{ "schema_version": "chamgap-public-criteria-1.0", "title": "Oral Nigella sativa seed-oil supplementation × Relief of WOMAC pain and functional limitation in knee osteoarthritis", "language": "en", "translation_date": "2026-10-24", "criteria_version": "1.0", "criteria_date": "2026-10-06", "condition_origin": "Chamgap's own application conditions", "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." }, "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." } ] }