{ "schema_version": "chamgap-public-evidence-check-1.0", "public_id": "v3046-main", "verdict_number": "3046", "title": "Phytosomal Curcumin 250 mg/day × Migraine-Attack Frequency at 8 Weeks in Adults With Migraine Without Aura", "view_version": "1.0", "view_created_date": "2026-10-25", "criteria_version": "1.0", "criteria_date": "2026-10-06", "review_date": null, "legacy_evidence_date": "2026-09-08", "review_scope": { "materials_read": "Existing review summaries and stored records of methodological application", "clinical_papers_directly_read": false, "new_clinical_search": false, "limitation": "Existing stored summary and preserved methodology application records. External papers, abstracts, registration, protocols, SAPs, original result tables and support disclosures are unread, and review of existing content remains incomplete.", "date_meaning": "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." }, "claim_context": { "population": "Adults with migraine without aura who continued standard treatment", "intervention": "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.", "endpoint": "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.", "excluded_extensions": [ "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" ] }, "requirements": [ { "item_id": "N01", "question_type": "Evidence condition", "question": "Which migraine-attack frequency question is covered?", "needed": "An 8-week phytosomal-curcumin add-on comparison for migraine without aura", "role": "Required", "role_reason": "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_exception": "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.", "criterion": "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.", "basis": "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.", "condition_origin": "These existing in-house conditions are linked to the selected phytosomal-curcumin add-on and attack-frequency question. They explain material gaps without establishing new preregistration, official tool assessment or independent clinical validation.", "proposed_research": "Material needed: Direct original paper, protocol and registration. This records needed materials; no new research was executed.", "current_reports": [ "S01", "S02" ], "existence": "The information comes from stored report summaries and bibliographies. Existence, public availability, acquisition and actual reading of external papers, registration, protocols, analysis plans, original result tables and funding/product-support material remain separately unverified.", "acquired_read": "The retained Korean and English summaries and bibliography were read. External papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain unread, with no access attempt.", "observation": "The original claim is reduction of migraine-attack frequency without aura, distinguished from other formulations, biomarkers and combinations.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Detailed eligibility and prespecified endpoints in the external original trial remain unread.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Direct original paper, protocol and registration" }, { "item_id": "N02", "question_type": "Evidence condition", "question": "Which adults with migraine are represented?", "needed": "Diagnosis of migraine without aura, adult eligibility and continuation of standard treatment", "role": "Required", "role_reason": "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_exception": "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.", "criterion": "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.", "basis": "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.", "condition_origin": "These existing in-house conditions are linked to the selected phytosomal-curcumin add-on and attack-frequency question. They explain material gaps without establishing new preregistration, official tool assessment or independent clinical validation.", "proposed_research": "Material needed: Eligibility, diagnosis and baseline-characteristic tables. This records needed materials; no new research was executed.", "current_reports": [ "S01" ], "existence": "The information comes from stored report summaries and bibliographies. Existence, public availability, acquisition and actual reading of external papers, registration, protocols, analysis plans, original result tables and funding/product-support material remain separately unverified.", "acquired_read": "The retained Korean and English summaries and bibliography were read. External papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain unread, with no access attempt.", "observation": "The retained population is adults with migraine without aura who continued standard treatment.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Detailed diagnostic criteria, frequency range, age/sex and exclusion criteria remain unverified.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Eligibility, diagnosis and baseline-characteristic tables" }, { "item_id": "N03", "question_type": "Evidence condition", "question": "Is the phytosomal formulation interchangeable with other curcumin?", "needed": "Distinction between a phospholipid delivery system and conventional, nano, micellar and combination formulations", "role": "Required", "role_reason": "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_exception": "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.", "criterion": "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.", "basis": "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.", "condition_origin": "These existing in-house conditions are linked to the selected phytosomal-curcumin add-on and attack-frequency question. They explain material gaps without establishing new preregistration, official tool assessment or independent clinical validation.", "proposed_research": "Material needed: Formulation, product, batch and quantification material. This records needed materials; no new research was executed.", "current_reports": [ "S01" ], "existence": "The information comes from stored report summaries and bibliographies. Existence, public availability, acquisition and actual reading of external papers, registration, protocols, analysis plans, original result tables and funding/product-support material remain separately unverified.", "acquired_read": "The retained Korean and English summaries and bibliography were read. External papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain unread, with no access attempt.", "observation": "The selected formulation is phospholipid phytosomal curcumin derived from Curcuma longa, distinguished from nanocurcumin.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Product batches, active-ingredient quantification and manufacturing conditions remain unverified.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Formulation, product, batch and quantification material" }, { "item_id": "N04", "question_type": "Evidence condition", "question": "What were the dose and actual intake?", "needed": "Phytosomal curcumin 250 mg/day and actual adherence", "role": "Required", "role_reason": "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_exception": "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.", "criterion": "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.", "basis": "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.", "condition_origin": "These existing in-house conditions are linked to the selected phytosomal-curcumin add-on and attack-frequency question. They explain material gaps without establishing new preregistration, official tool assessment or independent clinical validation.", "proposed_research": "Material needed: Product amount, ingredient amount and adherence records. This records needed materials; no new research was executed.", "current_reports": [ "S01" ], "existence": "The information comes from stored report summaries and bibliographies. Existence, public availability, acquisition and actual reading of external papers, registration, protocols, analysis plans, original result tables and funding/product-support material remain separately unverified.", "acquired_read": "The retained Korean and English summaries and bibliography were read. External papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain unread, with no access attempt.", "observation": "The retained dose is an oral add-on at 250 mg/day.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Active-ingredient conversion, actual adherence and dose changes remain unverified.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Product amount, ingredient amount and adherence records" }, { "item_id": "N05", "question_type": "Evidence condition", "question": "What were the treatment and follow-up times?", "needed": "Treatment/follow-up over 8 weeks and persistence after stopping", "role": "Required", "role_reason": "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_exception": "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.", "criterion": "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.", "basis": "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.", "condition_origin": "These existing in-house conditions are linked to the selected phytosomal-curcumin add-on and attack-frequency question. They explain material gaps without establishing new preregistration, official tool assessment or independent clinical validation.", "proposed_research": "Material needed: Measurement schedule and follow-up plan. This records needed materials; no new research was executed.", "current_reports": [ "S01" ], "existence": "The information comes from stored report summaries and bibliographies. Existence, public availability, acquisition and actual reading of external papers, registration, protocols, analysis plans, original result tables and funding/product-support material remain separately unverified.", "acquired_read": "The retained Korean and English summaries and bibliography were read. External papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain unread, with no access attempt.", "observation": "The retained treatment and follow-up duration is 8 weeks.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Visit schedules, persistence beyond 8 weeks and long-term follow-up remain unverified.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Measurement schedule and follow-up plan" }, { "item_id": "N06", "question_type": "Evidence condition", "question": "What was the contribution of standard treatment and concurrent medication?", "needed": "Continuation/changes in standard treatment, preventive medication and rescue medication in both groups", "role": "Required", "role_reason": "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_exception": "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.", "criterion": "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.", "basis": "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.", "condition_origin": "These existing in-house conditions are linked to the selected phytosomal-curcumin add-on and attack-frequency question. They explain material gaps without establishing new preregistration, official tool assessment or independent clinical validation.", "proposed_research": "Material needed: Concurrent, preventive and rescue medication tables. This records needed materials; no new research was executed.", "current_reports": [ "S01" ], "existence": "The information comes from stored report summaries and bibliographies. Existence, public availability, acquisition and actual reading of external papers, registration, protocols, analysis plans, original result tables and funding/product-support material remain separately unverified.", "acquired_read": "The retained Korean and English summaries and bibliography were read. External papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain unread, with no access attempt.", "observation": "The original record describes an add-on trial with continued standard treatment.", "condition_status": "Unverified", "status_reason": "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.", "missingness": "Specific medications, doses, group-specific changes, rescue use and their control remain unverified.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Concurrent, preventive and rescue medication tables" }, { "item_id": "N07", "question_type": "Evidence condition", "question": "What was the maltodextrin-placebo comparison?", "needed": "Conditions of maltodextrin placebo added to standard treatment", "role": "Required", "role_reason": "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_exception": "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.", "criterion": "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.", "basis": "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.", "condition_origin": "These existing in-house conditions are linked to the selected phytosomal-curcumin add-on and attack-frequency question. They explain material gaps without establishing new preregistration, official tool assessment or independent clinical validation.", "proposed_research": "Material needed: Placebo and concurrent-treatment specifications. This records needed materials; no new research was executed.", "current_reports": [ "S01" ], "existence": "The information comes from stored report summaries and bibliographies. Existence, public availability, acquisition and actual reading of external papers, registration, protocols, analysis plans, original result tables and funding/product-support material remain separately unverified.", "acquired_read": "The retained Korean and English summaries and bibliography were read. External papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain unread, with no access attempt.", "observation": "The comparator is recorded as maltodextrin placebo added to standard treatment.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Placebo composition, appearance, intake schedule and details of common treatment remain unverified.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Placebo and concurrent-treatment specifications" }, { "item_id": "N08", "question_type": "Evidence condition", "question": "How is the direct report identified?", "needed": "Shojaei report title, PMID, DOI and retained result", "role": "Required", "role_reason": "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_exception": "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.", "criterion": "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.", "basis": "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.", "condition_origin": "These existing in-house conditions are linked to the selected phytosomal-curcumin add-on and attack-frequency question. They explain material gaps without establishing new preregistration, official tool assessment or independent clinical validation.", "proposed_research": "Material needed: Direct original paper and bibliographic record. This records needed materials; no new research was executed.", "current_reports": [ "S01" ], "existence": "The information comes from stored report summaries and bibliographies. Existence, public availability, acquisition and actual reading of external papers, registration, protocols, analysis plans, original result tables and funding/product-support material remain separately unverified.", "acquired_read": "The retained Korean and English summaries and bibliography were read. External papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain unread, with no access attempt.", "observation": "The bibliography records Shojaei 2025, PMID 41136816 and DOI 10.1007/s11655-025-3939-1.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Current external bibliographic identity, the original file and full-text content remain unread in this work.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Direct original paper and bibliographic record" }, { "item_id": "N09", "question_type": "Evidence condition", "question": "Is an IRCT number the same as actual registration verification?", "needed": "IRCT20201129049534N2, registration timing, endpoints and history", "role": "Required", "role_reason": "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_exception": "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.", "criterion": "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.", "basis": "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.", "condition_origin": "These existing in-house conditions are linked to the selected phytosomal-curcumin add-on and attack-frequency question. They explain material gaps without establishing new preregistration, official tool assessment or independent clinical validation.", "proposed_research": "Material needed: Original registration and change history. This records needed materials; no new research was executed.", "current_reports": [ "S01" ], "existence": "The information comes from stored report summaries and bibliographies. Existence, public availability, acquisition and actual reading of external papers, registration, protocols, analysis plans, original result tables and funding/product-support material remain separately unverified.", "acquired_read": "The retained Korean and English summaries and bibliography were read. External papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain unread, with no access attempt.", "observation": "The bibliography contains IRCT20201129049534N2, while registration status in the original record remains unverified.", "condition_status": "Unverified", "status_reason": "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.", "missingness": "Registration content, prospective timing, changes and correspondence with the paper remain unread.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original registration and change history" }, { "item_id": "N10", "question_type": "Evidence condition", "question": "Was attack frequency the single prespecified primary endpoint (1st in the hierarchy)?", "needed": "Prespecified hierarchy, analysis and timing for frequency among multiple clinical endpoints", "role": "Required", "role_reason": "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_exception": "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.", "criterion": "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.", "basis": "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.", "condition_origin": "These existing in-house conditions are linked to the selected phytosomal-curcumin add-on and attack-frequency question. They explain material gaps without establishing new preregistration, official tool assessment or independent clinical validation.", "proposed_research": "Material needed: Protocol, SAP and registered endpoints. This records needed materials; no new research was executed.", "current_reports": [ "S01" ], "existence": "The information comes from stored report summaries and bibliographies. Existence, public availability, acquisition and actual reading of external papers, registration, protocols, analysis plans, original result tables and funding/product-support material remain separately unverified.", "acquired_read": "The retained Korean and English summaries and bibliography were read. External papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain unread, with no access attempt.", "observation": "The retained record leaves unverified whether change in attack frequency at 8 weeks was the single prespecified primary endpoint (1st in the hierarchy).", "condition_status": "Unverified", "status_reason": "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.", "missingness": "The protocol, SAP and multiplicity plan remain unread.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Protocol, SAP and registered endpoints" }, { "item_id": "N11", "question_type": "Evidence condition", "question": "What were the randomization and concealment methods?", "needed": "Randomization procedures, concealment and recruitment flow", "role": "Required", "role_reason": "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_exception": "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.", "criterion": "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.", "basis": "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.", "condition_origin": "These existing in-house conditions are linked to the selected phytosomal-curcumin add-on and attack-frequency question. They explain material gaps without establishing new preregistration, official tool assessment or independent clinical validation.", "proposed_research": "Material needed: Allocation methods and participant flow diagram. This records needed materials; no new research was executed.", "current_reports": [ "S01" ], "existence": "The information comes from stored report summaries and bibliographies. Existence, public availability, acquisition and actual reading of external papers, registration, protocols, analysis plans, original result tables and funding/product-support material remain separately unverified.", "acquired_read": "The retained Korean and English summaries and bibliography were read. External papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain unread, with no access attempt.", "observation": "The retained design is a randomized double-blind placebo-add-on trial.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Allocation sequence, concealment methods and detailed recruitment flow remain unverified.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Allocation methods and participant flow diagram" }, { "item_id": "N12", "question_type": "Evidence condition", "question": "How were blinding and outcome measurement maintained?", "needed": "Participant/assessor blinding and placebo matching", "role": "Required", "role_reason": "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_exception": "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.", "criterion": "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.", "basis": "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.", "condition_origin": "These existing in-house conditions are linked to the selected phytosomal-curcumin add-on and attack-frequency question. They explain material gaps without establishing new preregistration, official tool assessment or independent clinical validation.", "proposed_research": "Material needed: Blinding, placebo and outcome-recording methods. This records needed materials; no new research was executed.", "current_reports": [ "S01" ], "existence": "The information comes from stored report summaries and bibliographies. Existence, public availability, acquisition and actual reading of external papers, registration, protocols, analysis plans, original result tables and funding/product-support material remain separately unverified.", "acquired_read": "The retained Korean and English summaries and bibliography were read. External papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain unread, with no access attempt.", "observation": "The original record describes a double-blind design.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Sensory placebo matching, assessor blinding/unblinding and recording methods remain unverified.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Blinding, placebo and outcome-recording methods" }, { "item_id": "N13", "question_type": "Evidence condition", "question": "How are 70 randomized participants and 65 completers distinguished?", "needed": "The 70 randomized participants, 65 completers and group correspondence for 33 versus 32", "role": "Required", "role_reason": "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_exception": "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.", "criterion": "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.", "basis": "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.", "condition_origin": "These existing in-house conditions are linked to the selected phytosomal-curcumin add-on and attack-frequency question. They explain material gaps without establishing new preregistration, official tool assessment or independent clinical validation.", "proposed_research": "Material needed: Group-specific allocation, completion and analysis flow and result tables. This records needed materials; no new research was executed.", "current_reports": [ "S01" ], "existence": "The information comes from stored report summaries and bibliographies. Existence, public availability, acquisition and actual reading of external papers, registration, protocols, analysis plans, original result tables and funding/product-support material remain separately unverified.", "acquired_read": "The retained Korean and English summaries and bibliography were read. External papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain unread, with no access attempt.", "observation": "The retained denominators are 70 randomized and 65 completed (33 versus 32); allocation and completion are not interchanged.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "The group correspondence for 33 and 32 and endpoint-specific analysis denominators remain unverified.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Group-specific allocation, completion and analysis flow and result tables" }, { "item_id": "N14", "question_type": "Evidence condition", "question": "What was the exact ITT analysis population?", "needed": "ITT, completer analyses and inclusion criteria for the frequency result", "role": "Required", "role_reason": "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_exception": "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.", "criterion": "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.", "basis": "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.", "condition_origin": "These existing in-house conditions are linked to the selected phytosomal-curcumin add-on and attack-frequency question. They explain material gaps without establishing new preregistration, official tool assessment or independent clinical validation.", "proposed_research": "Material needed: Analysis-population definitions, ITT, SAP and result tables. This records needed materials; no new research was executed.", "current_reports": [ "S01" ], "existence": "The information comes from stored report summaries and bibliographies. Existence, public availability, acquisition and actual reading of external papers, registration, protocols, analysis plans, original result tables and funding/product-support material remain separately unverified.", "acquired_read": "The retained Korean and English summaries and bibliography were read. External papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain unread, with no access attempt.", "observation": "The current summary states that the exact ITT denominator remains unverified.", "condition_status": "Unverified", "status_reason": "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.", "missingness": "Analysis-population definitions and actual result-inclusion criteria for the 70 and 65 participants remain unverified.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Analysis-population definitions, ITT, SAP and result tables" }, { "item_id": "N15", "question_type": "Evidence condition", "question": "What effects could missingness and withdrawal have?", "needed": "Group-specific withdrawal reasons, missing-data handling and sensitivity analyses", "role": "Required", "role_reason": "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_exception": "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.", "criterion": "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.", "basis": "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.", "condition_origin": "These existing in-house conditions are linked to the selected phytosomal-curcumin add-on and attack-frequency question. They explain material gaps without establishing new preregistration, official tool assessment or independent clinical validation.", "proposed_research": "Material needed: Missing-data and withdrawal reasons and analysis material. This records needed materials; no new research was executed.", "current_reports": [ "S01" ], "existence": "The information comes from stored report summaries and bibliographies. Existence, public availability, acquisition and actual reading of external papers, registration, protocols, analysis plans, original result tables and funding/product-support material remain separately unverified.", "acquired_read": "The retained Korean and English summaries and bibliography were read. External papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain unread, with no access attempt.", "observation": "The retained material distinguishes randomized and completed participant counts.", "condition_status": "Unverified", "status_reason": "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.", "missingness": "Group-specific withdrawal reasons, missing-data handling and sensitivity analyses remain unverified. Differences in participant counts are not newly calculated.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Missing-data and withdrawal reasons and analysis material" }, { "item_id": "N16", "question_type": "Evidence condition", "question": "In which units was attack frequency measured?", "needed": "Attack definition, frequency per period, diaries and baseline values", "role": "Required", "role_reason": "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_exception": "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.", "criterion": "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.", "basis": "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.", "condition_origin": "These existing in-house conditions are linked to the selected phytosomal-curcumin add-on and attack-frequency question. They explain material gaps without establishing new preregistration, official tool assessment or independent clinical validation.", "proposed_research": "Material needed: Frequency definition, diaries, baseline values and result tables. This records needed materials; no new research was executed.", "current_reports": [ "S01" ], "existence": "The information comes from stored report summaries and bibliographies. Existence, public availability, acquisition and actual reading of external papers, registration, protocols, analysis plans, original result tables and funding/product-support material remain separately unverified.", "acquired_read": "The retained Korean and English summaries and bibliography were read. External papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain unread, with no access attempt.", "observation": "The selected endpoint is change in attack frequency at 8 weeks.", "condition_status": "Unverified", "status_reason": "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.", "missingness": "Attack definition, weekly/monthly units, diary recording, baseline values and measurement reliability remain unverified.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Frequency definition, diaries, baseline values and result tables" }, { "item_id": "N17", "question_type": "Evidence condition", "question": "What was the exact between-group effect on frequency?", "needed": "Frequency-specific between-group change and analysis model", "role": "Required", "role_reason": "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_exception": "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.", "criterion": "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.", "basis": "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.", "condition_origin": "These existing in-house conditions are linked to the selected phytosomal-curcumin add-on and attack-frequency question. They explain material gaps without establishing new preregistration, official tool assessment or independent clinical validation.", "proposed_research": "Material needed: Original frequency-specific group values and between-group estimate tables. This records needed materials; no new research was executed.", "current_reports": [ "S01" ], "existence": "The information comes from stored report summaries and bibliographies. Existence, public availability, acquisition and actual reading of external papers, registration, protocols, analysis plans, original result tables and funding/product-support material remain separately unverified.", "acquired_read": "The retained Korean and English summaries and bibliography were read. External papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain unread, with no access attempt.", "observation": "The existing summary of broadly positive abstract results, including frequency, is retained. The exact frequency-specific between-group change remains unverified.", "condition_status": "Unverified", "status_reason": "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.", "missingness": "Group-specific values, between-group change and an adjustment model are absent from the retained scope.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original frequency-specific group values and between-group estimate tables" }, { "item_id": "N18", "question_type": "Evidence condition", "question": "Is there a confidence interval for the frequency effect?", "needed": "Exact frequency-specific between-group 95% CI", "role": "Required", "role_reason": "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_exception": "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.", "criterion": "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.", "basis": "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.", "condition_origin": "These existing in-house conditions are linked to the selected phytosomal-curcumin add-on and attack-frequency question. They explain material gaps without establishing new preregistration, official tool assessment or independent clinical validation.", "proposed_research": "Material needed: Between-group 95% CI and analysis output. This records needed materials; no new research was executed.", "current_reports": [ "S01" ], "existence": "The information comes from stored report summaries and bibliographies. Existence, public availability, acquisition and actual reading of external papers, registration, protocols, analysis plans, original result tables and funding/product-support material remain separately unverified.", "acquired_read": "The retained Korean and English summaries and bibliography were read. External papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain unread, with no access attempt.", "observation": "The retained record leaves the 95% CI unverified.", "condition_status": "Unverified", "status_reason": "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.", "missingness": "Variance, interval and precision material are unavailable in the retained scope. No new interval is calculated.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Between-group 95% CI and analysis output" }, { "item_id": "N19", "question_type": "Evidence condition", "question": "What was the P value in the direct phytosomal trial?", "needed": "Exact frequency-specific between-group P value, distinguished from values in another trial", "role": "Required", "role_reason": "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_exception": "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.", "criterion": "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.", "basis": "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.", "condition_origin": "These existing in-house conditions are linked to the selected phytosomal-curcumin add-on and attack-frequency question. They explain material gaps without establishing new preregistration, official tool assessment or independent clinical validation.", "proposed_research": "Material needed: Frequency-specific analysis tables and SAP. This records needed materials; no new research was executed.", "current_reports": [ "S01", "S02" ], "existence": "The information comes from stored report summaries and bibliographies. Existence, public availability, acquisition and actual reading of external papers, registration, protocols, analysis plans, original result tables and funding/product-support material remain separately unverified.", "acquired_read": "The retained Korean and English summaries and bibliography were read. External papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain unread, with no access attempt.", "observation": "The exact frequency-specific P value in the phytosomal trial remains unverified. P=.052 is not transferred here.", "condition_status": "Unverified", "status_reason": "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.", "missingness": "The original test, P value and multiplicity adjustment for the selected frequency endpoint remain unverified.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Frequency-specific analysis tables and SAP" }, { "item_id": "N20", "question_type": "Evidence condition", "question": "Are other clinical endpoints distinguished from frequency?", "needed": "Separate results for frequency, duration, intensity, quality of life and sleep", "role": "Required", "role_reason": "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_exception": "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.", "criterion": "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.", "basis": "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.", "condition_origin": "These existing in-house conditions are linked to the selected phytosomal-curcumin add-on and attack-frequency question. They explain material gaps without establishing new preregistration, official tool assessment or independent clinical validation.", "proposed_research": "Material needed: Prespecified plans and result tables for all endpoints. This records needed materials; no new research was executed.", "current_reports": [ "S01" ], "existence": "The information comes from stored report summaries and bibliographies. Existence, public availability, acquisition and actual reading of external papers, registration, protocols, analysis plans, original result tables and funding/product-support material remain separately unverified.", "acquired_read": "The retained Korean and English summaries and bibliography were read. External papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain unread, with no access attempt.", "observation": "The original record states that multiple outcomes were measured. A broad positive statement is not reconstructed as an exact frequency-specific effect.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Individual outcome hierarchy, tests, omissions and the complete result table remain unverified.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Prespecified plans and result tables for all endpoints" }, { "item_id": "N21", "question_type": "Evidence condition", "question": "Was the change in attack count important to patients?", "needed": "Minimum important difference, responders, medication use and patient-important outcomes", "role": "Required", "role_reason": "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_exception": "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.", "criterion": "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.", "basis": "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.", "condition_origin": "These existing in-house conditions are linked to the selected phytosomal-curcumin add-on and attack-frequency question. They explain material gaps without establishing new preregistration, official tool assessment or independent clinical validation.", "proposed_research": "Material needed: Responder, important-difference and patient-outcome material. This records needed materials; no new research was executed.", "current_reports": [ "S01" ], "existence": "The information comes from stored report summaries and bibliographies. Existence, public availability, acquisition and actual reading of external papers, registration, protocols, analysis plans, original result tables and funding/product-support material remain separately unverified.", "acquired_read": "The retained Korean and English summaries and bibliography were read. External papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain unread, with no access attempt.", "observation": "The retained material records a positive frequency signal, but the exact effect remains unverified.", "condition_status": "Unverified", "status_reason": "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.", "missingness": "Important-difference and responder definitions, rescue-medication changes and links to functional outcomes remain unverified.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Responder, important-difference and patient-outcome material" }, { "item_id": "N22", "question_type": "Evidence condition", "question": "Is the conventional-curcumin trial in 44 people the same intervention?", "needed": "A trial in 44 women using conventional curcumin 500 mg, 2 times per 1 day, over 8 weeks", "role": "Required", "role_reason": "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_exception": "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.", "criterion": "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.", "basis": "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.", "condition_origin": "These existing in-house conditions are linked to the selected phytosomal-curcumin add-on and attack-frequency question. They explain material gaps without establishing new preregistration, official tool assessment or independent clinical validation.", "proposed_research": "Material needed: Separate original paper, result tables and intervention specifications. This records needed materials; no new research was executed.", "current_reports": [ "S02" ], "existence": "The information comes from stored report summaries and bibliographies. Existence, public availability, acquisition and actual reading of external papers, registration, protocols, analysis plans, original result tables and funding/product-support material remain separately unverified.", "acquired_read": "The retained Korean and English summaries and bibliography were read. External papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain unread, with no access attempt.", "observation": "The separate report concerns conventional curcumin in 44 women. Retained results are between-group P=.052 and within-group P=.014.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Group-specific change, 95% CI and detailed denominators remain unverified. These values are not transferred into phytosomal effects.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Separate original paper, result tables and intervention specifications" }, { "item_id": "N23", "question_type": "Evidence condition", "question": "What differences separate the trials?", "needed": "Distinction between a phospholipid formulation at 250 mg/day and conventional curcumin 500 mg, 2 times per 1 day", "role": "Required", "role_reason": "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_exception": "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.", "criterion": "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.", "basis": "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.", "condition_origin": "These existing in-house conditions are linked to the selected phytosomal-curcumin add-on and attack-frequency question. They explain material gaps without establishing new preregistration, official tool assessment or independent clinical validation.", "proposed_research": "Material needed: Trial-specific intervention, population and analysis specifications. This records needed materials; no new research was executed.", "current_reports": [ "S01", "S02" ], "existence": "The information comes from stored report summaries and bibliographies. Existence, public availability, acquisition and actual reading of external papers, registration, protocols, analysis plans, original result tables and funding/product-support material remain separately unverified.", "acquired_read": "The retained Korean and English summaries and bibliography were read. External papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain unread, with no access attempt.", "observation": "The reports differ in formulation, dose and population wording. They are not combined as the same effect or a common denominator.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Details of baseline conditions, concurrent medications and analysis contracts, and comparable quantitative material remain unverified.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Trial-specific intervention, population and analysis specifications" }, { "item_id": "N24", "question_type": "Evidence condition", "question": "Are mechanistic, omega-3 and CoQ10 reports counted as clinical replication?", "needed": "Directness of mechanistic markers and combination trials", "role": "Required", "role_reason": "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_exception": "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.", "criterion": "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.", "basis": "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.", "condition_origin": "These existing in-house conditions are linked to the selected phytosomal-curcumin add-on and attack-frequency question. They explain material gaps without establishing new preregistration, official tool assessment or independent clinical validation.", "proposed_research": "Material needed: Related-report lists, cohorts, interventions and endpoint material. This records needed materials; no new research was executed.", "current_reports": [ "S01", "S02" ], "existence": "The information comes from stored report summaries and bibliographies. Existence, public availability, acquisition and actual reading of external papers, registration, protocols, analysis plans, original result tables and funding/product-support material remain separately unverified.", "acquired_read": "The retained Korean and English summaries and bibliography were read. External papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain unread, with no access attempt.", "observation": "The original record states that CGRP/inflammatory-marker and omega-3/CoQ10 combination trials were excluded from independent clinical-frequency replication.", "condition_status": "Unverified", "status_reason": "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.", "missingness": "Exact excluded-report lists, shared cohorts and endpoint links remain unverified in detail in this input.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Related-report lists, cohorts, interventions and endpoint material" }, { "item_id": "N25", "question_type": "Evidence condition", "question": "How far are unique trials and independent replications established?", "needed": "Report-trial-endpoint relationships and independence", "role": "Required", "role_reason": "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_exception": "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.", "criterion": "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.", "basis": "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.", "condition_origin": "These existing in-house conditions are linked to the selected phytosomal-curcumin add-on and attack-frequency question. They explain material gaps without establishing new preregistration, official tool assessment or independent clinical validation.", "proposed_research": "Material needed: Report-trial mapping and specifications of replication-study interventions. This records needed materials; no new research was executed.", "current_reports": [ "S01", "S02" ], "existence": "The information comes from stored report summaries and bibliographies. Existence, public availability, acquisition and actual reading of external papers, registration, protocols, analysis plans, original result tables and funding/product-support material remain separately unverified.", "acquired_read": "The retained Korean and English summaries and bibliography were read. External papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain unread, with no access attempt.", "observation": "The 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.", "condition_status": "Unverified", "status_reason": "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.", "missingness": "Unique trials, total participants and independent replications meeting the selected conditions remain unverified.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Report-trial mapping and specifications of replication-study interventions" }, { "item_id": "N26", "question_type": "Evidence condition", "question": "What information is retained on research funding?", "needed": "Funding for the direct trial and the separate academic-institution trial", "role": "Required", "role_reason": "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_exception": "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.", "criterion": "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.", "basis": "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.", "condition_origin": "These existing in-house conditions are linked to the selected phytosomal-curcumin add-on and attack-frequency question. They explain material gaps without establishing new preregistration, official tool assessment or independent clinical validation.", "proposed_research": "Material needed: Original funding and institutional-role statements. This records needed materials; no new research was executed.", "current_reports": [ "S01", "S02" ], "existence": "The information comes from stored report summaries and bibliographies. Existence, public availability, acquisition and actual reading of external papers, registration, protocols, analysis plans, original result tables and funding/product-support material remain separately unverified.", "acquired_read": "The retained Korean and English summaries and bibliography were read. External papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain unread, with no access attempt.", "observation": "The 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.", "condition_status": "Unverified", "status_reason": "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.", "missingness": "Funding sources, contracts and roles in design, analysis and publication remain separately unverified.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original funding and institutional-role statements" }, { "item_id": "N27", "question_type": "Evidence condition", "question": "Are product supply and manufacturer involvement known?", "needed": "Free product support, manufacturer, batches and institutional roles", "role": "Required", "role_reason": "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_exception": "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.", "criterion": "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.", "basis": "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.", "condition_origin": "These existing in-house conditions are linked to the selected phytosomal-curcumin add-on and attack-frequency question. They explain material gaps without establishing new preregistration, official tool assessment or independent clinical validation.", "proposed_research": "Material needed: Product-supply and manufacturer-role material. This records needed materials; no new research was executed.", "current_reports": [ "S01" ], "existence": "The information comes from stored report summaries and bibliographies. Existence, public availability, acquisition and actual reading of external papers, registration, protocols, analysis plans, original result tables and funding/product-support material remain separately unverified.", "acquired_read": "The retained Korean and English summaries and bibliography were read. External papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain unread, with no access attempt.", "observation": "The retained direct report says product-supply details remain unverified.", "condition_status": "Unverified", "status_reason": "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.", "missingness": "Product supply, payment of costs and manufacturer involvement in analysis/publication remain unverified.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Product-supply and manufacturer-role material" }, { "item_id": "N28", "question_type": "Evidence condition", "question": "Does no-conflict wording answer employee-authorship and support questions?", "needed": "Distinction among COI declarations, affiliations, employee authors and individual support", "role": "Required", "role_reason": "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_exception": "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.", "criterion": "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.", "basis": "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.", "condition_origin": "These existing in-house conditions are linked to the selected phytosomal-curcumin add-on and attack-frequency question. They explain material gaps without establishing new preregistration, official tool assessment or independent clinical validation.", "proposed_research": "Material needed: Original COI, affiliation and support statements. This records needed materials; no new research was executed.", "current_reports": [ "S01", "S02" ], "existence": "The information comes from stored report summaries and bibliographies. Existence, public availability, acquisition and actual reading of external papers, registration, protocols, analysis plans, original result tables and funding/product-support material remain separately unverified.", "acquired_read": "The retained Korean and English summaries and bibliography were read. External papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain unread, with no access attempt.", "observation": "The direct report wording that authors declared no conflicts is retained.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "That wording alone does not establish employee authorship, funding or product-support status.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original COI, affiliation and support statements" }, { "item_id": "N29", "question_type": "Evidence condition", "question": "Does no reported adverse reaction establish safety?", "needed": "Adverse-event definitions, collection, group-specific events and exposure denominators", "role": "Supplementary", "role_reason": "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_exception": "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.", "criterion": "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.", "basis": "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.", "condition_origin": "These existing in-house conditions are linked to the selected phytosomal-curcumin add-on and attack-frequency question. They explain material gaps without establishing new preregistration, official tool assessment or independent clinical validation.", "proposed_research": "Material needed: Adverse-event collection methods and group-specific tables. This records needed materials; no new research was executed.", "current_reports": [ "S01" ], "existence": "The information comes from stored report summaries and bibliographies. Existence, public availability, acquisition and actual reading of external papers, registration, protocols, analysis plans, original result tables and funding/product-support material remain separately unverified.", "acquired_read": "The retained Korean and English summaries and bibliography were read. External papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain unread, with no access attempt.", "observation": "The original record says no adverse effects were reported in the trial.", "condition_status": "Unverified", "status_reason": "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.", "missingness": "Event definitions, active collection, group-specific event counts and exposure denominators remain unverified. No reporting is not changed into risk 0.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Adverse-event collection methods and group-specific tables" }, { "item_id": "N30", "question_type": "Evidence condition", "question": "Are harms beyond 8 weeks and concurrent-treatment risks answered?", "needed": "Follow-up of long-term/rare harms, concurrent medication and vulnerable groups", "role": "Supplementary", "role_reason": "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_exception": "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.", "criterion": "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.", "basis": "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.", "condition_origin": "These existing in-house conditions are linked to the selected phytosomal-curcumin add-on and attack-frequency question. They explain material gaps without establishing new preregistration, official tool assessment or independent clinical validation.", "proposed_research": "Material needed: Long-term follow-up, concurrent-medication and harm-denominator material. This records needed materials; no new research was executed.", "current_reports": [ "S01" ], "existence": "The information comes from stored report summaries and bibliographies. Existence, public availability, acquisition and actual reading of external papers, registration, protocols, analysis plans, original result tables and funding/product-support material remain separately unverified.", "acquired_read": "The retained Korean and English summaries and bibliography were read. External papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain unread, with no access attempt.", "observation": "The original record limits interpretation: 65 people over 8 weeks cannot exclude rare harms or long-term add-on safety concerns.", "condition_status": "Unverified", "status_reason": "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.", "missingness": "Longer follow-up, medication-specific harms and vulnerable-group analyses remain unverified.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Long-term follow-up, concurrent-medication and harm-denominator material" }, { "item_id": "N31", "question_type": "Evidence condition", "question": "Can findings be extended to replacing preventive medication or other products?", "needed": "Distinction between add-on and replacement treatment and conventional turmeric, nano formulations and combinations", "role": "Required", "role_reason": "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_exception": "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.", "criterion": "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.", "basis": "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.", "condition_origin": "These existing in-house conditions are linked to the selected phytosomal-curcumin add-on and attack-frequency question. They explain material gaps without establishing new preregistration, official tool assessment or independent clinical validation.", "proposed_research": "Material needed: Direct comparisons for replacement treatment and other formulations. This records needed materials; no new research was executed.", "current_reports": [ "S01", "S02" ], "existence": "The information comes from stored report summaries and bibliographies. Existence, public availability, acquisition and actual reading of external papers, registration, protocols, analysis plans, original result tables and funding/product-support material remain separately unverified.", "acquired_read": "The retained Korean and English summaries and bibliography were read. External papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain unread, with no access attempt.", "observation": "The original record limits preventive-medication replacement claims and claims of the same effect for conventional turmeric, nano formulations or combinations.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Stopping/replacing preventive medication and direct effects of other products have not been established.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Direct comparisons for replacement treatment and other formulations" }, { "item_id": "N32", "question_type": "Evidence condition", "question": "What are the current English wording and historical language correction?", "needed": "Retained Korean/English wording, generic English text and the correction event of 2026-09-14", "role": "Required", "role_reason": "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_exception": "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.", "criterion": "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.", "basis": "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.", "condition_origin": "These existing in-house conditions are linked to the selected phytosomal-curcumin add-on and attack-frequency question. They explain material gaps without establishing new preregistration, official tool assessment or independent clinical validation.", "proposed_research": "Material needed: Original wording before/after correction and language-mapping material. This records needed materials; no new research was executed.", "current_reports": [ "S01", "S02" ], "existence": "The information comes from stored report summaries and bibliographies. Existence, public availability, acquisition and actual reading of external papers, registration, protocols, analysis plans, original result tables and funding/product-support material remain separately unverified.", "acquired_read": "The retained Korean and English summaries and bibliography were read. External papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain unread, with no access attempt.", "observation": "The current English wording separates P=.052 for another formulation from unverified values in the direct trial. The correction history for 2 English fields is retained.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "The prior individual English fields before/after correction and their precise correspondence with the original full text remain unread.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original wording before/after correction and language-mapping material" }, { "item_id": "N33", "question_type": "Evidence condition", "question": "How are the original C score of 50, axes and historical verification retained?", "needed": "Historical preservation of the current original grade, score, EX/CX, axes and previous cross-check", "role": "Required", "role_reason": "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_exception": "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.", "criterion": "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.", "basis": "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.", "condition_origin": "These existing in-house conditions are linked to the selected phytosomal-curcumin add-on and attack-frequency question. They explain material gaps without establishing new preregistration, official tool assessment or independent clinical validation.", "proposed_research": "Material needed: Additional review comments and future correction material. This records needed materials; no new research was executed.", "current_reports": [ "S01", "S02" ], "existence": "The information comes from stored report summaries and bibliographies. Existence, public availability, acquisition and actual reading of external papers, registration, protocols, analysis plans, original result tables and funding/product-support material remain separately unverified.", "acquired_read": "The retained Korean and English summaries and bibliography were read. External papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain unread, with no access attempt.", "observation": "The 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.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Review of existing content remains incomplete.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Additional review comments and future correction material" }, { "item_id": "N34", "question_type": "Evidence condition", "question": "What dates, unrecorded information and actual reading scope are retained?", "needed": "Original verdict date, correction date, empty detailed-claim list and external material unread", "role": "Required", "role_reason": "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_exception": "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.", "criterion": "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.", "basis": "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.", "condition_origin": "These existing in-house conditions are linked to the selected phytosomal-curcumin add-on and attack-frequency question. They explain material gaps without establishing new preregistration, official tool assessment or independent clinical validation.", "proposed_research": "Material needed: Required originals and planning material when provided. This records needed materials; no new research was executed.", "current_reports": [ "S01", "S02" ], "existence": "The information comes from stored report summaries and bibliographies. Existence, public availability, acquisition and actual reading of external papers, registration, protocols, analysis plans, original result tables and funding/product-support material remain separately unverified.", "acquired_read": "The retained Korean and English summaries and bibliography were read. External papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain unread, with no access attempt.", "observation": "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.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "External abstracts, full texts, registration, protocols and SAPs remain unread, with no access attempt in this work.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Required originals and planning material when provided" } ], "reports": [ { "report_id": "S01", "title": "Shojaei et al. (2025): Effect and Safety of Phytosomal Curcumin Supplementation on Migraine Patients: A Randomized, Double-Blind and Placebo-Controlled Trial", "url": "https://pubmed.ncbi.nlm.nih.gov/41136816/", "report_type": "Report of a randomized double-blind placebo-add-on trial", "existence": "The information comes from stored report summaries and bibliographies. Existence, public availability, acquisition and actual reading of external papers, registration, protocols, analysis plans, original result tables and funding/product-support material remain separately unverified.", "acquired_read": "Stored summary and bibliography read; external paper, registration and planning material unread", "study_family": "Formulation-specific phytosomal-curcumin report", "independent_replication": "The stored direct report is not used as new certification of independent replication.", "observed_result": "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.", "result_level": "Formulation-specific directional information in a stored summary; exact effect unverified", "source_evidence_date": "2026-09-08", "materials": [ { "material_type": "Stored existing review summary", "public_status": "Existing stored summary acquired", "access_status": "Stored summary", "acquired": true, "actually_read": "Stored summary read", "as_of": "2026-09-08", "qualification": "The stored 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." }, { "material_type": "External article, abstract and full text", "public_status": "Original bibliography link only; external content unread", "access_status": "Unread; no access attempt", "acquired": false, "actually_read": "Unread", "as_of": "2026-09-08", "qualification": "Only the 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." }, { "material_type": "Registration material", "public_status": "Needed material; existence and public availability unverified", "access_status": "Unread; no access attempt", "acquired": false, "actually_read": "Unread", "as_of": "2026-09-08", "qualification": "Original 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." }, { "material_type": "Protocol", "public_status": "Needed material; existence and public availability unverified", "access_status": "Unread; no access attempt", "acquired": false, "actually_read": "Unread", "as_of": "2026-09-08", "qualification": "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." }, { "material_type": "Statistical analysis plan (SAP)", "public_status": "Needed material; existence and public availability unverified", "access_status": "Unread; no access attempt", "acquired": false, "actually_read": "Unread", "as_of": "2026-09-08", "qualification": "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." }, { "material_type": "Funding, product-support and conflict material", "public_status": "Needed material; existence and public availability unverified", "access_status": "Unread; no access attempt", "acquired": false, "actually_read": "Unread", "as_of": "2026-09-08", "qualification": "Original funding, product-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." } ], "links": [ { "label": "PubMed", "url": "https://pubmed.ncbi.nlm.nih.gov/41136816/" } ] }, { "report_id": "S02", "title": "Rezaie et al. (2021): Effects of Curcumin Supplementation on Clinical Features and Inflammation, in Migraine Patients: A Double-Blind Controlled, Placebo Randomized Clinical Trial", "url": "https://pubmed.ncbi.nlm.nih.gov/35070194/", "report_type": "Report of a randomized double-blind placebo-controlled trial of another formulation", "existence": "The information comes from stored report summaries and bibliographies. Existence, public availability, acquisition and actual reading of external papers, registration, protocols, analysis plans, original result tables and funding/product-support material remain separately unverified.", "acquired_read": "Stored summary and bibliography read; external paper, registration and planning material unread", "study_family": "Conventional-curcumin boundary report; not counted as direct phytosomal replication", "independent_replication": "The conventional-curcumin trial is not transferred into independent replication of the phytosomal formulation.", "observed_result": "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.", "result_level": "Between/within-group significance values for another formulation; not phytosomal effect estimates", "source_evidence_date": "2026-09-08", "materials": [ { "material_type": "Stored existing review summary", "public_status": "Existing stored summary acquired", "access_status": "Stored summary", "acquired": true, "actually_read": "Stored summary read", "as_of": "2026-09-08", "qualification": "The stored 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." }, { "material_type": "External article, abstract and full text", "public_status": "Original bibliography link only; external content unread", "access_status": "Unread; no access attempt", "acquired": false, "actually_read": "Unread", "as_of": "2026-09-08", "qualification": "Only the 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." }, { "material_type": "Registration material", "public_status": "Needed material; existence and public availability unverified", "access_status": "Unread; no access attempt", "acquired": false, "actually_read": "Unread", "as_of": "2026-09-08", "qualification": "Original 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." }, { "material_type": "Protocol", "public_status": "Needed material; existence and public availability unverified", "access_status": "Unread; no access attempt", "acquired": false, "actually_read": "Unread", "as_of": "2026-09-08", "qualification": "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." }, { "material_type": "Statistical analysis plan (SAP)", "public_status": "Needed material; existence and public availability unverified", "access_status": "Unread; no access attempt", "acquired": false, "actually_read": "Unread", "as_of": "2026-09-08", "qualification": "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." }, { "material_type": "Funding, product-support and conflict material", "public_status": "Needed material; existence and public availability unverified", "access_status": "Unread; no access attempt", "acquired": false, "actually_read": "Unread", "as_of": "2026-09-08", "qualification": "Original funding, product-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." } ], "links": [ { "label": "PubMed", "url": "https://pubmed.ncbi.nlm.nih.gov/35070194/" } ] } ], "method_sources": [ { "id": "M03", "version": "Cochrane Handbook 6.5 (2024), chapter updated 2023-08", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-03", "section": "§3.1, §3.2.1–3.2.3, MECIR C5/C7/C13", "official_principle": "Clearly record the question, eligibility conditions and reasons for changes, and distinguish variations in interventions.", "review_level": "Existing methodological links were reused for production. External originals were not reread and methodological content was not reassessed." }, { "id": "M04", "version": "Cochrane Handbook 6.5.1 (2025), chapter updated 2025-03", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-04", "section": "§4.5, §4.6.1–4.6.3, MECIR C42", "official_principle": "Distinguish studies from reports and link them; do not omit a study solely because results are unreported.", "review_level": "Existing methodological links were reused for production. External originals were not reread and methodological content was not reassessed." }, { "id": "M08", "version": "Cochrane Handbook 6.5 (2024), chapter updated 2019-10", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-08", "section": "§8.1–8.2.3, Table 8.2.a", "official_principle": "Define the outcome and effect of interest, then examine randomization, deviations, missing data, measurement and selective reporting.", "review_level": "Existing methodological links were reused for production. External originals were not reread and methodological content was not reassessed." }, { "id": "M15", "version": "Cochrane Handbook 6.5 (2024), chapter updated 2023-08", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-15", "section": "§15.2.4, §15.3.1–15.3.3", "official_principle": "Distinguish effect estimates, intervals, importance and applicability. Sample size alone does not determine precision.", "review_level": "Existing methodological links were reused for production. External originals were not reread and methodological content was not reassessed." }, { "id": "M19", "version": "Cochrane Handbook 6.5 (2024), chapter updated 2019-10", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-19", "section": "§19.1.2, §19.2.1–19.2.4", "official_principle": "Harm questions may require different designs, populations and follow-up from efficacy questions. Case reports do not establish incidence rates.", "review_level": "Existing methodological links were reused for production. External originals were not reread and methodological content was not reassessed." } ], "status_dictionary": { "Partly verified": "Partial information from the stored summary is linked; detailed originals and content review remain incomplete.", "Unverified": "Required details cannot be established within the preserved scope. This does not establish absence of effects or studies, or safety.", "Review incomplete": "Review of existing content remains incomplete.", "Met": "This state is used only within the relevant conditions after material verification and content review. It was not automatically assigned in this work.", "Not reported": "Unreported within material actually read. Unread external material is not relabeled as unreported.", "Inaccessible": "This means actual access failure. External access was not attempted in this work, so this state was not assigned.", "Not applicable": "Used only with an application exception and reason based on the question scope.", "Conflicting data": "This requires actual comparison of materials; no new conflict judgment was made in this work.", "Insufficient evidence for the conditions": "This indicates gaps in additional material for the selected conditions. Unread material as a whole is not converted into an efficacy grade." }, "study_overlap": { "state": "Unverified", "unique_trial_count": null, "unique_participant_count": null, "reason": "The 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." }, "history": [ { "date": "2026-10-25", "kind": "Separation of public-facing pages and materials", "view_version": "1.0", "change": "The public view and materials were prepared from the existing 34 items. No new clinical search, verification-state change or scoring was performed." } ], "language": "en", "translation_date": "2026-10-25" }