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

Required evidence, verification status and materials actually read
Item	AVerification status	BReading scope	CReview item	DCurrent findings	EWhy unverified	FRequired materials and conditions	GFurther research
1	Partly verified	Full text not readStored summary read	N01 · Evidence conditionWhich PCOS HOMA-IR question is presented?Required	The original claim concerns HOMA-IR improvement in polycystic ovary syndrome. A combination-arm result is not transferred to a nanocurcumin-only main effect. S01	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.	Nanocurcumin HOMA-IR and attribution to monotherapy/combination in a factorial trial	Material needed: Factorial analysis plans, group results, main effects and interaction tables. This records needed materials; no new research was executed.
2	Partly verified	Full text not readStored summary read	N02 · Evidence conditionWhat are the diagnostic and baseline conditions of the PCOS population?Required	The retained population is 200 women with PCOS, with diagnostic details described as governed by the full paper. S01	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.	PCOS diagnosis, age, baseline metabolism, recruitment and exclusion criteria	Material needed: Eligibility, diagnosis and baseline-characteristic tables. This records needed materials; no new research was executed.
3	Partly verified	Full text not readStored summary read	N03 · Evidence conditionWhich nanocurcumin formulation is involved?Required	The retained formulation is a soft-gel containing nanoformulated curcumin derived from Curcuma longa. S01	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.	Distinguishing nanocurcumin soft-gels from other curcumin delivery formulations	Material needed: Product, batch, nano-characteristic and quantification material. This records needed materials; no new research was executed.
4	Partly verified	Full text not readStored summary read	N04 · Evidence conditionWhat are the oral dose and dosing interval?Required	The retained scope states 80 mg every 8 hours, totaling 240 mg/day; the Korean ingredient description retains 80 mg 3 times daily. S01	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.	Actual administration of 80 mg every 8 hours, totaling 240 mg/day	Material needed: Dosing schedules, product amounts and adherence records. This records needed materials; no new research was executed.
5	Partly verified	Full text not readStored summary read	N05 · Evidence conditionWhat do 12 weeks of treatment and effect persistence mean?Required	The retained duration is 12 weeks of treatment and follow-up. S01	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.	12 weeks of treatment/follow-up and post-treatment persistence	Material needed: Follow-up schedules and post-treatment material. This records needed materials; no new research was executed.
6	Partly verified	Full text not readStored summary read	N06 · Evidence conditionWhat are the four arms in the 2×2 factorial trial?Required	The original record lists metformin, nanocurcumin, combination and double placebo as the four arms. These are not counted as four independent trials. S01	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.	Factorial arrangement of metformin, nanocurcumin, combination and double placebo	Material needed: Group-specific interventions, factors and analysis specifications. This records needed materials; no new research was executed.
7	Partly verified	Full text not readStored summary read	N07 · Evidence conditionWhat denominators do 200 people and 1:1:1:1 represent?Required	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. S01	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.	Total 200 people, 4-arm allocation ratio and group-specific allocated/completed/analyzed counts	Material needed: Group flow, analysis populations and original HOMA-IR tables. This records needed materials; no new research was executed.
8	Unverified	Full text not readStored summary read	N08 · Evidence conditionWhat are the metformin dose and common treatments?Required	The retained record states that metformin factorial arms were included. S01	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.	Actual metformin-factor dose/administration, lifestyle care and concomitant medicines	Material needed: Metformin, lifestyle-care and concomitant-medicine records. This records needed materials; no new research was executed.
9	Partly verified	Full text not readStored summary read	N09 · Evidence conditionWhat is the identity of the direct report?Required	The stored bibliography records Feghhi 2024, PMID 39461199, DOI 10.1016/j.phymed.2024.156160. S01	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.	Feghhi report title, PMID, DOI and stored result	Material needed: Original paper and bibliographic records. This records needed materials; no new research was executed.
10	Unverified	Full text not readStored summary read	N10 · Evidence conditionAre registration, protocol and SAP publicly available?Required	The retained trial-registration field says unverified; the citation has no registration identifier. S01	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.	Registration identifier, prespecification timing, study plans and factorial analysis plans	Material needed: Registration, protocol, SAP and amendments. This records needed materials; no new research was executed.
11	Unverified	Full text not readStored summary read	N11 · Evidence conditionWhat is the prespecified hierarchy of HOMA-IR?Required	The retained endpoint description is HOMA-IR and metabolic markers, with prespecified hierarchy unverified. S01	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.	Prespecified endpoints, timepoints and analyses for HOMA-IR and other metabolic markers	Material needed: Endpoint hierarchy in registration, protocol and SAP. This records needed materials; no new research was executed.
12	Partly verified	Full text not readStored summary read	N12 · Evidence conditionWhat are the randomization and concealment methods?Required	The retained design is a randomized double-blind placebo-controlled 2×2 factorial trial. S01	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.	2×2 factorial randomization, allocation concealment and recruitment flow	Material needed: Allocation, concealment and participant-flow material. This records needed materials; no new research was executed.
13	Partly verified	Full text not readStored summary read	N13 · Evidence conditionHow were double blinding and double placebo implemented?Required	The original record describes double blinding and double placebo. S01	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.	Factor-specific placebos, appearance, blinded parties and maintenance	Material needed: Factor-specific placebo and blinding methods. This records needed materials; no new research was executed.
14	Unverified	Full text not readStored summary read	N14 · Evidence conditionWhat is known about observation loss and ITT?Required	The retained record gives a total of 200 people and the allocation ratio. S01	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.	Group completion, attrition, missing-data handling and ITT analysis	Material needed: Group flow, analysis populations and missing-data handling. This records needed materials; no new research was executed.
15	Partly verified	Full text not readStored summary read	N15 · Evidence conditionWhat is the HOMA-IR measurement arrangement?Required	The selected endpoint is HOMA-IR change at 12 weeks. S01	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.	Measurement formula, fasting conditions, insulin/glucose assays, baseline and 12 weeks	Material needed: Measurement methods, assays, baseline values and result tables. This records needed materials; no new research was executed.
16	Partly verified	Full text not readStored summary read	N16 · Evidence conditionWhich analysis underlies approximately −0.99 in the combination arm?Required	The stored result records combination-arm HOMA-IR approximately −0.99. It remains a combination-arm value. S01	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.	Reference, comparator and denominator for combination-arm HOMA-IR approximately −0.99	Material needed: Original combination-arm result tables and analysis definitions. This records needed materials; no new research was executed.
17	Unverified	Full text not readStored summary read	N17 · Evidence conditionWhat is the nanocurcumin-only arm comparison?Required	The original record says the public abstract did not establish an exact isolated HOMA-IR estimate. S01	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.	Exact comparison between nanocurcumin-only and double-placebo arms	Material needed: Monotherapy-arm and double-placebo result tables. This records needed materials; no new research was executed.
18	Unverified	Full text not readStored summary read	N18 · Evidence conditionIs the nanocurcumin main effect the same as a combination-arm value?Required	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. S01	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.	Factorial marginal main effects, analysis models and exact estimates	Material needed: Original factorial main-effect tables, models and SAP. This records needed materials; no new research was executed.
19	Unverified	Full text not readStored summary read	N19 · Evidence conditionAre metformin main effects distinguished from nanocurcumin contribution?Required	The retained design switches each factor on and off independently. S01	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.	Separating metformin-factor effects from nanocurcumin effects	Material needed: Both-factor effect tables and analysis models. This records needed materials; no new research was executed.
20	Unverified	Full text not readStored summary read	N20 · Evidence conditionWas interaction between the factors estimated?Required	The original record says main effects and interaction tests must be separated. S01	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.	Metformin×nanocurcumin interaction tests and intervals	Material needed: Original interaction tables, tests and SAP. This records needed materials; no new research was executed.
21	Unverified	Full text not readStored summary read	N21 · Evidence conditionAre CIs available for main effects and interaction?Required	The retained record leaves CIs for the nanocurcumin main effect and interaction unverified. S01	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.	95% CIs for each factor, the selected monotherapy comparison and interaction	Material needed: Factor-specific estimates, 95% CIs and model output. This records needed materials; no new research was executed.
22	Unverified	Full text not readStored summary read	N22 · Evidence conditionWhat are the P values, multiplicity and model choices?Required	The current summary retains a combination-benefit narrative while withholding exact monotherapy attribution. S01	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.	Exact factor-specific tests, multiple endpoints and analysis plans	Material needed: SAP, all tests and analysis output. This records needed materials; no new research was executed.
23	Partly verified	Full text not readStored summary read	N23 · Evidence conditionDoes HOMA-IR establish improvement in weight and hormones too?Required	The original record cautions against expanding combination-arm results into claims that nanocurcumin alone corrects insulin resistance, weight and hormones. S01	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.	Separate results for metabolic markers, weight and hormones	Material needed: Endpoint-specific results and prespecified hierarchy. This records needed materials; no new research was executed.
24	Unverified	Full text not readStored summary read	N24 · Evidence conditionIs HOMA-IR change clinically important?Required	The original record selects HOMA-IR and excludes pregnancy and fertility outcomes. S01	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.	Important differences in metabolic markers and long-term clinical outcomes	Material needed: Important-difference and clinical-outcome material. This records needed materials; no new research was executed.
25	Unverified	Full text not readStored summary read	N25 · Evidence conditionWhat are the unique trial, endpoint and independent-replication units?Required	The current evidence and citation describe one direct factorial-trial report. Four arms and multiple metabolic markers are not added as independent replications. S01	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.	Reporting relationships among one factorial trial, four arms and multiple outcomes	Material needed: Report-to-trial, factor and endpoint links. This records needed materials; no new research was executed.
26	Unverified	Full text not readStored summary read	N26 · Evidence conditionWhat funding information is retained?Required	The retained funding description reports an author declaration of no conflicts, with funding details unverified. S01	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.	Distinguishing funding sources/research roles from a no-conflict declaration	Material needed: Original funding and institutional-role disclosures. This records needed materials; no new research was executed.
27	Unverified	Full text not readStored summary read	N27 · Evidence conditionAre product provision, manufacturer roles, employee authors and COI distinguished?Required	The reported no-conflict wording is retained. It does not establish absence of all product support or employee authors. S01	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.	Individual records on product support, employment, manufacturer roles and declared COI	Material needed: Original product-support, author-affiliation and COI disclosures. This records needed materials; no new research was executed.
28	Unverified	Full text not readStored summary read	N28 · Evidence conditionHow were harms in monotherapy and combination arms collected?Supplementary	The retained safety wording calls for gastrointestinal and glycemic clinical monitoring during metformin co-treatment. S01	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.	Four-arm adverse-event definitions, collection, events and exposure denominators	Material needed: Group adverse events, concomitant medicines and exposure denominators. This records needed materials; no new research was executed.
29	Unverified	Full text not readStored summary read	N29 · Evidence conditionIs safety during pregnancy and pregnancy planning known?Supplementary	The original record says safety of nanocurcumin supplementation during pregnancy is not established. S01	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.	Nanocurcumin exposure during pregnancy, pregnancy planning and vulnerable populations	Material needed: Pregnancy exposure, reproductive-safety and follow-up material. This records needed materials; no new research was executed.
30	Unverified	Full text not readStored summary read	N30 · Evidence conditionAre ovulation, fertility and pregnancy outcomes the same as HOMA-IR?Required	The original record excludes pregnancy planning, ovulation and fertility outcomes from this HOMA-IR verdict. S01	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.	Separate questions on ovulation, fertility and pregnancy outcomes	Material needed: Ovulation, fertility and pregnancy-outcome material. This records needed materials; no new research was executed.
31	Partly verified	Full text not readStored summary read	N31 · Evidence conditionCan findings extend to other curcumin products or monotherapy?Required	The original record limits interchangeability across formulations and transfer of combination-arm results to monotherapy. S01	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.	Distinguishing nano soft-gels from conventional, phytosomal or combination products and combination-arm results	Material needed: Direct formulation-specific and monotherapy comparisons. This records needed materials; no new research was executed.
32	Partly verified	Full text not readStored summary read	N32 · Evidence conditionWhat are the current Korean/English records and historical English correction?Required	The current English record distinguishes combination arms, main effects and interaction. The correction of 1 English field is retained as an original event. S01	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.	Current English wording, generic evidence wording and correction of 1 field on 2026-09-14	Material needed: Before/after-correction and language-alignment material. This records needed materials; no new research was executed.
33	Partly verified	Full text not readStored summary read	N33 · Evidence conditionHow are C/54, original axes and historical cross-checking retained?Required	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. S01	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.	Original C/54, EX/CX, all axes and historical verification wording	Material needed: Review comments and future correction material. This records needed materials; no new research was executed.
34	Partly verified	Full text not readStored summary read	N34 · Evidence conditionWhat are the original dates, blank fields and actual reading scope?Required	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. S01	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.	Original verdict date, correction date, blank original fields and external unread status	Material needed: Needed original material and factorial analysis plans when provided. This records needed materials; no new research was executed.

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34 itemsWhat the statuses mean

Assessment scope

Stored-material review date: Not recorded
Original evidence cut-off: 2026-09-08
Scope actually checked: Existing review summaries and stored records of methodological application. Full papers, supplements, registrations, plans and original data were not read.
What the dates mean: 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.
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.

Evidence and sources

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

S01 · 2024 · Factorial trial of metformin and nanocurcumin in women with PCOS

PubMed

Material type: Stored description of a randomized double-blind placebo-controlled 2×2 factorial trial; external methods and original result tables remain unread
Materials actually read: Stored summary read; external material unread
Findings recorded in the stored 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.
Study overlap and 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.

Public availability, access and reading status by material
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.

Report counts versus independent study counts

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.

Review criteria

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

N01 · Which PCOS HOMA-IR question is presented?

Required materials and conditions: Nanocurcumin HOMA-IR and attribution to monotherapy/combination in a factorial trial
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.
Requirement and applicability: Required
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.
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.
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.

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

Required materials and conditions: PCOS diagnosis, age, baseline metabolism, recruitment and exclusion criteria
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.
Requirement and applicability: Required
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.
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.
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.

N03 · Which nanocurcumin formulation is involved?

Required materials and conditions: Distinguishing nanocurcumin soft-gels from other curcumin delivery formulations
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.
Requirement and applicability: Required
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.
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.
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.

N04 · What are the oral dose and dosing interval?

Required materials and conditions: Actual administration of 80 mg every 8 hours, totaling 240 mg/day
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.
Requirement and applicability: Required
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.
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.
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.

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

Required materials and conditions: 12 weeks of treatment/follow-up and post-treatment persistence
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.
Requirement and applicability: Required
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.
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.
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.

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

Required materials and conditions: Factorial arrangement of metformin, nanocurcumin, combination and double placebo
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.
Requirement and applicability: Required
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.
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.
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.

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

Required materials and conditions: Total 200 people, 4-arm allocation ratio and group-specific allocated/completed/analyzed counts
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.
Requirement and applicability: Required
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.
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.
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.

N08 · What are the metformin dose and common treatments?

Required materials and conditions: Actual metformin-factor dose/administration, lifestyle care and concomitant medicines
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.
Requirement and applicability: Required
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.
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.
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.

N09 · What is the identity of the direct report?

Required materials and conditions: Feghhi report title, PMID, DOI and stored result
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.
Requirement and applicability: Required
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.
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.
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.

N10 · Are registration, protocol and SAP publicly available?

Required materials and conditions: Registration identifier, prespecification timing, study plans and factorial analysis plans
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.
Requirement and applicability: Required
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.
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.
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.

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

Required materials and conditions: Prespecified endpoints, timepoints and analyses for HOMA-IR and other metabolic markers
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.
Requirement and applicability: Required
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.
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.
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.

N12 · What are the randomization and concealment methods?

Required materials and conditions: 2×2 factorial randomization, allocation concealment and recruitment flow
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.
Requirement and applicability: Required
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.
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.
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.

N13 · How were double blinding and double placebo implemented?

Required materials and conditions: Factor-specific placebos, appearance, blinded parties and maintenance
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.
Requirement and applicability: Required
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.
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.
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.

N14 · What is known about observation loss and ITT?

Required materials and conditions: Group completion, attrition, missing-data handling and ITT analysis
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.
Requirement and applicability: Required
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.
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.
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.

N15 · What is the HOMA-IR measurement arrangement?

Required materials and conditions: Measurement formula, fasting conditions, insulin/glucose assays, baseline and 12 weeks
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.
Requirement and applicability: Required
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.
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.
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.

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

Required materials and conditions: Reference, comparator and denominator for combination-arm HOMA-IR approximately −0.99
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.
Requirement and applicability: Required
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.
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.
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.

N17 · What is the nanocurcumin-only arm comparison?

Required materials and conditions: Exact comparison between nanocurcumin-only and double-placebo arms
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.
Requirement and applicability: Required
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.
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.
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.

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

Required materials and conditions: Factorial marginal main effects, analysis models and exact estimates
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.
Requirement and applicability: Required
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.
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.
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.

N19 · Are metformin main effects distinguished from nanocurcumin contribution?

Required materials and conditions: Separating metformin-factor effects from nanocurcumin effects
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.
Requirement and applicability: Required
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.
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.
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.

N20 · Was interaction between the factors estimated?

Required materials and conditions: Metformin×nanocurcumin interaction tests and intervals
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.
Requirement and applicability: Required
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.
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.
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.

N21 · Are CIs available for main effects and interaction?

Required materials and conditions: 95% CIs for each factor, the selected monotherapy comparison and interaction
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.
Requirement and applicability: Required
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.
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.
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.

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

Required materials and conditions: Exact factor-specific tests, multiple endpoints and analysis plans
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.
Requirement and applicability: Required
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.
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.
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.

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

Required materials and conditions: Separate results for metabolic markers, weight and hormones
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.
Requirement and applicability: Required
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.
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.
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.

N24 · Is HOMA-IR change clinically important?

Required materials and conditions: Important differences in metabolic markers and long-term clinical outcomes
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.
Requirement and applicability: Required
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.
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.
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.

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

Required materials and conditions: Reporting relationships among one factorial trial, four arms and multiple outcomes
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.
Requirement and applicability: Required
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.
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.
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.

N26 · What funding information is retained?

Required materials and conditions: Distinguishing funding sources/research roles from a no-conflict declaration
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.
Requirement and applicability: Required
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.
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.
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.

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

Required materials and conditions: Individual records on product support, employment, manufacturer roles and declared COI
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.
Requirement and applicability: Required
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.
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.
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.

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

Required materials and conditions: Four-arm adverse-event definitions, collection, events and exposure denominators
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.
Requirement and applicability: Supplementary
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.
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.
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.

N29 · Is safety during pregnancy and pregnancy planning known?

Required materials and conditions: Nanocurcumin exposure during pregnancy, pregnancy planning and vulnerable populations
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.
Requirement and applicability: Supplementary
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.
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.
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.

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

Required materials and conditions: Separate questions on ovulation, fertility and pregnancy outcomes
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.
Requirement and applicability: Required
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.
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.
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.

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

Required materials and conditions: Distinguishing nano soft-gels from conventional, phytosomal or combination products and combination-arm results
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.
Requirement and applicability: Required
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.
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.
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.

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

Required materials and conditions: Current English wording, generic evidence wording and correction of 1 field on 2026-09-14
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.
Requirement and applicability: Required
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.
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.
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.

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

Required materials and conditions: Original C/54, EX/CX, all axes and historical verification wording
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.
Requirement and applicability: Required
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.
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.
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.

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

Required materials and conditions: Original verdict date, correction date, blank original fields and external unread status
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.
Requirement and applicability: Required
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.
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.
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.

Referenced methods and the sections actually reviewed

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

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

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

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

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

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

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

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

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

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

Official methodology · §15.2.4, §15.3.1–15.3.3

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

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

Official methodology · §19.1.2, §19.2.1–19.2.4

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

What the statuses mean

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

Change history

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

The public view and materials were prepared from the existing 34 items. No new clinical search, verification-state change or scoring was performed.

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

Researcher downloads

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

View all item details

N01 · Which PCOS HOMA-IR question is presented?

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.
Verification status: Partly verified
Materials actually read: The retained Korean and English summaries and bibliography were read. External papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain unread, with no access attempt.
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.
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.
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.
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?

Current findings: The retained population is 200 women with PCOS, with diagnostic details described as governed by the full paper.
Verification status: Partly verified
Materials actually read: The retained Korean and English summaries and bibliography were read. External papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain unread, with no access attempt.
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.
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.
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.
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?

Current findings: The retained formulation is a soft-gel containing nanoformulated curcumin derived from Curcuma longa.
Verification status: Partly verified
Materials actually read: The retained Korean and English summaries and bibliography were read. External papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain unread, with no access attempt.
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.
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.
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.
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?

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.
Verification status: Partly verified
Materials actually read: The retained Korean and English summaries and bibliography were read. External papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain unread, with no access attempt.
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.
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.
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.
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?

Current findings: The retained duration is 12 weeks of treatment and follow-up.
Verification status: Partly verified
Materials actually read: The retained Korean and English summaries and bibliography were read. External papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain unread, with no access attempt.
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.
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.
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.
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?

Current findings: The original record lists metformin, nanocurcumin, combination and double placebo as the four arms. These are not counted as four independent trials.
Verification status: Partly verified
Materials actually read: The retained Korean and English summaries and bibliography were read. External papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain unread, with no access attempt.
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.
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.
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.
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?

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.
Verification status: Partly verified
Materials actually read: The retained Korean and English summaries and bibliography were read. External papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain unread, with no access attempt.
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.
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.
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.
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?

Current findings: The retained record states that metformin factorial arms were included.
Verification status: Unverified
Materials actually read: The retained Korean and English summaries and bibliography were read. External papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain unread, with no access attempt.
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.
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.
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.
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?

Current findings: The stored bibliography records Feghhi 2024, PMID 39461199, DOI 10.1016/j.phymed.2024.156160.
Verification status: Partly verified
Materials actually read: The retained Korean and English summaries and bibliography were read. External papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain unread, with no access attempt.
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.
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.
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.
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?

Current findings: The retained trial-registration field says unverified; the citation has no registration identifier.
Verification status: Unverified
Materials actually read: The retained Korean and English summaries and bibliography were read. External papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain unread, with no access attempt.
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.
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.
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.
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?

Current findings: The retained endpoint description is HOMA-IR and metabolic markers, with prespecified hierarchy unverified.
Verification status: Unverified
Materials actually read: The retained Korean and English summaries and bibliography were read. External papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain unread, with no access attempt.
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.
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.
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.
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?

Current findings: The retained design is a randomized double-blind placebo-controlled 2×2 factorial trial.
Verification status: Partly verified
Materials actually read: The retained Korean and English summaries and bibliography were read. External papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain unread, with no access attempt.
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.
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.
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.
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.

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N13 · How were double blinding and double placebo implemented?

Current findings: The original record describes double blinding and double placebo.
Verification status: Partly verified
Materials actually read: The retained Korean and English summaries and bibliography were read. External papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain unread, with no access attempt.
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.
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.
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.
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.

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N14 · What is known about observation loss and ITT?

Current findings: The retained record gives a total of 200 people and the allocation ratio.
Verification status: Unverified
Materials actually read: The retained Korean and English summaries and bibliography were read. External papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain unread, with no access attempt.
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.
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.
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.
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.

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N15 · What is the HOMA-IR measurement arrangement?

Current findings: The selected endpoint is HOMA-IR change at 12 weeks.
Verification status: Partly verified
Materials actually read: The retained Korean and English summaries and bibliography were read. External papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain unread, with no access attempt.
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.
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.
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.
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.

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

Current findings: The stored result records combination-arm HOMA-IR approximately −0.99. It remains a combination-arm value.
Verification status: Partly verified
Materials actually read: The retained Korean and English summaries and bibliography were read. External papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain unread, with no access attempt.
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.
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.
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.
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.

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N17 · What is the nanocurcumin-only arm comparison?

Current findings: The original record says the public abstract did not establish an exact isolated HOMA-IR estimate.
Verification status: Unverified
Materials actually read: The retained Korean and English summaries and bibliography were read. External papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain unread, with no access attempt.
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.
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.
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.
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.

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

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.
Verification status: Unverified
Materials actually read: The retained Korean and English summaries and bibliography were read. External papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain unread, with no access attempt.
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.
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.
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.
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.

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N19 · Are metformin main effects distinguished from nanocurcumin contribution?

Current findings: The retained design switches each factor on and off independently.
Verification status: Unverified
Materials actually read: The retained Korean and English summaries and bibliography were read. External papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain unread, with no access attempt.
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.
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.
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.
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.

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N20 · Was interaction between the factors estimated?

Current findings: The original record says main effects and interaction tests must be separated.
Verification status: Unverified
Materials actually read: The retained Korean and English summaries and bibliography were read. External papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain unread, with no access attempt.
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.
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.
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.
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.

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N21 · Are CIs available for main effects and interaction?

Current findings: The retained record leaves CIs for the nanocurcumin main effect and interaction unverified.
Verification status: Unverified
Materials actually read: The retained Korean and English summaries and bibliography were read. External papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain unread, with no access attempt.
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.
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.
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.
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.

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

Current findings: The current summary retains a combination-benefit narrative while withholding exact monotherapy attribution.
Verification status: Unverified
Materials actually read: The retained Korean and English summaries and bibliography were read. External papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain unread, with no access attempt.
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.
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.
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.
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.

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

Current findings: The original record cautions against expanding combination-arm results into claims that nanocurcumin alone corrects insulin resistance, weight and hormones.
Verification status: Partly verified
Materials actually read: The retained Korean and English summaries and bibliography were read. External papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain unread, with no access attempt.
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.
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.
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.
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.

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N24 · Is HOMA-IR change clinically important?

Current findings: The original record selects HOMA-IR and excludes pregnancy and fertility outcomes.
Verification status: Unverified
Materials actually read: The retained Korean and English summaries and bibliography were read. External papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain unread, with no access attempt.
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.
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.
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.
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.

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

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.
Verification status: Unverified
Materials actually read: The retained Korean and English summaries and bibliography were read. External papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain unread, with no access attempt.
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.
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.
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.
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.

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N26 · What funding information is retained?

Current findings: The retained funding description reports an author declaration of no conflicts, with funding details unverified.
Verification status: Unverified
Materials actually read: The retained Korean and English summaries and bibliography were read. External papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain unread, with no access attempt.
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.
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.
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.
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.

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

Current findings: The reported no-conflict wording is retained. It does not establish absence of all product support or employee authors.
Verification status: Unverified
Materials actually read: The retained Korean and English summaries and bibliography were read. External papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain unread, with no access attempt.
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.
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.
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.
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?

Current findings: The retained safety wording calls for gastrointestinal and glycemic clinical monitoring during metformin co-treatment.
Verification status: Unverified
Materials actually read: The retained Korean and English summaries and bibliography were read. External papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain unread, with no access attempt.
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.
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.
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.
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?

Current findings: The original record says safety of nanocurcumin supplementation during pregnancy is not established.
Verification status: Unverified
Materials actually read: The retained Korean and English summaries and bibliography were read. External papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain unread, with no access attempt.
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.
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.
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.
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?

Current findings: The original record excludes pregnancy planning, ovulation and fertility outcomes from this HOMA-IR verdict.
Verification status: Unverified
Materials actually read: The retained Korean and English summaries and bibliography were read. External papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain unread, with no access attempt.
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.
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.
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.
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?

Current findings: The original record limits interchangeability across formulations and transfer of combination-arm results to monotherapy.
Verification status: Partly verified
Materials actually read: The retained Korean and English summaries and bibliography were read. External papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain unread, with no access attempt.
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.
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.
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.
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?

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.
Verification status: Partly verified
Materials actually read: The retained Korean and English summaries and bibliography were read. External papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain unread, with no access attempt.
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.
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.
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.
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?

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.
Verification status: Partly verified
Materials actually read: The retained Korean and English summaries and bibliography were read. External papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain unread, with no access attempt.
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.
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.
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.
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.

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

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.
Verification status: Partly verified
Materials actually read: The retained Korean and English summaries and bibliography were read. External papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain unread, with no access attempt.
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.
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.
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.
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