Phytosomal Curcumin 250 mg/day × Migraine-Attack Frequency at 8 Weeks in Adults With Migraine Without Aura

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 migraine-attack frequency question is covered?Required	The original claim is reduction of migraine-attack frequency without aura, distinguished from other formulations, biomarkers and combinations. S01 S02	Information in stored summaries is linked to gaps in detailed material. External original-source comparison and content review remain incomplete; effects, safety, prespecification, independence or fulfilled conditions are not certified.	An 8-week phytosomal-curcumin add-on comparison for migraine without aura	Material needed: Direct original paper, protocol and registration. This records needed materials; no new research was executed.
2	Partly verified	Full text not readStored summary read	N02 · Evidence conditionWhich adults with migraine are represented?Required	The retained population is adults with migraine without aura who continued standard treatment. S01	Information in stored summaries is linked to gaps in detailed material. External original-source comparison and content review remain incomplete; effects, safety, prespecification, independence or fulfilled conditions are not certified.	Diagnosis of migraine without aura, adult eligibility and continuation of standard treatment	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 conditionIs the phytosomal formulation interchangeable with other curcumin?Required	The selected formulation is phospholipid phytosomal curcumin derived from Curcuma longa, distinguished from nanocurcumin. S01	Information in stored summaries is linked to gaps in detailed material. External original-source comparison and content review remain incomplete; effects, safety, prespecification, independence or fulfilled conditions are not certified.	Distinction between a phospholipid delivery system and conventional, nano, micellar and combination formulations	Material needed: Formulation, product, batch and quantification material. This records needed materials; no new research was executed.
4	Partly verified	Full text not readStored summary read	N04 · Evidence conditionWhat were the dose and actual intake?Required	The retained dose is an oral add-on at 250 mg/day. S01	Information in stored summaries is linked to gaps in detailed material. External original-source comparison and content review remain incomplete; effects, safety, prespecification, independence or fulfilled conditions are not certified.	Phytosomal curcumin 250 mg/day and actual adherence	Material needed: Product amount, ingredient amount and adherence records. This records needed materials; no new research was executed.
5	Partly verified	Full text not readStored summary read	N05 · Evidence conditionWhat were the treatment and follow-up times?Required	The retained treatment and follow-up duration is 8 weeks. S01	Information in stored summaries is linked to gaps in detailed material. External original-source comparison and content review remain incomplete; effects, safety, prespecification, independence or fulfilled conditions are not certified.	Treatment/follow-up over 8 weeks and persistence after stopping	Material needed: Measurement schedule and follow-up plan. This records needed materials; no new research was executed.
6	Unverified	Full text not readStored summary read	N06 · Evidence conditionWhat was the contribution of standard treatment and concurrent medication?Required	The original record describes an add-on trial with continued standard treatment. S01	Information in stored summaries is linked to gaps in detailed material. External original-source comparison and content review remain incomplete; effects, safety, prespecification, independence or fulfilled conditions are not certified.	Continuation/changes in standard treatment, preventive medication and rescue medication in both groups	Material needed: Concurrent, preventive and rescue medication tables. This records needed materials; no new research was executed.
7	Partly verified	Full text not readStored summary read	N07 · Evidence conditionWhat was the maltodextrin-placebo comparison?Required	The comparator is recorded as maltodextrin placebo added to standard treatment. S01	Information in stored summaries is linked to gaps in detailed material. External original-source comparison and content review remain incomplete; effects, safety, prespecification, independence or fulfilled conditions are not certified.	Conditions of maltodextrin placebo added to standard treatment	Material needed: Placebo and concurrent-treatment specifications. This records needed materials; no new research was executed.
8	Partly verified	Full text not readStored summary read	N08 · Evidence conditionHow is the direct report identified?Required	The bibliography records Shojaei 2025, PMID 41136816 and DOI 10.1007/s11655-025-3939-1. S01	Information in stored summaries is linked to gaps in detailed material. External original-source comparison and content review remain incomplete; effects, safety, prespecification, independence or fulfilled conditions are not certified.	Shojaei report title, PMID, DOI and retained result	Material needed: Direct original paper and bibliographic record. This records needed materials; no new research was executed.
9	Unverified	Full text not readStored summary read	N09 · Evidence conditionIs an IRCT number the same as actual registration verification?Required	The bibliography contains IRCT20201129049534N2, while registration status in the original record remains unverified. S01	Information in stored summaries is linked to gaps in detailed material. External original-source comparison and content review remain incomplete; effects, safety, prespecification, independence or fulfilled conditions are not certified.	IRCT20201129049534N2, registration timing, endpoints and history	Material needed: Original registration and change history. This records needed materials; no new research was executed.
10	Unverified	Full text not readStored summary read	N10 · Evidence conditionWas attack frequency the single prespecified primary endpoint (1st in the hierarchy)?Required	The retained record leaves unverified whether change in attack frequency at 8 weeks was the single prespecified primary endpoint (1st in the hierarchy). S01	Information in stored summaries is linked to gaps in detailed material. External original-source comparison and content review remain incomplete; effects, safety, prespecification, independence or fulfilled conditions are not certified.	Prespecified hierarchy, analysis and timing for frequency among multiple clinical endpoints	Material needed: Protocol, SAP and registered endpoints. This records needed materials; no new research was executed.
11	Partly verified	Full text not readStored summary read	N11 · Evidence conditionWhat were the randomization and concealment methods?Required	The retained design is a randomized double-blind placebo-add-on trial. S01	Information in stored summaries is linked to gaps in detailed material. External original-source comparison and content review remain incomplete; effects, safety, prespecification, independence or fulfilled conditions are not certified.	Randomization procedures, concealment and recruitment flow	Material needed: Allocation methods and participant flow diagram. This records needed materials; no new research was executed.
12	Partly verified	Full text not readStored summary read	N12 · Evidence conditionHow were blinding and outcome measurement maintained?Required	The original record describes a double-blind design. S01	Information in stored summaries is linked to gaps in detailed material. External original-source comparison and content review remain incomplete; effects, safety, prespecification, independence or fulfilled conditions are not certified.	Participant/assessor blinding and placebo matching	Material needed: Blinding, placebo and outcome-recording methods. This records needed materials; no new research was executed.
13	Partly verified	Full text not readStored summary read	N13 · Evidence conditionHow are 70 randomized participants and 65 completers distinguished?Required	The retained denominators are 70 randomized and 65 completed (33 versus 32); allocation and completion are not interchanged. S01	Information in stored summaries is linked to gaps in detailed material. External original-source comparison and content review remain incomplete; effects, safety, prespecification, independence or fulfilled conditions are not certified.	The 70 randomized participants, 65 completers and group correspondence for 33 versus 32	Material needed: Group-specific allocation, completion and analysis flow and result tables. This records needed materials; no new research was executed.
14	Unverified	Full text not readStored summary read	N14 · Evidence conditionWhat was the exact ITT analysis population?Required	The current summary states that the exact ITT denominator remains unverified. S01	Information in stored summaries is linked to gaps in detailed material. External original-source comparison and content review remain incomplete; effects, safety, prespecification, independence or fulfilled conditions are not certified.	ITT, completer analyses and inclusion criteria for the frequency result	Material needed: Analysis-population definitions, ITT, SAP and result tables. This records needed materials; no new research was executed.
15	Unverified	Full text not readStored summary read	N15 · Evidence conditionWhat effects could missingness and withdrawal have?Required	The retained material distinguishes randomized and completed participant counts. S01	Information in stored summaries is linked to gaps in detailed material. External original-source comparison and content review remain incomplete; effects, safety, prespecification, independence or fulfilled conditions are not certified.	Group-specific withdrawal reasons, missing-data handling and sensitivity analyses	Material needed: Missing-data and withdrawal reasons and analysis material. This records needed materials; no new research was executed.
16	Unverified	Full text not readStored summary read	N16 · Evidence conditionIn which units was attack frequency measured?Required	The selected endpoint is change in attack frequency at 8 weeks. S01	Information in stored summaries is linked to gaps in detailed material. External original-source comparison and content review remain incomplete; effects, safety, prespecification, independence or fulfilled conditions are not certified.	Attack definition, frequency per period, diaries and baseline values	Material needed: Frequency definition, diaries, baseline values and result tables. This records needed materials; no new research was executed.
17	Unverified	Full text not readStored summary read	N17 · Evidence conditionWhat was the exact between-group effect on frequency?Required	The existing summary of broadly positive abstract results, including frequency, is retained. The exact frequency-specific between-group change remains unverified. S01	Information in stored summaries is linked to gaps in detailed material. External original-source comparison and content review remain incomplete; effects, safety, prespecification, independence or fulfilled conditions are not certified.	Frequency-specific between-group change and analysis model	Material needed: Original frequency-specific group values and between-group estimate tables. This records needed materials; no new research was executed.
18	Unverified	Full text not readStored summary read	N18 · Evidence conditionIs there a confidence interval for the frequency effect?Required	The retained record leaves the 95% CI unverified. S01	Information in stored summaries is linked to gaps in detailed material. External original-source comparison and content review remain incomplete; effects, safety, prespecification, independence or fulfilled conditions are not certified.	Exact frequency-specific between-group 95% CI	Material needed: Between-group 95% CI and analysis output. This records needed materials; no new research was executed.
19	Unverified	Full text not readStored summary read	N19 · Evidence conditionWhat was the P value in the direct phytosomal trial?Required	The exact frequency-specific P value in the phytosomal trial remains unverified. P=.052 is not transferred here. S01 S02	Information in stored summaries is linked to gaps in detailed material. External original-source comparison and content review remain incomplete; effects, safety, prespecification, independence or fulfilled conditions are not certified.	Exact frequency-specific between-group P value, distinguished from values in another trial	Material needed: Frequency-specific analysis tables and SAP. This records needed materials; no new research was executed.
20	Partly verified	Full text not readStored summary read	N20 · Evidence conditionAre other clinical endpoints distinguished from frequency?Required	The original record states that multiple outcomes were measured. A broad positive statement is not reconstructed as an exact frequency-specific effect. S01	Information in stored summaries is linked to gaps in detailed material. External original-source comparison and content review remain incomplete; effects, safety, prespecification, independence or fulfilled conditions are not certified.	Separate results for frequency, duration, intensity, quality of life and sleep	Material needed: Prespecified plans and result tables for all endpoints. This records needed materials; no new research was executed.
21	Unverified	Full text not readStored summary read	N21 · Evidence conditionWas the change in attack count important to patients?Required	The retained material records a positive frequency signal, but the exact effect remains unverified. S01	Information in stored summaries is linked to gaps in detailed material. External original-source comparison and content review remain incomplete; effects, safety, prespecification, independence or fulfilled conditions are not certified.	Minimum important difference, responders, medication use and patient-important outcomes	Material needed: Responder, important-difference and patient-outcome material. This records needed materials; no new research was executed.
22	Partly verified	Full text not readStored summary read	N22 · Evidence conditionIs the conventional-curcumin trial in 44 people the same intervention?Required	The separate report concerns conventional curcumin in 44 women. Retained results are between-group P=.052 and within-group P=.014. S02	Information in stored summaries is linked to gaps in detailed material. External original-source comparison and content review remain incomplete; effects, safety, prespecification, independence or fulfilled conditions are not certified.	A trial in 44 women using conventional curcumin 500 mg, 2 times per 1 day, over 8 weeks	Material needed: Separate original paper, result tables and intervention specifications. This records needed materials; no new research was executed.
23	Partly verified	Full text not readStored summary read	N23 · Evidence conditionWhat differences separate the trials?Required	The reports differ in formulation, dose and population wording. They are not combined as the same effect or a common denominator. S01 S02	Information in stored summaries is linked to gaps in detailed material. External original-source comparison and content review remain incomplete; effects, safety, prespecification, independence or fulfilled conditions are not certified.	Distinction between a phospholipid formulation at 250 mg/day and conventional curcumin 500 mg, 2 times per 1 day	Material needed: Trial-specific intervention, population and analysis specifications. This records needed materials; no new research was executed.
24	Unverified	Full text not readStored summary read	N24 · Evidence conditionAre mechanistic, omega-3 and CoQ10 reports counted as clinical replication?Required	The original record states that CGRP/inflammatory-marker and omega-3/CoQ10 combination trials were excluded from independent clinical-frequency replication. S01 S02	Information in stored summaries is linked to gaps in detailed material. External original-source comparison and content review remain incomplete; effects, safety, prespecification, independence or fulfilled conditions are not certified.	Directness of mechanistic markers and combination trials	Material needed: Related-report lists, cohorts, interventions and endpoint material. This records needed materials; no new research was executed.
25	Unverified	Full text not readStored summary read	N25 · Evidence conditionHow far are unique trials and independent replications established?Required	The direct formulation-specific report is separated from the boundary report of another formulation. The counts of 70 and 44 participants and 65 completers are not added. S01 S02	Information in stored summaries is linked to gaps in detailed material. External original-source comparison and content review remain incomplete; effects, safety, prespecification, independence or fulfilled conditions are not certified.	Report-trial-endpoint relationships and independence	Material needed: Report-trial mapping and specifications of replication-study interventions. This records needed materials; no new research was executed.
26	Unverified	Full text not readStored summary read	N26 · Evidence conditionWhat information is retained on research funding?Required	The direct report is retained as declaring no conflicts with funding details unverified; the separate report is retained as academic-institution research with funding details unverified. S01 S02	Information in stored summaries is linked to gaps in detailed material. External original-source comparison and content review remain incomplete; effects, safety, prespecification, independence or fulfilled conditions are not certified.	Funding for the direct trial and the separate academic-institution trial	Material needed: Original funding and institutional-role statements. This records needed materials; no new research was executed.
27	Unverified	Full text not readStored summary read	N27 · Evidence conditionAre product supply and manufacturer involvement known?Required	The retained direct report says product-supply details remain unverified. S01	Information in stored summaries is linked to gaps in detailed material. External original-source comparison and content review remain incomplete; effects, safety, prespecification, independence or fulfilled conditions are not certified.	Free product support, manufacturer, batches and institutional roles	Material needed: Product-supply and manufacturer-role material. This records needed materials; no new research was executed.
28	Partly verified	Full text not readStored summary read	N28 · Evidence conditionDoes no-conflict wording answer employee-authorship and support questions?Required	The direct report wording that authors declared no conflicts is retained. S01 S02	Information in stored summaries is linked to gaps in detailed material. External original-source comparison and content review remain incomplete; effects, safety, prespecification, independence or fulfilled conditions are not certified.	Distinction among COI declarations, affiliations, employee authors and individual support	Material needed: Original COI, affiliation and support statements. This records needed materials; no new research was executed.
29	Unverified	Full text not readStored summary read	N29 · Evidence conditionDoes no reported adverse reaction establish safety?Supplementary	The original record says no adverse effects were reported in the trial. S01	Information in stored summaries is linked to gaps in detailed material. External original-source comparison and content review remain incomplete; effects, safety, prespecification, independence or fulfilled conditions are not certified.	Adverse-event definitions, collection, group-specific events and exposure denominators	Material needed: Adverse-event collection methods and group-specific tables. This records needed materials; no new research was executed.
30	Unverified	Full text not readStored summary read	N30 · Evidence conditionAre harms beyond 8 weeks and concurrent-treatment risks answered?Supplementary	The original record limits interpretation: 65 people over 8 weeks cannot exclude rare harms or long-term add-on safety concerns. S01	Information in stored summaries is linked to gaps in detailed material. External original-source comparison and content review remain incomplete; effects, safety, prespecification, independence or fulfilled conditions are not certified.	Follow-up of long-term/rare harms, concurrent medication and vulnerable groups	Material needed: Long-term follow-up, concurrent-medication and harm-denominator material. This records needed materials; no new research was executed.
31	Partly verified	Full text not readStored summary read	N31 · Evidence conditionCan findings be extended to replacing preventive medication or other products?Required	The original record limits preventive-medication replacement claims and claims of the same effect for conventional turmeric, nano formulations or combinations. S01 S02	Information in stored summaries is linked to gaps in detailed material. External original-source comparison and content review remain incomplete; effects, safety, prespecification, independence or fulfilled conditions are not certified.	Distinction between add-on and replacement treatment and conventional turmeric, nano formulations and combinations	Material needed: Direct comparisons for replacement treatment and other formulations. This records needed materials; no new research was executed.
32	Partly verified	Full text not readStored summary read	N32 · Evidence conditionWhat are the current English wording and historical language correction?Required	The current English wording separates P=.052 for another formulation from unverified values in the direct trial. The correction history for 2 English fields is retained. S01 S02	Information in stored summaries is linked to gaps in detailed material. External original-source comparison and content review remain incomplete; effects, safety, prespecification, independence or fulfilled conditions are not certified.	Retained Korean/English wording, generic English text and the correction event of 2026-09-14	Material needed: Original wording before/after correction and language-mapping material. This records needed materials; no new research was executed.
33	Partly verified	Full text not readStored summary read	N33 · Evidence conditionHow are the original C score of 50, axes and historical verification retained?Required	The C score of 50, original axes and previous independent cross-check are existing records. They are not inherited as fulfilled conditions or completed content review for this table. S01 S02	Information in stored summaries is linked to gaps in detailed material. External original-source comparison and content review remain incomplete; effects, safety, prespecification, independence or fulfilled conditions are not certified.	Historical preservation of the current original grade, score, EX/CX, axes and previous cross-check	Material needed: Additional 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 dates, unrecorded information and actual reading scope are retained?Required	Preparation read the complete stored summary. The original verdict date is 2026-09-08 and the correction date is 2026-09-14. Empty lists of additional detailed claims and deliberation records are also preserved. S01 S02	Information in stored summaries is linked to gaps in detailed material. External original-source comparison and content review remain incomplete; effects, safety, prespecification, independence or fulfilled conditions are not certified.	Original verdict date, correction date, empty detailed-claim list and external material unread	Material needed: Required originals and planning material 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: The retained material date 2026-09-08 is the original verdict date, not an external-reading date for this work. The date 2026-10-06 is a production date, not a completed-review date. Current external access, acquisition and reading remain separately unverified.
Population: Adults with migraine without aura who continued standard treatment
Ingredient, formulation and route: Oral add-on phytosomal curcumin derived from Curcuma longa in a phospholipid delivery system, distinguished from conventional, nano, micellar and combination formulations.
Dose: Phytosomal formulation at 250 mg/day. This is not changed into another formulation dose or a converted active-ingredient amount.
Comparator: Maltodextrin placebo added to standard treatment. Details of concurrent medication, rescue medication and placebo conditions remain unverified.
Measured outcome: Change in attack frequency at 8 weeks. Whether it was the single prespecified primary endpoint (1st in the hierarchy) and its exact between-group effect, confidence interval and significance value remain unverified.
Duration: Treatment and follow-up over 8 weeks. Persistence afterward and long-term follow-up remain unverified.
Questions outside this scope: Transfer of effects to conventional curcumin, nano/micellar formulations or other products; Substitution of CGRP or inflammatory markers for clinical attack-frequency effects; Counting omega-3/CoQ10 combination trials as replication of a single phytosomal formulation; Stopping/replacing preventive medication or establishing long-term safety

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 · Shojaei et al. (2025): Effect and Safety of Phytosomal Curcumin Supplementation on Migraine Patients: A Randomized, Double-Blind and Placebo-Controlled Trial

PubMed

Material type: Report of a randomized double-blind placebo-add-on trial
Materials actually read: Stored summary and bibliography read; external paper, registration and planning material unread
Findings recorded in the stored summary: Trial at 250 mg/day over 8 weeks: 70 randomized, 65 completed (33 versus 32). The summary of broadly positive abstract results, including frequency, is retained, while the exact frequency-specific between-group contrast, 95% CI, P value and ITT denominator remain unverified.
Record level: Formulation-specific directional information in a stored summary; exact effect unverified
Study overlap and independent replication: The direct phytosomal-formulation report is separated from the conventional-curcumin boundary report. The 70 randomized participants, 65 completers and 44 women in the other trial are not added together. Unique trials, participant totals and independent replications for the same formulation remain unverified.

Public availability, access and reading status by material
Material	Public availability	Access status	Actually read	Notes
Stored existing review summary	Existing stored summary acquired	Stored summary	Stored summary read	The stored existing evidence and bibliography summary was read. Shojaei M et al. Chin J Integr Med. 2025;31:963-972. PMID: 41136816. DOI: 10.1007/s11655-025-3939-1. IRCT20201129049534N2. The bibliographic IRCT20201129049534N2 is distinguished from the unverified registration status in the original record. Actual reading of registration content, prospective timing, endpoints and changes remains unverified. The retained material date 2026-09-08 is the original verdict date, not an external-reading date for this work. The date 2026-10-06 is a production date, not a completed-review date. Current external access, acquisition and reading remain separately unverified.
External article, abstract and full text	Original bibliography link only; external content unread	Unread; no access attempt	Unread	Only the bibliographic article/abstract/full-text link is retained. External content is unread, with no access attempt. The bibliographic IRCT20201129049534N2 is distinguished from the unverified registration status in the original record. Actual reading of registration content, prospective timing, endpoints and changes remains unverified. The retained material date 2026-09-08 is the original verdict date, not an external-reading date for this work. The date 2026-10-06 is a production date, not a completed-review date. Current external access, acquisition and reading remain separately unverified.
Registration material	Needed material; existence and public availability unverified	Unread; no access attempt	Unread	Original registration/changes and prespecified endpoints remain unread. The bibliographic IRCT20201129049534N2 is distinguished from the unverified registration status in the original record. Actual reading of registration content, prospective timing, endpoints and changes remains unverified. The retained material date 2026-09-08 is the original verdict date, not an external-reading date for this work. The date 2026-10-06 is a production date, not a completed-review date. Current external access, acquisition and reading remain separately unverified.
Protocol	Needed material; existence and public availability unverified	Unread; no access attempt	Unread	The original protocol and its changes remain unread. The bibliographic IRCT20201129049534N2 is distinguished from the unverified registration status in the original record. Actual reading of registration content, prospective timing, endpoints and changes remains unverified. The retained material date 2026-09-08 is the original verdict date, not an external-reading date for this work. The date 2026-10-06 is a production date, not a completed-review date. Current external access, acquisition and reading remain separately unverified.
Statistical analysis plan (SAP)	Needed material; existence and public availability unverified	Unread; no access attempt	Unread	The original prespecified statistical analysis plan and multiplicity plan remain unread. The bibliographic IRCT20201129049534N2 is distinguished from the unverified registration status in the original record. Actual reading of registration content, prospective timing, endpoints and changes remains unverified. The retained material date 2026-09-08 is the original verdict date, not an external-reading date for this work. The date 2026-10-06 is a production date, not a completed-review date. Current external access, acquisition and reading remain separately unverified.
Funding, product-support and conflict material	Needed material; existence and public availability unverified	Unread; no access attempt	Unread	Original funding, product-support, employee-authorship and conflict disclosures remain unread. The bibliographic IRCT20201129049534N2 is distinguished from the unverified registration status in the original record. Actual reading of registration content, prospective timing, endpoints and changes remains unverified. The retained material date 2026-09-08 is the original verdict date, not an external-reading date for this work. The date 2026-10-06 is a production date, not a completed-review date. Current external access, acquisition and reading remain separately unverified.

S02 · Rezaie et al. (2021): Effects of Curcumin Supplementation on Clinical Features and Inflammation, in Migraine Patients: A Double-Blind Controlled, Placebo Randomized Clinical Trial

PubMed

Material type: Report of a randomized double-blind placebo-controlled trial of another formulation
Materials actually read: Stored summary and bibliography read; external paper, registration and planning material unread
Findings recorded in the stored summary: Trial in 44 women using conventional curcumin 500 mg, 2 times per 1 day for 8 weeks: between-group P=.052 and within-group P=.014. The formulation differs; these comparisons are not confused or transferred to the phytosomal trial.
Record level: Between/within-group significance values for another formulation; not phytosomal effect estimates
Study overlap and independent replication: The direct phytosomal-formulation report is separated from the conventional-curcumin boundary report. The 70 randomized participants, 65 completers and 44 women in the other trial are not added together. Unique trials, participant totals and independent replications for the same formulation remain unverified.

Public availability, access and reading status by material
Material	Public availability	Access status	Actually read	Notes
Stored existing review summary	Existing stored summary acquired	Stored summary	Stored summary read	The stored existing evidence and bibliography summary was read. Rezaie S et al. Int J Prev Med. 2021;12:161. PMID: 35070194. PMCID: PMC8724631. DOI: 10.4103/ijpvm.IJPVM_405_20. The bibliographic PMC8724631 is identifying information and does not establish full-text reading in this work. Registration status in the original record remains unverified, and shared historical review wording is not inherited as current reading of this report. The retained material date 2026-09-08 is the original verdict date, not an external-reading date for this work. The date 2026-10-06 is a production date, not a completed-review date. Current external access, acquisition and reading remain separately unverified.
External article, abstract and full text	Original bibliography link only; external content unread	Unread; no access attempt	Unread	Only the bibliographic article/abstract/full-text link is retained. External content is unread, with no access attempt. The bibliographic PMC8724631 is identifying information and does not establish full-text reading in this work. Registration status in the original record remains unverified, and shared historical review wording is not inherited as current reading of this report. The retained material date 2026-09-08 is the original verdict date, not an external-reading date for this work. The date 2026-10-06 is a production date, not a completed-review date. Current external access, acquisition and reading remain separately unverified.
Registration material	Needed material; existence and public availability unverified	Unread; no access attempt	Unread	Original registration/changes and prespecified endpoints remain unread. The bibliographic PMC8724631 is identifying information and does not establish full-text reading in this work. Registration status in the original record remains unverified, and shared historical review wording is not inherited as current reading of this report. The retained material date 2026-09-08 is the original verdict date, not an external-reading date for this work. The date 2026-10-06 is a production date, not a completed-review date. Current external access, acquisition and reading remain separately unverified.
Protocol	Needed material; existence and public availability unverified	Unread; no access attempt	Unread	The original protocol and its changes remain unread. The bibliographic PMC8724631 is identifying information and does not establish full-text reading in this work. Registration status in the original record remains unverified, and shared historical review wording is not inherited as current reading of this report. The retained material date 2026-09-08 is the original verdict date, not an external-reading date for this work. The date 2026-10-06 is a production date, not a completed-review date. Current external access, acquisition and reading remain separately unverified.
Statistical analysis plan (SAP)	Needed material; existence and public availability unverified	Unread; no access attempt	Unread	The original prespecified statistical analysis plan and multiplicity plan remain unread. The bibliographic PMC8724631 is identifying information and does not establish full-text reading in this work. Registration status in the original record remains unverified, and shared historical review wording is not inherited as current reading of this report. The retained material date 2026-09-08 is the original verdict date, not an external-reading date for this work. The date 2026-10-06 is a production date, not a completed-review date. Current external access, acquisition and reading remain separately unverified.
Funding, product-support and conflict material	Needed material; existence and public availability unverified	Unread; no access attempt	Unread	Original funding, product-support, employee-authorship and conflict disclosures remain unread. The bibliographic PMC8724631 is identifying information and does not establish full-text reading in this work. Registration status in the original record remains unverified, and shared historical review wording is not inherited as current reading of this report. The retained material date 2026-09-08 is the original verdict date, not an external-reading date for this work. The date 2026-10-06 is a production date, not a completed-review date. Current external access, acquisition and reading remain separately unverified.

Report counts versus independent study counts

The direct phytosomal-formulation report is separated from the conventional-curcumin boundary report. The 70 randomized participants, 65 completers and 44 women in the other trial are not added together. Unique trials, participant totals and independent replications for the same formulation 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 migraine-attack frequency question is covered?

Required materials and conditions: An 8-week phytosomal-curcumin add-on comparison for migraine without aura
Conditions for verification: Original material and analysis scope on An 8-week phytosomal-curcumin add-on comparison for migraine without aura must link to formulation, dose, duration, population, add-on comparison and the frequency endpoint, distinguishing stored information from what remains unverified.
Requirement and applicability: Required
Application exceptions: Between-group or within-group values from another formulation are not transferred to the phytosomal formulation. Allocation, completion and analysis denominators are not interchanged or added; new effects, confidence intervals, daily totals or withdrawal counts are not calculated. Frequency results are not extended to other endpoints, long-term safety or replacement of preventive medication.
Why this condition is needed: Material on An 8-week phytosomal-curcumin add-on comparison for migraine without aura is needed to connect the selected formulation, population, common treatment, frequency endpoint, denominators, comparison scope or harm gaps.
Referenced methods: Existing principles distinguish population, formulation, oral dose, add-on treatment, frequency endpoint, prespecified hierarchy, between/within-group comparisons, denominators, overlapping reports, support and harms in the retained phytosomal-curcumin and other-formulation reports.

N02 · Which adults with migraine are represented?

Required materials and conditions: Diagnosis of migraine without aura, adult eligibility and continuation of standard treatment
Conditions for verification: Original material and analysis scope on Diagnosis of migraine without aura, adult eligibility and continuation of standard treatment must link to formulation, dose, duration, population, add-on comparison and the frequency endpoint, distinguishing stored information from what remains unverified.
Requirement and applicability: Required
Application exceptions: Between-group or within-group values from another formulation are not transferred to the phytosomal formulation. Allocation, completion and analysis denominators are not interchanged or added; new effects, confidence intervals, daily totals or withdrawal counts are not calculated. Frequency results are not extended to other endpoints, long-term safety or replacement of preventive medication.
Why this condition is needed: Material on Diagnosis of migraine without aura, adult eligibility and continuation of standard treatment is needed to connect the selected formulation, population, common treatment, frequency endpoint, denominators, comparison scope or harm gaps.
Referenced methods: Existing principles distinguish population, formulation, oral dose, add-on treatment, frequency endpoint, prespecified hierarchy, between/within-group comparisons, denominators, overlapping reports, support and harms in the retained phytosomal-curcumin and other-formulation reports.

N03 · Is the phytosomal formulation interchangeable with other curcumin?

Required materials and conditions: Distinction between a phospholipid delivery system and conventional, nano, micellar and combination formulations
Conditions for verification: Original material and analysis scope on Distinction between a phospholipid delivery system and conventional, nano, micellar and combination formulations must link to formulation, dose, duration, population, add-on comparison and the frequency endpoint, distinguishing stored information from what remains unverified.
Requirement and applicability: Required
Application exceptions: Between-group or within-group values from another formulation are not transferred to the phytosomal formulation. Allocation, completion and analysis denominators are not interchanged or added; new effects, confidence intervals, daily totals or withdrawal counts are not calculated. Frequency results are not extended to other endpoints, long-term safety or replacement of preventive medication.
Why this condition is needed: Material on Distinction between a phospholipid delivery system and conventional, nano, micellar and combination formulations is needed to connect the selected formulation, population, common treatment, frequency endpoint, denominators, comparison scope or harm gaps.
Referenced methods: Existing principles distinguish population, formulation, oral dose, add-on treatment, frequency endpoint, prespecified hierarchy, between/within-group comparisons, denominators, overlapping reports, support and harms in the retained phytosomal-curcumin and other-formulation reports.

N04 · What were the dose and actual intake?

Required materials and conditions: Phytosomal curcumin 250 mg/day and actual adherence
Conditions for verification: Original material and analysis scope on Phytosomal curcumin 250 mg/day and actual adherence must link to formulation, dose, duration, population, add-on comparison and the frequency endpoint, distinguishing stored information from what remains unverified.
Requirement and applicability: Required
Application exceptions: Between-group or within-group values from another formulation are not transferred to the phytosomal formulation. Allocation, completion and analysis denominators are not interchanged or added; new effects, confidence intervals, daily totals or withdrawal counts are not calculated. Frequency results are not extended to other endpoints, long-term safety or replacement of preventive medication.
Why this condition is needed: Material on Phytosomal curcumin 250 mg/day and actual adherence is needed to connect the selected formulation, population, common treatment, frequency endpoint, denominators, comparison scope or harm gaps.
Referenced methods: Existing principles distinguish population, formulation, oral dose, add-on treatment, frequency endpoint, prespecified hierarchy, between/within-group comparisons, denominators, overlapping reports, support and harms in the retained phytosomal-curcumin and other-formulation reports.

N05 · What were the treatment and follow-up times?

Required materials and conditions: Treatment/follow-up over 8 weeks and persistence after stopping
Conditions for verification: Original material and analysis scope on Treatment/follow-up over 8 weeks and persistence after stopping must link to formulation, dose, duration, population, add-on comparison and the frequency endpoint, distinguishing stored information from what remains unverified.
Requirement and applicability: Required
Application exceptions: Between-group or within-group values from another formulation are not transferred to the phytosomal formulation. Allocation, completion and analysis denominators are not interchanged or added; new effects, confidence intervals, daily totals or withdrawal counts are not calculated. Frequency results are not extended to other endpoints, long-term safety or replacement of preventive medication.
Why this condition is needed: Material on Treatment/follow-up over 8 weeks and persistence after stopping is needed to connect the selected formulation, population, common treatment, frequency endpoint, denominators, comparison scope or harm gaps.
Referenced methods: Existing principles distinguish population, formulation, oral dose, add-on treatment, frequency endpoint, prespecified hierarchy, between/within-group comparisons, denominators, overlapping reports, support and harms in the retained phytosomal-curcumin and other-formulation reports.

N06 · What was the contribution of standard treatment and concurrent medication?

Required materials and conditions: Continuation/changes in standard treatment, preventive medication and rescue medication in both groups
Conditions for verification: Original material and analysis scope on Continuation/changes in standard treatment, preventive medication and rescue medication in both groups must link to formulation, dose, duration, population, add-on comparison and the frequency endpoint, distinguishing stored information from what remains unverified.
Requirement and applicability: Required
Application exceptions: Between-group or within-group values from another formulation are not transferred to the phytosomal formulation. Allocation, completion and analysis denominators are not interchanged or added; new effects, confidence intervals, daily totals or withdrawal counts are not calculated. Frequency results are not extended to other endpoints, long-term safety or replacement of preventive medication.
Why this condition is needed: Material on Continuation/changes in standard treatment, preventive medication and rescue medication in both groups is needed to connect the selected formulation, population, common treatment, frequency endpoint, denominators, comparison scope or harm gaps.
Referenced methods: Existing principles distinguish population, formulation, oral dose, add-on treatment, frequency endpoint, prespecified hierarchy, between/within-group comparisons, denominators, overlapping reports, support and harms in the retained phytosomal-curcumin and other-formulation reports.

N07 · What was the maltodextrin-placebo comparison?

Required materials and conditions: Conditions of maltodextrin placebo added to standard treatment
Conditions for verification: Original material and analysis scope on Conditions of maltodextrin placebo added to standard treatment must link to formulation, dose, duration, population, add-on comparison and the frequency endpoint, distinguishing stored information from what remains unverified.
Requirement and applicability: Required
Application exceptions: Between-group or within-group values from another formulation are not transferred to the phytosomal formulation. Allocation, completion and analysis denominators are not interchanged or added; new effects, confidence intervals, daily totals or withdrawal counts are not calculated. Frequency results are not extended to other endpoints, long-term safety or replacement of preventive medication.
Why this condition is needed: Material on Conditions of maltodextrin placebo added to standard treatment is needed to connect the selected formulation, population, common treatment, frequency endpoint, denominators, comparison scope or harm gaps.
Referenced methods: Existing principles distinguish population, formulation, oral dose, add-on treatment, frequency endpoint, prespecified hierarchy, between/within-group comparisons, denominators, overlapping reports, support and harms in the retained phytosomal-curcumin and other-formulation reports.

N08 · How is the direct report identified?

Required materials and conditions: Shojaei report title, PMID, DOI and retained result
Conditions for verification: Original material and analysis scope on Shojaei report title, PMID, DOI and retained result must link to formulation, dose, duration, population, add-on comparison and the frequency endpoint, distinguishing stored information from what remains unverified.
Requirement and applicability: Required
Application exceptions: Between-group or within-group values from another formulation are not transferred to the phytosomal formulation. Allocation, completion and analysis denominators are not interchanged or added; new effects, confidence intervals, daily totals or withdrawal counts are not calculated. Frequency results are not extended to other endpoints, long-term safety or replacement of preventive medication.
Why this condition is needed: Material on Shojaei report title, PMID, DOI and retained result is needed to connect the selected formulation, population, common treatment, frequency endpoint, denominators, comparison scope or harm gaps.
Referenced methods: Existing principles distinguish population, formulation, oral dose, add-on treatment, frequency endpoint, prespecified hierarchy, between/within-group comparisons, denominators, overlapping reports, support and harms in the retained phytosomal-curcumin and other-formulation reports.

N09 · Is an IRCT number the same as actual registration verification?

Required materials and conditions: IRCT20201129049534N2, registration timing, endpoints and history
Conditions for verification: Original material and analysis scope on IRCT20201129049534N2, registration timing, endpoints and history must link to formulation, dose, duration, population, add-on comparison and the frequency endpoint, distinguishing stored information from what remains unverified.
Requirement and applicability: Required
Application exceptions: Between-group or within-group values from another formulation are not transferred to the phytosomal formulation. Allocation, completion and analysis denominators are not interchanged or added; new effects, confidence intervals, daily totals or withdrawal counts are not calculated. Frequency results are not extended to other endpoints, long-term safety or replacement of preventive medication.
Why this condition is needed: Material on IRCT20201129049534N2, registration timing, endpoints and history is needed to connect the selected formulation, population, common treatment, frequency endpoint, denominators, comparison scope or harm gaps.
Referenced methods: Existing principles distinguish population, formulation, oral dose, add-on treatment, frequency endpoint, prespecified hierarchy, between/within-group comparisons, denominators, overlapping reports, support and harms in the retained phytosomal-curcumin and other-formulation reports.

N10 · Was attack frequency the single prespecified primary endpoint (1st in the hierarchy)?

Required materials and conditions: Prespecified hierarchy, analysis and timing for frequency among multiple clinical endpoints
Conditions for verification: Original material and analysis scope on Prespecified hierarchy, analysis and timing for frequency among multiple clinical endpoints must link to formulation, dose, duration, population, add-on comparison and the frequency endpoint, distinguishing stored information from what remains unverified.
Requirement and applicability: Required
Application exceptions: Between-group or within-group values from another formulation are not transferred to the phytosomal formulation. Allocation, completion and analysis denominators are not interchanged or added; new effects, confidence intervals, daily totals or withdrawal counts are not calculated. Frequency results are not extended to other endpoints, long-term safety or replacement of preventive medication.
Why this condition is needed: Material on Prespecified hierarchy, analysis and timing for frequency among multiple clinical endpoints is needed to connect the selected formulation, population, common treatment, frequency endpoint, denominators, comparison scope or harm gaps.
Referenced methods: Existing principles distinguish population, formulation, oral dose, add-on treatment, frequency endpoint, prespecified hierarchy, between/within-group comparisons, denominators, overlapping reports, support and harms in the retained phytosomal-curcumin and other-formulation reports.

N11 · What were the randomization and concealment methods?

Required materials and conditions: Randomization procedures, concealment and recruitment flow
Conditions for verification: Original material and analysis scope on Randomization procedures, concealment and recruitment flow must link to formulation, dose, duration, population, add-on comparison and the frequency endpoint, distinguishing stored information from what remains unverified.
Requirement and applicability: Required
Application exceptions: Between-group or within-group values from another formulation are not transferred to the phytosomal formulation. Allocation, completion and analysis denominators are not interchanged or added; new effects, confidence intervals, daily totals or withdrawal counts are not calculated. Frequency results are not extended to other endpoints, long-term safety or replacement of preventive medication.
Why this condition is needed: Material on Randomization procedures, concealment and recruitment flow is needed to connect the selected formulation, population, common treatment, frequency endpoint, denominators, comparison scope or harm gaps.
Referenced methods: Existing principles distinguish population, formulation, oral dose, add-on treatment, frequency endpoint, prespecified hierarchy, between/within-group comparisons, denominators, overlapping reports, support and harms in the retained phytosomal-curcumin and other-formulation reports.

N12 · How were blinding and outcome measurement maintained?

Required materials and conditions: Participant/assessor blinding and placebo matching
Conditions for verification: Original material and analysis scope on Participant/assessor blinding and placebo matching must link to formulation, dose, duration, population, add-on comparison and the frequency endpoint, distinguishing stored information from what remains unverified.
Requirement and applicability: Required
Application exceptions: Between-group or within-group values from another formulation are not transferred to the phytosomal formulation. Allocation, completion and analysis denominators are not interchanged or added; new effects, confidence intervals, daily totals or withdrawal counts are not calculated. Frequency results are not extended to other endpoints, long-term safety or replacement of preventive medication.
Why this condition is needed: Material on Participant/assessor blinding and placebo matching is needed to connect the selected formulation, population, common treatment, frequency endpoint, denominators, comparison scope or harm gaps.
Referenced methods: Existing principles distinguish population, formulation, oral dose, add-on treatment, frequency endpoint, prespecified hierarchy, between/within-group comparisons, denominators, overlapping reports, support and harms in the retained phytosomal-curcumin and other-formulation reports.

N13 · How are 70 randomized participants and 65 completers distinguished?

Required materials and conditions: The 70 randomized participants, 65 completers and group correspondence for 33 versus 32
Conditions for verification: Original material and analysis scope on The 70 randomized participants, 65 completers and group correspondence for 33 versus 32 must link to formulation, dose, duration, population, add-on comparison and the frequency endpoint, distinguishing stored information from what remains unverified.
Requirement and applicability: Required
Application exceptions: Between-group or within-group values from another formulation are not transferred to the phytosomal formulation. Allocation, completion and analysis denominators are not interchanged or added; new effects, confidence intervals, daily totals or withdrawal counts are not calculated. Frequency results are not extended to other endpoints, long-term safety or replacement of preventive medication.
Why this condition is needed: Material on The 70 randomized participants, 65 completers and group correspondence for 33 versus 32 is needed to connect the selected formulation, population, common treatment, frequency endpoint, denominators, comparison scope or harm gaps.
Referenced methods: Existing principles distinguish population, formulation, oral dose, add-on treatment, frequency endpoint, prespecified hierarchy, between/within-group comparisons, denominators, overlapping reports, support and harms in the retained phytosomal-curcumin and other-formulation reports.

N14 · What was the exact ITT analysis population?

Required materials and conditions: ITT, completer analyses and inclusion criteria for the frequency result
Conditions for verification: Original material and analysis scope on ITT, completer analyses and inclusion criteria for the frequency result must link to formulation, dose, duration, population, add-on comparison and the frequency endpoint, distinguishing stored information from what remains unverified.
Requirement and applicability: Required
Application exceptions: Between-group or within-group values from another formulation are not transferred to the phytosomal formulation. Allocation, completion and analysis denominators are not interchanged or added; new effects, confidence intervals, daily totals or withdrawal counts are not calculated. Frequency results are not extended to other endpoints, long-term safety or replacement of preventive medication.
Why this condition is needed: Material on ITT, completer analyses and inclusion criteria for the frequency result is needed to connect the selected formulation, population, common treatment, frequency endpoint, denominators, comparison scope or harm gaps.
Referenced methods: Existing principles distinguish population, formulation, oral dose, add-on treatment, frequency endpoint, prespecified hierarchy, between/within-group comparisons, denominators, overlapping reports, support and harms in the retained phytosomal-curcumin and other-formulation reports.

N15 · What effects could missingness and withdrawal have?

Required materials and conditions: Group-specific withdrawal reasons, missing-data handling and sensitivity analyses
Conditions for verification: Original material and analysis scope on Group-specific withdrawal reasons, missing-data handling and sensitivity analyses must link to formulation, dose, duration, population, add-on comparison and the frequency endpoint, distinguishing stored information from what remains unverified.
Requirement and applicability: Required
Application exceptions: Between-group or within-group values from another formulation are not transferred to the phytosomal formulation. Allocation, completion and analysis denominators are not interchanged or added; new effects, confidence intervals, daily totals or withdrawal counts are not calculated. Frequency results are not extended to other endpoints, long-term safety or replacement of preventive medication.
Why this condition is needed: Material on Group-specific withdrawal reasons, missing-data handling and sensitivity analyses is needed to connect the selected formulation, population, common treatment, frequency endpoint, denominators, comparison scope or harm gaps.
Referenced methods: Existing principles distinguish population, formulation, oral dose, add-on treatment, frequency endpoint, prespecified hierarchy, between/within-group comparisons, denominators, overlapping reports, support and harms in the retained phytosomal-curcumin and other-formulation reports.

N16 · In which units was attack frequency measured?

Required materials and conditions: Attack definition, frequency per period, diaries and baseline values
Conditions for verification: Original material and analysis scope on Attack definition, frequency per period, diaries and baseline values must link to formulation, dose, duration, population, add-on comparison and the frequency endpoint, distinguishing stored information from what remains unverified.
Requirement and applicability: Required
Application exceptions: Between-group or within-group values from another formulation are not transferred to the phytosomal formulation. Allocation, completion and analysis denominators are not interchanged or added; new effects, confidence intervals, daily totals or withdrawal counts are not calculated. Frequency results are not extended to other endpoints, long-term safety or replacement of preventive medication.
Why this condition is needed: Material on Attack definition, frequency per period, diaries and baseline values is needed to connect the selected formulation, population, common treatment, frequency endpoint, denominators, comparison scope or harm gaps.
Referenced methods: Existing principles distinguish population, formulation, oral dose, add-on treatment, frequency endpoint, prespecified hierarchy, between/within-group comparisons, denominators, overlapping reports, support and harms in the retained phytosomal-curcumin and other-formulation reports.

N17 · What was the exact between-group effect on frequency?

Required materials and conditions: Frequency-specific between-group change and analysis model
Conditions for verification: Original material and analysis scope on Frequency-specific between-group change and analysis model must link to formulation, dose, duration, population, add-on comparison and the frequency endpoint, distinguishing stored information from what remains unverified.
Requirement and applicability: Required
Application exceptions: Between-group or within-group values from another formulation are not transferred to the phytosomal formulation. Allocation, completion and analysis denominators are not interchanged or added; new effects, confidence intervals, daily totals or withdrawal counts are not calculated. Frequency results are not extended to other endpoints, long-term safety or replacement of preventive medication.
Why this condition is needed: Material on Frequency-specific between-group change and analysis model is needed to connect the selected formulation, population, common treatment, frequency endpoint, denominators, comparison scope or harm gaps.
Referenced methods: Existing principles distinguish population, formulation, oral dose, add-on treatment, frequency endpoint, prespecified hierarchy, between/within-group comparisons, denominators, overlapping reports, support and harms in the retained phytosomal-curcumin and other-formulation reports.

N18 · Is there a confidence interval for the frequency effect?

Required materials and conditions: Exact frequency-specific between-group 95% CI
Conditions for verification: Original material and analysis scope on Exact frequency-specific between-group 95% CI must link to formulation, dose, duration, population, add-on comparison and the frequency endpoint, distinguishing stored information from what remains unverified.
Requirement and applicability: Required
Application exceptions: Between-group or within-group values from another formulation are not transferred to the phytosomal formulation. Allocation, completion and analysis denominators are not interchanged or added; new effects, confidence intervals, daily totals or withdrawal counts are not calculated. Frequency results are not extended to other endpoints, long-term safety or replacement of preventive medication.
Why this condition is needed: Material on Exact frequency-specific between-group 95% CI is needed to connect the selected formulation, population, common treatment, frequency endpoint, denominators, comparison scope or harm gaps.
Referenced methods: Existing principles distinguish population, formulation, oral dose, add-on treatment, frequency endpoint, prespecified hierarchy, between/within-group comparisons, denominators, overlapping reports, support and harms in the retained phytosomal-curcumin and other-formulation reports.

N19 · What was the P value in the direct phytosomal trial?

Required materials and conditions: Exact frequency-specific between-group P value, distinguished from values in another trial
Conditions for verification: Original material and analysis scope on Exact frequency-specific between-group P value, distinguished from values in another trial must link to formulation, dose, duration, population, add-on comparison and the frequency endpoint, distinguishing stored information from what remains unverified.
Requirement and applicability: Required
Application exceptions: Between-group or within-group values from another formulation are not transferred to the phytosomal formulation. Allocation, completion and analysis denominators are not interchanged or added; new effects, confidence intervals, daily totals or withdrawal counts are not calculated. Frequency results are not extended to other endpoints, long-term safety or replacement of preventive medication.
Why this condition is needed: Material on Exact frequency-specific between-group P value, distinguished from values in another trial is needed to connect the selected formulation, population, common treatment, frequency endpoint, denominators, comparison scope or harm gaps.
Referenced methods: Existing principles distinguish population, formulation, oral dose, add-on treatment, frequency endpoint, prespecified hierarchy, between/within-group comparisons, denominators, overlapping reports, support and harms in the retained phytosomal-curcumin and other-formulation reports.

N20 · Are other clinical endpoints distinguished from frequency?

Required materials and conditions: Separate results for frequency, duration, intensity, quality of life and sleep
Conditions for verification: Original material and analysis scope on Separate results for frequency, duration, intensity, quality of life and sleep must link to formulation, dose, duration, population, add-on comparison and the frequency endpoint, distinguishing stored information from what remains unverified.
Requirement and applicability: Required
Application exceptions: Between-group or within-group values from another formulation are not transferred to the phytosomal formulation. Allocation, completion and analysis denominators are not interchanged or added; new effects, confidence intervals, daily totals or withdrawal counts are not calculated. Frequency results are not extended to other endpoints, long-term safety or replacement of preventive medication.
Why this condition is needed: Material on Separate results for frequency, duration, intensity, quality of life and sleep is needed to connect the selected formulation, population, common treatment, frequency endpoint, denominators, comparison scope or harm gaps.
Referenced methods: Existing principles distinguish population, formulation, oral dose, add-on treatment, frequency endpoint, prespecified hierarchy, between/within-group comparisons, denominators, overlapping reports, support and harms in the retained phytosomal-curcumin and other-formulation reports.

N21 · Was the change in attack count important to patients?

Required materials and conditions: Minimum important difference, responders, medication use and patient-important outcomes
Conditions for verification: Original material and analysis scope on Minimum important difference, responders, medication use and patient-important outcomes must link to formulation, dose, duration, population, add-on comparison and the frequency endpoint, distinguishing stored information from what remains unverified.
Requirement and applicability: Required
Application exceptions: Between-group or within-group values from another formulation are not transferred to the phytosomal formulation. Allocation, completion and analysis denominators are not interchanged or added; new effects, confidence intervals, daily totals or withdrawal counts are not calculated. Frequency results are not extended to other endpoints, long-term safety or replacement of preventive medication.
Why this condition is needed: Material on Minimum important difference, responders, medication use and patient-important outcomes is needed to connect the selected formulation, population, common treatment, frequency endpoint, denominators, comparison scope or harm gaps.
Referenced methods: Existing principles distinguish population, formulation, oral dose, add-on treatment, frequency endpoint, prespecified hierarchy, between/within-group comparisons, denominators, overlapping reports, support and harms in the retained phytosomal-curcumin and other-formulation reports.

N22 · Is the conventional-curcumin trial in 44 people the same intervention?

Required materials and conditions: A trial in 44 women using conventional curcumin 500 mg, 2 times per 1 day, over 8 weeks
Conditions for verification: Original material and analysis scope on A trial in 44 women using conventional curcumin 500 mg, 2 times per 1 day, over 8 weeks must link to formulation, dose, duration, population, add-on comparison and the frequency endpoint, distinguishing stored information from what remains unverified.
Requirement and applicability: Required
Application exceptions: Between-group or within-group values from another formulation are not transferred to the phytosomal formulation. Allocation, completion and analysis denominators are not interchanged or added; new effects, confidence intervals, daily totals or withdrawal counts are not calculated. Frequency results are not extended to other endpoints, long-term safety or replacement of preventive medication.
Why this condition is needed: Material on A trial in 44 women using conventional curcumin 500 mg, 2 times per 1 day, over 8 weeks is needed to connect the selected formulation, population, common treatment, frequency endpoint, denominators, comparison scope or harm gaps.
Referenced methods: Existing principles distinguish population, formulation, oral dose, add-on treatment, frequency endpoint, prespecified hierarchy, between/within-group comparisons, denominators, overlapping reports, support and harms in the retained phytosomal-curcumin and other-formulation reports.

N23 · What differences separate the trials?

Required materials and conditions: Distinction between a phospholipid formulation at 250 mg/day and conventional curcumin 500 mg, 2 times per 1 day
Conditions for verification: Original material and analysis scope on Distinction between a phospholipid formulation at 250 mg/day and conventional curcumin 500 mg, 2 times per 1 day must link to formulation, dose, duration, population, add-on comparison and the frequency endpoint, distinguishing stored information from what remains unverified.
Requirement and applicability: Required
Application exceptions: Between-group or within-group values from another formulation are not transferred to the phytosomal formulation. Allocation, completion and analysis denominators are not interchanged or added; new effects, confidence intervals, daily totals or withdrawal counts are not calculated. Frequency results are not extended to other endpoints, long-term safety or replacement of preventive medication.
Why this condition is needed: Material on Distinction between a phospholipid formulation at 250 mg/day and conventional curcumin 500 mg, 2 times per 1 day is needed to connect the selected formulation, population, common treatment, frequency endpoint, denominators, comparison scope or harm gaps.
Referenced methods: Existing principles distinguish population, formulation, oral dose, add-on treatment, frequency endpoint, prespecified hierarchy, between/within-group comparisons, denominators, overlapping reports, support and harms in the retained phytosomal-curcumin and other-formulation reports.

N24 · Are mechanistic, omega-3 and CoQ10 reports counted as clinical replication?

Required materials and conditions: Directness of mechanistic markers and combination trials
Conditions for verification: Original material and analysis scope on Directness of mechanistic markers and combination trials must link to formulation, dose, duration, population, add-on comparison and the frequency endpoint, distinguishing stored information from what remains unverified.
Requirement and applicability: Required
Application exceptions: Between-group or within-group values from another formulation are not transferred to the phytosomal formulation. Allocation, completion and analysis denominators are not interchanged or added; new effects, confidence intervals, daily totals or withdrawal counts are not calculated. Frequency results are not extended to other endpoints, long-term safety or replacement of preventive medication.
Why this condition is needed: Material on Directness of mechanistic markers and combination trials is needed to connect the selected formulation, population, common treatment, frequency endpoint, denominators, comparison scope or harm gaps.
Referenced methods: Existing principles distinguish population, formulation, oral dose, add-on treatment, frequency endpoint, prespecified hierarchy, between/within-group comparisons, denominators, overlapping reports, support and harms in the retained phytosomal-curcumin and other-formulation reports.

N25 · How far are unique trials and independent replications established?

Required materials and conditions: Report-trial-endpoint relationships and independence
Conditions for verification: Original material and analysis scope on Report-trial-endpoint relationships and independence must link to formulation, dose, duration, population, add-on comparison and the frequency endpoint, distinguishing stored information from what remains unverified.
Requirement and applicability: Required
Application exceptions: Between-group or within-group values from another formulation are not transferred to the phytosomal formulation. Allocation, completion and analysis denominators are not interchanged or added; new effects, confidence intervals, daily totals or withdrawal counts are not calculated. Frequency results are not extended to other endpoints, long-term safety or replacement of preventive medication.
Why this condition is needed: Material on Report-trial-endpoint relationships and independence is needed to connect the selected formulation, population, common treatment, frequency endpoint, denominators, comparison scope or harm gaps.
Referenced methods: Existing principles distinguish population, formulation, oral dose, add-on treatment, frequency endpoint, prespecified hierarchy, between/within-group comparisons, denominators, overlapping reports, support and harms in the retained phytosomal-curcumin and other-formulation reports.

N26 · What information is retained on research funding?

Required materials and conditions: Funding for the direct trial and the separate academic-institution trial
Conditions for verification: Original material and analysis scope on Funding for the direct trial and the separate academic-institution trial must link to formulation, dose, duration, population, add-on comparison and the frequency endpoint, distinguishing stored information from what remains unverified.
Requirement and applicability: Required
Application exceptions: Between-group or within-group values from another formulation are not transferred to the phytosomal formulation. Allocation, completion and analysis denominators are not interchanged or added; new effects, confidence intervals, daily totals or withdrawal counts are not calculated. Frequency results are not extended to other endpoints, long-term safety or replacement of preventive medication.
Why this condition is needed: Material on Funding for the direct trial and the separate academic-institution trial is needed to connect the selected formulation, population, common treatment, frequency endpoint, denominators, comparison scope or harm gaps.
Referenced methods: Existing principles distinguish population, formulation, oral dose, add-on treatment, frequency endpoint, prespecified hierarchy, between/within-group comparisons, denominators, overlapping reports, support and harms in the retained phytosomal-curcumin and other-formulation reports.

N27 · Are product supply and manufacturer involvement known?

Required materials and conditions: Free product support, manufacturer, batches and institutional roles
Conditions for verification: Original material and analysis scope on Free product support, manufacturer, batches and institutional roles must link to formulation, dose, duration, population, add-on comparison and the frequency endpoint, distinguishing stored information from what remains unverified.
Requirement and applicability: Required
Application exceptions: Between-group or within-group values from another formulation are not transferred to the phytosomal formulation. Allocation, completion and analysis denominators are not interchanged or added; new effects, confidence intervals, daily totals or withdrawal counts are not calculated. Frequency results are not extended to other endpoints, long-term safety or replacement of preventive medication.
Why this condition is needed: Material on Free product support, manufacturer, batches and institutional roles is needed to connect the selected formulation, population, common treatment, frequency endpoint, denominators, comparison scope or harm gaps.
Referenced methods: Existing principles distinguish population, formulation, oral dose, add-on treatment, frequency endpoint, prespecified hierarchy, between/within-group comparisons, denominators, overlapping reports, support and harms in the retained phytosomal-curcumin and other-formulation reports.

N28 · Does no-conflict wording answer employee-authorship and support questions?

Required materials and conditions: Distinction among COI declarations, affiliations, employee authors and individual support
Conditions for verification: Original material and analysis scope on Distinction among COI declarations, affiliations, employee authors and individual support must link to formulation, dose, duration, population, add-on comparison and the frequency endpoint, distinguishing stored information from what remains unverified.
Requirement and applicability: Required
Application exceptions: Between-group or within-group values from another formulation are not transferred to the phytosomal formulation. Allocation, completion and analysis denominators are not interchanged or added; new effects, confidence intervals, daily totals or withdrawal counts are not calculated. Frequency results are not extended to other endpoints, long-term safety or replacement of preventive medication.
Why this condition is needed: Material on Distinction among COI declarations, affiliations, employee authors and individual support is needed to connect the selected formulation, population, common treatment, frequency endpoint, denominators, comparison scope or harm gaps.
Referenced methods: Existing principles distinguish population, formulation, oral dose, add-on treatment, frequency endpoint, prespecified hierarchy, between/within-group comparisons, denominators, overlapping reports, support and harms in the retained phytosomal-curcumin and other-formulation reports.

N29 · Does no reported adverse reaction establish safety?

Required materials and conditions: Adverse-event definitions, collection, group-specific events and exposure denominators
Conditions for verification: Original material and analysis scope on Adverse-event definitions, collection, group-specific events and exposure denominators must link to formulation, dose, duration, population, add-on comparison and the frequency endpoint, distinguishing stored information from what remains unverified.
Requirement and applicability: Supplementary
Application exceptions: Between-group or within-group values from another formulation are not transferred to the phytosomal formulation. Allocation, completion and analysis denominators are not interchanged or added; new effects, confidence intervals, daily totals or withdrawal counts are not calculated. Frequency results are not extended to other endpoints, long-term safety or replacement of preventive medication.
Why this condition is needed: Material on Adverse-event definitions, collection, group-specific events and exposure denominators is needed to connect the selected formulation, population, common treatment, frequency endpoint, denominators, comparison scope or harm gaps.
Referenced methods: Existing principles distinguish population, formulation, oral dose, add-on treatment, frequency endpoint, prespecified hierarchy, between/within-group comparisons, denominators, overlapping reports, support and harms in the retained phytosomal-curcumin and other-formulation reports.

N30 · Are harms beyond 8 weeks and concurrent-treatment risks answered?

Required materials and conditions: Follow-up of long-term/rare harms, concurrent medication and vulnerable groups
Conditions for verification: Original material and analysis scope on Follow-up of long-term/rare harms, concurrent medication and vulnerable groups must link to formulation, dose, duration, population, add-on comparison and the frequency endpoint, distinguishing stored information from what remains unverified.
Requirement and applicability: Supplementary
Application exceptions: Between-group or within-group values from another formulation are not transferred to the phytosomal formulation. Allocation, completion and analysis denominators are not interchanged or added; new effects, confidence intervals, daily totals or withdrawal counts are not calculated. Frequency results are not extended to other endpoints, long-term safety or replacement of preventive medication.
Why this condition is needed: Material on Follow-up of long-term/rare harms, concurrent medication and vulnerable groups is needed to connect the selected formulation, population, common treatment, frequency endpoint, denominators, comparison scope or harm gaps.
Referenced methods: Existing principles distinguish population, formulation, oral dose, add-on treatment, frequency endpoint, prespecified hierarchy, between/within-group comparisons, denominators, overlapping reports, support and harms in the retained phytosomal-curcumin and other-formulation reports.

N31 · Can findings be extended to replacing preventive medication or other products?

Required materials and conditions: Distinction between add-on and replacement treatment and conventional turmeric, nano formulations and combinations
Conditions for verification: Original material and analysis scope on Distinction between add-on and replacement treatment and conventional turmeric, nano formulations and combinations must link to formulation, dose, duration, population, add-on comparison and the frequency endpoint, distinguishing stored information from what remains unverified.
Requirement and applicability: Required
Application exceptions: Between-group or within-group values from another formulation are not transferred to the phytosomal formulation. Allocation, completion and analysis denominators are not interchanged or added; new effects, confidence intervals, daily totals or withdrawal counts are not calculated. Frequency results are not extended to other endpoints, long-term safety or replacement of preventive medication.
Why this condition is needed: Material on Distinction between add-on and replacement treatment and conventional turmeric, nano formulations and combinations is needed to connect the selected formulation, population, common treatment, frequency endpoint, denominators, comparison scope or harm gaps.
Referenced methods: Existing principles distinguish population, formulation, oral dose, add-on treatment, frequency endpoint, prespecified hierarchy, between/within-group comparisons, denominators, overlapping reports, support and harms in the retained phytosomal-curcumin and other-formulation reports.

N32 · What are the current English wording and historical language correction?

Required materials and conditions: Retained Korean/English wording, generic English text and the correction event of 2026-09-14
Conditions for verification: Original material and analysis scope on Retained Korean/English wording, generic English text and the correction event of 2026-09-14 must link to formulation, dose, duration, population, add-on comparison and the frequency endpoint, distinguishing stored information from what remains unverified.
Requirement and applicability: Required
Application exceptions: Between-group or within-group values from another formulation are not transferred to the phytosomal formulation. Allocation, completion and analysis denominators are not interchanged or added; new effects, confidence intervals, daily totals or withdrawal counts are not calculated. Frequency results are not extended to other endpoints, long-term safety or replacement of preventive medication.
Why this condition is needed: Material on Retained Korean/English wording, generic English text and the correction event of 2026-09-14 is needed to connect the selected formulation, population, common treatment, frequency endpoint, denominators, comparison scope or harm gaps.
Referenced methods: Existing principles distinguish population, formulation, oral dose, add-on treatment, frequency endpoint, prespecified hierarchy, between/within-group comparisons, denominators, overlapping reports, support and harms in the retained phytosomal-curcumin and other-formulation reports.

N33 · How are the original C score of 50, axes and historical verification retained?

Required materials and conditions: Historical preservation of the current original grade, score, EX/CX, axes and previous cross-check
Conditions for verification: Original material and analysis scope on Historical preservation of the current original grade, score, EX/CX, axes and previous cross-check must link to formulation, dose, duration, population, add-on comparison and the frequency endpoint, distinguishing stored information from what remains unverified.
Requirement and applicability: Required
Application exceptions: Between-group or within-group values from another formulation are not transferred to the phytosomal formulation. Allocation, completion and analysis denominators are not interchanged or added; new effects, confidence intervals, daily totals or withdrawal counts are not calculated. Frequency results are not extended to other endpoints, long-term safety or replacement of preventive medication.
Why this condition is needed: Material on Historical preservation of the current original grade, score, EX/CX, axes and previous cross-check is needed to connect the selected formulation, population, common treatment, frequency endpoint, denominators, comparison scope or harm gaps.
Referenced methods: Existing principles distinguish population, formulation, oral dose, add-on treatment, frequency endpoint, prespecified hierarchy, between/within-group comparisons, denominators, overlapping reports, support and harms in the retained phytosomal-curcumin and other-formulation reports.

N34 · What dates, unrecorded information and actual reading scope are retained?

Required materials and conditions: Original verdict date, correction date, empty detailed-claim list and external material unread
Conditions for verification: Original material and analysis scope on Original verdict date, correction date, empty detailed-claim list and external material unread must link to formulation, dose, duration, population, add-on comparison and the frequency endpoint, distinguishing stored information from what remains unverified.
Requirement and applicability: Required
Application exceptions: Between-group or within-group values from another formulation are not transferred to the phytosomal formulation. Allocation, completion and analysis denominators are not interchanged or added; new effects, confidence intervals, daily totals or withdrawal counts are not calculated. Frequency results are not extended to other endpoints, long-term safety or replacement of preventive medication.
Why this condition is needed: Material on Original verdict date, correction date, empty detailed-claim list and external material unread is needed to connect the selected formulation, population, common treatment, frequency endpoint, denominators, comparison scope or harm gaps.
Referenced methods: Existing principles distinguish population, formulation, oral dose, add-on treatment, frequency endpoint, prespecified hierarchy, between/within-group comparisons, denominators, overlapping reports, support and harms in the retained phytosomal-curcumin and other-formulation reports.

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

2026-10-25 · 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 migraine-attack frequency question is covered?

Current findings: The original claim is reduction of migraine-attack frequency without aura, distinguished from other formulations, biomarkers and combinations.
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 original-source comparison and content review remain incomplete; effects, safety, prespecification, independence or fulfilled conditions are not certified.
Reason for missing information: Detailed eligibility and prespecified endpoints in the external original trial remain unread.
Required materials and conditions: An 8-week phytosomal-curcumin add-on comparison for migraine without aura
Materials to obtain first: Direct original paper, protocol and registration
Further research: Material needed: Direct original paper, protocol and registration. This records needed materials; no new research was executed.
Remaining uncertainty: Gaps remain in formulation-specific directness, prespecified endpoint hierarchy, exact between-group effects, denominators, allocation, blinding, missingness, measurement, multiplicity, independent replication, support and harms. Existing grade, cross-check and correction wording are historical records, not current external reading or new clinical certification.
Conditions for verification: Original material and analysis scope on An 8-week phytosomal-curcumin add-on comparison for migraine without aura must link to formulation, dose, duration, population, add-on comparison and the frequency endpoint, distinguishing stored information from what remains unverified.
Why this condition is needed: Material on An 8-week phytosomal-curcumin add-on comparison for migraine without aura is needed to connect the selected formulation, population, common treatment, frequency endpoint, denominators, comparison scope or harm gaps.
Application exceptions: Between-group or within-group values from another formulation are not transferred to the phytosomal formulation. Allocation, completion and analysis denominators are not interchanged or added; new effects, confidence intervals, daily totals or withdrawal counts are not calculated. Frequency results are not extended to other endpoints, long-term safety or replacement of preventive medication.
Referenced methods: Existing principles distinguish population, formulation, oral dose, add-on treatment, frequency endpoint, prespecified hierarchy, between/within-group comparisons, denominators, overlapping reports, support and harms in the retained phytosomal-curcumin and other-formulation reports.

Related sources S01 S02

N02 · Which adults with migraine are represented?

Current findings: The retained population is adults with migraine without aura who continued standard treatment.
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 original-source comparison and content review remain incomplete; effects, safety, prespecification, independence or fulfilled conditions are not certified.
Reason for missing information: Detailed diagnostic criteria, frequency range, age/sex and exclusion criteria remain unverified.
Required materials and conditions: Diagnosis of migraine without aura, adult eligibility and continuation of standard treatment
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 formulation-specific directness, prespecified endpoint hierarchy, exact between-group effects, denominators, allocation, blinding, missingness, measurement, multiplicity, independent replication, support and harms. Existing grade, cross-check and correction wording are historical records, not current external reading or new clinical certification.
Conditions for verification: Original material and analysis scope on Diagnosis of migraine without aura, adult eligibility and continuation of standard treatment must link to formulation, dose, duration, population, add-on comparison and the frequency endpoint, distinguishing stored information from what remains unverified.
Why this condition is needed: Material on Diagnosis of migraine without aura, adult eligibility and continuation of standard treatment is needed to connect the selected formulation, population, common treatment, frequency endpoint, denominators, comparison scope or harm gaps.
Application exceptions: Between-group or within-group values from another formulation are not transferred to the phytosomal formulation. Allocation, completion and analysis denominators are not interchanged or added; new effects, confidence intervals, daily totals or withdrawal counts are not calculated. Frequency results are not extended to other endpoints, long-term safety or replacement of preventive medication.
Referenced methods: Existing principles distinguish population, formulation, oral dose, add-on treatment, frequency endpoint, prespecified hierarchy, between/within-group comparisons, denominators, overlapping reports, support and harms in the retained phytosomal-curcumin and other-formulation reports.

Related sources S01

N03 · Is the phytosomal formulation interchangeable with other curcumin?

Current findings: The selected formulation is phospholipid phytosomal curcumin derived from Curcuma longa, distinguished from nanocurcumin.
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 original-source comparison and content review remain incomplete; effects, safety, prespecification, independence or fulfilled conditions are not certified.
Reason for missing information: Product batches, active-ingredient quantification and manufacturing conditions remain unverified.
Required materials and conditions: Distinction between a phospholipid delivery system and conventional, nano, micellar and combination formulations
Materials to obtain first: Formulation, product, batch and quantification material
Further research: Material needed: Formulation, product, batch and quantification material. This records needed materials; no new research was executed.
Remaining uncertainty: Gaps remain in formulation-specific directness, prespecified endpoint hierarchy, exact between-group effects, denominators, allocation, blinding, missingness, measurement, multiplicity, independent replication, support and harms. Existing grade, cross-check and correction wording are historical records, not current external reading or new clinical certification.
Conditions for verification: Original material and analysis scope on Distinction between a phospholipid delivery system and conventional, nano, micellar and combination formulations must link to formulation, dose, duration, population, add-on comparison and the frequency endpoint, distinguishing stored information from what remains unverified.
Why this condition is needed: Material on Distinction between a phospholipid delivery system and conventional, nano, micellar and combination formulations is needed to connect the selected formulation, population, common treatment, frequency endpoint, denominators, comparison scope or harm gaps.
Application exceptions: Between-group or within-group values from another formulation are not transferred to the phytosomal formulation. Allocation, completion and analysis denominators are not interchanged or added; new effects, confidence intervals, daily totals or withdrawal counts are not calculated. Frequency results are not extended to other endpoints, long-term safety or replacement of preventive medication.
Referenced methods: Existing principles distinguish population, formulation, oral dose, add-on treatment, frequency endpoint, prespecified hierarchy, between/within-group comparisons, denominators, overlapping reports, support and harms in the retained phytosomal-curcumin and other-formulation reports.

Related sources S01

N04 · What were the dose and actual intake?

Current findings: The retained dose is an oral add-on at 250 mg/day.
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 original-source comparison and content review remain incomplete; effects, safety, prespecification, independence or fulfilled conditions are not certified.
Reason for missing information: Active-ingredient conversion, actual adherence and dose changes remain unverified.
Required materials and conditions: Phytosomal curcumin 250 mg/day and actual adherence
Materials to obtain first: Product amount, ingredient amount and adherence records
Further research: Material needed: Product amount, ingredient amount and adherence records. This records needed materials; no new research was executed.
Remaining uncertainty: Gaps remain in formulation-specific directness, prespecified endpoint hierarchy, exact between-group effects, denominators, allocation, blinding, missingness, measurement, multiplicity, independent replication, support and harms. Existing grade, cross-check and correction wording are historical records, not current external reading or new clinical certification.
Conditions for verification: Original material and analysis scope on Phytosomal curcumin 250 mg/day and actual adherence must link to formulation, dose, duration, population, add-on comparison and the frequency endpoint, distinguishing stored information from what remains unverified.
Why this condition is needed: Material on Phytosomal curcumin 250 mg/day and actual adherence is needed to connect the selected formulation, population, common treatment, frequency endpoint, denominators, comparison scope or harm gaps.
Application exceptions: Between-group or within-group values from another formulation are not transferred to the phytosomal formulation. Allocation, completion and analysis denominators are not interchanged or added; new effects, confidence intervals, daily totals or withdrawal counts are not calculated. Frequency results are not extended to other endpoints, long-term safety or replacement of preventive medication.
Referenced methods: Existing principles distinguish population, formulation, oral dose, add-on treatment, frequency endpoint, prespecified hierarchy, between/within-group comparisons, denominators, overlapping reports, support and harms in the retained phytosomal-curcumin and other-formulation reports.

Related sources S01

N05 · What were the treatment and follow-up times?

Current findings: The retained treatment and follow-up duration is 8 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 original-source comparison and content review remain incomplete; effects, safety, prespecification, independence or fulfilled conditions are not certified.
Reason for missing information: Visit schedules, persistence beyond 8 weeks and long-term follow-up remain unverified.
Required materials and conditions: Treatment/follow-up over 8 weeks and persistence after stopping
Materials to obtain first: Measurement schedule and follow-up plan
Further research: Material needed: Measurement schedule and follow-up plan. This records needed materials; no new research was executed.
Remaining uncertainty: Gaps remain in formulation-specific directness, prespecified endpoint hierarchy, exact between-group effects, denominators, allocation, blinding, missingness, measurement, multiplicity, independent replication, support and harms. Existing grade, cross-check and correction wording are historical records, not current external reading or new clinical certification.
Conditions for verification: Original material and analysis scope on Treatment/follow-up over 8 weeks and persistence after stopping must link to formulation, dose, duration, population, add-on comparison and the frequency endpoint, distinguishing stored information from what remains unverified.
Why this condition is needed: Material on Treatment/follow-up over 8 weeks and persistence after stopping is needed to connect the selected formulation, population, common treatment, frequency endpoint, denominators, comparison scope or harm gaps.
Application exceptions: Between-group or within-group values from another formulation are not transferred to the phytosomal formulation. Allocation, completion and analysis denominators are not interchanged or added; new effects, confidence intervals, daily totals or withdrawal counts are not calculated. Frequency results are not extended to other endpoints, long-term safety or replacement of preventive medication.
Referenced methods: Existing principles distinguish population, formulation, oral dose, add-on treatment, frequency endpoint, prespecified hierarchy, between/within-group comparisons, denominators, overlapping reports, support and harms in the retained phytosomal-curcumin and other-formulation reports.

Related sources S01

N06 · What was the contribution of standard treatment and concurrent medication?

Current findings: The original record describes an add-on trial with continued standard 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 original-source comparison and content review remain incomplete; effects, safety, prespecification, independence or fulfilled conditions are not certified.
Reason for missing information: Specific medications, doses, group-specific changes, rescue use and their control remain unverified.
Required materials and conditions: Continuation/changes in standard treatment, preventive medication and rescue medication in both groups
Materials to obtain first: Concurrent, preventive and rescue medication tables
Further research: Material needed: Concurrent, preventive and rescue medication tables. This records needed materials; no new research was executed.
Remaining uncertainty: Gaps remain in formulation-specific directness, prespecified endpoint hierarchy, exact between-group effects, denominators, allocation, blinding, missingness, measurement, multiplicity, independent replication, support and harms. Existing grade, cross-check and correction wording are historical records, not current external reading or new clinical certification.
Conditions for verification: Original material and analysis scope on Continuation/changes in standard treatment, preventive medication and rescue medication in both groups must link to formulation, dose, duration, population, add-on comparison and the frequency endpoint, distinguishing stored information from what remains unverified.
Why this condition is needed: Material on Continuation/changes in standard treatment, preventive medication and rescue medication in both groups is needed to connect the selected formulation, population, common treatment, frequency endpoint, denominators, comparison scope or harm gaps.
Application exceptions: Between-group or within-group values from another formulation are not transferred to the phytosomal formulation. Allocation, completion and analysis denominators are not interchanged or added; new effects, confidence intervals, daily totals or withdrawal counts are not calculated. Frequency results are not extended to other endpoints, long-term safety or replacement of preventive medication.
Referenced methods: Existing principles distinguish population, formulation, oral dose, add-on treatment, frequency endpoint, prespecified hierarchy, between/within-group comparisons, denominators, overlapping reports, support and harms in the retained phytosomal-curcumin and other-formulation reports.

Related sources S01

N07 · What was the maltodextrin-placebo comparison?

Current findings: The comparator is recorded as maltodextrin placebo added to standard treatment.
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 original-source comparison and content review remain incomplete; effects, safety, prespecification, independence or fulfilled conditions are not certified.
Reason for missing information: Placebo composition, appearance, intake schedule and details of common treatment remain unverified.
Required materials and conditions: Conditions of maltodextrin placebo added to standard treatment
Materials to obtain first: Placebo and concurrent-treatment specifications
Further research: Material needed: Placebo and concurrent-treatment specifications. This records needed materials; no new research was executed.
Remaining uncertainty: Gaps remain in formulation-specific directness, prespecified endpoint hierarchy, exact between-group effects, denominators, allocation, blinding, missingness, measurement, multiplicity, independent replication, support and harms. Existing grade, cross-check and correction wording are historical records, not current external reading or new clinical certification.
Conditions for verification: Original material and analysis scope on Conditions of maltodextrin placebo added to standard treatment must link to formulation, dose, duration, population, add-on comparison and the frequency endpoint, distinguishing stored information from what remains unverified.
Why this condition is needed: Material on Conditions of maltodextrin placebo added to standard treatment is needed to connect the selected formulation, population, common treatment, frequency endpoint, denominators, comparison scope or harm gaps.
Application exceptions: Between-group or within-group values from another formulation are not transferred to the phytosomal formulation. Allocation, completion and analysis denominators are not interchanged or added; new effects, confidence intervals, daily totals or withdrawal counts are not calculated. Frequency results are not extended to other endpoints, long-term safety or replacement of preventive medication.
Referenced methods: Existing principles distinguish population, formulation, oral dose, add-on treatment, frequency endpoint, prespecified hierarchy, between/within-group comparisons, denominators, overlapping reports, support and harms in the retained phytosomal-curcumin and other-formulation reports.

Related sources S01

N08 · How is the direct report identified?

Current findings: The bibliography records Shojaei 2025, PMID 41136816 and DOI 10.1007/s11655-025-3939-1.
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 original-source comparison and content review remain incomplete; effects, safety, prespecification, independence or fulfilled conditions are not certified.
Reason for missing information: Current external bibliographic identity, the original file and full-text content remain unread in this work.
Required materials and conditions: Shojaei report title, PMID, DOI and retained result
Materials to obtain first: Direct original paper and bibliographic record
Further research: Material needed: Direct original paper and bibliographic record. This records needed materials; no new research was executed.
Remaining uncertainty: Gaps remain in formulation-specific directness, prespecified endpoint hierarchy, exact between-group effects, denominators, allocation, blinding, missingness, measurement, multiplicity, independent replication, support and harms. Existing grade, cross-check and correction wording are historical records, not current external reading or new clinical certification.
Conditions for verification: Original material and analysis scope on Shojaei report title, PMID, DOI and retained result must link to formulation, dose, duration, population, add-on comparison and the frequency endpoint, distinguishing stored information from what remains unverified.
Why this condition is needed: Material on Shojaei report title, PMID, DOI and retained result is needed to connect the selected formulation, population, common treatment, frequency endpoint, denominators, comparison scope or harm gaps.
Application exceptions: Between-group or within-group values from another formulation are not transferred to the phytosomal formulation. Allocation, completion and analysis denominators are not interchanged or added; new effects, confidence intervals, daily totals or withdrawal counts are not calculated. Frequency results are not extended to other endpoints, long-term safety or replacement of preventive medication.
Referenced methods: Existing principles distinguish population, formulation, oral dose, add-on treatment, frequency endpoint, prespecified hierarchy, between/within-group comparisons, denominators, overlapping reports, support and harms in the retained phytosomal-curcumin and other-formulation reports.

Related sources S01

N09 · Is an IRCT number the same as actual registration verification?

Current findings: The bibliography contains IRCT20201129049534N2, while registration status in the original record remains 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 original-source comparison and content review remain incomplete; effects, safety, prespecification, independence or fulfilled conditions are not certified.
Reason for missing information: Registration content, prospective timing, changes and correspondence with the paper remain unread.
Required materials and conditions: IRCT20201129049534N2, registration timing, endpoints and history
Materials to obtain first: Original registration and change history
Further research: Material needed: Original registration and change history. This records needed materials; no new research was executed.
Remaining uncertainty: Gaps remain in formulation-specific directness, prespecified endpoint hierarchy, exact between-group effects, denominators, allocation, blinding, missingness, measurement, multiplicity, independent replication, support and harms. Existing grade, cross-check and correction wording are historical records, not current external reading or new clinical certification.
Conditions for verification: Original material and analysis scope on IRCT20201129049534N2, registration timing, endpoints and history must link to formulation, dose, duration, population, add-on comparison and the frequency endpoint, distinguishing stored information from what remains unverified.
Why this condition is needed: Material on IRCT20201129049534N2, registration timing, endpoints and history is needed to connect the selected formulation, population, common treatment, frequency endpoint, denominators, comparison scope or harm gaps.
Application exceptions: Between-group or within-group values from another formulation are not transferred to the phytosomal formulation. Allocation, completion and analysis denominators are not interchanged or added; new effects, confidence intervals, daily totals or withdrawal counts are not calculated. Frequency results are not extended to other endpoints, long-term safety or replacement of preventive medication.
Referenced methods: Existing principles distinguish population, formulation, oral dose, add-on treatment, frequency endpoint, prespecified hierarchy, between/within-group comparisons, denominators, overlapping reports, support and harms in the retained phytosomal-curcumin and other-formulation reports.

Related sources S01

N10 · Was attack frequency the single prespecified primary endpoint (1st in the hierarchy)?

Current findings: The retained record leaves unverified whether change in attack frequency at 8 weeks was the single prespecified primary endpoint (1st in the hierarchy).
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 original-source comparison and content review remain incomplete; effects, safety, prespecification, independence or fulfilled conditions are not certified.
Reason for missing information: The protocol, SAP and multiplicity plan remain unread.
Required materials and conditions: Prespecified hierarchy, analysis and timing for frequency among multiple clinical endpoints
Materials to obtain first: Protocol, SAP and registered endpoints
Further research: Material needed: Protocol, SAP and registered endpoints. This records needed materials; no new research was executed.
Remaining uncertainty: Gaps remain in formulation-specific directness, prespecified endpoint hierarchy, exact between-group effects, denominators, allocation, blinding, missingness, measurement, multiplicity, independent replication, support and harms. Existing grade, cross-check and correction wording are historical records, not current external reading or new clinical certification.
Conditions for verification: Original material and analysis scope on Prespecified hierarchy, analysis and timing for frequency among multiple clinical endpoints must link to formulation, dose, duration, population, add-on comparison and the frequency endpoint, distinguishing stored information from what remains unverified.
Why this condition is needed: Material on Prespecified hierarchy, analysis and timing for frequency among multiple clinical endpoints is needed to connect the selected formulation, population, common treatment, frequency endpoint, denominators, comparison scope or harm gaps.
Application exceptions: Between-group or within-group values from another formulation are not transferred to the phytosomal formulation. Allocation, completion and analysis denominators are not interchanged or added; new effects, confidence intervals, daily totals or withdrawal counts are not calculated. Frequency results are not extended to other endpoints, long-term safety or replacement of preventive medication.
Referenced methods: Existing principles distinguish population, formulation, oral dose, add-on treatment, frequency endpoint, prespecified hierarchy, between/within-group comparisons, denominators, overlapping reports, support and harms in the retained phytosomal-curcumin and other-formulation reports.

Related sources S01

N11 · What were the randomization and concealment methods?

Current findings: The retained design is a randomized double-blind placebo-add-on 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 original-source comparison and content review remain incomplete; effects, safety, prespecification, independence or fulfilled conditions are not certified.
Reason for missing information: Allocation sequence, concealment methods and detailed recruitment flow remain unverified.
Required materials and conditions: Randomization procedures, concealment and recruitment flow
Materials to obtain first: Allocation methods and participant flow diagram
Further research: Material needed: Allocation methods and participant flow diagram. This records needed materials; no new research was executed.
Remaining uncertainty: Gaps remain in formulation-specific directness, prespecified endpoint hierarchy, exact between-group effects, denominators, allocation, blinding, missingness, measurement, multiplicity, independent replication, support and harms. Existing grade, cross-check and correction wording are historical records, not current external reading or new clinical certification.
Conditions for verification: Original material and analysis scope on Randomization procedures, concealment and recruitment flow must link to formulation, dose, duration, population, add-on comparison and the frequency endpoint, distinguishing stored information from what remains unverified.
Why this condition is needed: Material on Randomization procedures, concealment and recruitment flow is needed to connect the selected formulation, population, common treatment, frequency endpoint, denominators, comparison scope or harm gaps.
Application exceptions: Between-group or within-group values from another formulation are not transferred to the phytosomal formulation. Allocation, completion and analysis denominators are not interchanged or added; new effects, confidence intervals, daily totals or withdrawal counts are not calculated. Frequency results are not extended to other endpoints, long-term safety or replacement of preventive medication.
Referenced methods: Existing principles distinguish population, formulation, oral dose, add-on treatment, frequency endpoint, prespecified hierarchy, between/within-group comparisons, denominators, overlapping reports, support and harms in the retained phytosomal-curcumin and other-formulation reports.

Related sources S01

N12 · How were blinding and outcome measurement maintained?

Current findings: The original record describes a double-blind design.
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 original-source comparison and content review remain incomplete; effects, safety, prespecification, independence or fulfilled conditions are not certified.
Reason for missing information: Sensory placebo matching, assessor blinding/unblinding and recording methods remain unverified.
Required materials and conditions: Participant/assessor blinding and placebo matching
Materials to obtain first: Blinding, placebo and outcome-recording methods
Further research: Material needed: Blinding, placebo and outcome-recording methods. This records needed materials; no new research was executed.
Remaining uncertainty: Gaps remain in formulation-specific directness, prespecified endpoint hierarchy, exact between-group effects, denominators, allocation, blinding, missingness, measurement, multiplicity, independent replication, support and harms. Existing grade, cross-check and correction wording are historical records, not current external reading or new clinical certification.
Conditions for verification: Original material and analysis scope on Participant/assessor blinding and placebo matching must link to formulation, dose, duration, population, add-on comparison and the frequency endpoint, distinguishing stored information from what remains unverified.
Why this condition is needed: Material on Participant/assessor blinding and placebo matching is needed to connect the selected formulation, population, common treatment, frequency endpoint, denominators, comparison scope or harm gaps.
Application exceptions: Between-group or within-group values from another formulation are not transferred to the phytosomal formulation. Allocation, completion and analysis denominators are not interchanged or added; new effects, confidence intervals, daily totals or withdrawal counts are not calculated. Frequency results are not extended to other endpoints, long-term safety or replacement of preventive medication.
Referenced methods: Existing principles distinguish population, formulation, oral dose, add-on treatment, frequency endpoint, prespecified hierarchy, between/within-group comparisons, denominators, overlapping reports, support and harms in the retained phytosomal-curcumin and other-formulation reports.

Related sources S01

N13 · How are 70 randomized participants and 65 completers distinguished?

Current findings: The retained denominators are 70 randomized and 65 completed (33 versus 32); allocation and completion are not interchanged.
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 original-source comparison and content review remain incomplete; effects, safety, prespecification, independence or fulfilled conditions are not certified.
Reason for missing information: The group correspondence for 33 and 32 and endpoint-specific analysis denominators remain unverified.
Required materials and conditions: The 70 randomized participants, 65 completers and group correspondence for 33 versus 32
Materials to obtain first: Group-specific allocation, completion and analysis flow and result tables
Further research: Material needed: Group-specific allocation, completion and analysis flow and result tables. This records needed materials; no new research was executed.
Remaining uncertainty: Gaps remain in formulation-specific directness, prespecified endpoint hierarchy, exact between-group effects, denominators, allocation, blinding, missingness, measurement, multiplicity, independent replication, support and harms. Existing grade, cross-check and correction wording are historical records, not current external reading or new clinical certification.
Conditions for verification: Original material and analysis scope on The 70 randomized participants, 65 completers and group correspondence for 33 versus 32 must link to formulation, dose, duration, population, add-on comparison and the frequency endpoint, distinguishing stored information from what remains unverified.
Why this condition is needed: Material on The 70 randomized participants, 65 completers and group correspondence for 33 versus 32 is needed to connect the selected formulation, population, common treatment, frequency endpoint, denominators, comparison scope or harm gaps.
Application exceptions: Between-group or within-group values from another formulation are not transferred to the phytosomal formulation. Allocation, completion and analysis denominators are not interchanged or added; new effects, confidence intervals, daily totals or withdrawal counts are not calculated. Frequency results are not extended to other endpoints, long-term safety or replacement of preventive medication.
Referenced methods: Existing principles distinguish population, formulation, oral dose, add-on treatment, frequency endpoint, prespecified hierarchy, between/within-group comparisons, denominators, overlapping reports, support and harms in the retained phytosomal-curcumin and other-formulation reports.

Related sources S01

N14 · What was the exact ITT analysis population?

Current findings: The current summary states that the exact ITT denominator remains 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 original-source comparison and content review remain incomplete; effects, safety, prespecification, independence or fulfilled conditions are not certified.
Reason for missing information: Analysis-population definitions and actual result-inclusion criteria for the 70 and 65 participants remain unverified.
Required materials and conditions: ITT, completer analyses and inclusion criteria for the frequency result
Materials to obtain first: Analysis-population definitions, ITT, SAP and result tables
Further research: Material needed: Analysis-population definitions, ITT, SAP and result tables. This records needed materials; no new research was executed.
Remaining uncertainty: Gaps remain in formulation-specific directness, prespecified endpoint hierarchy, exact between-group effects, denominators, allocation, blinding, missingness, measurement, multiplicity, independent replication, support and harms. Existing grade, cross-check and correction wording are historical records, not current external reading or new clinical certification.
Conditions for verification: Original material and analysis scope on ITT, completer analyses and inclusion criteria for the frequency result must link to formulation, dose, duration, population, add-on comparison and the frequency endpoint, distinguishing stored information from what remains unverified.
Why this condition is needed: Material on ITT, completer analyses and inclusion criteria for the frequency result is needed to connect the selected formulation, population, common treatment, frequency endpoint, denominators, comparison scope or harm gaps.
Application exceptions: Between-group or within-group values from another formulation are not transferred to the phytosomal formulation. Allocation, completion and analysis denominators are not interchanged or added; new effects, confidence intervals, daily totals or withdrawal counts are not calculated. Frequency results are not extended to other endpoints, long-term safety or replacement of preventive medication.
Referenced methods: Existing principles distinguish population, formulation, oral dose, add-on treatment, frequency endpoint, prespecified hierarchy, between/within-group comparisons, denominators, overlapping reports, support and harms in the retained phytosomal-curcumin and other-formulation reports.

Related sources S01

N15 · What effects could missingness and withdrawal have?

Current findings: The retained material distinguishes randomized and completed participant counts.
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 original-source comparison and content review remain incomplete; effects, safety, prespecification, independence or fulfilled conditions are not certified.
Reason for missing information: Group-specific withdrawal reasons, missing-data handling and sensitivity analyses remain unverified. Differences in participant counts are not newly calculated.
Required materials and conditions: Group-specific withdrawal reasons, missing-data handling and sensitivity analyses
Materials to obtain first: Missing-data and withdrawal reasons and analysis material
Further research: Material needed: Missing-data and withdrawal reasons and analysis material. This records needed materials; no new research was executed.
Remaining uncertainty: Gaps remain in formulation-specific directness, prespecified endpoint hierarchy, exact between-group effects, denominators, allocation, blinding, missingness, measurement, multiplicity, independent replication, support and harms. Existing grade, cross-check and correction wording are historical records, not current external reading or new clinical certification.
Conditions for verification: Original material and analysis scope on Group-specific withdrawal reasons, missing-data handling and sensitivity analyses must link to formulation, dose, duration, population, add-on comparison and the frequency endpoint, distinguishing stored information from what remains unverified.
Why this condition is needed: Material on Group-specific withdrawal reasons, missing-data handling and sensitivity analyses is needed to connect the selected formulation, population, common treatment, frequency endpoint, denominators, comparison scope or harm gaps.
Application exceptions: Between-group or within-group values from another formulation are not transferred to the phytosomal formulation. Allocation, completion and analysis denominators are not interchanged or added; new effects, confidence intervals, daily totals or withdrawal counts are not calculated. Frequency results are not extended to other endpoints, long-term safety or replacement of preventive medication.
Referenced methods: Existing principles distinguish population, formulation, oral dose, add-on treatment, frequency endpoint, prespecified hierarchy, between/within-group comparisons, denominators, overlapping reports, support and harms in the retained phytosomal-curcumin and other-formulation reports.

Related sources S01

N16 · In which units was attack frequency measured?

Current findings: The selected endpoint is change in attack frequency at 8 weeks.
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 original-source comparison and content review remain incomplete; effects, safety, prespecification, independence or fulfilled conditions are not certified.
Reason for missing information: Attack definition, weekly/monthly units, diary recording, baseline values and measurement reliability remain unverified.
Required materials and conditions: Attack definition, frequency per period, diaries and baseline values
Materials to obtain first: Frequency definition, diaries, baseline values and result tables
Further research: Material needed: Frequency definition, diaries, baseline values and result tables. This records needed materials; no new research was executed.
Remaining uncertainty: Gaps remain in formulation-specific directness, prespecified endpoint hierarchy, exact between-group effects, denominators, allocation, blinding, missingness, measurement, multiplicity, independent replication, support and harms. Existing grade, cross-check and correction wording are historical records, not current external reading or new clinical certification.
Conditions for verification: Original material and analysis scope on Attack definition, frequency per period, diaries and baseline values must link to formulation, dose, duration, population, add-on comparison and the frequency endpoint, distinguishing stored information from what remains unverified.
Why this condition is needed: Material on Attack definition, frequency per period, diaries and baseline values is needed to connect the selected formulation, population, common treatment, frequency endpoint, denominators, comparison scope or harm gaps.
Application exceptions: Between-group or within-group values from another formulation are not transferred to the phytosomal formulation. Allocation, completion and analysis denominators are not interchanged or added; new effects, confidence intervals, daily totals or withdrawal counts are not calculated. Frequency results are not extended to other endpoints, long-term safety or replacement of preventive medication.
Referenced methods: Existing principles distinguish population, formulation, oral dose, add-on treatment, frequency endpoint, prespecified hierarchy, between/within-group comparisons, denominators, overlapping reports, support and harms in the retained phytosomal-curcumin and other-formulation reports.

Related sources S01

N17 · What was the exact between-group effect on frequency?

Current findings: The existing summary of broadly positive abstract results, including frequency, is retained. The exact frequency-specific between-group change remains 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 original-source comparison and content review remain incomplete; effects, safety, prespecification, independence or fulfilled conditions are not certified.
Reason for missing information: Group-specific values, between-group change and an adjustment model are absent from the retained scope.
Required materials and conditions: Frequency-specific between-group change and analysis model
Materials to obtain first: Original frequency-specific group values and between-group estimate tables
Further research: Material needed: Original frequency-specific group values and between-group estimate tables. This records needed materials; no new research was executed.
Remaining uncertainty: Gaps remain in formulation-specific directness, prespecified endpoint hierarchy, exact between-group effects, denominators, allocation, blinding, missingness, measurement, multiplicity, independent replication, support and harms. Existing grade, cross-check and correction wording are historical records, not current external reading or new clinical certification.
Conditions for verification: Original material and analysis scope on Frequency-specific between-group change and analysis model must link to formulation, dose, duration, population, add-on comparison and the frequency endpoint, distinguishing stored information from what remains unverified.
Why this condition is needed: Material on Frequency-specific between-group change and analysis model is needed to connect the selected formulation, population, common treatment, frequency endpoint, denominators, comparison scope or harm gaps.
Application exceptions: Between-group or within-group values from another formulation are not transferred to the phytosomal formulation. Allocation, completion and analysis denominators are not interchanged or added; new effects, confidence intervals, daily totals or withdrawal counts are not calculated. Frequency results are not extended to other endpoints, long-term safety or replacement of preventive medication.
Referenced methods: Existing principles distinguish population, formulation, oral dose, add-on treatment, frequency endpoint, prespecified hierarchy, between/within-group comparisons, denominators, overlapping reports, support and harms in the retained phytosomal-curcumin and other-formulation reports.

Related sources S01

N18 · Is there a confidence interval for the frequency effect?

Current findings: The retained record leaves the 95% CI 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 original-source comparison and content review remain incomplete; effects, safety, prespecification, independence or fulfilled conditions are not certified.
Reason for missing information: Variance, interval and precision material are unavailable in the retained scope. No new interval is calculated.
Required materials and conditions: Exact frequency-specific between-group 95% CI
Materials to obtain first: Between-group 95% CI and analysis output
Further research: Material needed: Between-group 95% CI and analysis output. This records needed materials; no new research was executed.
Remaining uncertainty: Gaps remain in formulation-specific directness, prespecified endpoint hierarchy, exact between-group effects, denominators, allocation, blinding, missingness, measurement, multiplicity, independent replication, support and harms. Existing grade, cross-check and correction wording are historical records, not current external reading or new clinical certification.
Conditions for verification: Original material and analysis scope on Exact frequency-specific between-group 95% CI must link to formulation, dose, duration, population, add-on comparison and the frequency endpoint, distinguishing stored information from what remains unverified.
Why this condition is needed: Material on Exact frequency-specific between-group 95% CI is needed to connect the selected formulation, population, common treatment, frequency endpoint, denominators, comparison scope or harm gaps.
Application exceptions: Between-group or within-group values from another formulation are not transferred to the phytosomal formulation. Allocation, completion and analysis denominators are not interchanged or added; new effects, confidence intervals, daily totals or withdrawal counts are not calculated. Frequency results are not extended to other endpoints, long-term safety or replacement of preventive medication.
Referenced methods: Existing principles distinguish population, formulation, oral dose, add-on treatment, frequency endpoint, prespecified hierarchy, between/within-group comparisons, denominators, overlapping reports, support and harms in the retained phytosomal-curcumin and other-formulation reports.

Related sources S01

N19 · What was the P value in the direct phytosomal trial?

Current findings: The exact frequency-specific P value in the phytosomal trial remains unverified. P=.052 is not transferred here.
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 original-source comparison and content review remain incomplete; effects, safety, prespecification, independence or fulfilled conditions are not certified.
Reason for missing information: The original test, P value and multiplicity adjustment for the selected frequency endpoint remain unverified.
Required materials and conditions: Exact frequency-specific between-group P value, distinguished from values in another trial
Materials to obtain first: Frequency-specific analysis tables and SAP
Further research: Material needed: Frequency-specific analysis tables and SAP. This records needed materials; no new research was executed.
Remaining uncertainty: Gaps remain in formulation-specific directness, prespecified endpoint hierarchy, exact between-group effects, denominators, allocation, blinding, missingness, measurement, multiplicity, independent replication, support and harms. Existing grade, cross-check and correction wording are historical records, not current external reading or new clinical certification.
Conditions for verification: Original material and analysis scope on Exact frequency-specific between-group P value, distinguished from values in another trial must link to formulation, dose, duration, population, add-on comparison and the frequency endpoint, distinguishing stored information from what remains unverified.
Why this condition is needed: Material on Exact frequency-specific between-group P value, distinguished from values in another trial is needed to connect the selected formulation, population, common treatment, frequency endpoint, denominators, comparison scope or harm gaps.
Application exceptions: Between-group or within-group values from another formulation are not transferred to the phytosomal formulation. Allocation, completion and analysis denominators are not interchanged or added; new effects, confidence intervals, daily totals or withdrawal counts are not calculated. Frequency results are not extended to other endpoints, long-term safety or replacement of preventive medication.
Referenced methods: Existing principles distinguish population, formulation, oral dose, add-on treatment, frequency endpoint, prespecified hierarchy, between/within-group comparisons, denominators, overlapping reports, support and harms in the retained phytosomal-curcumin and other-formulation reports.

Related sources S01 S02

N20 · Are other clinical endpoints distinguished from frequency?

Current findings: The original record states that multiple outcomes were measured. A broad positive statement is not reconstructed as an exact frequency-specific 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 original-source comparison and content review remain incomplete; effects, safety, prespecification, independence or fulfilled conditions are not certified.
Reason for missing information: Individual outcome hierarchy, tests, omissions and the complete result table remain unverified.
Required materials and conditions: Separate results for frequency, duration, intensity, quality of life and sleep
Materials to obtain first: Prespecified plans and result tables for all endpoints
Further research: Material needed: Prespecified plans and result tables for all endpoints. This records needed materials; no new research was executed.
Remaining uncertainty: Gaps remain in formulation-specific directness, prespecified endpoint hierarchy, exact between-group effects, denominators, allocation, blinding, missingness, measurement, multiplicity, independent replication, support and harms. Existing grade, cross-check and correction wording are historical records, not current external reading or new clinical certification.
Conditions for verification: Original material and analysis scope on Separate results for frequency, duration, intensity, quality of life and sleep must link to formulation, dose, duration, population, add-on comparison and the frequency endpoint, distinguishing stored information from what remains unverified.
Why this condition is needed: Material on Separate results for frequency, duration, intensity, quality of life and sleep is needed to connect the selected formulation, population, common treatment, frequency endpoint, denominators, comparison scope or harm gaps.
Application exceptions: Between-group or within-group values from another formulation are not transferred to the phytosomal formulation. Allocation, completion and analysis denominators are not interchanged or added; new effects, confidence intervals, daily totals or withdrawal counts are not calculated. Frequency results are not extended to other endpoints, long-term safety or replacement of preventive medication.
Referenced methods: Existing principles distinguish population, formulation, oral dose, add-on treatment, frequency endpoint, prespecified hierarchy, between/within-group comparisons, denominators, overlapping reports, support and harms in the retained phytosomal-curcumin and other-formulation reports.

Related sources S01

N21 · Was the change in attack count important to patients?

Current findings: The retained material records a positive frequency signal, but the exact effect remains 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 original-source comparison and content review remain incomplete; effects, safety, prespecification, independence or fulfilled conditions are not certified.
Reason for missing information: Important-difference and responder definitions, rescue-medication changes and links to functional outcomes remain unverified.
Required materials and conditions: Minimum important difference, responders, medication use and patient-important outcomes
Materials to obtain first: Responder, important-difference and patient-outcome material
Further research: Material needed: Responder, important-difference and patient-outcome material. This records needed materials; no new research was executed.
Remaining uncertainty: Gaps remain in formulation-specific directness, prespecified endpoint hierarchy, exact between-group effects, denominators, allocation, blinding, missingness, measurement, multiplicity, independent replication, support and harms. Existing grade, cross-check and correction wording are historical records, not current external reading or new clinical certification.
Conditions for verification: Original material and analysis scope on Minimum important difference, responders, medication use and patient-important outcomes must link to formulation, dose, duration, population, add-on comparison and the frequency endpoint, distinguishing stored information from what remains unverified.
Why this condition is needed: Material on Minimum important difference, responders, medication use and patient-important outcomes is needed to connect the selected formulation, population, common treatment, frequency endpoint, denominators, comparison scope or harm gaps.
Application exceptions: Between-group or within-group values from another formulation are not transferred to the phytosomal formulation. Allocation, completion and analysis denominators are not interchanged or added; new effects, confidence intervals, daily totals or withdrawal counts are not calculated. Frequency results are not extended to other endpoints, long-term safety or replacement of preventive medication.
Referenced methods: Existing principles distinguish population, formulation, oral dose, add-on treatment, frequency endpoint, prespecified hierarchy, between/within-group comparisons, denominators, overlapping reports, support and harms in the retained phytosomal-curcumin and other-formulation reports.

Related sources S01

N22 · Is the conventional-curcumin trial in 44 people the same intervention?

Current findings: The separate report concerns conventional curcumin in 44 women. Retained results are between-group P=.052 and within-group P=.014.
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 original-source comparison and content review remain incomplete; effects, safety, prespecification, independence or fulfilled conditions are not certified.
Reason for missing information: Group-specific change, 95% CI and detailed denominators remain unverified. These values are not transferred into phytosomal effects.
Required materials and conditions: A trial in 44 women using conventional curcumin 500 mg, 2 times per 1 day, over 8 weeks
Materials to obtain first: Separate original paper, result tables and intervention specifications
Further research: Material needed: Separate original paper, result tables and intervention specifications. This records needed materials; no new research was executed.
Remaining uncertainty: Gaps remain in formulation-specific directness, prespecified endpoint hierarchy, exact between-group effects, denominators, allocation, blinding, missingness, measurement, multiplicity, independent replication, support and harms. Existing grade, cross-check and correction wording are historical records, not current external reading or new clinical certification.
Conditions for verification: Original material and analysis scope on A trial in 44 women using conventional curcumin 500 mg, 2 times per 1 day, over 8 weeks must link to formulation, dose, duration, population, add-on comparison and the frequency endpoint, distinguishing stored information from what remains unverified.
Why this condition is needed: Material on A trial in 44 women using conventional curcumin 500 mg, 2 times per 1 day, over 8 weeks is needed to connect the selected formulation, population, common treatment, frequency endpoint, denominators, comparison scope or harm gaps.
Application exceptions: Between-group or within-group values from another formulation are not transferred to the phytosomal formulation. Allocation, completion and analysis denominators are not interchanged or added; new effects, confidence intervals, daily totals or withdrawal counts are not calculated. Frequency results are not extended to other endpoints, long-term safety or replacement of preventive medication.
Referenced methods: Existing principles distinguish population, formulation, oral dose, add-on treatment, frequency endpoint, prespecified hierarchy, between/within-group comparisons, denominators, overlapping reports, support and harms in the retained phytosomal-curcumin and other-formulation reports.

Related sources S02

N23 · What differences separate the trials?

Current findings: The reports differ in formulation, dose and population wording. They are not combined as the same effect or a common denominator.
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 original-source comparison and content review remain incomplete; effects, safety, prespecification, independence or fulfilled conditions are not certified.
Reason for missing information: Details of baseline conditions, concurrent medications and analysis contracts, and comparable quantitative material remain unverified.
Required materials and conditions: Distinction between a phospholipid formulation at 250 mg/day and conventional curcumin 500 mg, 2 times per 1 day
Materials to obtain first: Trial-specific intervention, population and analysis specifications
Further research: Material needed: Trial-specific intervention, population and analysis specifications. This records needed materials; no new research was executed.
Remaining uncertainty: Gaps remain in formulation-specific directness, prespecified endpoint hierarchy, exact between-group effects, denominators, allocation, blinding, missingness, measurement, multiplicity, independent replication, support and harms. Existing grade, cross-check and correction wording are historical records, not current external reading or new clinical certification.
Conditions for verification: Original material and analysis scope on Distinction between a phospholipid formulation at 250 mg/day and conventional curcumin 500 mg, 2 times per 1 day must link to formulation, dose, duration, population, add-on comparison and the frequency endpoint, distinguishing stored information from what remains unverified.
Why this condition is needed: Material on Distinction between a phospholipid formulation at 250 mg/day and conventional curcumin 500 mg, 2 times per 1 day is needed to connect the selected formulation, population, common treatment, frequency endpoint, denominators, comparison scope or harm gaps.
Application exceptions: Between-group or within-group values from another formulation are not transferred to the phytosomal formulation. Allocation, completion and analysis denominators are not interchanged or added; new effects, confidence intervals, daily totals or withdrawal counts are not calculated. Frequency results are not extended to other endpoints, long-term safety or replacement of preventive medication.
Referenced methods: Existing principles distinguish population, formulation, oral dose, add-on treatment, frequency endpoint, prespecified hierarchy, between/within-group comparisons, denominators, overlapping reports, support and harms in the retained phytosomal-curcumin and other-formulation reports.

Related sources S01 S02

N24 · Are mechanistic, omega-3 and CoQ10 reports counted as clinical replication?

Current findings: The original record states that CGRP/inflammatory-marker and omega-3/CoQ10 combination trials were excluded from independent clinical-frequency replication.
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 original-source comparison and content review remain incomplete; effects, safety, prespecification, independence or fulfilled conditions are not certified.
Reason for missing information: Exact excluded-report lists, shared cohorts and endpoint links remain unverified in detail in this input.
Required materials and conditions: Directness of mechanistic markers and combination trials
Materials to obtain first: Related-report lists, cohorts, interventions and endpoint material
Further research: Material needed: Related-report lists, cohorts, interventions and endpoint material. This records needed materials; no new research was executed.
Remaining uncertainty: Gaps remain in formulation-specific directness, prespecified endpoint hierarchy, exact between-group effects, denominators, allocation, blinding, missingness, measurement, multiplicity, independent replication, support and harms. Existing grade, cross-check and correction wording are historical records, not current external reading or new clinical certification.
Conditions for verification: Original material and analysis scope on Directness of mechanistic markers and combination trials must link to formulation, dose, duration, population, add-on comparison and the frequency endpoint, distinguishing stored information from what remains unverified.
Why this condition is needed: Material on Directness of mechanistic markers and combination trials is needed to connect the selected formulation, population, common treatment, frequency endpoint, denominators, comparison scope or harm gaps.
Application exceptions: Between-group or within-group values from another formulation are not transferred to the phytosomal formulation. Allocation, completion and analysis denominators are not interchanged or added; new effects, confidence intervals, daily totals or withdrawal counts are not calculated. Frequency results are not extended to other endpoints, long-term safety or replacement of preventive medication.
Referenced methods: Existing principles distinguish population, formulation, oral dose, add-on treatment, frequency endpoint, prespecified hierarchy, between/within-group comparisons, denominators, overlapping reports, support and harms in the retained phytosomal-curcumin and other-formulation reports.

Related sources S01 S02

N25 · How far are unique trials and independent replications established?

Current findings: The direct formulation-specific report is separated from the boundary report of another formulation. The counts of 70 and 44 participants and 65 completers are not added.
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 original-source comparison and content review remain incomplete; effects, safety, prespecification, independence or fulfilled conditions are not certified.
Reason for missing information: Unique trials, total participants and independent replications meeting the selected conditions remain unverified.
Required materials and conditions: Report-trial-endpoint relationships and independence
Materials to obtain first: Report-trial mapping and specifications of replication-study interventions
Further research: Material needed: Report-trial mapping and specifications of replication-study interventions. This records needed materials; no new research was executed.
Remaining uncertainty: Gaps remain in formulation-specific directness, prespecified endpoint hierarchy, exact between-group effects, denominators, allocation, blinding, missingness, measurement, multiplicity, independent replication, support and harms. Existing grade, cross-check and correction wording are historical records, not current external reading or new clinical certification.
Conditions for verification: Original material and analysis scope on Report-trial-endpoint relationships and independence must link to formulation, dose, duration, population, add-on comparison and the frequency endpoint, distinguishing stored information from what remains unverified.
Why this condition is needed: Material on Report-trial-endpoint relationships and independence is needed to connect the selected formulation, population, common treatment, frequency endpoint, denominators, comparison scope or harm gaps.
Application exceptions: Between-group or within-group values from another formulation are not transferred to the phytosomal formulation. Allocation, completion and analysis denominators are not interchanged or added; new effects, confidence intervals, daily totals or withdrawal counts are not calculated. Frequency results are not extended to other endpoints, long-term safety or replacement of preventive medication.
Referenced methods: Existing principles distinguish population, formulation, oral dose, add-on treatment, frequency endpoint, prespecified hierarchy, between/within-group comparisons, denominators, overlapping reports, support and harms in the retained phytosomal-curcumin and other-formulation reports.

Related sources S01 S02

N26 · What information is retained on research funding?

Current findings: The direct report is retained as declaring no conflicts with funding details unverified; the separate report is retained as academic-institution research 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 original-source comparison and content review remain incomplete; effects, safety, prespecification, independence or fulfilled conditions are not certified.
Reason for missing information: Funding sources, contracts and roles in design, analysis and publication remain separately unverified.
Required materials and conditions: Funding for the direct trial and the separate academic-institution trial
Materials to obtain first: Original funding and institutional-role statements
Further research: Material needed: Original funding and institutional-role statements. This records needed materials; no new research was executed.
Remaining uncertainty: Gaps remain in formulation-specific directness, prespecified endpoint hierarchy, exact between-group effects, denominators, allocation, blinding, missingness, measurement, multiplicity, independent replication, support and harms. Existing grade, cross-check and correction wording are historical records, not current external reading or new clinical certification.
Conditions for verification: Original material and analysis scope on Funding for the direct trial and the separate academic-institution trial must link to formulation, dose, duration, population, add-on comparison and the frequency endpoint, distinguishing stored information from what remains unverified.
Why this condition is needed: Material on Funding for the direct trial and the separate academic-institution trial is needed to connect the selected formulation, population, common treatment, frequency endpoint, denominators, comparison scope or harm gaps.
Application exceptions: Between-group or within-group values from another formulation are not transferred to the phytosomal formulation. Allocation, completion and analysis denominators are not interchanged or added; new effects, confidence intervals, daily totals or withdrawal counts are not calculated. Frequency results are not extended to other endpoints, long-term safety or replacement of preventive medication.
Referenced methods: Existing principles distinguish population, formulation, oral dose, add-on treatment, frequency endpoint, prespecified hierarchy, between/within-group comparisons, denominators, overlapping reports, support and harms in the retained phytosomal-curcumin and other-formulation reports.

Related sources S01 S02

N27 · Are product supply and manufacturer involvement known?

Current findings: The retained direct report says product-supply details remain 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 original-source comparison and content review remain incomplete; effects, safety, prespecification, independence or fulfilled conditions are not certified.
Reason for missing information: Product supply, payment of costs and manufacturer involvement in analysis/publication remain unverified.
Required materials and conditions: Free product support, manufacturer, batches and institutional roles
Materials to obtain first: Product-supply and manufacturer-role material
Further research: Material needed: Product-supply and manufacturer-role material. This records needed materials; no new research was executed.
Remaining uncertainty: Gaps remain in formulation-specific directness, prespecified endpoint hierarchy, exact between-group effects, denominators, allocation, blinding, missingness, measurement, multiplicity, independent replication, support and harms. Existing grade, cross-check and correction wording are historical records, not current external reading or new clinical certification.
Conditions for verification: Original material and analysis scope on Free product support, manufacturer, batches and institutional roles must link to formulation, dose, duration, population, add-on comparison and the frequency endpoint, distinguishing stored information from what remains unverified.
Why this condition is needed: Material on Free product support, manufacturer, batches and institutional roles is needed to connect the selected formulation, population, common treatment, frequency endpoint, denominators, comparison scope or harm gaps.
Application exceptions: Between-group or within-group values from another formulation are not transferred to the phytosomal formulation. Allocation, completion and analysis denominators are not interchanged or added; new effects, confidence intervals, daily totals or withdrawal counts are not calculated. Frequency results are not extended to other endpoints, long-term safety or replacement of preventive medication.
Referenced methods: Existing principles distinguish population, formulation, oral dose, add-on treatment, frequency endpoint, prespecified hierarchy, between/within-group comparisons, denominators, overlapping reports, support and harms in the retained phytosomal-curcumin and other-formulation reports.

Related sources S01

N28 · Does no-conflict wording answer employee-authorship and support questions?

Current findings: The direct report wording that authors declared no conflicts is retained.
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 original-source comparison and content review remain incomplete; effects, safety, prespecification, independence or fulfilled conditions are not certified.
Reason for missing information: That wording alone does not establish employee authorship, funding or product-support status.
Required materials and conditions: Distinction among COI declarations, affiliations, employee authors and individual support
Materials to obtain first: Original COI, affiliation and support statements
Further research: Material needed: Original COI, affiliation and support statements. This records needed materials; no new research was executed.
Remaining uncertainty: Gaps remain in formulation-specific directness, prespecified endpoint hierarchy, exact between-group effects, denominators, allocation, blinding, missingness, measurement, multiplicity, independent replication, support and harms. Existing grade, cross-check and correction wording are historical records, not current external reading or new clinical certification.
Conditions for verification: Original material and analysis scope on Distinction among COI declarations, affiliations, employee authors and individual support must link to formulation, dose, duration, population, add-on comparison and the frequency endpoint, distinguishing stored information from what remains unverified.
Why this condition is needed: Material on Distinction among COI declarations, affiliations, employee authors and individual support is needed to connect the selected formulation, population, common treatment, frequency endpoint, denominators, comparison scope or harm gaps.
Application exceptions: Between-group or within-group values from another formulation are not transferred to the phytosomal formulation. Allocation, completion and analysis denominators are not interchanged or added; new effects, confidence intervals, daily totals or withdrawal counts are not calculated. Frequency results are not extended to other endpoints, long-term safety or replacement of preventive medication.
Referenced methods: Existing principles distinguish population, formulation, oral dose, add-on treatment, frequency endpoint, prespecified hierarchy, between/within-group comparisons, denominators, overlapping reports, support and harms in the retained phytosomal-curcumin and other-formulation reports.

Related sources S01 S02

N29 · Does no reported adverse reaction establish safety?

Current findings: The original record says no adverse effects were reported in the trial.
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 original-source comparison and content review remain incomplete; effects, safety, prespecification, independence or fulfilled conditions are not certified.
Reason for missing information: Event definitions, active collection, group-specific event counts and exposure denominators remain unverified. No reporting is not changed into risk 0.
Required materials and conditions: Adverse-event definitions, collection, group-specific events and exposure denominators
Materials to obtain first: Adverse-event collection methods and group-specific tables
Further research: Material needed: Adverse-event collection methods and group-specific tables. This records needed materials; no new research was executed.
Remaining uncertainty: Gaps remain in formulation-specific directness, prespecified endpoint hierarchy, exact between-group effects, denominators, allocation, blinding, missingness, measurement, multiplicity, independent replication, support and harms. Existing grade, cross-check and correction wording are historical records, not current external reading or new clinical certification.
Conditions for verification: Original material and analysis scope on Adverse-event definitions, collection, group-specific events and exposure denominators must link to formulation, dose, duration, population, add-on comparison and the frequency endpoint, distinguishing stored information from what remains unverified.
Why this condition is needed: Material on Adverse-event definitions, collection, group-specific events and exposure denominators is needed to connect the selected formulation, population, common treatment, frequency endpoint, denominators, comparison scope or harm gaps.
Application exceptions: Between-group or within-group values from another formulation are not transferred to the phytosomal formulation. Allocation, completion and analysis denominators are not interchanged or added; new effects, confidence intervals, daily totals or withdrawal counts are not calculated. Frequency results are not extended to other endpoints, long-term safety or replacement of preventive medication.
Referenced methods: Existing principles distinguish population, formulation, oral dose, add-on treatment, frequency endpoint, prespecified hierarchy, between/within-group comparisons, denominators, overlapping reports, support and harms in the retained phytosomal-curcumin and other-formulation reports.

Related sources S01

N30 · Are harms beyond 8 weeks and concurrent-treatment risks answered?

Current findings: The original record limits interpretation: 65 people over 8 weeks cannot exclude rare harms or long-term add-on safety concerns.
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 original-source comparison and content review remain incomplete; effects, safety, prespecification, independence or fulfilled conditions are not certified.
Reason for missing information: Longer follow-up, medication-specific harms and vulnerable-group analyses remain unverified.
Required materials and conditions: Follow-up of long-term/rare harms, concurrent medication and vulnerable groups
Materials to obtain first: Long-term follow-up, concurrent-medication and harm-denominator material
Further research: Material needed: Long-term follow-up, concurrent-medication and harm-denominator material. This records needed materials; no new research was executed.
Remaining uncertainty: Gaps remain in formulation-specific directness, prespecified endpoint hierarchy, exact between-group effects, denominators, allocation, blinding, missingness, measurement, multiplicity, independent replication, support and harms. Existing grade, cross-check and correction wording are historical records, not current external reading or new clinical certification.
Conditions for verification: Original material and analysis scope on Follow-up of long-term/rare harms, concurrent medication and vulnerable groups must link to formulation, dose, duration, population, add-on comparison and the frequency endpoint, distinguishing stored information from what remains unverified.
Why this condition is needed: Material on Follow-up of long-term/rare harms, concurrent medication and vulnerable groups is needed to connect the selected formulation, population, common treatment, frequency endpoint, denominators, comparison scope or harm gaps.
Application exceptions: Between-group or within-group values from another formulation are not transferred to the phytosomal formulation. Allocation, completion and analysis denominators are not interchanged or added; new effects, confidence intervals, daily totals or withdrawal counts are not calculated. Frequency results are not extended to other endpoints, long-term safety or replacement of preventive medication.
Referenced methods: Existing principles distinguish population, formulation, oral dose, add-on treatment, frequency endpoint, prespecified hierarchy, between/within-group comparisons, denominators, overlapping reports, support and harms in the retained phytosomal-curcumin and other-formulation reports.

Related sources S01

N31 · Can findings be extended to replacing preventive medication or other products?

Current findings: The original record limits preventive-medication replacement claims and claims of the same effect for conventional turmeric, nano formulations or combinations.
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 original-source comparison and content review remain incomplete; effects, safety, prespecification, independence or fulfilled conditions are not certified.
Reason for missing information: Stopping/replacing preventive medication and direct effects of other products have not been established.
Required materials and conditions: Distinction between add-on and replacement treatment and conventional turmeric, nano formulations and combinations
Materials to obtain first: Direct comparisons for replacement treatment and other formulations
Further research: Material needed: Direct comparisons for replacement treatment and other formulations. This records needed materials; no new research was executed.
Remaining uncertainty: Gaps remain in formulation-specific directness, prespecified endpoint hierarchy, exact between-group effects, denominators, allocation, blinding, missingness, measurement, multiplicity, independent replication, support and harms. Existing grade, cross-check and correction wording are historical records, not current external reading or new clinical certification.
Conditions for verification: Original material and analysis scope on Distinction between add-on and replacement treatment and conventional turmeric, nano formulations and combinations must link to formulation, dose, duration, population, add-on comparison and the frequency endpoint, distinguishing stored information from what remains unverified.
Why this condition is needed: Material on Distinction between add-on and replacement treatment and conventional turmeric, nano formulations and combinations is needed to connect the selected formulation, population, common treatment, frequency endpoint, denominators, comparison scope or harm gaps.
Application exceptions: Between-group or within-group values from another formulation are not transferred to the phytosomal formulation. Allocation, completion and analysis denominators are not interchanged or added; new effects, confidence intervals, daily totals or withdrawal counts are not calculated. Frequency results are not extended to other endpoints, long-term safety or replacement of preventive medication.
Referenced methods: Existing principles distinguish population, formulation, oral dose, add-on treatment, frequency endpoint, prespecified hierarchy, between/within-group comparisons, denominators, overlapping reports, support and harms in the retained phytosomal-curcumin and other-formulation reports.

Related sources S01 S02

N32 · What are the current English wording and historical language correction?

Current findings: The current English wording separates P=.052 for another formulation from unverified values in the direct trial. The correction history for 2 English fields is retained.
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 original-source comparison and content review remain incomplete; effects, safety, prespecification, independence or fulfilled conditions are not certified.
Reason for missing information: The prior individual English fields before/after correction and their precise correspondence with the original full text remain unread.
Required materials and conditions: Retained Korean/English wording, generic English text and the correction event of 2026-09-14
Materials to obtain first: Original wording before/after correction and language-mapping material
Further research: Material needed: Original wording before/after correction and language-mapping material. This records needed materials; no new research was executed.
Remaining uncertainty: Gaps remain in formulation-specific directness, prespecified endpoint hierarchy, exact between-group effects, denominators, allocation, blinding, missingness, measurement, multiplicity, independent replication, support and harms. Existing grade, cross-check and correction wording are historical records, not current external reading or new clinical certification.
Conditions for verification: Original material and analysis scope on Retained Korean/English wording, generic English text and the correction event of 2026-09-14 must link to formulation, dose, duration, population, add-on comparison and the frequency endpoint, distinguishing stored information from what remains unverified.
Why this condition is needed: Material on Retained Korean/English wording, generic English text and the correction event of 2026-09-14 is needed to connect the selected formulation, population, common treatment, frequency endpoint, denominators, comparison scope or harm gaps.
Application exceptions: Between-group or within-group values from another formulation are not transferred to the phytosomal formulation. Allocation, completion and analysis denominators are not interchanged or added; new effects, confidence intervals, daily totals or withdrawal counts are not calculated. Frequency results are not extended to other endpoints, long-term safety or replacement of preventive medication.
Referenced methods: Existing principles distinguish population, formulation, oral dose, add-on treatment, frequency endpoint, prespecified hierarchy, between/within-group comparisons, denominators, overlapping reports, support and harms in the retained phytosomal-curcumin and other-formulation reports.

Related sources S01 S02

N33 · How are the original C score of 50, axes and historical verification retained?

Current findings: The C score of 50, original axes and previous independent cross-check are existing records. They are not inherited as fulfilled conditions or completed content review for this table.
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 original-source comparison and content review remain incomplete; effects, safety, prespecification, independence or fulfilled conditions are not certified.
Reason for missing information: Review of existing content remains incomplete.
Required materials and conditions: Historical preservation of the current original grade, score, EX/CX, axes and previous cross-check
Materials to obtain first: Additional review comments and future correction material
Further research: Material needed: Additional review comments and future correction material. This records needed materials; no new research was executed.
Remaining uncertainty: Gaps remain in formulation-specific directness, prespecified endpoint hierarchy, exact between-group effects, denominators, allocation, blinding, missingness, measurement, multiplicity, independent replication, support and harms. Existing grade, cross-check and correction wording are historical records, not current external reading or new clinical certification.
Conditions for verification: Original material and analysis scope on Historical preservation of the current original grade, score, EX/CX, axes and previous cross-check must link to formulation, dose, duration, population, add-on comparison and the frequency endpoint, distinguishing stored information from what remains unverified.
Why this condition is needed: Material on Historical preservation of the current original grade, score, EX/CX, axes and previous cross-check is needed to connect the selected formulation, population, common treatment, frequency endpoint, denominators, comparison scope or harm gaps.
Application exceptions: Between-group or within-group values from another formulation are not transferred to the phytosomal formulation. Allocation, completion and analysis denominators are not interchanged or added; new effects, confidence intervals, daily totals or withdrawal counts are not calculated. Frequency results are not extended to other endpoints, long-term safety or replacement of preventive medication.
Referenced methods: Existing principles distinguish population, formulation, oral dose, add-on treatment, frequency endpoint, prespecified hierarchy, between/within-group comparisons, denominators, overlapping reports, support and harms in the retained phytosomal-curcumin and other-formulation reports.

Related sources S01 S02

N34 · What dates, unrecorded information and actual reading scope are retained?

Current findings: Preparation read the complete stored summary. The original verdict date is 2026-09-08 and the correction date is 2026-09-14. Empty lists of additional detailed claims and deliberation records are also 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 original-source comparison and content review remain incomplete; effects, safety, prespecification, independence or fulfilled conditions are not certified.
Reason for missing information: External abstracts, full texts, registration, protocols and SAPs remain unread, with no access attempt in this work.
Required materials and conditions: Original verdict date, correction date, empty detailed-claim list and external material unread
Materials to obtain first: Required originals and planning material when provided
Further research: Material needed: Required originals and planning material when provided. This records needed materials; no new research was executed.
Remaining uncertainty: Gaps remain in formulation-specific directness, prespecified endpoint hierarchy, exact between-group effects, denominators, allocation, blinding, missingness, measurement, multiplicity, independent replication, support and harms. Existing grade, cross-check and correction wording are historical records, not current external reading or new clinical certification.
Conditions for verification: Original material and analysis scope on Original verdict date, correction date, empty detailed-claim list and external material unread must link to formulation, dose, duration, population, add-on comparison and the frequency endpoint, distinguishing stored information from what remains unverified.
Why this condition is needed: Material on Original verdict date, correction date, empty detailed-claim list and external material unread is needed to connect the selected formulation, population, common treatment, frequency endpoint, denominators, comparison scope or harm gaps.
Application exceptions: Between-group or within-group values from another formulation are not transferred to the phytosomal formulation. Allocation, completion and analysis denominators are not interchanged or added; new effects, confidence intervals, daily totals or withdrawal counts are not calculated. Frequency results are not extended to other endpoints, long-term safety or replacement of preventive medication.
Referenced methods: Existing principles distinguish population, formulation, oral dose, add-on treatment, frequency endpoint, prespecified hierarchy, between/within-group comparisons, denominators, overlapping reports, support and harms in the retained phytosomal-curcumin and other-formulation reports.

Related sources S01 S02