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

Verdict 3033 · Evidence Check

Stored-material review date: Not recorded  
Original evidence cut-off: 2026-09-08  
Review-criteria version: 1.0  
Public page/material preparation date: 2026-10-24

Clinical papers were not read directly; existing review summaries were checked. No new clinical-literature search was performed. Unverified does not mean that research is absent or that there is no effect.

## Assessment scope

- 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.

## Checklist items

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

Verification status: Partly verified  
Reading scope: The retained Korean and English summaries and bibliography were read. External articles, registration, plans and additional material remain unread, with no access attempt.

- Current findings: The original effect description concerns increased complete clearance or expulsion of adult kidney stones; the selected endpoint is complete disappearance on ultrasound.
- 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.
- 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.
- 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.
- 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?

Verification status: Partly verified  
Reading scope: The retained Korean and English summaries and bibliography were read. External articles, registration, plans and additional material remain unread, with no access attempt.

- Current findings: The retained intervention description specifies Nigella sativa L. seeds and ground-seed 500 mg capsules.
- 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.
- 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.
- 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.
- 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?

Verification status: Partly verified  
Reading scope: The retained Korean and English summaries and bibliography were read. External articles, registration, plans and additional material remain unread, with no access attempt.

- Current findings: The original product description states that seed powder, fixed oil, aqueous extracts, ethanolic topical preparations, purified thymoquinone and combinations are not interchangeable.
- 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.
- 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.
- 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.
- 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?

Verification status: Partly verified  
Reading scope: The retained Korean and English summaries and bibliography were read. External articles, registration, plans and additional material remain unread, with no access attempt.

- Current findings: The original dose is 500 mg, 2 times daily.
- 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.
- 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.
- 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.
- 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?

Verification status: Partly verified  
Reading scope: The retained Korean and English summaries and bibliography were read. External articles, registration, plans and additional material remain unread, with no access attempt.

- Current findings: The retained duration is 10 weeks of treatment and ultrasound follow-up.
- 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.
- 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.
- 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.
- 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?

Verification status: Partly verified  
Reading scope: The retained Korean and English summaries and bibliography were read. External articles, registration, plans and additional material remain unread, with no access attempt.

- Current findings: The retained population is limited to adults with kidney stones.
- 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.
- 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.
- 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.
- 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?

Verification status: Partly verified  
Reading scope: The retained Korean and English summaries and bibliography were read. External articles, registration, plans and additional material remain unread, with no access attempt.

- 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.
- 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.
- 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.
- 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.
- 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?

Verification status: Partly verified  
Reading scope: The retained Korean and English summaries and bibliography were read. External articles, registration, plans and additional material remain unread, with no access attempt.

- Current findings: The retained comparison is matched placebo and the design description is a randomized, triple-blind, placebo trial.
- 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.
- 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.
- 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.
- 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?

Verification status: Unverified  
Reading scope: The retained Korean and English summaries and bibliography were read. External articles, registration, plans and additional material remain unread, with no access attempt.

- Current findings: The original explanation mentions limited reporting of hydration, stone location and spontaneous-passage influences.
- 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.
- 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.
- 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.
- 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?

Verification status: Partly verified  
Reading scope: The retained Korean and English summaries and bibliography were read. External articles, registration, plans and additional material remain unread, with no access attempt.

- Current findings: The retained principal endpoint is complete disappearance of stones on ultrasound. The original effect description uses both disappearance and expulsion.
- 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.
- 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.
- 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.
- 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?

Verification status: Unverified  
Reading scope: The retained Korean and English summaries and bibliography were read. External articles, registration, plans and additional material remain unread, with no access attempt.

- Current findings: The article title includes kidney stone dissolution, but the retained verdict selects complete ultrasound disappearance.
- 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.
- 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.
- 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.
- 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?

Verification status: Unverified  
Reading scope: The retained Korean and English summaries and bibliography were read. External articles, registration, plans and additional material remain unread, with no access attempt.

- 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.
- 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.
- 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.
- 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.
- 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?

Verification status: Unverified  
Reading scope: The retained Korean and English summaries and bibliography were read. External articles, registration, plans and additional material remain unread, with no access attempt.

- Current findings: The original text describes ultrasound assessment of stone status and limited reporting of imaging-assessment procedures.
- 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.
- 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.
- 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.
- 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?

Verification status: Partly verified  
Reading scope: The retained Korean and English summaries and bibliography were read. External articles, registration, plans and additional material remain unread, with no access attempt.

- Current findings: The retained participant record states 60 randomized; percentage-based analysis approximately 27 versus 26.
- 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.
- 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.
- 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.
- 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?

Verification status: Partly verified  
Reading scope: The retained Korean and English summaries and bibliography were read. External articles, registration, plans and additional material remain unread, with no access attempt.

- 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.
- 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.
- 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.
- 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.
- 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?

Verification status: Partly verified  
Reading scope: The retained Korean and English summaries and bibliography were read. External articles, registration, plans and additional material remain unread, with no access attempt.

- Current findings: The result labels 12/27 versus 4/26 as reconstructed, while the reader answer presents approximately 12/27 versus 4/26.
- 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.
- 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.
- 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.
- 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?

Verification status: Partly verified  
Reading scope: The retained Korean and English summaries and bibliography were read. External articles, registration, plans and additional material remain unread, with no access attempt.

- Current findings: The original result and reader answer report complete disappearance of 44.4% versus 15.3%.
- 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.
- 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.
- 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.
- 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?

Verification status: Partly verified  
Reading scope: The retained Korean and English summaries and bibliography were read. External articles, registration, plans and additional material remain unread, with no access attempt.

- 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.
- 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.
- 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.
- 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.
- 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?

Verification status: Partly verified  
Reading scope: The retained Korean and English summaries and bibliography were read. External articles, registration, plans and additional material remain unread, with no access attempt.

- 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.
- 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.
- 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.
- 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.
- 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

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

Verification status: Unverified  
Reading scope: The retained Korean and English summaries and bibliography were read. External articles, registration, plans and additional material remain unread, with no access attempt.

- Current findings: The retained intervention record labels complete ultrasound disappearance as the primary endpoint; the registration identifier is unconfirmed.
- 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.
- 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.
- 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.
- 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?

Verification status: Unverified  
Reading scope: The retained Korean and English summaries and bibliography were read. External articles, registration, plans and additional material remain unread, with no access attempt.

- Current findings: The original design is described as a randomized, triple-blind, placebo trial, with 60 randomized participants.
- 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.
- 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.
- 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.
- 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?

Verification status: Unverified  
Reading scope: The retained Korean and English summaries and bibliography were read. External articles, registration, plans and additional material remain unread, with no access attempt.

- Current findings: The original design description states triple blinding.
- 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.
- 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.
- 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.
- 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

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

Verification status: Unverified  
Reading scope: The retained Korean and English summaries and bibliography were read. External articles, registration, plans and additional material remain unread, with no access attempt.

- Current findings: The original record specifies 500 mg, 2 times daily, 10 weeks of treatment and comparison with placebo.
- 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.
- 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.
- 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.
- 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

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

Verification status: Unverified  
Reading scope: The retained Korean and English summaries and bibliography were read. External articles, registration, plans and additional material remain unread, with no access attempt.

- Current findings: The original participant record combines 60 randomized with percentage-based analysis of approximately 27/26.
- 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.
- 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.
- 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.
- 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?

Verification status: Unverified  
Reading scope: The retained Korean and English summaries and bibliography were read. External articles, registration, plans and additional material remain unread, with no access attempt.

- Current findings: The recorded duration is 10 weeks of treatment and ultrasound follow-up.
- 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.
- 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.
- 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.
- 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?

Verification status: Unverified  
Reading scope: The retained Korean and English summaries and bibliography were read. External articles, registration, plans and additional material remain unread, with no access attempt.

- Current findings: The original reader answer explains 12/27 and 4/26 in the context of participant denominators.
- 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.
- 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.
- 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.
- 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?

Verification status: Unverified  
Reading scope: The retained Korean and English summaries and bibliography were read. External articles, registration, plans and additional material remain unread, with no access attempt.

- Current findings: The original explanation describes limited reporting of hydration, stone location and spontaneous-passage influences.
- 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.
- 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.
- 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.
- 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?

Verification status: Unverified  
Reading scope: The retained Korean and English summaries and bibliography were read. External articles, registration, plans and additional material remain unread, with no access attempt.

- Current findings: The original endpoint description separates complete disappearance from size reduction; the registration identifier is unconfirmed.
- 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.
- 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.
- 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.
- 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?

Verification status: Unverified  
Reading scope: The retained Korean and English summaries and bibliography were read. External articles, registration, plans and additional material remain unread, with no access attempt.

- 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.
- 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.
- 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.
- 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.
- 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?

Verification status: Partly verified  
Reading scope: The retained Korean and English summaries and bibliography were read. External articles, registration, plans and additional material remain unread, with no access attempt.

- Current findings: The original citation is Ardakani Movaghati MR et al., Phytother Res.2019, PMID30873671, DOI10.1002/ptr.6331.
- 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.
- 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.
- 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.
- 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

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

Verification status: Partly verified  
Reading scope: The retained Korean and English summaries and bibliography were read. External articles, registration, plans and additional material remain unread, with no access attempt.

- 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.
- 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.
- 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.
- 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.
- 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?

Verification status: Unverified  
Reading scope: The retained Korean and English summaries and bibliography were read. External articles, registration, plans and additional material remain unread, with no access attempt.

- Current findings: The original funding record states support from Mashhad University.
- 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.
- 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.
- 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.
- 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?

Verification status: Partly verified  
Reading scope: The retained Korean and English summaries and bibliography were read. External articles, registration, plans and additional material remain unread, with no access attempt.

- Current findings: The clinical material read was the entire stored JSON summary. The PubMed URL is recorded as in the original citation.
- 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.
- 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.
- 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.
- 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?

Verification status: Partly verified  
Reading scope: The retained Korean and English summaries and bibliography were read. External articles, registration, plans and additional material remain unread, with no access attempt.

- Current findings: The original evidence date is 2026-09-08, the correction date is 2026-09-14 and the bibliography is from 2019.
- 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.
- 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.
- 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.
- 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?

Verification status: Partly verified  
Reading scope: The retained Korean and English summaries and bibliography were read. External articles, registration, plans and additional material remain unread, with no access attempt.

- 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.
- 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.
- 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.
- 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.
- 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?

Verification status: Partly verified  
Reading scope: The retained Korean and English summaries and bibliography were read. External articles, registration, plans and additional material remain unread, with no access attempt.

- 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.
- 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.
- 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.
- 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.
- 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?

Verification status: Partly verified  
Reading scope: The retained Korean and English summaries and bibliography were read. External articles, registration, plans and additional material remain unread, with no access attempt.

- Current findings: The original safety text states that small trials do not exclude rare adverse events or long-term safety concerns.
- 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.
- 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.
- 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.
- 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?

Verification status: Unverified  
Reading scope: The retained Korean and English summaries and bibliography were read. External articles, registration, plans and additional material remain unread, with no access attempt.

- Current findings: The original text records the oral 10-week exposure and general cautionary wording.
- 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.
- 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.
- 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.
- 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?

Verification status: Unverified  
Reading scope: The retained Korean and English summaries and bibliography were read. External articles, registration, plans and additional material remain unread, with no access attempt.

- Current findings: The retained safety explanation preserves cautionary wording to consult a clinician while taking relevant drugs.
- 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.
- 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.
- 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.
- 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?

Verification status: Partly verified  
Reading scope: The retained Korean and English summaries and bibliography were read. External articles, registration, plans and additional material remain unread, with no access attempt.

- 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.
- 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.
- 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.
- 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.
- 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?

Verification status: Unverified  
Reading scope: The retained Korean and English summaries and bibliography were read. External articles, registration, plans and additional material remain unread, with no access attempt.

- Current findings: The retained text preserves general cautionary wording and does not present an actual unique-case list.
- 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.
- 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.
- 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.
- 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?

Verification status: Partly verified  
Reading scope: The retained Korean and English summaries and bibliography were read. External articles, registration, plans and additional material remain unread, with no access attempt.

- 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.
- 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.
- 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.
- 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.
- 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

## Evidence and sources

### R01

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

[PubMed](https://pubmed.ncbi.nlm.nih.gov/30873671/)

Materials actually read: Summary read; external abstracts/full text, registration and plans unread, with no access attempt  
Findings recorded in the 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.  
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.

| 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. |

## Review criteria and methods

These are Chamgap's own application conditions, informed by the relevant sections of official methodological guidance. They do not constitute official assessment-tool certification or a new efficacy score.

- M03 [Cochrane Handbook 6.5 (2024), chapter updated 2023-08](https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-03) · §3.1, §3.2.1–3.2.3, MECIR C5/C7/C13 · Clearly record the question, eligibility conditions and reasons for changes, and distinguish variations in interventions. · 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](https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-04) · §4.5, §4.6.1–4.6.3, MECIR C42 · Distinguish studies from reports and link them; do not omit a study solely because results are unreported. · 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](https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-08) · §8.1–8.2.3, Table 8.2.a · Define the outcome and effect of interest, then examine randomization, deviations, missing data, measurement and selective reporting. · 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](https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-15) · §15.2.4, §15.3.1–15.3.3 · Distinguish effect estimates, intervals, importance and applicability. Sample size alone does not determine precision. · 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](https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-19) · §19.1.2, §19.2.1–19.2.4 · Harm questions may require different designs, populations and follow-up from efficacy questions. Case reports do not establish incidence rates. · 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/materials 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.
