{ "schema_version": "chamgap-public-evidence-check-1.0", "public_id": "v3041-main", "verdict_number": "3041", "title": "Nanocurcumin 80 mg three times daily × Improvement of HOMA-IR in polycystic ovary syndrome", "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": "Each material date of 2026-09-08 is a retained historical evidence date. It is not an actual external-reading date and remains distinct from stored-material production on 2026-10-06 and actual completed content review. The actual completed-review date is unrecorded." }, "claim_context": { "population": "The retained population is 200 women with PCOS. Diagnostic details are described as governed by the full paper; diagnosis, phenotype, age, baseline metabolism and recruitment/exclusion criteria remain incompletely verified.", "intervention": "The intervention is oral supplementation with a nanocurcumin soft-gel derived from Curcuma longa. Products, batches, particles and active amounts remain incompletely verified; equivalence to conventional, phytosomal or other nano/combination formulations is not established.", "dose": "The original values are 80 mg every 8 hours, totaling 240 mg/day. Actual dosing, adherence, dose changes and exposure quantification remain unverified; no new dose conversion or recommended amount is generated.", "comparator": "The factorial arms are metformin, nanocurcumin, their combination and double placebo. Metformin doses/schedules, placebo matching, common lifestyle care and concomitant medicines remain unverified. Combination benefit is not established as nanocurcumin-only contribution.", "endpoint": "The selected endpoint is HOMA-IR change at 12 weeks. Measurement formula, fasting conditions, assays, baseline values, prespecified hierarchy, exact main effects/interactions and intervals remain unverified. Weight, hormones, ovulation, fertility and pregnancy outcomes address different questions.", "duration": "The record describes 12 weeks of treatment and follow-up. Visit schedules, actual exposure, post-discontinuation persistence and long-term follow-up remain unverified; scope is not extended to long-term efficacy or safety.", "excluded_extensions": [ "The original C/54/Caution and B/S/R1/I2/EX/B0/CX are retained. The EX cap and historical cross-checking are historical records, not current external original-source reading, efficacy reassessment or independent clinical certification.", "200 people, 4 arms allocated 1:1:1:1 and a 2×2 factorial design are retained as original values. Allocation, completion and analysis counts are not calculated from the ratio; the four arms are not counted as independent trials or four replications.", "The stored value is approximately −0.99 for HOMA-IR in the combination arm. Whether it is a within-group change or a between-group difference, its comparator, adjustment and denominator remain unverified; it is not transferred to a nanocurcumin-only main effect.", "Nanocurcumin/metformin main effects, interaction and the selected monotherapy comparison remain distinct. Exact estimates, P values and 95% CIs remain unverified; interaction is not assumed to be 0, and intervals are not calculated from the total sample.", "80 mg every 8 hours, totaling 240 mg/day, and the original ingredient description of 80 mg 3 times daily are retained. These expressions already exist in the original record; they are not new arithmetic, adherence verification or optimum-dose certification.", "The reported author declaration of no conflicts and unverified funding details are both retained. Original funding, product-support, employee-authorship, manufacturer-role and COI disclosures remain unread; absence of company involvement or independence is not established.", "Original precautions concerning unestablished pregnancy safety and the need for gastrointestinal/glycemic monitoring with metformin are retained. Actual events, collection, group exposure/denominators, causality, fertility/pregnancy and long-term safety remain unverified.", "The original evidence date 2026-09-08, correction of 1 English field on 2026-09-14 and stored-material production date 2026-10-06 remain distinct. Actual content-review dates remain unrecorded; production dates and historical abstract narratives are not relabeled as current external reading." ] }, "requirements": [ { "item_id": "N01", "question_type": "Evidence condition", "question": "Which PCOS HOMA-IR question is presented?", "needed": "Nanocurcumin HOMA-IR and attribution to monotherapy/combination in a factorial trial", "role": "Required", "role_reason": "Material on Nanocurcumin HOMA-IR and attribution to monotherapy/combination in a factorial trial is needed to connect the relevant PCOS population, nanoformulation, factorial arm, HOMA-IR measurement/timepoint, main effect/interaction, denominator or harm scope.", "application_exception": "Arms, main effects and interactions within one factorial trial remain distinct. A combination-arm value is not transferred to a monotherapy main effect, and allocation ratios are not used to calculate group analysis counts. Scope is not extended to other formulations, weight/hormones, ovulation/fertility/pregnancy outcomes or overall safety.", "criterion": "Original records on Nanocurcumin HOMA-IR and attribution to monotherapy/combination in a factorial trial must link to populations, products, factorial comparisons, denominators, HOMA-IR analyses and timepoints, distinguishing stored information from what remains unverified.", "basis": "Existing principles distinguish population, nanoformulation, dose/duration, factorial arms, main effects/interactions, measurement, denominators, support and harms in the retained PCOS HOMA-IR record.", "condition_origin": "These existing conditions are linked to the retained PCOS HOMA-IR question. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Factorial analysis plans, group results, main effects and interaction tables. This records needed materials; no new research was executed.", "current_reports": [ "S01" ], "existence": "The information comes from the stored summary and bibliography of a factorial-trial report. Existence/public availability, acquisition and actual reading of external papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain separately unverified.", "acquired_read": "The retained Korean and English summaries and bibliography were read. External papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain unread, with no access attempt.", "observation": "The original claim concerns HOMA-IR improvement in polycystic ovary syndrome. A combination-arm result is not transferred to a nanocurcumin-only main effect.", "condition_status": "Partly verified", "status_reason": "Information 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": "Exact HOMA-IR effects for the monotherapy main effect and interaction remain unverified.", "uncertainty": "Gaps remain in diagnosis, products, actual exposure, factorial treatments, measurement, main effects/interactions, intervals, denominators, missingness, support and harms. Original numbers, grades and historical verification wording do not constitute new calculation, reassessment or clinical validation.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Factorial analysis plans, group results, main effects and interaction tables" }, { "item_id": "N02", "question_type": "Evidence condition", "question": "What are the diagnostic and baseline conditions of the PCOS population?", "needed": "PCOS diagnosis, age, baseline metabolism, recruitment and exclusion criteria", "role": "Required", "role_reason": "Material on PCOS diagnosis, age, baseline metabolism, recruitment and exclusion criteria is needed to connect the relevant PCOS population, nanoformulation, factorial arm, HOMA-IR measurement/timepoint, main effect/interaction, denominator or harm scope.", "application_exception": "Arms, main effects and interactions within one factorial trial remain distinct. A combination-arm value is not transferred to a monotherapy main effect, and allocation ratios are not used to calculate group analysis counts. Scope is not extended to other formulations, weight/hormones, ovulation/fertility/pregnancy outcomes or overall safety.", "criterion": "Original records on PCOS diagnosis, age, baseline metabolism, recruitment and exclusion criteria must link to populations, products, factorial comparisons, denominators, HOMA-IR analyses and timepoints, distinguishing stored information from what remains unverified.", "basis": "Existing principles distinguish population, nanoformulation, dose/duration, factorial arms, main effects/interactions, measurement, denominators, support and harms in the retained PCOS HOMA-IR record.", "condition_origin": "These existing conditions are linked to the retained PCOS HOMA-IR question. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Eligibility, diagnosis and baseline-characteristic tables. This records needed materials; no new research was executed.", "current_reports": [ "S01" ], "existence": "The information comes from the stored summary and bibliography of a factorial-trial report. Existence/public availability, acquisition and actual reading of external papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain separately unverified.", "acquired_read": "The retained Korean and English summaries and bibliography were read. External papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain unread, with no access attempt.", "observation": "The retained population is 200 women with PCOS, with diagnostic details described as governed by the full paper.", "condition_status": "Partly verified", "status_reason": "Information 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": "Diagnostic criteria, phenotypes, baseline insulin resistance, recruitment and exclusion criteria remain unverified.", "uncertainty": "Gaps remain in diagnosis, products, actual exposure, factorial treatments, measurement, main effects/interactions, intervals, denominators, missingness, support and harms. Original numbers, grades and historical verification wording do not constitute new calculation, reassessment or clinical validation.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Eligibility, diagnosis and baseline-characteristic tables" }, { "item_id": "N03", "question_type": "Evidence condition", "question": "Which nanocurcumin formulation is involved?", "needed": "Distinguishing nanocurcumin soft-gels from other curcumin delivery formulations", "role": "Required", "role_reason": "Material on Distinguishing nanocurcumin soft-gels from other curcumin delivery formulations is needed to connect the relevant PCOS population, nanoformulation, factorial arm, HOMA-IR measurement/timepoint, main effect/interaction, denominator or harm scope.", "application_exception": "Arms, main effects and interactions within one factorial trial remain distinct. A combination-arm value is not transferred to a monotherapy main effect, and allocation ratios are not used to calculate group analysis counts. Scope is not extended to other formulations, weight/hormones, ovulation/fertility/pregnancy outcomes or overall safety.", "criterion": "Original records on Distinguishing nanocurcumin soft-gels from other curcumin delivery formulations must link to populations, products, factorial comparisons, denominators, HOMA-IR analyses and timepoints, distinguishing stored information from what remains unverified.", "basis": "Existing principles distinguish population, nanoformulation, dose/duration, factorial arms, main effects/interactions, measurement, denominators, support and harms in the retained PCOS HOMA-IR record.", "condition_origin": "These existing conditions are linked to the retained PCOS HOMA-IR question. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Product, batch, nano-characteristic and quantification material. This records needed materials; no new research was executed.", "current_reports": [ "S01" ], "existence": "The information comes from the stored summary and bibliography of a factorial-trial report. Existence/public availability, acquisition and actual reading of external papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain separately unverified.", "acquired_read": "The retained Korean and English summaries and bibliography were read. External papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain unread, with no access attempt.", "observation": "The retained formulation is a soft-gel containing nanoformulated curcumin derived from Curcuma longa.", "condition_status": "Partly verified", "status_reason": "Information 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": "Product names, batches, particle characteristics, active-ingredient quantification and manufacturing conditions remain unverified.", "uncertainty": "Gaps remain in diagnosis, products, actual exposure, factorial treatments, measurement, main effects/interactions, intervals, denominators, missingness, support and harms. Original numbers, grades and historical verification wording do not constitute new calculation, reassessment or clinical validation.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Product, batch, nano-characteristic and quantification material" }, { "item_id": "N04", "question_type": "Evidence condition", "question": "What are the oral dose and dosing interval?", "needed": "Actual administration of 80 mg every 8 hours, totaling 240 mg/day", "role": "Required", "role_reason": "Material on Actual administration of 80 mg every 8 hours, totaling 240 mg/day is needed to connect the relevant PCOS population, nanoformulation, factorial arm, HOMA-IR measurement/timepoint, main effect/interaction, denominator or harm scope.", "application_exception": "Arms, main effects and interactions within one factorial trial remain distinct. A combination-arm value is not transferred to a monotherapy main effect, and allocation ratios are not used to calculate group analysis counts. Scope is not extended to other formulations, weight/hormones, ovulation/fertility/pregnancy outcomes or overall safety.", "criterion": "Original records on Actual administration of 80 mg every 8 hours, totaling 240 mg/day must link to populations, products, factorial comparisons, denominators, HOMA-IR analyses and timepoints, distinguishing stored information from what remains unverified.", "basis": "Existing principles distinguish population, nanoformulation, dose/duration, factorial arms, main effects/interactions, measurement, denominators, support and harms in the retained PCOS HOMA-IR record.", "condition_origin": "These existing conditions are linked to the retained PCOS HOMA-IR question. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Dosing schedules, product amounts and adherence records. This records needed materials; no new research was executed.", "current_reports": [ "S01" ], "existence": "The information comes from the stored summary and bibliography of a factorial-trial report. Existence/public availability, acquisition and actual reading of external papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain separately unverified.", "acquired_read": "The retained Korean and English summaries and bibliography were read. External papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain unread, with no access attempt.", "observation": "The retained scope states 80 mg every 8 hours, totaling 240 mg/day; the Korean ingredient description retains 80 mg 3 times daily.", "condition_status": "Partly verified", "status_reason": "Information 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": "Actual dosing, adherence, dose changes and exposure quantification remain unverified.", "uncertainty": "Gaps remain in diagnosis, products, actual exposure, factorial treatments, measurement, main effects/interactions, intervals, denominators, missingness, support and harms. Original numbers, grades and historical verification wording do not constitute new calculation, reassessment or clinical validation.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Dosing schedules, product amounts and adherence records" }, { "item_id": "N05", "question_type": "Evidence condition", "question": "What do 12 weeks of treatment and effect persistence mean?", "needed": "12 weeks of treatment/follow-up and post-treatment persistence", "role": "Required", "role_reason": "Material on 12 weeks of treatment/follow-up and post-treatment persistence is needed to connect the relevant PCOS population, nanoformulation, factorial arm, HOMA-IR measurement/timepoint, main effect/interaction, denominator or harm scope.", "application_exception": "Arms, main effects and interactions within one factorial trial remain distinct. A combination-arm value is not transferred to a monotherapy main effect, and allocation ratios are not used to calculate group analysis counts. Scope is not extended to other formulations, weight/hormones, ovulation/fertility/pregnancy outcomes or overall safety.", "criterion": "Original records on 12 weeks of treatment/follow-up and post-treatment persistence must link to populations, products, factorial comparisons, denominators, HOMA-IR analyses and timepoints, distinguishing stored information from what remains unverified.", "basis": "Existing principles distinguish population, nanoformulation, dose/duration, factorial arms, main effects/interactions, measurement, denominators, support and harms in the retained PCOS HOMA-IR record.", "condition_origin": "These existing conditions are linked to the retained PCOS HOMA-IR question. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Follow-up schedules and post-treatment material. This records needed materials; no new research was executed.", "current_reports": [ "S01" ], "existence": "The information comes from the stored summary and bibliography of a factorial-trial report. Existence/public availability, acquisition and actual reading of external papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain separately unverified.", "acquired_read": "The retained Korean and English summaries and bibliography were read. External papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain unread, with no access attempt.", "observation": "The retained duration is 12 weeks of treatment and follow-up.", "condition_status": "Partly verified", "status_reason": "Information 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": "Visit-specific schedules, post-treatment persistence and long-term follow-up remain unverified.", "uncertainty": "Gaps remain in diagnosis, products, actual exposure, factorial treatments, measurement, main effects/interactions, intervals, denominators, missingness, support and harms. Original numbers, grades and historical verification wording do not constitute new calculation, reassessment or clinical validation.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Follow-up schedules and post-treatment material" }, { "item_id": "N06", "question_type": "Evidence condition", "question": "What are the four arms in the 2×2 factorial trial?", "needed": "Factorial arrangement of metformin, nanocurcumin, combination and double placebo", "role": "Required", "role_reason": "Material on Factorial arrangement of metformin, nanocurcumin, combination and double placebo is needed to connect the relevant PCOS population, nanoformulation, factorial arm, HOMA-IR measurement/timepoint, main effect/interaction, denominator or harm scope.", "application_exception": "Arms, main effects and interactions within one factorial trial remain distinct. A combination-arm value is not transferred to a monotherapy main effect, and allocation ratios are not used to calculate group analysis counts. Scope is not extended to other formulations, weight/hormones, ovulation/fertility/pregnancy outcomes or overall safety.", "criterion": "Original records on Factorial arrangement of metformin, nanocurcumin, combination and double placebo must link to populations, products, factorial comparisons, denominators, HOMA-IR analyses and timepoints, distinguishing stored information from what remains unverified.", "basis": "Existing principles distinguish population, nanoformulation, dose/duration, factorial arms, main effects/interactions, measurement, denominators, support and harms in the retained PCOS HOMA-IR record.", "condition_origin": "These existing conditions are linked to the retained PCOS HOMA-IR question. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Group-specific interventions, factors and analysis specifications. This records needed materials; no new research was executed.", "current_reports": [ "S01" ], "existence": "The information comes from the stored summary and bibliography of a factorial-trial report. Existence/public availability, acquisition and actual reading of external papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain separately unverified.", "acquired_read": "The retained Korean and English summaries and bibliography were read. External papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain unread, with no access attempt.", "observation": "The original record lists metformin, nanocurcumin, combination and double placebo as the four arms. These are not counted as four independent trials.", "condition_status": "Partly verified", "status_reason": "Information 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 interventions, placebo matching and analysis-population definitions for each arm remain unverified.", "uncertainty": "Gaps remain in diagnosis, products, actual exposure, factorial treatments, measurement, main effects/interactions, intervals, denominators, missingness, support and harms. Original numbers, grades and historical verification wording do not constitute new calculation, reassessment or clinical validation.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Group-specific interventions, factors and analysis specifications" }, { "item_id": "N07", "question_type": "Evidence condition", "question": "What denominators do 200 people and 1:1:1:1 represent?", "needed": "Total 200 people, 4-arm allocation ratio and group-specific allocated/completed/analyzed counts", "role": "Required", "role_reason": "Material on Total 200 people, 4-arm allocation ratio and group-specific allocated/completed/analyzed counts is needed to connect the relevant PCOS population, nanoformulation, factorial arm, HOMA-IR measurement/timepoint, main effect/interaction, denominator or harm scope.", "application_exception": "Arms, main effects and interactions within one factorial trial remain distinct. A combination-arm value is not transferred to a monotherapy main effect, and allocation ratios are not used to calculate group analysis counts. Scope is not extended to other formulations, weight/hormones, ovulation/fertility/pregnancy outcomes or overall safety.", "criterion": "Original records on Total 200 people, 4-arm allocation ratio and group-specific allocated/completed/analyzed counts must link to populations, products, factorial comparisons, denominators, HOMA-IR analyses and timepoints, distinguishing stored information from what remains unverified.", "basis": "Existing principles distinguish population, nanoformulation, dose/duration, factorial arms, main effects/interactions, measurement, denominators, support and harms in the retained PCOS HOMA-IR record.", "condition_origin": "These existing conditions are linked to the retained PCOS HOMA-IR question. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Group flow, analysis populations and original HOMA-IR tables. This records needed materials; no new research was executed.", "current_reports": [ "S01" ], "existence": "The information comes from the stored summary and bibliography of a factorial-trial report. Existence/public availability, acquisition and actual reading of external papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain separately unverified.", "acquired_read": "The retained Korean and English summaries and bibliography were read. External papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain unread, with no access attempt.", "observation": "The retained sample description is 200 people, 4 arms allocated 1:1:1:1. Group-specific analysis counts are not calculated from the allocation ratio.", "condition_status": "Partly verified", "status_reason": "Information 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": "Group-specific allocation, completion and HOMA-IR analysis counts, and ITT denominators, remain unverified.", "uncertainty": "Gaps remain in diagnosis, products, actual exposure, factorial treatments, measurement, main effects/interactions, intervals, denominators, missingness, support and harms. Original numbers, grades and historical verification wording do not constitute new calculation, reassessment or clinical validation.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Group flow, analysis populations and original HOMA-IR tables" }, { "item_id": "N08", "question_type": "Evidence condition", "question": "What are the metformin dose and common treatments?", "needed": "Actual metformin-factor dose/administration, lifestyle care and concomitant medicines", "role": "Required", "role_reason": "Material on Actual metformin-factor dose/administration, lifestyle care and concomitant medicines is needed to connect the relevant PCOS population, nanoformulation, factorial arm, HOMA-IR measurement/timepoint, main effect/interaction, denominator or harm scope.", "application_exception": "Arms, main effects and interactions within one factorial trial remain distinct. A combination-arm value is not transferred to a monotherapy main effect, and allocation ratios are not used to calculate group analysis counts. Scope is not extended to other formulations, weight/hormones, ovulation/fertility/pregnancy outcomes or overall safety.", "criterion": "Original records on Actual metformin-factor dose/administration, lifestyle care and concomitant medicines must link to populations, products, factorial comparisons, denominators, HOMA-IR analyses and timepoints, distinguishing stored information from what remains unverified.", "basis": "Existing principles distinguish population, nanoformulation, dose/duration, factorial arms, main effects/interactions, measurement, denominators, support and harms in the retained PCOS HOMA-IR record.", "condition_origin": "These existing conditions are linked to the retained PCOS HOMA-IR question. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Metformin, lifestyle-care and concomitant-medicine records. This records needed materials; no new research was executed.", "current_reports": [ "S01" ], "existence": "The information comes from the stored summary and bibliography of a factorial-trial report. Existence/public availability, acquisition and actual reading of external papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain separately unverified.", "acquired_read": "The retained Korean and English summaries and bibliography were read. External papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain unread, with no access attempt.", "observation": "The retained record states that metformin factorial arms were included.", "condition_status": "Unverified", "status_reason": "Information 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": "Metformin doses/schedules, lifestyle care, other medicines and group-specific changes remain unverified.", "uncertainty": "Gaps remain in diagnosis, products, actual exposure, factorial treatments, measurement, main effects/interactions, intervals, denominators, missingness, support and harms. Original numbers, grades and historical verification wording do not constitute new calculation, reassessment or clinical validation.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Metformin, lifestyle-care and concomitant-medicine records" }, { "item_id": "N09", "question_type": "Evidence condition", "question": "What is the identity of the direct report?", "needed": "Feghhi report title, PMID, DOI and stored result", "role": "Required", "role_reason": "Material on Feghhi report title, PMID, DOI and stored result is needed to connect the relevant PCOS population, nanoformulation, factorial arm, HOMA-IR measurement/timepoint, main effect/interaction, denominator or harm scope.", "application_exception": "Arms, main effects and interactions within one factorial trial remain distinct. A combination-arm value is not transferred to a monotherapy main effect, and allocation ratios are not used to calculate group analysis counts. Scope is not extended to other formulations, weight/hormones, ovulation/fertility/pregnancy outcomes or overall safety.", "criterion": "Original records on Feghhi report title, PMID, DOI and stored result must link to populations, products, factorial comparisons, denominators, HOMA-IR analyses and timepoints, distinguishing stored information from what remains unverified.", "basis": "Existing principles distinguish population, nanoformulation, dose/duration, factorial arms, main effects/interactions, measurement, denominators, support and harms in the retained PCOS HOMA-IR record.", "condition_origin": "These existing conditions are linked to the retained PCOS HOMA-IR question. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Original paper and bibliographic records. This records needed materials; no new research was executed.", "current_reports": [ "S01" ], "existence": "The information comes from the stored summary and bibliography of a factorial-trial report. Existence/public availability, acquisition and actual reading of external papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain separately unverified.", "acquired_read": "The retained Korean and English summaries and bibliography were read. External papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain unread, with no access attempt.", "observation": "The stored bibliography records Feghhi 2024, PMID 39461199, DOI 10.1016/j.phymed.2024.156160.", "condition_status": "Partly verified", "status_reason": "Information 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": "Current external bibliography, original-paper files and full text remain unread in this work.", "uncertainty": "Gaps remain in diagnosis, products, actual exposure, factorial treatments, measurement, main effects/interactions, intervals, denominators, missingness, support and harms. Original numbers, grades and historical verification wording do not constitute new calculation, reassessment or clinical validation.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original paper and bibliographic records" }, { "item_id": "N10", "question_type": "Evidence condition", "question": "Are registration, protocol and SAP publicly available?", "needed": "Registration identifier, prespecification timing, study plans and factorial analysis plans", "role": "Required", "role_reason": "Material on Registration identifier, prespecification timing, study plans and factorial analysis plans is needed to connect the relevant PCOS population, nanoformulation, factorial arm, HOMA-IR measurement/timepoint, main effect/interaction, denominator or harm scope.", "application_exception": "Arms, main effects and interactions within one factorial trial remain distinct. A combination-arm value is not transferred to a monotherapy main effect, and allocation ratios are not used to calculate group analysis counts. Scope is not extended to other formulations, weight/hormones, ovulation/fertility/pregnancy outcomes or overall safety.", "criterion": "Original records on Registration identifier, prespecification timing, study plans and factorial analysis plans must link to populations, products, factorial comparisons, denominators, HOMA-IR analyses and timepoints, distinguishing stored information from what remains unverified.", "basis": "Existing principles distinguish population, nanoformulation, dose/duration, factorial arms, main effects/interactions, measurement, denominators, support and harms in the retained PCOS HOMA-IR record.", "condition_origin": "These existing conditions are linked to the retained PCOS HOMA-IR question. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Registration, protocol, SAP and amendments. This records needed materials; no new research was executed.", "current_reports": [ "S01" ], "existence": "The information comes from the stored summary and bibliography of a factorial-trial report. Existence/public availability, acquisition and actual reading of external papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain separately unverified.", "acquired_read": "The retained Korean and English summaries and bibliography were read. External papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain unread, with no access attempt.", "observation": "The retained trial-registration field says unverified; the citation has no registration identifier.", "condition_status": "Unverified", "status_reason": "Information 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 registration, prespecification timing, protocol, SAP and amendment history remain unread.", "uncertainty": "Gaps remain in diagnosis, products, actual exposure, factorial treatments, measurement, main effects/interactions, intervals, denominators, missingness, support and harms. Original numbers, grades and historical verification wording do not constitute new calculation, reassessment or clinical validation.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Registration, protocol, SAP and amendments" }, { "item_id": "N11", "question_type": "Evidence condition", "question": "What is the prespecified hierarchy of HOMA-IR?", "needed": "Prespecified endpoints, timepoints and analyses for HOMA-IR and other metabolic markers", "role": "Required", "role_reason": "Material on Prespecified endpoints, timepoints and analyses for HOMA-IR and other metabolic markers is needed to connect the relevant PCOS population, nanoformulation, factorial arm, HOMA-IR measurement/timepoint, main effect/interaction, denominator or harm scope.", "application_exception": "Arms, main effects and interactions within one factorial trial remain distinct. A combination-arm value is not transferred to a monotherapy main effect, and allocation ratios are not used to calculate group analysis counts. Scope is not extended to other formulations, weight/hormones, ovulation/fertility/pregnancy outcomes or overall safety.", "criterion": "Original records on Prespecified endpoints, timepoints and analyses for HOMA-IR and other metabolic markers must link to populations, products, factorial comparisons, denominators, HOMA-IR analyses and timepoints, distinguishing stored information from what remains unverified.", "basis": "Existing principles distinguish population, nanoformulation, dose/duration, factorial arms, main effects/interactions, measurement, denominators, support and harms in the retained PCOS HOMA-IR record.", "condition_origin": "These existing conditions are linked to the retained PCOS HOMA-IR question. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Endpoint hierarchy in registration, protocol and SAP. This records needed materials; no new research was executed.", "current_reports": [ "S01" ], "existence": "The information comes from the stored summary and bibliography of a factorial-trial report. Existence/public availability, acquisition and actual reading of external papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain separately unverified.", "acquired_read": "The retained Korean and English summaries and bibliography were read. External papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain unread, with no access attempt.", "observation": "The retained endpoint description is HOMA-IR and metabolic markers, with prespecified hierarchy unverified.", "condition_status": "Unverified", "status_reason": "Information 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": "Whether it was the single primary (1st) endpoint, multiplicity, analysis order and timepoint plans remain unverified.", "uncertainty": "Gaps remain in diagnosis, products, actual exposure, factorial treatments, measurement, main effects/interactions, intervals, denominators, missingness, support and harms. Original numbers, grades and historical verification wording do not constitute new calculation, reassessment or clinical validation.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Endpoint hierarchy in registration, protocol and SAP" }, { "item_id": "N12", "question_type": "Evidence condition", "question": "What are the randomization and concealment methods?", "needed": "2×2 factorial randomization, allocation concealment and recruitment flow", "role": "Required", "role_reason": "Material on 2×2 factorial randomization, allocation concealment and recruitment flow is needed to connect the relevant PCOS population, nanoformulation, factorial arm, HOMA-IR measurement/timepoint, main effect/interaction, denominator or harm scope.", "application_exception": "Arms, main effects and interactions within one factorial trial remain distinct. A combination-arm value is not transferred to a monotherapy main effect, and allocation ratios are not used to calculate group analysis counts. Scope is not extended to other formulations, weight/hormones, ovulation/fertility/pregnancy outcomes or overall safety.", "criterion": "Original records on 2×2 factorial randomization, allocation concealment and recruitment flow must link to populations, products, factorial comparisons, denominators, HOMA-IR analyses and timepoints, distinguishing stored information from what remains unverified.", "basis": "Existing principles distinguish population, nanoformulation, dose/duration, factorial arms, main effects/interactions, measurement, denominators, support and harms in the retained PCOS HOMA-IR record.", "condition_origin": "These existing conditions are linked to the retained PCOS HOMA-IR question. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Allocation, concealment and participant-flow material. This records needed materials; no new research was executed.", "current_reports": [ "S01" ], "existence": "The information comes from the stored summary and bibliography of a factorial-trial report. Existence/public availability, acquisition and actual reading of external papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain separately unverified.", "acquired_read": "The retained Korean and English summaries and bibliography were read. External papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain unread, with no access attempt.", "observation": "The retained design is a randomized double-blind placebo-controlled 2×2 factorial trial.", "condition_status": "Partly verified", "status_reason": "Information 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": "Sequence generation, concealment, stratification and factor-specific allocation methods remain incompletely verified.", "uncertainty": "Gaps remain in diagnosis, products, actual exposure, factorial treatments, measurement, main effects/interactions, intervals, denominators, missingness, support and harms. Original numbers, grades and historical verification wording do not constitute new calculation, reassessment or clinical validation.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Allocation, concealment and participant-flow material" }, { "item_id": "N13", "question_type": "Evidence condition", "question": "How were double blinding and double placebo implemented?", "needed": "Factor-specific placebos, appearance, blinded parties and maintenance", "role": "Required", "role_reason": "Material on Factor-specific placebos, appearance, blinded parties and maintenance is needed to connect the relevant PCOS population, nanoformulation, factorial arm, HOMA-IR measurement/timepoint, main effect/interaction, denominator or harm scope.", "application_exception": "Arms, main effects and interactions within one factorial trial remain distinct. A combination-arm value is not transferred to a monotherapy main effect, and allocation ratios are not used to calculate group analysis counts. Scope is not extended to other formulations, weight/hormones, ovulation/fertility/pregnancy outcomes or overall safety.", "criterion": "Original records on Factor-specific placebos, appearance, blinded parties and maintenance must link to populations, products, factorial comparisons, denominators, HOMA-IR analyses and timepoints, distinguishing stored information from what remains unverified.", "basis": "Existing principles distinguish population, nanoformulation, dose/duration, factorial arms, main effects/interactions, measurement, denominators, support and harms in the retained PCOS HOMA-IR record.", "condition_origin": "These existing conditions are linked to the retained PCOS HOMA-IR question. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Factor-specific placebo and blinding methods. This records needed materials; no new research was executed.", "current_reports": [ "S01" ], "existence": "The information comes from the stored summary and bibliography of a factorial-trial report. Existence/public availability, acquisition and actual reading of external papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain separately unverified.", "acquired_read": "The retained Korean and English summaries and bibliography were read. External papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain unread, with no access attempt.", "observation": "The original record describes double blinding and double placebo.", "condition_status": "Partly verified", "status_reason": "Information 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": "Placebo matching, participant/assessor blinding and unblinding for each factor remain incompletely verified.", "uncertainty": "Gaps remain in diagnosis, products, actual exposure, factorial treatments, measurement, main effects/interactions, intervals, denominators, missingness, support and harms. Original numbers, grades and historical verification wording do not constitute new calculation, reassessment or clinical validation.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Factor-specific placebo and blinding methods" }, { "item_id": "N14", "question_type": "Evidence condition", "question": "What is known about observation loss and ITT?", "needed": "Group completion, attrition, missing-data handling and ITT analysis", "role": "Required", "role_reason": "Material on Group completion, attrition, missing-data handling and ITT analysis is needed to connect the relevant PCOS population, nanoformulation, factorial arm, HOMA-IR measurement/timepoint, main effect/interaction, denominator or harm scope.", "application_exception": "Arms, main effects and interactions within one factorial trial remain distinct. A combination-arm value is not transferred to a monotherapy main effect, and allocation ratios are not used to calculate group analysis counts. Scope is not extended to other formulations, weight/hormones, ovulation/fertility/pregnancy outcomes or overall safety.", "criterion": "Original records on Group completion, attrition, missing-data handling and ITT analysis must link to populations, products, factorial comparisons, denominators, HOMA-IR analyses and timepoints, distinguishing stored information from what remains unverified.", "basis": "Existing principles distinguish population, nanoformulation, dose/duration, factorial arms, main effects/interactions, measurement, denominators, support and harms in the retained PCOS HOMA-IR record.", "condition_origin": "These existing conditions are linked to the retained PCOS HOMA-IR question. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Group flow, analysis populations and missing-data handling. This records needed materials; no new research was executed.", "current_reports": [ "S01" ], "existence": "The information comes from the stored summary and bibliography of a factorial-trial report. Existence/public availability, acquisition and actual reading of external papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain separately unverified.", "acquired_read": "The retained Korean and English summaries and bibliography were read. External papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain unread, with no access attempt.", "observation": "The retained record gives a total of 200 people and the allocation ratio.", "condition_status": "Unverified", "status_reason": "Information 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": "Completion, attrition, group analysis counts, missing-data handling, ITT and sensitivity analyses remain unverified.", "uncertainty": "Gaps remain in diagnosis, products, actual exposure, factorial treatments, measurement, main effects/interactions, intervals, denominators, missingness, support and harms. Original numbers, grades and historical verification wording do not constitute new calculation, reassessment or clinical validation.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Group flow, analysis populations and missing-data handling" }, { "item_id": "N15", "question_type": "Evidence condition", "question": "What is the HOMA-IR measurement arrangement?", "needed": "Measurement formula, fasting conditions, insulin/glucose assays, baseline and 12 weeks", "role": "Required", "role_reason": "Material on Measurement formula, fasting conditions, insulin/glucose assays, baseline and 12 weeks is needed to connect the relevant PCOS population, nanoformulation, factorial arm, HOMA-IR measurement/timepoint, main effect/interaction, denominator or harm scope.", "application_exception": "Arms, main effects and interactions within one factorial trial remain distinct. A combination-arm value is not transferred to a monotherapy main effect, and allocation ratios are not used to calculate group analysis counts. Scope is not extended to other formulations, weight/hormones, ovulation/fertility/pregnancy outcomes or overall safety.", "criterion": "Original records on Measurement formula, fasting conditions, insulin/glucose assays, baseline and 12 weeks must link to populations, products, factorial comparisons, denominators, HOMA-IR analyses and timepoints, distinguishing stored information from what remains unverified.", "basis": "Existing principles distinguish population, nanoformulation, dose/duration, factorial arms, main effects/interactions, measurement, denominators, support and harms in the retained PCOS HOMA-IR record.", "condition_origin": "These existing conditions are linked to the retained PCOS HOMA-IR question. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Measurement methods, assays, baseline values and result tables. This records needed materials; no new research was executed.", "current_reports": [ "S01" ], "existence": "The information comes from the stored summary and bibliography of a factorial-trial report. Existence/public availability, acquisition and actual reading of external papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain separately unverified.", "acquired_read": "The retained Korean and English summaries and bibliography were read. External papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain unread, with no access attempt.", "observation": "The selected endpoint is HOMA-IR change at 12 weeks.", "condition_status": "Partly verified", "status_reason": "Information 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": "Measurement formula, assays, fasting conditions, baseline values and result distributions remain unverified.", "uncertainty": "Gaps remain in diagnosis, products, actual exposure, factorial treatments, measurement, main effects/interactions, intervals, denominators, missingness, support and harms. Original numbers, grades and historical verification wording do not constitute new calculation, reassessment or clinical validation.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Measurement methods, assays, baseline values and result tables" }, { "item_id": "N16", "question_type": "Evidence condition", "question": "Which analysis underlies approximately −0.99 in the combination arm?", "needed": "Reference, comparator and denominator for combination-arm HOMA-IR approximately −0.99", "role": "Required", "role_reason": "Material on Reference, comparator and denominator for combination-arm HOMA-IR approximately −0.99 is needed to connect the relevant PCOS population, nanoformulation, factorial arm, HOMA-IR measurement/timepoint, main effect/interaction, denominator or harm scope.", "application_exception": "Arms, main effects and interactions within one factorial trial remain distinct. A combination-arm value is not transferred to a monotherapy main effect, and allocation ratios are not used to calculate group analysis counts. Scope is not extended to other formulations, weight/hormones, ovulation/fertility/pregnancy outcomes or overall safety.", "criterion": "Original records on Reference, comparator and denominator for combination-arm HOMA-IR approximately −0.99 must link to populations, products, factorial comparisons, denominators, HOMA-IR analyses and timepoints, distinguishing stored information from what remains unverified.", "basis": "Existing principles distinguish population, nanoformulation, dose/duration, factorial arms, main effects/interactions, measurement, denominators, support and harms in the retained PCOS HOMA-IR record.", "condition_origin": "These existing conditions are linked to the retained PCOS HOMA-IR question. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Original combination-arm result tables and analysis definitions. This records needed materials; no new research was executed.", "current_reports": [ "S01" ], "existence": "The information comes from the stored summary and bibliography of a factorial-trial report. Existence/public availability, acquisition and actual reading of external papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain separately unverified.", "acquired_read": "The retained Korean and English summaries and bibliography were read. External papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain unread, with no access attempt.", "observation": "The stored result records combination-arm HOMA-IR approximately −0.99. It remains a combination-arm value.", "condition_status": "Partly verified", "status_reason": "Information 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": "Whether it is a within-group change or between-group difference, its reference, adjustment, denominator and original table remain unverified.", "uncertainty": "Gaps remain in diagnosis, products, actual exposure, factorial treatments, measurement, main effects/interactions, intervals, denominators, missingness, support and harms. Original numbers, grades and historical verification wording do not constitute new calculation, reassessment or clinical validation.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original combination-arm result tables and analysis definitions" }, { "item_id": "N17", "question_type": "Evidence condition", "question": "What is the nanocurcumin-only arm comparison?", "needed": "Exact comparison between nanocurcumin-only and double-placebo arms", "role": "Required", "role_reason": "Material on Exact comparison between nanocurcumin-only and double-placebo arms is needed to connect the relevant PCOS population, nanoformulation, factorial arm, HOMA-IR measurement/timepoint, main effect/interaction, denominator or harm scope.", "application_exception": "Arms, main effects and interactions within one factorial trial remain distinct. A combination-arm value is not transferred to a monotherapy main effect, and allocation ratios are not used to calculate group analysis counts. Scope is not extended to other formulations, weight/hormones, ovulation/fertility/pregnancy outcomes or overall safety.", "criterion": "Original records on Exact comparison between nanocurcumin-only and double-placebo arms must link to populations, products, factorial comparisons, denominators, HOMA-IR analyses and timepoints, distinguishing stored information from what remains unverified.", "basis": "Existing principles distinguish population, nanoformulation, dose/duration, factorial arms, main effects/interactions, measurement, denominators, support and harms in the retained PCOS HOMA-IR record.", "condition_origin": "These existing conditions are linked to the retained PCOS HOMA-IR question. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Monotherapy-arm and double-placebo result tables. This records needed materials; no new research was executed.", "current_reports": [ "S01" ], "existence": "The information comes from the stored summary and bibliography of a factorial-trial report. Existence/public availability, acquisition and actual reading of external papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain separately unverified.", "acquired_read": "The retained Korean and English summaries and bibliography were read. External papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain unread, with no access attempt.", "observation": "The original record says the public abstract did not establish an exact isolated HOMA-IR estimate.", "condition_status": "Unverified", "status_reason": "Information 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": "Monotherapy group values/changes, estimates versus double placebo and intervals remain unverified.", "uncertainty": "Gaps remain in diagnosis, products, actual exposure, factorial treatments, measurement, main effects/interactions, intervals, denominators, missingness, support and harms. Original numbers, grades and historical verification wording do not constitute new calculation, reassessment or clinical validation.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Monotherapy-arm and double-placebo result tables" }, { "item_id": "N18", "question_type": "Evidence condition", "question": "Is the nanocurcumin main effect the same as a combination-arm value?", "needed": "Factorial marginal main effects, analysis models and exact estimates", "role": "Required", "role_reason": "Material on Factorial marginal main effects, analysis models and exact estimates is needed to connect the relevant PCOS population, nanoformulation, factorial arm, HOMA-IR measurement/timepoint, main effect/interaction, denominator or harm scope.", "application_exception": "Arms, main effects and interactions within one factorial trial remain distinct. A combination-arm value is not transferred to a monotherapy main effect, and allocation ratios are not used to calculate group analysis counts. Scope is not extended to other formulations, weight/hormones, ovulation/fertility/pregnancy outcomes or overall safety.", "criterion": "Original records on Factorial marginal main effects, analysis models and exact estimates must link to populations, products, factorial comparisons, denominators, HOMA-IR analyses and timepoints, distinguishing stored information from what remains unverified.", "basis": "Existing principles distinguish population, nanoformulation, dose/duration, factorial arms, main effects/interactions, measurement, denominators, support and harms in the retained PCOS HOMA-IR record.", "condition_origin": "These existing conditions are linked to the retained PCOS HOMA-IR question. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Original factorial main-effect tables, models and SAP. This records needed materials; no new research was executed.", "current_reports": [ "S01" ], "existence": "The information comes from the stored summary and bibliography of a factorial-trial report. Existence/public availability, acquisition and actual reading of external papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain separately unverified.", "acquired_read": "The retained Korean and English summaries and bibliography were read. External papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain unread, with no access attempt.", "observation": "The original record distinguishes the nanocurcumin main effect from the combination-arm result. Combination-arm approximately −0.99 is not transferred into an isolated main effect.", "condition_status": "Unverified", "status_reason": "Information 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": "Definition, model, exact difference and 95% CI for the nanocurcumin main effect remain unverified.", "uncertainty": "Gaps remain in diagnosis, products, actual exposure, factorial treatments, measurement, main effects/interactions, intervals, denominators, missingness, support and harms. Original numbers, grades and historical verification wording do not constitute new calculation, reassessment or clinical validation.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original factorial main-effect tables, models and SAP" }, { "item_id": "N19", "question_type": "Evidence condition", "question": "Are metformin main effects distinguished from nanocurcumin contribution?", "needed": "Separating metformin-factor effects from nanocurcumin effects", "role": "Required", "role_reason": "Material on Separating metformin-factor effects from nanocurcumin effects is needed to connect the relevant PCOS population, nanoformulation, factorial arm, HOMA-IR measurement/timepoint, main effect/interaction, denominator or harm scope.", "application_exception": "Arms, main effects and interactions within one factorial trial remain distinct. A combination-arm value is not transferred to a monotherapy main effect, and allocation ratios are not used to calculate group analysis counts. Scope is not extended to other formulations, weight/hormones, ovulation/fertility/pregnancy outcomes or overall safety.", "criterion": "Original records on Separating metformin-factor effects from nanocurcumin effects must link to populations, products, factorial comparisons, denominators, HOMA-IR analyses and timepoints, distinguishing stored information from what remains unverified.", "basis": "Existing principles distinguish population, nanoformulation, dose/duration, factorial arms, main effects/interactions, measurement, denominators, support and harms in the retained PCOS HOMA-IR record.", "condition_origin": "These existing conditions are linked to the retained PCOS HOMA-IR question. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Both-factor effect tables and analysis models. This records needed materials; no new research was executed.", "current_reports": [ "S01" ], "existence": "The information comes from the stored summary and bibliography of a factorial-trial report. Existence/public availability, acquisition and actual reading of external papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain separately unverified.", "acquired_read": "The retained Korean and English summaries and bibliography were read. External papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain unread, with no access attempt.", "observation": "The retained design switches each factor on and off independently.", "condition_status": "Unverified", "status_reason": "Information 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": "Exact estimates of each factor's main effect, adjustment, simple effects and independent contribution remain unverified.", "uncertainty": "Gaps remain in diagnosis, products, actual exposure, factorial treatments, measurement, main effects/interactions, intervals, denominators, missingness, support and harms. Original numbers, grades and historical verification wording do not constitute new calculation, reassessment or clinical validation.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Both-factor effect tables and analysis models" }, { "item_id": "N20", "question_type": "Evidence condition", "question": "Was interaction between the factors estimated?", "needed": "Metformin×nanocurcumin interaction tests and intervals", "role": "Required", "role_reason": "Material on Metformin×nanocurcumin interaction tests and intervals is needed to connect the relevant PCOS population, nanoformulation, factorial arm, HOMA-IR measurement/timepoint, main effect/interaction, denominator or harm scope.", "application_exception": "Arms, main effects and interactions within one factorial trial remain distinct. A combination-arm value is not transferred to a monotherapy main effect, and allocation ratios are not used to calculate group analysis counts. Scope is not extended to other formulations, weight/hormones, ovulation/fertility/pregnancy outcomes or overall safety.", "criterion": "Original records on Metformin×nanocurcumin interaction tests and intervals must link to populations, products, factorial comparisons, denominators, HOMA-IR analyses and timepoints, distinguishing stored information from what remains unverified.", "basis": "Existing principles distinguish population, nanoformulation, dose/duration, factorial arms, main effects/interactions, measurement, denominators, support and harms in the retained PCOS HOMA-IR record.", "condition_origin": "These existing conditions are linked to the retained PCOS HOMA-IR question. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Original interaction tables, tests and SAP. This records needed materials; no new research was executed.", "current_reports": [ "S01" ], "existence": "The information comes from the stored summary and bibliography of a factorial-trial report. Existence/public availability, acquisition and actual reading of external papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain separately unverified.", "acquired_read": "The retained Korean and English summaries and bibliography were read. External papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain unread, with no access attempt.", "observation": "The original record says main effects and interaction tests must be separated.", "condition_status": "Unverified", "status_reason": "Information 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": "Interaction definition, estimate, P value, 95% CI and power remain unverified. Interaction is not assumed to be 0.", "uncertainty": "Gaps remain in diagnosis, products, actual exposure, factorial treatments, measurement, main effects/interactions, intervals, denominators, missingness, support and harms. Original numbers, grades and historical verification wording do not constitute new calculation, reassessment or clinical validation.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original interaction tables, tests and SAP" }, { "item_id": "N21", "question_type": "Evidence condition", "question": "Are CIs available for main effects and interaction?", "needed": "95% CIs for each factor, the selected monotherapy comparison and interaction", "role": "Required", "role_reason": "Material on 95% CIs for each factor, the selected monotherapy comparison and interaction is needed to connect the relevant PCOS population, nanoformulation, factorial arm, HOMA-IR measurement/timepoint, main effect/interaction, denominator or harm scope.", "application_exception": "Arms, main effects and interactions within one factorial trial remain distinct. A combination-arm value is not transferred to a monotherapy main effect, and allocation ratios are not used to calculate group analysis counts. Scope is not extended to other formulations, weight/hormones, ovulation/fertility/pregnancy outcomes or overall safety.", "criterion": "Original records on 95% CIs for each factor, the selected monotherapy comparison and interaction must link to populations, products, factorial comparisons, denominators, HOMA-IR analyses and timepoints, distinguishing stored information from what remains unverified.", "basis": "Existing principles distinguish population, nanoformulation, dose/duration, factorial arms, main effects/interactions, measurement, denominators, support and harms in the retained PCOS HOMA-IR record.", "condition_origin": "These existing conditions are linked to the retained PCOS HOMA-IR question. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Factor-specific estimates, 95% CIs and model output. This records needed materials; no new research was executed.", "current_reports": [ "S01" ], "existence": "The information comes from the stored summary and bibliography of a factorial-trial report. Existence/public availability, acquisition and actual reading of external papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain separately unverified.", "acquired_read": "The retained Korean and English summaries and bibliography were read. External papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain unread, with no access attempt.", "observation": "The retained record leaves CIs for the nanocurcumin main effect and interaction unverified.", "condition_status": "Unverified", "status_reason": "Information 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": "Exact intervals, variation and covariance material are absent. A total of 200 people does not substitute for intervals.", "uncertainty": "Gaps remain in diagnosis, products, actual exposure, factorial treatments, measurement, main effects/interactions, intervals, denominators, missingness, support and harms. Original numbers, grades and historical verification wording do not constitute new calculation, reassessment or clinical validation.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Factor-specific estimates, 95% CIs and model output" }, { "item_id": "N22", "question_type": "Evidence condition", "question": "What are the P values, multiplicity and model choices?", "needed": "Exact factor-specific tests, multiple endpoints and analysis plans", "role": "Required", "role_reason": "Material on Exact factor-specific tests, multiple endpoints and analysis plans is needed to connect the relevant PCOS population, nanoformulation, factorial arm, HOMA-IR measurement/timepoint, main effect/interaction, denominator or harm scope.", "application_exception": "Arms, main effects and interactions within one factorial trial remain distinct. A combination-arm value is not transferred to a monotherapy main effect, and allocation ratios are not used to calculate group analysis counts. Scope is not extended to other formulations, weight/hormones, ovulation/fertility/pregnancy outcomes or overall safety.", "criterion": "Original records on Exact factor-specific tests, multiple endpoints and analysis plans must link to populations, products, factorial comparisons, denominators, HOMA-IR analyses and timepoints, distinguishing stored information from what remains unverified.", "basis": "Existing principles distinguish population, nanoformulation, dose/duration, factorial arms, main effects/interactions, measurement, denominators, support and harms in the retained PCOS HOMA-IR record.", "condition_origin": "These existing conditions are linked to the retained PCOS HOMA-IR question. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: SAP, all tests and analysis output. This records needed materials; no new research was executed.", "current_reports": [ "S01" ], "existence": "The information comes from the stored summary and bibliography of a factorial-trial report. Existence/public availability, acquisition and actual reading of external papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain separately unverified.", "acquired_read": "The retained Korean and English summaries and bibliography were read. External papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain unread, with no access attempt.", "observation": "The current summary retains a combination-benefit narrative while withholding exact monotherapy attribution.", "condition_status": "Unverified", "status_reason": "Information 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": "Factor-specific P values, multiplicity adjustment, model choices and adjustment variables remain unverified.", "uncertainty": "Gaps remain in diagnosis, products, actual exposure, factorial treatments, measurement, main effects/interactions, intervals, denominators, missingness, support and harms. Original numbers, grades and historical verification wording do not constitute new calculation, reassessment or clinical validation.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "SAP, all tests and analysis output" }, { "item_id": "N23", "question_type": "Evidence condition", "question": "Does HOMA-IR establish improvement in weight and hormones too?", "needed": "Separate results for metabolic markers, weight and hormones", "role": "Required", "role_reason": "Material on Separate results for metabolic markers, weight and hormones is needed to connect the relevant PCOS population, nanoformulation, factorial arm, HOMA-IR measurement/timepoint, main effect/interaction, denominator or harm scope.", "application_exception": "Arms, main effects and interactions within one factorial trial remain distinct. A combination-arm value is not transferred to a monotherapy main effect, and allocation ratios are not used to calculate group analysis counts. Scope is not extended to other formulations, weight/hormones, ovulation/fertility/pregnancy outcomes or overall safety.", "criterion": "Original records on Separate results for metabolic markers, weight and hormones must link to populations, products, factorial comparisons, denominators, HOMA-IR analyses and timepoints, distinguishing stored information from what remains unverified.", "basis": "Existing principles distinguish population, nanoformulation, dose/duration, factorial arms, main effects/interactions, measurement, denominators, support and harms in the retained PCOS HOMA-IR record.", "condition_origin": "These existing conditions are linked to the retained PCOS HOMA-IR question. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Endpoint-specific results and prespecified hierarchy. This records needed materials; no new research was executed.", "current_reports": [ "S01" ], "existence": "The information comes from the stored summary and bibliography of a factorial-trial report. Existence/public availability, acquisition and actual reading of external papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain separately unverified.", "acquired_read": "The retained Korean and English summaries and bibliography were read. External papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain unread, with no access attempt.", "observation": "The original record cautions against expanding combination-arm results into claims that nanocurcumin alone corrects insulin resistance, weight and hormones.", "condition_status": "Partly verified", "status_reason": "Information 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": "Exact separate effects, hierarchy and denominators for weight and hormones remain unverified.", "uncertainty": "Gaps remain in diagnosis, products, actual exposure, factorial treatments, measurement, main effects/interactions, intervals, denominators, missingness, support and harms. Original numbers, grades and historical verification wording do not constitute new calculation, reassessment or clinical validation.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Endpoint-specific results and prespecified hierarchy" }, { "item_id": "N24", "question_type": "Evidence condition", "question": "Is HOMA-IR change clinically important?", "needed": "Important differences in metabolic markers and long-term clinical outcomes", "role": "Required", "role_reason": "Material on Important differences in metabolic markers and long-term clinical outcomes is needed to connect the relevant PCOS population, nanoformulation, factorial arm, HOMA-IR measurement/timepoint, main effect/interaction, denominator or harm scope.", "application_exception": "Arms, main effects and interactions within one factorial trial remain distinct. A combination-arm value is not transferred to a monotherapy main effect, and allocation ratios are not used to calculate group analysis counts. Scope is not extended to other formulations, weight/hormones, ovulation/fertility/pregnancy outcomes or overall safety.", "criterion": "Original records on Important differences in metabolic markers and long-term clinical outcomes must link to populations, products, factorial comparisons, denominators, HOMA-IR analyses and timepoints, distinguishing stored information from what remains unverified.", "basis": "Existing principles distinguish population, nanoformulation, dose/duration, factorial arms, main effects/interactions, measurement, denominators, support and harms in the retained PCOS HOMA-IR record.", "condition_origin": "These existing conditions are linked to the retained PCOS HOMA-IR question. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Important-difference and clinical-outcome material. This records needed materials; no new research was executed.", "current_reports": [ "S01" ], "existence": "The information comes from the stored summary and bibliography of a factorial-trial report. Existence/public availability, acquisition and actual reading of external papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain separately unverified.", "acquired_read": "The retained Korean and English summaries and bibliography were read. External papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain unread, with no access attempt.", "observation": "The original record selects HOMA-IR and excludes pregnancy and fertility outcomes.", "condition_status": "Unverified", "status_reason": "Information 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": "Important differences and links to disease events, quality of life and long-term outcomes remain unverified.", "uncertainty": "Gaps remain in diagnosis, products, actual exposure, factorial treatments, measurement, main effects/interactions, intervals, denominators, missingness, support and harms. Original numbers, grades and historical verification wording do not constitute new calculation, reassessment or clinical validation.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Important-difference and clinical-outcome material" }, { "item_id": "N25", "question_type": "Evidence condition", "question": "What are the unique trial, endpoint and independent-replication units?", "needed": "Reporting relationships among one factorial trial, four arms and multiple outcomes", "role": "Required", "role_reason": "Material on Reporting relationships among one factorial trial, four arms and multiple outcomes is needed to connect the relevant PCOS population, nanoformulation, factorial arm, HOMA-IR measurement/timepoint, main effect/interaction, denominator or harm scope.", "application_exception": "Arms, main effects and interactions within one factorial trial remain distinct. A combination-arm value is not transferred to a monotherapy main effect, and allocation ratios are not used to calculate group analysis counts. Scope is not extended to other formulations, weight/hormones, ovulation/fertility/pregnancy outcomes or overall safety.", "criterion": "Original records on Reporting relationships among one factorial trial, four arms and multiple outcomes must link to populations, products, factorial comparisons, denominators, HOMA-IR analyses and timepoints, distinguishing stored information from what remains unverified.", "basis": "Existing principles distinguish population, nanoformulation, dose/duration, factorial arms, main effects/interactions, measurement, denominators, support and harms in the retained PCOS HOMA-IR record.", "condition_origin": "These existing conditions are linked to the retained PCOS HOMA-IR question. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Report-to-trial, factor and endpoint links. This records needed materials; no new research was executed.", "current_reports": [ "S01" ], "existence": "The information comes from the stored summary and bibliography of a factorial-trial report. Existence/public availability, acquisition and actual reading of external papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain separately unverified.", "acquired_read": "The retained Korean and English summaries and bibliography were read. External papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain unread, with no access attempt.", "observation": "The current evidence and citation describe one direct factorial-trial report. Four arms and multiple metabolic markers are not added as independent replications.", "condition_status": "Unverified", "status_reason": "Information 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": "Unique-trial/participant totals and independent-replication counts for the same formulation remain unverified.", "uncertainty": "Gaps remain in diagnosis, products, actual exposure, factorial treatments, measurement, main effects/interactions, intervals, denominators, missingness, support and harms. Original numbers, grades and historical verification wording do not constitute new calculation, reassessment or clinical validation.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Report-to-trial, factor and endpoint links" }, { "item_id": "N26", "question_type": "Evidence condition", "question": "What funding information is retained?", "needed": "Distinguishing funding sources/research roles from a no-conflict declaration", "role": "Required", "role_reason": "Material on Distinguishing funding sources/research roles from a no-conflict declaration is needed to connect the relevant PCOS population, nanoformulation, factorial arm, HOMA-IR measurement/timepoint, main effect/interaction, denominator or harm scope.", "application_exception": "Arms, main effects and interactions within one factorial trial remain distinct. A combination-arm value is not transferred to a monotherapy main effect, and allocation ratios are not used to calculate group analysis counts. Scope is not extended to other formulations, weight/hormones, ovulation/fertility/pregnancy outcomes or overall safety.", "criterion": "Original records on Distinguishing funding sources/research roles from a no-conflict declaration must link to populations, products, factorial comparisons, denominators, HOMA-IR analyses and timepoints, distinguishing stored information from what remains unverified.", "basis": "Existing principles distinguish population, nanoformulation, dose/duration, factorial arms, main effects/interactions, measurement, denominators, support and harms in the retained PCOS HOMA-IR record.", "condition_origin": "These existing conditions are linked to the retained PCOS HOMA-IR question. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Original funding and institutional-role disclosures. This records needed materials; no new research was executed.", "current_reports": [ "S01" ], "existence": "The information comes from the stored summary and bibliography of a factorial-trial report. Existence/public availability, acquisition and actual reading of external papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain separately unverified.", "acquired_read": "The retained Korean and English summaries and bibliography were read. External papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain unread, with no access attempt.", "observation": "The retained funding description reports an author declaration of no conflicts, with funding details unverified.", "condition_status": "Unverified", "status_reason": "Information 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": "Funding sources, contracts and roles in design, analysis and publication remain unverified.", "uncertainty": "Gaps remain in diagnosis, products, actual exposure, factorial treatments, measurement, main effects/interactions, intervals, denominators, missingness, support and harms. Original numbers, grades and historical verification wording do not constitute new calculation, reassessment or clinical validation.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original funding and institutional-role disclosures" }, { "item_id": "N27", "question_type": "Evidence condition", "question": "Are product provision, manufacturer roles, employee authors and COI distinguished?", "needed": "Individual records on product support, employment, manufacturer roles and declared COI", "role": "Required", "role_reason": "Material on Individual records on product support, employment, manufacturer roles and declared COI is needed to connect the relevant PCOS population, nanoformulation, factorial arm, HOMA-IR measurement/timepoint, main effect/interaction, denominator or harm scope.", "application_exception": "Arms, main effects and interactions within one factorial trial remain distinct. A combination-arm value is not transferred to a monotherapy main effect, and allocation ratios are not used to calculate group analysis counts. Scope is not extended to other formulations, weight/hormones, ovulation/fertility/pregnancy outcomes or overall safety.", "criterion": "Original records on Individual records on product support, employment, manufacturer roles and declared COI must link to populations, products, factorial comparisons, denominators, HOMA-IR analyses and timepoints, distinguishing stored information from what remains unverified.", "basis": "Existing principles distinguish population, nanoformulation, dose/duration, factorial arms, main effects/interactions, measurement, denominators, support and harms in the retained PCOS HOMA-IR record.", "condition_origin": "These existing conditions are linked to the retained PCOS HOMA-IR question. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Original product-support, author-affiliation and COI disclosures. This records needed materials; no new research was executed.", "current_reports": [ "S01" ], "existence": "The information comes from the stored summary and bibliography of a factorial-trial report. Existence/public availability, acquisition and actual reading of external papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain separately unverified.", "acquired_read": "The retained Korean and English summaries and bibliography were read. External papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain unread, with no access attempt.", "observation": "The reported no-conflict wording is retained. It does not establish absence of all product support or employee authors.", "condition_status": "Unverified", "status_reason": "Information 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": "Product provision, manufacturer involvement, author employment and individual COI remain incompletely verified.", "uncertainty": "Gaps remain in diagnosis, products, actual exposure, factorial treatments, measurement, main effects/interactions, intervals, denominators, missingness, support and harms. Original numbers, grades and historical verification wording do not constitute new calculation, reassessment or clinical validation.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original product-support, author-affiliation and COI disclosures" }, { "item_id": "N28", "question_type": "Evidence condition", "question": "How were harms in monotherapy and combination arms collected?", "needed": "Four-arm adverse-event definitions, collection, events and exposure denominators", "role": "Supplementary", "role_reason": "Material on Four-arm adverse-event definitions, collection, events and exposure denominators is needed to connect the relevant PCOS population, nanoformulation, factorial arm, HOMA-IR measurement/timepoint, main effect/interaction, denominator or harm scope.", "application_exception": "Arms, main effects and interactions within one factorial trial remain distinct. A combination-arm value is not transferred to a monotherapy main effect, and allocation ratios are not used to calculate group analysis counts. Scope is not extended to other formulations, weight/hormones, ovulation/fertility/pregnancy outcomes or overall safety.", "criterion": "Original records on Four-arm adverse-event definitions, collection, events and exposure denominators must link to populations, products, factorial comparisons, denominators, HOMA-IR analyses and timepoints, distinguishing stored information from what remains unverified.", "basis": "Existing principles distinguish population, nanoformulation, dose/duration, factorial arms, main effects/interactions, measurement, denominators, support and harms in the retained PCOS HOMA-IR record.", "condition_origin": "These existing conditions are linked to the retained PCOS HOMA-IR question. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Group adverse events, concomitant medicines and exposure denominators. This records needed materials; no new research was executed.", "current_reports": [ "S01" ], "existence": "The information comes from the stored summary and bibliography of a factorial-trial report. Existence/public availability, acquisition and actual reading of external papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain separately unverified.", "acquired_read": "The retained Korean and English summaries and bibliography were read. External papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain unread, with no access attempt.", "observation": "The retained safety wording calls for gastrointestinal and glycemic clinical monitoring during metformin co-treatment.", "condition_status": "Unverified", "status_reason": "Information 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": "Event definitions, collection, occurrence counts and exposure/follow-up denominators across the four arms remain unverified.", "uncertainty": "Gaps remain in diagnosis, products, actual exposure, factorial treatments, measurement, main effects/interactions, intervals, denominators, missingness, support and harms. Original numbers, grades and historical verification wording do not constitute new calculation, reassessment or clinical validation.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Group adverse events, concomitant medicines and exposure denominators" }, { "item_id": "N29", "question_type": "Evidence condition", "question": "Is safety during pregnancy and pregnancy planning known?", "needed": "Nanocurcumin exposure during pregnancy, pregnancy planning and vulnerable populations", "role": "Supplementary", "role_reason": "Material on Nanocurcumin exposure during pregnancy, pregnancy planning and vulnerable populations is needed to connect the relevant PCOS population, nanoformulation, factorial arm, HOMA-IR measurement/timepoint, main effect/interaction, denominator or harm scope.", "application_exception": "Arms, main effects and interactions within one factorial trial remain distinct. A combination-arm value is not transferred to a monotherapy main effect, and allocation ratios are not used to calculate group analysis counts. Scope is not extended to other formulations, weight/hormones, ovulation/fertility/pregnancy outcomes or overall safety.", "criterion": "Original records on Nanocurcumin exposure during pregnancy, pregnancy planning and vulnerable populations must link to populations, products, factorial comparisons, denominators, HOMA-IR analyses and timepoints, distinguishing stored information from what remains unverified.", "basis": "Existing principles distinguish population, nanoformulation, dose/duration, factorial arms, main effects/interactions, measurement, denominators, support and harms in the retained PCOS HOMA-IR record.", "condition_origin": "These existing conditions are linked to the retained PCOS HOMA-IR question. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Pregnancy exposure, reproductive-safety and follow-up material. This records needed materials; no new research was executed.", "current_reports": [ "S01" ], "existence": "The information comes from the stored summary and bibliography of a factorial-trial report. Existence/public availability, acquisition and actual reading of external papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain separately unverified.", "acquired_read": "The retained Korean and English summaries and bibliography were read. External papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain unread, with no access attempt.", "observation": "The original record says safety of nanocurcumin supplementation during pregnancy is not established.", "condition_status": "Unverified", "status_reason": "Information 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 pregnancy exposure/planning, fetal/maternal outcomes and vulnerable populations remains unverified.", "uncertainty": "Gaps remain in diagnosis, products, actual exposure, factorial treatments, measurement, main effects/interactions, intervals, denominators, missingness, support and harms. Original numbers, grades and historical verification wording do not constitute new calculation, reassessment or clinical validation.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Pregnancy exposure, reproductive-safety and follow-up material" }, { "item_id": "N30", "question_type": "Evidence condition", "question": "Are ovulation, fertility and pregnancy outcomes the same as HOMA-IR?", "needed": "Separate questions on ovulation, fertility and pregnancy outcomes", "role": "Required", "role_reason": "Material on Separate questions on ovulation, fertility and pregnancy outcomes is needed to connect the relevant PCOS population, nanoformulation, factorial arm, HOMA-IR measurement/timepoint, main effect/interaction, denominator or harm scope.", "application_exception": "Arms, main effects and interactions within one factorial trial remain distinct. A combination-arm value is not transferred to a monotherapy main effect, and allocation ratios are not used to calculate group analysis counts. Scope is not extended to other formulations, weight/hormones, ovulation/fertility/pregnancy outcomes or overall safety.", "criterion": "Original records on Separate questions on ovulation, fertility and pregnancy outcomes must link to populations, products, factorial comparisons, denominators, HOMA-IR analyses and timepoints, distinguishing stored information from what remains unverified.", "basis": "Existing principles distinguish population, nanoformulation, dose/duration, factorial arms, main effects/interactions, measurement, denominators, support and harms in the retained PCOS HOMA-IR record.", "condition_origin": "These existing conditions are linked to the retained PCOS HOMA-IR question. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Ovulation, fertility and pregnancy-outcome material. This records needed materials; no new research was executed.", "current_reports": [ "S01" ], "existence": "The information comes from the stored summary and bibliography of a factorial-trial report. Existence/public availability, acquisition and actual reading of external papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain separately unverified.", "acquired_read": "The retained Korean and English summaries and bibliography were read. External papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain unread, with no access attempt.", "observation": "The original record excludes pregnancy planning, ovulation and fertility outcomes from this HOMA-IR verdict.", "condition_status": "Unverified", "status_reason": "Information 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 estimates, denominators and timepoints for these clinical outcomes remain unverified.", "uncertainty": "Gaps remain in diagnosis, products, actual exposure, factorial treatments, measurement, main effects/interactions, intervals, denominators, missingness, support and harms. Original numbers, grades and historical verification wording do not constitute new calculation, reassessment or clinical validation.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Ovulation, fertility and pregnancy-outcome material" }, { "item_id": "N31", "question_type": "Evidence condition", "question": "Can findings extend to other curcumin products or monotherapy?", "needed": "Distinguishing nano soft-gels from conventional, phytosomal or combination products and combination-arm results", "role": "Required", "role_reason": "Material on Distinguishing nano soft-gels from conventional, phytosomal or combination products and combination-arm results is needed to connect the relevant PCOS population, nanoformulation, factorial arm, HOMA-IR measurement/timepoint, main effect/interaction, denominator or harm scope.", "application_exception": "Arms, main effects and interactions within one factorial trial remain distinct. A combination-arm value is not transferred to a monotherapy main effect, and allocation ratios are not used to calculate group analysis counts. Scope is not extended to other formulations, weight/hormones, ovulation/fertility/pregnancy outcomes or overall safety.", "criterion": "Original records on Distinguishing nano soft-gels from conventional, phytosomal or combination products and combination-arm results must link to populations, products, factorial comparisons, denominators, HOMA-IR analyses and timepoints, distinguishing stored information from what remains unverified.", "basis": "Existing principles distinguish population, nanoformulation, dose/duration, factorial arms, main effects/interactions, measurement, denominators, support and harms in the retained PCOS HOMA-IR record.", "condition_origin": "These existing conditions are linked to the retained PCOS HOMA-IR question. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Direct formulation-specific and monotherapy comparisons. This records needed materials; no new research was executed.", "current_reports": [ "S01" ], "existence": "The information comes from the stored summary and bibliography of a factorial-trial report. Existence/public availability, acquisition and actual reading of external papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain separately unverified.", "acquired_read": "The retained Korean and English summaries and bibliography were read. External papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain unread, with no access attempt.", "observation": "The original record limits interchangeability across formulations and transfer of combination-arm results to monotherapy.", "condition_status": "Partly verified", "status_reason": "Information 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": "Identical effects of other products/formulations or monotherapy remain unverified.", "uncertainty": "Gaps remain in diagnosis, products, actual exposure, factorial treatments, measurement, main effects/interactions, intervals, denominators, missingness, support and harms. Original numbers, grades and historical verification wording do not constitute new calculation, reassessment or clinical validation.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Direct formulation-specific and monotherapy comparisons" }, { "item_id": "N32", "question_type": "Evidence condition", "question": "What are the current Korean/English records and historical English correction?", "needed": "Current English wording, generic evidence wording and correction of 1 field on 2026-09-14", "role": "Required", "role_reason": "Material on Current English wording, generic evidence wording and correction of 1 field on 2026-09-14 is needed to connect the relevant PCOS population, nanoformulation, factorial arm, HOMA-IR measurement/timepoint, main effect/interaction, denominator or harm scope.", "application_exception": "Arms, main effects and interactions within one factorial trial remain distinct. A combination-arm value is not transferred to a monotherapy main effect, and allocation ratios are not used to calculate group analysis counts. Scope is not extended to other formulations, weight/hormones, ovulation/fertility/pregnancy outcomes or overall safety.", "criterion": "Original records on Current English wording, generic evidence wording and correction of 1 field on 2026-09-14 must link to populations, products, factorial comparisons, denominators, HOMA-IR analyses and timepoints, distinguishing stored information from what remains unverified.", "basis": "Existing principles distinguish population, nanoformulation, dose/duration, factorial arms, main effects/interactions, measurement, denominators, support and harms in the retained PCOS HOMA-IR record.", "condition_origin": "These existing conditions are linked to the retained PCOS HOMA-IR question. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Before/after-correction and language-alignment material. This records needed materials; no new research was executed.", "current_reports": [ "S01" ], "existence": "The information comes from the stored summary and bibliography of a factorial-trial report. Existence/public availability, acquisition and actual reading of external papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain separately unverified.", "acquired_read": "The retained Korean and English summaries and bibliography were read. External papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain unread, with no access attempt.", "observation": "The current English record distinguishes combination arms, main effects and interaction. The correction of 1 English field is retained as an original event.", "condition_status": "Partly verified", "status_reason": "Information 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": "Historical before/after English wording and full-text alignment of individual numerical values remain unread.", "uncertainty": "Gaps remain in diagnosis, products, actual exposure, factorial treatments, measurement, main effects/interactions, intervals, denominators, missingness, support and harms. Original numbers, grades and historical verification wording do not constitute new calculation, reassessment or clinical validation.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Before/after-correction and language-alignment material" }, { "item_id": "N33", "question_type": "Evidence condition", "question": "How are C/54, original axes and historical cross-checking retained?", "needed": "Original C/54, EX/CX, all axes and historical verification wording", "role": "Required", "role_reason": "Material on Original C/54, EX/CX, all axes and historical verification wording is needed to connect the relevant PCOS population, nanoformulation, factorial arm, HOMA-IR measurement/timepoint, main effect/interaction, denominator or harm scope.", "application_exception": "Arms, main effects and interactions within one factorial trial remain distinct. A combination-arm value is not transferred to a monotherapy main effect, and allocation ratios are not used to calculate group analysis counts. Scope is not extended to other formulations, weight/hormones, ovulation/fertility/pregnancy outcomes or overall safety.", "criterion": "Original records on Original C/54, EX/CX, all axes and historical verification wording must link to populations, products, factorial comparisons, denominators, HOMA-IR analyses and timepoints, distinguishing stored information from what remains unverified.", "basis": "Existing principles distinguish population, nanoformulation, dose/duration, factorial arms, main effects/interactions, measurement, denominators, support and harms in the retained PCOS HOMA-IR record.", "condition_origin": "These existing conditions are linked to the retained PCOS HOMA-IR question. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Review comments and future correction material. This records needed materials; no new research was executed.", "current_reports": [ "S01" ], "existence": "The information comes from the stored summary and bibliography of a factorial-trial report. Existence/public availability, acquisition and actual reading of external papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain separately unverified.", "acquired_read": "The retained Korean and English summaries and bibliography were read. External papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain unread, with no access attempt.", "observation": "The original C/54, all axes and historical cross-checking are historical values. They are not inherited as completed current content review or fulfilled conditions.", "condition_status": "Partly verified", "status_reason": "Information 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": "Completed content review is not recorded in the retained material.", "uncertainty": "Gaps remain in diagnosis, products, actual exposure, factorial treatments, measurement, main effects/interactions, intervals, denominators, missingness, support and harms. Original numbers, grades and historical verification wording do not constitute new calculation, reassessment or clinical validation.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Review comments and future correction material" }, { "item_id": "N34", "question_type": "Evidence condition", "question": "What are the original dates, blank fields and actual reading scope?", "needed": "Original verdict date, correction date, blank original fields and external unread status", "role": "Required", "role_reason": "Material on Original verdict date, correction date, blank original fields and external unread status is needed to connect the relevant PCOS population, nanoformulation, factorial arm, HOMA-IR measurement/timepoint, main effect/interaction, denominator or harm scope.", "application_exception": "Arms, main effects and interactions within one factorial trial remain distinct. A combination-arm value is not transferred to a monotherapy main effect, and allocation ratios are not used to calculate group analysis counts. Scope is not extended to other formulations, weight/hormones, ovulation/fertility/pregnancy outcomes or overall safety.", "criterion": "Original records on Original verdict date, correction date, blank original fields and external unread status must link to populations, products, factorial comparisons, denominators, HOMA-IR analyses and timepoints, distinguishing stored information from what remains unverified.", "basis": "Existing principles distinguish population, nanoformulation, dose/duration, factorial arms, main effects/interactions, measurement, denominators, support and harms in the retained PCOS HOMA-IR record.", "condition_origin": "These existing conditions are linked to the retained PCOS HOMA-IR question. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Needed original material and factorial analysis plans when provided. This records needed materials; no new research was executed.", "current_reports": [ "S01" ], "existence": "The information comes from the stored summary and bibliography of a factorial-trial report. Existence/public availability, acquisition and actual reading of external papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain separately unverified.", "acquired_read": "The retained Korean and English summaries and bibliography were read. External papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain unread, with no access attempt.", "observation": "The full retained record was used for preparation. Original verdict date 2026-09-08, correction date 2026-09-14, absence of additional selected questions and a blank additional-deliberation value remain preserved.", "condition_status": "Partly verified", "status_reason": "Information 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 texts, registration, protocols and SAPs remain unread, with no access attempt.", "uncertainty": "Gaps remain in diagnosis, products, actual exposure, factorial treatments, measurement, main effects/interactions, intervals, denominators, missingness, support and harms. Original numbers, grades and historical verification wording do not constitute new calculation, reassessment or clinical validation.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Needed original material and factorial analysis plans when provided" } ], "reports": [ { "report_id": "S01", "title": "2024 · Factorial trial of metformin and nanocurcumin in women with PCOS", "url": "https://pubmed.ncbi.nlm.nih.gov/39461199/", "report_type": "Stored description of a randomized double-blind placebo-controlled 2×2 factorial trial; external methods and original result tables remain unread", "existence": "The information comes from the stored summary and bibliography of a factorial-trial report. Existence/public availability, acquisition and actual reading of external papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain separately unverified.", "acquired_read": "Stored summary read; external material unread", "study_family": "TF3041-01", "independent_replication": null, "observed_result": "Combination-arm HOMA-IR approximately −0.99 reported; CIs for nanocurcumin main effect and interaction unverified", "result_level": "This is retained combination-arm result wording. Within/between-group comparison type, denominator, adjustment and interval remain unverified; it is not relabeled as a monotherapy-arm, factorial main-effect or interaction estimate.", "source_evidence_date": "2026-09-08", "materials": [ { "material_type": "Stored existing trial summary", "public_status": "Existing stored summary acquired", "access_status": "Stored summary", "acquired": true, "actually_read": "Stored summary read", "as_of": "2026-09-08", "qualification": "The stored report/citation summary was read. This does not record possession or abstract/full-text reading of the external original paper. Only the stored summary and bibliography were read. External papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain unread. URLs and historical abstract narratives alone do not certify existence/public availability, accessibility, acquisition, reading, fulfilled conditions or independence. Each material date of 2026-09-08 is a retained historical evidence date. It is not an actual external-reading date and remains distinct from stored-material production on 2026-10-06 and actual completed content review. The actual completed-review date is unrecorded." }, { "material_type": "External paper · Abstract/full text unread", "public_status": "Original bibliography link only; external content unread", "access_status": "Unread; no access attempt", "acquired": false, "actually_read": "Unread", "as_of": "2026-09-08", "qualification": "Only the original PubMed URL is linked. Separate acquisition/reading of abstracts and full texts is not recorded; actual accessibility and identity verification remain incomplete. Only the stored summary and bibliography were read. External papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain unread. URLs and historical abstract narratives alone do not certify existence/public availability, accessibility, acquisition, reading, fulfilled conditions or independence. Each material date of 2026-09-08 is a retained historical evidence date. It is not an actual external-reading date and remains distinct from stored-material production on 2026-10-06 and actual completed content review. The actual completed-review date is unrecorded." }, { "material_type": "Trial registration and amendments", "public_status": "Needed material; existence and public availability unverified", "access_status": "Unread; no access attempt", "acquired": false, "actually_read": "Unread", "as_of": "2026-09-08", "qualification": "Actual registration identifiers, contents, prespecification timing and amendments remain unverified. Prespecification is not certified. Only the stored summary and bibliography were read. External papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain unread. URLs and historical abstract narratives alone do not certify existence/public availability, accessibility, acquisition, reading, fulfilled conditions or independence. Each material date of 2026-09-08 is a retained historical evidence date. It is not an actual external-reading date and remains distinct from stored-material production on 2026-10-06 and actual completed content review. The actual completed-review date is unrecorded." }, { "material_type": "Study protocol", "public_status": "Needed material; existence and public availability unverified", "access_status": "Unread; no access attempt", "acquired": false, "actually_read": "Unread", "as_of": "2026-09-08", "qualification": "Original study plans, factorial arms, endpoint hierarchy, timepoints and amendment rules remain unread. Only the stored summary and bibliography were read. External papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain unread. URLs and historical abstract narratives alone do not certify existence/public availability, accessibility, acquisition, reading, fulfilled conditions or independence. Each material date of 2026-09-08 is a retained historical evidence date. It is not an actual external-reading date and remains distinct from stored-material production on 2026-10-06 and actual completed content review. The actual completed-review date is unrecorded." }, { "material_type": "Statistical analysis plan", "public_status": "Needed material; existence and public availability unverified", "access_status": "Unread; no access attempt", "acquired": false, "actually_read": "Unread", "as_of": "2026-09-08", "qualification": "Original analysis plans for factorial main effects, interactions, multiplicity, adjustment and ITT/missing-data handling remain unread. Only the stored summary and bibliography were read. External papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain unread. URLs and historical abstract narratives alone do not certify existence/public availability, accessibility, acquisition, reading, fulfilled conditions or independence. Each material date of 2026-09-08 is a retained historical evidence date. It is not an actual external-reading date and remains distinct from stored-material production on 2026-10-06 and actual completed content review. The actual completed-review date is unrecorded." }, { "material_type": "Original funding, product-support, employee-authorship and COI disclosures", "public_status": "Needed material; existence and public availability unverified", "access_status": "Unread; no access attempt", "acquired": false, "actually_read": "Unread", "as_of": "2026-09-08", "qualification": "Original funding, product provision, author employment, manufacturer roles and individual COI disclosures remain unread. A no-conflict narrative does not certify absence of support or independence. Only the stored summary and bibliography were read. External papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain unread. URLs and historical abstract narratives alone do not certify existence/public availability, accessibility, acquisition, reading, fulfilled conditions or independence. Each material date of 2026-09-08 is a retained historical evidence date. It is not an actual external-reading date and remains distinct from stored-material production on 2026-10-06 and actual completed content review. The actual completed-review date is unrecorded." } ], "links": [ { "label": "PubMed", "url": "https://pubmed.ncbi.nlm.nih.gov/39461199/" } ] } ], "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": "One report of a 200-person, 4-arm, 2×2 factorial trial remains distinct from nanocurcumin, metformin, combination and double-placebo arms. Arms, metabolic markers and main effects/interactions are not added as independent trials or replications; final unique-trial, participant and independent-replication counts remain unverified." }, "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" }