Oral Nigella sativa seed powder plus omeprazole × Claimed equivalence to standard triple therapy for H. pylori eradication

Required evidence, verification status and materials actually read
Item	AVerification status	BReading scope	CReview item	DCurrent findings	EWhy unverified	FRequired materials and conditions	GFurther research
1	Partly verified	Full text not readStored summary read	N01 · Evidence conditionWhat is the exact scope of the equivalence claim?Required	The original claim is equivalence to standard 3-drug therapy for H. pylori eradication. The selected question remains the 2 g arm of the seed-powder-plus-PPI combination. S01	Information retained in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, equivalence, safety, prespecification and independence are not certified.	The question of 2 g Nigella powder plus omeprazole, adults, eradication and equivalence to standard 3-drug therapy	Material needed: Original records defining the exact population, formulation, dose, comparison and equivalence question This records needed materials; no new research was executed.
2	Partly verified	Full text not readStored summary read	N02 · Evidence conditionWhich materials were actually read?Required	The complete stored summary, 1 evidence entry and 1 citation were used for preparation. External abstracts, full text, registration, protocol and SAP were unread, with no access attempted. S01	Information retained in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, equivalence, safety, prespecification and independence are not certified.	Separate reading records for the stored JSON summary, external article, registration and plans	Material needed: Original materials and access histories supplied by the user or acquired in subsequent work This records needed materials; no new research was executed.
3	Partly verified	Full text not readStored summary read	N03 · Evidence conditionWhat is the identity of the report?Required	The stored comparative study is by Salem EM et al., Saudi J Gastroenterol 2010, PMID20616418, PMCIDPMC3003218 and DOI10.4103/1319-3767.65201. S01	Information retained in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, equivalence, safety, prespecification and independence are not certified.	Link the authors, year, title, PMID/PMCID/DOI and report	Material needed: Complete original bibliography, related reports and registration lists This records needed materials; no new research was executed.
4	Partly verified	Full text not readStored summary read	N04 · Evidence conditionHow do the 4 arms relate within the comparison?Required	The stored material is a report of an open-label alternate-allocation 4-arm comparison. The 1, 2 and 3 g arms are not turned into three independent trials, and the shared 3-drug group is not repeatedly pooled. S01	Information retained in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, equivalence, safety, prespecification and independence are not certified.	3-drug therapy, 1/2/3 g arms, the shared comparison group and participant relationships	Material needed: Original arm structure, participant flow and lists of related reports This records needed materials; no new research was executed.
5	Partly verified	Full text not readStored summary read	N05 · Evidence conditionTo which adults does the question apply?Required	The population is adults with H. pylori-positive nonulcer dyspepsia. S01	Information retained in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, equivalence, safety, prespecification and independence are not certified.	H. pylori-positive nonulcer dyspepsia, selection/exclusion and baseline status	Material needed: Selection criteria, baseline characteristics and prior-treatment/resistance tables This records needed materials; no new research was executed.
6	Partly verified	Full text not readStored summary read	N06 · Evidence conditionWhat is the seed-powder preparation?Required	The preparation is a combination of Nigella sativa L. seed-powder capsules and a PPI. S01	Information retained in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, equivalence, safety, prespecification and independence are not certified.	Powder capsules, plant part, constituent content, quality and batch	Material needed: Trial-product specifications and constituent/batch records This records needed materials; no new research was executed.
7	Partly verified	Full text not readStored summary read	N07 · Evidence conditionWhat combined dose was used in the selected 2 g arm?Required	The record of 2 g/day seed powder plus 40 mg/day omeprazole is retained. S01	Information retained in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, equivalence, safety, prespecification and independence are not certified.	Nominal and actual powder and omeprazole doses, dosing frequency and adherence	Material needed: Arm-specific dose, administration and adherence tables This records needed materials; no new research was executed.
8	Partly verified	Full text not readStored summary read	N08 · Evidence conditionIs the PPI used in every Nigella arm distinguished?Required	The stored summary records concomitant omeprazole in every Nigella arm. S01	Information retained in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, equivalence, safety, prespecification and independence are not certified.	Shared omeprazole, arm-specific concomitant treatment and limits on attributing effects to Nigella alone	Material needed: Direct comparisons or factorial records separating PPI/Nigella alone and in combination This records needed materials; no new research was executed.
9	Partly verified	Full text not readStored summary read	N09 · Evidence conditionWhat treatment formed the standard 3-drug comparison?Required	The principal comparison is standard 3-drug therapy with clarithromycin, amoxicillin and omeprazole. S01	Information retained in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, equivalence, safety, prespecification and independence are not certified.	Doses, duration and adherence for clarithromycin, amoxicillin and omeprazole	Material needed: Arm-specific drug doses/durations, adherence and treatment-setting specifications This records needed materials; no new research was executed.
10	Partly verified	Full text not readStored summary read	N10 · Evidence conditionAre treatment and test timing distinguished?Required	The selected question specifies 4 weeks of treatment followed by stool-antigen testing 4 weeks after treatment ends. S01	Information retained in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, equivalence, safety, prespecification and independence are not certified.	4 weeks of treatment, testing 4 weeks after completion and arm-specific schedules	Material needed: Treatment/test schedules and arm-specific visit records This records needed materials; no new research was executed.
11	Partly verified	Full text not readStored summary read	N11 · Evidence conditionAre alternate allocation and randomization distinguished?Required	The original design is an open-label alternate-allocation 4-arm comparison; it is not promoted into a randomized RCT. S01	Information retained in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, equivalence, safety, prespecification and independence are not certified.	Actual allocation method, concealment and baseline balance	Material needed: Allocation methods, baseline tables and adjustment plans This records needed materials; no new research was executed.
12	Partly verified	Full text not readStored summary read	N12 · Evidence conditionWhat measurement or behavioral differences may accompany open-label design?Required	The original open-label design and stool-antigen endpoint are retained. S01	Information retained in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, equivalence, safety, prespecification and independence are not certified.	Masking of participants, treatment providers and test assessors, with arm-specific behavior/measurement	Material needed: Records of masking, test conduct and additional treatment in each arm This records needed materials; no new research was executed.
13	Partly verified	Full text not readStored summary read	N13 · Evidence conditionWhat criteria identify eradication?Required	The selected endpoint is negative H. pylori stool antigen 4 weeks after treatment ends. S01	Information retained in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, equivalence, safety, prespecification and independence are not certified.	Stool-antigen testing, negativity criteria, assay, test timing and medication conditions	Material needed: Assay details, classification/medication-discontinuation rules and test records This records needed materials; no new research was executed.
14	Partly verified	Full text not readStored summary read	N14 · Evidence conditionHow do 110 assigned participants relate to 88 analyzed participants?Required	The original records of 110 assigned, 88 analyzed and analysis denominators 23/21/21/23 are retained. S01	Information retained in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, equivalence, safety, prespecification and independence are not certified.	Allocation, completion, testing, analysis and arm-specific denominators	Material needed: Participant-flow and arm-specific allocation/testing/analysis tables This records needed materials; no new research was executed.
15	Unverified	Full text not readStored summary read	N15 · Evidence conditionHow were attrition and missing data handled?Required	The stored summary describes completer analysis and 88 analyzed after 110 were assigned. S01	Information retained in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, equivalence, safety, prespecification and independence are not certified.	Arm-specific attrition, reasons, denominators, missingness and completer/ITT/PP populations	Material needed: Reasons for attrition/missingness, analysis populations and sensitivity analyses This records needed materials; no new research was executed.
16	Partly verified	Full text not readStored summary read	N16 · Evidence conditionWhich denominators underlie the 2 g and 3-drug eradication results?Required	Among completers, 2 g plus omeprazole 14/21 (66.7%) and standard 3-drug therapy 19/23 (82.6%) are retained. S01	Information retained in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, equivalence, safety, prespecification and independence are not certified.	Original eradication events/denominators, the completer population and comparison direction	Material needed: Arm-specific eradication tables, assigned/completer analyses and original intervals This records needed materials; no new research was executed.
17	Partly verified	Full text not readStored summary read	N17 · Evidence conditionHow are the 1 g and 3 g arm results kept separate?Required	The original results of 1 g 10/21 and 3 g 11/23, with stored approximate percentages of 47.6% and 47.8%, are retained. Values from the selected 2 g arm are not reassigned to other doses. S01	Information retained in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, equivalence, safety, prespecification and independence are not certified.	Eradication denominators/results for the other dose arms and direct dose comparisons	Material needed: Arm-specific dose contrasts, intervals and prospective plans This records needed materials; no new research was executed.
18	Partly verified	Full text not readStored summary read	N18 · Evidence conditionIs a nonsignificant difference kept distinct from equivalence?Required	The stored summary records that the P value against standard treatment was nonsignificant, while P>.05 alone does not establish equivalence. S01	Information retained in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, equivalence, safety, prespecification and independence are not certified.	Distinguish superiority P values from equivalence/noninferiority questions	Material needed: Original tests, hypotheses and equivalence plans This records needed materials; no new research was executed.
19	Unverified	Full text not readStored summary read	N19 · Evidence conditionWas a noninferiority/equivalence margin prespecified?Required	The stored result records “no equivalence margin,” and the summary describes absence of an equivalence design. S01	Information retained in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, equivalence, safety, prespecification and independence are not certified.	Clinically acceptable margins, one-/two-sided hypotheses, justification and testing plans	Material needed: Original protocol, SAP and margin justification This records needed materials; no new research was executed.
20	Unverified	Full text not readStored summary read	N20 · Evidence conditionWere sample size and analysis adequate for the equivalence question?Required	The stored summary records that antibiotic replacement/equivalent treatment cannot be claimed without adequate sample size and a noninferiority margin. S01	Information retained in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, equivalence, safety, prespecification and independence are not certified.	Prospective sample-size planning, ITT/PP, failure/missing-data assumptions and intervals against the margin	Material needed: Sample-size plans, ITT/PP/SAP and missing-data sensitivity analyses This records needed materials; no new research was executed.
21	Partly verified	Full text not readStored summary read	N21 · Evidence conditionWhat historical event produced the risk difference and CI?Required	The historical wording retained in the Korean and English verdict rationale is “Codex reconstructed risk difference −15.9 percentage points, approximate 95% CI −41.8 to +10.0 percentage points.” S01	Information retained in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, equivalence, safety, prespecification and independence are not certified.	Distinguish original article intervals from the historical Codex recalculation	Material needed: Historical calculation records/methods, comparison with the original article and a separate change event This records needed materials; no new research was executed.
22	Unverified	Full text not readStored summary read	N22 · Evidence conditionWere registration, prospective endpoints and plans actually verified?Required	The registration identifier is recorded as “unconfirmed”; registration, protocol and SAP were unread, with no access attempted here. S01	Information retained in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, equivalence, safety, prespecification and independence are not certified.	Registration identity/history, principal endpoints, analyses/timing and changes	Material needed: Registration history, original plans and SAP This records needed materials; no new research was executed.
23	Partly verified	Full text not readStored summary read	N23 · Evidence conditionWhat reporting selection accompanies multiple doses and tests?Required	Eradication events/denominators for all three doses and standard 3-drug therapy are retained; the favorable 2 g arm is not selectively retained alone. S01	Information retained in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, equivalence, safety, prespecification and independence are not certified.	1/2/3 g doses, the shared 3-drug comparison, timing, all results and multiplicity	Material needed: Complete endpoint/dose tables, registration and SAP This records needed materials; no new research was executed.
24	Unverified	Full text not readStored summary read	N24 · Evidence conditionCould adherence, additional drugs or resistance affect the comparison?Required	The original comparison of powder plus omeprazole with standard 3-drug therapy is retained. S01	Information retained in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, equivalence, safety, prespecification and independence are not certified.	Medication adherence, rescue/additional treatment, prior antibiotics, resistance and baseline differences	Material needed: Adherence, additional-treatment and resistance/baseline records This records needed materials; no new research was executed.
25	Partly verified	Full text not readStored summary read	N25 · Evidence conditionWhat are the actual limits of funding and independence records?Required	The stored wording reports King Faisal University grant KFU:8051 and no conflicts of interest. S01	Information retained in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, equivalence, safety, prespecification and independence are not certified.	Funding sources, sponsor roles, study family and disclosure level	Material needed: Original support-role, funding and COI text This records needed materials; no new research was executed.
26	Unverified	Full text not readStored summary read	N26 · Evidence conditionWhat is recorded about product provision, employee authorship and patents?Required	The stored grant and reported absence of COI are not converted into verification of product support or employee authorship. S01	Information retained in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, equivalence, safety, prespecification and independence are not certified.	Separate specifications of product provision/free support, author employment, patents and COI	Material needed: Original product-provision, employment, patent and COI specifications This records needed materials; no new research was executed.
27	Unverified	Full text not readStored summary read	N27 · Evidence conditionIs there independent replication of the same question?Required	The stored evidence is a direct-comparison report, and the original summary uses the historical wording “independent study.” S01	Information retained in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, equivalence, safety, prespecification and independence are not certified.	Unique families matching powder plus PPI, eradication, comparison with 3-drug therapy and an equivalence design	Material needed: Related reports and lists of direct trials under the same conditions This records needed materials; no new research was executed.
28	Partly verified	Full text not readStored summary read	N28 · Evidence conditionCan the record be extended to other combinations or formulations?Required	The stored summary treats honey combinations separately and states that different Nigella formulations are not interchangeable. S01	Information retained in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, equivalence, safety, prespecification and independence are not certified.	Distinguish powder plus omeprazole from honey, oil, aqueous extracts and purified constituents	Material needed: Separate direct comparisons for each combination/formulation This records needed materials; no new research was executed.
29	Unverified	Full text not readStored summary read	N29 · Evidence conditionWhat is known about sustained eradication and longer-term dose questions?Required	The stored question concerns negativity 4 weeks after treatment ends. S01	Information retained in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, equivalence, safety, prespecification and independence are not certified.	Reinfection/relapse, sustained negativity, other doses and subgroups	Material needed: Long-term eradication follow-up and direct dose/subgroup records This records needed materials; no new research was executed.
30	Unverified	Full text not readStored summary read	N30 · Evidence conditionDoes eradication negativity answer other clinical-outcome questions?Required	The selected endpoint is negative stool antigen, and the stored summary limits antibiotic-replacement/equivalent-treatment wording. S01	Information retained in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, equivalence, safety, prespecification and independence are not certified.	Separate evidence for dyspepsia, ulcers, bleeding, cancer, quality of life and eradication	Material needed: Separate clinical outcomes, durations, denominators and direct comparisons This records needed materials; no new research was executed.
31	Unverified	Full text not readStored summary read	N31 · Evidence conditionHow was safety information collected?Supplementary	The original Caution label and wording that small trials cannot exclude rare/long-term harms are retained. S01	Information retained in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, equivalence, safety, prespecification and independence are not certified.	Arm-specific adverse events, collection methods, severity, discontinuation and denominators	Material needed: Arm-specific harms, discontinuation and collection methods This records needed materials; no new research was executed.
32	Unverified	Full text not readStored summary read	N32 · Evidence conditionWhat supports attribution of harms in the combination and concomitant drugs?Supplementary	The original cautionary wording on product/extraction differences, medication use and vulnerable populations is retained. S01	Information retained in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, equivalence, safety, prespecification and independence are not certified.	Nigella, PPI, antibiotics, underlying conditions, timelines and alternative explanations	Material needed: Concomitant exposures, timelines, discontinuation/recovery and alternative-explanation records This records needed materials; no new research was executed.
33	Unverified	Full text not readStored summary read	N33 · Evidence conditionWhat is known about long-term/rare harms and vulnerable populations?Supplementary	The original cautions concerning vulnerable populations, surgery and medication are linked unchanged. S01	Information retained in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, equivalence, safety, prespecification and independence are not certified.	Direct safety data for long-term exposure, pregnancy/breastfeeding, children, liver/kidney conditions and other groups	Material needed: Long-term/population-specific exposure, harm and interaction records This records needed materials; no new research was executed.
34	Partly verified	Full text not readStored summary read	N34 · Evidence conditionHow are D34, axes and historical cross-checking retained?Required	D34, the original axes and verdict explanations, inactive flags and empty subclaim/additional-rationale records are retained unchanged. S01	Information retained in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, equivalence, safety, prespecification and independence are not certified.	Existing grade/score, E0/R1/I2 and other axis labels, inactive/empty records and verdict history	Material needed: Separate histories of the verdict and correction events This records needed materials; no new research was executed.
35	Partly verified	Full text not readStored summary read	N35 · Evidence conditionWhat is the scope of the current English text, corrections and dates?Required	The original evidence date 2026-09-08, correction of 1 English field on 2026-09-14 with grade D retained, and the current specific/generic English wording are preserved. The original production record does not establish completed content review. S01	Information retained in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, equivalence, safety, prespecification and independence are not certified.	Distinguish Korean/English text, the original evidence date and English corrections from preparation/reading here	Material needed: Before/after correction records, user comments and subsequent original material This records needed materials; no new research was executed.

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35 itemsWhat the statuses mean

Assessment scope

Stored-material review date: Not recorded
Original evidence cut-off: 2026-09-08
Scope actually checked: Existing review summaries and stored records of methodological application. Full papers, supplements, registrations, plans and original data were not read.
What the dates mean: The date 2026-09-08 retained in every material item is the original evidence date, not a date of external reading. The date 2026-10-06 is the original production date, not a completed-content-review date. Pending-review wording is not a verification date.
Population: The population is adults with H. pylori-positive nonulcer dyspepsia. Detailed diagnosis, prior eradication, antibiotic resistance, age, baseline status and inclusion/exclusion criteria remain unverified. Applicability to people with ulcers, children or other clinical questions is not assumed.
Ingredient, formulation and route: The intervention is oral Nigella sativa L. seed-powder capsules combined with omeprazole. The original record that every Nigella arm also received a PPI is retained. Product specifications, manufacture, composition, batch and the contribution of Nigella alone remain unverified.
Dose: The selected arm retains 2 g/day seed powder plus 40 mg/day omeprazole. The 1 g and 3 g dose arms remain separate. Actual dosing frequency, adherence, missed doses and adjustments remain unverified; no new optimal dose, cumulative dose or individual dosing guidance is created.
Comparator: The record compares with the original trial's standard triple therapy of clarithromycin, amoxicillin and omeprazole. Each drug's dose, actual duration, adherence, additional treatment and correspondence between the original and current treatment settings remain unverified. Current treatment recommendations are not newly assessed.
Measured outcome: The original selected endpoint is negative H. pylori stool antigen 4 weeks after treatment ends. Test product, criteria, medication discontinuation, assessor masking, missing tests, misclassification and prospective endpoint/analysis specifications remain unverified.
Duration: The original question distinguishes 4 weeks of treatment from the stool-antigen test 4 weeks after treatment ends. Abbreviated timing in the evidence table is not newly interpreted, and the same treatment schedule is not assigned to every comparison arm. Actual arm-specific schedules, sustained negativity, relapse and reinfection remain unverified.
Questions outside this scope: The selected question is the claimed eradication equivalence of 2 g/day seed powder plus 40 mg/day omeprazole to standard 3-drug therapy. It is not extended to Nigella alone, other formulations, honey combinations, symptoms, ulcer/cancer prevention, antibiotic replacement or long-term safety.; The existing D·34 points·Caution and B/H/R1/I2/E0/B2/C0 are retained. Historical independent-cross-check and independent-study wording does not establish completed content review, certified independent replication or equivalence here.; The records of 110 assigned participants, 88 analyzed participants and original arm-specific analysis denominators 23/21/21/23 remain distinct. Open alternate allocation is not converted into a randomized RCT, and no new dropout count, ITT set, safety denominator or participant total is created.; The original completer results are 3-drug therapy 19/23 (82.6%), 1 g 10/21 (about 47.6%), 2 g 14/21 (66.7%) and 3 g 11/23 (about 47.8%). Dose arms are not counted as independent trials, the shared comparison group is not repeatedly pooled, and no new eradication rate, difference or interval is calculated.; The original P>.05 narrative does not prove equivalence or no effect. The historical Codex reconstruction of a risk difference of −15.9 percentage points and an approximate 95% CI of −41.8 to +10.0 percentage points is retained only as a historical record. It is not used as a current recalculation, trial-reported interval or prospective acceptable margin.; The stored summary records no equivalence margin and no equivalence design. With external registration, protocol and SAP unread, absence of registration or plans is not newly established. Exact P values, prospective hypotheses, margins, sample-size planning, ITT/PP, missing-data sensitivity and multiplicity remain unverified.; The stored wording on King Faisal University grant KFU:8051 and reported absence of conflicts is retained. It is not converted into absence of free product provision, manufacturer involvement, employee authorship or patents, or into new confirmation of independence. Arm-specific harm collection, denominators, causality and long-term or vulnerable-population safety also remain unverified.; PMID20616418, PMCID PMC3003218, DOI10.4103/1319-3767.65201, the original evidence date 2026-09-08 and the English-placeholder correction date 2026-09-14 for 1 field are retained. The date 2026-10-06 is the original production date. Identifiers and historical generic verification wording do not establish current external reading or completed review.

Evidence and sources

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

S01 · Salem et al. 2010 · Eradication comparison of seed powder plus omeprazole and standard triple therapy

PubMed

Material type: Open-label alternate-allocation 4-arm comparison; completer analysis
Materials actually read: Summary read; external material unread
Findings recorded in the stored summary: 3-drug therapy 19/23, 1 g 10/21, 2 g 14/21, 3 g 11/23; recorded in the stored summary as having no equivalence margin
Record level: The original completer record reports 88 analyzed after 110 were assigned. Initial arm allocations, ITT, original between-group CIs, exact P values and prospective plans remain unverified. The historical Codex reconstructed interval remains distinct from a trial-reported interval.
Study overlap and independent replication: The Salem report comparing standard triple therapy with several powder-plus-omeprazole doses remains distinct from possible related reports. Dose arms and the shared comparison group are not converted into new unique trials or participant totals; an established independent-replication count remains unverified.

Public availability, access and reading status by material
Material	Public availability	Access status	Actually read	Notes
Stored existing review summary	Preserved copy of the complete existing review summary	Stored summary	Summary read	PMID20616418, PMCID PMC3003218 and DOI10.4103/1319-3767.65201 are retained bibliography. An unconfirmed registration identifier does not establish absence of registration. External articles, registration, protocols, analysis plans and support disclosures are unread; identifiers alone do not establish full-text acquisition or actual reading. The date 2026-09-08 retained in every material item is the original evidence date, not a date of external reading. The date 2026-10-06 is the original production date, not a completed-content-review date. Pending-review wording is not a verification date.
External article	Original bibliographic link or needed material; external public availability/access status unverified	Unread; access not attempted	Not read	PMID20616418, PMCID PMC3003218 and DOI10.4103/1319-3767.65201 are retained bibliography. An unconfirmed registration identifier does not establish absence of registration. External articles, registration, protocols, analysis plans and support disclosures are unread; identifiers alone do not establish full-text acquisition or actual reading. The date 2026-09-08 retained in every material item is the original evidence date, not a date of external reading. The date 2026-10-06 is the original production date, not a completed-content-review date. Pending-review wording is not a verification date.
Registration material	Original bibliographic link or needed material; external public availability/access status unverified	Unread; access not attempted	Not read	PMID20616418, PMCID PMC3003218 and DOI10.4103/1319-3767.65201 are retained bibliography. An unconfirmed registration identifier does not establish absence of registration. External articles, registration, protocols, analysis plans and support disclosures are unread; identifiers alone do not establish full-text acquisition or actual reading. The date 2026-09-08 retained in every material item is the original evidence date, not a date of external reading. The date 2026-10-06 is the original production date, not a completed-content-review date. Pending-review wording is not a verification date.
Protocol	Original bibliographic link or needed material; external public availability/access status unverified	Unread; access not attempted	Not read	PMID20616418, PMCID PMC3003218 and DOI10.4103/1319-3767.65201 are retained bibliography. An unconfirmed registration identifier does not establish absence of registration. External articles, registration, protocols, analysis plans and support disclosures are unread; identifiers alone do not establish full-text acquisition or actual reading. The date 2026-09-08 retained in every material item is the original evidence date, not a date of external reading. The date 2026-10-06 is the original production date, not a completed-content-review date. Pending-review wording is not a verification date.
Statistical analysis plan	Original bibliographic link or needed material; external public availability/access status unverified	Unread; access not attempted	Not read	PMID20616418, PMCID PMC3003218 and DOI10.4103/1319-3767.65201 are retained bibliography. An unconfirmed registration identifier does not establish absence of registration. External articles, registration, protocols, analysis plans and support disclosures are unread; identifiers alone do not establish full-text acquisition or actual reading. The date 2026-09-08 retained in every material item is the original evidence date, not a date of external reading. The date 2026-10-06 is the original production date, not a completed-content-review date. Pending-review wording is not a verification date.
Funding, product-support and COI material	Original bibliographic link or needed material; external public availability/access status unverified	Unread; access not attempted	Not read	PMID20616418, PMCID PMC3003218 and DOI10.4103/1319-3767.65201 are retained bibliography. An unconfirmed registration identifier does not establish absence of registration. External articles, registration, protocols, analysis plans and support disclosures are unread; identifiers alone do not establish full-text acquisition or actual reading. The date 2026-09-08 retained in every material item is the original evidence date, not a date of external reading. The date 2026-10-06 is the original production date, not a completed-content-review date. Pending-review wording is not a verification date.

Report counts versus independent study counts

The Salem report comparing standard triple therapy with several powder-plus-omeprazole doses remains distinct from possible related reports. Dose arms and the shared comparison group are not converted into new unique trials or participant totals; an established independent-replication count remains unverified.

Review criteria

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

N01 · What is the exact scope of the equivalence claim?

Required materials and conditions: The question of 2 g Nigella powder plus omeprazole, adults, eradication and equivalence to standard 3-drug therapy
Conditions for verification: Original records on The question of 2 g Nigella powder plus omeprazole, adults, eradication and equivalence to standard 3-drug therapy must link to the relevant report, design, concomitant treatment, dose, endpoint, timing and denominator, distinguishing recorded information from what remains unverified.
Requirement and applicability: Required
Application exceptions: The records of 110 assigned participants and 88 analyzed participants are not converted into randomization, initial arm allocations, ITT or safety denominators, and no new dropout count or rate is calculated. A nonsignificant comparison is not converted into equivalence, nor a historical reconstructed interval into a current calculation or trial-reported interval.
Why this condition is needed: Material on The question of 2 g Nigella powder plus omeprazole, adults, eradication and equivalence to standard 3-drug therapy is needed to connect the combination to its population, formulation, selected dose, comparison, eradication, timing, denominator, equivalence question or harms.
Referenced methods: Existing principles distinguish the formulation, selected dose, population, active comparison, eradication test, allocation and analysis, equivalence question, report relationships, support and harms of the combination.

N02 · Which materials were actually read?

Required materials and conditions: Separate reading records for the stored JSON summary, external article, registration and plans
Conditions for verification: Original records on Separate reading records for the stored JSON summary, external article, registration and plans must link to the relevant report, design, concomitant treatment, dose, endpoint, timing and denominator, distinguishing recorded information from what remains unverified.
Requirement and applicability: Required
Application exceptions: The records of 110 assigned participants and 88 analyzed participants are not converted into randomization, initial arm allocations, ITT or safety denominators, and no new dropout count or rate is calculated. A nonsignificant comparison is not converted into equivalence, nor a historical reconstructed interval into a current calculation or trial-reported interval.
Why this condition is needed: Material on Separate reading records for the stored JSON summary, external article, registration and plans is needed to connect the combination to its population, formulation, selected dose, comparison, eradication, timing, denominator, equivalence question or harms.
Referenced methods: Existing principles distinguish the formulation, selected dose, population, active comparison, eradication test, allocation and analysis, equivalence question, report relationships, support and harms of the combination.

N03 · What is the identity of the report?

Required materials and conditions: Link the authors, year, title, PMID/PMCID/DOI and report
Conditions for verification: Original records on Link the authors, year, title, PMID/PMCID/DOI and report must link to the relevant report, design, concomitant treatment, dose, endpoint, timing and denominator, distinguishing recorded information from what remains unverified.
Requirement and applicability: Required
Application exceptions: The records of 110 assigned participants and 88 analyzed participants are not converted into randomization, initial arm allocations, ITT or safety denominators, and no new dropout count or rate is calculated. A nonsignificant comparison is not converted into equivalence, nor a historical reconstructed interval into a current calculation or trial-reported interval.
Why this condition is needed: Material on Link the authors, year, title, PMID/PMCID/DOI and report is needed to connect the combination to its population, formulation, selected dose, comparison, eradication, timing, denominator, equivalence question or harms.
Referenced methods: Existing principles distinguish the formulation, selected dose, population, active comparison, eradication test, allocation and analysis, equivalence question, report relationships, support and harms of the combination.

N04 · How do the 4 arms relate within the comparison?

Required materials and conditions: 3-drug therapy, 1/2/3 g arms, the shared comparison group and participant relationships
Conditions for verification: Original records on 3-drug therapy, 1/2/3 g arms, the shared comparison group and participant relationships must link to the relevant report, design, concomitant treatment, dose, endpoint, timing and denominator, distinguishing recorded information from what remains unverified.
Requirement and applicability: Required
Application exceptions: The records of 110 assigned participants and 88 analyzed participants are not converted into randomization, initial arm allocations, ITT or safety denominators, and no new dropout count or rate is calculated. A nonsignificant comparison is not converted into equivalence, nor a historical reconstructed interval into a current calculation or trial-reported interval.
Why this condition is needed: Material on 3-drug therapy, 1/2/3 g arms, the shared comparison group and participant relationships is needed to connect the combination to its population, formulation, selected dose, comparison, eradication, timing, denominator, equivalence question or harms.
Referenced methods: Existing principles distinguish the formulation, selected dose, population, active comparison, eradication test, allocation and analysis, equivalence question, report relationships, support and harms of the combination.

N05 · To which adults does the question apply?

Required materials and conditions: H. pylori-positive nonulcer dyspepsia, selection/exclusion and baseline status
Conditions for verification: Original records on H. pylori-positive nonulcer dyspepsia, selection/exclusion and baseline status must link to the relevant report, design, concomitant treatment, dose, endpoint, timing and denominator, distinguishing recorded information from what remains unverified.
Requirement and applicability: Required
Application exceptions: The records of 110 assigned participants and 88 analyzed participants are not converted into randomization, initial arm allocations, ITT or safety denominators, and no new dropout count or rate is calculated. A nonsignificant comparison is not converted into equivalence, nor a historical reconstructed interval into a current calculation or trial-reported interval.
Why this condition is needed: Material on H. pylori-positive nonulcer dyspepsia, selection/exclusion and baseline status is needed to connect the combination to its population, formulation, selected dose, comparison, eradication, timing, denominator, equivalence question or harms.
Referenced methods: Existing principles distinguish the formulation, selected dose, population, active comparison, eradication test, allocation and analysis, equivalence question, report relationships, support and harms of the combination.

N06 · What is the seed-powder preparation?

Required materials and conditions: Powder capsules, plant part, constituent content, quality and batch
Conditions for verification: Original records on Powder capsules, plant part, constituent content, quality and batch must link to the relevant report, design, concomitant treatment, dose, endpoint, timing and denominator, distinguishing recorded information from what remains unverified.
Requirement and applicability: Required
Application exceptions: The records of 110 assigned participants and 88 analyzed participants are not converted into randomization, initial arm allocations, ITT or safety denominators, and no new dropout count or rate is calculated. A nonsignificant comparison is not converted into equivalence, nor a historical reconstructed interval into a current calculation or trial-reported interval.
Why this condition is needed: Material on Powder capsules, plant part, constituent content, quality and batch is needed to connect the combination to its population, formulation, selected dose, comparison, eradication, timing, denominator, equivalence question or harms.
Referenced methods: Existing principles distinguish the formulation, selected dose, population, active comparison, eradication test, allocation and analysis, equivalence question, report relationships, support and harms of the combination.

N07 · What combined dose was used in the selected 2 g arm?

Required materials and conditions: Nominal and actual powder and omeprazole doses, dosing frequency and adherence
Conditions for verification: Original records on Nominal and actual powder and omeprazole doses, dosing frequency and adherence must link to the relevant report, design, concomitant treatment, dose, endpoint, timing and denominator, distinguishing recorded information from what remains unverified.
Requirement and applicability: Required
Application exceptions: The records of 110 assigned participants and 88 analyzed participants are not converted into randomization, initial arm allocations, ITT or safety denominators, and no new dropout count or rate is calculated. A nonsignificant comparison is not converted into equivalence, nor a historical reconstructed interval into a current calculation or trial-reported interval.
Why this condition is needed: Material on Nominal and actual powder and omeprazole doses, dosing frequency and adherence is needed to connect the combination to its population, formulation, selected dose, comparison, eradication, timing, denominator, equivalence question or harms.
Referenced methods: Existing principles distinguish the formulation, selected dose, population, active comparison, eradication test, allocation and analysis, equivalence question, report relationships, support and harms of the combination.

N08 · Is the PPI used in every Nigella arm distinguished?

Required materials and conditions: Shared omeprazole, arm-specific concomitant treatment and limits on attributing effects to Nigella alone
Conditions for verification: Original records on Shared omeprazole, arm-specific concomitant treatment and limits on attributing effects to Nigella alone must link to the relevant report, design, concomitant treatment, dose, endpoint, timing and denominator, distinguishing recorded information from what remains unverified.
Requirement and applicability: Required
Application exceptions: The records of 110 assigned participants and 88 analyzed participants are not converted into randomization, initial arm allocations, ITT or safety denominators, and no new dropout count or rate is calculated. A nonsignificant comparison is not converted into equivalence, nor a historical reconstructed interval into a current calculation or trial-reported interval.
Why this condition is needed: Material on Shared omeprazole, arm-specific concomitant treatment and limits on attributing effects to Nigella alone is needed to connect the combination to its population, formulation, selected dose, comparison, eradication, timing, denominator, equivalence question or harms.
Referenced methods: Existing principles distinguish the formulation, selected dose, population, active comparison, eradication test, allocation and analysis, equivalence question, report relationships, support and harms of the combination.

N09 · What treatment formed the standard 3-drug comparison?

Required materials and conditions: Doses, duration and adherence for clarithromycin, amoxicillin and omeprazole
Conditions for verification: Original records on Doses, duration and adherence for clarithromycin, amoxicillin and omeprazole must link to the relevant report, design, concomitant treatment, dose, endpoint, timing and denominator, distinguishing recorded information from what remains unverified.
Requirement and applicability: Required
Application exceptions: The records of 110 assigned participants and 88 analyzed participants are not converted into randomization, initial arm allocations, ITT or safety denominators, and no new dropout count or rate is calculated. A nonsignificant comparison is not converted into equivalence, nor a historical reconstructed interval into a current calculation or trial-reported interval.
Why this condition is needed: Material on Doses, duration and adherence for clarithromycin, amoxicillin and omeprazole is needed to connect the combination to its population, formulation, selected dose, comparison, eradication, timing, denominator, equivalence question or harms.
Referenced methods: Existing principles distinguish the formulation, selected dose, population, active comparison, eradication test, allocation and analysis, equivalence question, report relationships, support and harms of the combination.

N10 · Are treatment and test timing distinguished?

Required materials and conditions: 4 weeks of treatment, testing 4 weeks after completion and arm-specific schedules
Conditions for verification: Original records on 4 weeks of treatment, testing 4 weeks after completion and arm-specific schedules must link to the relevant report, design, concomitant treatment, dose, endpoint, timing and denominator, distinguishing recorded information from what remains unverified.
Requirement and applicability: Required
Application exceptions: The records of 110 assigned participants and 88 analyzed participants are not converted into randomization, initial arm allocations, ITT or safety denominators, and no new dropout count or rate is calculated. A nonsignificant comparison is not converted into equivalence, nor a historical reconstructed interval into a current calculation or trial-reported interval.
Why this condition is needed: Material on 4 weeks of treatment, testing 4 weeks after completion and arm-specific schedules is needed to connect the combination to its population, formulation, selected dose, comparison, eradication, timing, denominator, equivalence question or harms.
Referenced methods: Existing principles distinguish the formulation, selected dose, population, active comparison, eradication test, allocation and analysis, equivalence question, report relationships, support and harms of the combination.

N11 · Are alternate allocation and randomization distinguished?

Required materials and conditions: Actual allocation method, concealment and baseline balance
Conditions for verification: Original records on Actual allocation method, concealment and baseline balance must link to the relevant report, design, concomitant treatment, dose, endpoint, timing and denominator, distinguishing recorded information from what remains unverified.
Requirement and applicability: Required
Application exceptions: The records of 110 assigned participants and 88 analyzed participants are not converted into randomization, initial arm allocations, ITT or safety denominators, and no new dropout count or rate is calculated. A nonsignificant comparison is not converted into equivalence, nor a historical reconstructed interval into a current calculation or trial-reported interval.
Why this condition is needed: Material on Actual allocation method, concealment and baseline balance is needed to connect the combination to its population, formulation, selected dose, comparison, eradication, timing, denominator, equivalence question or harms.
Referenced methods: Existing principles distinguish the formulation, selected dose, population, active comparison, eradication test, allocation and analysis, equivalence question, report relationships, support and harms of the combination.

N12 · What measurement or behavioral differences may accompany open-label design?

Required materials and conditions: Masking of participants, treatment providers and test assessors, with arm-specific behavior/measurement
Conditions for verification: Original records on Masking of participants, treatment providers and test assessors, with arm-specific behavior/measurement must link to the relevant report, design, concomitant treatment, dose, endpoint, timing and denominator, distinguishing recorded information from what remains unverified.
Requirement and applicability: Required
Application exceptions: The records of 110 assigned participants and 88 analyzed participants are not converted into randomization, initial arm allocations, ITT or safety denominators, and no new dropout count or rate is calculated. A nonsignificant comparison is not converted into equivalence, nor a historical reconstructed interval into a current calculation or trial-reported interval.
Why this condition is needed: Material on Masking of participants, treatment providers and test assessors, with arm-specific behavior/measurement is needed to connect the combination to its population, formulation, selected dose, comparison, eradication, timing, denominator, equivalence question or harms.
Referenced methods: Existing principles distinguish the formulation, selected dose, population, active comparison, eradication test, allocation and analysis, equivalence question, report relationships, support and harms of the combination.

N13 · What criteria identify eradication?

Required materials and conditions: Stool-antigen testing, negativity criteria, assay, test timing and medication conditions
Conditions for verification: Original records on Stool-antigen testing, negativity criteria, assay, test timing and medication conditions must link to the relevant report, design, concomitant treatment, dose, endpoint, timing and denominator, distinguishing recorded information from what remains unverified.
Requirement and applicability: Required
Application exceptions: The records of 110 assigned participants and 88 analyzed participants are not converted into randomization, initial arm allocations, ITT or safety denominators, and no new dropout count or rate is calculated. A nonsignificant comparison is not converted into equivalence, nor a historical reconstructed interval into a current calculation or trial-reported interval.
Why this condition is needed: Material on Stool-antigen testing, negativity criteria, assay, test timing and medication conditions is needed to connect the combination to its population, formulation, selected dose, comparison, eradication, timing, denominator, equivalence question or harms.
Referenced methods: Existing principles distinguish the formulation, selected dose, population, active comparison, eradication test, allocation and analysis, equivalence question, report relationships, support and harms of the combination.

N14 · How do 110 assigned participants relate to 88 analyzed participants?

Required materials and conditions: Allocation, completion, testing, analysis and arm-specific denominators
Conditions for verification: Original records on Allocation, completion, testing, analysis and arm-specific denominators must link to the relevant report, design, concomitant treatment, dose, endpoint, timing and denominator, distinguishing recorded information from what remains unverified.
Requirement and applicability: Required
Application exceptions: The records of 110 assigned participants and 88 analyzed participants are not converted into randomization, initial arm allocations, ITT or safety denominators, and no new dropout count or rate is calculated. A nonsignificant comparison is not converted into equivalence, nor a historical reconstructed interval into a current calculation or trial-reported interval.
Why this condition is needed: Material on Allocation, completion, testing, analysis and arm-specific denominators is needed to connect the combination to its population, formulation, selected dose, comparison, eradication, timing, denominator, equivalence question or harms.
Referenced methods: Existing principles distinguish the formulation, selected dose, population, active comparison, eradication test, allocation and analysis, equivalence question, report relationships, support and harms of the combination.

N15 · How were attrition and missing data handled?

Required materials and conditions: Arm-specific attrition, reasons, denominators, missingness and completer/ITT/PP populations
Conditions for verification: Original records on Arm-specific attrition, reasons, denominators, missingness and completer/ITT/PP populations must link to the relevant report, design, concomitant treatment, dose, endpoint, timing and denominator, distinguishing recorded information from what remains unverified.
Requirement and applicability: Required
Application exceptions: The records of 110 assigned participants and 88 analyzed participants are not converted into randomization, initial arm allocations, ITT or safety denominators, and no new dropout count or rate is calculated. A nonsignificant comparison is not converted into equivalence, nor a historical reconstructed interval into a current calculation or trial-reported interval.
Why this condition is needed: Material on Arm-specific attrition, reasons, denominators, missingness and completer/ITT/PP populations is needed to connect the combination to its population, formulation, selected dose, comparison, eradication, timing, denominator, equivalence question or harms.
Referenced methods: Existing principles distinguish the formulation, selected dose, population, active comparison, eradication test, allocation and analysis, equivalence question, report relationships, support and harms of the combination.

N16 · Which denominators underlie the 2 g and 3-drug eradication results?

Required materials and conditions: Original eradication events/denominators, the completer population and comparison direction
Conditions for verification: Original records on Original eradication events/denominators, the completer population and comparison direction must link to the relevant report, design, concomitant treatment, dose, endpoint, timing and denominator, distinguishing recorded information from what remains unverified.
Requirement and applicability: Required
Application exceptions: The records of 110 assigned participants and 88 analyzed participants are not converted into randomization, initial arm allocations, ITT or safety denominators, and no new dropout count or rate is calculated. A nonsignificant comparison is not converted into equivalence, nor a historical reconstructed interval into a current calculation or trial-reported interval.
Why this condition is needed: Material on Original eradication events/denominators, the completer population and comparison direction is needed to connect the combination to its population, formulation, selected dose, comparison, eradication, timing, denominator, equivalence question or harms.
Referenced methods: Existing principles distinguish the formulation, selected dose, population, active comparison, eradication test, allocation and analysis, equivalence question, report relationships, support and harms of the combination.

N17 · How are the 1 g and 3 g arm results kept separate?

Required materials and conditions: Eradication denominators/results for the other dose arms and direct dose comparisons
Conditions for verification: Original records on Eradication denominators/results for the other dose arms and direct dose comparisons must link to the relevant report, design, concomitant treatment, dose, endpoint, timing and denominator, distinguishing recorded information from what remains unverified.
Requirement and applicability: Required
Application exceptions: The records of 110 assigned participants and 88 analyzed participants are not converted into randomization, initial arm allocations, ITT or safety denominators, and no new dropout count or rate is calculated. A nonsignificant comparison is not converted into equivalence, nor a historical reconstructed interval into a current calculation or trial-reported interval.
Why this condition is needed: Material on Eradication denominators/results for the other dose arms and direct dose comparisons is needed to connect the combination to its population, formulation, selected dose, comparison, eradication, timing, denominator, equivalence question or harms.
Referenced methods: Existing principles distinguish the formulation, selected dose, population, active comparison, eradication test, allocation and analysis, equivalence question, report relationships, support and harms of the combination.

N18 · Is a nonsignificant difference kept distinct from equivalence?

Required materials and conditions: Distinguish superiority P values from equivalence/noninferiority questions
Conditions for verification: Original records on Distinguish superiority P values from equivalence/noninferiority questions must link to the relevant report, design, concomitant treatment, dose, endpoint, timing and denominator, distinguishing recorded information from what remains unverified.
Requirement and applicability: Required
Application exceptions: The records of 110 assigned participants and 88 analyzed participants are not converted into randomization, initial arm allocations, ITT or safety denominators, and no new dropout count or rate is calculated. A nonsignificant comparison is not converted into equivalence, nor a historical reconstructed interval into a current calculation or trial-reported interval.
Why this condition is needed: Material on Distinguish superiority P values from equivalence/noninferiority questions is needed to connect the combination to its population, formulation, selected dose, comparison, eradication, timing, denominator, equivalence question or harms.
Referenced methods: Existing principles distinguish the formulation, selected dose, population, active comparison, eradication test, allocation and analysis, equivalence question, report relationships, support and harms of the combination.

N19 · Was a noninferiority/equivalence margin prespecified?

Required materials and conditions: Clinically acceptable margins, one-/two-sided hypotheses, justification and testing plans
Conditions for verification: Original records on Clinically acceptable margins, one-/two-sided hypotheses, justification and testing plans must link to the relevant report, design, concomitant treatment, dose, endpoint, timing and denominator, distinguishing recorded information from what remains unverified.
Requirement and applicability: Required
Application exceptions: The records of 110 assigned participants and 88 analyzed participants are not converted into randomization, initial arm allocations, ITT or safety denominators, and no new dropout count or rate is calculated. A nonsignificant comparison is not converted into equivalence, nor a historical reconstructed interval into a current calculation or trial-reported interval.
Why this condition is needed: Material on Clinically acceptable margins, one-/two-sided hypotheses, justification and testing plans is needed to connect the combination to its population, formulation, selected dose, comparison, eradication, timing, denominator, equivalence question or harms.
Referenced methods: Existing principles distinguish the formulation, selected dose, population, active comparison, eradication test, allocation and analysis, equivalence question, report relationships, support and harms of the combination.

N20 · Were sample size and analysis adequate for the equivalence question?

Required materials and conditions: Prospective sample-size planning, ITT/PP, failure/missing-data assumptions and intervals against the margin
Conditions for verification: Original records on Prospective sample-size planning, ITT/PP, failure/missing-data assumptions and intervals against the margin must link to the relevant report, design, concomitant treatment, dose, endpoint, timing and denominator, distinguishing recorded information from what remains unverified.
Requirement and applicability: Required
Application exceptions: The records of 110 assigned participants and 88 analyzed participants are not converted into randomization, initial arm allocations, ITT or safety denominators, and no new dropout count or rate is calculated. A nonsignificant comparison is not converted into equivalence, nor a historical reconstructed interval into a current calculation or trial-reported interval.
Why this condition is needed: Material on Prospective sample-size planning, ITT/PP, failure/missing-data assumptions and intervals against the margin is needed to connect the combination to its population, formulation, selected dose, comparison, eradication, timing, denominator, equivalence question or harms.
Referenced methods: Existing principles distinguish the formulation, selected dose, population, active comparison, eradication test, allocation and analysis, equivalence question, report relationships, support and harms of the combination.

N21 · What historical event produced the risk difference and CI?

Required materials and conditions: Distinguish original article intervals from the historical Codex recalculation
Conditions for verification: Original records on Distinguish original article intervals from the historical Codex recalculation must link to the relevant report, design, concomitant treatment, dose, endpoint, timing and denominator, distinguishing recorded information from what remains unverified.
Requirement and applicability: Required
Application exceptions: The records of 110 assigned participants and 88 analyzed participants are not converted into randomization, initial arm allocations, ITT or safety denominators, and no new dropout count or rate is calculated. A nonsignificant comparison is not converted into equivalence, nor a historical reconstructed interval into a current calculation or trial-reported interval.
Why this condition is needed: Material on Distinguish original article intervals from the historical Codex recalculation is needed to connect the combination to its population, formulation, selected dose, comparison, eradication, timing, denominator, equivalence question or harms.
Referenced methods: Existing principles distinguish the formulation, selected dose, population, active comparison, eradication test, allocation and analysis, equivalence question, report relationships, support and harms of the combination.

N22 · Were registration, prospective endpoints and plans actually verified?

Required materials and conditions: Registration identity/history, principal endpoints, analyses/timing and changes
Conditions for verification: Original records on Registration identity/history, principal endpoints, analyses/timing and changes must link to the relevant report, design, concomitant treatment, dose, endpoint, timing and denominator, distinguishing recorded information from what remains unverified.
Requirement and applicability: Required
Application exceptions: The records of 110 assigned participants and 88 analyzed participants are not converted into randomization, initial arm allocations, ITT or safety denominators, and no new dropout count or rate is calculated. A nonsignificant comparison is not converted into equivalence, nor a historical reconstructed interval into a current calculation or trial-reported interval.
Why this condition is needed: Material on Registration identity/history, principal endpoints, analyses/timing and changes is needed to connect the combination to its population, formulation, selected dose, comparison, eradication, timing, denominator, equivalence question or harms.
Referenced methods: Existing principles distinguish the formulation, selected dose, population, active comparison, eradication test, allocation and analysis, equivalence question, report relationships, support and harms of the combination.

N23 · What reporting selection accompanies multiple doses and tests?

Required materials and conditions: 1/2/3 g doses, the shared 3-drug comparison, timing, all results and multiplicity
Conditions for verification: Original records on 1/2/3 g doses, the shared 3-drug comparison, timing, all results and multiplicity must link to the relevant report, design, concomitant treatment, dose, endpoint, timing and denominator, distinguishing recorded information from what remains unverified.
Requirement and applicability: Required
Application exceptions: The records of 110 assigned participants and 88 analyzed participants are not converted into randomization, initial arm allocations, ITT or safety denominators, and no new dropout count or rate is calculated. A nonsignificant comparison is not converted into equivalence, nor a historical reconstructed interval into a current calculation or trial-reported interval.
Why this condition is needed: Material on 1/2/3 g doses, the shared 3-drug comparison, timing, all results and multiplicity is needed to connect the combination to its population, formulation, selected dose, comparison, eradication, timing, denominator, equivalence question or harms.
Referenced methods: Existing principles distinguish the formulation, selected dose, population, active comparison, eradication test, allocation and analysis, equivalence question, report relationships, support and harms of the combination.

N24 · Could adherence, additional drugs or resistance affect the comparison?

Required materials and conditions: Medication adherence, rescue/additional treatment, prior antibiotics, resistance and baseline differences
Conditions for verification: Original records on Medication adherence, rescue/additional treatment, prior antibiotics, resistance and baseline differences must link to the relevant report, design, concomitant treatment, dose, endpoint, timing and denominator, distinguishing recorded information from what remains unverified.
Requirement and applicability: Required
Application exceptions: The records of 110 assigned participants and 88 analyzed participants are not converted into randomization, initial arm allocations, ITT or safety denominators, and no new dropout count or rate is calculated. A nonsignificant comparison is not converted into equivalence, nor a historical reconstructed interval into a current calculation or trial-reported interval.
Why this condition is needed: Material on Medication adherence, rescue/additional treatment, prior antibiotics, resistance and baseline differences is needed to connect the combination to its population, formulation, selected dose, comparison, eradication, timing, denominator, equivalence question or harms.
Referenced methods: Existing principles distinguish the formulation, selected dose, population, active comparison, eradication test, allocation and analysis, equivalence question, report relationships, support and harms of the combination.

N25 · What are the actual limits of funding and independence records?

Required materials and conditions: Funding sources, sponsor roles, study family and disclosure level
Conditions for verification: Original records on Funding sources, sponsor roles, study family and disclosure level must link to the relevant report, design, concomitant treatment, dose, endpoint, timing and denominator, distinguishing recorded information from what remains unverified.
Requirement and applicability: Required
Application exceptions: The records of 110 assigned participants and 88 analyzed participants are not converted into randomization, initial arm allocations, ITT or safety denominators, and no new dropout count or rate is calculated. A nonsignificant comparison is not converted into equivalence, nor a historical reconstructed interval into a current calculation or trial-reported interval.
Why this condition is needed: Material on Funding sources, sponsor roles, study family and disclosure level is needed to connect the combination to its population, formulation, selected dose, comparison, eradication, timing, denominator, equivalence question or harms.
Referenced methods: Existing principles distinguish the formulation, selected dose, population, active comparison, eradication test, allocation and analysis, equivalence question, report relationships, support and harms of the combination.

N26 · What is recorded about product provision, employee authorship and patents?

Required materials and conditions: Separate specifications of product provision/free support, author employment, patents and COI
Conditions for verification: Original records on Separate specifications of product provision/free support, author employment, patents and COI must link to the relevant report, design, concomitant treatment, dose, endpoint, timing and denominator, distinguishing recorded information from what remains unverified.
Requirement and applicability: Required
Application exceptions: The records of 110 assigned participants and 88 analyzed participants are not converted into randomization, initial arm allocations, ITT or safety denominators, and no new dropout count or rate is calculated. A nonsignificant comparison is not converted into equivalence, nor a historical reconstructed interval into a current calculation or trial-reported interval.
Why this condition is needed: Material on Separate specifications of product provision/free support, author employment, patents and COI is needed to connect the combination to its population, formulation, selected dose, comparison, eradication, timing, denominator, equivalence question or harms.
Referenced methods: Existing principles distinguish the formulation, selected dose, population, active comparison, eradication test, allocation and analysis, equivalence question, report relationships, support and harms of the combination.

N27 · Is there independent replication of the same question?

Required materials and conditions: Unique families matching powder plus PPI, eradication, comparison with 3-drug therapy and an equivalence design
Conditions for verification: Original records on Unique families matching powder plus PPI, eradication, comparison with 3-drug therapy and an equivalence design must link to the relevant report, design, concomitant treatment, dose, endpoint, timing and denominator, distinguishing recorded information from what remains unverified.
Requirement and applicability: Required
Application exceptions: The records of 110 assigned participants and 88 analyzed participants are not converted into randomization, initial arm allocations, ITT or safety denominators, and no new dropout count or rate is calculated. A nonsignificant comparison is not converted into equivalence, nor a historical reconstructed interval into a current calculation or trial-reported interval.
Why this condition is needed: Material on Unique families matching powder plus PPI, eradication, comparison with 3-drug therapy and an equivalence design is needed to connect the combination to its population, formulation, selected dose, comparison, eradication, timing, denominator, equivalence question or harms.
Referenced methods: Existing principles distinguish the formulation, selected dose, population, active comparison, eradication test, allocation and analysis, equivalence question, report relationships, support and harms of the combination.

N28 · Can the record be extended to other combinations or formulations?

Required materials and conditions: Distinguish powder plus omeprazole from honey, oil, aqueous extracts and purified constituents
Conditions for verification: Original records on Distinguish powder plus omeprazole from honey, oil, aqueous extracts and purified constituents must link to the relevant report, design, concomitant treatment, dose, endpoint, timing and denominator, distinguishing recorded information from what remains unverified.
Requirement and applicability: Required
Application exceptions: The records of 110 assigned participants and 88 analyzed participants are not converted into randomization, initial arm allocations, ITT or safety denominators, and no new dropout count or rate is calculated. A nonsignificant comparison is not converted into equivalence, nor a historical reconstructed interval into a current calculation or trial-reported interval.
Why this condition is needed: Material on Distinguish powder plus omeprazole from honey, oil, aqueous extracts and purified constituents is needed to connect the combination to its population, formulation, selected dose, comparison, eradication, timing, denominator, equivalence question or harms.
Referenced methods: Existing principles distinguish the formulation, selected dose, population, active comparison, eradication test, allocation and analysis, equivalence question, report relationships, support and harms of the combination.

N29 · What is known about sustained eradication and longer-term dose questions?

Required materials and conditions: Reinfection/relapse, sustained negativity, other doses and subgroups
Conditions for verification: Original records on Reinfection/relapse, sustained negativity, other doses and subgroups must link to the relevant report, design, concomitant treatment, dose, endpoint, timing and denominator, distinguishing recorded information from what remains unverified.
Requirement and applicability: Required
Application exceptions: The records of 110 assigned participants and 88 analyzed participants are not converted into randomization, initial arm allocations, ITT or safety denominators, and no new dropout count or rate is calculated. A nonsignificant comparison is not converted into equivalence, nor a historical reconstructed interval into a current calculation or trial-reported interval.
Why this condition is needed: Material on Reinfection/relapse, sustained negativity, other doses and subgroups is needed to connect the combination to its population, formulation, selected dose, comparison, eradication, timing, denominator, equivalence question or harms.
Referenced methods: Existing principles distinguish the formulation, selected dose, population, active comparison, eradication test, allocation and analysis, equivalence question, report relationships, support and harms of the combination.

N30 · Does eradication negativity answer other clinical-outcome questions?

Required materials and conditions: Separate evidence for dyspepsia, ulcers, bleeding, cancer, quality of life and eradication
Conditions for verification: Original records on Separate evidence for dyspepsia, ulcers, bleeding, cancer, quality of life and eradication must link to the relevant report, design, concomitant treatment, dose, endpoint, timing and denominator, distinguishing recorded information from what remains unverified.
Requirement and applicability: Required
Application exceptions: The records of 110 assigned participants and 88 analyzed participants are not converted into randomization, initial arm allocations, ITT or safety denominators, and no new dropout count or rate is calculated. A nonsignificant comparison is not converted into equivalence, nor a historical reconstructed interval into a current calculation or trial-reported interval.
Why this condition is needed: Material on Separate evidence for dyspepsia, ulcers, bleeding, cancer, quality of life and eradication is needed to connect the combination to its population, formulation, selected dose, comparison, eradication, timing, denominator, equivalence question or harms.
Referenced methods: Existing principles distinguish the formulation, selected dose, population, active comparison, eradication test, allocation and analysis, equivalence question, report relationships, support and harms of the combination.

N31 · How was safety information collected?

Required materials and conditions: Arm-specific adverse events, collection methods, severity, discontinuation and denominators
Conditions for verification: Original records on Arm-specific adverse events, collection methods, severity, discontinuation and denominators must link to the relevant report, design, concomitant treatment, dose, endpoint, timing and denominator, distinguishing recorded information from what remains unverified.
Requirement and applicability: Supplementary
Application exceptions: The records of 110 assigned participants and 88 analyzed participants are not converted into randomization, initial arm allocations, ITT or safety denominators, and no new dropout count or rate is calculated. A nonsignificant comparison is not converted into equivalence, nor a historical reconstructed interval into a current calculation or trial-reported interval.
Why this condition is needed: Material on Arm-specific adverse events, collection methods, severity, discontinuation and denominators is needed to connect the combination to its population, formulation, selected dose, comparison, eradication, timing, denominator, equivalence question or harms.
Referenced methods: Existing principles distinguish the formulation, selected dose, population, active comparison, eradication test, allocation and analysis, equivalence question, report relationships, support and harms of the combination.

N32 · What supports attribution of harms in the combination and concomitant drugs?

Required materials and conditions: Nigella, PPI, antibiotics, underlying conditions, timelines and alternative explanations
Conditions for verification: Original records on Nigella, PPI, antibiotics, underlying conditions, timelines and alternative explanations must link to the relevant report, design, concomitant treatment, dose, endpoint, timing and denominator, distinguishing recorded information from what remains unverified.
Requirement and applicability: Supplementary
Application exceptions: The records of 110 assigned participants and 88 analyzed participants are not converted into randomization, initial arm allocations, ITT or safety denominators, and no new dropout count or rate is calculated. A nonsignificant comparison is not converted into equivalence, nor a historical reconstructed interval into a current calculation or trial-reported interval.
Why this condition is needed: Material on Nigella, PPI, antibiotics, underlying conditions, timelines and alternative explanations is needed to connect the combination to its population, formulation, selected dose, comparison, eradication, timing, denominator, equivalence question or harms.
Referenced methods: Existing principles distinguish the formulation, selected dose, population, active comparison, eradication test, allocation and analysis, equivalence question, report relationships, support and harms of the combination.

N33 · What is known about long-term/rare harms and vulnerable populations?

Required materials and conditions: Direct safety data for long-term exposure, pregnancy/breastfeeding, children, liver/kidney conditions and other groups
Conditions for verification: Original records on Direct safety data for long-term exposure, pregnancy/breastfeeding, children, liver/kidney conditions and other groups must link to the relevant report, design, concomitant treatment, dose, endpoint, timing and denominator, distinguishing recorded information from what remains unverified.
Requirement and applicability: Supplementary
Application exceptions: The records of 110 assigned participants and 88 analyzed participants are not converted into randomization, initial arm allocations, ITT or safety denominators, and no new dropout count or rate is calculated. A nonsignificant comparison is not converted into equivalence, nor a historical reconstructed interval into a current calculation or trial-reported interval.
Why this condition is needed: Material on Direct safety data for long-term exposure, pregnancy/breastfeeding, children, liver/kidney conditions and other groups is needed to connect the combination to its population, formulation, selected dose, comparison, eradication, timing, denominator, equivalence question or harms.
Referenced methods: Existing principles distinguish the formulation, selected dose, population, active comparison, eradication test, allocation and analysis, equivalence question, report relationships, support and harms of the combination.

N34 · How are D34, axes and historical cross-checking retained?

Required materials and conditions: Existing grade/score, E0/R1/I2 and other axis labels, inactive/empty records and verdict history
Conditions for verification: Original records on Existing grade/score, E0/R1/I2 and other axis labels, inactive/empty records and verdict history must link to the relevant report, design, concomitant treatment, dose, endpoint, timing and denominator, distinguishing recorded information from what remains unverified.
Requirement and applicability: Required
Application exceptions: The records of 110 assigned participants and 88 analyzed participants are not converted into randomization, initial arm allocations, ITT or safety denominators, and no new dropout count or rate is calculated. A nonsignificant comparison is not converted into equivalence, nor a historical reconstructed interval into a current calculation or trial-reported interval.
Why this condition is needed: Material on Existing grade/score, E0/R1/I2 and other axis labels, inactive/empty records and verdict history is needed to connect the combination to its population, formulation, selected dose, comparison, eradication, timing, denominator, equivalence question or harms.
Referenced methods: Existing principles distinguish the formulation, selected dose, population, active comparison, eradication test, allocation and analysis, equivalence question, report relationships, support and harms of the combination.

N35 · What is the scope of the current English text, corrections and dates?

Required materials and conditions: Distinguish Korean/English text, the original evidence date and English corrections from preparation/reading here
Conditions for verification: Original records on Distinguish Korean/English text, the original evidence date and English corrections from preparation/reading here must link to the relevant report, design, concomitant treatment, dose, endpoint, timing and denominator, distinguishing recorded information from what remains unverified.
Requirement and applicability: Required
Application exceptions: The records of 110 assigned participants and 88 analyzed participants are not converted into randomization, initial arm allocations, ITT or safety denominators, and no new dropout count or rate is calculated. A nonsignificant comparison is not converted into equivalence, nor a historical reconstructed interval into a current calculation or trial-reported interval.
Why this condition is needed: Material on Distinguish Korean/English text, the original evidence date and English corrections from preparation/reading here is needed to connect the combination to its population, formulation, selected dose, comparison, eradication, timing, denominator, equivalence question or harms.
Referenced methods: Existing principles distinguish the formulation, selected dose, population, active comparison, eradication test, allocation and analysis, equivalence question, report relationships, support and harms of the combination.

Referenced methods and the sections actually reviewed

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

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

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

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

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

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

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

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

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

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

Official methodology · §15.2.4, §15.3.1–15.3.3

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

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

Official methodology · §19.1.2, §19.2.1–19.2.4

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

What the statuses mean

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

Change history

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

The public view and materials were prepared from the existing 35 items. No new clinical search, verification-state change or scoring was performed.

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

Researcher downloads

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

View all item details

N01 · What is the exact scope of the equivalence claim?

Current findings: The original claim is equivalence to standard 3-drug therapy for H. pylori eradication. The selected question remains the 2 g arm of the seed-powder-plus-PPI combination.
Verification status: Partly verified
Materials actually read: Existing Korean and English stored summaries and the S01 citation read; external articles, registration, protocols, analysis plans and support disclosures unread
Why unverified: Information retained in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, equivalence, safety, prespecification and independence are not certified.
Reason for missing information: The question is not converted into proof of Nigella alone, other formulations or antibiotic replacement.
Required materials and conditions: The question of 2 g Nigella powder plus omeprazole, adults, eradication and equivalence to standard 3-drug therapy
Materials to obtain first: Original records defining the exact population, formulation, dose, comparison and equivalence question
Further research: Material needed: Original records defining the exact population, formulation, dose, comparison and equivalence question This records needed materials; no new research was executed.
Remaining uncertainty: Gaps in product details, concomitant drugs, active comparison, allocation, attrition, eradication testing, prospective hypotheses, acceptable margins, support roles and harms remain. A nonsignificant difference is not converted into equivalence, antibiotic replacement, symptom benefit or long-term safety.
Conditions for verification: Original records on The question of 2 g Nigella powder plus omeprazole, adults, eradication and equivalence to standard 3-drug therapy must link to the relevant report, design, concomitant treatment, dose, endpoint, timing and denominator, distinguishing recorded information from what remains unverified.
Why this condition is needed: Material on The question of 2 g Nigella powder plus omeprazole, adults, eradication and equivalence to standard 3-drug therapy is needed to connect the combination to its population, formulation, selected dose, comparison, eradication, timing, denominator, equivalence question or harms.
Application exceptions: The records of 110 assigned participants and 88 analyzed participants are not converted into randomization, initial arm allocations, ITT or safety denominators, and no new dropout count or rate is calculated. A nonsignificant comparison is not converted into equivalence, nor a historical reconstructed interval into a current calculation or trial-reported interval.
Referenced methods: Existing principles distinguish the formulation, selected dose, population, active comparison, eradication test, allocation and analysis, equivalence question, report relationships, support and harms of the combination.

Related sources S01

N02 · Which materials were actually read?

Current findings: The complete stored summary, 1 evidence entry and 1 citation were used for preparation. External abstracts, full text, registration, protocol and SAP were unread, with no access attempted.
Verification status: Partly verified
Materials actually read: Existing Korean and English stored summaries and the S01 citation read; external articles, registration, protocols, analysis plans and support disclosures unread
Why unverified: Information retained in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, equivalence, safety, prespecification and independence are not certified.
Reason for missing information: The PubMed URL or a PMCID does not establish full-text acquisition or completed review.
Required materials and conditions: Separate reading records for the stored JSON summary, external article, registration and plans
Materials to obtain first: Original materials and access histories supplied by the user or acquired in subsequent work
Further research: Material needed: Original materials and access histories supplied by the user or acquired in subsequent work This records needed materials; no new research was executed.
Remaining uncertainty: Gaps in product details, concomitant drugs, active comparison, allocation, attrition, eradication testing, prospective hypotheses, acceptable margins, support roles and harms remain. A nonsignificant difference is not converted into equivalence, antibiotic replacement, symptom benefit or long-term safety.
Conditions for verification: Original records on Separate reading records for the stored JSON summary, external article, registration and plans must link to the relevant report, design, concomitant treatment, dose, endpoint, timing and denominator, distinguishing recorded information from what remains unverified.
Why this condition is needed: Material on Separate reading records for the stored JSON summary, external article, registration and plans is needed to connect the combination to its population, formulation, selected dose, comparison, eradication, timing, denominator, equivalence question or harms.
Application exceptions: The records of 110 assigned participants and 88 analyzed participants are not converted into randomization, initial arm allocations, ITT or safety denominators, and no new dropout count or rate is calculated. A nonsignificant comparison is not converted into equivalence, nor a historical reconstructed interval into a current calculation or trial-reported interval.
Referenced methods: Existing principles distinguish the formulation, selected dose, population, active comparison, eradication test, allocation and analysis, equivalence question, report relationships, support and harms of the combination.

Related sources S01

N03 · What is the identity of the report?

Current findings: The stored comparative study is by Salem EM et al., Saudi J Gastroenterol 2010, PMID20616418, PMCIDPMC3003218 and DOI10.4103/1319-3767.65201.
Verification status: Partly verified
Materials actually read: Existing Korean and English stored summaries and the S01 citation read; external articles, registration, protocols, analysis plans and support disclosures unread
Why unverified: Information retained in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, equivalence, safety, prespecification and independence are not certified.
Reason for missing information: External originals, registration and the identity of related reports were not cross-checked here.
Required materials and conditions: Link the authors, year, title, PMID/PMCID/DOI and report
Materials to obtain first: Complete original bibliography, related reports and registration lists
Further research: Material needed: Complete original bibliography, related reports and registration lists This records needed materials; no new research was executed.
Remaining uncertainty: Gaps in product details, concomitant drugs, active comparison, allocation, attrition, eradication testing, prospective hypotheses, acceptable margins, support roles and harms remain. A nonsignificant difference is not converted into equivalence, antibiotic replacement, symptom benefit or long-term safety.
Conditions for verification: Original records on Link the authors, year, title, PMID/PMCID/DOI and report must link to the relevant report, design, concomitant treatment, dose, endpoint, timing and denominator, distinguishing recorded information from what remains unverified.
Why this condition is needed: Material on Link the authors, year, title, PMID/PMCID/DOI and report is needed to connect the combination to its population, formulation, selected dose, comparison, eradication, timing, denominator, equivalence question or harms.
Application exceptions: The records of 110 assigned participants and 88 analyzed participants are not converted into randomization, initial arm allocations, ITT or safety denominators, and no new dropout count or rate is calculated. A nonsignificant comparison is not converted into equivalence, nor a historical reconstructed interval into a current calculation or trial-reported interval.
Referenced methods: Existing principles distinguish the formulation, selected dose, population, active comparison, eradication test, allocation and analysis, equivalence question, report relationships, support and harms of the combination.

Related sources S01

N04 · How do the 4 arms relate within the comparison?

Current findings: The stored material is a report of an open-label alternate-allocation 4-arm comparison. The 1, 2 and 3 g arms are not turned into three independent trials, and the shared 3-drug group is not repeatedly pooled.
Verification status: Partly verified
Materials actually read: Existing Korean and English stored summaries and the S01 citation read; external articles, registration, protocols, analysis plans and support disclosures unread
Why unverified: Information retained in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, equivalence, safety, prespecification and independence are not certified.
Reason for missing information: Related report families and original participant matching remain externally unread; established unique clinical totals are not created.
Required materials and conditions: 3-drug therapy, 1/2/3 g arms, the shared comparison group and participant relationships
Materials to obtain first: Original arm structure, participant flow and lists of related reports
Further research: Material needed: Original arm structure, participant flow and lists of related reports This records needed materials; no new research was executed.
Remaining uncertainty: Gaps in product details, concomitant drugs, active comparison, allocation, attrition, eradication testing, prospective hypotheses, acceptable margins, support roles and harms remain. A nonsignificant difference is not converted into equivalence, antibiotic replacement, symptom benefit or long-term safety.
Conditions for verification: Original records on 3-drug therapy, 1/2/3 g arms, the shared comparison group and participant relationships must link to the relevant report, design, concomitant treatment, dose, endpoint, timing and denominator, distinguishing recorded information from what remains unverified.
Why this condition is needed: Material on 3-drug therapy, 1/2/3 g arms, the shared comparison group and participant relationships is needed to connect the combination to its population, formulation, selected dose, comparison, eradication, timing, denominator, equivalence question or harms.
Application exceptions: The records of 110 assigned participants and 88 analyzed participants are not converted into randomization, initial arm allocations, ITT or safety denominators, and no new dropout count or rate is calculated. A nonsignificant comparison is not converted into equivalence, nor a historical reconstructed interval into a current calculation or trial-reported interval.
Referenced methods: Existing principles distinguish the formulation, selected dose, population, active comparison, eradication test, allocation and analysis, equivalence question, report relationships, support and harms of the combination.

Related sources S01

N05 · To which adults does the question apply?

Current findings: The population is adults with H. pylori-positive nonulcer dyspepsia.
Verification status: Partly verified
Materials actually read: Existing Korean and English stored summaries and the S01 citation read; external articles, registration, protocols, analysis plans and support disclosures unread
Why unverified: Information retained in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, equivalence, safety, prespecification and independence are not certified.
Reason for missing information: The diagnostic process, prior eradication, resistance, ulcer-status assessment, age, detailed selection/exclusion and applicability to other populations remain unverified.
Required materials and conditions: H. pylori-positive nonulcer dyspepsia, selection/exclusion and baseline status
Materials to obtain first: Selection criteria, baseline characteristics and prior-treatment/resistance tables
Further research: Material needed: Selection criteria, baseline characteristics and prior-treatment/resistance tables This records needed materials; no new research was executed.
Remaining uncertainty: Gaps in product details, concomitant drugs, active comparison, allocation, attrition, eradication testing, prospective hypotheses, acceptable margins, support roles and harms remain. A nonsignificant difference is not converted into equivalence, antibiotic replacement, symptom benefit or long-term safety.
Conditions for verification: Original records on H. pylori-positive nonulcer dyspepsia, selection/exclusion and baseline status must link to the relevant report, design, concomitant treatment, dose, endpoint, timing and denominator, distinguishing recorded information from what remains unverified.
Why this condition is needed: Material on H. pylori-positive nonulcer dyspepsia, selection/exclusion and baseline status is needed to connect the combination to its population, formulation, selected dose, comparison, eradication, timing, denominator, equivalence question or harms.
Application exceptions: The records of 110 assigned participants and 88 analyzed participants are not converted into randomization, initial arm allocations, ITT or safety denominators, and no new dropout count or rate is calculated. A nonsignificant comparison is not converted into equivalence, nor a historical reconstructed interval into a current calculation or trial-reported interval.
Referenced methods: Existing principles distinguish the formulation, selected dose, population, active comparison, eradication test, allocation and analysis, equivalence question, report relationships, support and harms of the combination.

Related sources S01

N06 · What is the seed-powder preparation?

Current findings: The preparation is a combination of Nigella sativa L. seed-powder capsules and a PPI.
Verification status: Partly verified
Materials actually read: Existing Korean and English stored summaries and the S01 citation read; external articles, registration, protocols, analysis plans and support disclosures unread
Why unverified: Information retained in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, equivalence, safety, prespecification and independence are not certified.
Reason for missing information: Constituent specifications, batch, manufacture and identity with marketed products remain unverified; fixed oil, aqueous extracts and purified thymoquinone are not substituted.
Required materials and conditions: Powder capsules, plant part, constituent content, quality and batch
Materials to obtain first: Trial-product specifications and constituent/batch records
Further research: Material needed: Trial-product specifications and constituent/batch records This records needed materials; no new research was executed.
Remaining uncertainty: Gaps in product details, concomitant drugs, active comparison, allocation, attrition, eradication testing, prospective hypotheses, acceptable margins, support roles and harms remain. A nonsignificant difference is not converted into equivalence, antibiotic replacement, symptom benefit or long-term safety.
Conditions for verification: Original records on Powder capsules, plant part, constituent content, quality and batch must link to the relevant report, design, concomitant treatment, dose, endpoint, timing and denominator, distinguishing recorded information from what remains unverified.
Why this condition is needed: Material on Powder capsules, plant part, constituent content, quality and batch is needed to connect the combination to its population, formulation, selected dose, comparison, eradication, timing, denominator, equivalence question or harms.
Application exceptions: The records of 110 assigned participants and 88 analyzed participants are not converted into randomization, initial arm allocations, ITT or safety denominators, and no new dropout count or rate is calculated. A nonsignificant comparison is not converted into equivalence, nor a historical reconstructed interval into a current calculation or trial-reported interval.
Referenced methods: Existing principles distinguish the formulation, selected dose, population, active comparison, eradication test, allocation and analysis, equivalence question, report relationships, support and harms of the combination.

Related sources S01

N07 · What combined dose was used in the selected 2 g arm?

Current findings: The record of 2 g/day seed powder plus 40 mg/day omeprazole is retained.
Verification status: Partly verified
Materials actually read: Existing Korean and English stored summaries and the S01 citation read; external articles, registration, protocols, analysis plans and support disclosures unread
Why unverified: Information retained in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, equivalence, safety, prespecification and independence are not certified.
Reason for missing information: Actual use, capsule frequency, missed doses and adjustments remain unverified; values from the 1 and 3 g arms do not replace the selected dose.
Required materials and conditions: Nominal and actual powder and omeprazole doses, dosing frequency and adherence
Materials to obtain first: Arm-specific dose, administration and adherence tables
Further research: Material needed: Arm-specific dose, administration and adherence tables This records needed materials; no new research was executed.
Remaining uncertainty: Gaps in product details, concomitant drugs, active comparison, allocation, attrition, eradication testing, prospective hypotheses, acceptable margins, support roles and harms remain. A nonsignificant difference is not converted into equivalence, antibiotic replacement, symptom benefit or long-term safety.
Conditions for verification: Original records on Nominal and actual powder and omeprazole doses, dosing frequency and adherence must link to the relevant report, design, concomitant treatment, dose, endpoint, timing and denominator, distinguishing recorded information from what remains unverified.
Why this condition is needed: Material on Nominal and actual powder and omeprazole doses, dosing frequency and adherence is needed to connect the combination to its population, formulation, selected dose, comparison, eradication, timing, denominator, equivalence question or harms.
Application exceptions: The records of 110 assigned participants and 88 analyzed participants are not converted into randomization, initial arm allocations, ITT or safety denominators, and no new dropout count or rate is calculated. A nonsignificant comparison is not converted into equivalence, nor a historical reconstructed interval into a current calculation or trial-reported interval.
Referenced methods: Existing principles distinguish the formulation, selected dose, population, active comparison, eradication test, allocation and analysis, equivalence question, report relationships, support and harms of the combination.

Related sources S01

N08 · Is the PPI used in every Nigella arm distinguished?

Current findings: The stored summary records concomitant omeprazole in every Nigella arm.
Verification status: Partly verified
Materials actually read: Existing Korean and English stored summaries and the S01 citation read; external articles, registration, protocols, analysis plans and support disclosures unread
Why unverified: Information retained in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, equivalence, safety, prespecification and independence are not certified.
Reason for missing information: The effect of a PPI-only arm or the contribution of Nigella alone remains unverified in this comparison.
Required materials and conditions: Shared omeprazole, arm-specific concomitant treatment and limits on attributing effects to Nigella alone
Materials to obtain first: Direct comparisons or factorial records separating PPI/Nigella alone and in combination
Further research: Material needed: Direct comparisons or factorial records separating PPI/Nigella alone and in combination This records needed materials; no new research was executed.
Remaining uncertainty: Gaps in product details, concomitant drugs, active comparison, allocation, attrition, eradication testing, prospective hypotheses, acceptable margins, support roles and harms remain. A nonsignificant difference is not converted into equivalence, antibiotic replacement, symptom benefit or long-term safety.
Conditions for verification: Original records on Shared omeprazole, arm-specific concomitant treatment and limits on attributing effects to Nigella alone must link to the relevant report, design, concomitant treatment, dose, endpoint, timing and denominator, distinguishing recorded information from what remains unverified.
Why this condition is needed: Material on Shared omeprazole, arm-specific concomitant treatment and limits on attributing effects to Nigella alone is needed to connect the combination to its population, formulation, selected dose, comparison, eradication, timing, denominator, equivalence question or harms.
Application exceptions: The records of 110 assigned participants and 88 analyzed participants are not converted into randomization, initial arm allocations, ITT or safety denominators, and no new dropout count or rate is calculated. A nonsignificant comparison is not converted into equivalence, nor a historical reconstructed interval into a current calculation or trial-reported interval.
Referenced methods: Existing principles distinguish the formulation, selected dose, population, active comparison, eradication test, allocation and analysis, equivalence question, report relationships, support and harms of the combination.

Related sources S01

N09 · What treatment formed the standard 3-drug comparison?

Current findings: The principal comparison is standard 3-drug therapy with clarithromycin, amoxicillin and omeprazole.
Verification status: Partly verified
Materials actually read: Existing Korean and English stored summaries and the S01 citation read; external articles, registration, protocols, analysis plans and support disclosures unread
Why unverified: Information retained in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, equivalence, safety, prespecification and independence are not certified.
Reason for missing information: Each comparison drug's dose, actual duration, adherence and correspondence between the original and current treatment settings remain unverified; no new recommendation or judgment of the current standard is made.
Required materials and conditions: Doses, duration and adherence for clarithromycin, amoxicillin and omeprazole
Materials to obtain first: Arm-specific drug doses/durations, adherence and treatment-setting specifications
Further research: Material needed: Arm-specific drug doses/durations, adherence and treatment-setting specifications This records needed materials; no new research was executed.
Remaining uncertainty: Gaps in product details, concomitant drugs, active comparison, allocation, attrition, eradication testing, prospective hypotheses, acceptable margins, support roles and harms remain. A nonsignificant difference is not converted into equivalence, antibiotic replacement, symptom benefit or long-term safety.
Conditions for verification: Original records on Doses, duration and adherence for clarithromycin, amoxicillin and omeprazole must link to the relevant report, design, concomitant treatment, dose, endpoint, timing and denominator, distinguishing recorded information from what remains unverified.
Why this condition is needed: Material on Doses, duration and adherence for clarithromycin, amoxicillin and omeprazole is needed to connect the combination to its population, formulation, selected dose, comparison, eradication, timing, denominator, equivalence question or harms.
Application exceptions: The records of 110 assigned participants and 88 analyzed participants are not converted into randomization, initial arm allocations, ITT or safety denominators, and no new dropout count or rate is calculated. A nonsignificant comparison is not converted into equivalence, nor a historical reconstructed interval into a current calculation or trial-reported interval.
Referenced methods: Existing principles distinguish the formulation, selected dose, population, active comparison, eradication test, allocation and analysis, equivalence question, report relationships, support and harms of the combination.

Related sources S01

N10 · Are treatment and test timing distinguished?

Current findings: The selected question specifies 4 weeks of treatment followed by stool-antigen testing 4 weeks after treatment ends.
Verification status: Partly verified
Materials actually read: Existing Korean and English stored summaries and the S01 citation read; external articles, registration, protocols, analysis plans and support disclosures unread
Why unverified: Information retained in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, equivalence, safety, prespecification and independence are not certified.
Reason for missing information: The evidence table's abbreviation “after 4 weeks” is not newly assigned to treatment start or completion; actual schedules for each arm remain unverified.
Required materials and conditions: 4 weeks of treatment, testing 4 weeks after completion and arm-specific schedules
Materials to obtain first: Treatment/test schedules and arm-specific visit records
Further research: Material needed: Treatment/test schedules and arm-specific visit records This records needed materials; no new research was executed.
Remaining uncertainty: Gaps in product details, concomitant drugs, active comparison, allocation, attrition, eradication testing, prospective hypotheses, acceptable margins, support roles and harms remain. A nonsignificant difference is not converted into equivalence, antibiotic replacement, symptom benefit or long-term safety.
Conditions for verification: Original records on 4 weeks of treatment, testing 4 weeks after completion and arm-specific schedules must link to the relevant report, design, concomitant treatment, dose, endpoint, timing and denominator, distinguishing recorded information from what remains unverified.
Why this condition is needed: Material on 4 weeks of treatment, testing 4 weeks after completion and arm-specific schedules is needed to connect the combination to its population, formulation, selected dose, comparison, eradication, timing, denominator, equivalence question or harms.
Application exceptions: The records of 110 assigned participants and 88 analyzed participants are not converted into randomization, initial arm allocations, ITT or safety denominators, and no new dropout count or rate is calculated. A nonsignificant comparison is not converted into equivalence, nor a historical reconstructed interval into a current calculation or trial-reported interval.
Referenced methods: Existing principles distinguish the formulation, selected dose, population, active comparison, eradication test, allocation and analysis, equivalence question, report relationships, support and harms of the combination.

Related sources S01

N11 · Are alternate allocation and randomization distinguished?

Current findings: The original design is an open-label alternate-allocation 4-arm comparison; it is not promoted into a randomized RCT.
Verification status: Partly verified
Materials actually read: Existing Korean and English stored summaries and the S01 citation read; external articles, registration, protocols, analysis plans and support disclosures unread
Why unverified: Information retained in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, equivalence, safety, prespecification and independence are not certified.
Reason for missing information: Allocation sequence, predictability, concealment, baseline differences and adjustment remain unverified.
Required materials and conditions: Actual allocation method, concealment and baseline balance
Materials to obtain first: Allocation methods, baseline tables and adjustment plans
Further research: Material needed: Allocation methods, baseline tables and adjustment plans This records needed materials; no new research was executed.
Remaining uncertainty: Gaps in product details, concomitant drugs, active comparison, allocation, attrition, eradication testing, prospective hypotheses, acceptable margins, support roles and harms remain. A nonsignificant difference is not converted into equivalence, antibiotic replacement, symptom benefit or long-term safety.
Conditions for verification: Original records on Actual allocation method, concealment and baseline balance must link to the relevant report, design, concomitant treatment, dose, endpoint, timing and denominator, distinguishing recorded information from what remains unverified.
Why this condition is needed: Material on Actual allocation method, concealment and baseline balance is needed to connect the combination to its population, formulation, selected dose, comparison, eradication, timing, denominator, equivalence question or harms.
Application exceptions: The records of 110 assigned participants and 88 analyzed participants are not converted into randomization, initial arm allocations, ITT or safety denominators, and no new dropout count or rate is calculated. A nonsignificant comparison is not converted into equivalence, nor a historical reconstructed interval into a current calculation or trial-reported interval.
Referenced methods: Existing principles distinguish the formulation, selected dose, population, active comparison, eradication test, allocation and analysis, equivalence question, report relationships, support and harms of the combination.

Related sources S01

N12 · What measurement or behavioral differences may accompany open-label design?

Current findings: The original open-label design and stool-antigen endpoint are retained.
Verification status: Partly verified
Materials actually read: Existing Korean and English stored summaries and the S01 citation read; external articles, registration, protocols, analysis plans and support disclosures unread
Why unverified: Information retained in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, equivalence, safety, prespecification and independence are not certified.
Reason for missing information: Assessor masking, additional treatment, symptom expectations and measurement differences remain unverified; a laboratory endpoint alone does not establish absence of bias.
Required materials and conditions: Masking of participants, treatment providers and test assessors, with arm-specific behavior/measurement
Materials to obtain first: Records of masking, test conduct and additional treatment in each arm
Further research: Material needed: Records of masking, test conduct and additional treatment in each arm This records needed materials; no new research was executed.
Remaining uncertainty: Gaps in product details, concomitant drugs, active comparison, allocation, attrition, eradication testing, prospective hypotheses, acceptable margins, support roles and harms remain. A nonsignificant difference is not converted into equivalence, antibiotic replacement, symptom benefit or long-term safety.
Conditions for verification: Original records on Masking of participants, treatment providers and test assessors, with arm-specific behavior/measurement must link to the relevant report, design, concomitant treatment, dose, endpoint, timing and denominator, distinguishing recorded information from what remains unverified.
Why this condition is needed: Material on Masking of participants, treatment providers and test assessors, with arm-specific behavior/measurement is needed to connect the combination to its population, formulation, selected dose, comparison, eradication, timing, denominator, equivalence question or harms.
Application exceptions: The records of 110 assigned participants and 88 analyzed participants are not converted into randomization, initial arm allocations, ITT or safety denominators, and no new dropout count or rate is calculated. A nonsignificant comparison is not converted into equivalence, nor a historical reconstructed interval into a current calculation or trial-reported interval.
Referenced methods: Existing principles distinguish the formulation, selected dose, population, active comparison, eradication test, allocation and analysis, equivalence question, report relationships, support and harms of the combination.

Related sources S01

N13 · What criteria identify eradication?

Current findings: The selected endpoint is negative H. pylori stool antigen 4 weeks after treatment ends.
Verification status: Partly verified
Materials actually read: Existing Korean and English stored summaries and the S01 citation read; external articles, registration, protocols, analysis plans and support disclosures unread
Why unverified: Information retained in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, equivalence, safety, prespecification and independence are not certified.
Reason for missing information: The test product, sensitivity, negativity threshold, PPI/antibiotic discontinuation and test interval, and misclassification remain unverified.
Required materials and conditions: Stool-antigen testing, negativity criteria, assay, test timing and medication conditions
Materials to obtain first: Assay details, classification/medication-discontinuation rules and test records
Further research: Material needed: Assay details, classification/medication-discontinuation rules and test records This records needed materials; no new research was executed.
Remaining uncertainty: Gaps in product details, concomitant drugs, active comparison, allocation, attrition, eradication testing, prospective hypotheses, acceptable margins, support roles and harms remain. A nonsignificant difference is not converted into equivalence, antibiotic replacement, symptom benefit or long-term safety.
Conditions for verification: Original records on Stool-antigen testing, negativity criteria, assay, test timing and medication conditions must link to the relevant report, design, concomitant treatment, dose, endpoint, timing and denominator, distinguishing recorded information from what remains unverified.
Why this condition is needed: Material on Stool-antigen testing, negativity criteria, assay, test timing and medication conditions is needed to connect the combination to its population, formulation, selected dose, comparison, eradication, timing, denominator, equivalence question or harms.
Application exceptions: The records of 110 assigned participants and 88 analyzed participants are not converted into randomization, initial arm allocations, ITT or safety denominators, and no new dropout count or rate is calculated. A nonsignificant comparison is not converted into equivalence, nor a historical reconstructed interval into a current calculation or trial-reported interval.
Referenced methods: Existing principles distinguish the formulation, selected dose, population, active comparison, eradication test, allocation and analysis, equivalence question, report relationships, support and harms of the combination.

Related sources S01

N14 · How do 110 assigned participants relate to 88 analyzed participants?

Current findings: The original records of 110 assigned, 88 analyzed and analysis denominators 23/21/21/23 are retained.
Verification status: Partly verified
Materials actually read: Existing Korean and English stored summaries and the S01 citation read; external articles, registration, protocols, analysis plans and support disclosures unread
Why unverified: Information retained in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, equivalence, safety, prespecification and independence are not certified.
Reason for missing information: Initial arm allocations, testing/completion denominators and the ITT population remain unverified; the 88 analyzed participants are not relabeled as all assigned participants.
Required materials and conditions: Allocation, completion, testing, analysis and arm-specific denominators
Materials to obtain first: Participant-flow and arm-specific allocation/testing/analysis tables
Further research: Material needed: Participant-flow and arm-specific allocation/testing/analysis tables This records needed materials; no new research was executed.
Remaining uncertainty: Gaps in product details, concomitant drugs, active comparison, allocation, attrition, eradication testing, prospective hypotheses, acceptable margins, support roles and harms remain. A nonsignificant difference is not converted into equivalence, antibiotic replacement, symptom benefit or long-term safety.
Conditions for verification: Original records on Allocation, completion, testing, analysis and arm-specific denominators must link to the relevant report, design, concomitant treatment, dose, endpoint, timing and denominator, distinguishing recorded information from what remains unverified.
Why this condition is needed: Material on Allocation, completion, testing, analysis and arm-specific denominators is needed to connect the combination to its population, formulation, selected dose, comparison, eradication, timing, denominator, equivalence question or harms.
Application exceptions: The records of 110 assigned participants and 88 analyzed participants are not converted into randomization, initial arm allocations, ITT or safety denominators, and no new dropout count or rate is calculated. A nonsignificant comparison is not converted into equivalence, nor a historical reconstructed interval into a current calculation or trial-reported interval.
Referenced methods: Existing principles distinguish the formulation, selected dose, population, active comparison, eradication test, allocation and analysis, equivalence question, report relationships, support and harms of the combination.

Related sources S01

N15 · How were attrition and missing data handled?

Current findings: The stored summary describes completer analysis and 88 analyzed after 110 were assigned.
Verification status: Unverified
Materials actually read: Existing Korean and English stored summaries and the S01 citation read; external articles, registration, protocols, analysis plans and support disclosures unread
Why unverified: Information retained in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, equivalence, safety, prespecification and independence are not certified.
Reason for missing information: Arm-specific attrition reasons, handling of untested participants, failure assumptions and ITT/PP differences remain unverified; no new attrition rate is calculated.
Required materials and conditions: Arm-specific attrition, reasons, denominators, missingness and completer/ITT/PP populations
Materials to obtain first: Reasons for attrition/missingness, analysis populations and sensitivity analyses
Further research: Material needed: Reasons for attrition/missingness, analysis populations and sensitivity analyses This records needed materials; no new research was executed.
Remaining uncertainty: Gaps in product details, concomitant drugs, active comparison, allocation, attrition, eradication testing, prospective hypotheses, acceptable margins, support roles and harms remain. A nonsignificant difference is not converted into equivalence, antibiotic replacement, symptom benefit or long-term safety.
Conditions for verification: Original records on Arm-specific attrition, reasons, denominators, missingness and completer/ITT/PP populations must link to the relevant report, design, concomitant treatment, dose, endpoint, timing and denominator, distinguishing recorded information from what remains unverified.
Why this condition is needed: Material on Arm-specific attrition, reasons, denominators, missingness and completer/ITT/PP populations is needed to connect the combination to its population, formulation, selected dose, comparison, eradication, timing, denominator, equivalence question or harms.
Application exceptions: The records of 110 assigned participants and 88 analyzed participants are not converted into randomization, initial arm allocations, ITT or safety denominators, and no new dropout count or rate is calculated. A nonsignificant comparison is not converted into equivalence, nor a historical reconstructed interval into a current calculation or trial-reported interval.
Referenced methods: Existing principles distinguish the formulation, selected dose, population, active comparison, eradication test, allocation and analysis, equivalence question, report relationships, support and harms of the combination.

Related sources S01

N16 · Which denominators underlie the 2 g and 3-drug eradication results?

Current findings: Among completers, 2 g plus omeprazole 14/21 (66.7%) and standard 3-drug therapy 19/23 (82.6%) are retained.
Verification status: Partly verified
Materials actually read: Existing Korean and English stored summaries and the S01 citation read; external articles, registration, protocols, analysis plans and support disclosures unread
Why unverified: Information retained in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, equivalence, safety, prespecification and independence are not certified.
Reason for missing information: Eradication in the assigned population, original between-group CIs and outcomes for missing tests remain unverified; RR/RD/CIs are not newly calculated.
Required materials and conditions: Original eradication events/denominators, the completer population and comparison direction
Materials to obtain first: Arm-specific eradication tables, assigned/completer analyses and original intervals
Further research: Material needed: Arm-specific eradication tables, assigned/completer analyses and original intervals This records needed materials; no new research was executed.
Remaining uncertainty: Gaps in product details, concomitant drugs, active comparison, allocation, attrition, eradication testing, prospective hypotheses, acceptable margins, support roles and harms remain. A nonsignificant difference is not converted into equivalence, antibiotic replacement, symptom benefit or long-term safety.
Conditions for verification: Original records on Original eradication events/denominators, the completer population and comparison direction must link to the relevant report, design, concomitant treatment, dose, endpoint, timing and denominator, distinguishing recorded information from what remains unverified.
Why this condition is needed: Material on Original eradication events/denominators, the completer population and comparison direction is needed to connect the combination to its population, formulation, selected dose, comparison, eradication, timing, denominator, equivalence question or harms.
Application exceptions: The records of 110 assigned participants and 88 analyzed participants are not converted into randomization, initial arm allocations, ITT or safety denominators, and no new dropout count or rate is calculated. A nonsignificant comparison is not converted into equivalence, nor a historical reconstructed interval into a current calculation or trial-reported interval.
Referenced methods: Existing principles distinguish the formulation, selected dose, population, active comparison, eradication test, allocation and analysis, equivalence question, report relationships, support and harms of the combination.

Related sources S01

N17 · How are the 1 g and 3 g arm results kept separate?

Current findings: The original results of 1 g 10/21 and 3 g 11/23, with stored approximate percentages of 47.6% and 47.8%, are retained. Values from the selected 2 g arm are not reassigned to other doses.
Verification status: Partly verified
Materials actually read: Existing Korean and English stored summaries and the S01 citation read; external articles, registration, protocols, analysis plans and support disclosures unread
Why unverified: Information retained in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, equivalence, safety, prespecification and independence are not certified.
Reason for missing information: Prospective dose-comparison hypotheses, exact intervals and multiplicity handling remain unverified; an optimal dose is not newly established.
Required materials and conditions: Eradication denominators/results for the other dose arms and direct dose comparisons
Materials to obtain first: Arm-specific dose contrasts, intervals and prospective plans
Further research: Material needed: Arm-specific dose contrasts, intervals and prospective plans This records needed materials; no new research was executed.
Remaining uncertainty: Gaps in product details, concomitant drugs, active comparison, allocation, attrition, eradication testing, prospective hypotheses, acceptable margins, support roles and harms remain. A nonsignificant difference is not converted into equivalence, antibiotic replacement, symptom benefit or long-term safety.
Conditions for verification: Original records on Eradication denominators/results for the other dose arms and direct dose comparisons must link to the relevant report, design, concomitant treatment, dose, endpoint, timing and denominator, distinguishing recorded information from what remains unverified.
Why this condition is needed: Material on Eradication denominators/results for the other dose arms and direct dose comparisons is needed to connect the combination to its population, formulation, selected dose, comparison, eradication, timing, denominator, equivalence question or harms.
Application exceptions: The records of 110 assigned participants and 88 analyzed participants are not converted into randomization, initial arm allocations, ITT or safety denominators, and no new dropout count or rate is calculated. A nonsignificant comparison is not converted into equivalence, nor a historical reconstructed interval into a current calculation or trial-reported interval.
Referenced methods: Existing principles distinguish the formulation, selected dose, population, active comparison, eradication test, allocation and analysis, equivalence question, report relationships, support and harms of the combination.

Related sources S01

N18 · Is a nonsignificant difference kept distinct from equivalence?

Current findings: The stored summary records that the P value against standard treatment was nonsignificant, while P>.05 alone does not establish equivalence.
Verification status: Partly verified
Materials actually read: Existing Korean and English stored summaries and the S01 citation read; external articles, registration, protocols, analysis plans and support disclosures unread
Why unverified: Information retained in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, equivalence, safety, prespecification and independence are not certified.
Reason for missing information: The exact original P value, prospective equivalence design and acceptable margin remain unverified; nonsignificance is not converted into an effect of 0 or equivalence.
Required materials and conditions: Distinguish superiority P values from equivalence/noninferiority questions
Materials to obtain first: Original tests, hypotheses and equivalence plans
Further research: Material needed: Original tests, hypotheses and equivalence plans This records needed materials; no new research was executed.
Remaining uncertainty: Gaps in product details, concomitant drugs, active comparison, allocation, attrition, eradication testing, prospective hypotheses, acceptable margins, support roles and harms remain. A nonsignificant difference is not converted into equivalence, antibiotic replacement, symptom benefit or long-term safety.
Conditions for verification: Original records on Distinguish superiority P values from equivalence/noninferiority questions must link to the relevant report, design, concomitant treatment, dose, endpoint, timing and denominator, distinguishing recorded information from what remains unverified.
Why this condition is needed: Material on Distinguish superiority P values from equivalence/noninferiority questions is needed to connect the combination to its population, formulation, selected dose, comparison, eradication, timing, denominator, equivalence question or harms.
Application exceptions: The records of 110 assigned participants and 88 analyzed participants are not converted into randomization, initial arm allocations, ITT or safety denominators, and no new dropout count or rate is calculated. A nonsignificant comparison is not converted into equivalence, nor a historical reconstructed interval into a current calculation or trial-reported interval.
Referenced methods: Existing principles distinguish the formulation, selected dose, population, active comparison, eradication test, allocation and analysis, equivalence question, report relationships, support and harms of the combination.

Related sources S01

N19 · Was a noninferiority/equivalence margin prespecified?

Current findings: The stored result records “no equivalence margin,” and the summary describes absence of an equivalence design.
Verification status: Unverified
Materials actually read: Existing Korean and English stored summaries and the S01 citation read; external articles, registration, protocols, analysis plans and support disclosures unread
Why unverified: Information retained in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, equivalence, safety, prespecification and independence are not certified.
Reason for missing information: The existence/content of unread original plans is not newly verified; a justified prospective margin remains unverified.
Required materials and conditions: Clinically acceptable margins, one-/two-sided hypotheses, justification and testing plans
Materials to obtain first: Original protocol, SAP and margin justification
Further research: Material needed: Original protocol, SAP and margin justification This records needed materials; no new research was executed.
Remaining uncertainty: Gaps in product details, concomitant drugs, active comparison, allocation, attrition, eradication testing, prospective hypotheses, acceptable margins, support roles and harms remain. A nonsignificant difference is not converted into equivalence, antibiotic replacement, symptom benefit or long-term safety.
Conditions for verification: Original records on Clinically acceptable margins, one-/two-sided hypotheses, justification and testing plans must link to the relevant report, design, concomitant treatment, dose, endpoint, timing and denominator, distinguishing recorded information from what remains unverified.
Why this condition is needed: Material on Clinically acceptable margins, one-/two-sided hypotheses, justification and testing plans is needed to connect the combination to its population, formulation, selected dose, comparison, eradication, timing, denominator, equivalence question or harms.
Application exceptions: The records of 110 assigned participants and 88 analyzed participants are not converted into randomization, initial arm allocations, ITT or safety denominators, and no new dropout count or rate is calculated. A nonsignificant comparison is not converted into equivalence, nor a historical reconstructed interval into a current calculation or trial-reported interval.
Referenced methods: Existing principles distinguish the formulation, selected dose, population, active comparison, eradication test, allocation and analysis, equivalence question, report relationships, support and harms of the combination.

Related sources S01

N20 · Were sample size and analysis adequate for the equivalence question?

Current findings: The stored summary records that antibiotic replacement/equivalent treatment cannot be claimed without adequate sample size and a noninferiority margin.
Verification status: Unverified
Materials actually read: Existing Korean and English stored summaries and the S01 citation read; external articles, registration, protocols, analysis plans and support disclosures unread
Why unverified: Information retained in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, equivalence, safety, prespecification and independence are not certified.
Reason for missing information: Sample-size calculation, actual recruitment target, ITT/PP agreement, missing-data sensitivity and intervals against the margin remain unverified; power is not newly calculated.
Required materials and conditions: Prospective sample-size planning, ITT/PP, failure/missing-data assumptions and intervals against the margin
Materials to obtain first: Sample-size plans, ITT/PP/SAP and missing-data sensitivity analyses
Further research: Material needed: Sample-size plans, ITT/PP/SAP and missing-data sensitivity analyses This records needed materials; no new research was executed.
Remaining uncertainty: Gaps in product details, concomitant drugs, active comparison, allocation, attrition, eradication testing, prospective hypotheses, acceptable margins, support roles and harms remain. A nonsignificant difference is not converted into equivalence, antibiotic replacement, symptom benefit or long-term safety.
Conditions for verification: Original records on Prospective sample-size planning, ITT/PP, failure/missing-data assumptions and intervals against the margin must link to the relevant report, design, concomitant treatment, dose, endpoint, timing and denominator, distinguishing recorded information from what remains unverified.
Why this condition is needed: Material on Prospective sample-size planning, ITT/PP, failure/missing-data assumptions and intervals against the margin is needed to connect the combination to its population, formulation, selected dose, comparison, eradication, timing, denominator, equivalence question or harms.
Application exceptions: The records of 110 assigned participants and 88 analyzed participants are not converted into randomization, initial arm allocations, ITT or safety denominators, and no new dropout count or rate is calculated. A nonsignificant comparison is not converted into equivalence, nor a historical reconstructed interval into a current calculation or trial-reported interval.
Referenced methods: Existing principles distinguish the formulation, selected dose, population, active comparison, eradication test, allocation and analysis, equivalence question, report relationships, support and harms of the combination.

Related sources S01

N21 · What historical event produced the risk difference and CI?

Current findings: The historical wording retained in the Korean and English verdict rationale is “Codex reconstructed risk difference −15.9 percentage points, approximate 95% CI −41.8 to +10.0 percentage points.”
Verification status: Partly verified
Materials actually read: Existing Korean and English stored summaries and the S01 citation read; external articles, registration, protocols, analysis plans and support disclosures unread
Why unverified: Information retained in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, equivalence, safety, prespecification and independence are not certified.
Reason for missing information: This is not used as a current recalculation, a trial-reported CI or a prospective equivalence judgment. The original calculation method and comparison with the article's interval were not reviewed here.
Required materials and conditions: Distinguish original article intervals from the historical Codex recalculation
Materials to obtain first: Historical calculation records/methods, comparison with the original article and a separate change event
Further research: Material needed: Historical calculation records/methods, comparison with the original article and a separate change event This records needed materials; no new research was executed.
Remaining uncertainty: Gaps in product details, concomitant drugs, active comparison, allocation, attrition, eradication testing, prospective hypotheses, acceptable margins, support roles and harms remain. A nonsignificant difference is not converted into equivalence, antibiotic replacement, symptom benefit or long-term safety.
Conditions for verification: Original records on Distinguish original article intervals from the historical Codex recalculation must link to the relevant report, design, concomitant treatment, dose, endpoint, timing and denominator, distinguishing recorded information from what remains unverified.
Why this condition is needed: Material on Distinguish original article intervals from the historical Codex recalculation is needed to connect the combination to its population, formulation, selected dose, comparison, eradication, timing, denominator, equivalence question or harms.
Application exceptions: The records of 110 assigned participants and 88 analyzed participants are not converted into randomization, initial arm allocations, ITT or safety denominators, and no new dropout count or rate is calculated. A nonsignificant comparison is not converted into equivalence, nor a historical reconstructed interval into a current calculation or trial-reported interval.
Referenced methods: Existing principles distinguish the formulation, selected dose, population, active comparison, eradication test, allocation and analysis, equivalence question, report relationships, support and harms of the combination.

Related sources S01

N22 · Were registration, prospective endpoints and plans actually verified?

Current findings: The registration identifier is recorded as “unconfirmed”; registration, protocol and SAP were unread, with no access attempted here.
Verification status: Unverified
Materials actually read: Existing Korean and English stored summaries and the S01 citation read; external articles, registration, protocols, analysis plans and support disclosures unread
Why unverified: Information retained in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, equivalence, safety, prespecification and independence are not certified.
Reason for missing information: Absence of registration or an unregistered trial is not asserted; a prespecified 1st (primary) endpoint/analysis remains unverified.
Required materials and conditions: Registration identity/history, principal endpoints, analyses/timing and changes
Materials to obtain first: Registration history, original plans and SAP
Further research: Material needed: Registration history, original plans and SAP This records needed materials; no new research was executed.
Remaining uncertainty: Gaps in product details, concomitant drugs, active comparison, allocation, attrition, eradication testing, prospective hypotheses, acceptable margins, support roles and harms remain. A nonsignificant difference is not converted into equivalence, antibiotic replacement, symptom benefit or long-term safety.
Conditions for verification: Original records on Registration identity/history, principal endpoints, analyses/timing and changes must link to the relevant report, design, concomitant treatment, dose, endpoint, timing and denominator, distinguishing recorded information from what remains unverified.
Why this condition is needed: Material on Registration identity/history, principal endpoints, analyses/timing and changes is needed to connect the combination to its population, formulation, selected dose, comparison, eradication, timing, denominator, equivalence question or harms.
Application exceptions: The records of 110 assigned participants and 88 analyzed participants are not converted into randomization, initial arm allocations, ITT or safety denominators, and no new dropout count or rate is calculated. A nonsignificant comparison is not converted into equivalence, nor a historical reconstructed interval into a current calculation or trial-reported interval.
Referenced methods: Existing principles distinguish the formulation, selected dose, population, active comparison, eradication test, allocation and analysis, equivalence question, report relationships, support and harms of the combination.

Related sources S01

N23 · What reporting selection accompanies multiple doses and tests?

Current findings: Eradication events/denominators for all three doses and standard 3-drug therapy are retained; the favorable 2 g arm is not selectively retained alone.
Verification status: Partly verified
Materials actually read: Existing Korean and English stored summaries and the S01 citation read; external articles, registration, protocols, analysis plans and support disclosures unread
Why unverified: Information retained in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, equivalence, safety, prespecification and independence are not certified.
Reason for missing information: Prospective analyses, multiplicity handling, selective reporting and the process of choosing a dose remain unverified.
Required materials and conditions: 1/2/3 g doses, the shared 3-drug comparison, timing, all results and multiplicity
Materials to obtain first: Complete endpoint/dose tables, registration and SAP
Further research: Material needed: Complete endpoint/dose tables, registration and SAP This records needed materials; no new research was executed.
Remaining uncertainty: Gaps in product details, concomitant drugs, active comparison, allocation, attrition, eradication testing, prospective hypotheses, acceptable margins, support roles and harms remain. A nonsignificant difference is not converted into equivalence, antibiotic replacement, symptom benefit or long-term safety.
Conditions for verification: Original records on 1/2/3 g doses, the shared 3-drug comparison, timing, all results and multiplicity must link to the relevant report, design, concomitant treatment, dose, endpoint, timing and denominator, distinguishing recorded information from what remains unverified.
Why this condition is needed: Material on 1/2/3 g doses, the shared 3-drug comparison, timing, all results and multiplicity is needed to connect the combination to its population, formulation, selected dose, comparison, eradication, timing, denominator, equivalence question or harms.
Application exceptions: The records of 110 assigned participants and 88 analyzed participants are not converted into randomization, initial arm allocations, ITT or safety denominators, and no new dropout count or rate is calculated. A nonsignificant comparison is not converted into equivalence, nor a historical reconstructed interval into a current calculation or trial-reported interval.
Referenced methods: Existing principles distinguish the formulation, selected dose, population, active comparison, eradication test, allocation and analysis, equivalence question, report relationships, support and harms of the combination.

Related sources S01

N24 · Could adherence, additional drugs or resistance affect the comparison?

Current findings: The original comparison of powder plus omeprazole with standard 3-drug therapy is retained.
Verification status: Unverified
Materials actually read: Existing Korean and English stored summaries and the S01 citation read; external articles, registration, protocols, analysis plans and support disclosures unread
Why unverified: Information retained in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, equivalence, safety, prespecification and independence are not certified.
Reason for missing information: Actual adherence, other eradication medicines, resistance, prior treatment and arm-specific changes/adjustments remain unverified.
Required materials and conditions: Medication adherence, rescue/additional treatment, prior antibiotics, resistance and baseline differences
Materials to obtain first: Adherence, additional-treatment and resistance/baseline records
Further research: Material needed: Adherence, additional-treatment and resistance/baseline records This records needed materials; no new research was executed.
Remaining uncertainty: Gaps in product details, concomitant drugs, active comparison, allocation, attrition, eradication testing, prospective hypotheses, acceptable margins, support roles and harms remain. A nonsignificant difference is not converted into equivalence, antibiotic replacement, symptom benefit or long-term safety.
Conditions for verification: Original records on Medication adherence, rescue/additional treatment, prior antibiotics, resistance and baseline differences must link to the relevant report, design, concomitant treatment, dose, endpoint, timing and denominator, distinguishing recorded information from what remains unverified.
Why this condition is needed: Material on Medication adherence, rescue/additional treatment, prior antibiotics, resistance and baseline differences is needed to connect the combination to its population, formulation, selected dose, comparison, eradication, timing, denominator, equivalence question or harms.
Application exceptions: The records of 110 assigned participants and 88 analyzed participants are not converted into randomization, initial arm allocations, ITT or safety denominators, and no new dropout count or rate is calculated. A nonsignificant comparison is not converted into equivalence, nor a historical reconstructed interval into a current calculation or trial-reported interval.
Referenced methods: Existing principles distinguish the formulation, selected dose, population, active comparison, eradication test, allocation and analysis, equivalence question, report relationships, support and harms of the combination.

Related sources S01

N25 · What are the actual limits of funding and independence records?

Current findings: The stored wording reports King Faisal University grant KFU:8051 and no conflicts of interest.
Verification status: Partly verified
Materials actually read: Existing Korean and English stored summaries and the S01 citation read; external articles, registration, protocols, analysis plans and support disclosures unread
Why unverified: Information retained in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, equivalence, safety, prespecification and independence are not certified.
Reason for missing information: This is not extended to absence of free product support, absence of bias or current certification of clinical independence; the original external funding text remains unread.
Required materials and conditions: Funding sources, sponsor roles, study family and disclosure level
Materials to obtain first: Original support-role, funding and COI text
Further research: Material needed: Original support-role, funding and COI text This records needed materials; no new research was executed.
Remaining uncertainty: Gaps in product details, concomitant drugs, active comparison, allocation, attrition, eradication testing, prospective hypotheses, acceptable margins, support roles and harms remain. A nonsignificant difference is not converted into equivalence, antibiotic replacement, symptom benefit or long-term safety.
Conditions for verification: Original records on Funding sources, sponsor roles, study family and disclosure level must link to the relevant report, design, concomitant treatment, dose, endpoint, timing and denominator, distinguishing recorded information from what remains unverified.
Why this condition is needed: Material on Funding sources, sponsor roles, study family and disclosure level is needed to connect the combination to its population, formulation, selected dose, comparison, eradication, timing, denominator, equivalence question or harms.
Application exceptions: The records of 110 assigned participants and 88 analyzed participants are not converted into randomization, initial arm allocations, ITT or safety denominators, and no new dropout count or rate is calculated. A nonsignificant comparison is not converted into equivalence, nor a historical reconstructed interval into a current calculation or trial-reported interval.
Referenced methods: Existing principles distinguish the formulation, selected dose, population, active comparison, eradication test, allocation and analysis, equivalence question, report relationships, support and harms of the combination.

Related sources S01

N26 · What is recorded about product provision, employee authorship and patents?

Current findings: The stored grant and reported absence of COI are not converted into verification of product support or employee authorship.
Verification status: Unverified
Materials actually read: Existing Korean and English stored summaries and the S01 citation read; external articles, registration, protocols, analysis plans and support disclosures unread
Why unverified: Information retained in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, equivalence, safety, prespecification and independence are not certified.
Reason for missing information: Specific product support, manufacturer, employment and patent details remain unverified; the generic English “assessed separately” wording is not a current reading record.
Required materials and conditions: Separate specifications of product provision/free support, author employment, patents and COI
Materials to obtain first: Original product-provision, employment, patent and COI specifications
Further research: Material needed: Original product-provision, employment, patent and COI specifications This records needed materials; no new research was executed.
Remaining uncertainty: Gaps in product details, concomitant drugs, active comparison, allocation, attrition, eradication testing, prospective hypotheses, acceptable margins, support roles and harms remain. A nonsignificant difference is not converted into equivalence, antibiotic replacement, symptom benefit or long-term safety.
Conditions for verification: Original records on Separate specifications of product provision/free support, author employment, patents and COI must link to the relevant report, design, concomitant treatment, dose, endpoint, timing and denominator, distinguishing recorded information from what remains unverified.
Why this condition is needed: Material on Separate specifications of product provision/free support, author employment, patents and COI is needed to connect the combination to its population, formulation, selected dose, comparison, eradication, timing, denominator, equivalence question or harms.
Application exceptions: The records of 110 assigned participants and 88 analyzed participants are not converted into randomization, initial arm allocations, ITT or safety denominators, and no new dropout count or rate is calculated. A nonsignificant comparison is not converted into equivalence, nor a historical reconstructed interval into a current calculation or trial-reported interval.
Referenced methods: Existing principles distinguish the formulation, selected dose, population, active comparison, eradication test, allocation and analysis, equivalence question, report relationships, support and harms of the combination.

Related sources S01

N27 · Is there independent replication of the same question?

Current findings: The stored evidence is a direct-comparison report, and the original summary uses the historical wording “independent study.”
Verification status: Unverified
Materials actually read: Existing Korean and English stored summaries and the S01 citation read; external articles, registration, protocols, analysis plans and support disclosures unread
Why unverified: Information retained in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, equivalence, safety, prespecification and independence are not certified.
Reason for missing information: This is not inherited as established independent replication; the number of unique studies in the complete current literature and relationships with other reports remain unverified.
Required materials and conditions: Unique families matching powder plus PPI, eradication, comparison with 3-drug therapy and an equivalence design
Materials to obtain first: Related reports and lists of direct trials under the same conditions
Further research: Material needed: Related reports and lists of direct trials under the same conditions This records needed materials; no new research was executed.
Remaining uncertainty: Gaps in product details, concomitant drugs, active comparison, allocation, attrition, eradication testing, prospective hypotheses, acceptable margins, support roles and harms remain. A nonsignificant difference is not converted into equivalence, antibiotic replacement, symptom benefit or long-term safety.
Conditions for verification: Original records on Unique families matching powder plus PPI, eradication, comparison with 3-drug therapy and an equivalence design must link to the relevant report, design, concomitant treatment, dose, endpoint, timing and denominator, distinguishing recorded information from what remains unverified.
Why this condition is needed: Material on Unique families matching powder plus PPI, eradication, comparison with 3-drug therapy and an equivalence design is needed to connect the combination to its population, formulation, selected dose, comparison, eradication, timing, denominator, equivalence question or harms.
Application exceptions: The records of 110 assigned participants and 88 analyzed participants are not converted into randomization, initial arm allocations, ITT or safety denominators, and no new dropout count or rate is calculated. A nonsignificant comparison is not converted into equivalence, nor a historical reconstructed interval into a current calculation or trial-reported interval.
Referenced methods: Existing principles distinguish the formulation, selected dose, population, active comparison, eradication test, allocation and analysis, equivalence question, report relationships, support and harms of the combination.

Related sources S01

N28 · Can the record be extended to other combinations or formulations?

Current findings: The stored summary treats honey combinations separately and states that different Nigella formulations are not interchangeable.
Verification status: Partly verified
Materials actually read: Existing Korean and English stored summaries and the S01 citation read; external articles, registration, protocols, analysis plans and support disclosures unread
Why unverified: Information retained in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, equivalence, safety, prespecification and independence are not certified.
Reason for missing information: Results for other combinations/formulations are not used to fill this equivalence question.
Required materials and conditions: Distinguish powder plus omeprazole from honey, oil, aqueous extracts and purified constituents
Materials to obtain first: Separate direct comparisons for each combination/formulation
Further research: Material needed: Separate direct comparisons for each combination/formulation This records needed materials; no new research was executed.
Remaining uncertainty: Gaps in product details, concomitant drugs, active comparison, allocation, attrition, eradication testing, prospective hypotheses, acceptable margins, support roles and harms remain. A nonsignificant difference is not converted into equivalence, antibiotic replacement, symptom benefit or long-term safety.
Conditions for verification: Original records on Distinguish powder plus omeprazole from honey, oil, aqueous extracts and purified constituents must link to the relevant report, design, concomitant treatment, dose, endpoint, timing and denominator, distinguishing recorded information from what remains unverified.
Why this condition is needed: Material on Distinguish powder plus omeprazole from honey, oil, aqueous extracts and purified constituents is needed to connect the combination to its population, formulation, selected dose, comparison, eradication, timing, denominator, equivalence question or harms.
Application exceptions: The records of 110 assigned participants and 88 analyzed participants are not converted into randomization, initial arm allocations, ITT or safety denominators, and no new dropout count or rate is calculated. A nonsignificant comparison is not converted into equivalence, nor a historical reconstructed interval into a current calculation or trial-reported interval.
Referenced methods: Existing principles distinguish the formulation, selected dose, population, active comparison, eradication test, allocation and analysis, equivalence question, report relationships, support and harms of the combination.

Related sources S01

N29 · What is known about sustained eradication and longer-term dose questions?

Current findings: The stored question concerns negativity 4 weeks after treatment ends.
Verification status: Unverified
Materials actually read: Existing Korean and English stored summaries and the S01 citation read; external articles, registration, protocols, analysis plans and support disclosures unread
Why unverified: Information retained in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, equivalence, safety, prespecification and independence are not certified.
Reason for missing information: Long-term persistence, reinfection, appropriate dosing and subgroup effects remain unverified; the 2 g arm does not establish an optimal dose.
Required materials and conditions: Reinfection/relapse, sustained negativity, other doses and subgroups
Materials to obtain first: Long-term eradication follow-up and direct dose/subgroup records
Further research: Material needed: Long-term eradication follow-up and direct dose/subgroup records This records needed materials; no new research was executed.
Remaining uncertainty: Gaps in product details, concomitant drugs, active comparison, allocation, attrition, eradication testing, prospective hypotheses, acceptable margins, support roles and harms remain. A nonsignificant difference is not converted into equivalence, antibiotic replacement, symptom benefit or long-term safety.
Conditions for verification: Original records on Reinfection/relapse, sustained negativity, other doses and subgroups must link to the relevant report, design, concomitant treatment, dose, endpoint, timing and denominator, distinguishing recorded information from what remains unverified.
Why this condition is needed: Material on Reinfection/relapse, sustained negativity, other doses and subgroups is needed to connect the combination to its population, formulation, selected dose, comparison, eradication, timing, denominator, equivalence question or harms.
Application exceptions: The records of 110 assigned participants and 88 analyzed participants are not converted into randomization, initial arm allocations, ITT or safety denominators, and no new dropout count or rate is calculated. A nonsignificant comparison is not converted into equivalence, nor a historical reconstructed interval into a current calculation or trial-reported interval.
Referenced methods: Existing principles distinguish the formulation, selected dose, population, active comparison, eradication test, allocation and analysis, equivalence question, report relationships, support and harms of the combination.

Related sources S01

N30 · Does eradication negativity answer other clinical-outcome questions?

Current findings: The selected endpoint is negative stool antigen, and the stored summary limits antibiotic-replacement/equivalent-treatment wording.
Verification status: Unverified
Materials actually read: Existing Korean and English stored summaries and the S01 citation read; external articles, registration, protocols, analysis plans and support disclosures unread
Why unverified: Information retained in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, equivalence, safety, prespecification and independence are not certified.
Reason for missing information: The current negativity values do not fill gaps in direct evidence for symptom improvement, ulcer/cancer prevention or treatment replacement.
Required materials and conditions: Separate evidence for dyspepsia, ulcers, bleeding, cancer, quality of life and eradication
Materials to obtain first: Separate clinical outcomes, durations, denominators and direct comparisons
Further research: Material needed: Separate clinical outcomes, durations, denominators and direct comparisons This records needed materials; no new research was executed.
Remaining uncertainty: Gaps in product details, concomitant drugs, active comparison, allocation, attrition, eradication testing, prospective hypotheses, acceptable margins, support roles and harms remain. A nonsignificant difference is not converted into equivalence, antibiotic replacement, symptom benefit or long-term safety.
Conditions for verification: Original records on Separate evidence for dyspepsia, ulcers, bleeding, cancer, quality of life and eradication must link to the relevant report, design, concomitant treatment, dose, endpoint, timing and denominator, distinguishing recorded information from what remains unverified.
Why this condition is needed: Material on Separate evidence for dyspepsia, ulcers, bleeding, cancer, quality of life and eradication is needed to connect the combination to its population, formulation, selected dose, comparison, eradication, timing, denominator, equivalence question or harms.
Application exceptions: The records of 110 assigned participants and 88 analyzed participants are not converted into randomization, initial arm allocations, ITT or safety denominators, and no new dropout count or rate is calculated. A nonsignificant comparison is not converted into equivalence, nor a historical reconstructed interval into a current calculation or trial-reported interval.
Referenced methods: Existing principles distinguish the formulation, selected dose, population, active comparison, eradication test, allocation and analysis, equivalence question, report relationships, support and harms of the combination.

Related sources S01

N31 · How was safety information collected?

Current findings: The original Caution label and wording that small trials cannot exclude rare/long-term harms are retained.
Verification status: Unverified
Materials actually read: Existing Korean and English stored summaries and the S01 citation read; external articles, registration, protocols, analysis plans and support disclosures unread
Why unverified: Information retained in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, equivalence, safety, prespecification and independence are not certified.
Reason for missing information: Original adverse-event tables, arm-specific denominators/durations, discontinuation and collection scope remain unverified; an antibiotic-free comparison is not judged safer.
Required materials and conditions: Arm-specific adverse events, collection methods, severity, discontinuation and denominators
Materials to obtain first: Arm-specific harms, discontinuation and collection methods
Further research: Material needed: Arm-specific harms, discontinuation and collection methods This records needed materials; no new research was executed.
Remaining uncertainty: Gaps in product details, concomitant drugs, active comparison, allocation, attrition, eradication testing, prospective hypotheses, acceptable margins, support roles and harms remain. A nonsignificant difference is not converted into equivalence, antibiotic replacement, symptom benefit or long-term safety.
Conditions for verification: Original records on Arm-specific adverse events, collection methods, severity, discontinuation and denominators must link to the relevant report, design, concomitant treatment, dose, endpoint, timing and denominator, distinguishing recorded information from what remains unverified.
Why this condition is needed: Material on Arm-specific adverse events, collection methods, severity, discontinuation and denominators is needed to connect the combination to its population, formulation, selected dose, comparison, eradication, timing, denominator, equivalence question or harms.
Application exceptions: The records of 110 assigned participants and 88 analyzed participants are not converted into randomization, initial arm allocations, ITT or safety denominators, and no new dropout count or rate is calculated. A nonsignificant comparison is not converted into equivalence, nor a historical reconstructed interval into a current calculation or trial-reported interval.
Referenced methods: Existing principles distinguish the formulation, selected dose, population, active comparison, eradication test, allocation and analysis, equivalence question, report relationships, support and harms of the combination.

Related sources S01

N32 · What supports attribution of harms in the combination and concomitant drugs?

Current findings: The original cautionary wording on product/extraction differences, medication use and vulnerable populations is retained.
Verification status: Unverified
Materials actually read: Existing Korean and English stored summaries and the S01 citation read; external articles, registration, protocols, analysis plans and support disclosures unread
Why unverified: Information retained in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, equivalence, safety, prespecification and independence are not certified.
Reason for missing information: Causation by a particular constituent, interactions, improvement after discontinuation and re-exposure remain unverified; no new causality or incidence is created.
Required materials and conditions: Nigella, PPI, antibiotics, underlying conditions, timelines and alternative explanations
Materials to obtain first: Concomitant exposures, timelines, discontinuation/recovery and alternative-explanation records
Further research: Material needed: Concomitant exposures, timelines, discontinuation/recovery and alternative-explanation records This records needed materials; no new research was executed.
Remaining uncertainty: Gaps in product details, concomitant drugs, active comparison, allocation, attrition, eradication testing, prospective hypotheses, acceptable margins, support roles and harms remain. A nonsignificant difference is not converted into equivalence, antibiotic replacement, symptom benefit or long-term safety.
Conditions for verification: Original records on Nigella, PPI, antibiotics, underlying conditions, timelines and alternative explanations must link to the relevant report, design, concomitant treatment, dose, endpoint, timing and denominator, distinguishing recorded information from what remains unverified.
Why this condition is needed: Material on Nigella, PPI, antibiotics, underlying conditions, timelines and alternative explanations is needed to connect the combination to its population, formulation, selected dose, comparison, eradication, timing, denominator, equivalence question or harms.
Application exceptions: The records of 110 assigned participants and 88 analyzed participants are not converted into randomization, initial arm allocations, ITT or safety denominators, and no new dropout count or rate is calculated. A nonsignificant comparison is not converted into equivalence, nor a historical reconstructed interval into a current calculation or trial-reported interval.
Referenced methods: Existing principles distinguish the formulation, selected dose, population, active comparison, eradication test, allocation and analysis, equivalence question, report relationships, support and harms of the combination.

Related sources S01

N33 · What is known about long-term/rare harms and vulnerable populations?

Current findings: The original cautions concerning vulnerable populations, surgery and medication are linked unchanged.
Verification status: Unverified
Materials actually read: Existing Korean and English stored summaries and the S01 citation read; external articles, registration, protocols, analysis plans and support disclosures unread
Why unverified: Information retained in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, equivalence, safety, prespecification and independence are not certified.
Reason for missing information: A short adult eradication comparison does not establish safety for every vulnerable population or absence of rare harms.
Required materials and conditions: Direct safety data for long-term exposure, pregnancy/breastfeeding, children, liver/kidney conditions and other groups
Materials to obtain first: Long-term/population-specific exposure, harm and interaction records
Further research: Material needed: Long-term/population-specific exposure, harm and interaction records This records needed materials; no new research was executed.
Remaining uncertainty: Gaps in product details, concomitant drugs, active comparison, allocation, attrition, eradication testing, prospective hypotheses, acceptable margins, support roles and harms remain. A nonsignificant difference is not converted into equivalence, antibiotic replacement, symptom benefit or long-term safety.
Conditions for verification: Original records on Direct safety data for long-term exposure, pregnancy/breastfeeding, children, liver/kidney conditions and other groups must link to the relevant report, design, concomitant treatment, dose, endpoint, timing and denominator, distinguishing recorded information from what remains unverified.
Why this condition is needed: Material on Direct safety data for long-term exposure, pregnancy/breastfeeding, children, liver/kidney conditions and other groups is needed to connect the combination to its population, formulation, selected dose, comparison, eradication, timing, denominator, equivalence question or harms.
Application exceptions: The records of 110 assigned participants and 88 analyzed participants are not converted into randomization, initial arm allocations, ITT or safety denominators, and no new dropout count or rate is calculated. A nonsignificant comparison is not converted into equivalence, nor a historical reconstructed interval into a current calculation or trial-reported interval.
Referenced methods: Existing principles distinguish the formulation, selected dose, population, active comparison, eradication test, allocation and analysis, equivalence question, report relationships, support and harms of the combination.

Related sources S01

N34 · How are D34, axes and historical cross-checking retained?

Current findings: D34, the original axes and verdict explanations, inactive flags and empty subclaim/additional-rationale records are retained unchanged.
Verification status: Partly verified
Materials actually read: Existing Korean and English stored summaries and the S01 citation read; external articles, registration, protocols, analysis plans and support disclosures unread
Why unverified: Information retained in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, equivalence, safety, prespecification and independence are not certified.
Reason for missing information: Historical independent cross-checking or I2 is not used as current completed content review or certification of equivalence or independent replication.
Required materials and conditions: Existing grade/score, E0/R1/I2 and other axis labels, inactive/empty records and verdict history
Materials to obtain first: Separate histories of the verdict and correction events
Further research: Material needed: Separate histories of the verdict and correction events This records needed materials; no new research was executed.
Remaining uncertainty: Gaps in product details, concomitant drugs, active comparison, allocation, attrition, eradication testing, prospective hypotheses, acceptable margins, support roles and harms remain. A nonsignificant difference is not converted into equivalence, antibiotic replacement, symptom benefit or long-term safety.
Conditions for verification: Original records on Existing grade/score, E0/R1/I2 and other axis labels, inactive/empty records and verdict history must link to the relevant report, design, concomitant treatment, dose, endpoint, timing and denominator, distinguishing recorded information from what remains unverified.
Why this condition is needed: Material on Existing grade/score, E0/R1/I2 and other axis labels, inactive/empty records and verdict history is needed to connect the combination to its population, formulation, selected dose, comparison, eradication, timing, denominator, equivalence question or harms.
Application exceptions: The records of 110 assigned participants and 88 analyzed participants are not converted into randomization, initial arm allocations, ITT or safety denominators, and no new dropout count or rate is calculated. A nonsignificant comparison is not converted into equivalence, nor a historical reconstructed interval into a current calculation or trial-reported interval.
Referenced methods: Existing principles distinguish the formulation, selected dose, population, active comparison, eradication test, allocation and analysis, equivalence question, report relationships, support and harms of the combination.

Related sources S01

N35 · What is the scope of the current English text, corrections and dates?

Current findings: The original evidence date 2026-09-08, correction of 1 English field on 2026-09-14 with grade D retained, and the current specific/generic English wording are preserved. The original production record does not establish completed content review.
Verification status: Partly verified
Materials actually read: Existing Korean and English stored summaries and the S01 citation read; external articles, registration, protocols, analysis plans and support disclosures unread
Why unverified: Information retained in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, equivalence, safety, prespecification and independence are not certified.
Reason for missing information: Generic English “verified/assessed” wording is not inherited as new external verification; retractions, new literature and registration were not queried.
Required materials and conditions: Distinguish Korean/English text, the original evidence date and English corrections from preparation/reading here
Materials to obtain first: Before/after correction records, user comments and subsequent original material
Further research: Material needed: Before/after correction records, user comments and subsequent original material This records needed materials; no new research was executed.
Remaining uncertainty: Gaps in product details, concomitant drugs, active comparison, allocation, attrition, eradication testing, prospective hypotheses, acceptable margins, support roles and harms remain. A nonsignificant difference is not converted into equivalence, antibiotic replacement, symptom benefit or long-term safety.
Conditions for verification: Original records on Distinguish Korean/English text, the original evidence date and English corrections from preparation/reading here must link to the relevant report, design, concomitant treatment, dose, endpoint, timing and denominator, distinguishing recorded information from what remains unverified.
Why this condition is needed: Material on Distinguish Korean/English text, the original evidence date and English corrections from preparation/reading here is needed to connect the combination to its population, formulation, selected dose, comparison, eradication, timing, denominator, equivalence question or harms.
Application exceptions: The records of 110 assigned participants and 88 analyzed participants are not converted into randomization, initial arm allocations, ITT or safety denominators, and no new dropout count or rate is calculated. A nonsignificant comparison is not converted into equivalence, nor a historical reconstructed interval into a current calculation or trial-reported interval.
Referenced methods: Existing principles distinguish the formulation, selected dose, population, active comparison, eradication test, allocation and analysis, equivalence question, report relationships, support and harms of the combination.

Related sources S01