# Nanocurcumin 80 mg three times daily × Improvement of HOMA-IR in polycystic ovary syndrome

Verdict 3041 · Evidence Check

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

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

## Assessment scope

- Population: The 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.
- Ingredient, formulation and route: 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.
- Measured outcome: 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.
- Questions outside this scope: 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.

## Checklist items

### N01 · Which PCOS HOMA-IR question is presented?

Verification status: Partly verified  
Reading scope: 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.

- Current findings: The original claim concerns HOMA-IR improvement in polycystic ovary syndrome. A combination-arm result is not transferred to a nanocurcumin-only main effect.
- Why unverified: 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.
- Reason for missing information: Exact HOMA-IR effects for the monotherapy main effect and interaction remain unverified.
- Required materials and conditions: Nanocurcumin HOMA-IR and attribution to monotherapy/combination in a factorial trial
- Materials to obtain first: Factorial analysis plans, group results, main effects and interaction tables
- Further research: Material needed: Factorial analysis plans, group results, main effects and interaction tables. This records needed materials; no new research was executed.
- Conditions for verification: 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.
- Why this condition is needed: 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 exceptions: 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.
- Remaining 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.
- Referenced methods: Existing principles distinguish population, nanoformulation, dose/duration, factorial arms, main effects/interactions, measurement, denominators, support and harms in the retained PCOS HOMA-IR record.
- Related sources: S01

### N02 · What are the diagnostic and baseline conditions of the PCOS population?

Verification status: Partly verified  
Reading scope: 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.

- Current findings: The retained population is 200 women with PCOS, with diagnostic details described as governed by the full paper.
- Why unverified: 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.
- Reason for missing information: Diagnostic criteria, phenotypes, baseline insulin resistance, recruitment and exclusion criteria remain unverified.
- Required materials and conditions: PCOS diagnosis, age, baseline metabolism, recruitment and exclusion criteria
- Materials to obtain first: Eligibility, diagnosis and baseline-characteristic tables
- Further research: Material needed: Eligibility, diagnosis and baseline-characteristic tables. This records needed materials; no new research was executed.
- Conditions for verification: 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.
- Why this condition is needed: 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 exceptions: 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.
- Remaining 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.
- Referenced methods: Existing principles distinguish population, nanoformulation, dose/duration, factorial arms, main effects/interactions, measurement, denominators, support and harms in the retained PCOS HOMA-IR record.
- Related sources: S01

### N03 · Which nanocurcumin formulation is involved?

Verification status: Partly verified  
Reading scope: 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.

- Current findings: The retained formulation is a soft-gel containing nanoformulated curcumin derived from Curcuma longa.
- Why unverified: 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.
- Reason for missing information: Product names, batches, particle characteristics, active-ingredient quantification and manufacturing conditions remain unverified.
- Required materials and conditions: Distinguishing nanocurcumin soft-gels from other curcumin delivery formulations
- Materials to obtain first: Product, batch, nano-characteristic and quantification material
- Further research: Material needed: Product, batch, nano-characteristic and quantification material. This records needed materials; no new research was executed.
- Conditions for verification: 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.
- Why this condition is needed: 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 exceptions: 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.
- Remaining 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.
- Referenced methods: Existing principles distinguish population, nanoformulation, dose/duration, factorial arms, main effects/interactions, measurement, denominators, support and harms in the retained PCOS HOMA-IR record.
- Related sources: S01

### N04 · What are the oral dose and dosing interval?

Verification status: Partly verified  
Reading scope: 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.

- Current findings: The retained scope states 80 mg every 8 hours, totaling 240 mg/day; the Korean ingredient description retains 80 mg 3 times daily.
- Why unverified: 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.
- Reason for missing information: Actual dosing, adherence, dose changes and exposure quantification remain unverified.
- Required materials and conditions: Actual administration of 80 mg every 8 hours, totaling 240 mg/day
- Materials to obtain first: Dosing schedules, product amounts and adherence records
- Further research: Material needed: Dosing schedules, product amounts and adherence records. This records needed materials; no new research was executed.
- Conditions for verification: 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.
- Why this condition is needed: 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 exceptions: 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.
- Remaining 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.
- Referenced methods: Existing principles distinguish population, nanoformulation, dose/duration, factorial arms, main effects/interactions, measurement, denominators, support and harms in the retained PCOS HOMA-IR record.
- Related sources: S01

### N05 · What do 12 weeks of treatment and effect persistence mean?

Verification status: Partly verified  
Reading scope: 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.

- Current findings: The retained duration is 12 weeks of treatment and follow-up.
- Why unverified: 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.
- Reason for missing information: Visit-specific schedules, post-treatment persistence and long-term follow-up remain unverified.
- Required materials and conditions: 12 weeks of treatment/follow-up and post-treatment persistence
- Materials to obtain first: Follow-up schedules and post-treatment material
- Further research: Material needed: Follow-up schedules and post-treatment material. This records needed materials; no new research was executed.
- Conditions for verification: 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.
- Why this condition is needed: 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 exceptions: 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.
- Remaining 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.
- Referenced methods: Existing principles distinguish population, nanoformulation, dose/duration, factorial arms, main effects/interactions, measurement, denominators, support and harms in the retained PCOS HOMA-IR record.
- Related sources: S01

### N06 · What are the four arms in the 2×2 factorial trial?

Verification status: Partly verified  
Reading scope: 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.

- Current findings: The original record lists metformin, nanocurcumin, combination and double placebo as the four arms. These are not counted as four independent trials.
- Why unverified: 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.
- Reason for missing information: Detailed interventions, placebo matching and analysis-population definitions for each arm remain unverified.
- Required materials and conditions: Factorial arrangement of metformin, nanocurcumin, combination and double placebo
- Materials to obtain first: Group-specific interventions, factors and analysis specifications
- Further research: Material needed: Group-specific interventions, factors and analysis specifications. This records needed materials; no new research was executed.
- Conditions for verification: 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.
- Why this condition is needed: 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 exceptions: 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.
- Remaining 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.
- Referenced methods: Existing principles distinguish population, nanoformulation, dose/duration, factorial arms, main effects/interactions, measurement, denominators, support and harms in the retained PCOS HOMA-IR record.
- Related sources: S01

### N07 · What denominators do 200 people and 1:1:1:1 represent?

Verification status: Partly verified  
Reading scope: 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.

- Current findings: 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.
- Why unverified: 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.
- Reason for missing information: Group-specific allocation, completion and HOMA-IR analysis counts, and ITT denominators, remain unverified.
- Required materials and conditions: Total 200 people, 4-arm allocation ratio and group-specific allocated/completed/analyzed counts
- Materials to obtain first: Group flow, analysis populations and original HOMA-IR tables
- Further research: Material needed: Group flow, analysis populations and original HOMA-IR tables. This records needed materials; no new research was executed.
- Conditions for verification: 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.
- Why this condition is needed: 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 exceptions: 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.
- Remaining 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.
- Referenced methods: Existing principles distinguish population, nanoformulation, dose/duration, factorial arms, main effects/interactions, measurement, denominators, support and harms in the retained PCOS HOMA-IR record.
- Related sources: S01

### N08 · What are the metformin dose and common treatments?

Verification status: Unverified  
Reading scope: 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.

- Current findings: The retained record states that metformin factorial arms were included.
- Why unverified: 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.
- Reason for missing information: Metformin doses/schedules, lifestyle care, other medicines and group-specific changes remain unverified.
- Required materials and conditions: Actual metformin-factor dose/administration, lifestyle care and concomitant medicines
- Materials to obtain first: Metformin, lifestyle-care and concomitant-medicine records
- Further research: Material needed: Metformin, lifestyle-care and concomitant-medicine records. This records needed materials; no new research was executed.
- Conditions for verification: 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.
- Why this condition is needed: 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 exceptions: 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.
- Remaining 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.
- Referenced methods: Existing principles distinguish population, nanoformulation, dose/duration, factorial arms, main effects/interactions, measurement, denominators, support and harms in the retained PCOS HOMA-IR record.
- Related sources: S01

### N09 · What is the identity of the direct report?

Verification status: Partly verified  
Reading scope: 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.

- Current findings: The stored bibliography records Feghhi 2024, PMID 39461199, DOI 10.1016/j.phymed.2024.156160.
- Why unverified: 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.
- Reason for missing information: Current external bibliography, original-paper files and full text remain unread in this work.
- Required materials and conditions: Feghhi report title, PMID, DOI and stored result
- Materials to obtain first: Original paper and bibliographic records
- Further research: Material needed: Original paper and bibliographic records. This records needed materials; no new research was executed.
- Conditions for verification: 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.
- Why this condition is needed: 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 exceptions: 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.
- Remaining 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.
- Referenced methods: Existing principles distinguish population, nanoformulation, dose/duration, factorial arms, main effects/interactions, measurement, denominators, support and harms in the retained PCOS HOMA-IR record.
- Related sources: S01

### N10 · Are registration, protocol and SAP publicly available?

Verification status: Unverified  
Reading scope: 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.

- Current findings: The retained trial-registration field says unverified; the citation has no registration identifier.
- Why unverified: 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.
- Reason for missing information: Original registration, prespecification timing, protocol, SAP and amendment history remain unread.
- Required materials and conditions: Registration identifier, prespecification timing, study plans and factorial analysis plans
- Materials to obtain first: Registration, protocol, SAP and amendments
- Further research: Material needed: Registration, protocol, SAP and amendments. This records needed materials; no new research was executed.
- Conditions for verification: 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.
- Why this condition is needed: 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 exceptions: 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.
- Remaining 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.
- Referenced methods: Existing principles distinguish population, nanoformulation, dose/duration, factorial arms, main effects/interactions, measurement, denominators, support and harms in the retained PCOS HOMA-IR record.
- Related sources: S01

### N11 · What is the prespecified hierarchy of HOMA-IR?

Verification status: Unverified  
Reading scope: 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.

- Current findings: The retained endpoint description is HOMA-IR and metabolic markers, with prespecified hierarchy unverified.
- Why unverified: 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.
- Reason for missing information: Whether it was the single primary (1st) endpoint, multiplicity, analysis order and timepoint plans remain unverified.
- Required materials and conditions: Prespecified endpoints, timepoints and analyses for HOMA-IR and other metabolic markers
- Materials to obtain first: Endpoint hierarchy in registration, protocol and SAP
- Further research: Material needed: Endpoint hierarchy in registration, protocol and SAP. This records needed materials; no new research was executed.
- Conditions for verification: 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.
- Why this condition is needed: 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 exceptions: 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.
- Remaining 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.
- Referenced methods: Existing principles distinguish population, nanoformulation, dose/duration, factorial arms, main effects/interactions, measurement, denominators, support and harms in the retained PCOS HOMA-IR record.
- Related sources: S01

### N12 · What are the randomization and concealment methods?

Verification status: Partly verified  
Reading scope: 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.

- Current findings: The retained design is a randomized double-blind placebo-controlled 2×2 factorial trial.
- Why unverified: 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.
- Reason for missing information: Sequence generation, concealment, stratification and factor-specific allocation methods remain incompletely verified.
- Required materials and conditions: 2×2 factorial randomization, allocation concealment and recruitment flow
- Materials to obtain first: Allocation, concealment and participant-flow material
- Further research: Material needed: Allocation, concealment and participant-flow material. This records needed materials; no new research was executed.
- Conditions for verification: 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.
- Why this condition is needed: 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 exceptions: 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.
- Remaining 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.
- Referenced methods: Existing principles distinguish population, nanoformulation, dose/duration, factorial arms, main effects/interactions, measurement, denominators, support and harms in the retained PCOS HOMA-IR record.
- Related sources: S01

### N13 · How were double blinding and double placebo implemented?

Verification status: Partly verified  
Reading scope: 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.

- Current findings: The original record describes double blinding and double placebo.
- Why unverified: 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.
- Reason for missing information: Placebo matching, participant/assessor blinding and unblinding for each factor remain incompletely verified.
- Required materials and conditions: Factor-specific placebos, appearance, blinded parties and maintenance
- Materials to obtain first: Factor-specific placebo and blinding methods
- Further research: Material needed: Factor-specific placebo and blinding methods. This records needed materials; no new research was executed.
- Conditions for verification: 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.
- Why this condition is needed: 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 exceptions: 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.
- Remaining 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.
- Referenced methods: Existing principles distinguish population, nanoformulation, dose/duration, factorial arms, main effects/interactions, measurement, denominators, support and harms in the retained PCOS HOMA-IR record.
- Related sources: S01

### N14 · What is known about observation loss and ITT?

Verification status: Unverified  
Reading scope: 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.

- Current findings: The retained record gives a total of 200 people and the allocation ratio.
- Why unverified: 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.
- Reason for missing information: Completion, attrition, group analysis counts, missing-data handling, ITT and sensitivity analyses remain unverified.
- Required materials and conditions: Group completion, attrition, missing-data handling and ITT analysis
- Materials to obtain first: Group flow, analysis populations and missing-data handling
- Further research: Material needed: Group flow, analysis populations and missing-data handling. This records needed materials; no new research was executed.
- Conditions for verification: 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.
- Why this condition is needed: 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 exceptions: 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.
- Remaining 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.
- Referenced methods: Existing principles distinguish population, nanoformulation, dose/duration, factorial arms, main effects/interactions, measurement, denominators, support and harms in the retained PCOS HOMA-IR record.
- Related sources: S01

### N15 · What is the HOMA-IR measurement arrangement?

Verification status: Partly verified  
Reading scope: 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.

- Current findings: The selected endpoint is HOMA-IR change at 12 weeks.
- Why unverified: 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.
- Reason for missing information: Measurement formula, assays, fasting conditions, baseline values and result distributions remain unverified.
- Required materials and conditions: Measurement formula, fasting conditions, insulin/glucose assays, baseline and 12 weeks
- Materials to obtain first: Measurement methods, assays, baseline values and result tables
- Further research: Material needed: Measurement methods, assays, baseline values and result tables. This records needed materials; no new research was executed.
- Conditions for verification: 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.
- Why this condition is needed: 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 exceptions: 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.
- Remaining 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.
- Referenced methods: Existing principles distinguish population, nanoformulation, dose/duration, factorial arms, main effects/interactions, measurement, denominators, support and harms in the retained PCOS HOMA-IR record.
- Related sources: S01

### N16 · Which analysis underlies approximately −0.99 in the combination arm?

Verification status: Partly verified  
Reading scope: 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.

- Current findings: The stored result records combination-arm HOMA-IR approximately −0.99. It remains a combination-arm value.
- Why unverified: 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.
- Reason for missing information: Whether it is a within-group change or between-group difference, its reference, adjustment, denominator and original table remain unverified.
- Required materials and conditions: Reference, comparator and denominator for combination-arm HOMA-IR approximately −0.99
- Materials to obtain first: Original combination-arm result tables and analysis definitions
- Further research: Material needed: Original combination-arm result tables and analysis definitions. This records needed materials; no new research was executed.
- Conditions for verification: 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.
- Why this condition is needed: 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 exceptions: 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.
- Remaining 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.
- Referenced methods: Existing principles distinguish population, nanoformulation, dose/duration, factorial arms, main effects/interactions, measurement, denominators, support and harms in the retained PCOS HOMA-IR record.
- Related sources: S01

### N17 · What is the nanocurcumin-only arm comparison?

Verification status: Unverified  
Reading scope: 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.

- Current findings: The original record says the public abstract did not establish an exact isolated HOMA-IR estimate.
- Why unverified: 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.
- Reason for missing information: Monotherapy group values/changes, estimates versus double placebo and intervals remain unverified.
- Required materials and conditions: Exact comparison between nanocurcumin-only and double-placebo arms
- Materials to obtain first: Monotherapy-arm and double-placebo result tables
- Further research: Material needed: Monotherapy-arm and double-placebo result tables. This records needed materials; no new research was executed.
- Conditions for verification: 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.
- Why this condition is needed: 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 exceptions: 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.
- Remaining 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.
- Referenced methods: Existing principles distinguish population, nanoformulation, dose/duration, factorial arms, main effects/interactions, measurement, denominators, support and harms in the retained PCOS HOMA-IR record.
- Related sources: S01

### N18 · Is the nanocurcumin main effect the same as a combination-arm value?

Verification status: Unverified  
Reading scope: 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.

- Current findings: 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.
- Why unverified: 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.
- Reason for missing information: Definition, model, exact difference and 95% CI for the nanocurcumin main effect remain unverified.
- Required materials and conditions: Factorial marginal main effects, analysis models and exact estimates
- Materials to obtain first: Original factorial main-effect tables, models and SAP
- Further research: Material needed: Original factorial main-effect tables, models and SAP. This records needed materials; no new research was executed.
- Conditions for verification: 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.
- Why this condition is needed: 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 exceptions: 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.
- Remaining 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.
- Referenced methods: Existing principles distinguish population, nanoformulation, dose/duration, factorial arms, main effects/interactions, measurement, denominators, support and harms in the retained PCOS HOMA-IR record.
- Related sources: S01

### N19 · Are metformin main effects distinguished from nanocurcumin contribution?

Verification status: Unverified  
Reading scope: 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.

- Current findings: The retained design switches each factor on and off independently.
- Why unverified: 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.
- Reason for missing information: Exact estimates of each factor's main effect, adjustment, simple effects and independent contribution remain unverified.
- Required materials and conditions: Separating metformin-factor effects from nanocurcumin effects
- Materials to obtain first: Both-factor effect tables and analysis models
- Further research: Material needed: Both-factor effect tables and analysis models. This records needed materials; no new research was executed.
- Conditions for verification: 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.
- Why this condition is needed: 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 exceptions: 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.
- Remaining 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.
- Referenced methods: Existing principles distinguish population, nanoformulation, dose/duration, factorial arms, main effects/interactions, measurement, denominators, support and harms in the retained PCOS HOMA-IR record.
- Related sources: S01

### N20 · Was interaction between the factors estimated?

Verification status: Unverified  
Reading scope: 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.

- Current findings: The original record says main effects and interaction tests must be separated.
- Why unverified: 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.
- Reason for missing information: Interaction definition, estimate, P value, 95% CI and power remain unverified. Interaction is not assumed to be 0.
- Required materials and conditions: Metformin×nanocurcumin interaction tests and intervals
- Materials to obtain first: Original interaction tables, tests and SAP
- Further research: Material needed: Original interaction tables, tests and SAP. This records needed materials; no new research was executed.
- Conditions for verification: 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.
- Why this condition is needed: 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 exceptions: 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.
- Remaining 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.
- Referenced methods: Existing principles distinguish population, nanoformulation, dose/duration, factorial arms, main effects/interactions, measurement, denominators, support and harms in the retained PCOS HOMA-IR record.
- Related sources: S01

### N21 · Are CIs available for main effects and interaction?

Verification status: Unverified  
Reading scope: 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.

- Current findings: The retained record leaves CIs for the nanocurcumin main effect and interaction unverified.
- Why unverified: 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.
- Reason for missing information: Exact intervals, variation and covariance material are absent. A total of 200 people does not substitute for intervals.
- Required materials and conditions: 95% CIs for each factor, the selected monotherapy comparison and interaction
- Materials to obtain first: Factor-specific estimates, 95% CIs and model output
- Further research: Material needed: Factor-specific estimates, 95% CIs and model output. This records needed materials; no new research was executed.
- Conditions for verification: 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.
- Why this condition is needed: 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 exceptions: 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.
- Remaining 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.
- Referenced methods: Existing principles distinguish population, nanoformulation, dose/duration, factorial arms, main effects/interactions, measurement, denominators, support and harms in the retained PCOS HOMA-IR record.
- Related sources: S01

### N22 · What are the P values, multiplicity and model choices?

Verification status: Unverified  
Reading scope: 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.

- Current findings: The current summary retains a combination-benefit narrative while withholding exact monotherapy attribution.
- Why unverified: 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.
- Reason for missing information: Factor-specific P values, multiplicity adjustment, model choices and adjustment variables remain unverified.
- Required materials and conditions: Exact factor-specific tests, multiple endpoints and analysis plans
- Materials to obtain first: SAP, all tests and analysis output
- Further research: Material needed: SAP, all tests and analysis output. This records needed materials; no new research was executed.
- Conditions for verification: 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.
- Why this condition is needed: 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 exceptions: 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.
- Remaining 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.
- Referenced methods: Existing principles distinguish population, nanoformulation, dose/duration, factorial arms, main effects/interactions, measurement, denominators, support and harms in the retained PCOS HOMA-IR record.
- Related sources: S01

### N23 · Does HOMA-IR establish improvement in weight and hormones too?

Verification status: Partly verified  
Reading scope: 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.

- Current findings: The original record cautions against expanding combination-arm results into claims that nanocurcumin alone corrects insulin resistance, weight and hormones.
- Why unverified: 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.
- Reason for missing information: Exact separate effects, hierarchy and denominators for weight and hormones remain unverified.
- Required materials and conditions: Separate results for metabolic markers, weight and hormones
- Materials to obtain first: Endpoint-specific results and prespecified hierarchy
- Further research: Material needed: Endpoint-specific results and prespecified hierarchy. This records needed materials; no new research was executed.
- Conditions for verification: 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.
- Why this condition is needed: 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 exceptions: 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.
- Remaining 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.
- Referenced methods: Existing principles distinguish population, nanoformulation, dose/duration, factorial arms, main effects/interactions, measurement, denominators, support and harms in the retained PCOS HOMA-IR record.
- Related sources: S01

### N24 · Is HOMA-IR change clinically important?

Verification status: Unverified  
Reading scope: 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.

- Current findings: The original record selects HOMA-IR and excludes pregnancy and fertility outcomes.
- Why unverified: 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.
- Reason for missing information: Important differences and links to disease events, quality of life and long-term outcomes remain unverified.
- Required materials and conditions: Important differences in metabolic markers and long-term clinical outcomes
- Materials to obtain first: Important-difference and clinical-outcome material
- Further research: Material needed: Important-difference and clinical-outcome material. This records needed materials; no new research was executed.
- Conditions for verification: 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.
- Why this condition is needed: 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 exceptions: 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.
- Remaining 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.
- Referenced methods: Existing principles distinguish population, nanoformulation, dose/duration, factorial arms, main effects/interactions, measurement, denominators, support and harms in the retained PCOS HOMA-IR record.
- Related sources: S01

### N25 · What are the unique trial, endpoint and independent-replication units?

Verification status: Unverified  
Reading scope: 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.

- Current findings: The current evidence and citation describe one direct factorial-trial report. Four arms and multiple metabolic markers are not added as independent replications.
- Why unverified: 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.
- Reason for missing information: Unique-trial/participant totals and independent-replication counts for the same formulation remain unverified.
- Required materials and conditions: Reporting relationships among one factorial trial, four arms and multiple outcomes
- Materials to obtain first: Report-to-trial, factor and endpoint links
- Further research: Material needed: Report-to-trial, factor and endpoint links. This records needed materials; no new research was executed.
- Conditions for verification: 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.
- Why this condition is needed: 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 exceptions: 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.
- Remaining 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.
- Referenced methods: Existing principles distinguish population, nanoformulation, dose/duration, factorial arms, main effects/interactions, measurement, denominators, support and harms in the retained PCOS HOMA-IR record.
- Related sources: S01

### N26 · What funding information is retained?

Verification status: Unverified  
Reading scope: 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.

- Current findings: The retained funding description reports an author declaration of no conflicts, with funding details unverified.
- Why unverified: 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.
- Reason for missing information: Funding sources, contracts and roles in design, analysis and publication remain unverified.
- Required materials and conditions: Distinguishing funding sources/research roles from a no-conflict declaration
- Materials to obtain first: Original funding and institutional-role disclosures
- Further research: Material needed: Original funding and institutional-role disclosures. This records needed materials; no new research was executed.
- Conditions for verification: 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.
- Why this condition is needed: 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 exceptions: 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.
- Remaining 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.
- Referenced methods: Existing principles distinguish population, nanoformulation, dose/duration, factorial arms, main effects/interactions, measurement, denominators, support and harms in the retained PCOS HOMA-IR record.
- Related sources: S01

### N27 · Are product provision, manufacturer roles, employee authors and COI distinguished?

Verification status: Unverified  
Reading scope: 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.

- Current findings: The reported no-conflict wording is retained. It does not establish absence of all product support or employee authors.
- Why unverified: 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.
- Reason for missing information: Product provision, manufacturer involvement, author employment and individual COI remain incompletely verified.
- Required materials and conditions: Individual records on product support, employment, manufacturer roles and declared COI
- Materials to obtain first: Original product-support, author-affiliation and COI disclosures
- Further research: Material needed: Original product-support, author-affiliation and COI disclosures. This records needed materials; no new research was executed.
- Conditions for verification: 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.
- Why this condition is needed: 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 exceptions: 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.
- Remaining 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.
- Referenced methods: Existing principles distinguish population, nanoformulation, dose/duration, factorial arms, main effects/interactions, measurement, denominators, support and harms in the retained PCOS HOMA-IR record.
- Related sources: S01

### N28 · How were harms in monotherapy and combination arms collected?

Verification status: Unverified  
Reading scope: 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.

- Current findings: The retained safety wording calls for gastrointestinal and glycemic clinical monitoring during metformin co-treatment.
- Why unverified: 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.
- Reason for missing information: Event definitions, collection, occurrence counts and exposure/follow-up denominators across the four arms remain unverified.
- Required materials and conditions: Four-arm adverse-event definitions, collection, events and exposure denominators
- Materials to obtain first: Group adverse events, concomitant medicines and exposure denominators
- Further research: Material needed: Group adverse events, concomitant medicines and exposure denominators. This records needed materials; no new research was executed.
- Conditions for verification: 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.
- Why this condition is needed: 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 exceptions: 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.
- Remaining 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.
- Referenced methods: Existing principles distinguish population, nanoformulation, dose/duration, factorial arms, main effects/interactions, measurement, denominators, support and harms in the retained PCOS HOMA-IR record.
- Related sources: S01

### N29 · Is safety during pregnancy and pregnancy planning known?

Verification status: Unverified  
Reading scope: 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.

- Current findings: The original record says safety of nanocurcumin supplementation during pregnancy is not established.
- Why unverified: 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.
- Reason for missing information: Direct material on pregnancy exposure/planning, fetal/maternal outcomes and vulnerable populations remains unverified.
- Required materials and conditions: Nanocurcumin exposure during pregnancy, pregnancy planning and vulnerable populations
- Materials to obtain first: Pregnancy exposure, reproductive-safety and follow-up material
- Further research: Material needed: Pregnancy exposure, reproductive-safety and follow-up material. This records needed materials; no new research was executed.
- Conditions for verification: 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.
- Why this condition is needed: 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 exceptions: 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.
- Remaining 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.
- Referenced methods: Existing principles distinguish population, nanoformulation, dose/duration, factorial arms, main effects/interactions, measurement, denominators, support and harms in the retained PCOS HOMA-IR record.
- Related sources: S01

### N30 · Are ovulation, fertility and pregnancy outcomes the same as HOMA-IR?

Verification status: Unverified  
Reading scope: 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.

- Current findings: The original record excludes pregnancy planning, ovulation and fertility outcomes from this HOMA-IR verdict.
- Why unverified: 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.
- Reason for missing information: Direct estimates, denominators and timepoints for these clinical outcomes remain unverified.
- Required materials and conditions: Separate questions on ovulation, fertility and pregnancy outcomes
- Materials to obtain first: Ovulation, fertility and pregnancy-outcome material
- Further research: Material needed: Ovulation, fertility and pregnancy-outcome material. This records needed materials; no new research was executed.
- Conditions for verification: 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.
- Why this condition is needed: 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 exceptions: 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.
- Remaining 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.
- Referenced methods: Existing principles distinguish population, nanoformulation, dose/duration, factorial arms, main effects/interactions, measurement, denominators, support and harms in the retained PCOS HOMA-IR record.
- Related sources: S01

### N31 · Can findings extend to other curcumin products or monotherapy?

Verification status: Partly verified  
Reading scope: 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.

- Current findings: The original record limits interchangeability across formulations and transfer of combination-arm results to monotherapy.
- Why unverified: 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.
- Reason for missing information: Identical effects of other products/formulations or monotherapy remain unverified.
- Required materials and conditions: Distinguishing nano soft-gels from conventional, phytosomal or combination products and combination-arm results
- Materials to obtain first: Direct formulation-specific and monotherapy comparisons
- Further research: Material needed: Direct formulation-specific and monotherapy comparisons. This records needed materials; no new research was executed.
- Conditions for verification: 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.
- Why this condition is needed: 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 exceptions: 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.
- Remaining 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.
- Referenced methods: Existing principles distinguish population, nanoformulation, dose/duration, factorial arms, main effects/interactions, measurement, denominators, support and harms in the retained PCOS HOMA-IR record.
- Related sources: S01

### N32 · What are the current Korean/English records and historical English correction?

Verification status: Partly verified  
Reading scope: 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.

- Current findings: The current English record distinguishes combination arms, main effects and interaction. The correction of 1 English field is retained as an original event.
- Why unverified: 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.
- Reason for missing information: Historical before/after English wording and full-text alignment of individual numerical values remain unread.
- Required materials and conditions: Current English wording, generic evidence wording and correction of 1 field on 2026-09-14
- Materials to obtain first: Before/after-correction and language-alignment material
- Further research: Material needed: Before/after-correction and language-alignment material. This records needed materials; no new research was executed.
- Conditions for verification: 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.
- Why this condition is needed: 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 exceptions: 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.
- Remaining 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.
- Referenced methods: Existing principles distinguish population, nanoformulation, dose/duration, factorial arms, main effects/interactions, measurement, denominators, support and harms in the retained PCOS HOMA-IR record.
- Related sources: S01

### N33 · How are C/54, original axes and historical cross-checking retained?

Verification status: Partly verified  
Reading scope: 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.

- Current findings: 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.
- Why unverified: 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.
- Reason for missing information: Completed content review is not recorded in the retained material.
- Required materials and conditions: Original C/54, EX/CX, all axes and historical verification wording
- Materials to obtain first: Review comments and future correction material
- Further research: Material needed: Review comments and future correction material. This records needed materials; no new research was executed.
- Conditions for verification: 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.
- Why this condition is needed: 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 exceptions: 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.
- Remaining 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.
- Referenced methods: Existing principles distinguish population, nanoformulation, dose/duration, factorial arms, main effects/interactions, measurement, denominators, support and harms in the retained PCOS HOMA-IR record.
- Related sources: S01

### N34 · What are the original dates, blank fields and actual reading scope?

Verification status: Partly verified  
Reading scope: 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.

- Current findings: 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.
- Why unverified: 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.
- Reason for missing information: External abstracts, full texts, registration, protocols and SAPs remain unread, with no access attempt.
- Required materials and conditions: Original verdict date, correction date, blank original fields and external unread status
- Materials to obtain first: Needed original material and factorial analysis plans when provided
- Further research: Material needed: Needed original material and factorial analysis plans when provided. This records needed materials; no new research was executed.
- Conditions for verification: 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.
- Why this condition is needed: 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 exceptions: 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.
- Remaining 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.
- Referenced methods: Existing principles distinguish population, nanoformulation, dose/duration, factorial arms, main effects/interactions, measurement, denominators, support and harms in the retained PCOS HOMA-IR record.
- Related sources: S01

## Evidence and sources

### S01

2024 · Factorial trial of metformin and nanocurcumin in women with PCOS

[PubMed](https://pubmed.ncbi.nlm.nih.gov/39461199/)

Materials actually read: Stored summary read; external material unread  
Findings recorded in the summary: Combination-arm HOMA-IR approximately −0.99 reported; CIs for nanocurcumin main effect and interaction unverified  
Record 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.  
Independent replication: 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.

| Material | Public availability | Access status | Actually read | Notes |
|---|---|---|---|---|
| Stored existing trial summary | Existing stored summary acquired | Stored summary | Stored summary read | 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. |
| External paper · Abstract/full text unread | Original bibliography link only; external content unread | Unread; no access attempt | Unread | 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. |
| Trial registration and amendments | Needed material; existence and public availability unverified | Unread; no access attempt | Unread | 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. |
| Study protocol | Needed material; existence and public availability unverified | Unread; no access attempt | Unread | 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. |
| Statistical analysis plan | Needed material; existence and public availability unverified | Unread; no access attempt | Unread | 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. |
| Original funding, product-support, employee-authorship and COI disclosures | Needed material; existence and public availability unverified | Unread; no access attempt | Unread | 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. |

## Review criteria and methods

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

- M03 [Cochrane Handbook 6.5 (2024), chapter updated 2023-08](https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-03) · §3.1, §3.2.1–3.2.3, MECIR C5/C7/C13 · Clearly record the question, eligibility conditions and reasons for changes, and distinguish variations in interventions. · Existing methodological links were reused for production. External originals were not reread and methodological content was not reassessed.
- M04 [Cochrane Handbook 6.5.1 (2025), chapter updated 2025-03](https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-04) · §4.5, §4.6.1–4.6.3, MECIR C42 · Distinguish studies from reports and link them; do not omit a study solely because results are unreported. · Existing methodological links were reused for production. External originals were not reread and methodological content was not reassessed.
- M08 [Cochrane Handbook 6.5 (2024), chapter updated 2019-10](https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-08) · §8.1–8.2.3, Table 8.2.a · Define the outcome and effect of interest, then examine randomization, deviations, missing data, measurement and selective reporting. · Existing methodological links were reused for production. External originals were not reread and methodological content was not reassessed.
- M15 [Cochrane Handbook 6.5 (2024), chapter updated 2023-08](https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-15) · §15.2.4, §15.3.1–15.3.3 · Distinguish effect estimates, intervals, importance and applicability. Sample size alone does not determine precision. · Existing methodological links were reused for production. External originals were not reread and methodological content was not reassessed.
- M19 [Cochrane Handbook 6.5 (2024), chapter updated 2019-10](https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-19) · §19.1.2, §19.2.1–19.2.4 · Harm questions may require different designs, populations and follow-up from efficacy questions. Case reports do not establish incidence rates. · Existing methodological links were reused for production. External originals were not reread and methodological content was not reassessed.

## What the statuses mean

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

## Change history

2026-10-24 · Public page/materials 1.0. The public view and materials were prepared from the existing 34 items. No new clinical search, verification-state change or scoring was performed.