visits, cumulative/single-visit events and denominators
Materials to obtain first: Visit-specific clearance tables, event timing and follow-up/denominators
Further research: Material needed: Visit-specific clearance tables, event timing and follow-up/denominators This records needed materials; no new research was executed.
Remaining uncertainty: Gaps remain in original denominators, allocation and masking, imaging assessment, the correspondence of disappearance and expulsion, conditions for spontaneous passage, missing data, prospective analyses, support roles and harms. Historical reconstructions are not presented as new calculations or adjusted estimates from the paper.
Conditions for verification: Original records on Clearance-assessment timing, interim/end visits, cumulative/single-visit events and denominators must link to the relevant report, analysis unit, timing and denominator, distinguishing recorded information from what remains unverified.
Why this condition is needed: Material on Clearance-assessment timing, interim/end visits, cumulative/single-visit events and denominators is needed to connect adult kidney stones to formulation, population, comparison, exposure, imaging, denominators, the effect of interest or harms.
Application exceptions: Ultrasound disappearance, actual expulsion, size reduction and dissolution mechanisms remain distinct. Randomized counts and historically reconstructed denominators or effects are not converted into confirmed paper values or harm denominators, or extended to other formulations, every stone, replacement of standard care or overall safety.
Referenced methods: Existing principles distinguish the question, formulation, population, denominators, imaging disappearance, actual expulsion, size change, support and harms in the retained comparison of ground-seed capsules and placebo in adults with kidney stones.

Related sources R01

N26 · How were event units for people and stones defined?

Current findings: The original reader answer explains 12/27 and 4/26 in the context of participant denominators.
Verification status: Unverified
Materials actually read: The retained Korean and English summaries and bibliography were read. External articles, registration, plans and additional material remain unread, with no access attempt.
Why unverified: Information retained in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.
Reason for missing information: Complete-clearance criteria for multiple stones, stone-level versus person-level analysis and unit handling remain unverified.
Required materials and conditions: People/stones, multiple stones, complete-clearance criteria and group denominators
Materials to obtain first: Person/stone definitions and multiple-stone/denominator tables
Further research: Material needed: Person/stone definitions and multiple-stone/denominator tables This records needed materials; no new research was executed.
Remaining uncertainty: Gaps remain in original denominators, allocation and masking, imaging assessment, the correspondence of disappearance and expulsion, conditions for spontaneous passage, missing data, prospective analyses, support roles and harms. Historical reconstructions are not presented as new calculations or adjusted estimates from the paper.
Conditions for verification: Original records on People/stones, multiple stones, complete-clearance criteria and group denominators must link to the relevant report, analysis unit, timing and denominator, distinguishing recorded information from what remains unverified.
Why this condition is needed: Material on People/stones, multiple stones, complete-clearance criteria and group denominators is needed to connect adult kidney stones to formulation, population, comparison, exposure, imaging, denominators, the effect of interest or harms.
Application exceptions: Ultrasound disappearance, actual expulsion, size reduction and dissolution mechanisms remain distinct. Randomized counts and historically reconstructed denominators or effects are not converted into confirmed paper values or harm denominators, or extended to other formulations, every stone, replacement of standard care or overall safety.
Referenced methods: Existing principles distinguish the question, formulation, population, denominators, imaging disappearance, actual expulsion, size change, support and harms in the retained comparison of ground-seed capsules and placebo in adults with kidney stones.

Related sources R01

N27 · How were spontaneous passage and intervention effects distinguished?

Current findings: The original explanation describes limited reporting of hydration, stone location and spontaneous-passage influences.
Verification status: Unverified
Materials actually read: The retained Korean and English summaries and bibliography were read. External articles, registration, plans and additional material remain unread, with no access attempt.
Why unverified: Information retained in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.
Reason for missing information: Spontaneous-passage conditions in the groups, follow-up time, direct expulsion and differences/adjustments for other interventions remain unverified.
Required materials and conditions: Hydration/location/size, spontaneous passage, comparison conditions and assessment/timing
Materials to obtain first: Baseline stones, hydration/common management and expulsion/adjustment material
Further research: Material needed: Baseline stones, hydration/common management and expulsion/adjustment material This records needed materials; no new research was executed.
Remaining uncertainty: Gaps remain in original denominators, allocation and masking, imaging assessment, the correspondence of disappearance and expulsion, conditions for spontaneous passage, missing data, prospective analyses, support roles and harms. Historical reconstructions are not presented as new calculations or adjusted estimates from the paper.
Conditions for verification: Original records on Hydration/location/size, spontaneous passage, comparison conditions and assessment/timing must link to the relevant report, analysis unit, timing and denominator, distinguishing recorded information from what remains unverified.
Why this condition is needed: Material on Hydration/location/size, spontaneous passage, comparison conditions and assessment/timing is needed to connect adult kidney stones to formulation, population, comparison, exposure, imaging, denominators, the effect of interest or harms.
Application exceptions: Ultrasound disappearance, actual expulsion, size reduction and dissolution mechanisms remain distinct. Randomized counts and historically reconstructed denominators or effects are not converted into confirmed paper values or harm denominators, or extended to other formulations, every stone, replacement of standard care or overall safety.
Referenced methods: Existing principles distinguish the question, formulation, population, denominators, imaging disappearance, actual expulsion, size change, support and harms in the retained comparison of ground-seed capsules and placebo in adults with kidney stones.

Related sources R01

N28 · How were analyses of clearance, size and expulsion specified in advance?

Current findings: The original endpoint description separates complete disappearance from size reduction; the registration identifier is unconfirmed.
Verification status: Unverified
Materials actually read: The retained Korean and English summaries and bibliography were read. External articles, registration, plans and additional material remain unread, with no access attempt.
Why unverified: Information retained in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.
Reason for missing information: Planned comparisons, multiplicity, correspondence between registration and reporting, and analysis changes remain unverified.
Required materials and conditions: Planned endpoints, analyses/timing, multiple comparisons and reporting changes
Materials to obtain first: Plans/registration and result tables for all analyses/times
Further research: Material needed: Plans/registration and result tables for all analyses/times This records needed materials; no new research was executed.
Remaining uncertainty: Gaps remain in original denominators, allocation and masking, imaging assessment, the correspondence of disappearance and expulsion, conditions for spontaneous passage, missing data, prospective analyses, support roles and harms. Historical reconstructions are not presented as new calculations or adjusted estimates from the paper.
Conditions for verification: Original records on Planned endpoints, analyses/timing, multiple comparisons and reporting changes must link to the relevant report, analysis unit, timing and denominator, distinguishing recorded information from what remains unverified.
Why this condition is needed: Material on Planned endpoints, analyses/timing, multiple comparisons and reporting changes is needed to connect adult kidney stones to formulation, population, comparison, exposure, imaging, denominators, the effect of interest or harms.
Application exceptions: Ultrasound disappearance, actual expulsion, size reduction and dissolution mechanisms remain distinct. Randomized counts and historically reconstructed denominators or effects are not converted into confirmed paper values or harm denominators, or extended to other formulations, every stone, replacement of standard care or overall safety.
Referenced methods: Existing principles distinguish the question, formulation, population, denominators, imaging disappearance, actual expulsion, size change, support and harms in the retained comparison of ground-seed capsules and placebo in adults with kidney stones.

Related sources R01

N29 · Does a clearance signal establish replacement of standard care or effects on symptoms/kidney function?

Current findings: The original advertising-boundary text states that replacement of surgery/standard care cannot be claimed for stones of every size, composition and location.
Verification status: Unverified
Materials actually read: The retained Korean and English summaries and bibliography were read. External articles, registration, plans and additional material remain unread, with no access attempt.
Why unverified: Information retained in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.
Reason for missing information: Direct results for symptoms, kidney function, infection/obstruction, avoidance of procedures and treatment replacement remain unverified.
Required materials and conditions: Standard treatment/procedures, pain/infection/obstruction, kidney function and patient-important outcomes
Materials to obtain first: Patient-important outcomes and standard-care coadministration/procedure material
Further research: Material needed: Patient-important outcomes and standard-care coadministration/procedure material This records needed materials; no new research was executed.
Remaining uncertainty: Gaps remain in original denominators, allocation and masking, imaging assessment, the correspondence of disappearance and expulsion, conditions for spontaneous passage, missing data, prospective analyses, support roles and harms. Historical reconstructions are not presented as new calculations or adjusted estimates from the paper.
Conditions for verification: Original records on Standard treatment/procedures, pain/infection/obstruction, kidney function and patient-important outcomes must link to the relevant report, analysis unit, timing and denominator, distinguishing recorded information from what remains unverified.
Why this condition is needed: Material on Standard treatment/procedures, pain/infection/obstruction, kidney function and patient-important outcomes is needed to connect adult kidney stones to formulation, population, comparison, exposure, imaging, denominators, the effect of interest or harms.
Application exceptions: Ultrasound disappearance, actual expulsion, size reduction and dissolution mechanisms remain distinct. Randomized counts and historically reconstructed denominators or effects are not converted into confirmed paper values or harm denominators, or extended to other formulations, every stone, replacement of standard care or overall safety.
Referenced methods: Existing principles distinguish the question, formulation, population, denominators, imaging disappearance, actual expulsion, size change, support and harms in the retained comparison of ground-seed capsules and placebo in adults with kidney stones.

Related sources R01

N30 · Which original report do the current summary and citation identify?

Current findings: The original citation is Ardakani Movaghati MR et al., Phytother Res.2019, PMID30873671, DOI10.1002/ptr.6331.
Verification status: Partly verified
Materials actually read: The retained Korean and English summaries and bibliography were read. External articles, registration, plans and additional material remain unread, with no access attempt.
Why unverified: Information retained in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.
Reason for missing information: External identity, original article/registration, subsequent reports of the same trial and unique counts remain unverified.
Required materials and conditions: Evidence/citation, PMID/DOI and study-report families
Materials to obtain first: Article/registration and lists of reports from the same trial
Further research: Material needed: Article/registration and lists of reports from the same trial This records needed materials; no new research was executed.
Remaining uncertainty: Gaps remain in original denominators, allocation and masking, imaging assessment, the correspondence of disappearance and expulsion, conditions for spontaneous passage, missing data, prospective analyses, support roles and harms. Historical reconstructions are not presented as new calculations or adjusted estimates from the paper.
Conditions for verification: Original records on Evidence/citation, PMID/DOI and study-report families must link to the relevant report, analysis unit, timing and denominator, distinguishing recorded information from what remains unverified.
Why this condition is needed: Material on Evidence/citation, PMID/DOI and study-report families is needed to connect adult kidney stones to formulation, population, comparison, exposure, imaging, denominators, the effect of interest or harms.
Application exceptions: Ultrasound disappearance, actual expulsion, size reduction and dissolution mechanisms remain distinct. Randomized counts and historically reconstructed denominators or effects are not converted into confirmed paper values or harm denominators, or extended to other formulations, every stone, replacement of standard care or overall safety.
Referenced methods: Existing principles distinguish the question, formulation, population, denominators, imaging disappearance, actual expulsion, size change, support and harms in the retained comparison of ground-seed capsules and placebo in adults with kidney stones.

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N31 · Has the small-sample signal been repeated in other independent material?

Current findings: The original rationale lists independent research as a strength while noting a single small sample, denominator reconstruction and imaging limitations. The original R1/I2 axes are retained.
Verification status: Partly verified
Materials actually read: The retained Korean and English summaries and bibliography were read. External articles, registration, plans and additional material remain unread, with no access attempt.
Why unverified: Information retained in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.
Reason for missing information: Independent replication under the same formulation, spontaneous-passage/imaging conditions, and unique trial/team/participant counts remain unverified.
Required materials and conditions: Teams/trial families, the same formulation/conditions and independent replication
Materials to obtain first: Original trials addressing the same formulation/question and imaging/expulsion conditions
Further research: Material needed: Original trials addressing the same formulation/question and imaging/expulsion conditions This records needed materials; no new research was executed.
Remaining uncertainty: Gaps remain in original denominators, allocation and masking, imaging assessment, the correspondence of disappearance and expulsion, conditions for spontaneous passage, missing data, prospective analyses, support roles and harms. Historical reconstructions are not presented as new calculations or adjusted estimates from the paper.
Conditions for verification: Original records on Teams/trial families, the same formulation/conditions and independent replication must link to the relevant report, analysis unit, timing and denominator, distinguishing recorded information from what remains unverified.
Why this condition is needed: Material on Teams/trial families, the same formulation/conditions and independent replication is needed to connect adult kidney stones to formulation, population, comparison, exposure, imaging, denominators, the effect of interest or harms.
Application exceptions: Ultrasound disappearance, actual expulsion, size reduction and dissolution mechanisms remain distinct. Randomized counts and historically reconstructed denominators or effects are not converted into confirmed paper values or harm denominators, or extended to other formulations, every stone, replacement of standard care or overall safety.
Referenced methods: Existing principles distinguish the question, formulation, population, denominators, imaging disappearance, actual expulsion, size change, support and harms in the retained comparison of ground-seed capsules and placebo in adults with kidney stones.

Related sources R01

N32 · What was the actual role of Mashhad University support?

Current findings: The original funding record states support from Mashhad University.
Verification status: Unverified
Materials actually read: The retained Korean and English summaries and bibliography were read. External articles, registration, plans and additional material remain unread, with no access attempt.
Why unverified: Information retained in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.
Reason for missing information: Support amounts/preparations, employee authorship/COI and funding/product roles remain unverified.
Required materials and conditions: Funding/product support, affiliations, COI and support roles
Materials to obtain first: Original funding/COI, author-affiliation and product-support disclosures
Further research: Material needed: Original funding/COI, author-affiliation and product-support disclosures This records needed materials; no new research was executed.
Remaining uncertainty: Gaps remain in original denominators, allocation and masking, imaging assessment, the correspondence of disappearance and expulsion, conditions for spontaneous passage, missing data, prospective analyses, support roles and harms. Historical reconstructions are not presented as new calculations or adjusted estimates from the paper.
Conditions for verification: Original records on Funding/product support, affiliations, COI and support roles must link to the relevant report, analysis unit, timing and denominator, distinguishing recorded information from what remains unverified.
Why this condition is needed: Material on Funding/product support, affiliations, COI and support roles is needed to connect adult kidney stones to formulation, population, comparison, exposure, imaging, denominators, the effect of interest or harms.
Application exceptions: Ultrasound disappearance, actual expulsion, size reduction and dissolution mechanisms remain distinct. Randomized counts and historically reconstructed denominators or effects are not converted into confirmed paper values or harm denominators, or extended to other formulations, every stone, replacement of standard care or overall safety.
Referenced methods: Existing principles distinguish the question, formulation, population, denominators, imaging disappearance, actual expulsion, size change, support and harms in the retained comparison of ground-seed capsules and placebo in adults with kidney stones.

Related sources R01

N33 · Were the PubMed link, original article and registration read?

Current findings: The clinical material read was the entire stored JSON summary. The PubMed URL is recorded as in the original citation.
Verification status: Partly verified
Materials actually read: The retained Korean and English summaries and bibliography were read. External articles, registration, plans and additional material remain unread, with no access attempt.
Why unverified: Information retained in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.
Reason for missing information: External abstracts/full text/registration, plans and additional material were unread, with no access attempt; public availability is not inferred.
Required materials and conditions: Stored JSON, external abstracts/full text, registration/plans and acquisition/reading
Materials to obtain first: Original text, registration/plans and supplementary material corresponding to the citation
Further research: Material needed: Original text, registration/plans and supplementary material corresponding to the citation This records needed materials; no new research was executed.
Remaining uncertainty: Gaps remain in original denominators, allocation and masking, imaging assessment, the correspondence of disappearance and expulsion, conditions for spontaneous passage, missing data, prospective analyses, support roles and harms. Historical reconstructions are not presented as new calculations or adjusted estimates from the paper.
Conditions for verification: Original records on Stored JSON, external abstracts/full text, registration/plans and acquisition/reading must link to the relevant report, analysis unit, timing and denominator, distinguishing recorded information from what remains unverified.
Why this condition is needed: Material on Stored JSON, external abstracts/full text, registration/plans and acquisition/reading is needed to connect adult kidney stones to formulation, population, comparison, exposure, imaging, denominators, the effect of interest or harms.
Application exceptions: Ultrasound disappearance, actual expulsion, size reduction and dissolution mechanisms remain distinct. Randomized counts and historically reconstructed denominators or effects are not converted into confirmed paper values or harm denominators, or extended to other formulations, every stone, replacement of standard care or overall safety.
Referenced methods: Existing principles distinguish the question, formulation, population, denominators, imaging disappearance, actual expulsion, size change, support and harms in the retained comparison of ground-seed capsules and placebo in adults with kidney stones.

Related sources R01

N34 · What dates are 2026-09-08 and the correction date?

Current findings: The original evidence date is 2026-09-08, the correction date is 2026-09-14 and the bibliography is from 2019.
Verification status: Partly verified
Materials actually read: The retained Korean and English summaries and bibliography were read. External articles, registration, plans and additional material remain unread, with no access attempt.
Why unverified: Information retained in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.
Reason for missing information: Actual external-reading dates, original trial-search cutoff and completion of a current literature search are absent or unverified.
Required materials and conditions: Roles of the original evidence date, correction/bibliography and current preparation date
Materials to obtain first: Original search, receipt, publication and correction records
Further research: Material needed: Original search, receipt, publication and correction records This records needed materials; no new research was executed.
Remaining uncertainty: Gaps remain in original denominators, allocation and masking, imaging assessment, the correspondence of disappearance and expulsion, conditions for spontaneous passage, missing data, prospective analyses, support roles and harms. Historical reconstructions are not presented as new calculations or adjusted estimates from the paper.
Conditions for verification: Original records on Roles of the original evidence date, correction/bibliography and current preparation date must link to the relevant report, analysis unit, timing and denominator, distinguishing recorded information from what remains unverified.
Why this condition is needed: Material on Roles of the original evidence date, correction/bibliography and current preparation date is needed to connect adult kidney stones to formulation, population, comparison, exposure, imaging, denominators, the effect of interest or harms.
Application exceptions: Ultrasound disappearance, actual expulsion, size reduction and dissolution mechanisms remain distinct. Randomized counts and historically reconstructed denominators or effects are not converted into confirmed paper values or harm denominators, or extended to other formulations, every stone, replacement of standard care or overall safety.
Referenced methods: Existing principles distinguish the question, formulation, population, denominators, imaging disappearance, actual expulsion, size change, support and harms in the retained comparison of ground-seed capsules and placebo in adults with kidney stones.

Related sources R01

N35 · Are generic English wording and the 1-field correction retained?

Current findings: The English reader answer gives approximately 12/27 and 4/26 and historical RR/CI. Generic explanations remain for English funding, endpoint and result fields, while the English participant explanation describes preservation without actual denominators. The correction records replacement of 1 field.
Verification status: Partly verified
Materials actually read: The retained Korean and English summaries and bibliography were read. External articles, registration, plans and additional material remain unread, with no access attempt.
Why unverified: Information retained in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.
Reason for missing information: The specific field and its before/after originals, and review of current detailed English correspondence, remain unverified.
Required materials and conditions: Korean/English numbers, generic explanations and before/after correction events
Materials to obtain first: Complete before/after correction originals and English result/denominator correspondence
Further research: Material needed: Complete before/after correction originals and English result/denominator correspondence This records needed materials; no new research was executed.
Remaining uncertainty: Gaps remain in original denominators, allocation and masking, imaging assessment, the correspondence of disappearance and expulsion, conditions for spontaneous passage, missing data, prospective analyses, support roles and harms. Historical reconstructions are not presented as new calculations or adjusted estimates from the paper.
Conditions for verification: Original records on Korean/English numbers, generic explanations and before/after correction events must link to the relevant report, analysis unit, timing and denominator, distinguishing recorded information from what remains unverified.
Why this condition is needed: Material on Korean/English numbers, generic explanations and before/after correction events is needed to connect adult kidney stones to formulation, population, comparison, exposure, imaging, denominators, the effect of interest or harms.
Application exceptions: Ultrasound disappearance, actual expulsion, size reduction and dissolution mechanisms remain distinct. Randomized counts and historically reconstructed denominators or effects are not converted into confirmed paper values or harm denominators, or extended to other formulations, every stone, replacement of standard care or overall safety.
Referenced methods: Existing principles distinguish the question, formulation, population, denominators, imaging disappearance, actual expulsion, size change, support and harms in the retained comparison of ground-seed capsules and placebo in adults with kidney stones.

Related sources R01

N36 · What roles do C56 and historical Codex reconstruction/cross-checks have here?

Current findings: The original C56, Caution, B/H/R1/I2/E+/B2/C0 axes and historical independent Codex cross-check/reconstruction wording are preserved in the original copy.
Verification status: Partly verified
Materials actually read: The retained Korean and English summaries and bibliography were read. External articles, registration, plans and additional material remain unread, with no access attempt.
Why unverified: Information retained in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.
Reason for missing information: Current content review, external clinical validation and official assessment certification remain incomplete.
Required materials and conditions: Separate grade, score, caution label, axes, verdict decisions, historical calculation and current preparation
Materials to obtain first: Original verdict/reconstruction events and separately authorized subsequent corrections
Further research: Material needed: Original verdict/reconstruction events and separately authorized subsequent corrections This records needed materials; no new research was executed.
Remaining uncertainty: Gaps remain in original denominators, allocation and masking, imaging assessment, the correspondence of disappearance and expulsion, conditions for spontaneous passage, missing data, prospective analyses, support roles and harms. Historical reconstructions are not presented as new calculations or adjusted estimates from the paper.
Conditions for verification: Original records on Separate grade, score, caution label, axes, verdict decisions, historical calculation and current preparation must link to the relevant report, analysis unit, timing and denominator, distinguishing recorded information from what remains unverified.
Why this condition is needed: Material on Separate grade, score, caution label, axes, verdict decisions, historical calculation and current preparation is needed to connect adult kidney stones to formulation, population, comparison, exposure, imaging, denominators, the effect of interest or harms.
Application exceptions: Ultrasound disappearance, actual expulsion, size reduction and dissolution mechanisms remain distinct. Randomized counts and historically reconstructed denominators or effects are not converted into confirmed paper values or harm denominators, or extended to other formulations, every stone, replacement of standard care or overall safety.
Referenced methods: Existing principles distinguish the question, formulation, population, denominators, imaging disappearance, actual expulsion, size change, support and harms in the retained comparison of ground-seed capsules and placebo in adults with kidney stones.

Related sources R01

N37 · From which denominators were actual adverse events for this formulation collected?

Current findings: The original safety text states that small trials do not exclude rare adverse events or long-term safety concerns.
Verification status: Partly verified
Materials actually read: The retained Korean and English summaries and bibliography were read. External articles, registration, plans and additional material remain unread, with no access attempt.
Why unverified: Information retained in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.
Reason for missing information: Trial-formulation event counts, collection/discontinuation, group denominators, durations and omissions remain unverified.
Required materials and conditions: Event definitions/collection, group event/person counts, harm denominators and discontinuation/missingness
Materials to obtain first: Original adverse-event/discontinuation tables and group-specific collection/denominators
Further research: Material needed: Original adverse-event/discontinuation tables and group-specific collection/denominators This records needed materials; no new research was executed.
Remaining uncertainty: Gaps remain in original denominators, allocation and masking, imaging assessment, the correspondence of disappearance and expulsion, conditions for spontaneous passage, missing data, prospective analyses, support roles and harms. Historical reconstructions are not presented as new calculations or adjusted estimates from the paper.
Conditions for verification: Original records on Event definitions/collection, group event/person counts, harm denominators and discontinuation/missingness must link to the relevant report, analysis unit, timing and denominator, distinguishing recorded information from what remains unverified.
Why this condition is needed: Material on Event definitions/collection, group event/person counts, harm denominators and discontinuation/missingness is needed to connect adult kidney stones to formulation, population, comparison, exposure, imaging, denominators, the effect of interest or harms.
Application exceptions: Ultrasound disappearance, actual expulsion, size reduction and dissolution mechanisms remain distinct. Randomized counts and historically reconstructed denominators or effects are not converted into confirmed paper values or harm denominators, or extended to other formulations, every stone, replacement of standard care or overall safety.
Referenced methods: Existing principles distinguish the question, formulation, population, denominators, imaging disappearance, actual expulsion, size change, support and harms in the retained comparison of ground-seed capsules and placebo in adults with kidney stones.

Related sources R01

N38 · What are the onset/recovery and concomitant-condition/treatment limits for harms?

Current findings: The original text records the oral 10-week exposure and general cautionary wording.
Verification status: Unverified
Materials actually read: The retained Korean and English summaries and bibliography were read. External articles, registration, plans and additional material remain unread, with no access attempt.
Why unverified: Information retained in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.
Reason for missing information: Individual harm onset/recovery, improvement after discontinuation/re-exposure and alternative explanations involving kidney disease/concomitant drugs remain unverified.
Required materials and conditions: Event timing, discontinuation/re-exposure, baseline conditions/concomitant drugs and alternative causes
Materials to obtain first: Individual event timing, concomitant treatment/baseline conditions and causal material
Further research: Material needed: Individual event timing, concomitant treatment/baseline conditions and causal material This records needed materials; no new research was executed.
Remaining uncertainty: Gaps remain in original denominators, allocation and masking, imaging assessment, the correspondence of disappearance and expulsion, conditions for spontaneous passage, missing data, prospective analyses, support roles and harms. Historical reconstructions are not presented as new calculations or adjusted estimates from the paper.
Conditions for verification: Original records on Event timing, discontinuation/re-exposure, baseline conditions/concomitant drugs and alternative causes must link to the relevant report, analysis unit, timing and denominator, distinguishing recorded information from what remains unverified.
Why this condition is needed: Material on Event timing, discontinuation/re-exposure, baseline conditions/concomitant drugs and alternative causes is needed to connect adult kidney stones to formulation, population, comparison, exposure, imaging, denominators, the effect of interest or harms.
Application exceptions: Ultrasound disappearance, actual expulsion, size reduction and dissolution mechanisms remain distinct. Randomized counts and historically reconstructed denominators or effects are not converted into confirmed paper values or harm denominators, or extended to other formulations, every stone, replacement of standard care or overall safety.
Referenced methods: Existing principles distinguish the question, formulation, population, denominators, imaging disappearance, actual expulsion, size change, support and harms in the retained comparison of ground-seed capsules and placebo in adults with kidney stones.

Related sources R01

N39 · Are drugs mentioned in cautions actual interaction events?

Current findings: The retained safety explanation preserves cautionary wording to consult a clinician while taking relevant drugs.
Verification status: Unverified
Materials actually read: The retained Korean and English summaries and bibliography were read. External articles, registration, plans and additional material remain unread, with no access attempt.
Why unverified: Information retained in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.
Reason for missing information: Trial concomitant-use/exclusion, specific interaction events/denominators and drug-specific causal material remain unverified.
Required materials and conditions: Glucose-lowering, blood-pressure, anticoagulant, antiseizure and immunomodulatory drugs, exposures/events and alternatives
Materials to obtain first: Drug-specific exposure/formulation and original interaction material
Further research: Material needed: Drug-specific exposure/formulation and original interaction material This records needed materials; no new research was executed.
Remaining uncertainty: Gaps remain in original denominators, allocation and masking, imaging assessment, the correspondence of disappearance and expulsion, conditions for spontaneous passage, missing data, prospective analyses, support roles and harms. Historical reconstructions are not presented as new calculations or adjusted estimates from the paper.
Conditions for verification: Original records on Glucose-lowering, blood-pressure, anticoagulant, antiseizure and immunomodulatory drugs, exposures/events and alternatives must link to the relevant report, analysis unit, timing and denominator, distinguishing recorded information from what remains unverified.
Why this condition is needed: Material on Glucose-lowering, blood-pressure, anticoagulant, antiseizure and immunomodulatory drugs, exposures/events and alternatives is needed to connect adult kidney stones to formulation, population, comparison, exposure, imaging, denominators, the effect of interest or harms.
Application exceptions: Ultrasound disappearance, actual expulsion, size reduction and dissolution mechanisms remain distinct. Randomized counts and historically reconstructed denominators or effects are not converted into confirmed paper values or harm denominators, or extended to other formulations, every stone, replacement of standard care or overall safety.
Referenced methods: Existing principles distinguish the question, formulation, population, denominators, imaging disappearance, actual expulsion, size change, support and harms in the retained comparison of ground-seed capsules and placebo in adults with kidney stones.

Related sources R01

N40 · What remains unknown about rare/long-term safety and vulnerable groups?

Current findings: The original text describes constituent differences between products/extraction methods, cautions for vulnerable groups/perioperative use and the inability of small trials to exclude rare/long-term harms.
Verification status: Partly verified
Materials actually read: The retained Korean and English summaries and bibliography were read. External articles, registration, plans and additional material remain unread, with no access attempt.
Why unverified: Information retained in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.
Reason for missing information: Direct material for this formulation on long-term/rare events, vulnerable groups, perioperative use and kidney function remains unverified.
Required materials and conditions: Duration/formulation, pregnancy/breastfeeding, children, liver/kidney disease, perioperative use and rare harms
Materials to obtain first: Long-term/rare, formulation-specific and population-specific harm material
Further research: Material needed: Long-term/rare, formulation-specific and population-specific harm material This records needed materials; no new research was executed.
Remaining uncertainty: Gaps remain in original denominators, allocation and masking, imaging assessment, the correspondence of disappearance and expulsion, conditions for spontaneous passage, missing data, prospective analyses, support roles and harms. Historical reconstructions are not presented as new calculations or adjusted estimates from the paper.
Conditions for verification: Original records on Duration/formulation, pregnancy/breastfeeding, children, liver/kidney disease, perioperative use and rare harms must link to the relevant report, analysis unit, timing and denominator, distinguishing recorded information from what remains unverified.
Why this condition is needed: Material on Duration/formulation, pregnancy/breastfeeding, children, liver/kidney disease, perioperative use and rare harms is needed to connect adult kidney stones to formulation, population, comparison, exposure, imaging, denominators, the effect of interest or harms.
Application exceptions: Ultrasound disappearance, actual expulsion, size reduction and dissolution mechanisms remain distinct. Randomized counts and historically reconstructed denominators or effects are not converted into confirmed paper values or harm denominators, or extended to other formulations, every stone, replacement of standard care or overall safety.
Referenced methods: Existing principles distinguish the question, formulation, population, denominators, imaging disappearance, actual expulsion, size change, support and harms in the retained comparison of ground-seed capsules and placebo in adults with kidney stones.

Related sources R01

N41 · Is the same formulation/event recorded in independent material?

Current findings: The retained text preserves general cautionary wording and does not present an actual unique-case list.
Verification status: Unverified
Materials actually read: The retained Korean and English summaries and bibliography were read. External articles, registration, plans and additional material remain unread, with no access attempt.
Why unverified: Information retained in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.
Reason for missing information: Independent harm cases versus recitations, repeated matching exposures/events and case denominators remain unverified.
Required materials and conditions: Unique harm cases, report families and matching formulation/exposure/event
Materials to obtain first: Unique cases/report families and actual formulation/exposure material
Further research: Material needed: Unique cases/report families and actual formulation/exposure material This records needed materials; no new research was executed.
Remaining uncertainty: Gaps remain in original denominators, allocation and masking, imaging assessment, the correspondence of disappearance and expulsion, conditions for spontaneous passage, missing data, prospective analyses, support roles and harms. Historical reconstructions are not presented as new calculations or adjusted estimates from the paper.
Conditions for verification: Original records on Unique harm cases, report families and matching formulation/exposure/event must link to the relevant report, analysis unit, timing and denominator, distinguishing recorded information from what remains unverified.
Why this condition is needed: Material on Unique harm cases, report families and matching formulation/exposure/event is needed to connect adult kidney stones to formulation, population, comparison, exposure, imaging, denominators, the effect of interest or harms.
Application exceptions: Ultrasound disappearance, actual expulsion, size reduction and dissolution mechanisms remain distinct. Randomized counts and historically reconstructed denominators or effects are not converted into confirmed paper values or harm denominators, or extended to other formulations, every stone, replacement of standard care or overall safety.
Referenced methods: Existing principles distinguish the question, formulation, population, denominators, imaging disappearance, actual expulsion, size change, support and harms in the retained comparison of ground-seed capsules and placebo in adults with kidney stones.

Related sources R01

N42 · How are unread material and subsequent changes connected?

Current findings: The stored JSON summary is used for preparation and only the original PubMed link is connected. External material was unread, with no access attempt.
Verification status: Partly verified
Materials actually read: The retained Korean and English summaries and bibliography were read. External articles, registration, plans and additional material remain unread, with no access attempt.
Why unverified: Information retained in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.
Reason for missing information: Original denominators/imaging, registration/plans/product/concomitant-use/harm material and existing-content review remain outstanding.
Required materials and conditions: Stored summary, external articles/registration/denominators/imaging, complete pre-change originals and condition/evidence events
Materials to obtain first: User-provided or separately authorized original material and corrections
Further research: Material needed: User-provided or separately authorized original material and corrections This records needed materials; no new research was executed.
Remaining uncertainty: Gaps remain in original denominators, allocation and masking, imaging assessment, the correspondence of disappearance and expulsion, conditions for spontaneous passage, missing data, prospective analyses, support roles and harms. Historical reconstructions are not presented as new calculations or adjusted estimates from the paper.
Conditions for verification: Original records on Stored summary, external articles/registration/denominators/imaging, complete pre-change originals and condition/evidence events must link to the relevant report, analysis unit, timing and denominator, distinguishing recorded information from what remains unverified.
Why this condition is needed: Material on Stored summary, external articles/registration/denominators/imaging, complete pre-change originals and condition/evidence events is needed to connect adult kidney stones to formulation, population, comparison, exposure, imaging, denominators, the effect of interest or harms.
Application exceptions: Ultrasound disappearance, actual expulsion, size reduction and dissolution mechanisms remain distinct. Randomized counts and historically reconstructed denominators or effects are not converted into confirmed paper values or harm denominators, or extended to other formulations, every stone, replacement of standard care or overall safety.
Referenced methods: Existing principles distinguish the question, formulation, population, denominators, imaging disappearance, actual expulsion, size change, support and harms in the retained comparison of ground-seed capsules and placebo in adults with kidney stones.

Related sources R01