Oral whole Nigella sativa seed powder capsules × Improvement in TSH and anti-TPO in Hashimoto thyroiditis

Required evidence, verification status and materials actually read
Item	AVerification status	BReading scope	CReview item	DCurrent findings	EWhy unverified	FRequired materials and conditions	GFurther research
1	Partly verified	Full text not readStored summary read	N01 · Evidence conditionWhich Hashimoto thyroiditis question is addressed?Required	The selected claim is improvement in TSH and anti-TPO in Hashimoto thyroiditis. The original facets distinguish 8-week TSH from anti-TPO reported alongside it. R01	Information retained in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.	Oral seed powder over 8 weeks and TSH/anti-TPO in adults continuing stable levothyroxine	Material needed: Original eligibility criteria and results tables linking population, continued standard treatment, comparator and each endpoint are needed. Symptoms, medication withdrawal and cure are excluded. This records needed materials; no new research was executed.
2	Partly verified	Full text not readStored summary read	N02 · Evidence conditionAre whole-seed-powder capsules distinguished from other Nigella formulations?Required	The retained plant part is whole seed and the formulation is ground whole-seed powder in 1 g capsules. Oil, extracts, topical preparations, purified thymoquinone and combinations are not treated as equivalent. R01	Information retained in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.	Product and constituent details for ground whole Nigella sativa L. seed powder in 1 g capsules	Material needed: Original manufacturing, constituent-content, standardization and lot records are needed. No efficacy or equivalence of other formulations is added. This records needed materials; no new research was executed.
3	Partly verified	Full text not readStored summary read	N03 · Evidence conditionHow are the original dose and dosing times retained?Required	The original dose is 1 g before lunch and dinner, totaling 2 g/day. The recorded amount is retained without creating active-dose conversions, conversions to other formulations or recommended doses. R01	Information retained in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.	1 g before lunch and dinner, 2 g/day total, and actual adherence	Material needed: Original dosing/adherence, actual exposure, concomitant-medication timing and product-constituent records are needed. This records needed materials; no new research was executed.
4	Partly verified	Full text not readStored summary read	N04 · Evidence conditionAre the 8-week treatment/follow-up period and later course distinguished?Required	The original duration is 8 weeks of treatment and follow-up. This does not establish long-term thyroid function or persistence after discontinuation. R01	Information retained in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.	8-week exposure and test timing, with longer-term and post-discontinuation follow-up	Material needed: Original test schedules, exposure/discontinuation records and longer follow-up material are needed. This records needed materials; no new research was executed.
5	Partly verified	Full text not readStored summary read	N05 · Evidence conditionWhat are the diagnosis and baseline characteristics of the population?Required	The original population is adults with Hashimoto thyroiditis continuing stable levothyroxine. The effect is not extended to all untreated thyroid conditions. R01	Information retained in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.	Hashimoto diagnosis, baseline TSH/antibodies, levothyroxine dose and eligibility criteria	Material needed: Original diagnosis, baseline tests, dose/maintenance period, age, comorbidities and arm-specific eligibility tables are needed. This records needed materials; no new research was executed.
6	Partly verified	Full text not readStored summary read	N06 · Evidence conditionIs adjunctive use with continued levothyroxine distinguished from replacement?Required	The existing research summary says seed powder at 2 g/day was added to stable levothyroxine. This was not a trial of medication reduction, withdrawal or replacement. R01	Information retained in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.	Continued or changed standard treatment, medication use and the adjunctive-intervention specification in both arms	Material needed: Original medication dose/change, adherence, diet/other-treatment and common-care records are needed. This records needed materials; no new research was executed.
7	Partly verified	Full text not readStored summary read	N07 · Evidence conditionAre the starch placebo and masking specification known?Required	The comparator adds starch placebo to standard treatment. R01 is recorded as a double-blind placebo-controlled trial. R01	Information retained in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.	Starch-placebo composition/appearance, equal care and masking in both arms	Material needed: Original placebo composition, packaging, allocation/masking, adherence and equal-care records are needed. Successful masking is not certified. This records needed materials; no new research was executed.
8	Partly verified	Full text not readStored summary read	N08 · Evidence conditionAre trial design and completer analysis retained separately?Required	R01 is recorded as a randomized double-blind placebo-controlled trial with completer analysis. Randomization is kept distinct from the limitations of completer analysis. R01	Information retained in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.	Analysis populations in the randomized double-blind placebo-controlled trial	Material needed: Original sequence, concealment, allocation, analysis-plan and ITT/completer-population material is needed. No new official risk assessment is produced. This records needed materials; no new research was executed.
9	Partly verified	Full text not readStored summary read	N09 · Evidence conditionWhat do the denominators of 47 and 40 represent?Required	The original participant record is 47 randomized and 40 completed/analyzed. These numbers are retained separately without calculating withdrawals, participant totals or arm-specific numbers. R01	Information retained in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.	Total allocation, completion/analysis and arm-specific/endpoint-specific denominators	Material needed: Arm-specific allocation, completion, TSH/anti-TPO analysis denominators and the original participant flow diagram are needed. This records needed materials; no new research was executed.
10	Partly verified	Full text not readStored summary read	N10 · Evidence conditionWhat are the limitations of completer analysis and missing-data handling?Required	A completer analysis of 40 participants is retained. This is not converted into an effect for all randomized participants or an absence of missing data. R01	Information retained in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.	Analysis exclusions, missing tests, reasons for attrition and sensitivity analyses	Material needed: Original arm-specific missing/exclusion reasons, missing-data handling, analysis against the plan and sensitivity material are needed. This records needed materials; no new research was executed.
11	Partly verified	Full text not readStored summary read	N11 · Evidence conditionAre withdrawals with itching and nausea retained separately?Supplementary	The existing Korean/English rationale says active-arm withdrawals with itching and nausea occurred. No specific event count, timing, causality or arm-specific safety denominator is created. R01	Information retained in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.	Events, timing, denominators and missing outcomes linked to active-arm harm-related attrition	Material needed: Original adverse-event, attrition/discontinuation, missing-measurement, control-arm and event-course material is needed, linking safety to missing efficacy data. This records needed materials; no new research was executed.
12	Partly verified	Full text not readStored summary read	N12 · Evidence conditionWhat are the original reported TSH values?Required	The retained result is TSH 4.13±2.35 versus 8.27±7.21, adjusted P=.02. The original numbers and ± notation are retained without creating a new between-group difference, unit or CI. R01	Information retained in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.	8-week TSH arm-specific values, original dispersion and adjusted analysis	Material needed: Original results tables defining laboratory units, group matching, dispersion, baseline/final values, covariates and denominators are needed. This records needed materials; no new research was executed.
13	Partly verified	Full text not readStored summary read	N13 · Evidence conditionWhat are the original reported anti-TPO values?Required	The retained result is anti-TPO 147.99±158.33 versus 274.30±167.20, P=.01. The original counterview describes significant adjusted between-group differences for both markers. Each original form is retained. R01	Information retained in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.	8-week anti-TPO arm-specific values, original dispersion and P/analysis specification	Material needed: Original antibody units, arms/timepoints, dispersion, denominators and adjusted-analysis tables are needed. TSH P values or numbers are not copied into the antibody result. This records needed materials; no new research was executed.
14	Partly verified	Full text not readStored summary read	N14 · Evidence conditionAre adjusted effects and 95% CIs available?Required	The original result says the adjusted-effect CI was not reported. Significant P values are kept distinct from the absence of an exact effect estimate and interval. R01	Information retained in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.	Marker-specific adjusted between-group effects and 95% CIs	Material needed: Original adjusted between-group estimates, variances, CIs and models are needed. Nonreporting in the original summary remains distinct from unread external text; no back-calculation is performed. This records needed materials; no new research was executed.
15	Unverified	Full text not readStored summary read	N15 · Evidence conditionAre original ± notation, units and final values versus changes distinguished?Required	The retained result provides ± and P for both markers, but units, dispersion type and the change-score/final-value specification are not detailed. R01	Information retained in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.	Measurement units, means/dispersion, estimands and timing	Material needed: Original laboratory/statistical tables, baseline values, units and dispersion definitions are needed. The ± notation is not arbitrarily relabeled as a CI or SE. This records needed materials; no new research was executed.
16	Partly verified	Full text not readStored summary read	N16 · Evidence conditionWhat is the specification for baseline adjustment and multiple comparisons?Required	Adjusted TSH P=.02 and the narrative of significant adjusted between-group results for both markers are original records. The original adjustment and multiplicity details are unread. R01	Information retained in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.	Adjustment variables, test timepoints, estimands and multiplicity	Material needed: Original SAPs, models, covariates, all markers/timepoints and analysis-population material are needed. This records needed materials; no new research was executed.
17	Partly verified	Full text not readStored summary read	N17 · Evidence conditionHas the prospective hierarchy of principal TSH and related anti-TPO been confirmed?Required	The original facets specify 8-week TSH with anti-TPO as a related thyroid marker; the original evidence lists TSH and anti-TPO with other markers 2nd-tier. The original prospective hierarchy is not verified here. R01	Information retained in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.	Prospective endpoint hierarchy for 8-week TSH and the antibody reported alongside it	Material needed: Registration, protocol/SAP and a complete endpoint/timepoint table are needed. No new co-primary (1st) status, splitting or regrading is declared. This records needed materials; no new research was executed.
18	Unverified	Full text not readStored summary read	N18 · Evidence conditionWhat are the assay and assessor procedures?Required	The original principal endpoint and results concern laboratory markers. Specific assay, blood-sampling and assessor procedures are not detailed in the stored summary. R01	Information retained in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.	TSH/anti-TPO assays, blood-sampling timepoints and laboratory/assessor masking	Material needed: Original assay/laboratory methods, repeated measurements, units and assessor-masking material are needed. This records needed materials; no new research was executed.
19	Partly verified	Full text not readStored summary read	N19 · Evidence conditionWhat are the original randomization, concealment and masking methods?Required	The original randomized and double-blind design labels are retained. The adequacy of original methods and success of masking are not newly certified. R01	Information retained in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.	Allocation sequence, concealment and participant/assessor masking	Material needed: Original methods, registration/plans and arm-specific follow-up/assessment records are needed. No official RoB2/GRADE assessment is produced. This records needed materials; no new research was executed.
20	Partly verified	Full text not readStored summary read	N20 · Evidence conditionAre the IRCT registration record and actual reading distinguished?Required	IRCT2015021719082N4 appears in the original evidence registration field and citation. Its bibliographic presence is retained, but registration text and adherence to prospective plans were not checked here. R01	Information retained in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.	Original registration/version and timing for IRCT2015021719082N4	Material needed: Original registration, revision history, protocol/SAP and matching with the paper are needed. Identifier presence is not promoted into prospective registration or completed content verification. This records needed materials; no new research was executed.
21	Partly verified	Full text not readStored summary read	N21 · Evidence conditionAre T3 and T4 kept separate from the principal claim?Supplementary	The original summary retains T3 and T4 as 2nd-tier or mechanistic results. TSH/antibody numbers are not copied as values for other hormones. R01	Information retained in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.	Separate T3/T4 results, timing, denominators and hierarchy	Material needed: Original results, CIs, denominators and hierarchy for each marker are needed. No new separate efficacy grade is created. This records needed materials; no new research was executed.
22	Partly verified	Full text not readStored summary read	N22 · Evidence conditionAre weight, VEGF and Nesfatin-1 kept separate?Supplementary	The original summary separates weight, VEGF and Nesfatin-1 from the principal efficacy claim. Appearance in the paper title does not make these independent replications of clinical thyroid effects. R01	Information retained in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.	Separate results, denominators and prospective hierarchy for body weight/mechanistic markers	Material needed: Original separate-endpoint tables and links to the same participants/denominators are needed. Mechanistic or weight changes are not converted into cure or symptom effects. This records needed materials; no new research was executed.
23	Partly verified	Full text not readStored summary read	N23 · Evidence conditionAre symptom improvement and laboratory results distinguished?Supplementary	The existing crux and reader answer distinguish laboratory results from patient symptoms and say symptom benefit was not established. Favorable surrogate markers are not transferred to symptom effects. R01	Information retained in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.	Direct results for patient symptoms, quality of life and function	Material needed: Original material on prespecified patient outcomes, symptoms and quality of life is needed. This records needed materials; no new research was executed.
24	Partly verified	Full text not readStored summary read	N24 · Evidence conditionAre medication reduction, withdrawal and cure excluded from the claim?Supplementary	The original excluded-claim summary says medication withdrawal and cure were not tested. A laboratory signal from adjunctive use with continued stable treatment is not used as a replacement effect. R01	Information retained in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.	Direct comparisons for levothyroxine reduction/withdrawal and autoimmune cure	Material needed: Direct studies of medication reduction/discontinuation and clinical course are needed. These outcomes are not added here. This records needed materials; no new research was executed.
25	Partly verified	Full text not readStored summary read	N25 · Evidence conditionAre long-term thyroid function and persistent effects known?Supplementary	The original reader answer says long-term thyroid function was not established. The 8-week laboratory result is not a long-term or persistent effect. R01	Information retained in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.	Laboratory/clinical course beyond 8 weeks and after discontinuation	Material needed: Longer follow-up, post-discontinuation course and repeated material for the same formulation are needed. This records needed materials; no new research was executed.
26	Partly verified	Full text not readStored summary read	N26 · Evidence conditionIs a single report distinguished from independent replication?Required	The structured record covers the Farhangi et al. 2016 trial report. The historical grade rationale’s description of an independent registered trial is retained without newly certifying independence or replication. R01	Information retained in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.	Trial families, shared participants and independent teams using the same formulation	Material needed: Team, product, funding, additional-report/registration links and replication material for the same question are needed. Final unique-trial/participant totals remain unverified. This records needed materials; no new research was executed.
27	Partly verified	Full text not readStored summary read	N27 · Evidence conditionAre university support, product manufacture and company-involvement routes distinguished?Required	The original funding record is Tabriz University grant 93173 and Goldaroo capsule manufacture. Manufacture is not converted into full confirmation of company funding, employee authorship or product support. R01	Information retained in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.	Original records of funding, product support, employee authorship and conflicts of interest	Material needed: Original support/manufacturing contracts, product provision, author affiliations and COI text are needed. University support alone is not labeled as absence of all company involvement. This records needed materials; no new research was executed.
28	Partly verified	Full text not readStored summary read	N28 · Evidence conditionWhat are the harm-collection procedures and course of itching/nausea?Supplementary	The active-arm itching/nausea withdrawal narrative and general safety caution are retained separately. Harm-event counts, collection methods and established causality remain unverified. R01	Information retained in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.	Harm definitions, active ascertainment, events/discontinuation and severity	Material needed: Original harm tables, ascertainment/discontinuation, arm-specific course and missing-material records are needed. This records needed materials; no new research was executed.
29	Unverified	Full text not readStored summary read	N29 · Evidence conditionAre safety denominators, exposure and controls separately known?Supplementary	47 randomized and 40 completed/analyzed participants do not establish safety denominators. Event counts and control-arm safety denominators are absent from the summary. R01	Information retained in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.	Arm-specific safety populations, actual dosing and 8-week exposure/events	Material needed: Original safety denominators, events, controls, exposure time and attrition records are needed. Incidence is not calculated. This records needed materials; no new research was executed.
30	Partly verified	Full text not readStored summary read	N30 · Evidence conditionAre concomitant levothyroxine and alternative causes distinguished?Supplementary	The original treatment continued stable levothyroxine. The general safety record calls for consultation during medication use. Actual concomitant interactions or event causality are not established here. R01	Information retained in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.	Concomitant medication/dosing times, changes, baseline conditions and event timing	Material needed: Medication/timing, changes, baseline conditions, controls, post-discontinuation course and alternative-cause material are needed. This records needed materials; no new research was executed.
31	Partly verified	Full text not readStored summary read	N31 · Evidence conditionWere long-term, rare and vulnerable-population harms verified?Supplementary	The original safety detail retains caution about pregnancy/breastfeeding, children, liver/kidney disease, surgery and concomitant medicines, alongside the limits of small trials for long-term or rare harms. R01	Information retained in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.	Longer follow-up, independent harm reports, vulnerable populations and exposure/denominators	Material needed: Longer follow-up, vulnerable-population material, independent reports and exposure/denominators are needed. Unverified status is retained without a new harm investigation or judgment. This records needed materials; no new research was executed.
32	Partly verified	Full text not readStored summary read	N32 · Evidence conditionAre summary reading, PubMed, PMCID and registration distinguished?Required	The complete stored summary was read for preparation. The PubMed URL, PMC5112739 and IRCT bibliography are original records; external full text and registration were not read here. R01	Information retained in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.	An access table for stored JSON, external abstracts, full text, IRCT and protocols/SAPs	Material needed: External material remains unread pending actual acquisition and review. Identifiers or URLs are not labeled as reading, accessibility or fulfilled conditions. This records needed materials; no new research was executed.
33	Partly verified	Full text not readStored summary read	N33 · Evidence conditionAre generic English wording and historical corrections preserved?Supplementary	The correction record says 1 English-placeholder field was corrected while grade, score, citations and evidence date were retained. The remaining generic evidence-table wording and original Korean/English records are preserved. R01	Information retained in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.	Original Korean/English text and limits of the 2026-09-14 correction	Material needed: External English text and historical correction targets remain uncompared here. Historical verification wording is not converted into newly completed content verification. This records needed materials; no new research was executed.
34	Partly verified	Full text not readStored summary read	N34 · Evidence conditionAre original grade, axes, evidence date and preparation kept separate?Required	The original C/54/Caution, axes and evidence date 2026-09-08 are retained. Preparation does not establish a new efficacy grade, independent certification or official-method certification. R01	Information retained in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.	Original C54, Caution, axes, evidence date and correction values	Material needed: New evidence, condition revisions and verdict changes are separate events following content review. The original date is not used as a current search or external-reading date. This records needed materials; no new research was executed.

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34 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: This is the date the stored materials were checked, not the date of a new search of the clinical literature.
Population: The population is adults with Hashimoto thyroiditis continuing stable levothyroxine. Detailed diagnosis, baseline tests, dose and maintenance period, age, comorbidities and inclusion/exclusion criteria remain unverified. Applicability to all untreated thyroid conditions is not assumed.
Ingredient, formulation and route: The question concerns oral adjunctive ground whole-seed powder in 1 g capsules. Detailed manufacture, constituent content, standardization, batch and quality information remains unverified. Fixed oil, extracts, topical preparations, purified thymoquinone and combinations are not treated as interchangeable.
Dose: The original record of 1 g before lunch and dinner, totaling 2 g/day, is retained. Actual use, adherence, discontinuation and timing of concomitant medication remain unverified. No new active-dose conversion, cumulative dose, optimal dose or individual dosing guidance is created.
Comparator: The comparison adds starch placebo to common standard treatment. Details of maintained or changed levothyroxine, adherence, other care, placebo composition, appearance, packaging and masking in both arms remain unverified.
Measured outcome: The original facets retain 8-week TSH as the principal endpoint and anti-TPO as a related reported thyroid marker. The original evidence distinguishes these markers from other markers. Prospective hierarchy, measurement units, dispersion and the final-value versus change-score specification remain unverified.
Duration: The original 8 weeks of treatment and follow-up are retained. Details of actual exposure, test schedules, missing measurements and the course after discontinuation remain unverified. Results over this period do not establish long-term thyroid function or persistence after discontinuation.
Questions outside this scope: The question concerns adjunctive whole-seed powder in adults continuing stable levothyroxine. It is not extended to established effects of other formulations, symptoms, quality of life, function, medication reduction/discontinuation/replacement, cure or long-term outcomes.; The existing C·54 points·Caution, B/S/R1/I2/E+/B2/C0 and evidence date 2026-09-08 are retained. Historical independent-registered-trial and cross-checking wording does not establish new independent clinical validation or completed review here.; The original records of 47 randomized participants and 40 completers/analyzed participants are retained separately. No new withdrawal count, arm-specific number, marker-specific analysis set, participant total or safety denominator is calculated, and the result is not converted into an effect for all randomized participants.; TSH 4.13±2.35 versus 8.27±7.21, adjusted P=.02, and anti-TPO 147.99±158.33 versus 274.30±167.20, P=.01, are retained. The original narrative of adjusted between-group significance remains alongside the absence of a reported adjusted-effect CI; no new difference, unit, dispersion definition or interval is created.; The original principal TSH, related reported anti-TPO and original coprimary-split false are retained. T3, T4, weight, VEGF and Nesfatin-1 remain separate secondary or mechanistic outcomes and are not counted as independent clinical replications or evidence of symptom improvement or cure.; Tabriz University grant 93173 is distinguished from the Goldaroo capsule-manufacture record. University support, product manufacture, product provision, company funding, employment and declared conflicts do not substitute for one another; all company involvement or new independence is not established.; PMID27852303, PMC5112739, DOI10.1186/s12906-016-1432-2, IRCT2015021719082N4 and the English-placeholder correction date 2026-09-14 for 1 field are retained. Identifiers and URLs do not establish actual external reading, prospective registration or adherence to original plans; historical generic verification wording is not promoted into current verification.; The narrative of active-arm withdrawals with itching and nausea and the original safety caution are retained. No new event count, timing, causality or harm rate is created; gaps concerning pregnancy/breastfeeding, children, liver/kidney disease, surgery, concomitant medicines and long-term or rare harms remain.

Evidence and sources

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

R01 · Farhangi et al. 2016 · Whole-seed-powder and Hashimoto thyroid-marker report

PubMed

Material type: Randomized double-blind placebo-controlled trial; completer analysis
Materials actually read: Stored existing review summary read; external material unread
Findings recorded in the stored summary: TSH 4.13±2.35 versus 8.27±7.21, adjusted P=.02; anti-TPO 147.99±158.33 versus 274.30±167.20, P=.01; adjusted-effect CI not reported in the stored summary
Record level: The original records are 47 randomized participants and 40 completers/analyzed participants. Detailed matching of arm-specific, marker-specific and safety denominators, laboratory units, the meaning of ±, final values/change scores and adjusted effects remains unverified.
Study overlap and independent replication: The existing record distinguishes the Farhangi 2016 report from possible additional reports and links to the same participants. Established totals of unique trials, participants and independent replications remain unverified. Report counts and randomized/completion numbers are not pooled.

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	PMID27852303, PMCID PMC5112739, DOI10.1186/s12906-016-1432-2 and IRCT2015021719082N4 are retained as bibliography. External abstracts, full text, registration, protocols and analysis plans are unread. A PMCID or registration identifier alone does not establish successful access, actual reading or adherence to prospective plans. Material dates for stored summaries are historical production-reading records, not current external-reading dates. Unrecorded dates for external material remain unrecorded.
External abstract	Original bibliographic link or needed material; external public availability/access status unverified	Unread; access not attempted	Not read	PMID27852303, PMCID PMC5112739, DOI10.1186/s12906-016-1432-2 and IRCT2015021719082N4 are retained as bibliography. External abstracts, full text, registration, protocols and analysis plans are unread. A PMCID or registration identifier alone does not establish successful access, actual reading or adherence to prospective plans. Material dates for stored summaries are historical production-reading records, not current external-reading dates. Unrecorded dates for external material remain unrecorded.
External full text	Original bibliographic link or needed material; external public availability/access status unverified	Unread; access not attempted	Not read	PMID27852303, PMCID PMC5112739, DOI10.1186/s12906-016-1432-2 and IRCT2015021719082N4 are retained as bibliography. External abstracts, full text, registration, protocols and analysis plans are unread. A PMCID or registration identifier alone does not establish successful access, actual reading or adherence to prospective plans. Material dates for stored summaries are historical production-reading records, not current external-reading dates. Unrecorded dates for external material remain unrecorded.
Registration material	Original bibliographic link or needed material; external public availability/access status unverified	Unread; access not attempted	Not read	PMID27852303, PMCID PMC5112739, DOI10.1186/s12906-016-1432-2 and IRCT2015021719082N4 are retained as bibliography. External abstracts, full text, registration, protocols and analysis plans are unread. A PMCID or registration identifier alone does not establish successful access, actual reading or adherence to prospective plans. Material dates for stored summaries are historical production-reading records, not current external-reading dates. Unrecorded dates for external material remain unrecorded.
Protocol and analysis plan	Original bibliographic link or needed material; external public availability/access status unverified	Unread; access not attempted	Not read	PMID27852303, PMCID PMC5112739, DOI10.1186/s12906-016-1432-2 and IRCT2015021719082N4 are retained as bibliography. External abstracts, full text, registration, protocols and analysis plans are unread. A PMCID or registration identifier alone does not establish successful access, actual reading or adherence to prospective plans. Material dates for stored summaries are historical production-reading records, not current external-reading dates. Unrecorded dates for external material remain unrecorded.

Report counts versus independent study counts

The existing record distinguishes the Farhangi 2016 report from possible additional reports and links to the same participants. Established totals of unique trials, participants and independent replications remain unverified. Report counts and randomized/completion numbers are not pooled.

Review criteria

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

N01 · Which Hashimoto thyroiditis question is addressed?

Required materials and conditions: Oral seed powder over 8 weeks and TSH/anti-TPO in adults continuing stable levothyroxine
Conditions for verification: Original records on Oral seed powder over 8 weeks and TSH/anti-TPO in adults continuing stable levothyroxine must link to the relevant report, design, formulation, background treatment, endpoint, timing and denominator, distinguishing recorded information from what remains unverified.
Requirement and applicability: Required
Application exceptions: The records of 47 randomized participants and 40 completers/analyzed participants are not converted into arm-specific analysis sets or safety denominators, and withdrawals are not calculated. Marker values are not used to create new differences, units, dispersion definitions or CIs; registration bibliography is not converted into actual reading or confirmation of prospective plans.
Why this condition is needed: Material on Oral seed powder over 8 weeks and TSH/anti-TPO in adults continuing stable levothyroxine is needed to connect adjunctive whole-seed powder to its population, formulation, concomitant treatment, comparison, laboratory marker, timing, denominator or harms.
Referenced methods: Existing principles distinguish the population, formulation, continued levothyroxine, placebo, thyroid markers, timing, denominators, related reports, company involvement and harms of adjunctive whole-seed powder.

N02 · Are whole-seed-powder capsules distinguished from other Nigella formulations?

Required materials and conditions: Product and constituent details for ground whole Nigella sativa L. seed powder in 1 g capsules
Conditions for verification: Original records on Product and constituent details for ground whole Nigella sativa L. seed powder in 1 g capsules must link to the relevant report, design, formulation, background treatment, endpoint, timing and denominator, distinguishing recorded information from what remains unverified.
Requirement and applicability: Required
Application exceptions: The records of 47 randomized participants and 40 completers/analyzed participants are not converted into arm-specific analysis sets or safety denominators, and withdrawals are not calculated. Marker values are not used to create new differences, units, dispersion definitions or CIs; registration bibliography is not converted into actual reading or confirmation of prospective plans.
Why this condition is needed: Material on Product and constituent details for ground whole Nigella sativa L. seed powder in 1 g capsules is needed to connect adjunctive whole-seed powder to its population, formulation, concomitant treatment, comparison, laboratory marker, timing, denominator or harms.
Referenced methods: Existing principles distinguish the population, formulation, continued levothyroxine, placebo, thyroid markers, timing, denominators, related reports, company involvement and harms of adjunctive whole-seed powder.

N03 · How are the original dose and dosing times retained?

Required materials and conditions: 1 g before lunch and dinner, 2 g/day total, and actual adherence
Conditions for verification: Original records on 1 g before lunch and dinner, 2 g/day total, and actual adherence must link to the relevant report, design, formulation, background treatment, endpoint, timing and denominator, distinguishing recorded information from what remains unverified.
Requirement and applicability: Required
Application exceptions: The records of 47 randomized participants and 40 completers/analyzed participants are not converted into arm-specific analysis sets or safety denominators, and withdrawals are not calculated. Marker values are not used to create new differences, units, dispersion definitions or CIs; registration bibliography is not converted into actual reading or confirmation of prospective plans.
Why this condition is needed: Material on 1 g before lunch and dinner, 2 g/day total, and actual adherence is needed to connect adjunctive whole-seed powder to its population, formulation, concomitant treatment, comparison, laboratory marker, timing, denominator or harms.
Referenced methods: Existing principles distinguish the population, formulation, continued levothyroxine, placebo, thyroid markers, timing, denominators, related reports, company involvement and harms of adjunctive whole-seed powder.

N04 · Are the 8-week treatment/follow-up period and later course distinguished?

Required materials and conditions: 8-week exposure and test timing, with longer-term and post-discontinuation follow-up
Conditions for verification: Original records on 8-week exposure and test timing, with longer-term and post-discontinuation follow-up must link to the relevant report, design, formulation, background treatment, endpoint, timing and denominator, distinguishing recorded information from what remains unverified.
Requirement and applicability: Required
Application exceptions: The records of 47 randomized participants and 40 completers/analyzed participants are not converted into arm-specific analysis sets or safety denominators, and withdrawals are not calculated. Marker values are not used to create new differences, units, dispersion definitions or CIs; registration bibliography is not converted into actual reading or confirmation of prospective plans.
Why this condition is needed: Material on 8-week exposure and test timing, with longer-term and post-discontinuation follow-up is needed to connect adjunctive whole-seed powder to its population, formulation, concomitant treatment, comparison, laboratory marker, timing, denominator or harms.
Referenced methods: Existing principles distinguish the population, formulation, continued levothyroxine, placebo, thyroid markers, timing, denominators, related reports, company involvement and harms of adjunctive whole-seed powder.

N05 · What are the diagnosis and baseline characteristics of the population?

Required materials and conditions: Hashimoto diagnosis, baseline TSH/antibodies, levothyroxine dose and eligibility criteria
Conditions for verification: Original records on Hashimoto diagnosis, baseline TSH/antibodies, levothyroxine dose and eligibility criteria must link to the relevant report, design, formulation, background treatment, endpoint, timing and denominator, distinguishing recorded information from what remains unverified.
Requirement and applicability: Required
Application exceptions: The records of 47 randomized participants and 40 completers/analyzed participants are not converted into arm-specific analysis sets or safety denominators, and withdrawals are not calculated. Marker values are not used to create new differences, units, dispersion definitions or CIs; registration bibliography is not converted into actual reading or confirmation of prospective plans.
Why this condition is needed: Material on Hashimoto diagnosis, baseline TSH/antibodies, levothyroxine dose and eligibility criteria is needed to connect adjunctive whole-seed powder to its population, formulation, concomitant treatment, comparison, laboratory marker, timing, denominator or harms.
Referenced methods: Existing principles distinguish the population, formulation, continued levothyroxine, placebo, thyroid markers, timing, denominators, related reports, company involvement and harms of adjunctive whole-seed powder.

N06 · Is adjunctive use with continued levothyroxine distinguished from replacement?

Required materials and conditions: Continued or changed standard treatment, medication use and the adjunctive-intervention specification in both arms
Conditions for verification: Original records on Continued or changed standard treatment, medication use and the adjunctive-intervention specification in both arms must link to the relevant report, design, formulation, background treatment, endpoint, timing and denominator, distinguishing recorded information from what remains unverified.
Requirement and applicability: Required
Application exceptions: The records of 47 randomized participants and 40 completers/analyzed participants are not converted into arm-specific analysis sets or safety denominators, and withdrawals are not calculated. Marker values are not used to create new differences, units, dispersion definitions or CIs; registration bibliography is not converted into actual reading or confirmation of prospective plans.
Why this condition is needed: Material on Continued or changed standard treatment, medication use and the adjunctive-intervention specification in both arms is needed to connect adjunctive whole-seed powder to its population, formulation, concomitant treatment, comparison, laboratory marker, timing, denominator or harms.
Referenced methods: Existing principles distinguish the population, formulation, continued levothyroxine, placebo, thyroid markers, timing, denominators, related reports, company involvement and harms of adjunctive whole-seed powder.

N07 · Are the starch placebo and masking specification known?

Required materials and conditions: Starch-placebo composition/appearance, equal care and masking in both arms
Conditions for verification: Original records on Starch-placebo composition/appearance, equal care and masking in both arms must link to the relevant report, design, formulation, background treatment, endpoint, timing and denominator, distinguishing recorded information from what remains unverified.
Requirement and applicability: Required
Application exceptions: The records of 47 randomized participants and 40 completers/analyzed participants are not converted into arm-specific analysis sets or safety denominators, and withdrawals are not calculated. Marker values are not used to create new differences, units, dispersion definitions or CIs; registration bibliography is not converted into actual reading or confirmation of prospective plans.
Why this condition is needed: Material on Starch-placebo composition/appearance, equal care and masking in both arms is needed to connect adjunctive whole-seed powder to its population, formulation, concomitant treatment, comparison, laboratory marker, timing, denominator or harms.
Referenced methods: Existing principles distinguish the population, formulation, continued levothyroxine, placebo, thyroid markers, timing, denominators, related reports, company involvement and harms of adjunctive whole-seed powder.

N08 · Are trial design and completer analysis retained separately?

Required materials and conditions: Analysis populations in the randomized double-blind placebo-controlled trial
Conditions for verification: Original records on Analysis populations in the randomized double-blind placebo-controlled trial must link to the relevant report, design, formulation, background treatment, endpoint, timing and denominator, distinguishing recorded information from what remains unverified.
Requirement and applicability: Required
Application exceptions: The records of 47 randomized participants and 40 completers/analyzed participants are not converted into arm-specific analysis sets or safety denominators, and withdrawals are not calculated. Marker values are not used to create new differences, units, dispersion definitions or CIs; registration bibliography is not converted into actual reading or confirmation of prospective plans.
Why this condition is needed: Material on Analysis populations in the randomized double-blind placebo-controlled trial is needed to connect adjunctive whole-seed powder to its population, formulation, concomitant treatment, comparison, laboratory marker, timing, denominator or harms.
Referenced methods: Existing principles distinguish the population, formulation, continued levothyroxine, placebo, thyroid markers, timing, denominators, related reports, company involvement and harms of adjunctive whole-seed powder.

N09 · What do the denominators of 47 and 40 represent?

Required materials and conditions: Total allocation, completion/analysis and arm-specific/endpoint-specific denominators
Conditions for verification: Original records on Total allocation, completion/analysis and arm-specific/endpoint-specific denominators must link to the relevant report, design, formulation, background treatment, endpoint, timing and denominator, distinguishing recorded information from what remains unverified.
Requirement and applicability: Required
Application exceptions: The records of 47 randomized participants and 40 completers/analyzed participants are not converted into arm-specific analysis sets or safety denominators, and withdrawals are not calculated. Marker values are not used to create new differences, units, dispersion definitions or CIs; registration bibliography is not converted into actual reading or confirmation of prospective plans.
Why this condition is needed: Material on Total allocation, completion/analysis and arm-specific/endpoint-specific denominators is needed to connect adjunctive whole-seed powder to its population, formulation, concomitant treatment, comparison, laboratory marker, timing, denominator or harms.
Referenced methods: Existing principles distinguish the population, formulation, continued levothyroxine, placebo, thyroid markers, timing, denominators, related reports, company involvement and harms of adjunctive whole-seed powder.

N10 · What are the limitations of completer analysis and missing-data handling?

Required materials and conditions: Analysis exclusions, missing tests, reasons for attrition and sensitivity analyses
Conditions for verification: Original records on Analysis exclusions, missing tests, reasons for attrition and sensitivity analyses must link to the relevant report, design, formulation, background treatment, endpoint, timing and denominator, distinguishing recorded information from what remains unverified.
Requirement and applicability: Required
Application exceptions: The records of 47 randomized participants and 40 completers/analyzed participants are not converted into arm-specific analysis sets or safety denominators, and withdrawals are not calculated. Marker values are not used to create new differences, units, dispersion definitions or CIs; registration bibliography is not converted into actual reading or confirmation of prospective plans.
Why this condition is needed: Material on Analysis exclusions, missing tests, reasons for attrition and sensitivity analyses is needed to connect adjunctive whole-seed powder to its population, formulation, concomitant treatment, comparison, laboratory marker, timing, denominator or harms.
Referenced methods: Existing principles distinguish the population, formulation, continued levothyroxine, placebo, thyroid markers, timing, denominators, related reports, company involvement and harms of adjunctive whole-seed powder.

N11 · Are withdrawals with itching and nausea retained separately?

Required materials and conditions: Events, timing, denominators and missing outcomes linked to active-arm harm-related attrition
Conditions for verification: Original records on Events, timing, denominators and missing outcomes linked to active-arm harm-related attrition must link to the relevant report, design, formulation, background treatment, endpoint, timing and denominator, distinguishing recorded information from what remains unverified.
Requirement and applicability: Supplementary
Application exceptions: The records of 47 randomized participants and 40 completers/analyzed participants are not converted into arm-specific analysis sets or safety denominators, and withdrawals are not calculated. Marker values are not used to create new differences, units, dispersion definitions or CIs; registration bibliography is not converted into actual reading or confirmation of prospective plans.
Why this condition is needed: Material on Events, timing, denominators and missing outcomes linked to active-arm harm-related attrition is needed to connect adjunctive whole-seed powder to its population, formulation, concomitant treatment, comparison, laboratory marker, timing, denominator or harms.
Referenced methods: Existing principles distinguish the population, formulation, continued levothyroxine, placebo, thyroid markers, timing, denominators, related reports, company involvement and harms of adjunctive whole-seed powder.

N12 · What are the original reported TSH values?

Required materials and conditions: 8-week TSH arm-specific values, original dispersion and adjusted analysis
Conditions for verification: Original records on 8-week TSH arm-specific values, original dispersion and adjusted analysis must link to the relevant report, design, formulation, background treatment, endpoint, timing and denominator, distinguishing recorded information from what remains unverified.
Requirement and applicability: Required
Application exceptions: The records of 47 randomized participants and 40 completers/analyzed participants are not converted into arm-specific analysis sets or safety denominators, and withdrawals are not calculated. Marker values are not used to create new differences, units, dispersion definitions or CIs; registration bibliography is not converted into actual reading or confirmation of prospective plans.
Why this condition is needed: Material on 8-week TSH arm-specific values, original dispersion and adjusted analysis is needed to connect adjunctive whole-seed powder to its population, formulation, concomitant treatment, comparison, laboratory marker, timing, denominator or harms.
Referenced methods: Existing principles distinguish the population, formulation, continued levothyroxine, placebo, thyroid markers, timing, denominators, related reports, company involvement and harms of adjunctive whole-seed powder.

N13 · What are the original reported anti-TPO values?

Required materials and conditions: 8-week anti-TPO arm-specific values, original dispersion and P/analysis specification
Conditions for verification: Original records on 8-week anti-TPO arm-specific values, original dispersion and P/analysis specification must link to the relevant report, design, formulation, background treatment, endpoint, timing and denominator, distinguishing recorded information from what remains unverified.
Requirement and applicability: Required
Application exceptions: The records of 47 randomized participants and 40 completers/analyzed participants are not converted into arm-specific analysis sets or safety denominators, and withdrawals are not calculated. Marker values are not used to create new differences, units, dispersion definitions or CIs; registration bibliography is not converted into actual reading or confirmation of prospective plans.
Why this condition is needed: Material on 8-week anti-TPO arm-specific values, original dispersion and P/analysis specification is needed to connect adjunctive whole-seed powder to its population, formulation, concomitant treatment, comparison, laboratory marker, timing, denominator or harms.
Referenced methods: Existing principles distinguish the population, formulation, continued levothyroxine, placebo, thyroid markers, timing, denominators, related reports, company involvement and harms of adjunctive whole-seed powder.

N14 · Are adjusted effects and 95% CIs available?

Required materials and conditions: Marker-specific adjusted between-group effects and 95% CIs
Conditions for verification: Original records on Marker-specific adjusted between-group effects and 95% CIs must link to the relevant report, design, formulation, background treatment, endpoint, timing and denominator, distinguishing recorded information from what remains unverified.
Requirement and applicability: Required
Application exceptions: The records of 47 randomized participants and 40 completers/analyzed participants are not converted into arm-specific analysis sets or safety denominators, and withdrawals are not calculated. Marker values are not used to create new differences, units, dispersion definitions or CIs; registration bibliography is not converted into actual reading or confirmation of prospective plans.
Why this condition is needed: Material on Marker-specific adjusted between-group effects and 95% CIs is needed to connect adjunctive whole-seed powder to its population, formulation, concomitant treatment, comparison, laboratory marker, timing, denominator or harms.
Referenced methods: Existing principles distinguish the population, formulation, continued levothyroxine, placebo, thyroid markers, timing, denominators, related reports, company involvement and harms of adjunctive whole-seed powder.

N15 · Are original ± notation, units and final values versus changes distinguished?

Required materials and conditions: Measurement units, means/dispersion, estimands and timing
Conditions for verification: Original records on Measurement units, means/dispersion, estimands and timing must link to the relevant report, design, formulation, background treatment, endpoint, timing and denominator, distinguishing recorded information from what remains unverified.
Requirement and applicability: Required
Application exceptions: The records of 47 randomized participants and 40 completers/analyzed participants are not converted into arm-specific analysis sets or safety denominators, and withdrawals are not calculated. Marker values are not used to create new differences, units, dispersion definitions or CIs; registration bibliography is not converted into actual reading or confirmation of prospective plans.
Why this condition is needed: Material on Measurement units, means/dispersion, estimands and timing is needed to connect adjunctive whole-seed powder to its population, formulation, concomitant treatment, comparison, laboratory marker, timing, denominator or harms.
Referenced methods: Existing principles distinguish the population, formulation, continued levothyroxine, placebo, thyroid markers, timing, denominators, related reports, company involvement and harms of adjunctive whole-seed powder.

N16 · What is the specification for baseline adjustment and multiple comparisons?

Required materials and conditions: Adjustment variables, test timepoints, estimands and multiplicity
Conditions for verification: Original records on Adjustment variables, test timepoints, estimands and multiplicity must link to the relevant report, design, formulation, background treatment, endpoint, timing and denominator, distinguishing recorded information from what remains unverified.
Requirement and applicability: Required
Application exceptions: The records of 47 randomized participants and 40 completers/analyzed participants are not converted into arm-specific analysis sets or safety denominators, and withdrawals are not calculated. Marker values are not used to create new differences, units, dispersion definitions or CIs; registration bibliography is not converted into actual reading or confirmation of prospective plans.
Why this condition is needed: Material on Adjustment variables, test timepoints, estimands and multiplicity is needed to connect adjunctive whole-seed powder to its population, formulation, concomitant treatment, comparison, laboratory marker, timing, denominator or harms.
Referenced methods: Existing principles distinguish the population, formulation, continued levothyroxine, placebo, thyroid markers, timing, denominators, related reports, company involvement and harms of adjunctive whole-seed powder.

N17 · Has the prospective hierarchy of principal TSH and related anti-TPO been confirmed?

Required materials and conditions: Prospective endpoint hierarchy for 8-week TSH and the antibody reported alongside it
Conditions for verification: Original records on Prospective endpoint hierarchy for 8-week TSH and the antibody reported alongside it must link to the relevant report, design, formulation, background treatment, endpoint, timing and denominator, distinguishing recorded information from what remains unverified.
Requirement and applicability: Required
Application exceptions: The records of 47 randomized participants and 40 completers/analyzed participants are not converted into arm-specific analysis sets or safety denominators, and withdrawals are not calculated. Marker values are not used to create new differences, units, dispersion definitions or CIs; registration bibliography is not converted into actual reading or confirmation of prospective plans.
Why this condition is needed: Material on Prospective endpoint hierarchy for 8-week TSH and the antibody reported alongside it is needed to connect adjunctive whole-seed powder to its population, formulation, concomitant treatment, comparison, laboratory marker, timing, denominator or harms.
Referenced methods: Existing principles distinguish the population, formulation, continued levothyroxine, placebo, thyroid markers, timing, denominators, related reports, company involvement and harms of adjunctive whole-seed powder.

N18 · What are the assay and assessor procedures?

Required materials and conditions: TSH/anti-TPO assays, blood-sampling timepoints and laboratory/assessor masking
Conditions for verification: Original records on TSH/anti-TPO assays, blood-sampling timepoints and laboratory/assessor masking must link to the relevant report, design, formulation, background treatment, endpoint, timing and denominator, distinguishing recorded information from what remains unverified.
Requirement and applicability: Required
Application exceptions: The records of 47 randomized participants and 40 completers/analyzed participants are not converted into arm-specific analysis sets or safety denominators, and withdrawals are not calculated. Marker values are not used to create new differences, units, dispersion definitions or CIs; registration bibliography is not converted into actual reading or confirmation of prospective plans.
Why this condition is needed: Material on TSH/anti-TPO assays, blood-sampling timepoints and laboratory/assessor masking is needed to connect adjunctive whole-seed powder to its population, formulation, concomitant treatment, comparison, laboratory marker, timing, denominator or harms.
Referenced methods: Existing principles distinguish the population, formulation, continued levothyroxine, placebo, thyroid markers, timing, denominators, related reports, company involvement and harms of adjunctive whole-seed powder.

N19 · What are the original randomization, concealment and masking methods?

Required materials and conditions: Allocation sequence, concealment and participant/assessor masking
Conditions for verification: Original records on Allocation sequence, concealment and participant/assessor masking must link to the relevant report, design, formulation, background treatment, endpoint, timing and denominator, distinguishing recorded information from what remains unverified.
Requirement and applicability: Required
Application exceptions: The records of 47 randomized participants and 40 completers/analyzed participants are not converted into arm-specific analysis sets or safety denominators, and withdrawals are not calculated. Marker values are not used to create new differences, units, dispersion definitions or CIs; registration bibliography is not converted into actual reading or confirmation of prospective plans.
Why this condition is needed: Material on Allocation sequence, concealment and participant/assessor masking is needed to connect adjunctive whole-seed powder to its population, formulation, concomitant treatment, comparison, laboratory marker, timing, denominator or harms.
Referenced methods: Existing principles distinguish the population, formulation, continued levothyroxine, placebo, thyroid markers, timing, denominators, related reports, company involvement and harms of adjunctive whole-seed powder.

N20 · Are the IRCT registration record and actual reading distinguished?

Required materials and conditions: Original registration/version and timing for IRCT2015021719082N4
Conditions for verification: Original records on Original registration/version and timing for IRCT2015021719082N4 must link to the relevant report, design, formulation, background treatment, endpoint, timing and denominator, distinguishing recorded information from what remains unverified.
Requirement and applicability: Required
Application exceptions: The records of 47 randomized participants and 40 completers/analyzed participants are not converted into arm-specific analysis sets or safety denominators, and withdrawals are not calculated. Marker values are not used to create new differences, units, dispersion definitions or CIs; registration bibliography is not converted into actual reading or confirmation of prospective plans.
Why this condition is needed: Material on Original registration/version and timing for IRCT2015021719082N4 is needed to connect adjunctive whole-seed powder to its population, formulation, concomitant treatment, comparison, laboratory marker, timing, denominator or harms.
Referenced methods: Existing principles distinguish the population, formulation, continued levothyroxine, placebo, thyroid markers, timing, denominators, related reports, company involvement and harms of adjunctive whole-seed powder.

N21 · Are T3 and T4 kept separate from the principal claim?

Required materials and conditions: Separate T3/T4 results, timing, denominators and hierarchy
Conditions for verification: Original records on Separate T3/T4 results, timing, denominators and hierarchy must link to the relevant report, design, formulation, background treatment, endpoint, timing and denominator, distinguishing recorded information from what remains unverified.
Requirement and applicability: Supplementary
Application exceptions: The records of 47 randomized participants and 40 completers/analyzed participants are not converted into arm-specific analysis sets or safety denominators, and withdrawals are not calculated. Marker values are not used to create new differences, units, dispersion definitions or CIs; registration bibliography is not converted into actual reading or confirmation of prospective plans.
Why this condition is needed: Material on Separate T3/T4 results, timing, denominators and hierarchy is needed to connect adjunctive whole-seed powder to its population, formulation, concomitant treatment, comparison, laboratory marker, timing, denominator or harms.
Referenced methods: Existing principles distinguish the population, formulation, continued levothyroxine, placebo, thyroid markers, timing, denominators, related reports, company involvement and harms of adjunctive whole-seed powder.

N22 · Are weight, VEGF and Nesfatin-1 kept separate?

Required materials and conditions: Separate results, denominators and prospective hierarchy for body weight/mechanistic markers
Conditions for verification: Original records on Separate results, denominators and prospective hierarchy for body weight/mechanistic markers must link to the relevant report, design, formulation, background treatment, endpoint, timing and denominator, distinguishing recorded information from what remains unverified.
Requirement and applicability: Supplementary
Application exceptions: The records of 47 randomized participants and 40 completers/analyzed participants are not converted into arm-specific analysis sets or safety denominators, and withdrawals are not calculated. Marker values are not used to create new differences, units, dispersion definitions or CIs; registration bibliography is not converted into actual reading or confirmation of prospective plans.
Why this condition is needed: Material on Separate results, denominators and prospective hierarchy for body weight/mechanistic markers is needed to connect adjunctive whole-seed powder to its population, formulation, concomitant treatment, comparison, laboratory marker, timing, denominator or harms.
Referenced methods: Existing principles distinguish the population, formulation, continued levothyroxine, placebo, thyroid markers, timing, denominators, related reports, company involvement and harms of adjunctive whole-seed powder.

N23 · Are symptom improvement and laboratory results distinguished?

Required materials and conditions: Direct results for patient symptoms, quality of life and function
Conditions for verification: Original records on Direct results for patient symptoms, quality of life and function must link to the relevant report, design, formulation, background treatment, endpoint, timing and denominator, distinguishing recorded information from what remains unverified.
Requirement and applicability: Supplementary
Application exceptions: The records of 47 randomized participants and 40 completers/analyzed participants are not converted into arm-specific analysis sets or safety denominators, and withdrawals are not calculated. Marker values are not used to create new differences, units, dispersion definitions or CIs; registration bibliography is not converted into actual reading or confirmation of prospective plans.
Why this condition is needed: Material on Direct results for patient symptoms, quality of life and function is needed to connect adjunctive whole-seed powder to its population, formulation, concomitant treatment, comparison, laboratory marker, timing, denominator or harms.
Referenced methods: Existing principles distinguish the population, formulation, continued levothyroxine, placebo, thyroid markers, timing, denominators, related reports, company involvement and harms of adjunctive whole-seed powder.

N24 · Are medication reduction, withdrawal and cure excluded from the claim?

Required materials and conditions: Direct comparisons for levothyroxine reduction/withdrawal and autoimmune cure
Conditions for verification: Original records on Direct comparisons for levothyroxine reduction/withdrawal and autoimmune cure must link to the relevant report, design, formulation, background treatment, endpoint, timing and denominator, distinguishing recorded information from what remains unverified.
Requirement and applicability: Supplementary
Application exceptions: The records of 47 randomized participants and 40 completers/analyzed participants are not converted into arm-specific analysis sets or safety denominators, and withdrawals are not calculated. Marker values are not used to create new differences, units, dispersion definitions or CIs; registration bibliography is not converted into actual reading or confirmation of prospective plans.
Why this condition is needed: Material on Direct comparisons for levothyroxine reduction/withdrawal and autoimmune cure is needed to connect adjunctive whole-seed powder to its population, formulation, concomitant treatment, comparison, laboratory marker, timing, denominator or harms.
Referenced methods: Existing principles distinguish the population, formulation, continued levothyroxine, placebo, thyroid markers, timing, denominators, related reports, company involvement and harms of adjunctive whole-seed powder.

N25 · Are long-term thyroid function and persistent effects known?

Required materials and conditions: Laboratory/clinical course beyond 8 weeks and after discontinuation
Conditions for verification: Original records on Laboratory/clinical course beyond 8 weeks and after discontinuation must link to the relevant report, design, formulation, background treatment, endpoint, timing and denominator, distinguishing recorded information from what remains unverified.
Requirement and applicability: Supplementary
Application exceptions: The records of 47 randomized participants and 40 completers/analyzed participants are not converted into arm-specific analysis sets or safety denominators, and withdrawals are not calculated. Marker values are not used to create new differences, units, dispersion definitions or CIs; registration bibliography is not converted into actual reading or confirmation of prospective plans.
Why this condition is needed: Material on Laboratory/clinical course beyond 8 weeks and after discontinuation is needed to connect adjunctive whole-seed powder to its population, formulation, concomitant treatment, comparison, laboratory marker, timing, denominator or harms.
Referenced methods: Existing principles distinguish the population, formulation, continued levothyroxine, placebo, thyroid markers, timing, denominators, related reports, company involvement and harms of adjunctive whole-seed powder.

N26 · Is a single report distinguished from independent replication?

Required materials and conditions: Trial families, shared participants and independent teams using the same formulation
Conditions for verification: Original records on Trial families, shared participants and independent teams using the same formulation must link to the relevant report, design, formulation, background treatment, endpoint, timing and denominator, distinguishing recorded information from what remains unverified.
Requirement and applicability: Required
Application exceptions: The records of 47 randomized participants and 40 completers/analyzed participants are not converted into arm-specific analysis sets or safety denominators, and withdrawals are not calculated. Marker values are not used to create new differences, units, dispersion definitions or CIs; registration bibliography is not converted into actual reading or confirmation of prospective plans.
Why this condition is needed: Material on Trial families, shared participants and independent teams using the same formulation is needed to connect adjunctive whole-seed powder to its population, formulation, concomitant treatment, comparison, laboratory marker, timing, denominator or harms.
Referenced methods: Existing principles distinguish the population, formulation, continued levothyroxine, placebo, thyroid markers, timing, denominators, related reports, company involvement and harms of adjunctive whole-seed powder.

N27 · Are university support, product manufacture and company-involvement routes distinguished?

Required materials and conditions: Original records of funding, product support, employee authorship and conflicts of interest
Conditions for verification: Original records on Original records of funding, product support, employee authorship and conflicts of interest must link to the relevant report, design, formulation, background treatment, endpoint, timing and denominator, distinguishing recorded information from what remains unverified.
Requirement and applicability: Required
Application exceptions: The records of 47 randomized participants and 40 completers/analyzed participants are not converted into arm-specific analysis sets or safety denominators, and withdrawals are not calculated. Marker values are not used to create new differences, units, dispersion definitions or CIs; registration bibliography is not converted into actual reading or confirmation of prospective plans.
Why this condition is needed: Material on Original records of funding, product support, employee authorship and conflicts of interest is needed to connect adjunctive whole-seed powder to its population, formulation, concomitant treatment, comparison, laboratory marker, timing, denominator or harms.
Referenced methods: Existing principles distinguish the population, formulation, continued levothyroxine, placebo, thyroid markers, timing, denominators, related reports, company involvement and harms of adjunctive whole-seed powder.

N28 · What are the harm-collection procedures and course of itching/nausea?

Required materials and conditions: Harm definitions, active ascertainment, events/discontinuation and severity
Conditions for verification: Original records on Harm definitions, active ascertainment, events/discontinuation and severity must link to the relevant report, design, formulation, background treatment, endpoint, timing and denominator, distinguishing recorded information from what remains unverified.
Requirement and applicability: Supplementary
Application exceptions: The records of 47 randomized participants and 40 completers/analyzed participants are not converted into arm-specific analysis sets or safety denominators, and withdrawals are not calculated. Marker values are not used to create new differences, units, dispersion definitions or CIs; registration bibliography is not converted into actual reading or confirmation of prospective plans.
Why this condition is needed: Material on Harm definitions, active ascertainment, events/discontinuation and severity is needed to connect adjunctive whole-seed powder to its population, formulation, concomitant treatment, comparison, laboratory marker, timing, denominator or harms.
Referenced methods: Existing principles distinguish the population, formulation, continued levothyroxine, placebo, thyroid markers, timing, denominators, related reports, company involvement and harms of adjunctive whole-seed powder.

N29 · Are safety denominators, exposure and controls separately known?

Required materials and conditions: Arm-specific safety populations, actual dosing and 8-week exposure/events
Conditions for verification: Original records on Arm-specific safety populations, actual dosing and 8-week exposure/events must link to the relevant report, design, formulation, background treatment, endpoint, timing and denominator, distinguishing recorded information from what remains unverified.
Requirement and applicability: Supplementary
Application exceptions: The records of 47 randomized participants and 40 completers/analyzed participants are not converted into arm-specific analysis sets or safety denominators, and withdrawals are not calculated. Marker values are not used to create new differences, units, dispersion definitions or CIs; registration bibliography is not converted into actual reading or confirmation of prospective plans.
Why this condition is needed: Material on Arm-specific safety populations, actual dosing and 8-week exposure/events is needed to connect adjunctive whole-seed powder to its population, formulation, concomitant treatment, comparison, laboratory marker, timing, denominator or harms.
Referenced methods: Existing principles distinguish the population, formulation, continued levothyroxine, placebo, thyroid markers, timing, denominators, related reports, company involvement and harms of adjunctive whole-seed powder.

N30 · Are concomitant levothyroxine and alternative causes distinguished?

Required materials and conditions: Concomitant medication/dosing times, changes, baseline conditions and event timing
Conditions for verification: Original records on Concomitant medication/dosing times, changes, baseline conditions and event timing must link to the relevant report, design, formulation, background treatment, endpoint, timing and denominator, distinguishing recorded information from what remains unverified.
Requirement and applicability: Supplementary
Application exceptions: The records of 47 randomized participants and 40 completers/analyzed participants are not converted into arm-specific analysis sets or safety denominators, and withdrawals are not calculated. Marker values are not used to create new differences, units, dispersion definitions or CIs; registration bibliography is not converted into actual reading or confirmation of prospective plans.
Why this condition is needed: Material on Concomitant medication/dosing times, changes, baseline conditions and event timing is needed to connect adjunctive whole-seed powder to its population, formulation, concomitant treatment, comparison, laboratory marker, timing, denominator or harms.
Referenced methods: Existing principles distinguish the population, formulation, continued levothyroxine, placebo, thyroid markers, timing, denominators, related reports, company involvement and harms of adjunctive whole-seed powder.

N31 · Were long-term, rare and vulnerable-population harms verified?

Required materials and conditions: Longer follow-up, independent harm reports, vulnerable populations and exposure/denominators
Conditions for verification: Original records on Longer follow-up, independent harm reports, vulnerable populations and exposure/denominators must link to the relevant report, design, formulation, background treatment, endpoint, timing and denominator, distinguishing recorded information from what remains unverified.
Requirement and applicability: Supplementary
Application exceptions: The records of 47 randomized participants and 40 completers/analyzed participants are not converted into arm-specific analysis sets or safety denominators, and withdrawals are not calculated. Marker values are not used to create new differences, units, dispersion definitions or CIs; registration bibliography is not converted into actual reading or confirmation of prospective plans.
Why this condition is needed: Material on Longer follow-up, independent harm reports, vulnerable populations and exposure/denominators is needed to connect adjunctive whole-seed powder to its population, formulation, concomitant treatment, comparison, laboratory marker, timing, denominator or harms.
Referenced methods: Existing principles distinguish the population, formulation, continued levothyroxine, placebo, thyroid markers, timing, denominators, related reports, company involvement and harms of adjunctive whole-seed powder.

N32 · Are summary reading, PubMed, PMCID and registration distinguished?

Required materials and conditions: An access table for stored JSON, external abstracts, full text, IRCT and protocols/SAPs
Conditions for verification: Original records on An access table for stored JSON, external abstracts, full text, IRCT and protocols/SAPs must link to the relevant report, design, formulation, background treatment, endpoint, timing and denominator, distinguishing recorded information from what remains unverified.
Requirement and applicability: Required
Application exceptions: The records of 47 randomized participants and 40 completers/analyzed participants are not converted into arm-specific analysis sets or safety denominators, and withdrawals are not calculated. Marker values are not used to create new differences, units, dispersion definitions or CIs; registration bibliography is not converted into actual reading or confirmation of prospective plans.
Why this condition is needed: Material on An access table for stored JSON, external abstracts, full text, IRCT and protocols/SAPs is needed to connect adjunctive whole-seed powder to its population, formulation, concomitant treatment, comparison, laboratory marker, timing, denominator or harms.
Referenced methods: Existing principles distinguish the population, formulation, continued levothyroxine, placebo, thyroid markers, timing, denominators, related reports, company involvement and harms of adjunctive whole-seed powder.

N33 · Are generic English wording and historical corrections preserved?

Required materials and conditions: Original Korean/English text and limits of the 2026-09-14 correction
Conditions for verification: Original records on Original Korean/English text and limits of the 2026-09-14 correction must link to the relevant report, design, formulation, background treatment, endpoint, timing and denominator, distinguishing recorded information from what remains unverified.
Requirement and applicability: Supplementary
Application exceptions: The records of 47 randomized participants and 40 completers/analyzed participants are not converted into arm-specific analysis sets or safety denominators, and withdrawals are not calculated. Marker values are not used to create new differences, units, dispersion definitions or CIs; registration bibliography is not converted into actual reading or confirmation of prospective plans.
Why this condition is needed: Material on Original Korean/English text and limits of the 2026-09-14 correction is needed to connect adjunctive whole-seed powder to its population, formulation, concomitant treatment, comparison, laboratory marker, timing, denominator or harms.
Referenced methods: Existing principles distinguish the population, formulation, continued levothyroxine, placebo, thyroid markers, timing, denominators, related reports, company involvement and harms of adjunctive whole-seed powder.

N34 · Are original grade, axes, evidence date and preparation kept separate?

Required materials and conditions: Original C54, Caution, axes, evidence date and correction values
Conditions for verification: Original records on Original C54, Caution, axes, evidence date and correction values must link to the relevant report, design, formulation, background treatment, endpoint, timing and denominator, distinguishing recorded information from what remains unverified.
Requirement and applicability: Required
Application exceptions: The records of 47 randomized participants and 40 completers/analyzed participants are not converted into arm-specific analysis sets or safety denominators, and withdrawals are not calculated. Marker values are not used to create new differences, units, dispersion definitions or CIs; registration bibliography is not converted into actual reading or confirmation of prospective plans.
Why this condition is needed: Material on Original C54, Caution, axes, evidence date and correction values is needed to connect adjunctive whole-seed powder to its population, formulation, concomitant treatment, comparison, laboratory marker, timing, denominator or harms.
Referenced methods: Existing principles distinguish the population, formulation, continued levothyroxine, placebo, thyroid markers, timing, denominators, related reports, company involvement and harms of adjunctive whole-seed powder.

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 34 items. No new clinical search, verification-state change or scoring was performed.

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

Researcher downloads

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

View all item details

N01 · Which Hashimoto thyroiditis question is addressed?

Current findings: The selected claim is improvement in TSH and anti-TPO in Hashimoto thyroiditis. The original facets distinguish 8-week TSH from anti-TPO reported alongside it.
Verification status: Partly verified
Materials actually read: Existing Korean and English stored summaries and the R01 citation read; external abstracts, full text, registration, protocols and analysis plans 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, safety, prespecification and independence are not certified.
Reason for missing information: Detailed matching of original eligibility, continued standard treatment, the comparator and marker-specific assessment is not established in the stored summary. Symptoms, medication withdrawal and cure are outside this question.
Required materials and conditions: Oral seed powder over 8 weeks and TSH/anti-TPO in adults continuing stable levothyroxine
Materials to obtain first: Original eligibility criteria and results tables linking population, continued standard treatment, comparator and each endpoint are needed. Symptoms, medication withdrawal and cure are excluded.
Further research: Material needed: Original eligibility criteria and results tables linking population, continued standard treatment, comparator and each endpoint are needed. Symptoms, medication withdrawal and cure are excluded. This records needed materials; no new research was executed.
Remaining uncertainty: Gaps in product details, standard treatment, measurement, marker-specific denominators, dispersion, prospective plans, company roles and harms remain. Favorable laboratory directions are not converted into symptom improvement, medication withdrawal, cure, independent replication or long-term safety.
Conditions for verification: Original records on Oral seed powder over 8 weeks and TSH/anti-TPO in adults continuing stable levothyroxine must link to the relevant report, design, formulation, background treatment, endpoint, timing and denominator, distinguishing recorded information from what remains unverified.
Why this condition is needed: Material on Oral seed powder over 8 weeks and TSH/anti-TPO in adults continuing stable levothyroxine is needed to connect adjunctive whole-seed powder to its population, formulation, concomitant treatment, comparison, laboratory marker, timing, denominator or harms.
Application exceptions: The records of 47 randomized participants and 40 completers/analyzed participants are not converted into arm-specific analysis sets or safety denominators, and withdrawals are not calculated. Marker values are not used to create new differences, units, dispersion definitions or CIs; registration bibliography is not converted into actual reading or confirmation of prospective plans.
Referenced methods: Existing principles distinguish the population, formulation, continued levothyroxine, placebo, thyroid markers, timing, denominators, related reports, company involvement and harms of adjunctive whole-seed powder.

Related sources R01

N02 · Are whole-seed-powder capsules distinguished from other Nigella formulations?

Current findings: The retained plant part is whole seed and the formulation is ground whole-seed powder in 1 g capsules. Oil, extracts, topical preparations, purified thymoquinone and combinations are not treated as equivalent.
Verification status: Partly verified
Materials actually read: Existing Korean and English stored summaries and the R01 citation read; external abstracts, full text, registration, protocols and analysis plans 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, safety, prespecification and independence are not certified.
Reason for missing information: Detailed manufacture, constituent content, standardization and lot information is not established. The stored formulation description does not verify efficacy or equivalence for other formulations.
Required materials and conditions: Product and constituent details for ground whole Nigella sativa L. seed powder in 1 g capsules
Materials to obtain first: Original manufacturing, constituent-content, standardization and lot records are needed. No efficacy or equivalence of other formulations is added.
Further research: Material needed: Original manufacturing, constituent-content, standardization and lot records are needed. No efficacy or equivalence of other formulations is added. This records needed materials; no new research was executed.
Remaining uncertainty: Gaps in product details, standard treatment, measurement, marker-specific denominators, dispersion, prospective plans, company roles and harms remain. Favorable laboratory directions are not converted into symptom improvement, medication withdrawal, cure, independent replication or long-term safety.
Conditions for verification: Original records on Product and constituent details for ground whole Nigella sativa L. seed powder in 1 g capsules must link to the relevant report, design, formulation, background treatment, endpoint, timing and denominator, distinguishing recorded information from what remains unverified.
Why this condition is needed: Material on Product and constituent details for ground whole Nigella sativa L. seed powder in 1 g capsules is needed to connect adjunctive whole-seed powder to its population, formulation, concomitant treatment, comparison, laboratory marker, timing, denominator or harms.
Application exceptions: The records of 47 randomized participants and 40 completers/analyzed participants are not converted into arm-specific analysis sets or safety denominators, and withdrawals are not calculated. Marker values are not used to create new differences, units, dispersion definitions or CIs; registration bibliography is not converted into actual reading or confirmation of prospective plans.
Referenced methods: Existing principles distinguish the population, formulation, continued levothyroxine, placebo, thyroid markers, timing, denominators, related reports, company involvement and harms of adjunctive whole-seed powder.

Related sources R01

N03 · How are the original dose and dosing times retained?

Current findings: The original dose is 1 g before lunch and dinner, totaling 2 g/day. The recorded amount is retained without creating active-dose conversions, conversions to other formulations or recommended doses.
Verification status: Partly verified
Materials actually read: Existing Korean and English stored summaries and the R01 citation read; external abstracts, full text, registration, protocols and analysis plans 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, safety, prespecification and independence are not certified.
Reason for missing information: Details of actual use, adherence, exposure, concomitant-medication timing and product constituents are not established. The recorded amount is not converted into actual exposure or an individual recommendation.
Required materials and conditions: 1 g before lunch and dinner, 2 g/day total, and actual adherence
Materials to obtain first: Original dosing/adherence, actual exposure, concomitant-medication timing and product-constituent records are needed.
Further research: Material needed: Original dosing/adherence, actual exposure, concomitant-medication timing and product-constituent records are needed. This records needed materials; no new research was executed.
Remaining uncertainty: Gaps in product details, standard treatment, measurement, marker-specific denominators, dispersion, prospective plans, company roles and harms remain. Favorable laboratory directions are not converted into symptom improvement, medication withdrawal, cure, independent replication or long-term safety.
Conditions for verification: Original records on 1 g before lunch and dinner, 2 g/day total, and actual adherence must link to the relevant report, design, formulation, background treatment, endpoint, timing and denominator, distinguishing recorded information from what remains unverified.
Why this condition is needed: Material on 1 g before lunch and dinner, 2 g/day total, and actual adherence is needed to connect adjunctive whole-seed powder to its population, formulation, concomitant treatment, comparison, laboratory marker, timing, denominator or harms.
Application exceptions: The records of 47 randomized participants and 40 completers/analyzed participants are not converted into arm-specific analysis sets or safety denominators, and withdrawals are not calculated. Marker values are not used to create new differences, units, dispersion definitions or CIs; registration bibliography is not converted into actual reading or confirmation of prospective plans.
Referenced methods: Existing principles distinguish the population, formulation, continued levothyroxine, placebo, thyroid markers, timing, denominators, related reports, company involvement and harms of adjunctive whole-seed powder.

Related sources R01

N04 · Are the 8-week treatment/follow-up period and later course distinguished?

Current findings: The original duration is 8 weeks of treatment and follow-up. This does not establish long-term thyroid function or persistence after discontinuation.
Verification status: Partly verified
Materials actually read: Existing Korean and English stored summaries and the R01 citation read; external abstracts, full text, registration, protocols and analysis plans 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, safety, prespecification and independence are not certified.
Reason for missing information: Details of actual test schedules, exposure, discontinuation and longer follow-up are not established. Results over a limited period do not verify subsequent persistence.
Required materials and conditions: 8-week exposure and test timing, with longer-term and post-discontinuation follow-up
Materials to obtain first: Original test schedules, exposure/discontinuation records and longer follow-up material are needed.
Further research: Material needed: Original test schedules, exposure/discontinuation records and longer follow-up material are needed. This records needed materials; no new research was executed.
Remaining uncertainty: Gaps in product details, standard treatment, measurement, marker-specific denominators, dispersion, prospective plans, company roles and harms remain. Favorable laboratory directions are not converted into symptom improvement, medication withdrawal, cure, independent replication or long-term safety.
Conditions for verification: Original records on 8-week exposure and test timing, with longer-term and post-discontinuation follow-up must link to the relevant report, design, formulation, background treatment, endpoint, timing and denominator, distinguishing recorded information from what remains unverified.
Why this condition is needed: Material on 8-week exposure and test timing, with longer-term and post-discontinuation follow-up is needed to connect adjunctive whole-seed powder to its population, formulation, concomitant treatment, comparison, laboratory marker, timing, denominator or harms.
Application exceptions: The records of 47 randomized participants and 40 completers/analyzed participants are not converted into arm-specific analysis sets or safety denominators, and withdrawals are not calculated. Marker values are not used to create new differences, units, dispersion definitions or CIs; registration bibliography is not converted into actual reading or confirmation of prospective plans.
Referenced methods: Existing principles distinguish the population, formulation, continued levothyroxine, placebo, thyroid markers, timing, denominators, related reports, company involvement and harms of adjunctive whole-seed powder.

Related sources R01

N05 · What are the diagnosis and baseline characteristics of the population?

Current findings: The original population is adults with Hashimoto thyroiditis continuing stable levothyroxine. The effect is not extended to all untreated thyroid conditions.
Verification status: Partly verified
Materials actually read: Existing Korean and English stored summaries and the R01 citation read; external abstracts, full text, registration, protocols and analysis plans 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, safety, prespecification and independence are not certified.
Reason for missing information: Details of diagnosis, baseline tests, medication dose and maintenance period, age, comorbidities and arm-specific inclusion/exclusion are not established.
Required materials and conditions: Hashimoto diagnosis, baseline TSH/antibodies, levothyroxine dose and eligibility criteria
Materials to obtain first: Original diagnosis, baseline tests, dose/maintenance period, age, comorbidities and arm-specific eligibility tables are needed.
Further research: Material needed: Original diagnosis, baseline tests, dose/maintenance period, age, comorbidities and arm-specific eligibility tables are needed. This records needed materials; no new research was executed.
Remaining uncertainty: Gaps in product details, standard treatment, measurement, marker-specific denominators, dispersion, prospective plans, company roles and harms remain. Favorable laboratory directions are not converted into symptom improvement, medication withdrawal, cure, independent replication or long-term safety.
Conditions for verification: Original records on Hashimoto diagnosis, baseline TSH/antibodies, levothyroxine dose and eligibility criteria must link to the relevant report, design, formulation, background treatment, endpoint, timing and denominator, distinguishing recorded information from what remains unverified.
Why this condition is needed: Material on Hashimoto diagnosis, baseline TSH/antibodies, levothyroxine dose and eligibility criteria is needed to connect adjunctive whole-seed powder to its population, formulation, concomitant treatment, comparison, laboratory marker, timing, denominator or harms.
Application exceptions: The records of 47 randomized participants and 40 completers/analyzed participants are not converted into arm-specific analysis sets or safety denominators, and withdrawals are not calculated. Marker values are not used to create new differences, units, dispersion definitions or CIs; registration bibliography is not converted into actual reading or confirmation of prospective plans.
Referenced methods: Existing principles distinguish the population, formulation, continued levothyroxine, placebo, thyroid markers, timing, denominators, related reports, company involvement and harms of adjunctive whole-seed powder.

Related sources R01

N06 · Is adjunctive use with continued levothyroxine distinguished from replacement?

Current findings: The existing research summary says seed powder at 2 g/day was added to stable levothyroxine. This was not a trial of medication reduction, withdrawal or replacement.
Verification status: Partly verified
Materials actually read: Existing Korean and English stored summaries and the R01 citation read; external abstracts, full text, registration, protocols and analysis plans 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, safety, prespecification and independence are not certified.
Reason for missing information: Detailed records of medication maintenance, changes, adherence, diet and other treatment in both arms are not established. An adjunctive-use description does not verify replacement effects.
Required materials and conditions: Continued or changed standard treatment, medication use and the adjunctive-intervention specification in both arms
Materials to obtain first: Original medication dose/change, adherence, diet/other-treatment and common-care records are needed.
Further research: Material needed: Original medication dose/change, adherence, diet/other-treatment and common-care records are needed. This records needed materials; no new research was executed.
Remaining uncertainty: Gaps in product details, standard treatment, measurement, marker-specific denominators, dispersion, prospective plans, company roles and harms remain. Favorable laboratory directions are not converted into symptom improvement, medication withdrawal, cure, independent replication or long-term safety.
Conditions for verification: Original records on Continued or changed standard treatment, medication use and the adjunctive-intervention specification in both arms must link to the relevant report, design, formulation, background treatment, endpoint, timing and denominator, distinguishing recorded information from what remains unverified.
Why this condition is needed: Material on Continued or changed standard treatment, medication use and the adjunctive-intervention specification in both arms is needed to connect adjunctive whole-seed powder to its population, formulation, concomitant treatment, comparison, laboratory marker, timing, denominator or harms.
Application exceptions: The records of 47 randomized participants and 40 completers/analyzed participants are not converted into arm-specific analysis sets or safety denominators, and withdrawals are not calculated. Marker values are not used to create new differences, units, dispersion definitions or CIs; registration bibliography is not converted into actual reading or confirmation of prospective plans.
Referenced methods: Existing principles distinguish the population, formulation, continued levothyroxine, placebo, thyroid markers, timing, denominators, related reports, company involvement and harms of adjunctive whole-seed powder.

Related sources R01

N07 · Are the starch placebo and masking specification known?

Current findings: The comparator adds starch placebo to standard treatment. R01 is recorded as a double-blind placebo-controlled trial.
Verification status: Partly verified
Materials actually read: Existing Korean and English stored summaries and the R01 citation read; external abstracts, full text, registration, protocols and analysis plans 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, safety, prespecification and independence are not certified.
Reason for missing information: Details of placebo composition, appearance, packaging, allocation, masking, adherence and equal care are not established. The design label alone does not verify successful masking.
Required materials and conditions: Starch-placebo composition/appearance, equal care and masking in both arms
Materials to obtain first: Original placebo composition, packaging, allocation/masking, adherence and equal-care records are needed. Successful masking is not certified.
Further research: Material needed: Original placebo composition, packaging, allocation/masking, adherence and equal-care records are needed. Successful masking is not certified. This records needed materials; no new research was executed.
Remaining uncertainty: Gaps in product details, standard treatment, measurement, marker-specific denominators, dispersion, prospective plans, company roles and harms remain. Favorable laboratory directions are not converted into symptom improvement, medication withdrawal, cure, independent replication or long-term safety.
Conditions for verification: Original records on Starch-placebo composition/appearance, equal care and masking in both arms must link to the relevant report, design, formulation, background treatment, endpoint, timing and denominator, distinguishing recorded information from what remains unverified.
Why this condition is needed: Material on Starch-placebo composition/appearance, equal care and masking in both arms is needed to connect adjunctive whole-seed powder to its population, formulation, concomitant treatment, comparison, laboratory marker, timing, denominator or harms.
Application exceptions: The records of 47 randomized participants and 40 completers/analyzed participants are not converted into arm-specific analysis sets or safety denominators, and withdrawals are not calculated. Marker values are not used to create new differences, units, dispersion definitions or CIs; registration bibliography is not converted into actual reading or confirmation of prospective plans.
Referenced methods: Existing principles distinguish the population, formulation, continued levothyroxine, placebo, thyroid markers, timing, denominators, related reports, company involvement and harms of adjunctive whole-seed powder.

Related sources R01

N08 · Are trial design and completer analysis retained separately?

Current findings: R01 is recorded as a randomized double-blind placebo-controlled trial with completer analysis. Randomization is kept distinct from the limitations of completer analysis.
Verification status: Partly verified
Materials actually read: Existing Korean and English stored summaries and the R01 citation read; external abstracts, full text, registration, protocols and analysis plans 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, safety, prespecification and independence are not certified.
Reason for missing information: Details of the original sequence, concealment, analysis plan and ITT/completer populations are not established. A randomization label is not converted into analysis of all randomized participants.
Required materials and conditions: Analysis populations in the randomized double-blind placebo-controlled trial
Materials to obtain first: Original sequence, concealment, allocation, analysis-plan and ITT/completer-population material is needed. No new official risk assessment is produced.
Further research: Material needed: Original sequence, concealment, allocation, analysis-plan and ITT/completer-population material is needed. No new official risk assessment is produced. This records needed materials; no new research was executed.
Remaining uncertainty: Gaps in product details, standard treatment, measurement, marker-specific denominators, dispersion, prospective plans, company roles and harms remain. Favorable laboratory directions are not converted into symptom improvement, medication withdrawal, cure, independent replication or long-term safety.
Conditions for verification: Original records on Analysis populations in the randomized double-blind placebo-controlled trial must link to the relevant report, design, formulation, background treatment, endpoint, timing and denominator, distinguishing recorded information from what remains unverified.
Why this condition is needed: Material on Analysis populations in the randomized double-blind placebo-controlled trial is needed to connect adjunctive whole-seed powder to its population, formulation, concomitant treatment, comparison, laboratory marker, timing, denominator or harms.
Application exceptions: The records of 47 randomized participants and 40 completers/analyzed participants are not converted into arm-specific analysis sets or safety denominators, and withdrawals are not calculated. Marker values are not used to create new differences, units, dispersion definitions or CIs; registration bibliography is not converted into actual reading or confirmation of prospective plans.
Referenced methods: Existing principles distinguish the population, formulation, continued levothyroxine, placebo, thyroid markers, timing, denominators, related reports, company involvement and harms of adjunctive whole-seed powder.

Related sources R01

N09 · What do the denominators of 47 and 40 represent?

Current findings: The original participant record is 47 randomized and 40 completed/analyzed. These numbers are retained separately without calculating withdrawals, participant totals or arm-specific numbers.
Verification status: Partly verified
Materials actually read: Existing Korean and English stored summaries and the R01 citation read; external abstracts, full text, registration, protocols and analysis plans 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, safety, prespecification and independence are not certified.
Reason for missing information: Detailed matching of arm-specific allocation/completion and each marker analysis denominator is not established. Allocation/completion numbers alone do not determine arm sizes or analysis populations.
Required materials and conditions: Total allocation, completion/analysis and arm-specific/endpoint-specific denominators
Materials to obtain first: Arm-specific allocation, completion, TSH/anti-TPO analysis denominators and the original participant flow diagram are needed.
Further research: Material needed: Arm-specific allocation, completion, TSH/anti-TPO analysis denominators and the original participant flow diagram are needed. This records needed materials; no new research was executed.
Remaining uncertainty: Gaps in product details, standard treatment, measurement, marker-specific denominators, dispersion, prospective plans, company roles and harms remain. Favorable laboratory directions are not converted into symptom improvement, medication withdrawal, cure, independent replication or long-term safety.
Conditions for verification: Original records on Total allocation, completion/analysis and arm-specific/endpoint-specific denominators must link to the relevant report, design, formulation, background treatment, endpoint, timing and denominator, distinguishing recorded information from what remains unverified.
Why this condition is needed: Material on Total allocation, completion/analysis and arm-specific/endpoint-specific denominators is needed to connect adjunctive whole-seed powder to its population, formulation, concomitant treatment, comparison, laboratory marker, timing, denominator or harms.
Application exceptions: The records of 47 randomized participants and 40 completers/analyzed participants are not converted into arm-specific analysis sets or safety denominators, and withdrawals are not calculated. Marker values are not used to create new differences, units, dispersion definitions or CIs; registration bibliography is not converted into actual reading or confirmation of prospective plans.
Referenced methods: Existing principles distinguish the population, formulation, continued levothyroxine, placebo, thyroid markers, timing, denominators, related reports, company involvement and harms of adjunctive whole-seed powder.

Related sources R01

N10 · What are the limitations of completer analysis and missing-data handling?

Current findings: A completer analysis of 40 participants is retained. This is not converted into an effect for all randomized participants or an absence of missing data.
Verification status: Partly verified
Materials actually read: Existing Korean and English stored summaries and the R01 citation read; external abstracts, full text, registration, protocols and analysis plans 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, safety, prespecification and independence are not certified.
Reason for missing information: Arm-specific missingness, exclusion reasons, missing-data handling, analysis against the plan and sensitivity results are not established. Completer results alone do not exclude the effects of missing data.
Required materials and conditions: Analysis exclusions, missing tests, reasons for attrition and sensitivity analyses
Materials to obtain first: Original arm-specific missing/exclusion reasons, missing-data handling, analysis against the plan and sensitivity material are needed.
Further research: Material needed: Original arm-specific missing/exclusion reasons, missing-data handling, analysis against the plan and sensitivity material are needed. This records needed materials; no new research was executed.
Remaining uncertainty: Gaps in product details, standard treatment, measurement, marker-specific denominators, dispersion, prospective plans, company roles and harms remain. Favorable laboratory directions are not converted into symptom improvement, medication withdrawal, cure, independent replication or long-term safety.
Conditions for verification: Original records on Analysis exclusions, missing tests, reasons for attrition and sensitivity analyses must link to the relevant report, design, formulation, background treatment, endpoint, timing and denominator, distinguishing recorded information from what remains unverified.
Why this condition is needed: Material on Analysis exclusions, missing tests, reasons for attrition and sensitivity analyses is needed to connect adjunctive whole-seed powder to its population, formulation, concomitant treatment, comparison, laboratory marker, timing, denominator or harms.
Application exceptions: The records of 47 randomized participants and 40 completers/analyzed participants are not converted into arm-specific analysis sets or safety denominators, and withdrawals are not calculated. Marker values are not used to create new differences, units, dispersion definitions or CIs; registration bibliography is not converted into actual reading or confirmation of prospective plans.
Referenced methods: Existing principles distinguish the population, formulation, continued levothyroxine, placebo, thyroid markers, timing, denominators, related reports, company involvement and harms of adjunctive whole-seed powder.

Related sources R01

N11 · Are withdrawals with itching and nausea retained separately?

Current findings: The existing Korean/English rationale says active-arm withdrawals with itching and nausea occurred. No specific event count, timing, causality or arm-specific safety denominator is created.
Verification status: Partly verified
Materials actually read: Existing Korean and English stored summaries and the R01 citation read; external abstracts, full text, registration, protocols and analysis plans 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, safety, prespecification and independence are not certified.
Reason for missing information: Detailed original adverse-event, attrition/discontinuation, missing-test, control-arm and event-course material is not established. Links between safety events and missing efficacy data remain unresolved.
Required materials and conditions: Events, timing, denominators and missing outcomes linked to active-arm harm-related attrition
Materials to obtain first: Original adverse-event, attrition/discontinuation, missing-measurement, control-arm and event-course material is needed, linking safety to missing efficacy data.
Further research: Material needed: Original adverse-event, attrition/discontinuation, missing-measurement, control-arm and event-course material is needed, linking safety to missing efficacy data. This records needed materials; no new research was executed.
Remaining uncertainty: Gaps in product details, standard treatment, measurement, marker-specific denominators, dispersion, prospective plans, company roles and harms remain. Favorable laboratory directions are not converted into symptom improvement, medication withdrawal, cure, independent replication or long-term safety.
Conditions for verification: Original records on Events, timing, denominators and missing outcomes linked to active-arm harm-related attrition must link to the relevant report, design, formulation, background treatment, endpoint, timing and denominator, distinguishing recorded information from what remains unverified.
Why this condition is needed: Material on Events, timing, denominators and missing outcomes linked to active-arm harm-related attrition is needed to connect adjunctive whole-seed powder to its population, formulation, concomitant treatment, comparison, laboratory marker, timing, denominator or harms.
Application exceptions: The records of 47 randomized participants and 40 completers/analyzed participants are not converted into arm-specific analysis sets or safety denominators, and withdrawals are not calculated. Marker values are not used to create new differences, units, dispersion definitions or CIs; registration bibliography is not converted into actual reading or confirmation of prospective plans.
Referenced methods: Existing principles distinguish the population, formulation, continued levothyroxine, placebo, thyroid markers, timing, denominators, related reports, company involvement and harms of adjunctive whole-seed powder.

Related sources R01

N12 · What are the original reported TSH values?

Current findings: The retained result is TSH 4.13±2.35 versus 8.27±7.21, adjusted P=.02. The original numbers and ± notation are retained without creating a new between-group difference, unit or CI.
Verification status: Partly verified
Materials actually read: Existing Korean and English stored summaries and the R01 citation read; external abstracts, full text, registration, protocols and analysis plans 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, safety, prespecification and independence are not certified.
Reason for missing information: The original results table defining laboratory units, group matching, dispersion, baseline/final values, covariates and analysis denominators is not established.
Required materials and conditions: 8-week TSH arm-specific values, original dispersion and adjusted analysis
Materials to obtain first: Original results tables defining laboratory units, group matching, dispersion, baseline/final values, covariates and denominators are needed.
Further research: Material needed: Original results tables defining laboratory units, group matching, dispersion, baseline/final values, covariates and denominators are needed. This records needed materials; no new research was executed.
Remaining uncertainty: Gaps in product details, standard treatment, measurement, marker-specific denominators, dispersion, prospective plans, company roles and harms remain. Favorable laboratory directions are not converted into symptom improvement, medication withdrawal, cure, independent replication or long-term safety.
Conditions for verification: Original records on 8-week TSH arm-specific values, original dispersion and adjusted analysis must link to the relevant report, design, formulation, background treatment, endpoint, timing and denominator, distinguishing recorded information from what remains unverified.
Why this condition is needed: Material on 8-week TSH arm-specific values, original dispersion and adjusted analysis is needed to connect adjunctive whole-seed powder to its population, formulation, concomitant treatment, comparison, laboratory marker, timing, denominator or harms.
Application exceptions: The records of 47 randomized participants and 40 completers/analyzed participants are not converted into arm-specific analysis sets or safety denominators, and withdrawals are not calculated. Marker values are not used to create new differences, units, dispersion definitions or CIs; registration bibliography is not converted into actual reading or confirmation of prospective plans.
Referenced methods: Existing principles distinguish the population, formulation, continued levothyroxine, placebo, thyroid markers, timing, denominators, related reports, company involvement and harms of adjunctive whole-seed powder.

Related sources R01

N13 · What are the original reported anti-TPO values?

Current findings: The retained result is anti-TPO 147.99±158.33 versus 274.30±167.20, P=.01. The original counterview describes significant adjusted between-group differences for both markers. Each original form is retained.
Verification status: Partly verified
Materials actually read: Existing Korean and English stored summaries and the R01 citation read; external abstracts, full text, registration, protocols and analysis plans 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, safety, prespecification and independence are not certified.
Reason for missing information: The original table for antibody units, arms/timepoints, dispersion, denominators and adjusted analysis is not established. Another marker’s numbers or P value are not transferred to fill gaps.
Required materials and conditions: 8-week anti-TPO arm-specific values, original dispersion and P/analysis specification
Materials to obtain first: Original antibody units, arms/timepoints, dispersion, denominators and adjusted-analysis tables are needed. TSH P values or numbers are not copied into the antibody result.
Further research: Material needed: Original antibody units, arms/timepoints, dispersion, denominators and adjusted-analysis tables are needed. TSH P values or numbers are not copied into the antibody result. This records needed materials; no new research was executed.
Remaining uncertainty: Gaps in product details, standard treatment, measurement, marker-specific denominators, dispersion, prospective plans, company roles and harms remain. Favorable laboratory directions are not converted into symptom improvement, medication withdrawal, cure, independent replication or long-term safety.
Conditions for verification: Original records on 8-week anti-TPO arm-specific values, original dispersion and P/analysis specification must link to the relevant report, design, formulation, background treatment, endpoint, timing and denominator, distinguishing recorded information from what remains unverified.
Why this condition is needed: Material on 8-week anti-TPO arm-specific values, original dispersion and P/analysis specification is needed to connect adjunctive whole-seed powder to its population, formulation, concomitant treatment, comparison, laboratory marker, timing, denominator or harms.
Application exceptions: The records of 47 randomized participants and 40 completers/analyzed participants are not converted into arm-specific analysis sets or safety denominators, and withdrawals are not calculated. Marker values are not used to create new differences, units, dispersion definitions or CIs; registration bibliography is not converted into actual reading or confirmation of prospective plans.
Referenced methods: Existing principles distinguish the population, formulation, continued levothyroxine, placebo, thyroid markers, timing, denominators, related reports, company involvement and harms of adjunctive whole-seed powder.

Related sources R01

N14 · Are adjusted effects and 95% CIs available?

Current findings: The original result says the adjusted-effect CI was not reported. Significant P values are kept distinct from the absence of an exact effect estimate and interval.
Verification status: Partly verified
Materials actually read: Existing Korean and English stored summaries and the R01 citation read; external abstracts, full text, registration, protocols and analysis plans 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, safety, prespecification and independence are not certified.
Reason for missing information: The original adjusted between-group estimate, variance, CI and model have not been obtained. Nonreporting in the stored summary is separate from unread external text; the estimate is not reconstructed from P.
Required materials and conditions: Marker-specific adjusted between-group effects and 95% CIs
Materials to obtain first: Original adjusted between-group estimates, variances, CIs and models are needed. Nonreporting in the original summary remains distinct from unread external text; no back-calculation is performed.
Further research: Material needed: Original adjusted between-group estimates, variances, CIs and models are needed. Nonreporting in the original summary remains distinct from unread external text; no back-calculation is performed. This records needed materials; no new research was executed.
Remaining uncertainty: Gaps in product details, standard treatment, measurement, marker-specific denominators, dispersion, prospective plans, company roles and harms remain. Favorable laboratory directions are not converted into symptom improvement, medication withdrawal, cure, independent replication or long-term safety.
Conditions for verification: Original records on Marker-specific adjusted between-group effects and 95% CIs must link to the relevant report, design, formulation, background treatment, endpoint, timing and denominator, distinguishing recorded information from what remains unverified.
Why this condition is needed: Material on Marker-specific adjusted between-group effects and 95% CIs is needed to connect adjunctive whole-seed powder to its population, formulation, concomitant treatment, comparison, laboratory marker, timing, denominator or harms.
Application exceptions: The records of 47 randomized participants and 40 completers/analyzed participants are not converted into arm-specific analysis sets or safety denominators, and withdrawals are not calculated. Marker values are not used to create new differences, units, dispersion definitions or CIs; registration bibliography is not converted into actual reading or confirmation of prospective plans.
Referenced methods: Existing principles distinguish the population, formulation, continued levothyroxine, placebo, thyroid markers, timing, denominators, related reports, company involvement and harms of adjunctive whole-seed powder.

Related sources R01

N15 · Are original ± notation, units and final values versus changes distinguished?

Current findings: The retained result provides ± and P for both markers, but units, dispersion type and the change-score/final-value specification are not detailed.
Verification status: Unverified
Materials actually read: Existing Korean and English stored summaries and the R01 citation read; external abstracts, full text, registration, protocols and analysis plans 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, safety, prespecification and independence are not certified.
Reason for missing information: The original laboratory/statistical table, baseline values, units and dispersion definitions are not established. The ± notation is not relabeled as an assumed CI or SE.
Required materials and conditions: Measurement units, means/dispersion, estimands and timing
Materials to obtain first: Original laboratory/statistical tables, baseline values, units and dispersion definitions are needed. The ± notation is not arbitrarily relabeled as a CI or SE.
Further research: Material needed: Original laboratory/statistical tables, baseline values, units and dispersion definitions are needed. The ± notation is not arbitrarily relabeled as a CI or SE. This records needed materials; no new research was executed.
Remaining uncertainty: Gaps in product details, standard treatment, measurement, marker-specific denominators, dispersion, prospective plans, company roles and harms remain. Favorable laboratory directions are not converted into symptom improvement, medication withdrawal, cure, independent replication or long-term safety.
Conditions for verification: Original records on Measurement units, means/dispersion, estimands and timing must link to the relevant report, design, formulation, background treatment, endpoint, timing and denominator, distinguishing recorded information from what remains unverified.
Why this condition is needed: Material on Measurement units, means/dispersion, estimands and timing is needed to connect adjunctive whole-seed powder to its population, formulation, concomitant treatment, comparison, laboratory marker, timing, denominator or harms.
Application exceptions: The records of 47 randomized participants and 40 completers/analyzed participants are not converted into arm-specific analysis sets or safety denominators, and withdrawals are not calculated. Marker values are not used to create new differences, units, dispersion definitions or CIs; registration bibliography is not converted into actual reading or confirmation of prospective plans.
Referenced methods: Existing principles distinguish the population, formulation, continued levothyroxine, placebo, thyroid markers, timing, denominators, related reports, company involvement and harms of adjunctive whole-seed powder.

Related sources R01

N16 · What is the specification for baseline adjustment and multiple comparisons?

Current findings: Adjusted TSH P=.02 and the narrative of significant adjusted between-group results for both markers are original records. The original adjustment and multiplicity details are unread.
Verification status: Partly verified
Materials actually read: Existing Korean and English stored summaries and the R01 citation read; external abstracts, full text, registration, protocols and analysis plans 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, safety, prespecification and independence are not certified.
Reason for missing information: The original SAP, model, covariates, complete marker/timepoint set and analysis populations are not established. A significance narrative alone does not verify multiplicity handling or adherence to the analysis plan.
Required materials and conditions: Adjustment variables, test timepoints, estimands and multiplicity
Materials to obtain first: Original SAPs, models, covariates, all markers/timepoints and analysis-population material are needed.
Further research: Material needed: Original SAPs, models, covariates, all markers/timepoints and analysis-population material are needed. This records needed materials; no new research was executed.
Remaining uncertainty: Gaps in product details, standard treatment, measurement, marker-specific denominators, dispersion, prospective plans, company roles and harms remain. Favorable laboratory directions are not converted into symptom improvement, medication withdrawal, cure, independent replication or long-term safety.
Conditions for verification: Original records on Adjustment variables, test timepoints, estimands and multiplicity must link to the relevant report, design, formulation, background treatment, endpoint, timing and denominator, distinguishing recorded information from what remains unverified.
Why this condition is needed: Material on Adjustment variables, test timepoints, estimands and multiplicity is needed to connect adjunctive whole-seed powder to its population, formulation, concomitant treatment, comparison, laboratory marker, timing, denominator or harms.
Application exceptions: The records of 47 randomized participants and 40 completers/analyzed participants are not converted into arm-specific analysis sets or safety denominators, and withdrawals are not calculated. Marker values are not used to create new differences, units, dispersion definitions or CIs; registration bibliography is not converted into actual reading or confirmation of prospective plans.
Referenced methods: Existing principles distinguish the population, formulation, continued levothyroxine, placebo, thyroid markers, timing, denominators, related reports, company involvement and harms of adjunctive whole-seed powder.

Related sources R01

N17 · Has the prospective hierarchy of principal TSH and related anti-TPO been confirmed?

Current findings: The original facets specify 8-week TSH with anti-TPO as a related thyroid marker; the original evidence lists TSH and anti-TPO with other markers 2nd-tier. The original prospective hierarchy is not verified here.
Verification status: Partly verified
Materials actually read: Existing Korean and English stored summaries and the R01 citation read; external abstracts, full text, registration, protocols and analysis plans 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, safety, prespecification and independence are not certified.
Reason for missing information: The original prospective hierarchy and co-primary (1st) status are not established. Reporting markers together does not verify prespecification or the validity of splitting.
Required materials and conditions: Prospective endpoint hierarchy for 8-week TSH and the antibody reported alongside it
Materials to obtain first: Registration, protocol/SAP and a complete endpoint/timepoint table are needed. No new co-primary (1st) status, splitting or regrading is declared.
Further research: Material needed: Registration, protocol/SAP and a complete endpoint/timepoint table are needed. No new co-primary (1st) status, splitting or regrading is declared. This records needed materials; no new research was executed.
Remaining uncertainty: Gaps in product details, standard treatment, measurement, marker-specific denominators, dispersion, prospective plans, company roles and harms remain. Favorable laboratory directions are not converted into symptom improvement, medication withdrawal, cure, independent replication or long-term safety.
Conditions for verification: Original records on Prospective endpoint hierarchy for 8-week TSH and the antibody reported alongside it must link to the relevant report, design, formulation, background treatment, endpoint, timing and denominator, distinguishing recorded information from what remains unverified.
Why this condition is needed: Material on Prospective endpoint hierarchy for 8-week TSH and the antibody reported alongside it is needed to connect adjunctive whole-seed powder to its population, formulation, concomitant treatment, comparison, laboratory marker, timing, denominator or harms.
Application exceptions: The records of 47 randomized participants and 40 completers/analyzed participants are not converted into arm-specific analysis sets or safety denominators, and withdrawals are not calculated. Marker values are not used to create new differences, units, dispersion definitions or CIs; registration bibliography is not converted into actual reading or confirmation of prospective plans.
Referenced methods: Existing principles distinguish the population, formulation, continued levothyroxine, placebo, thyroid markers, timing, denominators, related reports, company involvement and harms of adjunctive whole-seed powder.

Related sources R01

N18 · What are the assay and assessor procedures?

Current findings: The original principal endpoint and results concern laboratory markers. Specific assay, blood-sampling and assessor procedures are not detailed in the stored summary.
Verification status: Unverified
Materials actually read: Existing Korean and English stored summaries and the R01 citation read; external abstracts, full text, registration, protocols and analysis plans 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, safety, prespecification and independence are not certified.
Reason for missing information: The original assay/laboratory methods, repeated measurements, units and assessor masking are not established. The design label alone does not verify actual measurement procedures.
Required materials and conditions: TSH/anti-TPO assays, blood-sampling timepoints and laboratory/assessor masking
Materials to obtain first: Original assay/laboratory methods, repeated measurements, units and assessor-masking material are needed.
Further research: Material needed: Original assay/laboratory methods, repeated measurements, units and assessor-masking material are needed. This records needed materials; no new research was executed.
Remaining uncertainty: Gaps in product details, standard treatment, measurement, marker-specific denominators, dispersion, prospective plans, company roles and harms remain. Favorable laboratory directions are not converted into symptom improvement, medication withdrawal, cure, independent replication or long-term safety.
Conditions for verification: Original records on TSH/anti-TPO assays, blood-sampling timepoints and laboratory/assessor masking must link to the relevant report, design, formulation, background treatment, endpoint, timing and denominator, distinguishing recorded information from what remains unverified.
Why this condition is needed: Material on TSH/anti-TPO assays, blood-sampling timepoints and laboratory/assessor masking is needed to connect adjunctive whole-seed powder to its population, formulation, concomitant treatment, comparison, laboratory marker, timing, denominator or harms.
Application exceptions: The records of 47 randomized participants and 40 completers/analyzed participants are not converted into arm-specific analysis sets or safety denominators, and withdrawals are not calculated. Marker values are not used to create new differences, units, dispersion definitions or CIs; registration bibliography is not converted into actual reading or confirmation of prospective plans.
Referenced methods: Existing principles distinguish the population, formulation, continued levothyroxine, placebo, thyroid markers, timing, denominators, related reports, company involvement and harms of adjunctive whole-seed powder.

Related sources R01

N19 · What are the original randomization, concealment and masking methods?

Current findings: The original randomized and double-blind design labels are retained. The adequacy of original methods and success of masking are not newly certified.
Verification status: Partly verified
Materials actually read: Existing Korean and English stored summaries and the R01 citation read; external abstracts, full text, registration, protocols and analysis plans 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, safety, prespecification and independence are not certified.
Reason for missing information: Original methods, registration/plans and arm-specific follow-up/assessment records are not established. This preparation is not an official RoB2/GRADE assessment.
Required materials and conditions: Allocation sequence, concealment and participant/assessor masking
Materials to obtain first: Original methods, registration/plans and arm-specific follow-up/assessment records are needed. No official RoB2/GRADE assessment is produced.
Further research: Material needed: Original methods, registration/plans and arm-specific follow-up/assessment records are needed. No official RoB2/GRADE assessment is produced. This records needed materials; no new research was executed.
Remaining uncertainty: Gaps in product details, standard treatment, measurement, marker-specific denominators, dispersion, prospective plans, company roles and harms remain. Favorable laboratory directions are not converted into symptom improvement, medication withdrawal, cure, independent replication or long-term safety.
Conditions for verification: Original records on Allocation sequence, concealment and participant/assessor masking must link to the relevant report, design, formulation, background treatment, endpoint, timing and denominator, distinguishing recorded information from what remains unverified.
Why this condition is needed: Material on Allocation sequence, concealment and participant/assessor masking is needed to connect adjunctive whole-seed powder to its population, formulation, concomitant treatment, comparison, laboratory marker, timing, denominator or harms.
Application exceptions: The records of 47 randomized participants and 40 completers/analyzed participants are not converted into arm-specific analysis sets or safety denominators, and withdrawals are not calculated. Marker values are not used to create new differences, units, dispersion definitions or CIs; registration bibliography is not converted into actual reading or confirmation of prospective plans.
Referenced methods: Existing principles distinguish the population, formulation, continued levothyroxine, placebo, thyroid markers, timing, denominators, related reports, company involvement and harms of adjunctive whole-seed powder.

Related sources R01

N20 · Are the IRCT registration record and actual reading distinguished?

Current findings: IRCT2015021719082N4 appears in the original evidence registration field and citation. Its bibliographic presence is retained, but registration text and adherence to prospective plans were not checked here.
Verification status: Partly verified
Materials actually read: Existing Korean and English stored summaries and the R01 citation read; external abstracts, full text, registration, protocols and analysis plans 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, safety, prespecification and independence are not certified.
Reason for missing information: Matching of the original registration, revision history, protocol/SAP and paper remains unverified. The identifier alone does not establish prospective registration or completed current content verification.
Required materials and conditions: Original registration/version and timing for IRCT2015021719082N4
Materials to obtain first: Original registration, revision history, protocol/SAP and matching with the paper are needed. Identifier presence is not promoted into prospective registration or completed content verification.
Further research: Material needed: Original registration, revision history, protocol/SAP and matching with the paper are needed. Identifier presence is not promoted into prospective registration or completed content verification. This records needed materials; no new research was executed.
Remaining uncertainty: Gaps in product details, standard treatment, measurement, marker-specific denominators, dispersion, prospective plans, company roles and harms remain. Favorable laboratory directions are not converted into symptom improvement, medication withdrawal, cure, independent replication or long-term safety.
Conditions for verification: Original records on Original registration/version and timing for IRCT2015021719082N4 must link to the relevant report, design, formulation, background treatment, endpoint, timing and denominator, distinguishing recorded information from what remains unverified.
Why this condition is needed: Material on Original registration/version and timing for IRCT2015021719082N4 is needed to connect adjunctive whole-seed powder to its population, formulation, concomitant treatment, comparison, laboratory marker, timing, denominator or harms.
Application exceptions: The records of 47 randomized participants and 40 completers/analyzed participants are not converted into arm-specific analysis sets or safety denominators, and withdrawals are not calculated. Marker values are not used to create new differences, units, dispersion definitions or CIs; registration bibliography is not converted into actual reading or confirmation of prospective plans.
Referenced methods: Existing principles distinguish the population, formulation, continued levothyroxine, placebo, thyroid markers, timing, denominators, related reports, company involvement and harms of adjunctive whole-seed powder.

Related sources R01

N21 · Are T3 and T4 kept separate from the principal claim?

Current findings: The original summary retains T3 and T4 as 2nd-tier or mechanistic results. TSH/antibody numbers are not copied as values for other hormones.
Verification status: Partly verified
Materials actually read: Existing Korean and English stored summaries and the R01 citation read; external abstracts, full text, registration, protocols and analysis plans 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, safety, prespecification and independence are not certified.
Reason for missing information: Original results, CIs, denominators and prospective hierarchy for each marker are not established. Results for principal markers do not determine an efficacy grade for other markers.
Required materials and conditions: Separate T3/T4 results, timing, denominators and hierarchy
Materials to obtain first: Original results, CIs, denominators and hierarchy for each marker are needed. No new separate efficacy grade is created.
Further research: Material needed: Original results, CIs, denominators and hierarchy for each marker are needed. No new separate efficacy grade is created. This records needed materials; no new research was executed.
Remaining uncertainty: Gaps in product details, standard treatment, measurement, marker-specific denominators, dispersion, prospective plans, company roles and harms remain. Favorable laboratory directions are not converted into symptom improvement, medication withdrawal, cure, independent replication or long-term safety.
Conditions for verification: Original records on Separate T3/T4 results, timing, denominators and hierarchy must link to the relevant report, design, formulation, background treatment, endpoint, timing and denominator, distinguishing recorded information from what remains unverified.
Why this condition is needed: Material on Separate T3/T4 results, timing, denominators and hierarchy is needed to connect adjunctive whole-seed powder to its population, formulation, concomitant treatment, comparison, laboratory marker, timing, denominator or harms.
Application exceptions: The records of 47 randomized participants and 40 completers/analyzed participants are not converted into arm-specific analysis sets or safety denominators, and withdrawals are not calculated. Marker values are not used to create new differences, units, dispersion definitions or CIs; registration bibliography is not converted into actual reading or confirmation of prospective plans.
Referenced methods: Existing principles distinguish the population, formulation, continued levothyroxine, placebo, thyroid markers, timing, denominators, related reports, company involvement and harms of adjunctive whole-seed powder.

Related sources R01

N22 · Are weight, VEGF and Nesfatin-1 kept separate?

Current findings: The original summary separates weight, VEGF and Nesfatin-1 from the principal efficacy claim. Appearance in the paper title does not make these independent replications of clinical thyroid effects.
Verification status: Partly verified
Materials actually read: Existing Korean and English stored summaries and the R01 citation read; external abstracts, full text, registration, protocols and analysis plans 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, safety, prespecification and independence are not certified.
Reason for missing information: Original tables for separate endpoints and links to the same participants/denominators are not established. Mechanistic or weight changes are not converted into cure or symptom effects.
Required materials and conditions: Separate results, denominators and prospective hierarchy for body weight/mechanistic markers
Materials to obtain first: Original separate-endpoint tables and links to the same participants/denominators are needed. Mechanistic or weight changes are not converted into cure or symptom effects.
Further research: Material needed: Original separate-endpoint tables and links to the same participants/denominators are needed. Mechanistic or weight changes are not converted into cure or symptom effects. This records needed materials; no new research was executed.
Remaining uncertainty: Gaps in product details, standard treatment, measurement, marker-specific denominators, dispersion, prospective plans, company roles and harms remain. Favorable laboratory directions are not converted into symptom improvement, medication withdrawal, cure, independent replication or long-term safety.
Conditions for verification: Original records on Separate results, denominators and prospective hierarchy for body weight/mechanistic markers must link to the relevant report, design, formulation, background treatment, endpoint, timing and denominator, distinguishing recorded information from what remains unverified.
Why this condition is needed: Material on Separate results, denominators and prospective hierarchy for body weight/mechanistic markers is needed to connect adjunctive whole-seed powder to its population, formulation, concomitant treatment, comparison, laboratory marker, timing, denominator or harms.
Application exceptions: The records of 47 randomized participants and 40 completers/analyzed participants are not converted into arm-specific analysis sets or safety denominators, and withdrawals are not calculated. Marker values are not used to create new differences, units, dispersion definitions or CIs; registration bibliography is not converted into actual reading or confirmation of prospective plans.
Referenced methods: Existing principles distinguish the population, formulation, continued levothyroxine, placebo, thyroid markers, timing, denominators, related reports, company involvement and harms of adjunctive whole-seed powder.

Related sources R01

N23 · Are symptom improvement and laboratory results distinguished?

Current findings: The existing crux and reader answer distinguish laboratory results from patient symptoms and say symptom benefit was not established. Favorable surrogate markers are not transferred to symptom effects.
Verification status: Partly verified
Materials actually read: Existing Korean and English stored summaries and the R01 citation read; external abstracts, full text, registration, protocols and analysis plans 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, safety, prespecification and independence are not certified.
Reason for missing information: Direct material on prespecified patient outcomes, symptoms and quality of life is not established. Laboratory changes alone do not verify improvement experienced by patients.
Required materials and conditions: Direct results for patient symptoms, quality of life and function
Materials to obtain first: Original material on prespecified patient outcomes, symptoms and quality of life is needed.
Further research: Material needed: Original material on prespecified patient outcomes, symptoms and quality of life is needed. This records needed materials; no new research was executed.
Remaining uncertainty: Gaps in product details, standard treatment, measurement, marker-specific denominators, dispersion, prospective plans, company roles and harms remain. Favorable laboratory directions are not converted into symptom improvement, medication withdrawal, cure, independent replication or long-term safety.
Conditions for verification: Original records on Direct results for patient symptoms, quality of life and function must link to the relevant report, design, formulation, background treatment, endpoint, timing and denominator, distinguishing recorded information from what remains unverified.
Why this condition is needed: Material on Direct results for patient symptoms, quality of life and function is needed to connect adjunctive whole-seed powder to its population, formulation, concomitant treatment, comparison, laboratory marker, timing, denominator or harms.
Application exceptions: The records of 47 randomized participants and 40 completers/analyzed participants are not converted into arm-specific analysis sets or safety denominators, and withdrawals are not calculated. Marker values are not used to create new differences, units, dispersion definitions or CIs; registration bibliography is not converted into actual reading or confirmation of prospective plans.
Referenced methods: Existing principles distinguish the population, formulation, continued levothyroxine, placebo, thyroid markers, timing, denominators, related reports, company involvement and harms of adjunctive whole-seed powder.

Related sources R01

N24 · Are medication reduction, withdrawal and cure excluded from the claim?

Current findings: The original excluded-claim summary says medication withdrawal and cure were not tested. A laboratory signal from adjunctive use with continued stable treatment is not used as a replacement effect.
Verification status: Partly verified
Materials actually read: Existing Korean and English stored summaries and the R01 citation read; external abstracts, full text, registration, protocols and analysis plans 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, safety, prespecification and independence are not certified.
Reason for missing information: Direct comparative material on medication reduction/discontinuation and clinical course is not established. Adjunctive use with continued standard treatment does not verify replacement or cure.
Required materials and conditions: Direct comparisons for levothyroxine reduction/withdrawal and autoimmune cure
Materials to obtain first: Direct studies of medication reduction/discontinuation and clinical course are needed. These outcomes are not added here.
Further research: Material needed: Direct studies of medication reduction/discontinuation and clinical course are needed. These outcomes are not added here. This records needed materials; no new research was executed.
Remaining uncertainty: Gaps in product details, standard treatment, measurement, marker-specific denominators, dispersion, prospective plans, company roles and harms remain. Favorable laboratory directions are not converted into symptom improvement, medication withdrawal, cure, independent replication or long-term safety.
Conditions for verification: Original records on Direct comparisons for levothyroxine reduction/withdrawal and autoimmune cure must link to the relevant report, design, formulation, background treatment, endpoint, timing and denominator, distinguishing recorded information from what remains unverified.
Why this condition is needed: Material on Direct comparisons for levothyroxine reduction/withdrawal and autoimmune cure is needed to connect adjunctive whole-seed powder to its population, formulation, concomitant treatment, comparison, laboratory marker, timing, denominator or harms.
Application exceptions: The records of 47 randomized participants and 40 completers/analyzed participants are not converted into arm-specific analysis sets or safety denominators, and withdrawals are not calculated. Marker values are not used to create new differences, units, dispersion definitions or CIs; registration bibliography is not converted into actual reading or confirmation of prospective plans.
Referenced methods: Existing principles distinguish the population, formulation, continued levothyroxine, placebo, thyroid markers, timing, denominators, related reports, company involvement and harms of adjunctive whole-seed powder.

Related sources R01

N25 · Are long-term thyroid function and persistent effects known?

Current findings: The original reader answer says long-term thyroid function was not established. The 8-week laboratory result is not a long-term or persistent effect.
Verification status: Partly verified
Materials actually read: Existing Korean and English stored summaries and the R01 citation read; external abstracts, full text, registration, protocols and analysis plans 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, safety, prespecification and independence are not certified.
Reason for missing information: Longer follow-up, the course after discontinuation and repeated evidence for the same formulation are not established. Short-term results alone do not determine long-term persistence.
Required materials and conditions: Laboratory/clinical course beyond 8 weeks and after discontinuation
Materials to obtain first: Longer follow-up, post-discontinuation course and repeated material for the same formulation are needed.
Further research: Material needed: Longer follow-up, post-discontinuation course and repeated material for the same formulation are needed. This records needed materials; no new research was executed.
Remaining uncertainty: Gaps in product details, standard treatment, measurement, marker-specific denominators, dispersion, prospective plans, company roles and harms remain. Favorable laboratory directions are not converted into symptom improvement, medication withdrawal, cure, independent replication or long-term safety.
Conditions for verification: Original records on Laboratory/clinical course beyond 8 weeks and after discontinuation must link to the relevant report, design, formulation, background treatment, endpoint, timing and denominator, distinguishing recorded information from what remains unverified.
Why this condition is needed: Material on Laboratory/clinical course beyond 8 weeks and after discontinuation is needed to connect adjunctive whole-seed powder to its population, formulation, concomitant treatment, comparison, laboratory marker, timing, denominator or harms.
Application exceptions: The records of 47 randomized participants and 40 completers/analyzed participants are not converted into arm-specific analysis sets or safety denominators, and withdrawals are not calculated. Marker values are not used to create new differences, units, dispersion definitions or CIs; registration bibliography is not converted into actual reading or confirmation of prospective plans.
Referenced methods: Existing principles distinguish the population, formulation, continued levothyroxine, placebo, thyroid markers, timing, denominators, related reports, company involvement and harms of adjunctive whole-seed powder.

Related sources R01

N26 · Is a single report distinguished from independent replication?

Current findings: The structured record covers the Farhangi et al. 2016 trial report. The historical grade rationale’s description of an independent registered trial is retained without newly certifying independence or replication.
Verification status: Partly verified
Materials actually read: Existing Korean and English stored summaries and the R01 citation read; external abstracts, full text, registration, protocols and analysis plans 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, safety, prespecification and independence are not certified.
Reason for missing information: Links among teams, products, funding, additional reports and registration, and replication of the same question, are not established. Established totals of unique trials and participants remain unverified.
Required materials and conditions: Trial families, shared participants and independent teams using the same formulation
Materials to obtain first: Team, product, funding, additional-report/registration links and replication material for the same question are needed. Final unique-trial/participant totals remain unverified.
Further research: Material needed: Team, product, funding, additional-report/registration links and replication material for the same question are needed. Final unique-trial/participant totals remain unverified. This records needed materials; no new research was executed.
Remaining uncertainty: Gaps in product details, standard treatment, measurement, marker-specific denominators, dispersion, prospective plans, company roles and harms remain. Favorable laboratory directions are not converted into symptom improvement, medication withdrawal, cure, independent replication or long-term safety.
Conditions for verification: Original records on Trial families, shared participants and independent teams using the same formulation must link to the relevant report, design, formulation, background treatment, endpoint, timing and denominator, distinguishing recorded information from what remains unverified.
Why this condition is needed: Material on Trial families, shared participants and independent teams using the same formulation is needed to connect adjunctive whole-seed powder to its population, formulation, concomitant treatment, comparison, laboratory marker, timing, denominator or harms.
Application exceptions: The records of 47 randomized participants and 40 completers/analyzed participants are not converted into arm-specific analysis sets or safety denominators, and withdrawals are not calculated. Marker values are not used to create new differences, units, dispersion definitions or CIs; registration bibliography is not converted into actual reading or confirmation of prospective plans.
Referenced methods: Existing principles distinguish the population, formulation, continued levothyroxine, placebo, thyroid markers, timing, denominators, related reports, company involvement and harms of adjunctive whole-seed powder.

Related sources R01

N27 · Are university support, product manufacture and company-involvement routes distinguished?

Current findings: The original funding record is Tabriz University grant 93173 and Goldaroo capsule manufacture. Manufacture is not converted into full confirmation of company funding, employee authorship or product support.
Verification status: Partly verified
Materials actually read: Existing Korean and English stored summaries and the R01 citation read; external abstracts, full text, registration, protocols and analysis plans 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, safety, prespecification and independence are not certified.
Reason for missing information: Original support/manufacturing contracts, product provision, author affiliations and COI text are not established. University support alone does not establish absence of all company involvement.
Required materials and conditions: Original records of funding, product support, employee authorship and conflicts of interest
Materials to obtain first: Original support/manufacturing contracts, product provision, author affiliations and COI text are needed. University support alone is not labeled as absence of all company involvement.
Further research: Material needed: Original support/manufacturing contracts, product provision, author affiliations and COI text are needed. University support alone is not labeled as absence of all company involvement. This records needed materials; no new research was executed.
Remaining uncertainty: Gaps in product details, standard treatment, measurement, marker-specific denominators, dispersion, prospective plans, company roles and harms remain. Favorable laboratory directions are not converted into symptom improvement, medication withdrawal, cure, independent replication or long-term safety.
Conditions for verification: Original records on Original records of funding, product support, employee authorship and conflicts of interest must link to the relevant report, design, formulation, background treatment, endpoint, timing and denominator, distinguishing recorded information from what remains unverified.
Why this condition is needed: Material on Original records of funding, product support, employee authorship and conflicts of interest is needed to connect adjunctive whole-seed powder to its population, formulation, concomitant treatment, comparison, laboratory marker, timing, denominator or harms.
Application exceptions: The records of 47 randomized participants and 40 completers/analyzed participants are not converted into arm-specific analysis sets or safety denominators, and withdrawals are not calculated. Marker values are not used to create new differences, units, dispersion definitions or CIs; registration bibliography is not converted into actual reading or confirmation of prospective plans.
Referenced methods: Existing principles distinguish the population, formulation, continued levothyroxine, placebo, thyroid markers, timing, denominators, related reports, company involvement and harms of adjunctive whole-seed powder.

Related sources R01

N28 · What are the harm-collection procedures and course of itching/nausea?

Current findings: The active-arm itching/nausea withdrawal narrative and general safety caution are retained separately. Harm-event counts, collection methods and established causality remain unverified.
Verification status: Partly verified
Materials actually read: Existing Korean and English stored summaries and the R01 citation read; external abstracts, full text, registration, protocols and analysis plans 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, safety, prespecification and independence are not certified.
Reason for missing information: Detailed harm tables, ascertainment methods, discontinuation, arm-specific course and missing material are not established. A withdrawal narrative alone does not establish incidence or causality.
Required materials and conditions: Harm definitions, active ascertainment, events/discontinuation and severity
Materials to obtain first: Original harm tables, ascertainment/discontinuation, arm-specific course and missing-material records are needed.
Further research: Material needed: Original harm tables, ascertainment/discontinuation, arm-specific course and missing-material records are needed. This records needed materials; no new research was executed.
Remaining uncertainty: Gaps in product details, standard treatment, measurement, marker-specific denominators, dispersion, prospective plans, company roles and harms remain. Favorable laboratory directions are not converted into symptom improvement, medication withdrawal, cure, independent replication or long-term safety.
Conditions for verification: Original records on Harm definitions, active ascertainment, events/discontinuation and severity must link to the relevant report, design, formulation, background treatment, endpoint, timing and denominator, distinguishing recorded information from what remains unverified.
Why this condition is needed: Material on Harm definitions, active ascertainment, events/discontinuation and severity is needed to connect adjunctive whole-seed powder to its population, formulation, concomitant treatment, comparison, laboratory marker, timing, denominator or harms.
Application exceptions: The records of 47 randomized participants and 40 completers/analyzed participants are not converted into arm-specific analysis sets or safety denominators, and withdrawals are not calculated. Marker values are not used to create new differences, units, dispersion definitions or CIs; registration bibliography is not converted into actual reading or confirmation of prospective plans.
Referenced methods: Existing principles distinguish the population, formulation, continued levothyroxine, placebo, thyroid markers, timing, denominators, related reports, company involvement and harms of adjunctive whole-seed powder.

Related sources R01

N29 · Are safety denominators, exposure and controls separately known?

Current findings: 47 randomized and 40 completed/analyzed participants do not establish safety denominators. Event counts and control-arm safety denominators are absent from the summary.
Verification status: Unverified
Materials actually read: Existing Korean and English stored summaries and the R01 citation read; external abstracts, full text, registration, protocols and analysis plans 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, safety, prespecification and independence are not certified.
Reason for missing information: Safety denominators, events, controls, exposure time and attrition records are not established. Allocation/completion records alone do not permit incidence calculations.
Required materials and conditions: Arm-specific safety populations, actual dosing and 8-week exposure/events
Materials to obtain first: Original safety denominators, events, controls, exposure time and attrition records are needed. Incidence is not calculated.
Further research: Material needed: Original safety denominators, events, controls, exposure time and attrition records are needed. Incidence is not calculated. This records needed materials; no new research was executed.
Remaining uncertainty: Gaps in product details, standard treatment, measurement, marker-specific denominators, dispersion, prospective plans, company roles and harms remain. Favorable laboratory directions are not converted into symptom improvement, medication withdrawal, cure, independent replication or long-term safety.
Conditions for verification: Original records on Arm-specific safety populations, actual dosing and 8-week exposure/events must link to the relevant report, design, formulation, background treatment, endpoint, timing and denominator, distinguishing recorded information from what remains unverified.
Why this condition is needed: Material on Arm-specific safety populations, actual dosing and 8-week exposure/events is needed to connect adjunctive whole-seed powder to its population, formulation, concomitant treatment, comparison, laboratory marker, timing, denominator or harms.
Application exceptions: The records of 47 randomized participants and 40 completers/analyzed participants are not converted into arm-specific analysis sets or safety denominators, and withdrawals are not calculated. Marker values are not used to create new differences, units, dispersion definitions or CIs; registration bibliography is not converted into actual reading or confirmation of prospective plans.
Referenced methods: Existing principles distinguish the population, formulation, continued levothyroxine, placebo, thyroid markers, timing, denominators, related reports, company involvement and harms of adjunctive whole-seed powder.

Related sources R01

N30 · Are concomitant levothyroxine and alternative causes distinguished?

Current findings: The original treatment continued stable levothyroxine. The general safety record calls for consultation during medication use. Actual concomitant interactions or event causality are not established here.
Verification status: Partly verified
Materials actually read: Existing Korean and English stored summaries and the R01 citation read; external abstracts, full text, registration, protocols and analysis plans 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, safety, prespecification and independence are not certified.
Reason for missing information: Details of medication, dosing times, changes, baseline conditions, controls, course after discontinuation and alternative causes are not established. Concomitant-use descriptions alone do not verify actual interactions.
Required materials and conditions: Concomitant medication/dosing times, changes, baseline conditions and event timing
Materials to obtain first: Medication/timing, changes, baseline conditions, controls, post-discontinuation course and alternative-cause material are needed.
Further research: Material needed: Medication/timing, changes, baseline conditions, controls, post-discontinuation course and alternative-cause material are needed. This records needed materials; no new research was executed.
Remaining uncertainty: Gaps in product details, standard treatment, measurement, marker-specific denominators, dispersion, prospective plans, company roles and harms remain. Favorable laboratory directions are not converted into symptom improvement, medication withdrawal, cure, independent replication or long-term safety.
Conditions for verification: Original records on Concomitant medication/dosing times, changes, baseline conditions and event timing must link to the relevant report, design, formulation, background treatment, endpoint, timing and denominator, distinguishing recorded information from what remains unverified.
Why this condition is needed: Material on Concomitant medication/dosing times, changes, baseline conditions and event timing is needed to connect adjunctive whole-seed powder to its population, formulation, concomitant treatment, comparison, laboratory marker, timing, denominator or harms.
Application exceptions: The records of 47 randomized participants and 40 completers/analyzed participants are not converted into arm-specific analysis sets or safety denominators, and withdrawals are not calculated. Marker values are not used to create new differences, units, dispersion definitions or CIs; registration bibliography is not converted into actual reading or confirmation of prospective plans.
Referenced methods: Existing principles distinguish the population, formulation, continued levothyroxine, placebo, thyroid markers, timing, denominators, related reports, company involvement and harms of adjunctive whole-seed powder.

Related sources R01

N31 · Were long-term, rare and vulnerable-population harms verified?

Current findings: The original safety detail retains caution about pregnancy/breastfeeding, children, liver/kidney disease, surgery and concomitant medicines, alongside the limits of small trials for long-term or rare harms.
Verification status: Partly verified
Materials actually read: Existing Korean and English stored summaries and the R01 citation read; external abstracts, full text, registration, protocols and analysis plans 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, safety, prespecification and independence are not certified.
Reason for missing information: Longer follow-up, vulnerable-population material, independent harm reports and exposure/denominators are not established. No new harm investigation or safety assessment was performed here.
Required materials and conditions: Longer follow-up, independent harm reports, vulnerable populations and exposure/denominators
Materials to obtain first: Longer follow-up, vulnerable-population material, independent reports and exposure/denominators are needed. Unverified status is retained without a new harm investigation or judgment.
Further research: Material needed: Longer follow-up, vulnerable-population material, independent reports and exposure/denominators are needed. Unverified status is retained without a new harm investigation or judgment. This records needed materials; no new research was executed.
Remaining uncertainty: Gaps in product details, standard treatment, measurement, marker-specific denominators, dispersion, prospective plans, company roles and harms remain. Favorable laboratory directions are not converted into symptom improvement, medication withdrawal, cure, independent replication or long-term safety.
Conditions for verification: Original records on Longer follow-up, independent harm reports, vulnerable populations and exposure/denominators must link to the relevant report, design, formulation, background treatment, endpoint, timing and denominator, distinguishing recorded information from what remains unverified.
Why this condition is needed: Material on Longer follow-up, independent harm reports, vulnerable populations and exposure/denominators is needed to connect adjunctive whole-seed powder to its population, formulation, concomitant treatment, comparison, laboratory marker, timing, denominator or harms.
Application exceptions: The records of 47 randomized participants and 40 completers/analyzed participants are not converted into arm-specific analysis sets or safety denominators, and withdrawals are not calculated. Marker values are not used to create new differences, units, dispersion definitions or CIs; registration bibliography is not converted into actual reading or confirmation of prospective plans.
Referenced methods: Existing principles distinguish the population, formulation, continued levothyroxine, placebo, thyroid markers, timing, denominators, related reports, company involvement and harms of adjunctive whole-seed powder.

Related sources R01

N32 · Are summary reading, PubMed, PMCID and registration distinguished?

Current findings: The complete stored summary was read for preparation. The PubMed URL, PMC5112739 and IRCT bibliography are original records; external full text and registration were not read here.
Verification status: Partly verified
Materials actually read: Existing Korean and English stored summaries and the R01 citation read; external abstracts, full text, registration, protocols and analysis plans 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, safety, prespecification and independence are not certified.
Reason for missing information: External abstracts, full text, registration and protocols/SAPs are unread here. Identifiers and URLs alone do not verify material access or fulfilled conditions.
Required materials and conditions: An access table for stored JSON, external abstracts, full text, IRCT and protocols/SAPs
Materials to obtain first: External material remains unread pending actual acquisition and review. Identifiers or URLs are not labeled as reading, accessibility or fulfilled conditions.
Further research: Material needed: External material remains unread pending actual acquisition and review. Identifiers or URLs are not labeled as reading, accessibility or fulfilled conditions. This records needed materials; no new research was executed.
Remaining uncertainty: Gaps in product details, standard treatment, measurement, marker-specific denominators, dispersion, prospective plans, company roles and harms remain. Favorable laboratory directions are not converted into symptom improvement, medication withdrawal, cure, independent replication or long-term safety.
Conditions for verification: Original records on An access table for stored JSON, external abstracts, full text, IRCT and protocols/SAPs must link to the relevant report, design, formulation, background treatment, endpoint, timing and denominator, distinguishing recorded information from what remains unverified.
Why this condition is needed: Material on An access table for stored JSON, external abstracts, full text, IRCT and protocols/SAPs is needed to connect adjunctive whole-seed powder to its population, formulation, concomitant treatment, comparison, laboratory marker, timing, denominator or harms.
Application exceptions: The records of 47 randomized participants and 40 completers/analyzed participants are not converted into arm-specific analysis sets or safety denominators, and withdrawals are not calculated. Marker values are not used to create new differences, units, dispersion definitions or CIs; registration bibliography is not converted into actual reading or confirmation of prospective plans.
Referenced methods: Existing principles distinguish the population, formulation, continued levothyroxine, placebo, thyroid markers, timing, denominators, related reports, company involvement and harms of adjunctive whole-seed powder.

Related sources R01

N33 · Are generic English wording and historical corrections preserved?

Current findings: The correction record says 1 English-placeholder field was corrected while grade, score, citations and evidence date were retained. The remaining generic evidence-table wording and original Korean/English records are preserved.
Verification status: Partly verified
Materials actually read: Existing Korean and English stored summaries and the R01 citation read; external abstracts, full text, registration, protocols and analysis plans 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, safety, prespecification and independence are not certified.
Reason for missing information: External English text and historical correction targets were not directly compared here. Historical verification wording does not establish completed current content verification.
Required materials and conditions: Original Korean/English text and limits of the 2026-09-14 correction
Materials to obtain first: External English text and historical correction targets remain uncompared here. Historical verification wording is not converted into newly completed content verification.
Further research: Material needed: External English text and historical correction targets remain uncompared here. Historical verification wording is not converted into newly completed content verification. This records needed materials; no new research was executed.
Remaining uncertainty: Gaps in product details, standard treatment, measurement, marker-specific denominators, dispersion, prospective plans, company roles and harms remain. Favorable laboratory directions are not converted into symptom improvement, medication withdrawal, cure, independent replication or long-term safety.
Conditions for verification: Original records on Original Korean/English text and limits of the 2026-09-14 correction must link to the relevant report, design, formulation, background treatment, endpoint, timing and denominator, distinguishing recorded information from what remains unverified.
Why this condition is needed: Material on Original Korean/English text and limits of the 2026-09-14 correction is needed to connect adjunctive whole-seed powder to its population, formulation, concomitant treatment, comparison, laboratory marker, timing, denominator or harms.
Application exceptions: The records of 47 randomized participants and 40 completers/analyzed participants are not converted into arm-specific analysis sets or safety denominators, and withdrawals are not calculated. Marker values are not used to create new differences, units, dispersion definitions or CIs; registration bibliography is not converted into actual reading or confirmation of prospective plans.
Referenced methods: Existing principles distinguish the population, formulation, continued levothyroxine, placebo, thyroid markers, timing, denominators, related reports, company involvement and harms of adjunctive whole-seed powder.

Related sources R01

N34 · Are original grade, axes, evidence date and preparation kept separate?

Current findings: The original C/54/Caution, axes and evidence date 2026-09-08 are retained. Preparation does not establish a new efficacy grade, independent certification or official-method certification.
Verification status: Partly verified
Materials actually read: Existing Korean and English stored summaries and the R01 citation read; external abstracts, full text, registration, protocols and analysis plans 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, safety, prespecification and independence are not certified.
Reason for missing information: Reader preparation does not replace review of new evidence, condition revisions or verdict changes. The original date is not converted into a current search or external-reading date.
Required materials and conditions: Original C54, Caution, axes, evidence date and correction values
Materials to obtain first: New evidence, condition revisions and verdict changes are separate events following content review. The original date is not used as a current search or external-reading date.
Further research: Material needed: New evidence, condition revisions and verdict changes are separate events following content review. The original date is not used as a current search or external-reading date. This records needed materials; no new research was executed.
Remaining uncertainty: Gaps in product details, standard treatment, measurement, marker-specific denominators, dispersion, prospective plans, company roles and harms remain. Favorable laboratory directions are not converted into symptom improvement, medication withdrawal, cure, independent replication or long-term safety.
Conditions for verification: Original records on Original C54, Caution, axes, evidence date and correction values must link to the relevant report, design, formulation, background treatment, endpoint, timing and denominator, distinguishing recorded information from what remains unverified.
Why this condition is needed: Material on Original C54, Caution, axes, evidence date and correction values is needed to connect adjunctive whole-seed powder to its population, formulation, concomitant treatment, comparison, laboratory marker, timing, denominator or harms.
Application exceptions: The records of 47 randomized participants and 40 completers/analyzed participants are not converted into arm-specific analysis sets or safety denominators, and withdrawals are not calculated. Marker values are not used to create new differences, units, dispersion definitions or CIs; registration bibliography is not converted into actual reading or confirmation of prospective plans.
Referenced methods: Existing principles distinguish the population, formulation, continued levothyroxine, placebo, thyroid markers, timing, denominators, related reports, company involvement and harms of adjunctive whole-seed powder.

Related sources R01