{ "schema_version": "chamgap-public-evidence-check-1.0", "public_id": "v3030-main", "verdict_number": "3030", "title": "Oral whole Nigella sativa seed powder capsules × Improvement in TSH and anti-TPO in Hashimoto thyroiditis", "view_version": "1.0", "view_created_date": "2026-10-24", "criteria_version": "1.0", "criteria_date": "2026-10-06", "review_date": null, "legacy_evidence_date": "2026-09-08", "review_scope": { "materials_read": "Existing review summaries and stored records of methodological application", "clinical_papers_directly_read": false, "new_clinical_search": false, "limitation": "Existing stored summary and preserved methodology application records. External papers, abstracts, registration, protocols, SAPs, original result tables and support disclosures are unread, and review of existing content remains incomplete.", "date_meaning": "This is the date the stored materials were checked, not the date of a new search of the clinical literature." }, "claim_context": { "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.", "intervention": "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.", "endpoint": "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.", "excluded_extensions": [ "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." ] }, "requirements": [ { "item_id": "N01", "question_type": "Evidence condition", "question": "Which Hashimoto thyroiditis question is addressed?", "needed": "Oral seed powder over 8 weeks and TSH/anti-TPO in adults continuing stable levothyroxine", "role": "Required", "role_reason": "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_exception": "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.", "criterion": "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.", "basis": "Existing principles distinguish the population, formulation, continued levothyroxine, placebo, thyroid markers, timing, denominators, related reports, company involvement and harms of adjunctive whole-seed powder.", "condition_origin": "These existing conditions are linked to adjunctive whole-seed powder and laboratory markers in adults with Hashimoto thyroiditis. They explain stored summaries and material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_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.", "current_reports": [ "R01" ], "existence": "The information is recorded in stored whole-seed-powder reports, citations and existing Korean and English summaries. Actual reading of external abstracts, full text, registration and plans remains separately unverified.", "acquired_read": "Existing Korean and English stored summaries and the R01 citation read; external abstracts, full text, registration, protocols and analysis plans unread", "observation": "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.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "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.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original eligibility criteria and results tables linking population, continued standard treatment, comparator and each endpoint are needed. Symptoms, medication withdrawal and cure are excluded." }, { "item_id": "N02", "question_type": "Evidence condition", "question": "Are whole-seed-powder capsules distinguished from other Nigella formulations?", "needed": "Product and constituent details for ground whole Nigella sativa L. seed powder in 1 g capsules", "role": "Required", "role_reason": "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_exception": "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.", "criterion": "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.", "basis": "Existing principles distinguish the population, formulation, continued levothyroxine, placebo, thyroid markers, timing, denominators, related reports, company involvement and harms of adjunctive whole-seed powder.", "condition_origin": "These existing conditions are linked to adjunctive whole-seed powder and laboratory markers in adults with Hashimoto thyroiditis. They explain stored summaries and material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_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.", "current_reports": [ "R01" ], "existence": "The information is recorded in stored whole-seed-powder reports, citations and existing Korean and English summaries. Actual reading of external abstracts, full text, registration and plans remains separately unverified.", "acquired_read": "Existing Korean and English stored summaries and the R01 citation read; external abstracts, full text, registration, protocols and analysis plans unread", "observation": "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.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Detailed manufacture, constituent content, standardization and lot information is not established. The stored formulation description does not verify efficacy or equivalence for other formulations.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original manufacturing, constituent-content, standardization and lot records are needed. No efficacy or equivalence of other formulations is added." }, { "item_id": "N03", "question_type": "Evidence condition", "question": "How are the original dose and dosing times retained?", "needed": "1 g before lunch and dinner, 2 g/day total, and actual adherence", "role": "Required", "role_reason": "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_exception": "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.", "criterion": "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.", "basis": "Existing principles distinguish the population, formulation, continued levothyroxine, placebo, thyroid markers, timing, denominators, related reports, company involvement and harms of adjunctive whole-seed powder.", "condition_origin": "These existing conditions are linked to adjunctive whole-seed powder and laboratory markers in adults with Hashimoto thyroiditis. They explain stored summaries and material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_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.", "current_reports": [ "R01" ], "existence": "The information is recorded in stored whole-seed-powder reports, citations and existing Korean and English summaries. Actual reading of external abstracts, full text, registration and plans remains separately unverified.", "acquired_read": "Existing Korean and English stored summaries and the R01 citation read; external abstracts, full text, registration, protocols and analysis plans unread", "observation": "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.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "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.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original dosing/adherence, actual exposure, concomitant-medication timing and product-constituent records are needed." }, { "item_id": "N04", "question_type": "Evidence condition", "question": "Are the 8-week treatment/follow-up period and later course distinguished?", "needed": "8-week exposure and test timing, with longer-term and post-discontinuation follow-up", "role": "Required", "role_reason": "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_exception": "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.", "criterion": "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.", "basis": "Existing principles distinguish the population, formulation, continued levothyroxine, placebo, thyroid markers, timing, denominators, related reports, company involvement and harms of adjunctive whole-seed powder.", "condition_origin": "These existing conditions are linked to adjunctive whole-seed powder and laboratory markers in adults with Hashimoto thyroiditis. They explain stored summaries and material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_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.", "current_reports": [ "R01" ], "existence": "The information is recorded in stored whole-seed-powder reports, citations and existing Korean and English summaries. Actual reading of external abstracts, full text, registration and plans remains separately unverified.", "acquired_read": "Existing Korean and English stored summaries and the R01 citation read; external abstracts, full text, registration, protocols and analysis plans unread", "observation": "The original duration is 8 weeks of treatment and follow-up. This does not establish long-term thyroid function or persistence after discontinuation.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Details of actual test schedules, exposure, discontinuation and longer follow-up are not established. Results over a limited period do not verify subsequent persistence.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original test schedules, exposure/discontinuation records and longer follow-up material are needed." }, { "item_id": "N05", "question_type": "Evidence condition", "question": "What are the diagnosis and baseline characteristics of the population?", "needed": "Hashimoto diagnosis, baseline TSH/antibodies, levothyroxine dose and eligibility criteria", "role": "Required", "role_reason": "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_exception": "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.", "criterion": "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.", "basis": "Existing principles distinguish the population, formulation, continued levothyroxine, placebo, thyroid markers, timing, denominators, related reports, company involvement and harms of adjunctive whole-seed powder.", "condition_origin": "These existing conditions are linked to adjunctive whole-seed powder and laboratory markers in adults with Hashimoto thyroiditis. They explain stored summaries and material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_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.", "current_reports": [ "R01" ], "existence": "The information is recorded in stored whole-seed-powder reports, citations and existing Korean and English summaries. Actual reading of external abstracts, full text, registration and plans remains separately unverified.", "acquired_read": "Existing Korean and English stored summaries and the R01 citation read; external abstracts, full text, registration, protocols and analysis plans unread", "observation": "The original population is adults with Hashimoto thyroiditis continuing stable levothyroxine. The effect is not extended to all untreated thyroid conditions.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Details of diagnosis, baseline tests, medication dose and maintenance period, age, comorbidities and arm-specific inclusion/exclusion are not established.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original diagnosis, baseline tests, dose/maintenance period, age, comorbidities and arm-specific eligibility tables are needed." }, { "item_id": "N06", "question_type": "Evidence condition", "question": "Is adjunctive use with continued levothyroxine distinguished from replacement?", "needed": "Continued or changed standard treatment, medication use and the adjunctive-intervention specification in both arms", "role": "Required", "role_reason": "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_exception": "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.", "criterion": "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.", "basis": "Existing principles distinguish the population, formulation, continued levothyroxine, placebo, thyroid markers, timing, denominators, related reports, company involvement and harms of adjunctive whole-seed powder.", "condition_origin": "These existing conditions are linked to adjunctive whole-seed powder and laboratory markers in adults with Hashimoto thyroiditis. They explain stored summaries and material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_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.", "current_reports": [ "R01" ], "existence": "The information is recorded in stored whole-seed-powder reports, citations and existing Korean and English summaries. Actual reading of external abstracts, full text, registration and plans remains separately unverified.", "acquired_read": "Existing Korean and English stored summaries and the R01 citation read; external abstracts, full text, registration, protocols and analysis plans unread", "observation": "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.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "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.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original medication dose/change, adherence, diet/other-treatment and common-care records are needed." }, { "item_id": "N07", "question_type": "Evidence condition", "question": "Are the starch placebo and masking specification known?", "needed": "Starch-placebo composition/appearance, equal care and masking in both arms", "role": "Required", "role_reason": "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_exception": "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.", "criterion": "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.", "basis": "Existing principles distinguish the population, formulation, continued levothyroxine, placebo, thyroid markers, timing, denominators, related reports, company involvement and harms of adjunctive whole-seed powder.", "condition_origin": "These existing conditions are linked to adjunctive whole-seed powder and laboratory markers in adults with Hashimoto thyroiditis. They explain stored summaries and material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_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.", "current_reports": [ "R01" ], "existence": "The information is recorded in stored whole-seed-powder reports, citations and existing Korean and English summaries. Actual reading of external abstracts, full text, registration and plans remains separately unverified.", "acquired_read": "Existing Korean and English stored summaries and the R01 citation read; external abstracts, full text, registration, protocols and analysis plans unread", "observation": "The comparator adds starch placebo to standard treatment. R01 is recorded as a double-blind placebo-controlled trial.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Details of placebo composition, appearance, packaging, allocation, masking, adherence and equal care are not established. The design label alone does not verify successful masking.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original placebo composition, packaging, allocation/masking, adherence and equal-care records are needed. Successful masking is not certified." }, { "item_id": "N08", "question_type": "Evidence condition", "question": "Are trial design and completer analysis retained separately?", "needed": "Analysis populations in the randomized double-blind placebo-controlled trial", "role": "Required", "role_reason": "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_exception": "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.", "criterion": "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.", "basis": "Existing principles distinguish the population, formulation, continued levothyroxine, placebo, thyroid markers, timing, denominators, related reports, company involvement and harms of adjunctive whole-seed powder.", "condition_origin": "These existing conditions are linked to adjunctive whole-seed powder and laboratory markers in adults with Hashimoto thyroiditis. They explain stored summaries and material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_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.", "current_reports": [ "R01" ], "existence": "The information is recorded in stored whole-seed-powder reports, citations and existing Korean and English summaries. Actual reading of external abstracts, full text, registration and plans remains separately unverified.", "acquired_read": "Existing Korean and English stored summaries and the R01 citation read; external abstracts, full text, registration, protocols and analysis plans unread", "observation": "R01 is recorded as a randomized double-blind placebo-controlled trial with completer analysis. Randomization is kept distinct from the limitations of completer analysis.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "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.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original sequence, concealment, allocation, analysis-plan and ITT/completer-population material is needed. No new official risk assessment is produced." }, { "item_id": "N09", "question_type": "Evidence condition", "question": "What do the denominators of 47 and 40 represent?", "needed": "Total allocation, completion/analysis and arm-specific/endpoint-specific denominators", "role": "Required", "role_reason": "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_exception": "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.", "criterion": "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.", "basis": "Existing principles distinguish the population, formulation, continued levothyroxine, placebo, thyroid markers, timing, denominators, related reports, company involvement and harms of adjunctive whole-seed powder.", "condition_origin": "These existing conditions are linked to adjunctive whole-seed powder and laboratory markers in adults with Hashimoto thyroiditis. They explain stored summaries and material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_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.", "current_reports": [ "R01" ], "existence": "The information is recorded in stored whole-seed-powder reports, citations and existing Korean and English summaries. Actual reading of external abstracts, full text, registration and plans remains separately unverified.", "acquired_read": "Existing Korean and English stored summaries and the R01 citation read; external abstracts, full text, registration, protocols and analysis plans unread", "observation": "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.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "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.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Arm-specific allocation, completion, TSH/anti-TPO analysis denominators and the original participant flow diagram are needed." }, { "item_id": "N10", "question_type": "Evidence condition", "question": "What are the limitations of completer analysis and missing-data handling?", "needed": "Analysis exclusions, missing tests, reasons for attrition and sensitivity analyses", "role": "Required", "role_reason": "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_exception": "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.", "criterion": "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.", "basis": "Existing principles distinguish the population, formulation, continued levothyroxine, placebo, thyroid markers, timing, denominators, related reports, company involvement and harms of adjunctive whole-seed powder.", "condition_origin": "These existing conditions are linked to adjunctive whole-seed powder and laboratory markers in adults with Hashimoto thyroiditis. They explain stored summaries and material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_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.", "current_reports": [ "R01" ], "existence": "The information is recorded in stored whole-seed-powder reports, citations and existing Korean and English summaries. Actual reading of external abstracts, full text, registration and plans remains separately unverified.", "acquired_read": "Existing Korean and English stored summaries and the R01 citation read; external abstracts, full text, registration, protocols and analysis plans unread", "observation": "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.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "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.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original arm-specific missing/exclusion reasons, missing-data handling, analysis against the plan and sensitivity material are needed." }, { "item_id": "N11", "question_type": "Evidence condition", "question": "Are withdrawals with itching and nausea retained separately?", "needed": "Events, timing, denominators and missing outcomes linked to active-arm harm-related attrition", "role": "Supplementary", "role_reason": "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_exception": "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.", "criterion": "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.", "basis": "Existing principles distinguish the population, formulation, continued levothyroxine, placebo, thyroid markers, timing, denominators, related reports, company involvement and harms of adjunctive whole-seed powder.", "condition_origin": "These existing conditions are linked to adjunctive whole-seed powder and laboratory markers in adults with Hashimoto thyroiditis. They explain stored summaries and material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_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.", "current_reports": [ "R01" ], "existence": "The information is recorded in stored whole-seed-powder reports, citations and existing Korean and English summaries. Actual reading of external abstracts, full text, registration and plans remains separately unverified.", "acquired_read": "Existing Korean and English stored summaries and the R01 citation read; external abstracts, full text, registration, protocols and analysis plans unread", "observation": "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.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "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.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original adverse-event, attrition/discontinuation, missing-measurement, control-arm and event-course material is needed, linking safety to missing efficacy data." }, { "item_id": "N12", "question_type": "Evidence condition", "question": "What are the original reported TSH values?", "needed": "8-week TSH arm-specific values, original dispersion and adjusted analysis", "role": "Required", "role_reason": "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_exception": "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.", "criterion": "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.", "basis": "Existing principles distinguish the population, formulation, continued levothyroxine, placebo, thyroid markers, timing, denominators, related reports, company involvement and harms of adjunctive whole-seed powder.", "condition_origin": "These existing conditions are linked to adjunctive whole-seed powder and laboratory markers in adults with Hashimoto thyroiditis. They explain stored summaries and material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_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.", "current_reports": [ "R01" ], "existence": "The information is recorded in stored whole-seed-powder reports, citations and existing Korean and English summaries. Actual reading of external abstracts, full text, registration and plans remains separately unverified.", "acquired_read": "Existing Korean and English stored summaries and the R01 citation read; external abstracts, full text, registration, protocols and analysis plans unread", "observation": "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.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "The original results table defining laboratory units, group matching, dispersion, baseline/final values, covariates and analysis denominators is not established.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original results tables defining laboratory units, group matching, dispersion, baseline/final values, covariates and denominators are needed." }, { "item_id": "N13", "question_type": "Evidence condition", "question": "What are the original reported anti-TPO values?", "needed": "8-week anti-TPO arm-specific values, original dispersion and P/analysis specification", "role": "Required", "role_reason": "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_exception": "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.", "criterion": "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.", "basis": "Existing principles distinguish the population, formulation, continued levothyroxine, placebo, thyroid markers, timing, denominators, related reports, company involvement and harms of adjunctive whole-seed powder.", "condition_origin": "These existing conditions are linked to adjunctive whole-seed powder and laboratory markers in adults with Hashimoto thyroiditis. They explain stored summaries and material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_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.", "current_reports": [ "R01" ], "existence": "The information is recorded in stored whole-seed-powder reports, citations and existing Korean and English summaries. Actual reading of external abstracts, full text, registration and plans remains separately unverified.", "acquired_read": "Existing Korean and English stored summaries and the R01 citation read; external abstracts, full text, registration, protocols and analysis plans unread", "observation": "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.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "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.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "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." }, { "item_id": "N14", "question_type": "Evidence condition", "question": "Are adjusted effects and 95% CIs available?", "needed": "Marker-specific adjusted between-group effects and 95% CIs", "role": "Required", "role_reason": "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_exception": "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.", "criterion": "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.", "basis": "Existing principles distinguish the population, formulation, continued levothyroxine, placebo, thyroid markers, timing, denominators, related reports, company involvement and harms of adjunctive whole-seed powder.", "condition_origin": "These existing conditions are linked to adjunctive whole-seed powder and laboratory markers in adults with Hashimoto thyroiditis. They explain stored summaries and material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_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.", "current_reports": [ "R01" ], "existence": "The information is recorded in stored whole-seed-powder reports, citations and existing Korean and English summaries. Actual reading of external abstracts, full text, registration and plans remains separately unverified.", "acquired_read": "Existing Korean and English stored summaries and the R01 citation read; external abstracts, full text, registration, protocols and analysis plans unread", "observation": "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.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "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.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "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." }, { "item_id": "N15", "question_type": "Evidence condition", "question": "Are original ± notation, units and final values versus changes distinguished?", "needed": "Measurement units, means/dispersion, estimands and timing", "role": "Required", "role_reason": "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_exception": "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.", "criterion": "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.", "basis": "Existing principles distinguish the population, formulation, continued levothyroxine, placebo, thyroid markers, timing, denominators, related reports, company involvement and harms of adjunctive whole-seed powder.", "condition_origin": "These existing conditions are linked to adjunctive whole-seed powder and laboratory markers in adults with Hashimoto thyroiditis. They explain stored summaries and material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_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.", "current_reports": [ "R01" ], "existence": "The information is recorded in stored whole-seed-powder reports, citations and existing Korean and English summaries. Actual reading of external abstracts, full text, registration and plans remains separately unverified.", "acquired_read": "Existing Korean and English stored summaries and the R01 citation read; external abstracts, full text, registration, protocols and analysis plans unread", "observation": "The retained result provides ± and P for both markers, but units, dispersion type and the change-score/final-value specification are not detailed.", "condition_status": "Unverified", "status_reason": "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.", "missingness": "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.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original laboratory/statistical tables, baseline values, units and dispersion definitions are needed. The ± notation is not arbitrarily relabeled as a CI or SE." }, { "item_id": "N16", "question_type": "Evidence condition", "question": "What is the specification for baseline adjustment and multiple comparisons?", "needed": "Adjustment variables, test timepoints, estimands and multiplicity", "role": "Required", "role_reason": "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_exception": "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.", "criterion": "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.", "basis": "Existing principles distinguish the population, formulation, continued levothyroxine, placebo, thyroid markers, timing, denominators, related reports, company involvement and harms of adjunctive whole-seed powder.", "condition_origin": "These existing conditions are linked to adjunctive whole-seed powder and laboratory markers in adults with Hashimoto thyroiditis. They explain stored summaries and material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_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.", "current_reports": [ "R01" ], "existence": "The information is recorded in stored whole-seed-powder reports, citations and existing Korean and English summaries. Actual reading of external abstracts, full text, registration and plans remains separately unverified.", "acquired_read": "Existing Korean and English stored summaries and the R01 citation read; external abstracts, full text, registration, protocols and analysis plans unread", "observation": "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.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "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.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original SAPs, models, covariates, all markers/timepoints and analysis-population material are needed." }, { "item_id": "N17", "question_type": "Evidence condition", "question": "Has the prospective hierarchy of principal TSH and related anti-TPO been confirmed?", "needed": "Prospective endpoint hierarchy for 8-week TSH and the antibody reported alongside it", "role": "Required", "role_reason": "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_exception": "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.", "criterion": "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.", "basis": "Existing principles distinguish the population, formulation, continued levothyroxine, placebo, thyroid markers, timing, denominators, related reports, company involvement and harms of adjunctive whole-seed powder.", "condition_origin": "These existing conditions are linked to adjunctive whole-seed powder and laboratory markers in adults with Hashimoto thyroiditis. They explain stored summaries and material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_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.", "current_reports": [ "R01" ], "existence": "The information is recorded in stored whole-seed-powder reports, citations and existing Korean and English summaries. Actual reading of external abstracts, full text, registration and plans remains separately unverified.", "acquired_read": "Existing Korean and English stored summaries and the R01 citation read; external abstracts, full text, registration, protocols and analysis plans unread", "observation": "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.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "The original prospective hierarchy and co-primary (1st) status are not established. Reporting markers together does not verify prespecification or the validity of splitting.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Registration, protocol/SAP and a complete endpoint/timepoint table are needed. No new co-primary (1st) status, splitting or regrading is declared." }, { "item_id": "N18", "question_type": "Evidence condition", "question": "What are the assay and assessor procedures?", "needed": "TSH/anti-TPO assays, blood-sampling timepoints and laboratory/assessor masking", "role": "Required", "role_reason": "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_exception": "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.", "criterion": "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.", "basis": "Existing principles distinguish the population, formulation, continued levothyroxine, placebo, thyroid markers, timing, denominators, related reports, company involvement and harms of adjunctive whole-seed powder.", "condition_origin": "These existing conditions are linked to adjunctive whole-seed powder and laboratory markers in adults with Hashimoto thyroiditis. They explain stored summaries and material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_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.", "current_reports": [ "R01" ], "existence": "The information is recorded in stored whole-seed-powder reports, citations and existing Korean and English summaries. Actual reading of external abstracts, full text, registration and plans remains separately unverified.", "acquired_read": "Existing Korean and English stored summaries and the R01 citation read; external abstracts, full text, registration, protocols and analysis plans unread", "observation": "The original principal endpoint and results concern laboratory markers. Specific assay, blood-sampling and assessor procedures are not detailed in the stored summary.", "condition_status": "Unverified", "status_reason": "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.", "missingness": "The original assay/laboratory methods, repeated measurements, units and assessor masking are not established. The design label alone does not verify actual measurement procedures.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original assay/laboratory methods, repeated measurements, units and assessor-masking material are needed." }, { "item_id": "N19", "question_type": "Evidence condition", "question": "What are the original randomization, concealment and masking methods?", "needed": "Allocation sequence, concealment and participant/assessor masking", "role": "Required", "role_reason": "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_exception": "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.", "criterion": "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.", "basis": "Existing principles distinguish the population, formulation, continued levothyroxine, placebo, thyroid markers, timing, denominators, related reports, company involvement and harms of adjunctive whole-seed powder.", "condition_origin": "These existing conditions are linked to adjunctive whole-seed powder and laboratory markers in adults with Hashimoto thyroiditis. They explain stored summaries and material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_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.", "current_reports": [ "R01" ], "existence": "The information is recorded in stored whole-seed-powder reports, citations and existing Korean and English summaries. Actual reading of external abstracts, full text, registration and plans remains separately unverified.", "acquired_read": "Existing Korean and English stored summaries and the R01 citation read; external abstracts, full text, registration, protocols and analysis plans unread", "observation": "The original randomized and double-blind design labels are retained. The adequacy of original methods and success of masking are not newly certified.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Original methods, registration/plans and arm-specific follow-up/assessment records are not established. This preparation is not an official RoB2/GRADE assessment.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original methods, registration/plans and arm-specific follow-up/assessment records are needed. No official RoB2/GRADE assessment is produced." }, { "item_id": "N20", "question_type": "Evidence condition", "question": "Are the IRCT registration record and actual reading distinguished?", "needed": "Original registration/version and timing for IRCT2015021719082N4", "role": "Required", "role_reason": "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_exception": "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.", "criterion": "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.", "basis": "Existing principles distinguish the population, formulation, continued levothyroxine, placebo, thyroid markers, timing, denominators, related reports, company involvement and harms of adjunctive whole-seed powder.", "condition_origin": "These existing conditions are linked to adjunctive whole-seed powder and laboratory markers in adults with Hashimoto thyroiditis. They explain stored summaries and material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_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.", "current_reports": [ "R01" ], "existence": "The information is recorded in stored whole-seed-powder reports, citations and existing Korean and English summaries. Actual reading of external abstracts, full text, registration and plans remains separately unverified.", "acquired_read": "Existing Korean and English stored summaries and the R01 citation read; external abstracts, full text, registration, protocols and analysis plans unread", "observation": "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.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "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.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "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." }, { "item_id": "N21", "question_type": "Evidence condition", "question": "Are T3 and T4 kept separate from the principal claim?", "needed": "Separate T3/T4 results, timing, denominators and hierarchy", "role": "Supplementary", "role_reason": "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_exception": "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.", "criterion": "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.", "basis": "Existing principles distinguish the population, formulation, continued levothyroxine, placebo, thyroid markers, timing, denominators, related reports, company involvement and harms of adjunctive whole-seed powder.", "condition_origin": "These existing conditions are linked to adjunctive whole-seed powder and laboratory markers in adults with Hashimoto thyroiditis. They explain stored summaries and material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_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.", "current_reports": [ "R01" ], "existence": "The information is recorded in stored whole-seed-powder reports, citations and existing Korean and English summaries. Actual reading of external abstracts, full text, registration and plans remains separately unverified.", "acquired_read": "Existing Korean and English stored summaries and the R01 citation read; external abstracts, full text, registration, protocols and analysis plans unread", "observation": "The original summary retains T3 and T4 as 2nd-tier or mechanistic results. TSH/antibody numbers are not copied as values for other hormones.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "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.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original results, CIs, denominators and hierarchy for each marker are needed. No new separate efficacy grade is created." }, { "item_id": "N22", "question_type": "Evidence condition", "question": "Are weight, VEGF and Nesfatin-1 kept separate?", "needed": "Separate results, denominators and prospective hierarchy for body weight/mechanistic markers", "role": "Supplementary", "role_reason": "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_exception": "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.", "criterion": "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.", "basis": "Existing principles distinguish the population, formulation, continued levothyroxine, placebo, thyroid markers, timing, denominators, related reports, company involvement and harms of adjunctive whole-seed powder.", "condition_origin": "These existing conditions are linked to adjunctive whole-seed powder and laboratory markers in adults with Hashimoto thyroiditis. They explain stored summaries and material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_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.", "current_reports": [ "R01" ], "existence": "The information is recorded in stored whole-seed-powder reports, citations and existing Korean and English summaries. Actual reading of external abstracts, full text, registration and plans remains separately unverified.", "acquired_read": "Existing Korean and English stored summaries and the R01 citation read; external abstracts, full text, registration, protocols and analysis plans unread", "observation": "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.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "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.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "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." }, { "item_id": "N23", "question_type": "Evidence condition", "question": "Are symptom improvement and laboratory results distinguished?", "needed": "Direct results for patient symptoms, quality of life and function", "role": "Supplementary", "role_reason": "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_exception": "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.", "criterion": "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.", "basis": "Existing principles distinguish the population, formulation, continued levothyroxine, placebo, thyroid markers, timing, denominators, related reports, company involvement and harms of adjunctive whole-seed powder.", "condition_origin": "These existing conditions are linked to adjunctive whole-seed powder and laboratory markers in adults with Hashimoto thyroiditis. They explain stored summaries and material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_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.", "current_reports": [ "R01" ], "existence": "The information is recorded in stored whole-seed-powder reports, citations and existing Korean and English summaries. Actual reading of external abstracts, full text, registration and plans remains separately unverified.", "acquired_read": "Existing Korean and English stored summaries and the R01 citation read; external abstracts, full text, registration, protocols and analysis plans unread", "observation": "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.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Direct material on prespecified patient outcomes, symptoms and quality of life is not established. Laboratory changes alone do not verify improvement experienced by patients.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original material on prespecified patient outcomes, symptoms and quality of life is needed." }, { "item_id": "N24", "question_type": "Evidence condition", "question": "Are medication reduction, withdrawal and cure excluded from the claim?", "needed": "Direct comparisons for levothyroxine reduction/withdrawal and autoimmune cure", "role": "Supplementary", "role_reason": "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_exception": "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.", "criterion": "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.", "basis": "Existing principles distinguish the population, formulation, continued levothyroxine, placebo, thyroid markers, timing, denominators, related reports, company involvement and harms of adjunctive whole-seed powder.", "condition_origin": "These existing conditions are linked to adjunctive whole-seed powder and laboratory markers in adults with Hashimoto thyroiditis. They explain stored summaries and material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_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.", "current_reports": [ "R01" ], "existence": "The information is recorded in stored whole-seed-powder reports, citations and existing Korean and English summaries. Actual reading of external abstracts, full text, registration and plans remains separately unverified.", "acquired_read": "Existing Korean and English stored summaries and the R01 citation read; external abstracts, full text, registration, protocols and analysis plans unread", "observation": "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.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "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.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Direct studies of medication reduction/discontinuation and clinical course are needed. These outcomes are not added here." }, { "item_id": "N25", "question_type": "Evidence condition", "question": "Are long-term thyroid function and persistent effects known?", "needed": "Laboratory/clinical course beyond 8 weeks and after discontinuation", "role": "Supplementary", "role_reason": "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_exception": "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.", "criterion": "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.", "basis": "Existing principles distinguish the population, formulation, continued levothyroxine, placebo, thyroid markers, timing, denominators, related reports, company involvement and harms of adjunctive whole-seed powder.", "condition_origin": "These existing conditions are linked to adjunctive whole-seed powder and laboratory markers in adults with Hashimoto thyroiditis. They explain stored summaries and material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_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.", "current_reports": [ "R01" ], "existence": "The information is recorded in stored whole-seed-powder reports, citations and existing Korean and English summaries. Actual reading of external abstracts, full text, registration and plans remains separately unverified.", "acquired_read": "Existing Korean and English stored summaries and the R01 citation read; external abstracts, full text, registration, protocols and analysis plans unread", "observation": "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.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "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.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Longer follow-up, post-discontinuation course and repeated material for the same formulation are needed." }, { "item_id": "N26", "question_type": "Evidence condition", "question": "Is a single report distinguished from independent replication?", "needed": "Trial families, shared participants and independent teams using the same formulation", "role": "Required", "role_reason": "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_exception": "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.", "criterion": "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.", "basis": "Existing principles distinguish the population, formulation, continued levothyroxine, placebo, thyroid markers, timing, denominators, related reports, company involvement and harms of adjunctive whole-seed powder.", "condition_origin": "These existing conditions are linked to adjunctive whole-seed powder and laboratory markers in adults with Hashimoto thyroiditis. They explain stored summaries and material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_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.", "current_reports": [ "R01" ], "existence": "The information is recorded in stored whole-seed-powder reports, citations and existing Korean and English summaries. Actual reading of external abstracts, full text, registration and plans remains separately unverified.", "acquired_read": "Existing Korean and English stored summaries and the R01 citation read; external abstracts, full text, registration, protocols and analysis plans unread", "observation": "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.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "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.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Team, product, funding, additional-report/registration links and replication material for the same question are needed. Final unique-trial/participant totals remain unverified." }, { "item_id": "N27", "question_type": "Evidence condition", "question": "Are university support, product manufacture and company-involvement routes distinguished?", "needed": "Original records of funding, product support, employee authorship and conflicts of interest", "role": "Required", "role_reason": "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_exception": "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.", "criterion": "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.", "basis": "Existing principles distinguish the population, formulation, continued levothyroxine, placebo, thyroid markers, timing, denominators, related reports, company involvement and harms of adjunctive whole-seed powder.", "condition_origin": "These existing conditions are linked to adjunctive whole-seed powder and laboratory markers in adults with Hashimoto thyroiditis. They explain stored summaries and material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_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.", "current_reports": [ "R01" ], "existence": "The information is recorded in stored whole-seed-powder reports, citations and existing Korean and English summaries. Actual reading of external abstracts, full text, registration and plans remains separately unverified.", "acquired_read": "Existing Korean and English stored summaries and the R01 citation read; external abstracts, full text, registration, protocols and analysis plans unread", "observation": "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.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "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.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "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." }, { "item_id": "N28", "question_type": "Evidence condition", "question": "What are the harm-collection procedures and course of itching/nausea?", "needed": "Harm definitions, active ascertainment, events/discontinuation and severity", "role": "Supplementary", "role_reason": "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_exception": "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.", "criterion": "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.", "basis": "Existing principles distinguish the population, formulation, continued levothyroxine, placebo, thyroid markers, timing, denominators, related reports, company involvement and harms of adjunctive whole-seed powder.", "condition_origin": "These existing conditions are linked to adjunctive whole-seed powder and laboratory markers in adults with Hashimoto thyroiditis. They explain stored summaries and material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_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.", "current_reports": [ "R01" ], "existence": "The information is recorded in stored whole-seed-powder reports, citations and existing Korean and English summaries. Actual reading of external abstracts, full text, registration and plans remains separately unverified.", "acquired_read": "Existing Korean and English stored summaries and the R01 citation read; external abstracts, full text, registration, protocols and analysis plans unread", "observation": "The active-arm itching/nausea withdrawal narrative and general safety caution are retained separately. Harm-event counts, collection methods and established causality remain unverified.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "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.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original harm tables, ascertainment/discontinuation, arm-specific course and missing-material records are needed." }, { "item_id": "N29", "question_type": "Evidence condition", "question": "Are safety denominators, exposure and controls separately known?", "needed": "Arm-specific safety populations, actual dosing and 8-week exposure/events", "role": "Supplementary", "role_reason": "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_exception": "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.", "criterion": "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.", "basis": "Existing principles distinguish the population, formulation, continued levothyroxine, placebo, thyroid markers, timing, denominators, related reports, company involvement and harms of adjunctive whole-seed powder.", "condition_origin": "These existing conditions are linked to adjunctive whole-seed powder and laboratory markers in adults with Hashimoto thyroiditis. They explain stored summaries and material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_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.", "current_reports": [ "R01" ], "existence": "The information is recorded in stored whole-seed-powder reports, citations and existing Korean and English summaries. Actual reading of external abstracts, full text, registration and plans remains separately unverified.", "acquired_read": "Existing Korean and English stored summaries and the R01 citation read; external abstracts, full text, registration, protocols and analysis plans unread", "observation": "47 randomized and 40 completed/analyzed participants do not establish safety denominators. Event counts and control-arm safety denominators are absent from the summary.", "condition_status": "Unverified", "status_reason": "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.", "missingness": "Safety denominators, events, controls, exposure time and attrition records are not established. Allocation/completion records alone do not permit incidence calculations.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original safety denominators, events, controls, exposure time and attrition records are needed. Incidence is not calculated." }, { "item_id": "N30", "question_type": "Evidence condition", "question": "Are concomitant levothyroxine and alternative causes distinguished?", "needed": "Concomitant medication/dosing times, changes, baseline conditions and event timing", "role": "Supplementary", "role_reason": "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_exception": "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.", "criterion": "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.", "basis": "Existing principles distinguish the population, formulation, continued levothyroxine, placebo, thyroid markers, timing, denominators, related reports, company involvement and harms of adjunctive whole-seed powder.", "condition_origin": "These existing conditions are linked to adjunctive whole-seed powder and laboratory markers in adults with Hashimoto thyroiditis. They explain stored summaries and material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_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.", "current_reports": [ "R01" ], "existence": "The information is recorded in stored whole-seed-powder reports, citations and existing Korean and English summaries. Actual reading of external abstracts, full text, registration and plans remains separately unverified.", "acquired_read": "Existing Korean and English stored summaries and the R01 citation read; external abstracts, full text, registration, protocols and analysis plans unread", "observation": "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.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "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.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Medication/timing, changes, baseline conditions, controls, post-discontinuation course and alternative-cause material are needed." }, { "item_id": "N31", "question_type": "Evidence condition", "question": "Were long-term, rare and vulnerable-population harms verified?", "needed": "Longer follow-up, independent harm reports, vulnerable populations and exposure/denominators", "role": "Supplementary", "role_reason": "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_exception": "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.", "criterion": "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.", "basis": "Existing principles distinguish the population, formulation, continued levothyroxine, placebo, thyroid markers, timing, denominators, related reports, company involvement and harms of adjunctive whole-seed powder.", "condition_origin": "These existing conditions are linked to adjunctive whole-seed powder and laboratory markers in adults with Hashimoto thyroiditis. They explain stored summaries and material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_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.", "current_reports": [ "R01" ], "existence": "The information is recorded in stored whole-seed-powder reports, citations and existing Korean and English summaries. Actual reading of external abstracts, full text, registration and plans remains separately unverified.", "acquired_read": "Existing Korean and English stored summaries and the R01 citation read; external abstracts, full text, registration, protocols and analysis plans unread", "observation": "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.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "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.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Longer follow-up, vulnerable-population material, independent reports and exposure/denominators are needed. Unverified status is retained without a new harm investigation or judgment." }, { "item_id": "N32", "question_type": "Evidence condition", "question": "Are summary reading, PubMed, PMCID and registration distinguished?", "needed": "An access table for stored JSON, external abstracts, full text, IRCT and protocols/SAPs", "role": "Required", "role_reason": "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_exception": "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.", "criterion": "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.", "basis": "Existing principles distinguish the population, formulation, continued levothyroxine, placebo, thyroid markers, timing, denominators, related reports, company involvement and harms of adjunctive whole-seed powder.", "condition_origin": "These existing conditions are linked to adjunctive whole-seed powder and laboratory markers in adults with Hashimoto thyroiditis. They explain stored summaries and material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_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.", "current_reports": [ "R01" ], "existence": "The information is recorded in stored whole-seed-powder reports, citations and existing Korean and English summaries. Actual reading of external abstracts, full text, registration and plans remains separately unverified.", "acquired_read": "Existing Korean and English stored summaries and the R01 citation read; external abstracts, full text, registration, protocols and analysis plans unread", "observation": "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.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "External abstracts, full text, registration and protocols/SAPs are unread here. Identifiers and URLs alone do not verify material access or fulfilled conditions.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "External material remains unread pending actual acquisition and review. Identifiers or URLs are not labeled as reading, accessibility or fulfilled conditions." }, { "item_id": "N33", "question_type": "Evidence condition", "question": "Are generic English wording and historical corrections preserved?", "needed": "Original Korean/English text and limits of the 2026-09-14 correction", "role": "Supplementary", "role_reason": "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_exception": "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.", "criterion": "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.", "basis": "Existing principles distinguish the population, formulation, continued levothyroxine, placebo, thyroid markers, timing, denominators, related reports, company involvement and harms of adjunctive whole-seed powder.", "condition_origin": "These existing conditions are linked to adjunctive whole-seed powder and laboratory markers in adults with Hashimoto thyroiditis. They explain stored summaries and material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_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.", "current_reports": [ "R01" ], "existence": "The information is recorded in stored whole-seed-powder reports, citations and existing Korean and English summaries. Actual reading of external abstracts, full text, registration and plans remains separately unverified.", "acquired_read": "Existing Korean and English stored summaries and the R01 citation read; external abstracts, full text, registration, protocols and analysis plans unread", "observation": "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.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "External English text and historical correction targets were not directly compared here. Historical verification wording does not establish completed current content verification.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "External English text and historical correction targets remain uncompared here. Historical verification wording is not converted into newly completed content verification." }, { "item_id": "N34", "question_type": "Evidence condition", "question": "Are original grade, axes, evidence date and preparation kept separate?", "needed": "Original C54, Caution, axes, evidence date and correction values", "role": "Required", "role_reason": "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_exception": "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.", "criterion": "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.", "basis": "Existing principles distinguish the population, formulation, continued levothyroxine, placebo, thyroid markers, timing, denominators, related reports, company involvement and harms of adjunctive whole-seed powder.", "condition_origin": "These existing conditions are linked to adjunctive whole-seed powder and laboratory markers in adults with Hashimoto thyroiditis. They explain stored summaries and material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_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.", "current_reports": [ "R01" ], "existence": "The information is recorded in stored whole-seed-powder reports, citations and existing Korean and English summaries. Actual reading of external abstracts, full text, registration and plans remains separately unverified.", "acquired_read": "Existing Korean and English stored summaries and the R01 citation read; external abstracts, full text, registration, protocols and analysis plans unread", "observation": "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.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "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.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "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." } ], "reports": [ { "report_id": "R01", "title": "Farhangi et al. 2016 · Whole-seed-powder and Hashimoto thyroid-marker report", "url": "https://pubmed.ncbi.nlm.nih.gov/27852303/", "report_type": "Randomized double-blind placebo-controlled trial; completer analysis", "existence": "The information is recorded in stored whole-seed-powder reports, citations and existing Korean and English summaries. Actual reading of external abstracts, full text, registration and plans remains separately unverified.", "acquired_read": "Stored existing review summary read; external material unread", "study_family": "The Farhangi 2016 single report distinguishes 47 randomized participants, 40 completers/analyzed participants, marker-specific denominators and links to additional reports; no new unique-trial/participant total or independent replication is certified.", "independent_replication": "Reports remain distinct from unique trials, independent teams and participant totals; these are not certified here", "observed_result": "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", "result_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.", "source_evidence_date": "2026-09-08", "materials": [ { "material_type": "Stored existing review summary", "public_status": "Preserved copy of the complete existing review summary", "access_status": "Stored summary", "acquired": true, "actually_read": "Summary read", "as_of": "2026-10-06T12:39:42.851698+09:00", "qualification": "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." }, { "material_type": "External abstract", "public_status": "Original bibliographic link or needed material; external public availability/access status unverified", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": null, "qualification": "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." }, { "material_type": "External full text", "public_status": "Original bibliographic link or needed material; external public availability/access status unverified", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": null, "qualification": "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." }, { "material_type": "Registration material", "public_status": "Original bibliographic link or needed material; external public availability/access status unverified", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": null, "qualification": "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." }, { "material_type": "Protocol and analysis plan", "public_status": "Original bibliographic link or needed material; external public availability/access status unverified", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": null, "qualification": "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." } ], "links": [ { "label": "PubMed", "url": "https://pubmed.ncbi.nlm.nih.gov/27852303/" } ] } ], "method_sources": [ { "id": "M03", "version": "Cochrane Handbook 6.5 (2024), chapter updated 2023-08", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-03", "section": "§3.1, §3.2.1–3.2.3, MECIR C5/C7/C13", "official_principle": "Clearly record the question, eligibility conditions and reasons for changes, and distinguish variations in interventions.", "review_level": "Existing methodological links were reused for production. External originals were not reread and methodological content was not reassessed." }, { "id": "M04", "version": "Cochrane Handbook 6.5.1 (2025), chapter updated 2025-03", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-04", "section": "§4.5, §4.6.1–4.6.3, MECIR C42", "official_principle": "Distinguish studies from reports and link them; do not omit a study solely because results are unreported.", "review_level": "Existing methodological links were reused for production. External originals were not reread and methodological content was not reassessed." }, { "id": "M08", "version": "Cochrane Handbook 6.5 (2024), chapter updated 2019-10", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-08", "section": "§8.1–8.2.3, Table 8.2.a", "official_principle": "Define the outcome and effect of interest, then examine randomization, deviations, missing data, measurement and selective reporting.", "review_level": "Existing methodological links were reused for production. External originals were not reread and methodological content was not reassessed." }, { "id": "M15", "version": "Cochrane Handbook 6.5 (2024), chapter updated 2023-08", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-15", "section": "§15.2.4, §15.3.1–15.3.3", "official_principle": "Distinguish effect estimates, intervals, importance and applicability. Sample size alone does not determine precision.", "review_level": "Existing methodological links were reused for production. External originals were not reread and methodological content was not reassessed." }, { "id": "M19", "version": "Cochrane Handbook 6.5 (2024), chapter updated 2019-10", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-19", "section": "§19.1.2, §19.2.1–19.2.4", "official_principle": "Harm questions may require different designs, populations and follow-up from efficacy questions. Case reports do not establish incidence rates.", "review_level": "Existing methodological links were reused for production. External originals were not reread and methodological content was not reassessed." } ], "status_dictionary": { "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." }, "study_overlap": { "state": "Unverified", "unique_trial_count": null, "unique_participant_count": null, "reason": "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." }, "history": [ { "date": "2026-10-24", "kind": "Separation of public-facing pages and materials", "view_version": "1.0", "change": "The public view and materials were prepared from the existing 34 items. No new clinical search, verification-state change or scoring was performed." } ], "language": "en", "translation_date": "2026-10-24" }