{ "schema_version": "chamgap-public-criteria-1.0", "title": "Oral Nigella sativa seed oil as adjunctive therapy × Improved ACT symptom control in adults continuing inhaled asthma therapy", "language": "en", "translation_date": "2026-10-23", "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": "What is the exact original claim scope?", "needed": "Seed oil, adults with asthma on inhaled maintenance therapy,4-week ACT and placebo add-on question", "role": "Required", "role_reason": "Material on Seed oil, adults with asthma on inhaled maintenance therapy,4-week ACT and placebo add-on question is needed to connect the selected adjunctive seed-oil question to its population, formulation, comparison, endpoint, timing, denominator or harms.", "application_exception": "Fixed seed oil remains separate from powder, aqueous extract, ethanolic topical preparations, purified thymoquinone and combinations. ACT is not extended to inhaler replacement or prevention of exacerbations/admissions; no new effects, intervals, denominators, harm rates or dose totals are calculated.", "criterion": "Original records on Seed oil, adults with asthma on inhaled maintenance therapy,4-week ACT and placebo add-on question must link to the same question, route, population, comparison, endpoint, timing and analysis denominator, distinguishing recorded information from gaps.", "basis": "Existing principles distinguish seed oil and powder, populations, addition to inhaled maintenance therapy, placebo, ACT and lung function, final values and changes, timing, reports and trials, denominators and harms.", "condition_origin": "These existing conditions concern adjunctive oral fixed seed oil and ACT in adults with asthma continuing inhaled maintenance therapy. They link stored summaries and gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Original material for the same population, formulation, comparison and endpoint This records needed materials; no new research was executed." }, { "item_id": "N02", "question_type": "Evidence condition", "question": "What material was actually read?", "needed": "Distinguishing stored summaries from external papers, registration and plans", "role": "Required", "role_reason": "Material on Distinguishing stored summaries from external papers, registration and plans is needed to connect the selected adjunctive seed-oil question to its population, formulation, comparison, endpoint, timing, denominator or harms.", "application_exception": "Fixed seed oil remains separate from powder, aqueous extract, ethanolic topical preparations, purified thymoquinone and combinations. ACT is not extended to inhaler replacement or prevention of exacerbations/admissions; no new effects, intervals, denominators, harm rates or dose totals are calculated.", "criterion": "Original records on Distinguishing stored summaries from external papers, registration and plans must link to the same question, route, population, comparison, endpoint, timing and analysis denominator, distinguishing recorded information from gaps.", "basis": "Existing principles distinguish seed oil and powder, populations, addition to inhaled maintenance therapy, placebo, ACT and lung function, final values and changes, timing, reports and trials, denominators and harms.", "condition_origin": "These existing conditions concern adjunctive oral fixed seed oil and ACT in adults with asthma continuing inhaled maintenance therapy. They link stored summaries and gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Original material and access history provided by the user or acquired in follow-up work This records needed materials; no new research was executed." }, { "item_id": "N03", "question_type": "Evidence condition", "question": "What identifies the seed-oil report?", "needed": "Title, authors, year, PMID/DOI and registration identity", "role": "Required", "role_reason": "Material on Title, authors, year, PMID/DOI and registration identity is needed to connect the selected adjunctive seed-oil question to its population, formulation, comparison, endpoint, timing, denominator or harms.", "application_exception": "Fixed seed oil remains separate from powder, aqueous extract, ethanolic topical preparations, purified thymoquinone and combinations. ACT is not extended to inhaler replacement or prevention of exacerbations/admissions; no new effects, intervals, denominators, harm rates or dose totals are calculated.", "criterion": "Original records on Title, authors, year, PMID/DOI and registration identity must link to the same question, route, population, comparison, endpoint, timing and analysis denominator, distinguishing recorded information from gaps.", "basis": "Existing principles distinguish seed oil and powder, populations, addition to inhaled maintenance therapy, placebo, ACT and lung function, final values and changes, timing, reports and trials, denominators and harms.", "condition_origin": "These existing conditions concern adjunctive oral fixed seed oil and ACT in adults with asthma continuing inhaled maintenance therapy. They link stored summaries and gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Complete original citation, registration history and related-report list This records needed materials; no new research was executed." }, { "item_id": "N04", "question_type": "Evidence condition", "question": "Is the seed-powder report the same oil replication?", "needed": "Distinguishing powder, dose,12 weeks, registration and study families", "role": "Required", "role_reason": "Material on Distinguishing powder, dose,12 weeks, registration and study families is needed to connect the selected adjunctive seed-oil question to its population, formulation, comparison, endpoint, timing, denominator or harms.", "application_exception": "Fixed seed oil remains separate from powder, aqueous extract, ethanolic topical preparations, purified thymoquinone and combinations. ACT is not extended to inhaler replacement or prevention of exacerbations/admissions; no new effects, intervals, denominators, harm rates or dose totals are calculated.", "criterion": "Original records on Distinguishing powder, dose,12 weeks, registration and study families must link to the same question, route, population, comparison, endpoint, timing and analysis denominator, distinguishing recorded information from gaps.", "basis": "Existing principles distinguish seed oil and powder, populations, addition to inhaled maintenance therapy, placebo, ACT and lung function, final values and changes, timing, reports and trials, denominators and harms.", "condition_origin": "These existing conditions concern adjunctive oral fixed seed oil and ACT in adults with asthma continuing inhaled maintenance therapy. They link stored summaries and gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Study specifications and registration/report mapping for each formulation This records needed materials; no new research was executed." }, { "item_id": "N05", "question_type": "Evidence condition", "question": "Are reports, trials and participants kept separate?", "needed": "Report/family relationships for80-person oil and76-person powder studies", "role": "Required", "role_reason": "Material on Report/family relationships for80-person oil and76-person powder studies is needed to connect the selected adjunctive seed-oil question to its population, formulation, comparison, endpoint, timing, denominator or harms.", "application_exception": "Fixed seed oil remains separate from powder, aqueous extract, ethanolic topical preparations, purified thymoquinone and combinations. ACT is not extended to inhaler replacement or prevention of exacerbations/admissions; no new effects, intervals, denominators, harm rates or dose totals are calculated.", "criterion": "Original records on Report/family relationships for80-person oil and76-person powder studies must link to the same question, route, population, comparison, endpoint, timing and analysis denominator, distinguishing recorded information from gaps.", "basis": "Existing principles distinguish seed oil and powder, populations, addition to inhaled maintenance therapy, placebo, ACT and lung function, final values and changes, timing, reports and trials, denominators and harms.", "condition_origin": "These existing conditions concern adjunctive oral fixed seed oil and ACT in adults with asthma continuing inhaled maintenance therapy. They link stored summaries and gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Study-specific participant flow and related-report relationships This records needed materials; no new research was executed." }, { "item_id": "N06", "question_type": "Evidence condition", "question": "Which adults with asthma are represented?", "needed": "Asthma diagnosis, severity, baseline control, age and inclusion/exclusion", "role": "Required", "role_reason": "Material on Asthma diagnosis, severity, baseline control, age and inclusion/exclusion is needed to connect the selected adjunctive seed-oil question to its population, formulation, comparison, endpoint, timing, denominator or harms.", "application_exception": "Fixed seed oil remains separate from powder, aqueous extract, ethanolic topical preparations, purified thymoquinone and combinations. ACT is not extended to inhaler replacement or prevention of exacerbations/admissions; no new effects, intervals, denominators, harm rates or dose totals are calculated.", "criterion": "Original records on Asthma diagnosis, severity, baseline control, age and inclusion/exclusion must link to the same question, route, population, comparison, endpoint, timing and analysis denominator, distinguishing recorded information from gaps.", "basis": "Existing principles distinguish seed oil and powder, populations, addition to inhaled maintenance therapy, placebo, ACT and lung function, final values and changes, timing, reports and trials, denominators and harms.", "condition_origin": "These existing conditions concern adjunctive oral fixed seed oil and ACT in adults with asthma continuing inhaled maintenance therapy. They link stored summaries and gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Population/baseline characteristics and selection tables This records needed materials; no new research was executed." }, { "item_id": "N07", "question_type": "Evidence condition", "question": "Which seed oil is represented?", "needed": "Fixed seed-oil capsules, composition, extraction/manufacture and batch", "role": "Required", "role_reason": "Material on Fixed seed-oil capsules, composition, extraction/manufacture and batch is needed to connect the selected adjunctive seed-oil question to its population, formulation, comparison, endpoint, timing, denominator or harms.", "application_exception": "Fixed seed oil remains separate from powder, aqueous extract, ethanolic topical preparations, purified thymoquinone and combinations. ACT is not extended to inhaler replacement or prevention of exacerbations/admissions; no new effects, intervals, denominators, harm rates or dose totals are calculated.", "criterion": "Original records on Fixed seed-oil capsules, composition, extraction/manufacture and batch must link to the same question, route, population, comparison, endpoint, timing and analysis denominator, distinguishing recorded information from gaps.", "basis": "Existing principles distinguish seed oil and powder, populations, addition to inhaled maintenance therapy, placebo, ACT and lung function, final values and changes, timing, reports and trials, denominators and harms.", "condition_origin": "These existing conditions concern adjunctive oral fixed seed oil and ACT in adults with asthma continuing inhaled maintenance therapy. They link stored summaries and gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Product, manufacturing, composition and batch specifications This records needed materials; no new research was executed." }, { "item_id": "N08", "question_type": "Evidence condition", "question": "What were the oil dose and actual use?", "needed": "500 mg2 times daily, dosing interval, actual amount and adherence", "role": "Required", "role_reason": "Material on 500 mg2 times daily, dosing interval, actual amount and adherence is needed to connect the selected adjunctive seed-oil question to its population, formulation, comparison, endpoint, timing, denominator or harms.", "application_exception": "Fixed seed oil remains separate from powder, aqueous extract, ethanolic topical preparations, purified thymoquinone and combinations. ACT is not extended to inhaler replacement or prevention of exacerbations/admissions; no new effects, intervals, denominators, harm rates or dose totals are calculated.", "criterion": "Original records on 500 mg2 times daily, dosing interval, actual amount and adherence must link to the same question, route, population, comparison, endpoint, timing and analysis denominator, distinguishing recorded information from gaps.", "basis": "Existing principles distinguish seed oil and powder, populations, addition to inhaled maintenance therapy, placebo, ACT and lung function, final values and changes, timing, reports and trials, denominators and harms.", "condition_origin": "These existing conditions concern adjunctive oral fixed seed oil and ACT in adults with asthma continuing inhaled maintenance therapy. They link stored summaries and gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Arm-specific use, adherence and product-composition records This records needed materials; no new research was executed." }, { "item_id": "N09", "question_type": "Evidence condition", "question": "Is this an effect added to inhaled maintenance therapy?", "needed": "Common inhaled medicines, doses, arm-specific changes and adjunctive contribution", "role": "Required", "role_reason": "Material on Common inhaled medicines, doses, arm-specific changes and adjunctive contribution is needed to connect the selected adjunctive seed-oil question to its population, formulation, comparison, endpoint, timing, denominator or harms.", "application_exception": "Fixed seed oil remains separate from powder, aqueous extract, ethanolic topical preparations, purified thymoquinone and combinations. ACT is not extended to inhaler replacement or prevention of exacerbations/admissions; no new effects, intervals, denominators, harm rates or dose totals are calculated.", "criterion": "Original records on Common inhaled medicines, doses, arm-specific changes and adjunctive contribution must link to the same question, route, population, comparison, endpoint, timing and analysis denominator, distinguishing recorded information from gaps.", "basis": "Existing principles distinguish seed oil and powder, populations, addition to inhaled maintenance therapy, placebo, ACT and lung function, final values and changes, timing, reports and trials, denominators and harms.", "condition_origin": "These existing conditions concern adjunctive oral fixed seed oil and ACT in adults with asthma continuing inhaled maintenance therapy. They link stored summaries and gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Inhaled medicines, changes, rescue treatment and adherence tables This records needed materials; no new research was executed." }, { "item_id": "N10", "question_type": "Evidence condition", "question": "What were the placebo conditions?", "needed": "Matched appearance, ingredients, administration, common therapy and masking", "role": "Required", "role_reason": "Material on Matched appearance, ingredients, administration, common therapy and masking is needed to connect the selected adjunctive seed-oil question to its population, formulation, comparison, endpoint, timing, denominator or harms.", "application_exception": "Fixed seed oil remains separate from powder, aqueous extract, ethanolic topical preparations, purified thymoquinone and combinations. ACT is not extended to inhaler replacement or prevention of exacerbations/admissions; no new effects, intervals, denominators, harm rates or dose totals are calculated.", "criterion": "Original records on Matched appearance, ingredients, administration, common therapy and masking must link to the same question, route, population, comparison, endpoint, timing and analysis denominator, distinguishing recorded information from gaps.", "basis": "Existing principles distinguish seed oil and powder, populations, addition to inhaled maintenance therapy, placebo, ACT and lung function, final values and changes, timing, reports and trials, denominators and harms.", "condition_origin": "These existing conditions concern adjunctive oral fixed seed oil and ACT in adults with asthma continuing inhaled maintenance therapy. They link stored summaries and gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Placebo specifications and masking/unmasking records This records needed materials; no new research was executed." }, { "item_id": "N11", "question_type": "Evidence condition", "question": "What was the actual allocation process?", "needed": "Random sequence generation, concealment, baseline balance and allocation denominators", "role": "Required", "role_reason": "Material on Random sequence generation, concealment, baseline balance and allocation denominators is needed to connect the selected adjunctive seed-oil question to its population, formulation, comparison, endpoint, timing, denominator or harms.", "application_exception": "Fixed seed oil remains separate from powder, aqueous extract, ethanolic topical preparations, purified thymoquinone and combinations. ACT is not extended to inhaler replacement or prevention of exacerbations/admissions; no new effects, intervals, denominators, harm rates or dose totals are calculated.", "criterion": "Original records on Random sequence generation, concealment, baseline balance and allocation denominators must link to the same question, route, population, comparison, endpoint, timing and analysis denominator, distinguishing recorded information from gaps.", "basis": "Existing principles distinguish seed oil and powder, populations, addition to inhaled maintenance therapy, placebo, ACT and lung function, final values and changes, timing, reports and trials, denominators and harms.", "condition_origin": "These existing conditions concern adjunctive oral fixed seed oil and ACT in adults with asthma continuing inhaled maintenance therapy. They link stored summaries and gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Allocation methods, baseline tables and participant flow This records needed materials; no new research was executed." }, { "item_id": "N12", "question_type": "Evidence condition", "question": "How are treatment and follow-up periods defined?", "needed": "Treatment4 weeks, follow-up4 weeks, assessment schedules and post-discontinuation observation", "role": "Required", "role_reason": "Material on Treatment4 weeks, follow-up4 weeks, assessment schedules and post-discontinuation observation is needed to connect the selected adjunctive seed-oil question to its population, formulation, comparison, endpoint, timing, denominator or harms.", "application_exception": "Fixed seed oil remains separate from powder, aqueous extract, ethanolic topical preparations, purified thymoquinone and combinations. ACT is not extended to inhaler replacement or prevention of exacerbations/admissions; no new effects, intervals, denominators, harm rates or dose totals are calculated.", "criterion": "Original records on Treatment4 weeks, follow-up4 weeks, assessment schedules and post-discontinuation observation must link to the same question, route, population, comparison, endpoint, timing and analysis denominator, distinguishing recorded information from gaps.", "basis": "Existing principles distinguish seed oil and powder, populations, addition to inhaled maintenance therapy, placebo, ACT and lung function, final values and changes, timing, reports and trials, denominators and harms.", "condition_origin": "These existing conditions concern adjunctive oral fixed seed oil and ACT in adults with asthma continuing inhaled maintenance therapy. They link stored summaries and gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Visit, dosing, discontinuation and follow-up schedules This records needed materials; no new research was executed." }, { "item_id": "N13", "question_type": "Evidence condition", "question": "What does ACT measure?", "needed": "Asthma Control Test, scale/direction, respondents, final values/changes and timing", "role": "Required", "role_reason": "Material on Asthma Control Test, scale/direction, respondents, final values/changes and timing is needed to connect the selected adjunctive seed-oil question to its population, formulation, comparison, endpoint, timing, denominator or harms.", "application_exception": "Fixed seed oil remains separate from powder, aqueous extract, ethanolic topical preparations, purified thymoquinone and combinations. ACT is not extended to inhaler replacement or prevention of exacerbations/admissions; no new effects, intervals, denominators, harm rates or dose totals are calculated.", "criterion": "Original records on Asthma Control Test, scale/direction, respondents, final values/changes and timing must link to the same question, route, population, comparison, endpoint, timing and analysis denominator, distinguishing recorded information from gaps.", "basis": "Existing principles distinguish seed oil and powder, populations, addition to inhaled maintenance therapy, placebo, ACT and lung function, final values and changes, timing, reports and trials, denominators and harms.", "condition_origin": "These existing conditions concern adjunctive oral fixed seed oil and ACT in adults with asthma continuing inhaled maintenance therapy. They link stored summaries and gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: ACT methods, baseline/4-week results and respondent denominators This records needed materials; no new research was executed." }, { "item_id": "N14", "question_type": "Evidence condition", "question": "What are the4-week ACT results?", "needed": "Oil/placebo final values, dispersion, denominators and testing", "role": "Required", "role_reason": "Material on Oil/placebo final values, dispersion, denominators and testing is needed to connect the selected adjunctive seed-oil question to its population, formulation, comparison, endpoint, timing, denominator or harms.", "application_exception": "Fixed seed oil remains separate from powder, aqueous extract, ethanolic topical preparations, purified thymoquinone and combinations. ACT is not extended to inhaler replacement or prevention of exacerbations/admissions; no new effects, intervals, denominators, harm rates or dose totals are calculated.", "criterion": "Original records on Oil/placebo final values, dispersion, denominators and testing must link to the same question, route, population, comparison, endpoint, timing and analysis denominator, distinguishing recorded information from gaps.", "basis": "Existing principles distinguish seed oil and powder, populations, addition to inhaled maintenance therapy, placebo, ACT and lung function, final values and changes, timing, reports and trials, denominators and harms.", "condition_origin": "These existing conditions concern adjunctive oral fixed seed oil and ACT in adults with asthma continuing inhaled maintenance therapy. They link stored summaries and gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Endpoint-specific result tables, dispersion, adjustment and intervals This records needed materials; no new research was executed." }, { "item_id": "N15", "question_type": "Evidence condition", "question": "What is the clinical importance of the small ACT contrast?", "needed": "Effect/CI, justified important difference and responder criteria", "role": "Required", "role_reason": "Material on Effect/CI, justified important difference and responder criteria is needed to connect the selected adjunctive seed-oil question to its population, formulation, comparison, endpoint, timing, denominator or harms.", "application_exception": "Fixed seed oil remains separate from powder, aqueous extract, ethanolic topical preparations, purified thymoquinone and combinations. ACT is not extended to inhaler replacement or prevention of exacerbations/admissions; no new effects, intervals, denominators, harm rates or dose totals are calculated.", "criterion": "Original records on Effect/CI, justified important difference and responder criteria must link to the same question, route, population, comparison, endpoint, timing and analysis denominator, distinguishing recorded information from gaps.", "basis": "Existing principles distinguish seed oil and powder, populations, addition to inhaled maintenance therapy, placebo, ACT and lung function, final values and changes, timing, reports and trials, denominators and harms.", "condition_origin": "These existing conditions concern adjunctive oral fixed seed oil and ACT in adults with asthma continuing inhaled maintenance therapy. They link stored summaries and gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Original effect/CI, important-difference rationale and responder results This records needed materials; no new research was executed." }, { "item_id": "N16", "question_type": "Evidence condition", "question": "Is the FEV1 result preserved alongside ACT?", "needed": "Separate FEV1 and ACT endpoints, units, denominators and timing", "role": "Required", "role_reason": "Material on Separate FEV1 and ACT endpoints, units, denominators and timing is needed to connect the selected adjunctive seed-oil question to its population, formulation, comparison, endpoint, timing, denominator or harms.", "application_exception": "Fixed seed oil remains separate from powder, aqueous extract, ethanolic topical preparations, purified thymoquinone and combinations. ACT is not extended to inhaler replacement or prevention of exacerbations/admissions; no new effects, intervals, denominators, harm rates or dose totals are calculated.", "criterion": "Original records on Separate FEV1 and ACT endpoints, units, denominators and timing must link to the same question, route, population, comparison, endpoint, timing and analysis denominator, distinguishing recorded information from gaps.", "basis": "Existing principles distinguish seed oil and powder, populations, addition to inhaled maintenance therapy, placebo, ACT and lung function, final values and changes, timing, reports and trials, denominators and harms.", "condition_origin": "These existing conditions concern adjunctive oral fixed seed oil and ACT in adults with asthma continuing inhaled maintenance therapy. They link stored summaries and gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Original FEV1 results, denominators, intervals and plans This records needed materials; no new research was executed." }, { "item_id": "N17", "question_type": "Evidence condition", "question": "What is the prespecified ACT/FEV1 hierarchy?", "needed": "Registry, protocol and SAP endpoints, timing, analysis and changes", "role": "Required", "role_reason": "Material on Registry, protocol and SAP endpoints, timing, analysis and changes is needed to connect the selected adjunctive seed-oil question to its population, formulation, comparison, endpoint, timing, denominator or harms.", "application_exception": "Fixed seed oil remains separate from powder, aqueous extract, ethanolic topical preparations, purified thymoquinone and combinations. ACT is not extended to inhaler replacement or prevention of exacerbations/admissions; no new effects, intervals, denominators, harm rates or dose totals are calculated.", "criterion": "Original records on Registry, protocol and SAP endpoints, timing, analysis and changes must link to the same question, route, population, comparison, endpoint, timing and analysis denominator, distinguishing recorded information from gaps.", "basis": "Existing principles distinguish seed oil and powder, populations, addition to inhaled maintenance therapy, placebo, ACT and lung function, final values and changes, timing, reports and trials, denominators and harms.", "condition_origin": "These existing conditions concern adjunctive oral fixed seed oil and ACT in adults with asthma continuing inhaled maintenance therapy. They link stored summaries and gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Registration history, protocol, SAP and all endpoints This records needed materials; no new research was executed." }, { "item_id": "N18", "question_type": "Evidence condition", "question": "What are the80-person allocation and post-attrition denominators?", "needed": "Arm-specific allocation, measurement, completion, ACT/FEV1 and ITT denominators", "role": "Required", "role_reason": "Material on Arm-specific allocation, measurement, completion, ACT/FEV1 and ITT denominators is needed to connect the selected adjunctive seed-oil question to its population, formulation, comparison, endpoint, timing, denominator or harms.", "application_exception": "Fixed seed oil remains separate from powder, aqueous extract, ethanolic topical preparations, purified thymoquinone and combinations. ACT is not extended to inhaler replacement or prevention of exacerbations/admissions; no new effects, intervals, denominators, harm rates or dose totals are calculated.", "criterion": "Original records on Arm-specific allocation, measurement, completion, ACT/FEV1 and ITT denominators must link to the same question, route, population, comparison, endpoint, timing and analysis denominator, distinguishing recorded information from gaps.", "basis": "Existing principles distinguish seed oil and powder, populations, addition to inhaled maintenance therapy, placebo, ACT and lung function, final values and changes, timing, reports and trials, denominators and harms.", "condition_origin": "These existing conditions concern adjunctive oral fixed seed oil and ACT in adults with asthma continuing inhaled maintenance therapy. They link stored summaries and gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Arm-specific participant flow and endpoint analysis tables This records needed materials; no new research was executed." }, { "item_id": "N19", "question_type": "Evidence condition", "question": "How were missing data handled in the reported ITT?", "needed": "ITT definition, imputation/estimation, withdrawal reasons and sensitivity analysis", "role": "Required", "role_reason": "Material on ITT definition, imputation/estimation, withdrawal reasons and sensitivity analysis is needed to connect the selected adjunctive seed-oil question to its population, formulation, comparison, endpoint, timing, denominator or harms.", "application_exception": "Fixed seed oil remains separate from powder, aqueous extract, ethanolic topical preparations, purified thymoquinone and combinations. ACT is not extended to inhaler replacement or prevention of exacerbations/admissions; no new effects, intervals, denominators, harm rates or dose totals are calculated.", "criterion": "Original records on ITT definition, imputation/estimation, withdrawal reasons and sensitivity analysis must link to the same question, route, population, comparison, endpoint, timing and analysis denominator, distinguishing recorded information from gaps.", "basis": "Existing principles distinguish seed oil and powder, populations, addition to inhaled maintenance therapy, placebo, ACT and lung function, final values and changes, timing, reports and trials, denominators and harms.", "condition_origin": "These existing conditions concern adjunctive oral fixed seed oil and ACT in adults with asthma continuing inhaled maintenance therapy. They link stored summaries and gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: ITT/missing-data methods, withdrawal reasons and sensitivity results This records needed materials; no new research was executed." }, { "item_id": "N20", "question_type": "Evidence condition", "question": "What are adherence, rescue medicines and treatment deviations?", "needed": "Oil/placebo adherence, inhaled-therapy changes, rescue medication and exacerbations", "role": "Required", "role_reason": "Material on Oil/placebo adherence, inhaled-therapy changes, rescue medication and exacerbations is needed to connect the selected adjunctive seed-oil question to its population, formulation, comparison, endpoint, timing, denominator or harms.", "application_exception": "Fixed seed oil remains separate from powder, aqueous extract, ethanolic topical preparations, purified thymoquinone and combinations. ACT is not extended to inhaler replacement or prevention of exacerbations/admissions; no new effects, intervals, denominators, harm rates or dose totals are calculated.", "criterion": "Original records on Oil/placebo adherence, inhaled-therapy changes, rescue medication and exacerbations must link to the same question, route, population, comparison, endpoint, timing and analysis denominator, distinguishing recorded information from gaps.", "basis": "Existing principles distinguish seed oil and powder, populations, addition to inhaled maintenance therapy, placebo, ACT and lung function, final values and changes, timing, reports and trials, denominators and harms.", "condition_origin": "These existing conditions concern adjunctive oral fixed seed oil and ACT in adults with asthma continuing inhaled maintenance therapy. They link stored summaries and gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Adherence, rescue-medication and treatment-change tables This records needed materials; no new research was executed." }, { "item_id": "N21", "question_type": "Evidence condition", "question": "What do the powder-study results cover?", "needed": "Powder1/2 g,12-week ACT,3 arms, denominators and plans", "role": "Required", "role_reason": "Material on Powder1/2 g,12-week ACT,3 arms, denominators and plans is needed to connect the selected adjunctive seed-oil question to its population, formulation, comparison, endpoint, timing, denominator or harms.", "application_exception": "Fixed seed oil remains separate from powder, aqueous extract, ethanolic topical preparations, purified thymoquinone and combinations. ACT is not extended to inhaler replacement or prevention of exacerbations/admissions; no new effects, intervals, denominators, harm rates or dose totals are calculated.", "criterion": "Original records on Powder1/2 g,12-week ACT,3 arms, denominators and plans must link to the same question, route, population, comparison, endpoint, timing and analysis denominator, distinguishing recorded information from gaps.", "basis": "Existing principles distinguish seed oil and powder, populations, addition to inhaled maintenance therapy, placebo, ACT and lung function, final values and changes, timing, reports and trials, denominators and harms.", "condition_origin": "These existing conditions concern adjunctive oral fixed seed oil and ACT in adults with asthma continuing inhaled maintenance therapy. They link stored summaries and gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Powder-study results, group composition, denominators and plans This records needed materials; no new research was executed." }, { "item_id": "N22", "question_type": "Evidence condition", "question": "What independent replication concerns the same oil?", "needed": "Unique families for the same formulation, population, comparison and4-week ACT", "role": "Required", "role_reason": "Material on Unique families for the same formulation, population, comparison and4-week ACT is needed to connect the selected adjunctive seed-oil question to its population, formulation, comparison, endpoint, timing, denominator or harms.", "application_exception": "Fixed seed oil remains separate from powder, aqueous extract, ethanolic topical preparations, purified thymoquinone and combinations. ACT is not extended to inhaler replacement or prevention of exacerbations/admissions; no new effects, intervals, denominators, harm rates or dose totals are calculated.", "criterion": "Original records on Unique families for the same formulation, population, comparison and4-week ACT must link to the same question, route, population, comparison, endpoint, timing and analysis denominator, distinguishing recorded information from gaps.", "basis": "Existing principles distinguish seed oil and powder, populations, addition to inhaled maintenance therapy, placebo, ACT and lung function, final values and changes, timing, reports and trials, denominators and harms.", "condition_origin": "These existing conditions concern adjunctive oral fixed seed oil and ACT in adults with asthma continuing inhaled maintenance therapy. They link stored summaries and gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Direct same-oil trials and related-report list This records needed materials; no new research was executed." }, { "item_id": "N23", "question_type": "Evidence condition", "question": "What would answer dose and long-term persistence questions?", "needed": "Direct oil dose, long-term/post-discontinuation outcomes and subgroups", "role": "Required", "role_reason": "Material on Direct oil dose, long-term/post-discontinuation outcomes and subgroups is needed to connect the selected adjunctive seed-oil question to its population, formulation, comparison, endpoint, timing, denominator or harms.", "application_exception": "Fixed seed oil remains separate from powder, aqueous extract, ethanolic topical preparations, purified thymoquinone and combinations. ACT is not extended to inhaler replacement or prevention of exacerbations/admissions; no new effects, intervals, denominators, harm rates or dose totals are calculated.", "criterion": "Original records on Direct oil dose, long-term/post-discontinuation outcomes and subgroups must link to the same question, route, population, comparison, endpoint, timing and analysis denominator, distinguishing recorded information from gaps.", "basis": "Existing principles distinguish seed oil and powder, populations, addition to inhaled maintenance therapy, placebo, ACT and lung function, final values and changes, timing, reports and trials, denominators and harms.", "condition_origin": "These existing conditions concern adjunctive oral fixed seed oil and ACT in adults with asthma continuing inhaled maintenance therapy. They link stored summaries and gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Same-oil dose/follow-up and prespecified-subgroup material This records needed materials; no new research was executed." }, { "item_id": "N24", "question_type": "Evidence condition", "question": "Does this establish exacerbation, attack or admission prevention or inhaler replacement?", "needed": "Boundaries between ACT, separate clinical events and replacement treatment", "role": "Required", "role_reason": "Material on Boundaries between ACT, separate clinical events and replacement treatment is needed to connect the selected adjunctive seed-oil question to its population, formulation, comparison, endpoint, timing, denominator or harms.", "application_exception": "Fixed seed oil remains separate from powder, aqueous extract, ethanolic topical preparations, purified thymoquinone and combinations. ACT is not extended to inhaler replacement or prevention of exacerbations/admissions; no new effects, intervals, denominators, harm rates or dose totals are calculated.", "criterion": "Original records on Boundaries between ACT, separate clinical events and replacement treatment must link to the same question, route, population, comparison, endpoint, timing and analysis denominator, distinguishing recorded information from gaps.", "basis": "Existing principles distinguish seed oil and powder, populations, addition to inhaled maintenance therapy, placebo, ACT and lung function, final values and changes, timing, reports and trials, denominators and harms.", "condition_origin": "These existing conditions concern adjunctive oral fixed seed oil and ACT in adults with asthma continuing inhaled maintenance therapy. They link stored summaries and gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Separate clinical events, periods, denominators and replacement designs This records needed materials; no new research was executed." }, { "item_id": "N25", "question_type": "Evidence condition", "question": "What records the oil-study funding?", "needed": "Reported funding, sponsor roles and independence level", "role": "Required", "role_reason": "Material on Reported funding, sponsor roles and independence level is needed to connect the selected adjunctive seed-oil question to its population, formulation, comparison, endpoint, timing, denominator or harms.", "application_exception": "Fixed seed oil remains separate from powder, aqueous extract, ethanolic topical preparations, purified thymoquinone and combinations. ACT is not extended to inhaler replacement or prevention of exacerbations/admissions; no new effects, intervals, denominators, harm rates or dose totals are calculated.", "criterion": "Original records on Reported funding, sponsor roles and independence level must link to the same question, route, population, comparison, endpoint, timing and analysis denominator, distinguishing recorded information from gaps.", "basis": "Existing principles distinguish seed oil and powder, populations, addition to inhaled maintenance therapy, placebo, ACT and lung function, final values and changes, timing, reports and trials, denominators and harms.", "condition_origin": "These existing conditions concern adjunctive oral fixed seed oil and ACT in adults with asthma continuing inhaled maintenance therapy. They link stored summaries and gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Original funding and sponsor-role documents This records needed materials; no new research was executed." }, { "item_id": "N26", "question_type": "Evidence condition", "question": "What are powder funding and product support/COI for both reports?", "needed": "Separate original funding, product provision, employee authorship, patent and COI records", "role": "Required", "role_reason": "Material on Separate original funding, product provision, employee authorship, patent and COI records is needed to connect the selected adjunctive seed-oil question to its population, formulation, comparison, endpoint, timing, denominator or harms.", "application_exception": "Fixed seed oil remains separate from powder, aqueous extract, ethanolic topical preparations, purified thymoquinone and combinations. ACT is not extended to inhaler replacement or prevention of exacerbations/admissions; no new effects, intervals, denominators, harm rates or dose totals are calculated.", "criterion": "Original records on Separate original funding, product provision, employee authorship, patent and COI records must link to the same question, route, population, comparison, endpoint, timing and analysis denominator, distinguishing recorded information from gaps.", "basis": "Existing principles distinguish seed oil and powder, populations, addition to inhaled maintenance therapy, placebo, ACT and lung function, final values and changes, timing, reports and trials, denominators and harms.", "condition_origin": "These existing conditions concern adjunctive oral fixed seed oil and ACT in adults with asthma continuing inhaled maintenance therapy. They link stored summaries and gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Support, manufacture, employment and COI specifications for each report This records needed materials; no new research was executed." }, { "item_id": "N27", "question_type": "Evidence condition", "question": "How were adverse events collected?", "needed": "Events, collection, discontinuation and denominators for the same adult oil exposure", "role": "Supplementary", "role_reason": "Material on Events, collection, discontinuation and denominators for the same adult oil exposure is needed to connect the selected adjunctive seed-oil question to its population, formulation, comparison, endpoint, timing, denominator or harms.", "application_exception": "Fixed seed oil remains separate from powder, aqueous extract, ethanolic topical preparations, purified thymoquinone and combinations. ACT is not extended to inhaler replacement or prevention of exacerbations/admissions; no new effects, intervals, denominators, harm rates or dose totals are calculated.", "criterion": "Original records on Events, collection, discontinuation and denominators for the same adult oil exposure must link to the same question, route, population, comparison, endpoint, timing and analysis denominator, distinguishing recorded information from gaps.", "basis": "Existing principles distinguish seed oil and powder, populations, addition to inhaled maintenance therapy, placebo, ACT and lung function, final values and changes, timing, reports and trials, denominators and harms.", "condition_origin": "These existing conditions concern adjunctive oral fixed seed oil and ACT in adults with asthma continuing inhaled maintenance therapy. They link stored summaries and gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Arm-specific event/discontinuation tables and collection methods This records needed materials; no new research was executed." }, { "item_id": "N28", "question_type": "Evidence condition", "question": "What are co-medication, event timing and harm attribution?", "needed": "Inhaled medicines, baseline asthma, cointerventions, onset/recovery and alternatives", "role": "Supplementary", "role_reason": "Material on Inhaled medicines, baseline asthma, cointerventions, onset/recovery and alternatives is needed to connect the selected adjunctive seed-oil question to its population, formulation, comparison, endpoint, timing, denominator or harms.", "application_exception": "Fixed seed oil remains separate from powder, aqueous extract, ethanolic topical preparations, purified thymoquinone and combinations. ACT is not extended to inhaler replacement or prevention of exacerbations/admissions; no new effects, intervals, denominators, harm rates or dose totals are calculated.", "criterion": "Original records on Inhaled medicines, baseline asthma, cointerventions, onset/recovery and alternatives must link to the same question, route, population, comparison, endpoint, timing and analysis denominator, distinguishing recorded information from gaps.", "basis": "Existing principles distinguish seed oil and powder, populations, addition to inhaled maintenance therapy, placebo, ACT and lung function, final values and changes, timing, reports and trials, denominators and harms.", "condition_origin": "These existing conditions concern adjunctive oral fixed seed oil and ACT in adults with asthma continuing inhaled maintenance therapy. They link stored summaries and gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Cointerventions, event timelines, withdrawal/recovery and alternative-cause material This records needed materials; no new research was executed." }, { "item_id": "N29", "question_type": "Evidence condition", "question": "What are long-term/rare harms and other vulnerable groups?", "needed": "Direct long-term exposure, pregnancy/breastfeeding, children and liver/kidney material", "role": "Supplementary", "role_reason": "Material on Direct long-term exposure, pregnancy/breastfeeding, children and liver/kidney material is needed to connect the selected adjunctive seed-oil question to its population, formulation, comparison, endpoint, timing, denominator or harms.", "application_exception": "Fixed seed oil remains separate from powder, aqueous extract, ethanolic topical preparations, purified thymoquinone and combinations. ACT is not extended to inhaler replacement or prevention of exacerbations/admissions; no new effects, intervals, denominators, harm rates or dose totals are calculated.", "criterion": "Original records on Direct long-term exposure, pregnancy/breastfeeding, children and liver/kidney material must link to the same question, route, population, comparison, endpoint, timing and analysis denominator, distinguishing recorded information from gaps.", "basis": "Existing principles distinguish seed oil and powder, populations, addition to inhaled maintenance therapy, placebo, ACT and lung function, final values and changes, timing, reports and trials, denominators and harms.", "condition_origin": "These existing conditions concern adjunctive oral fixed seed oil and ACT in adults with asthma continuing inhaled maintenance therapy. They link stored summaries and gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Long-term/population-specific exposure, harm and interaction material This records needed materials; no new research was executed." }, { "item_id": "N30", "question_type": "Evidence condition", "question": "What is the history of C50, assessment values and past validation?", "needed": "Original grade, score, assessment values, original states and change history", "role": "Required", "role_reason": "Material on Original grade, score, assessment values, original states and change history is needed to connect the selected adjunctive seed-oil question to its population, formulation, comparison, endpoint, timing, denominator or harms.", "application_exception": "Fixed seed oil remains separate from powder, aqueous extract, ethanolic topical preparations, purified thymoquinone and combinations. ACT is not extended to inhaler replacement or prevention of exacerbations/admissions; no new effects, intervals, denominators, harm rates or dose totals are calculated.", "criterion": "Original records on Original grade, score, assessment values, original states and change history must link to the same question, route, population, comparison, endpoint, timing and analysis denominator, distinguishing recorded information from gaps.", "basis": "Existing principles distinguish seed oil and powder, populations, addition to inhaled maintenance therapy, placebo, ACT and lung function, final values and changes, timing, reports and trials, denominators and harms.", "condition_origin": "These existing conditions concern adjunctive oral fixed seed oil and ACT in adults with asthma continuing inhaled maintenance therapy. They link stored summaries and gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Separate history of original verdict and change events This records needed materials; no new research was executed." }, { "item_id": "N31", "question_type": "Evidence condition", "question": "What are the boundaries of English wording, corrections and the original evidence date?", "needed": "Korean/English wording,2026-09-08,09-14 correction and production-date distinctions", "role": "Required", "role_reason": "Material on Korean/English wording,2026-09-08,09-14 correction and production-date distinctions is needed to connect the selected adjunctive seed-oil question to its population, formulation, comparison, endpoint, timing, denominator or harms.", "application_exception": "Fixed seed oil remains separate from powder, aqueous extract, ethanolic topical preparations, purified thymoquinone and combinations. ACT is not extended to inhaler replacement or prevention of exacerbations/admissions; no new effects, intervals, denominators, harm rates or dose totals are calculated.", "criterion": "Original records on Korean/English wording,2026-09-08,09-14 correction and production-date distinctions must link to the same question, route, population, comparison, endpoint, timing and analysis denominator, distinguishing recorded information from gaps.", "basis": "Existing principles distinguish seed oil and powder, populations, addition to inhaled maintenance therapy, placebo, ACT and lung function, final values and changes, timing, reports and trials, denominators and harms.", "condition_origin": "These existing conditions concern adjunctive oral fixed seed oil and ACT in adults with asthma continuing inhaled maintenance therapy. They link stored summaries and gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Before/after correction records, additional material and user comments This records needed materials; no new research was executed." } ] }