{ "schema_version": "chamgap-public-evidence-check-1.0", "public_id": "v3035-main", "verdict_number": "3035", "title": "Oral Nigella sativa seed-oil supplementation × Relief of WOMAC pain and functional limitation in knee osteoarthritis", "view_version": "1.0", "view_created_date": "2026-10-24", "criteria_version": "1.0", "criteria_date": "2026-10-06", "review_date": null, "legacy_evidence_date": "2026-09-08", "review_scope": { "materials_read": "Existing review summaries and stored records of methodological application", "clinical_papers_directly_read": false, "new_clinical_search": false, "limitation": "Existing stored summary and preserved methodology application records. External papers, abstracts, registration, protocols, SAPs, original result tables and support disclosures are unread, and review of existing content remains incomplete.", "date_meaning": "The date 2026-09-08 is the original evidence date. Material timestamps for stored summaries describe original production on 2026-10-06, not external reading. External-material timestamps and original review and verification dates remain unrecorded." }, "claim_context": { "population": "The population is adults with knee osteoarthritis. Details of diagnosis, imaging/symptom severity, baseline WOMAC, age, comorbidities and eligibility criteria remain unverified. Rheumatoid arthritis and other diseases remain distinct.", "intervention": "The intervention is oral liquid supplementation with Nigella sativa L. seed fixed oil. Product identity, extraction, standardized constituents and batch quality remain unverified. Topical oil, oral capsules, powder, aqueous extracts, purified thymoquinone and combinations are not treated as interchangeable.", "dose": "The original dose is 2.5 mL every 8 hours. Actual administration, adherence, discontinuation and active-constituent quantities remain unverified. No new daily total, cumulative dose, active dose, optimal dose or recommended dose is calculated or converted into personal dosing instructions.", "comparator": "The record describes comparison with matched placebo. Matching constituents, taste/odor, packaging, administration, common management, analgesics, exercise/rehabilitation and additional treatments by arm remains unverified.", "endpoint": "The selected endpoint is total WOMAC with pain, stiffness and function domains. Percentage reduction in the total, individual domains, VAS and analgesic use remain separate. Scale version, range, measurement, denominators, prospective hierarchy and importance thresholds remain unverified.", "duration": "The original record describes 1 month of treatment and follow-up. Exact assessment visits, post-discontinuation course, longer follow-up and replication of the same formulation remain unverified. Duration is not converted into weeks or days, and sustained long-term effects are not established.", "excluded_extensions": [ "The selected question concerns WOMAC pain/function relief in a comparison of oral liquid seed oil and matched placebo in adults with knee osteoarthritis. It is not extended to other routes, formulations or diseases, cartilage protection/regeneration, disease modification or analgesic replacement.", "The existing C·50 points·Caution and B/P/R1/I1/E+/B2/C0 are retained. Historical cross-check wording is not presented as completed content review, formal-method execution or new independent clinical validation.", "The 116 randomized participants remain distinct from 52 versus 54 completers. Arm-specific randomized/analyzed/completion correspondence is unconfirmed. The review’s 6 RCTs and 370 participants mix oral and topical routes, with overlap with the original trial unconfirmed. No new summation, missing/withdrawal count, denominator reconstruction or harm incidence is calculated.", "WOMAC reductions of 27.72±18.61% versus 1.34±2.31%, P<.001, are retained as original reported values. The definition of ± and exact adjusted between-group effects/intervals remain unverified. Dispersion is not converted into CI/SE, and no new difference or responder rate is calculated.", "Total WOMAC, pain/stiffness/function domains, VAS and analgesic use remain separate. The 1-month total-score result and P value are not replicated across all domains, other endpoints or longer follow-up, or interpreted as individual treatment success or cartilage regeneration.", "The review records a positive oral-oil finding in one of two trials, with mixed other oral/topical findings. Confirmed replication of the same oral liquid formulation, independent-team replication, optimal dosing and unique-trial counts are not newly certified.", "PMID36150238, DOI10.1016/j.ctcp.2022.101666, PMID38650731, PMCID PMC11033494 and DOI10.1002/hsr2.1989 are existing bibliography. Original-trial/review registration is unconfirmed; external abstracts, full texts, registration, protocols and analysis plans are unread. Acquisition, accessibility, reading and prespecification are not inferred from identifiers.", "The original evidence date 2026-09-08, the correction date 2026-09-14 for 2 English-placeholder fields and the original production date 2026-10-06 are retained. Generic English evidence wording, funding descriptions and cautions are not promoted to actual full-text reading or certification of independence, harm collection or overall safety." ] }, "requirements": [ { "item_id": "N01", "question_type": "Evidence condition", "question": "Which knee-osteoarthritis question is addressed?", "needed": "Oral liquid seed oil versus matched placebo and 1-month WOMAC in adults with knee osteoarthritis", "role": "Required", "role_reason": "Material on Oral liquid seed oil versus matched placebo and 1-month WOMAC in adults with knee osteoarthritis is needed to connect the relevant formulation, route, population, comparison, WOMAC endpoint, timing, denominator or harm scope.", "application_exception": "Total WOMAC, its domains, VAS and analgesic use remain distinct, as do randomized, analyzed, completion and harm denominators. Short-term symptom results are not extended to other formulations, routes, diseases, cartilage protection, long-term effects, drug replacement or overall safety.", "criterion": "Original records on Oral liquid seed oil versus matched placebo and 1-month WOMAC in adults with knee osteoarthritis must link to the relevant report, original trial, analysis unit, timing and denominator, distinguishing stored information from what remains unverified.", "basis": "Existing principles distinguish formulation, route, population, WOMAC endpoints, timing, randomized/analyzed/completion denominators, original trials versus reviews, overlap, support and harms in the retained knee-osteoarthritis record.", "condition_origin": "These existing conditions are linked to the stored knee-osteoarthritis record. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Original eligibility criteria and WOMAC endpoint tables are needed. Other joint diseases, routes, cartilage regeneration and drug replacement are excluded. This records needed materials; no new research was executed.", "current_reports": [ "R01", "R02" ], "existence": "The information is recorded in stored trial/review summaries and bibliography. Actual acquisition and content reading of external articles, registration, plans and additional material remain separately unverified.", "acquired_read": "The retained Korean and English summaries and bibliography were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with no access attempt.", "observation": "The original claim concerns WOMAC pain/function relief in knee osteoarthritis. The principal endpoint is total WOMAC in a 1-month comparison of oral liquid seed oil.", "condition_status": "Partly verified", "status_reason": "Information in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.", "missingness": "What remains unverified in stored summaries: Original eligibility criteria and WOMAC endpoint tables are needed. Other joint diseases, routes, cartilage regeneration and drug replacement are excluded.", "uncertainty": "Gaps remain in original denominators and arm correspondence, missing data, WOMAC measurement and dispersion, exact between-group effects and intervals, prospective analyses, review inclusion and overlap, support and harms. Original numbers and grades do not constitute new calculations, reassessment or clinical validation.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Additional material needed: Original eligibility criteria and WOMAC endpoint tables are needed. Other joint diseases, routes, cartilage regeneration and drug replacement are excluded." }, { "item_id": "N02", "question_type": "Evidence condition", "question": "Are oral liquid seed oil and other formulations distinguished?", "needed": "Constituent/manufacturing information for Nigella sativa L. seed fixed oil as an oral liquid product", "role": "Required", "role_reason": "Material on Constituent/manufacturing information for Nigella sativa L. seed fixed oil as an oral liquid product is needed to connect the relevant formulation, route, population, comparison, WOMAC endpoint, timing, denominator or harm scope.", "application_exception": "Total WOMAC, its domains, VAS and analgesic use remain distinct, as do randomized, analyzed, completion and harm denominators. Short-term symptom results are not extended to other formulations, routes, diseases, cartilage protection, long-term effects, drug replacement or overall safety.", "criterion": "Original records on Constituent/manufacturing information for Nigella sativa L. seed fixed oil as an oral liquid product must link to the relevant report, original trial, analysis unit, timing and denominator, distinguishing stored information from what remains unverified.", "basis": "Existing principles distinguish formulation, route, population, WOMAC endpoints, timing, randomized/analyzed/completion denominators, original trials versus reviews, overlap, support and harms in the retained knee-osteoarthritis record.", "condition_origin": "These existing conditions are linked to the stored knee-osteoarthritis record. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Product identity, manufacture/extraction, standardized constituents and batch material are needed. Equivalence to other formulations is unverified. This records needed materials; no new research was executed.", "current_reports": [ "R01", "R02" ], "existence": "The information is recorded in stored trial/review summaries and bibliography. Actual acquisition and content reading of external articles, registration, plans and additional material remain separately unverified.", "acquired_read": "The retained Korean and English summaries and bibliography were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with no access attempt.", "observation": "The plant part/preparation is seed fixed oil and the formulation is oral liquid seed oil. Seed powder, aqueous extracts, ethanolic topical preparations, purified thymoquinone and combinations are not treated as the same product.", "condition_status": "Partly verified", "status_reason": "Information in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.", "missingness": "What remains unverified in stored summaries: Product identity, manufacture/extraction, standardized constituents and batch material are needed. Equivalence to other formulations is unverified.", "uncertainty": "Gaps remain in original denominators and arm correspondence, missing data, WOMAC measurement and dispersion, exact between-group effects and intervals, prospective analyses, review inclusion and overlap, support and harms. Original numbers and grades do not constitute new calculations, reassessment or clinical validation.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Additional material needed: Product identity, manufacture/extraction, standardized constituents and batch material are needed. Equivalence to other formulations is unverified." }, { "item_id": "N03", "question_type": "Evidence condition", "question": "What are the dose, frequency and actual exposure?", "needed": "Original administration and adherence for 2.5 mL every 8 hours", "role": "Required", "role_reason": "Material on Original administration and adherence for 2.5 mL every 8 hours is needed to connect the relevant formulation, route, population, comparison, WOMAC endpoint, timing, denominator or harm scope.", "application_exception": "Total WOMAC, its domains, VAS and analgesic use remain distinct, as do randomized, analyzed, completion and harm denominators. Short-term symptom results are not extended to other formulations, routes, diseases, cartilage protection, long-term effects, drug replacement or overall safety.", "criterion": "Original records on Original administration and adherence for 2.5 mL every 8 hours must link to the relevant report, original trial, analysis unit, timing and denominator, distinguishing stored information from what remains unverified.", "basis": "Existing principles distinguish formulation, route, population, WOMAC endpoints, timing, randomized/analyzed/completion denominators, original trials versus reviews, overlap, support and harms in the retained knee-osteoarthritis record.", "condition_origin": "These existing conditions are linked to the stored knee-osteoarthritis record. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Original administration records, active-constituent quantities, adherence and actual administration/discontinuation material are needed. This records needed materials; no new research was executed.", "current_reports": [ "R01", "R02" ], "existence": "The information is recorded in stored trial/review summaries and bibliography. Actual acquisition and content reading of external articles, registration, plans and additional material remain separately unverified.", "acquired_read": "The retained Korean and English summaries and bibliography were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with no access attempt.", "observation": "The original dose is 2.5 mL every 8 hours. No daily total, active-constituent quantity or recommended dose is calculated or converted.", "condition_status": "Partly verified", "status_reason": "Information in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.", "missingness": "What remains unverified in stored summaries: Original administration records, active-constituent quantities, adherence and actual administration/discontinuation material are needed.", "uncertainty": "Gaps remain in original denominators and arm correspondence, missing data, WOMAC measurement and dispersion, exact between-group effects and intervals, prospective analyses, review inclusion and overlap, support and harms. Original numbers and grades do not constitute new calculations, reassessment or clinical validation.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Additional material needed: Original administration records, active-constituent quantities, adherence and actual administration/discontinuation material are needed." }, { "item_id": "N04", "question_type": "Evidence condition", "question": "What defines diagnosis and severity in the knee-osteoarthritis population?", "needed": "Adult diagnosis, imaging/symptom severity and baseline WOMAC", "role": "Required", "role_reason": "Material on Adult diagnosis, imaging/symptom severity and baseline WOMAC is needed to connect the relevant formulation, route, population, comparison, WOMAC endpoint, timing, denominator or harm scope.", "application_exception": "Total WOMAC, its domains, VAS and analgesic use remain distinct, as do randomized, analyzed, completion and harm denominators. Short-term symptom results are not extended to other formulations, routes, diseases, cartilage protection, long-term effects, drug replacement or overall safety.", "criterion": "Original records on Adult diagnosis, imaging/symptom severity and baseline WOMAC must link to the relevant report, original trial, analysis unit, timing and denominator, distinguishing stored information from what remains unverified.", "basis": "Existing principles distinguish formulation, route, population, WOMAC endpoints, timing, randomized/analyzed/completion denominators, original trials versus reviews, overlap, support and harms in the retained knee-osteoarthritis record.", "condition_origin": "These existing conditions are linked to the stored knee-osteoarthritis record. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Diagnosis/severity, baseline scores, age, comorbidity, eligibility criteria and arm-specific tables are needed. This records needed materials; no new research was executed.", "current_reports": [ "R01", "R02" ], "existence": "The information is recorded in stored trial/review summaries and bibliography. Actual acquisition and content reading of external articles, registration, plans and additional material remain separately unverified.", "acquired_read": "The retained Korean and English summaries and bibliography were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with no access attempt.", "observation": "The population is adults with knee osteoarthritis. The original research description states that rheumatoid arthritis evidence was excluded.", "condition_status": "Partly verified", "status_reason": "Information in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.", "missingness": "What remains unverified in stored summaries: Diagnosis/severity, baseline scores, age, comorbidity, eligibility criteria and arm-specific tables are needed.", "uncertainty": "Gaps remain in original denominators and arm correspondence, missing data, WOMAC measurement and dispersion, exact between-group effects and intervals, prospective analyses, review inclusion and overlap, support and harms. Original numbers and grades do not constitute new calculations, reassessment or clinical validation.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Additional material needed: Diagnosis/severity, baseline scores, age, comorbidity, eligibility criteria and arm-specific tables are needed." }, { "item_id": "N05", "question_type": "Evidence condition", "question": "What is known about the matched-placebo arrangements?", "needed": "Placebo constituents, taste/odor, packaging and common management", "role": "Required", "role_reason": "Material on Placebo constituents, taste/odor, packaging and common management is needed to connect the relevant formulation, route, population, comparison, WOMAC endpoint, timing, denominator or harm scope.", "application_exception": "Total WOMAC, its domains, VAS and analgesic use remain distinct, as do randomized, analyzed, completion and harm denominators. Short-term symptom results are not extended to other formulations, routes, diseases, cartilage protection, long-term effects, drug replacement or overall safety.", "criterion": "Original records on Placebo constituents, taste/odor, packaging and common management must link to the relevant report, original trial, analysis unit, timing and denominator, distinguishing stored information from what remains unverified.", "basis": "Existing principles distinguish formulation, route, population, WOMAC endpoints, timing, randomized/analyzed/completion denominators, original trials versus reviews, overlap, support and harms in the retained knee-osteoarthritis record.", "condition_origin": "These existing conditions are linked to the stored knee-osteoarthritis record. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Original placebo/masking methods, management and adherence material are needed. Placebo matching and successful masking are not certified here. This records needed materials; no new research was executed.", "current_reports": [ "R01", "R02" ], "existence": "The information is recorded in stored trial/review summaries and bibliography. Actual acquisition and content reading of external articles, registration, plans and additional material remain separately unverified.", "acquired_read": "The retained Korean and English summaries and bibliography were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with no access attempt.", "observation": "The original use conditions specify matched placebo, and R01 is described as a randomized, double-blind, placebo-controlled trial. Actual placebo composition and common management are absent from the summary.", "condition_status": "Partly verified", "status_reason": "Information in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.", "missingness": "What remains unverified in stored summaries: Original placebo/masking methods, management and adherence material are needed. Placebo matching and successful masking are not certified here.", "uncertainty": "Gaps remain in original denominators and arm correspondence, missing data, WOMAC measurement and dispersion, exact between-group effects and intervals, prospective analyses, review inclusion and overlap, support and harms. Original numbers and grades do not constitute new calculations, reassessment or clinical validation.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Additional material needed: Original placebo/masking methods, management and adherence material are needed. Placebo matching and successful masking are not certified here." }, { "item_id": "N06", "question_type": "Evidence condition", "question": "Are concomitant analgesics, exercise and other treatments distinguished?", "needed": "Arm-specific arrangements for baseline treatment, rescue analgesics, exercise/rehabilitation and changes", "role": "Required", "role_reason": "Material on Arm-specific arrangements for baseline treatment, rescue analgesics, exercise/rehabilitation and changes is needed to connect the relevant formulation, route, population, comparison, WOMAC endpoint, timing, denominator or harm scope.", "application_exception": "Total WOMAC, its domains, VAS and analgesic use remain distinct, as do randomized, analyzed, completion and harm denominators. Short-term symptom results are not extended to other formulations, routes, diseases, cartilage protection, long-term effects, drug replacement or overall safety.", "criterion": "Original records on Arm-specific arrangements for baseline treatment, rescue analgesics, exercise/rehabilitation and changes must link to the relevant report, original trial, analysis unit, timing and denominator, distinguishing stored information from what remains unverified.", "basis": "Existing principles distinguish formulation, route, population, WOMAC endpoints, timing, randomized/analyzed/completion denominators, original trials versus reviews, overlap, support and harms in the retained knee-osteoarthritis record.", "condition_origin": "These existing conditions are linked to the stored knee-osteoarthritis record. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Original analgesic maintenance/use, rescue-medication rules, exercise/rehabilitation and changes to additional treatment are needed. Efficacy is not extended to an isolated seed-oil effect or drug replacement. This records needed materials; no new research was executed.", "current_reports": [ "R01", "R02" ], "existence": "The information is recorded in stored trial/review summaries and bibliography. Actual acquisition and content reading of external articles, registration, plans and additional material remain separately unverified.", "acquired_read": "The retained Korean and English summaries and bibliography were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with no access attempt.", "observation": "The original key issue distinguishes WOMAC, VAS and analgesic use. The advertising assessment states that analgesic-replacement claims exceed the trial scope.", "condition_status": "Partly verified", "status_reason": "Information in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.", "missingness": "What remains unverified in stored summaries: Original analgesic maintenance/use, rescue-medication rules, exercise/rehabilitation and changes to additional treatment are needed. Efficacy is not extended to an isolated seed-oil effect or drug replacement.", "uncertainty": "Gaps remain in original denominators and arm correspondence, missing data, WOMAC measurement and dispersion, exact between-group effects and intervals, prospective analyses, review inclusion and overlap, support and harms. Original numbers and grades do not constitute new calculations, reassessment or clinical validation.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Additional material needed: Original analgesic maintenance/use, rescue-medication rules, exercise/rehabilitation and changes to additional treatment are needed. Efficacy is not extended to an isolated seed-oil effect or drug replacement." }, { "item_id": "N07", "question_type": "Evidence condition", "question": "What reporting units do the principal trial and review represent?", "needed": "Bibliography and inclusion correspondence for the Huseini original trial and the 2024 review", "role": "Required", "role_reason": "Material on Bibliography and inclusion correspondence for the Huseini original trial and the 2024 review is needed to connect the relevant formulation, route, population, comparison, WOMAC endpoint, timing, denominator or harm scope.", "application_exception": "Total WOMAC, its domains, VAS and analgesic use remain distinct, as do randomized, analyzed, completion and harm denominators. Short-term symptom results are not extended to other formulations, routes, diseases, cartilage protection, long-term effects, drug replacement or overall safety.", "criterion": "Original records on Bibliography and inclusion correspondence for the Huseini original trial and the 2024 review must link to the relevant report, original trial, analysis unit, timing and denominator, distinguishing stored information from what remains unverified.", "basis": "Existing principles distinguish formulation, route, population, WOMAC endpoints, timing, randomized/analyzed/completion denominators, original trials versus reviews, overlap, support and harms in the retained knee-osteoarthritis record.", "condition_origin": "These existing conditions are linked to the stored knee-osteoarthritis record. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: The review’s included articles, registration, additional reports and links to R01 are needed. Recitation of the same original trial is unconfirmed. This records needed materials; no new research was executed.", "current_reports": [ "R01", "R02" ], "existence": "The information is recorded in stored trial/review summaries and bibliography. Actual acquisition and content reading of external articles, registration, plans and additional material remain separately unverified.", "acquired_read": "The retained Korean and English summaries and bibliography were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with no access attempt.", "observation": "R01 is the 2022 Huseini original trial; R02 is the 2024 systematic review. The reports are not counted as independent original trials.", "condition_status": "Partly verified", "status_reason": "Information in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.", "missingness": "What remains unverified in stored summaries: The review’s included articles, registration, additional reports and links to R01 are needed. Recitation of the same original trial is unconfirmed.", "uncertainty": "Gaps remain in original denominators and arm correspondence, missing data, WOMAC measurement and dispersion, exact between-group effects and intervals, prospective analyses, review inclusion and overlap, support and harms. Original numbers and grades do not constitute new calculations, reassessment or clinical validation.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Additional material needed: The review’s included articles, registration, additional reports and links to R01 are needed. Recitation of the same original trial is unconfirmed." }, { "item_id": "N08", "question_type": "Evidence condition", "question": "What arm-specific denominators are represented by 116 randomized participants?", "needed": "Total randomization and arm-specific randomized/analysis denominators", "role": "Required", "role_reason": "Material on Total randomization and arm-specific randomized/analysis denominators is needed to connect the relevant formulation, route, population, comparison, WOMAC endpoint, timing, denominator or harm scope.", "application_exception": "Total WOMAC, its domains, VAS and analgesic use remain distinct, as do randomized, analyzed, completion and harm denominators. Short-term symptom results are not extended to other formulations, routes, diseases, cartilage protection, long-term effects, drug replacement or overall safety.", "criterion": "Original records on Total randomization and arm-specific randomized/analysis denominators must link to the relevant report, original trial, analysis unit, timing and denominator, distinguishing stored information from what remains unverified.", "basis": "Existing principles distinguish formulation, route, population, WOMAC endpoints, timing, randomized/analyzed/completion denominators, original trials versus reviews, overlap, support and harms in the retained knee-osteoarthritis record.", "condition_origin": "These existing conditions are linked to the stored knee-osteoarthritis record. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Arm labels and correspondence with randomized, analyzed and completion counts, plus WOMAC analysis denominators, are needed. Missing-person counts and effects are not newly calculated. This records needed materials; no new research was executed.", "current_reports": [ "R01", "R02" ], "existence": "The information is recorded in stored trial/review summaries and bibliography. Actual acquisition and content reading of external articles, registration, plans and additional material remain separately unverified.", "acquired_read": "The retained Korean and English summaries and bibliography were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with no access attempt.", "observation": "R01 records 116 randomized participants and 52 versus 54 completers. Total randomization remains distinct from completion; completion counts are not converted into arm-specific randomized counts.", "condition_status": "Partly verified", "status_reason": "Information in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.", "missingness": "What remains unverified in stored summaries: Arm labels and correspondence with randomized, analyzed and completion counts, plus WOMAC analysis denominators, are needed. Missing-person counts and effects are not newly calculated.", "uncertainty": "Gaps remain in original denominators and arm correspondence, missing data, WOMAC measurement and dispersion, exact between-group effects and intervals, prospective analyses, review inclusion and overlap, support and harms. Original numbers and grades do not constitute new calculations, reassessment or clinical validation.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Additional material needed: Arm labels and correspondence with randomized, analyzed and completion counts, plus WOMAC analysis denominators, are needed. Missing-person counts and effects are not newly calculated." }, { "item_id": "N09", "question_type": "Evidence condition", "question": "What is known about completers, missing data, withdrawals and analysis sets?", "needed": "Arm correspondence and analysis/missing-data arrangements for 52 versus 54 completers", "role": "Required", "role_reason": "Material on Arm correspondence and analysis/missing-data arrangements for 52 versus 54 completers is needed to connect the relevant formulation, route, population, comparison, WOMAC endpoint, timing, denominator or harm scope.", "application_exception": "Total WOMAC, its domains, VAS and analgesic use remain distinct, as do randomized, analyzed, completion and harm denominators. Short-term symptom results are not extended to other formulations, routes, diseases, cartilage protection, long-term effects, drug replacement or overall safety.", "criterion": "Original records on Arm correspondence and analysis/missing-data arrangements for 52 versus 54 completers must link to the relevant report, original trial, analysis unit, timing and denominator, distinguishing stored information from what remains unverified.", "basis": "Existing principles distinguish formulation, route, population, WOMAC endpoints, timing, randomized/analyzed/completion denominators, original trials versus reviews, overlap, support and harms in the retained knee-osteoarthritis record.", "condition_origin": "These existing conditions are linked to the stored knee-osteoarthritis record. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Original flow diagrams, exclusion/discontinuation reasons, missing WOMAC measurements, missing-data handling and sensitivity material are needed. Unread material is not converted into an absence of missing data. This records needed materials; no new research was executed.", "current_reports": [ "R01", "R02" ], "existence": "The information is recorded in stored trial/review summaries and bibliography. Actual acquisition and content reading of external articles, registration, plans and additional material remain separately unverified.", "acquired_read": "The retained Korean and English summaries and bibliography were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with no access attempt.", "observation": "The 52 versus 54 counts describe completion. The retained sample description does not specify arm labels, ITT/completer analyses or withdrawal reasons.", "condition_status": "Unverified", "status_reason": "Information in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.", "missingness": "What remains unverified in stored summaries: Original flow diagrams, exclusion/discontinuation reasons, missing WOMAC measurements, missing-data handling and sensitivity material are needed. Unread material is not converted into an absence of missing data.", "uncertainty": "Gaps remain in original denominators and arm correspondence, missing data, WOMAC measurement and dispersion, exact between-group effects and intervals, prospective analyses, review inclusion and overlap, support and harms. Original numbers and grades do not constitute new calculations, reassessment or clinical validation.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Additional material needed: Original flow diagrams, exclusion/discontinuation reasons, missing WOMAC measurements, missing-data handling and sensitivity material are needed. Unread material is not converted into an absence of missing data." }, { "item_id": "N10", "question_type": "Evidence condition", "question": "Are total WOMAC and its three domains distinguished?", "needed": "Separate scales/ranges/timing for total score, pain, stiffness and function", "role": "Required", "role_reason": "Material on Separate scales/ranges/timing for total score, pain, stiffness and function is needed to connect the relevant formulation, route, population, comparison, WOMAC endpoint, timing, denominator or harm scope.", "application_exception": "Total WOMAC, its domains, VAS and analgesic use remain distinct, as do randomized, analyzed, completion and harm denominators. Short-term symptom results are not extended to other formulations, routes, diseases, cartilage protection, long-term effects, drug replacement or overall safety.", "criterion": "Original records on Separate scales/ranges/timing for total score, pain, stiffness and function must link to the relevant report, original trial, analysis unit, timing and denominator, distinguishing stored information from what remains unverified.", "basis": "Existing principles distinguish formulation, route, population, WOMAC endpoints, timing, randomized/analyzed/completion denominators, original trials versus reviews, overlap, support and harms in the retained knee-osteoarthritis record.", "condition_origin": "These existing conditions are linked to the stored knee-osteoarthritis record. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Original scale versions, score ranges, assessment timing and effects/denominators for each domain are needed. Total-score percentage reduction is not replicated as values for all domains. This records needed materials; no new research was executed.", "current_reports": [ "R01", "R02" ], "existence": "The information is recorded in stored trial/review summaries and bibliography. Actual acquisition and content reading of external articles, registration, plans and additional material remain separately unverified.", "acquired_read": "The retained Korean and English summaries and bibliography were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with no access attempt.", "observation": "The principal endpoint is total WOMAC with pain, stiffness and function domains. The original key issue distinguishes total score from the pain domain.", "condition_status": "Partly verified", "status_reason": "Information in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.", "missingness": "What remains unverified in stored summaries: Original scale versions, score ranges, assessment timing and effects/denominators for each domain are needed. Total-score percentage reduction is not replicated as values for all domains.", "uncertainty": "Gaps remain in original denominators and arm correspondence, missing data, WOMAC measurement and dispersion, exact between-group effects and intervals, prospective analyses, review inclusion and overlap, support and harms. Original numbers and grades do not constitute new calculations, reassessment or clinical validation.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Additional material needed: Original scale versions, score ranges, assessment timing and effects/denominators for each domain are needed. Total-score percentage reduction is not replicated as values for all domains." }, { "item_id": "N11", "question_type": "Evidence condition", "question": "What do the original WOMAC reductions represent?", "needed": "Arm-specific percentage reductions, original ± notation and measurement/calculation definitions", "role": "Required", "role_reason": "Material on Arm-specific percentage reductions, original ± notation and measurement/calculation definitions is needed to connect the relevant formulation, route, population, comparison, WOMAC endpoint, timing, denominator or harm scope.", "application_exception": "Total WOMAC, its domains, VAS and analgesic use remain distinct, as do randomized, analyzed, completion and harm denominators. Short-term symptom results are not extended to other formulations, routes, diseases, cartilage protection, long-term effects, drug replacement or overall safety.", "criterion": "Original records on Arm-specific percentage reductions, original ± notation and measurement/calculation definitions must link to the relevant report, original trial, analysis unit, timing and denominator, distinguishing stored information from what remains unverified.", "basis": "Existing principles distinguish formulation, route, population, WOMAC endpoints, timing, randomized/analyzed/completion denominators, original trials versus reviews, overlap, support and harms in the retained knee-osteoarthritis record.", "condition_origin": "These existing conditions are linked to the stored knee-osteoarthritis record. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Original definitions of means/dispersion, baseline/change values, denominators and statistical methods are needed. ± is not arbitrarily converted into CI/SE, and no new between-group difference is calculated. This records needed materials; no new research was executed.", "current_reports": [ "R01", "R02" ], "existence": "The information is recorded in stored trial/review summaries and bibliography. Actual acquisition and content reading of external articles, registration, plans and additional material remain separately unverified.", "acquired_read": "The retained Korean and English summaries and bibliography were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with no access attempt.", "observation": "R01 retains WOMAC reductions of 27.72±18.61% versus 1.34±2.31%, P<.001; the original record describes the exact between-group CI as unreported.", "condition_status": "Partly verified", "status_reason": "Information in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.", "missingness": "What remains unverified in stored summaries: Original definitions of means/dispersion, baseline/change values, denominators and statistical methods are needed. ± is not arbitrarily converted into CI/SE, and no new between-group difference is calculated.", "uncertainty": "Gaps remain in original denominators and arm correspondence, missing data, WOMAC measurement and dispersion, exact between-group effects and intervals, prospective analyses, review inclusion and overlap, support and harms. Original numbers and grades do not constitute new calculations, reassessment or clinical validation.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Additional material needed: Original definitions of means/dispersion, baseline/change values, denominators and statistical methods are needed. ± is not arbitrarily converted into CI/SE, and no new between-group difference is calculated." }, { "item_id": "N12", "question_type": "Evidence condition", "question": "Are the exact adjusted between-group difference and 95% CI available?", "needed": "Adjusted/unadjusted between-group effects and 95% CI", "role": "Required", "role_reason": "Material on Adjusted/unadjusted between-group effects and 95% CI is needed to connect the relevant formulation, route, population, comparison, WOMAC endpoint, timing, denominator or harm scope.", "application_exception": "Total WOMAC, its domains, VAS and analgesic use remain distinct, as do randomized, analyzed, completion and harm denominators. Short-term symptom results are not extended to other formulations, routes, diseases, cartilage protection, long-term effects, drug replacement or overall safety.", "criterion": "Original records on Adjusted/unadjusted between-group effects and 95% CI must link to the relevant report, original trial, analysis unit, timing and denominator, distinguishing stored information from what remains unverified.", "basis": "Existing principles distinguish formulation, route, population, WOMAC endpoints, timing, randomized/analyzed/completion denominators, original trials versus reviews, overlap, support and harms in the retained knee-osteoarthritis record.", "condition_origin": "These existing conditions are linked to the stored knee-osteoarthritis record. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Original between-group analysis tables, adjustment variables, variance and CIs are needed. Unreported information in the original summary remains distinct from current external nonreading; numbers are not reverse-calculated. This records needed materials; no new research was executed.", "current_reports": [ "R01", "R02" ], "existence": "The information is recorded in stored trial/review summaries and bibliography. Actual acquisition and content reading of external articles, registration, plans and additional material remain separately unverified.", "acquired_read": "The retained Korean and English summaries and bibliography were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with no access attempt.", "observation": "The original reader answer describes the exact adjusted between-group difference and 95% CI as unreported. The result table retains the original label that the exact between-group CI is unreported.", "condition_status": "Partly verified", "status_reason": "Information in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.", "missingness": "What remains unverified in stored summaries: Original between-group analysis tables, adjustment variables, variance and CIs are needed. Unreported information in the original summary remains distinct from current external nonreading; numbers are not reverse-calculated.", "uncertainty": "Gaps remain in original denominators and arm correspondence, missing data, WOMAC measurement and dispersion, exact between-group effects and intervals, prospective analyses, review inclusion and overlap, support and harms. Original numbers and grades do not constitute new calculations, reassessment or clinical validation.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Additional material needed: Original between-group analysis tables, adjustment variables, variance and CIs are needed. Unreported information in the original summary remains distinct from current external nonreading; numbers are not reverse-calculated." }, { "item_id": "N13", "question_type": "Evidence condition", "question": "What endpoint and comparison does P<.001 concern?", "needed": "Original between-group WOMAC testing and multiplicity/analysis plans", "role": "Required", "role_reason": "Material on Original between-group WOMAC testing and multiplicity/analysis plans is needed to connect the relevant formulation, route, population, comparison, WOMAC endpoint, timing, denominator or harm scope.", "application_exception": "Total WOMAC, its domains, VAS and analgesic use remain distinct, as do randomized, analyzed, completion and harm denominators. Short-term symptom results are not extended to other formulations, routes, diseases, cartilage protection, long-term effects, drug replacement or overall safety.", "criterion": "Original records on Original between-group WOMAC testing and multiplicity/analysis plans must link to the relevant report, original trial, analysis unit, timing and denominator, distinguishing stored information from what remains unverified.", "basis": "Existing principles distinguish formulation, route, population, WOMAC endpoints, timing, randomized/analyzed/completion denominators, original trials versus reviews, overlap, support and harms in the retained knee-osteoarthritis record.", "condition_origin": "These existing conditions are linked to the stored knee-osteoarthritis record. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Original tests, primary endpoints/timing, multiplicity, analysis sets and adjustment arrangements are needed. This records needed materials; no new research was executed.", "current_reports": [ "R01", "R02" ], "existence": "The information is recorded in stored trial/review summaries and bibliography. Actual acquisition and content reading of external articles, registration, plans and additional material remain separately unverified.", "acquired_read": "The retained Korean and English summaries and bibliography were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with no access attempt.", "observation": "P<.001 is retained with the original WOMAC percentage-reduction result. It is not replicated as a P value for VAS, all domains or long-term results.", "condition_status": "Partly verified", "status_reason": "Information in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.", "missingness": "What remains unverified in stored summaries: Original tests, primary endpoints/timing, multiplicity, analysis sets and adjustment arrangements are needed.", "uncertainty": "Gaps remain in original denominators and arm correspondence, missing data, WOMAC measurement and dispersion, exact between-group effects and intervals, prospective analyses, review inclusion and overlap, support and harms. Original numbers and grades do not constitute new calculations, reassessment or clinical validation.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Additional material needed: Original tests, primary endpoints/timing, multiplicity, analysis sets and adjustment arrangements are needed." }, { "item_id": "N14", "question_type": "Evidence condition", "question": "Are 1-month results distinguished from sustained and post-discontinuation effects?", "needed": "The original 1 month of treatment/follow-up and separate later material", "role": "Required", "role_reason": "Material on The original 1 month of treatment/follow-up and separate later material is needed to connect the relevant formulation, route, population, comparison, WOMAC endpoint, timing, denominator or harm scope.", "application_exception": "Total WOMAC, its domains, VAS and analgesic use remain distinct, as do randomized, analyzed, completion and harm denominators. Short-term symptom results are not extended to other formulations, routes, diseases, cartilage protection, long-term effects, drug replacement or overall safety.", "criterion": "Original records on The original 1 month of treatment/follow-up and separate later material must link to the relevant report, original trial, analysis unit, timing and denominator, distinguishing stored information from what remains unverified.", "basis": "Existing principles distinguish formulation, route, population, WOMAC endpoints, timing, randomized/analyzed/completion denominators, original trials versus reviews, overlap, support and harms in the retained knee-osteoarthritis record.", "condition_origin": "These existing conditions are linked to the stored knee-osteoarthritis record. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Longer follow-up, post-discontinuation course and repeat trials of the same formulation are needed. A 1-month result is not converted into a long-term effect. This records needed materials; no new research was executed.", "current_reports": [ "R01", "R02" ], "existence": "The information is recorded in stored trial/review summaries and bibliography. Actual acquisition and content reading of external articles, registration, plans and additional material remain separately unverified.", "acquired_read": "The retained Korean and English summaries and bibliography were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with no access attempt.", "observation": "The original duration is 1 month of treatment and follow-up. The original rationale states that this is a symptom signal rather than cartilage protection or a sustained effect.", "condition_status": "Partly verified", "status_reason": "Information in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.", "missingness": "What remains unverified in stored summaries: Longer follow-up, post-discontinuation course and repeat trials of the same formulation are needed. A 1-month result is not converted into a long-term effect.", "uncertainty": "Gaps remain in original denominators and arm correspondence, missing data, WOMAC measurement and dispersion, exact between-group effects and intervals, prospective analyses, review inclusion and overlap, support and harms. Original numbers and grades do not constitute new calculations, reassessment or clinical validation.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Additional material needed: Longer follow-up, post-discontinuation course and repeat trials of the same formulation are needed. A 1-month result is not converted into a long-term effect." }, { "item_id": "N15", "question_type": "Evidence condition", "question": "Are the original allocation and masking methods known?", "needed": "Random sequence, concealment and participant/assessor masking", "role": "Required", "role_reason": "Material on Random sequence, concealment and participant/assessor masking is needed to connect the relevant formulation, route, population, comparison, WOMAC endpoint, timing, denominator or harm scope.", "application_exception": "Total WOMAC, its domains, VAS and analgesic use remain distinct, as do randomized, analyzed, completion and harm denominators. Short-term symptom results are not extended to other formulations, routes, diseases, cartilage protection, long-term effects, drug replacement or overall safety.", "criterion": "Original records on Random sequence, concealment and participant/assessor masking must link to the relevant report, original trial, analysis unit, timing and denominator, distinguishing stored information from what remains unverified.", "basis": "Existing principles distinguish formulation, route, population, WOMAC endpoints, timing, randomized/analyzed/completion denominators, original trials versus reviews, overlap, support and harms in the retained knee-osteoarthritis record.", "condition_origin": "These existing conditions are linked to the stored knee-osteoarthritis record. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Original methods, registration/plans and masking material are needed. No formal RoB2 result or new suitability judgment is created. This records needed materials; no new research was executed.", "current_reports": [ "R01", "R02" ], "existence": "The information is recorded in stored trial/review summaries and bibliography. Actual acquisition and content reading of external articles, registration, plans and additional material remain separately unverified.", "acquired_read": "The retained Korean and English summaries and bibliography were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with no access attempt.", "observation": "R01 is described as a randomized, double-blind, placebo-controlled trial. Original methodological details, successful masking and suitability remain unverified here.", "condition_status": "Partly verified", "status_reason": "Information in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.", "missingness": "What remains unverified in stored summaries: Original methods, registration/plans and masking material are needed. No formal RoB2 result or new suitability judgment is created.", "uncertainty": "Gaps remain in original denominators and arm correspondence, missing data, WOMAC measurement and dispersion, exact between-group effects and intervals, prospective analyses, review inclusion and overlap, support and harms. Original numbers and grades do not constitute new calculations, reassessment or clinical validation.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Additional material needed: Original methods, registration/plans and masking material are needed. No formal RoB2 result or new suitability judgment is created." }, { "item_id": "N16", "question_type": "Evidence condition", "question": "Are the prospective WOMAC hierarchy and reporting selection confirmed?", "needed": "Prospective plans for primary endpoints, domains, VAS and timing", "role": "Required", "role_reason": "Material on Prospective plans for primary endpoints, domains, VAS and timing is needed to connect the relevant formulation, route, population, comparison, WOMAC endpoint, timing, denominator or harm scope.", "application_exception": "Total WOMAC, its domains, VAS and analgesic use remain distinct, as do randomized, analyzed, completion and harm denominators. Short-term symptom results are not extended to other formulations, routes, diseases, cartilage protection, long-term effects, drug replacement or overall safety.", "criterion": "Original records on Prospective plans for primary endpoints, domains, VAS and timing must link to the relevant report, original trial, analysis unit, timing and denominator, distinguishing stored information from what remains unverified.", "basis": "Existing principles distinguish formulation, route, population, WOMAC endpoints, timing, randomized/analyzed/completion denominators, original trials versus reviews, overlap, support and harms in the retained knee-osteoarthritis record.", "condition_origin": "These existing conditions are linked to the stored knee-osteoarthritis record. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Registration, protocols/SAPs, original endpoint tables and all reported time points are needed. A summary selecting a principal outcome is not promoted to confirmed preregistration. This records needed materials; no new research was executed.", "current_reports": [ "R01", "R02" ], "existence": "The information is recorded in stored trial/review summaries and bibliography. Actual acquisition and content reading of external articles, registration, plans and additional material remain separately unverified.", "acquired_read": "The retained Korean and English summaries and bibliography were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with no access attempt.", "observation": "The stored evidence describes WOMAC as principal and VAS and other outcomes as secondary. Registration status is unconfirmed. The original prospective plan remains unread here.", "condition_status": "Partly verified", "status_reason": "Information in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.", "missingness": "What remains unverified in stored summaries: Registration, protocols/SAPs, original endpoint tables and all reported time points are needed. A summary selecting a principal outcome is not promoted to confirmed preregistration.", "uncertainty": "Gaps remain in original denominators and arm correspondence, missing data, WOMAC measurement and dispersion, exact between-group effects and intervals, prospective analyses, review inclusion and overlap, support and harms. Original numbers and grades do not constitute new calculations, reassessment or clinical validation.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Additional material needed: Registration, protocols/SAPs, original endpoint tables and all reported time points are needed. A summary selecting a principal outcome is not promoted to confirmed preregistration." }, { "item_id": "N17", "question_type": "Evidence condition", "question": "Is concordant VAS direction retained as a separate endpoint?", "needed": "Separate VAS effects, CIs, denominators and timing", "role": "Supplementary", "role_reason": "Material on Separate VAS effects, CIs, denominators and timing is needed to connect the relevant formulation, route, population, comparison, WOMAC endpoint, timing, denominator or harm scope.", "application_exception": "Total WOMAC, its domains, VAS and analgesic use remain distinct, as do randomized, analyzed, completion and harm denominators. Short-term symptom results are not extended to other formulations, routes, diseases, cartilage protection, long-term effects, drug replacement or overall safety.", "criterion": "Original records on Separate VAS effects, CIs, denominators and timing must link to the relevant report, original trial, analysis unit, timing and denominator, distinguishing stored information from what remains unverified.", "basis": "Existing principles distinguish formulation, route, population, WOMAC endpoints, timing, randomized/analyzed/completion denominators, original trials versus reviews, overlap, support and harms in the retained knee-osteoarthritis record.", "condition_origin": "These existing conditions are linked to the stored knee-osteoarthritis record. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Original VAS results and prospective hierarchy are needed. WOMAC reductions and gaps in P values/CIs are not transferred into VAS values. This records needed materials; no new research was executed.", "current_reports": [ "R01", "R02" ], "existence": "The information is recorded in stored trial/review summaries and bibliography. Actual acquisition and content reading of external articles, registration, plans and additional material remain separately unverified.", "acquired_read": "The retained Korean and English summaries and bibliography were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with no access attempt.", "observation": "The original counterview describes concordant WOMAC and VAS directions. VAS is secondary; specific VAS values are absent from the retained result.", "condition_status": "Partly verified", "status_reason": "Information in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.", "missingness": "What remains unverified in stored summaries: Original VAS results and prospective hierarchy are needed. WOMAC reductions and gaps in P values/CIs are not transferred into VAS values.", "uncertainty": "Gaps remain in original denominators and arm correspondence, missing data, WOMAC measurement and dispersion, exact between-group effects and intervals, prospective analyses, review inclusion and overlap, support and harms. Original numbers and grades do not constitute new calculations, reassessment or clinical validation.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Additional material needed: Original VAS results and prospective hierarchy are needed. WOMAC reductions and gaps in P values/CIs are not transferred into VAS values." }, { "item_id": "N18", "question_type": "Evidence condition", "question": "Are analgesic-use results separate from WOMAC?", "needed": "Rescue-medication definitions, timing and arm-specific effects/denominators", "role": "Supplementary", "role_reason": "Material on Rescue-medication definitions, timing and arm-specific effects/denominators is needed to connect the relevant formulation, route, population, comparison, WOMAC endpoint, timing, denominator or harm scope.", "application_exception": "Total WOMAC, its domains, VAS and analgesic use remain distinct, as do randomized, analyzed, completion and harm denominators. Short-term symptom results are not extended to other formulations, routes, diseases, cartilage protection, long-term effects, drug replacement or overall safety.", "criterion": "Original records on Rescue-medication definitions, timing and arm-specific effects/denominators must link to the relevant report, original trial, analysis unit, timing and denominator, distinguishing stored information from what remains unverified.", "basis": "Existing principles distinguish formulation, route, population, WOMAC endpoints, timing, randomized/analyzed/completion denominators, original trials versus reviews, overlap, support and harms in the retained knee-osteoarthritis record.", "condition_origin": "These existing conditions are linked to the stored knee-osteoarthritis record. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Original amounts used, rescue-medication rules, prospective hierarchy and result tables are needed. An analgesic-replacement effect is not established. This records needed materials; no new research was executed.", "current_reports": [ "R01", "R02" ], "existence": "The information is recorded in stored trial/review summaries and bibliography. Actual acquisition and content reading of external articles, registration, plans and additional material remain separately unverified.", "acquired_read": "The retained Korean and English summaries and bibliography were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with no access attempt.", "observation": "The original key issue distinguishes analgesic use from total score, pain and VAS. Structured evidence does not contain numeric analgesic-use results.", "condition_status": "Partly verified", "status_reason": "Information in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.", "missingness": "What remains unverified in stored summaries: Original amounts used, rescue-medication rules, prospective hierarchy and result tables are needed. An analgesic-replacement effect is not established.", "uncertainty": "Gaps remain in original denominators and arm correspondence, missing data, WOMAC measurement and dispersion, exact between-group effects and intervals, prospective analyses, review inclusion and overlap, support and harms. Original numbers and grades do not constitute new calculations, reassessment or clinical validation.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Additional material needed: Original amounts used, rescue-medication rules, prospective hierarchy and result tables are needed. An analgesic-replacement effect is not established." }, { "item_id": "N19", "question_type": "Evidence condition", "question": "Are patient importance and responder effects known?", "needed": "WOMAC importance thresholds and prospectively defined responder results", "role": "Supplementary", "role_reason": "Material on WOMAC importance thresholds and prospectively defined responder results is needed to connect the relevant formulation, route, population, comparison, WOMAC endpoint, timing, denominator or harm scope.", "application_exception": "Total WOMAC, its domains, VAS and analgesic use remain distinct, as do randomized, analyzed, completion and harm denominators. Short-term symptom results are not extended to other formulations, routes, diseases, cartilage protection, long-term effects, drug replacement or overall safety.", "criterion": "Original records on WOMAC importance thresholds and prospectively defined responder results must link to the relevant report, original trial, analysis unit, timing and denominator, distinguishing stored information from what remains unverified.", "basis": "Existing principles distinguish formulation, route, population, WOMAC endpoints, timing, randomized/analyzed/completion denominators, original trials versus reviews, overlap, support and harms in the retained knee-osteoarthritis record.", "condition_origin": "These existing conditions are linked to the stored knee-osteoarthritis record. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Original importance criteria, responder definitions/denominators and CIs are needed. Percentage reduction alone is not used for a new judgment of clinically large effects or treatment success. This records needed materials; no new research was executed.", "current_reports": [ "R01", "R02" ], "existence": "The information is recorded in stored trial/review summaries and bibliography. Actual acquisition and content reading of external articles, registration, plans and additional material remain separately unverified.", "acquired_read": "The retained Korean and English summaries and bibliography were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with no access attempt.", "observation": "The original grade rationale describes a positive patient-symptom-scale signal. Exact CIs, responder rates and prospective importance thresholds are absent from the structured summary.", "condition_status": "Partly verified", "status_reason": "Information in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.", "missingness": "What remains unverified in stored summaries: Original importance criteria, responder definitions/denominators and CIs are needed. Percentage reduction alone is not used for a new judgment of clinically large effects or treatment success.", "uncertainty": "Gaps remain in original denominators and arm correspondence, missing data, WOMAC measurement and dispersion, exact between-group effects and intervals, prospective analyses, review inclusion and overlap, support and harms. Original numbers and grades do not constitute new calculations, reassessment or clinical validation.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Additional material needed: Original importance criteria, responder definitions/denominators and CIs are needed. Percentage reduction alone is not used for a new judgment of clinically large effects or treatment success." }, { "item_id": "N20", "question_type": "Evidence condition", "question": "What is the scope of the review’s 6 RCTs and 370 participants?", "needed": "Included material and endpoint-specific denominators in the mixed oral/topical review", "role": "Required", "role_reason": "Material on Included material and endpoint-specific denominators in the mixed oral/topical review is needed to connect the relevant formulation, route, population, comparison, WOMAC endpoint, timing, denominator or harm scope.", "application_exception": "Total WOMAC, its domains, VAS and analgesic use remain distinct, as do randomized, analyzed, completion and harm denominators. Short-term symptom results are not extended to other formulations, routes, diseases, cartilage protection, long-term effects, drug replacement or overall safety.", "criterion": "Original records on Included material and endpoint-specific denominators in the mixed oral/topical review must link to the relevant report, original trial, analysis unit, timing and denominator, distinguishing stored information from what remains unverified.", "basis": "Existing principles distinguish formulation, route, population, WOMAC endpoints, timing, randomized/analyzed/completion denominators, original trials versus reviews, overlap, support and harms in the retained knee-osteoarthritis record.", "condition_origin": "These existing conditions are linked to the stored knee-osteoarthritis record. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Inclusion tables by route, formulation, original-trial family, endpoint and timing are needed. The 116 and 370 participants are not summed. This records needed materials; no new research was executed.", "current_reports": [ "R01", "R02" ], "existence": "The information is recorded in stored trial/review summaries and bibliography. Actual acquisition and content reading of external articles, registration, plans and additional material remain separately unverified.", "acquired_read": "The retained Korean and English summaries and bibliography were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with no access attempt.", "observation": "R02 records 6 RCTs and 370 participants, mixing oral and topical routes. These are not converted into 6 independent trials of oral liquid seed oil or WOMAC analysis denominators.", "condition_status": "Partly verified", "status_reason": "Information in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.", "missingness": "What remains unverified in stored summaries: Inclusion tables by route, formulation, original-trial family, endpoint and timing are needed. The 116 and 370 participants are not summed.", "uncertainty": "Gaps remain in original denominators and arm correspondence, missing data, WOMAC measurement and dispersion, exact between-group effects and intervals, prospective analyses, review inclusion and overlap, support and harms. Original numbers and grades do not constitute new calculations, reassessment or clinical validation.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Additional material needed: Inclusion tables by route, formulation, original-trial family, endpoint and timing are needed. The 116 and 370 participants are not summed." }, { "item_id": "N21", "question_type": "Evidence condition", "question": "Is the finding of a positive oral-oil result in one of two trials retained?", "needed": "Formulations, populations, timing and effects/CIs in the two oral-oil trials", "role": "Required", "role_reason": "Material on Formulations, populations, timing and effects/CIs in the two oral-oil trials is needed to connect the relevant formulation, route, population, comparison, WOMAC endpoint, timing, denominator or harm scope.", "application_exception": "Total WOMAC, its domains, VAS and analgesic use remain distinct, as do randomized, analyzed, completion and harm denominators. Short-term symptom results are not extended to other formulations, routes, diseases, cartilage protection, long-term effects, drug replacement or overall safety.", "criterion": "Original records on Formulations, populations, timing and effects/CIs in the two oral-oil trials must link to the relevant report, original trial, analysis unit, timing and denominator, distinguishing stored information from what remains unverified.", "basis": "Existing principles distinguish formulation, route, population, WOMAC endpoints, timing, randomized/analyzed/completion denominators, original trials versus reviews, overlap, support and harms in the retained knee-osteoarthritis record.", "condition_origin": "These existing conditions are linked to the stored knee-osteoarthritis record. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Identifiers, doses, endpoints/timing, effects, denominators and inclusion relationships for the two trials are needed. Numbers/CIs for another unidentified trial are not invented. This records needed materials; no new research was executed.", "current_reports": [ "R01", "R02" ], "existence": "The information is recorded in stored trial/review summaries and bibliography. Actual acquisition and content reading of external articles, registration, plans and additional material remain separately unverified.", "acquired_read": "The retained Korean and English summaries and bibliography were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with no access attempt.", "observation": "R02 records a positive oral-oil finding in one of two trials, with mixed other oral/topical results. This is not presented as confirmed replication of the same formulation.", "condition_status": "Partly verified", "status_reason": "Information in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.", "missingness": "What remains unverified in stored summaries: Identifiers, doses, endpoints/timing, effects, denominators and inclusion relationships for the two trials are needed. Numbers/CIs for another unidentified trial are not invented.", "uncertainty": "Gaps remain in original denominators and arm correspondence, missing data, WOMAC measurement and dispersion, exact between-group effects and intervals, prospective analyses, review inclusion and overlap, support and harms. Original numbers and grades do not constitute new calculations, reassessment or clinical validation.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Additional material needed: Identifiers, doses, endpoints/timing, effects, denominators and inclusion relationships for the two trials are needed. Numbers/CIs for another unidentified trial are not invented." }, { "item_id": "N22", "question_type": "Evidence condition", "question": "Are topical oil, oral capsules and rheumatoid-arthritis material separated?", "needed": "Eligibility boundaries by route, formulation and disease", "role": "Required", "role_reason": "Material on Eligibility boundaries by route, formulation and disease is needed to connect the relevant formulation, route, population, comparison, WOMAC endpoint, timing, denominator or harm scope.", "application_exception": "Total WOMAC, its domains, VAS and analgesic use remain distinct, as do randomized, analyzed, completion and harm denominators. Short-term symptom results are not extended to other formulations, routes, diseases, cartilage protection, long-term effects, drug replacement or overall safety.", "criterion": "Original records on Eligibility boundaries by route, formulation and disease must link to the relevant report, original trial, analysis unit, timing and denominator, distinguishing stored information from what remains unverified.", "basis": "Existing principles distinguish formulation, route, population, WOMAC endpoints, timing, randomized/analyzed/completion denominators, original trials versus reviews, overlap, support and harms in the retained knee-osteoarthritis record.", "condition_origin": "These existing conditions are linked to the stored knee-osteoarthritis record. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Original review tables by route, formulation and disease are needed. These are not combined as independent replication or equivalence for this oral liquid seed oil. This records needed materials; no new research was executed.", "current_reports": [ "R01", "R02" ], "existence": "The information is recorded in stored trial/review summaries and bibliography. Actual acquisition and content reading of external articles, registration, plans and additional material remain separately unverified.", "acquired_read": "The retained Korean and English summaries and bibliography were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with no access attempt.", "observation": "The original research description excludes topical oil/rheumatoid-arthritis material, while the original supplementary note states that topical oil and oral capsules are not identical replications.", "condition_status": "Partly verified", "status_reason": "Information in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.", "missingness": "What remains unverified in stored summaries: Original review tables by route, formulation and disease are needed. These are not combined as independent replication or equivalence for this oral liquid seed oil.", "uncertainty": "Gaps remain in original denominators and arm correspondence, missing data, WOMAC measurement and dispersion, exact between-group effects and intervals, prospective analyses, review inclusion and overlap, support and harms. Original numbers and grades do not constitute new calculations, reassessment or clinical validation.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Additional material needed: Original review tables by route, formulation and disease are needed. These are not combined as independent replication or equivalence for this oral liquid seed oil." }, { "item_id": "N23", "question_type": "Evidence condition", "question": "Are independent teams and unique trial/participant counts certified?", "needed": "Original-trial families and overlap/independence links for the same question", "role": "Required", "role_reason": "Material on Original-trial families and overlap/independence links for the same question is needed to connect the relevant formulation, route, population, comparison, WOMAC endpoint, timing, denominator or harm scope.", "application_exception": "Total WOMAC, its domains, VAS and analgesic use remain distinct, as do randomized, analyzed, completion and harm denominators. Short-term symptom results are not extended to other formulations, routes, diseases, cartilage protection, long-term effects, drug replacement or overall safety.", "criterion": "Original records on Original-trial families and overlap/independence links for the same question must link to the relevant report, original trial, analysis unit, timing and denominator, distinguishing stored information from what remains unverified.", "basis": "Existing principles distinguish formulation, route, population, WOMAC endpoints, timing, randomized/analyzed/completion denominators, original trials versus reviews, overlap, support and harms in the retained knee-osteoarthritis record.", "condition_origin": "These existing conditions are linked to the stored knee-osteoarthritis record. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Teams, institutions, funding, identical samples and original-trial/additional-report lists are needed. Final unique-trial and participant totals remain null. This records needed materials; no new research was executed.", "current_reports": [ "R01", "R02" ], "existence": "The information is recorded in stored trial/review summaries and bibliography. Actual acquisition and content reading of external articles, registration, plans and additional material remain separately unverified.", "acquired_read": "The retained Korean and English summaries and bibliography were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with no access attempt.", "observation": "The original principal verdict retains a single principal study and limited replication. The current reports represent an original trial and a review; shared-trial correspondence is unconfirmed.", "condition_status": "Partly verified", "status_reason": "Information in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.", "missingness": "What remains unverified in stored summaries: Teams, institutions, funding, identical samples and original-trial/additional-report lists are needed. Final unique-trial and participant totals remain null.", "uncertainty": "Gaps remain in original denominators and arm correspondence, missing data, WOMAC measurement and dispersion, exact between-group effects and intervals, prospective analyses, review inclusion and overlap, support and harms. Original numbers and grades do not constitute new calculations, reassessment or clinical validation.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Additional material needed: Teams, institutions, funding, identical samples and original-trial/additional-report lists are needed. Final unique-trial and participant totals remain null." }, { "item_id": "N24", "question_type": "Evidence condition", "question": "Are cartilage protection, disease modification and analgesic replacement separate questions?", "needed": "Direct material distinguishing symptom scales from structural/disease-modifying effects and drug replacement", "role": "Supplementary", "role_reason": "Material on Direct material distinguishing symptom scales from structural/disease-modifying effects and drug replacement is needed to connect the relevant formulation, route, population, comparison, WOMAC endpoint, timing, denominator or harm scope.", "application_exception": "Total WOMAC, its domains, VAS and analgesic use remain distinct, as do randomized, analyzed, completion and harm denominators. Short-term symptom results are not extended to other formulations, routes, diseases, cartilage protection, long-term effects, drug replacement or overall safety.", "criterion": "Original records on Direct material distinguishing symptom scales from structural/disease-modifying effects and drug replacement must link to the relevant report, original trial, analysis unit, timing and denominator, distinguishing stored information from what remains unverified.", "basis": "Existing principles distinguish formulation, route, population, WOMAC endpoints, timing, randomized/analyzed/completion denominators, original trials versus reviews, overlap, support and harms in the retained knee-osteoarthritis record.", "condition_origin": "These existing conditions are linked to the stored knee-osteoarthritis record. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Direct comparisons of imaging/structural endpoints, long-term clinical course and drug replacement are needed. Those efficacy claims are not added here. This records needed materials; no new research was executed.", "current_reports": [ "R01", "R02" ], "existence": "The information is recorded in stored trial/review summaries and bibliography. Actual acquisition and content reading of external articles, registration, plans and additional material remain separately unverified.", "acquired_read": "The retained Korean and English summaries and bibliography were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with no access attempt.", "observation": "The original rationale/advertising assessment does not extend a 1-month symptom signal to cartilage protection, regeneration, disease modification or analgesic replacement.", "condition_status": "Partly verified", "status_reason": "Information in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.", "missingness": "What remains unverified in stored summaries: Direct comparisons of imaging/structural endpoints, long-term clinical course and drug replacement are needed. Those efficacy claims are not added here.", "uncertainty": "Gaps remain in original denominators and arm correspondence, missing data, WOMAC measurement and dispersion, exact between-group effects and intervals, prospective analyses, review inclusion and overlap, support and harms. Original numbers and grades do not constitute new calculations, reassessment or clinical validation.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Additional material needed: Direct comparisons of imaging/structural endpoints, long-term clinical course and drug replacement are needed. Those efficacy claims are not added here." }, { "item_id": "N25", "question_type": "Evidence condition", "question": "Are the four channels of company involvement known separately?", "needed": "Trial/review-specific funding, product support, employee authorship and COI", "role": "Required", "role_reason": "Material on Trial/review-specific funding, product support, employee authorship and COI is needed to connect the relevant formulation, route, population, comparison, WOMAC endpoint, timing, denominator or harm scope.", "application_exception": "Total WOMAC, its domains, VAS and analgesic use remain distinct, as do randomized, analyzed, completion and harm denominators. Short-term symptom results are not extended to other formulations, routes, diseases, cartilage protection, long-term effects, drug replacement or overall safety.", "criterion": "Original records on Trial/review-specific funding, product support, employee authorship and COI must link to the relevant report, original trial, analysis unit, timing and denominator, distinguishing stored information from what remains unverified.", "basis": "Existing principles distinguish formulation, route, population, WOMAC endpoints, timing, randomized/analyzed/completion denominators, original trials versus reviews, overlap, support and harms in the retained knee-osteoarthritis record.", "condition_origin": "These existing conditions are linked to the stored knee-osteoarthritis record. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Original support, product provision, author affiliations and COI are needed. Unverified information is not converted into a noncommercial/independence strength. This records needed materials; no new research was executed.", "current_reports": [ "R01", "R02" ], "existence": "The information is recorded in stored trial/review summaries and bibliography. Actual acquisition and content reading of external articles, registration, plans and additional material remain separately unverified.", "acquired_read": "The retained Korean and English summaries and bibliography were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with no access attempt.", "observation": "R01 records unconfirmed funding/product-involvement details; R02 records differing funding across individual trials. Generic English funding wording remains distinct from complete item-specific material.", "condition_status": "Partly verified", "status_reason": "Information in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.", "missingness": "What remains unverified in stored summaries: Original support, product provision, author affiliations and COI are needed. Unverified information is not converted into a noncommercial/independence strength.", "uncertainty": "Gaps remain in original denominators and arm correspondence, missing data, WOMAC measurement and dispersion, exact between-group effects and intervals, prospective analyses, review inclusion and overlap, support and harms. Original numbers and grades do not constitute new calculations, reassessment or clinical validation.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Additional material needed: Original support, product provision, author affiliations and COI are needed. Unverified information is not converted into a noncommercial/independence strength." }, { "item_id": "N26", "question_type": "Evidence condition", "question": "Are harm-collection methods, discontinuations and events known?", "needed": "Adverse-event definitions, collection, severity and original event tables", "role": "Supplementary", "role_reason": "Material on Adverse-event definitions, collection, severity and original event tables is needed to connect the relevant formulation, route, population, comparison, WOMAC endpoint, timing, denominator or harm scope.", "application_exception": "Total WOMAC, its domains, VAS and analgesic use remain distinct, as do randomized, analyzed, completion and harm denominators. Short-term symptom results are not extended to other formulations, routes, diseases, cartilage protection, long-term effects, drug replacement or overall safety.", "criterion": "Original records on Adverse-event definitions, collection, severity and original event tables must link to the relevant report, original trial, analysis unit, timing and denominator, distinguishing stored information from what remains unverified.", "basis": "Existing principles distinguish formulation, route, population, WOMAC endpoints, timing, randomized/analyzed/completion denominators, original trials versus reviews, overlap, support and harms in the retained knee-osteoarthritis record.", "condition_origin": "These existing conditions are linked to the stored knee-osteoarthritis record. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Active/passive collection, events, discontinuations and missing-data material are needed. Unread material is not presented as an absence of adverse events. This records needed materials; no new research was executed.", "current_reports": [ "R01", "R02" ], "existence": "The information is recorded in stored trial/review summaries and bibliography. Actual acquisition and content reading of external articles, registration, plans and additional material remain separately unverified.", "acquired_read": "The retained Korean and English summaries and bibliography were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with no access attempt.", "observation": "The original safety label is Caution, and small trials cannot exclude rare adverse events or establish long-term safety. Specific harm-collection methods/event tables are absent from stored summaries.", "condition_status": "Unverified", "status_reason": "Information in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.", "missingness": "What remains unverified in stored summaries: Active/passive collection, events, discontinuations and missing-data material are needed. Unread material is not presented as an absence of adverse events.", "uncertainty": "Gaps remain in original denominators and arm correspondence, missing data, WOMAC measurement and dispersion, exact between-group effects and intervals, prospective analyses, review inclusion and overlap, support and harms. Original numbers and grades do not constitute new calculations, reassessment or clinical validation.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Additional material needed: Active/passive collection, events, discontinuations and missing-data material are needed. Unread material is not presented as an absence of adverse events." }, { "item_id": "N27", "question_type": "Evidence condition", "question": "What are the harm denominators and exposure durations?", "needed": "Safety denominators, actual administration and arm-specific events/exposure", "role": "Supplementary", "role_reason": "Material on Safety denominators, actual administration and arm-specific events/exposure is needed to connect the relevant formulation, route, population, comparison, WOMAC endpoint, timing, denominator or harm scope.", "application_exception": "Total WOMAC, its domains, VAS and analgesic use remain distinct, as do randomized, analyzed, completion and harm denominators. Short-term symptom results are not extended to other formulations, routes, diseases, cartilage protection, long-term effects, drug replacement or overall safety.", "criterion": "Original records on Safety denominators, actual administration and arm-specific events/exposure must link to the relevant report, original trial, analysis unit, timing and denominator, distinguishing stored information from what remains unverified.", "basis": "Existing principles distinguish formulation, route, population, WOMAC endpoints, timing, randomized/analyzed/completion denominators, original trials versus reviews, overlap, support and harms in the retained knee-osteoarthritis record.", "condition_origin": "These existing conditions are linked to the stored knee-osteoarthritis record. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Arm-specific safety sets, administration/discontinuation, event counts, exposure time and control-group records are needed. No new incidence is calculated. This records needed materials; no new research was executed.", "current_reports": [ "R01", "R02" ], "existence": "The information is recorded in stored trial/review summaries and bibliography. Actual acquisition and content reading of external articles, registration, plans and additional material remain separately unverified.", "acquired_read": "The retained Korean and English summaries and bibliography were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with no access attempt.", "observation": "The 116 randomized participants and 52 versus 54 completers do not establish safety denominators. Exposure for 1 month is not long-term harm evidence.", "condition_status": "Unverified", "status_reason": "Information in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.", "missingness": "What remains unverified in stored summaries: Arm-specific safety sets, administration/discontinuation, event counts, exposure time and control-group records are needed. No new incidence is calculated.", "uncertainty": "Gaps remain in original denominators and arm correspondence, missing data, WOMAC measurement and dispersion, exact between-group effects and intervals, prospective analyses, review inclusion and overlap, support and harms. Original numbers and grades do not constitute new calculations, reassessment or clinical validation.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Additional material needed: Arm-specific safety sets, administration/discontinuation, event counts, exposure time and control-group records are needed. No new incidence is calculated." }, { "item_id": "N28", "question_type": "Evidence condition", "question": "What is known about concomitant medicines, other causes and event timing?", "needed": "Glucose-, blood-pressure-, anticoagulant-, antiseizure- and immune-modifying drugs and other causes", "role": "Supplementary", "role_reason": "Material on Glucose-, blood-pressure-, anticoagulant-, antiseizure- and immune-modifying drugs and other causes is needed to connect the relevant formulation, route, population, comparison, WOMAC endpoint, timing, denominator or harm scope.", "application_exception": "Total WOMAC, its domains, VAS and analgesic use remain distinct, as do randomized, analyzed, completion and harm denominators. Short-term symptom results are not extended to other formulations, routes, diseases, cartilage protection, long-term effects, drug replacement or overall safety.", "criterion": "Original records on Glucose-, blood-pressure-, anticoagulant-, antiseizure- and immune-modifying drugs and other causes must link to the relevant report, original trial, analysis unit, timing and denominator, distinguishing stored information from what remains unverified.", "basis": "Existing principles distinguish formulation, route, population, WOMAC endpoints, timing, randomized/analyzed/completion denominators, original trials versus reviews, overlap, support and harms in the retained knee-osteoarthritis record.", "condition_origin": "These existing conditions are linked to the stored knee-osteoarthritis record. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Concomitant medicines, baseline diseases, event timing, changes, controls and post-discontinuation course are needed. New drug-specific causal judgments are not created. This records needed materials; no new research was executed.", "current_reports": [ "R01", "R02" ], "existence": "The information is recorded in stored trial/review summaries and bibliography. Actual acquisition and content reading of external articles, registration, plans and additional material remain separately unverified.", "acquired_read": "The retained Korean and English summaries and bibliography were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with no access attempt.", "observation": "The original safety description contains cautions calling for consultation during use of those medicines. This does not confirm actual drug-specific interactions or causal harms.", "condition_status": "Partly verified", "status_reason": "Information in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.", "missingness": "What remains unverified in stored summaries: Concomitant medicines, baseline diseases, event timing, changes, controls and post-discontinuation course are needed. New drug-specific causal judgments are not created.", "uncertainty": "Gaps remain in original denominators and arm correspondence, missing data, WOMAC measurement and dispersion, exact between-group effects and intervals, prospective analyses, review inclusion and overlap, support and harms. Original numbers and grades do not constitute new calculations, reassessment or clinical validation.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Additional material needed: Concomitant medicines, baseline diseases, event timing, changes, controls and post-discontinuation course are needed. New drug-specific causal judgments are not created." }, { "item_id": "N29", "question_type": "Evidence condition", "question": "Are long-term, rare and vulnerable-population harms verified?", "needed": "Independent harm reports, long-term/rare events, vulnerable groups and exposure", "role": "Supplementary", "role_reason": "Material on Independent harm reports, long-term/rare events, vulnerable groups and exposure is needed to connect the relevant formulation, route, population, comparison, WOMAC endpoint, timing, denominator or harm scope.", "application_exception": "Total WOMAC, its domains, VAS and analgesic use remain distinct, as do randomized, analyzed, completion and harm denominators. Short-term symptom results are not extended to other formulations, routes, diseases, cartilage protection, long-term effects, drug replacement or overall safety.", "criterion": "Original records on Independent harm reports, long-term/rare events, vulnerable groups and exposure must link to the relevant report, original trial, analysis unit, timing and denominator, distinguishing stored information from what remains unverified.", "basis": "Existing principles distinguish formulation, route, population, WOMAC endpoints, timing, randomized/analyzed/completion denominators, original trials versus reviews, overlap, support and harms in the retained knee-osteoarthritis record.", "condition_origin": "These existing conditions are linked to the stored knee-osteoarthritis record. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Longer follow-up, vulnerable populations, independent reports and exposure/denominator material are needed. No new harm search or reassessment is performed. This records needed materials; no new research was executed.", "current_reports": [ "R01", "R02" ], "existence": "The information is recorded in stored trial/review summaries and bibliography. Actual acquisition and content reading of external articles, registration, plans and additional material remain separately unverified.", "acquired_read": "The retained Korean and English summaries and bibliography were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with no access attempt.", "observation": "The original text retains consultation cautions for pregnancy/breastfeeding, children, liver/kidney disease and surgery, and the inability to exclude rare/long-term harms. This is not promoted to safety certification.", "condition_status": "Partly verified", "status_reason": "Information in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.", "missingness": "What remains unverified in stored summaries: Longer follow-up, vulnerable populations, independent reports and exposure/denominator material are needed. No new harm search or reassessment is performed.", "uncertainty": "Gaps remain in original denominators and arm correspondence, missing data, WOMAC measurement and dispersion, exact between-group effects and intervals, prospective analyses, review inclusion and overlap, support and harms. Original numbers and grades do not constitute new calculations, reassessment or clinical validation.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Additional material needed: Longer follow-up, vulnerable populations, independent reports and exposure/denominator material are needed. No new harm search or reassessment is performed." }, { "item_id": "N30", "question_type": "Evidence condition", "question": "Are actual stored-summary reading and original-source links distinguished?", "needed": "Access table for stored summaries, abstracts, full text, registration and protocols/SAPs", "role": "Required", "role_reason": "Material on Access table for stored summaries, abstracts, full text, registration and protocols/SAPs is needed to connect the relevant formulation, route, population, comparison, WOMAC endpoint, timing, denominator or harm scope.", "application_exception": "Total WOMAC, its domains, VAS and analgesic use remain distinct, as do randomized, analyzed, completion and harm denominators. Short-term symptom results are not extended to other formulations, routes, diseases, cartilage protection, long-term effects, drug replacement or overall safety.", "criterion": "Original records on Access table for stored summaries, abstracts, full text, registration and protocols/SAPs must link to the relevant report, original trial, analysis unit, timing and denominator, distinguishing stored information from what remains unverified.", "basis": "Existing principles distinguish formulation, route, population, WOMAC endpoints, timing, randomized/analyzed/completion denominators, original trials versus reviews, overlap, support and harms in the retained knee-osteoarthritis record.", "condition_origin": "These existing conditions are linked to the stored knee-osteoarthritis record. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: External material remains unread before user-provided acquisition and review. A PMCID/URL alone is not promoted to access, reading or fulfilled conditions. This records needed materials; no new research was executed.", "current_reports": [ "R01", "R02" ], "existence": "The information is recorded in stored trial/review summaries and bibliography. Actual acquisition and content reading of external articles, registration, plans and additional material remain separately unverified.", "acquired_read": "The retained Korean and English summaries and bibliography were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with no access attempt.", "observation": "The complete stored summary was read for preparation; the two PubMed URLs and review PMCID are retained records. External abstracts, full text, registration and protocols/SAPs remain unread here.", "condition_status": "Partly verified", "status_reason": "Information in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.", "missingness": "What remains unverified in stored summaries: External material remains unread before user-provided acquisition and review. A PMCID/URL alone is not promoted to access, reading or fulfilled conditions.", "uncertainty": "Gaps remain in original denominators and arm correspondence, missing data, WOMAC measurement and dispersion, exact between-group effects and intervals, prospective analyses, review inclusion and overlap, support and harms. Original numbers and grades do not constitute new calculations, reassessment or clinical validation.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Additional material needed: External material remains unread before user-provided acquisition and review. A PMCID/URL alone is not promoted to access, reading or fulfilled conditions." }, { "item_id": "N31", "question_type": "Evidence condition", "question": "Are generic English wording and the historical correction preserved?", "needed": "The full Korean/English record and targets/limits of the 2026-09-14 correction", "role": "Supplementary", "role_reason": "Material on The full Korean/English record and targets/limits of the 2026-09-14 correction is needed to connect the relevant formulation, route, population, comparison, WOMAC endpoint, timing, denominator or harm scope.", "application_exception": "Total WOMAC, its domains, VAS and analgesic use remain distinct, as do randomized, analyzed, completion and harm denominators. Short-term symptom results are not extended to other formulations, routes, diseases, cartilage protection, long-term effects, drug replacement or overall safety.", "criterion": "Original records on The full Korean/English record and targets/limits of the 2026-09-14 correction must link to the relevant report, original trial, analysis unit, timing and denominator, distinguishing stored information from what remains unverified.", "basis": "Existing principles distinguish formulation, route, population, WOMAC endpoints, timing, randomized/analyzed/completion denominators, original trials versus reviews, overlap, support and harms in the retained knee-osteoarthritis record.", "condition_origin": "These existing conditions are linked to the stored knee-osteoarthritis record. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: The original correction-target comparison and external English texts remain unverified here. Current preparation remains distinct from historical verification wording. This records needed materials; no new research was executed.", "current_reports": [ "R01", "R02" ], "existence": "The information is recorded in stored trial/review summaries and bibliography. Actual acquisition and content reading of external articles, registration, plans and additional material remain separately unverified.", "acquired_read": "The retained Korean and English summaries and bibliography were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with no access attempt.", "observation": "The correction records changes to 2 English-placeholder fields while preserving original values. Remaining generic English wording on sample size, results and funding is preserved in the original and is not presented as newly completed content review.", "condition_status": "Partly verified", "status_reason": "Information in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.", "missingness": "What remains unverified in stored summaries: The original correction-target comparison and external English texts remain unverified here. Current preparation remains distinct from historical verification wording.", "uncertainty": "Gaps remain in original denominators and arm correspondence, missing data, WOMAC measurement and dispersion, exact between-group effects and intervals, prospective analyses, review inclusion and overlap, support and harms. Original numbers and grades do not constitute new calculations, reassessment or clinical validation.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Additional material needed: The original correction-target comparison and external English texts remain unverified here. Current preparation remains distinct from historical verification wording." }, { "item_id": "N32", "question_type": "Evidence condition", "question": "Are original grades, axes, evidence date and production distinguished?", "needed": "Original C50, Caution, axes, evidence date and correction values", "role": "Required", "role_reason": "Material on Original C50, Caution, axes, evidence date and correction values is needed to connect the relevant formulation, route, population, comparison, WOMAC endpoint, timing, denominator or harm scope.", "application_exception": "Total WOMAC, its domains, VAS and analgesic use remain distinct, as do randomized, analyzed, completion and harm denominators. Short-term symptom results are not extended to other formulations, routes, diseases, cartilage protection, long-term effects, drug replacement or overall safety.", "criterion": "Original records on Original C50, Caution, axes, evidence date and correction values must link to the relevant report, original trial, analysis unit, timing and denominator, distinguishing stored information from what remains unverified.", "basis": "Existing principles distinguish formulation, route, population, WOMAC endpoints, timing, randomized/analyzed/completion denominators, original trials versus reviews, overlap, support and harms in the retained knee-osteoarthritis record.", "condition_origin": "These existing conditions are linked to the stored knee-osteoarthritis record. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: New evidence, condition revisions and verdict changes are separate events after user review. Original dates are not converted into a current search end date or external-reading date. This records needed materials; no new research was executed.", "current_reports": [ "R01", "R02" ], "existence": "The information is recorded in stored trial/review summaries and bibliography. Actual acquisition and content reading of external articles, registration, plans and additional material remain separately unverified.", "acquired_read": "The retained Korean and English summaries and bibliography were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with no access attempt.", "observation": "C/50/Caution, original axes and the evidence date 2026-09-08 are retained. This preparation is not a new efficacy grade, independent certification or formal-method certification.", "condition_status": "Partly verified", "status_reason": "Information in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.", "missingness": "What remains unverified in stored summaries: New evidence, condition revisions and verdict changes are separate events after user review. Original dates are not converted into a current search end date or external-reading date.", "uncertainty": "Gaps remain in original denominators and arm correspondence, missing data, WOMAC measurement and dispersion, exact between-group effects and intervals, prospective analyses, review inclusion and overlap, support and harms. Original numbers and grades do not constitute new calculations, reassessment or clinical validation.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Additional material needed: New evidence, condition revisions and verdict changes are separate events after user review. Original dates are not converted into a current search end date or external-reading date." } ], "reports": [ { "report_id": "R01", "title": "Huseini et al. 2022 · Trial of oral Nigella sativa seed oil and knee-osteoarthritis pain/function", "url": "https://pubmed.ncbi.nlm.nih.gov/36150238/", "report_type": "Retained description as a randomized, double-blind, placebo-controlled trial; actual allocation and masking procedures are not externally verified", "existence": "The information is recorded in stored trial/review summaries and bibliography. Actual acquisition and content reading of external articles, registration, plans and additional material remain separately unverified.", "acquired_read": "Stored existing review summary read; external material unread", "study_family": "Inclusion/overlap between the principal oral-liquid-seed-oil original trial and the mixed oral/topical review is unconfirmed; report counts remain distinct from unique trials and participants", "independent_replication": "Reports remain distinct from unique trials, independent teams and participant totals; these are not certified here", "observed_result": "WOMAC reductions 27.72±18.61% versus 1.34±2.31%, P<.001; retained record describes the exact between-group CI as unreported", "result_level": "These are existing reported values. The 116 randomized participants remain distinct from 52 versus 54 completers, with gaps in arm-specific analysis denominators, dispersion definitions and exact adjusted between-group effects/intervals. Unreported information in the original summary remains distinct from current external nonreading.", "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": "2026-10-06T12:32:34.042143+09:00 (original summary-production timestamp; not external reading)", "qualification": "The stored summary was read for preparation. This does not establish acquisition/reading of article full text or clinical validation. Existing bibliography is linked; external abstracts, full texts, registration, protocols and analysis plans are unread. A URL or identifier alone does not establish acquisition, accessibility, content reading, prespecification or fulfilled conditions. The date 2026-09-08 is the original evidence date. Material timestamps for stored summaries describe original production on 2026-10-06, not external reading. External-material timestamps and original review and verification dates remain unrecorded." }, { "material_type": "External abstract", "public_status": "Original bibliography link only; external content unread", "access_status": "Unread; no access attempt", "acquired": false, "actually_read": "Unread", "as_of": null, "qualification": "Only the identity link in the existing PubMed bibliography is connected. External abstract content reading and access testing were not performed. Existing bibliography is linked; external abstracts, full texts, registration, protocols and analysis plans are unread. A URL or identifier alone does not establish acquisition, accessibility, content reading, prespecification or fulfilled conditions. The date 2026-09-08 is the original evidence date. Material timestamps for stored summaries describe original production on 2026-10-06, not external reading. External-material timestamps and original review and verification dates remain unrecorded." }, { "material_type": "External full text", "public_status": "Needed material; existence and public availability unverified", "access_status": "Unread; no access attempt", "acquired": false, "actually_read": "Unread", "as_of": null, "qualification": "Article full text is unacquired and unread. A bibliographic link is not presented as full-text acquisition or successful access. Existing bibliography is linked; external abstracts, full texts, registration, protocols and analysis plans are unread. A URL or identifier alone does not establish acquisition, accessibility, content reading, prespecification or fulfilled conditions. The date 2026-09-08 is the original evidence date. Material timestamps for stored summaries describe original production on 2026-10-06, not external reading. External-material timestamps and original review and verification dates remain unrecorded." }, { "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": null, "qualification": "Original-trial/review registration identities and contents are unconfirmed and unread. Nonregistration, nonpublication and absence of prospective plans are not inferred. Existing bibliography is linked; external abstracts, full texts, registration, protocols and analysis plans are unread. A URL or identifier alone does not establish acquisition, accessibility, content reading, prespecification or fulfilled conditions. The date 2026-09-08 is the original evidence date. Material timestamps for stored summaries describe original production on 2026-10-06, not external reading. External-material timestamps and original review and verification dates remain unrecorded." }, { "material_type": "Protocols and analysis plans", "public_status": "Needed material; existence and public availability unverified", "access_status": "Unread; no access attempt", "acquired": false, "actually_read": "Unread", "as_of": null, "qualification": "Protocols and analysis plans are unread. Endpoints, timing, denominators, missing data, multiplicity and exact effects/intervals are not verified or reverse-calculated. Existing bibliography is linked; external abstracts, full texts, registration, protocols and analysis plans are unread. A URL or identifier alone does not establish acquisition, accessibility, content reading, prespecification or fulfilled conditions. The date 2026-09-08 is the original evidence date. Material timestamps for stored summaries describe original production on 2026-10-06, not external reading. External-material timestamps and original review and verification dates remain unrecorded." } ], "links": [ { "label": "PubMed", "url": "https://pubmed.ncbi.nlm.nih.gov/36150238/" } ] }, { "report_id": "R02", "title": "2024 · Systematic review of Nigella sativa and osteoarthritis", "url": "https://pubmed.ncbi.nlm.nih.gov/38650731/", "report_type": "Retained description as a systematic review including oral and topical studies; original included trials and route-specific correspondence are not externally verified", "existence": "The information is recorded in stored trial/review summaries and bibliography. Actual acquisition and content reading of external articles, registration, plans and additional material remain separately unverified.", "acquired_read": "Stored existing review summary read; external material unread", "study_family": "Inclusion/overlap between the principal oral-liquid-seed-oil original trial and the mixed oral/topical review is unconfirmed; report counts remain distinct from unique trials and participants", "independent_replication": "Reports remain distinct from unique trials, independent teams and participant totals; these are not certified here", "observed_result": "Positive oral-oil finding in one of two trials; mixed other oral/topical findings", "result_level": "The review’s 6 RCTs and 370 participants describe the original mixed-route scale. Inclusion/overlap of the principal original trial and independent replication of the same formulation remain unconfirmed. Original trials/participants are not summed, and effects/intervals for unidentified trials are not invented.", "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": "2026-10-06T12:32:34.042143+09:00 (original summary-production timestamp; not external reading)", "qualification": "The stored summary was read for preparation. This does not establish acquisition/reading of article full text or clinical validation. Existing bibliography is linked; external abstracts, full texts, registration, protocols and analysis plans are unread. A URL or identifier alone does not establish acquisition, accessibility, content reading, prespecification or fulfilled conditions. The date 2026-09-08 is the original evidence date. Material timestamps for stored summaries describe original production on 2026-10-06, not external reading. External-material timestamps and original review and verification dates remain unrecorded." }, { "material_type": "External abstract", "public_status": "Original bibliography link only; external content unread", "access_status": "Unread; no access attempt", "acquired": false, "actually_read": "Unread", "as_of": null, "qualification": "Only the identity link in the existing PubMed bibliography is connected. External abstract content reading and access testing were not performed. Existing bibliography is linked; external abstracts, full texts, registration, protocols and analysis plans are unread. A URL or identifier alone does not establish acquisition, accessibility, content reading, prespecification or fulfilled conditions. The date 2026-09-08 is the original evidence date. Material timestamps for stored summaries describe original production on 2026-10-06, not external reading. External-material timestamps and original review and verification dates remain unrecorded." }, { "material_type": "External full text", "public_status": "Needed material; existence and public availability unverified", "access_status": "Unread; no access attempt", "acquired": false, "actually_read": "Unread", "as_of": null, "qualification": "PMCID PMC11033494 is an identifier retained in the original bibliography. Full-text acquisition, public availability, successful access and actual reading were not verified in this work. Existing bibliography is linked; external abstracts, full texts, registration, protocols and analysis plans are unread. A URL or identifier alone does not establish acquisition, accessibility, content reading, prespecification or fulfilled conditions. The date 2026-09-08 is the original evidence date. Material timestamps for stored summaries describe original production on 2026-10-06, not external reading. External-material timestamps and original review and verification dates remain unrecorded." }, { "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": null, "qualification": "Original-trial/review registration identities and contents are unconfirmed and unread. Nonregistration, nonpublication and absence of prospective plans are not inferred. Existing bibliography is linked; external abstracts, full texts, registration, protocols and analysis plans are unread. A URL or identifier alone does not establish acquisition, accessibility, content reading, prespecification or fulfilled conditions. The date 2026-09-08 is the original evidence date. Material timestamps for stored summaries describe original production on 2026-10-06, not external reading. External-material timestamps and original review and verification dates remain unrecorded." }, { "material_type": "Protocols and analysis plans", "public_status": "Needed material; existence and public availability unverified", "access_status": "Unread; no access attempt", "acquired": false, "actually_read": "Unread", "as_of": null, "qualification": "Protocols and analysis plans are unread. Endpoints, timing, denominators, missing data, multiplicity and exact effects/intervals are not verified or reverse-calculated. Existing bibliography is linked; external abstracts, full texts, registration, protocols and analysis plans are unread. A URL or identifier alone does not establish acquisition, accessibility, content reading, prespecification or fulfilled conditions. The date 2026-09-08 is the original evidence date. Material timestamps for stored summaries describe original production on 2026-10-06, not external reading. External-material timestamps and original review and verification dates remain unrecorded." } ], "links": [ { "label": "PubMed", "url": "https://pubmed.ncbi.nlm.nih.gov/38650731/" } ] } ], "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": "Inclusion/overlap correspondence between the principal oral-liquid-seed-oil trial and the mixed oral/topical review is unconfirmed. Reports, original trials, independent teams and participant totals remain distinct; unique-trial and participant counts remain unrecorded." }, "history": [ { "date": "2026-10-24", "kind": "Separation of public-facing pages and materials", "view_version": "1.0", "change": "The public view and materials were prepared from the existing 32 items. No new clinical search, verification-state change or scoring was performed." } ], "language": "en", "translation_date": "2026-10-24" }