{ "schema_version": "chamgap-public-evidence-check-1.0", "public_id": "v3027-main", "verdict_number": "3027", "title": "Oral Nigella sativa seed oil as adjunctive therapy × Improved ACT symptom control in adults continuing inhaled asthma therapy", "view_version": "1.0", "view_created_date": "2026-10-23", "criteria_version": "1.0", "criteria_date": "2026-10-06", "review_date": null, "legacy_evidence_date": "2026-09-08", "review_scope": { "materials_read": "Existing review summaries and stored records of methodological application", "clinical_papers_directly_read": false, "new_clinical_search": false, "limitation": "Existing stored summary and preserved methodology application records. External papers, abstracts, registration, protocols, SAPs, original result tables and support disclosures are unread, and review of existing content remains incomplete.", "date_meaning": "This is the date the stored materials were checked, not the date of a new search of the clinical literature." }, "claim_context": { "population": "The population is adults with asthma continuing inhaled maintenance therapy. Detailed age, diagnosis, severity, baseline ACT, smoking, comorbidities and inclusion/exclusion remain unverified. Applicability to children or other vulnerable groups is not assumed.", "intervention": "Oral capsules of fixed oil from Nigella sativa L. seeds were added to maintenance therapy. Composition specifications, extraction/manufacture, batch and marketed-product identity remain unverified. Seed powder remains supportive material from a different formulation.", "dose": "The seed-oil dose is 500 mg 2 times daily. Actual use, omissions, adjustments and constituent exposure remain unverified. Powder at 1·2 g/day is not transferred to oil; no daily total, cumulative dose, optimal dose or individual dosing guidance is created.", "comparator": "Matched-appearance placebo was added to common inhaled maintenance therapy. Placebo ingredients, taste/smell, actual administration and maintained masking, and arm-specific balance of inhaled drugs, doses, changes and rescue medication remain unverified. This is an adjunctive comparison rather than oil monotherapy or inhaler replacement.", "endpoint": "The endpoint is patient-reported symptom control on the 4-week Asthma Control Test (ACT). Final values remain distinct from changes; the ± type, baseline adjustment, analysis denominator and original CI remain unverified. FEV1 is a separate result; nonsignificance is not converted into absence of effect or equivalence.", "duration": "The original Korean wording records treatment 4 weeks and follow-up 4 weeks; the original English says Four weeks of treatment and follow-up. No additional period or total duration is calculated; visits and post-discontinuation follow-up remain unverified. Powder at 12 weeks is not transferred to long-term oil effects.", "excluded_extensions": [ "The selected question concerns fixed seed oil added to inhaled maintenance therapy and ACT in adult asthma. Powder, extracts, topical preparations, purified thymoquinone and combinations are not merged as the same formulation.", "The existing C·50 points·Caution, P/R1/I2/E~/B2/C0 and evidence date 2026-09-08 are retained. Historical cross-checking and independent-funding descriptions remain historical records rather than new clinical certification.", "The oil trial’s 80 randomized people, 10 withdrawals per arm and the original account’s 25% attrition are retained. An ITT label alone does not establish robust missing-data handling, and completer or endpoint-specific denominators are not newly calculated.", "ACT 21.1±2.6 versus 19.6±3.7, P=.044 and FEV1 P=.170 are retained. The ± type, original CI, important difference and responder results remain unverified; no new difference, interval, P or NNT is calculated.", "The powder record of 76 people, 24/26/26, 1·2 g/day and 12 weeks remains separate. Arm mapping and analysis denominators remain unverified; it is not merged into same-formulation oil replication or participant totals.", "Preserved registration identifiers remain distinct from actual reading of registry documents and verification of prespecified hierarchy. The existing English-wording correction date 2026-09-14 is not converted into a new clinical-search or verdict date.", "The ACT signal is not extended to prevention of exacerbations, attacks or admissions, or evidence for stopping inhalers. Original caution about product differences, pregnancy/breastfeeding, children, liver/kidney disease, surgery and medicines is retained; no new harm rate, causality, contraindication or long-term safety judgment is created." ] }, "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.", "current_reports": [ "S01", "S02" ], "existence": "The information is recorded in stored summaries and citations for the seed-oil trial and separate seed-powder study. Current reading of external abstracts, full text, registrations and plans remains separately unverified.", "acquired_read": "Existing Korean and English stored summaries and bibliography for the oil and powder reports read; external abstracts, full text, registrations, protocols and analysis plans unread", "observation": "The selected claim is improved ACT symptom control in adults continuing inhaled asthma therapy. It concerns adjunctive oral seed oil.", "condition_status": "Partly verified", "status_reason": "Stored information is linked to gaps in detailed material. External verification and clinical content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.", "missingness": "Powder, inhaler replacement and exacerbation/admission prevention are not substituted for this question.", "uncertainty": "Gaps in product specifications, inhaled medicines, baseline scores, analysis denominators, missing-data handling, plans, support and harms remain. Significance is not converted into a large effect, nonsignificance into absence of effect or equivalence, or limited harm records into overall safety.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original material for the same population, formulation, comparison and endpoint" }, { "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.", "current_reports": [ "S01", "S02" ], "existence": "The information is recorded in stored summaries and citations for the seed-oil trial and separate seed-powder study. Current reading of external abstracts, full text, registrations and plans remains separately unverified.", "acquired_read": "Existing Korean and English stored summaries and bibliography for the oil and powder reports read; external abstracts, full text, registrations, protocols and analysis plans unread", "observation": "The complete stored summary,2 evidence entries,2 citations and Korean/English content were used. External papers, registration, protocols and SAPs remain unread and access unattempted.", "condition_status": "Partly verified", "status_reason": "Stored information is linked to gaps in detailed material. External verification and clinical content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.", "missingness": "Links, registration identifiers and historical registered-trial wording are not promoted to actual current reading.", "uncertainty": "Gaps in product specifications, inhaled medicines, baseline scores, analysis denominators, missing-data handling, plans, support and harms remain. Significance is not converted into a large effect, nonsignificance into absence of effect or equivalence, or limited harm records into overall safety.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original material and access history provided by the user or acquired in follow-up work" }, { "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.", "current_reports": [ "S01" ], "existence": "The information is recorded in stored summaries and citations for the seed-oil trial and separate seed-powder study. Current reading of external abstracts, full text, registrations and plans remains separately unverified.", "acquired_read": "Existing Korean and English stored summaries and bibliography for the oil and powder reports read; external abstracts, full text, registrations, protocols and analysis plans unread", "observation": "Koshak A et al., Phytother Res2017, PMID28093815, DOI10.1002/ptr.5761 and NCT02407262 are preserved.", "condition_status": "Partly verified", "status_reason": "Stored information is linked to gaps in detailed material. External verification and clinical content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.", "missingness": "Actual external paper/registry content and related-report mapping remain unverified here.", "uncertainty": "Gaps in product specifications, inhaled medicines, baseline scores, analysis denominators, missing-data handling, plans, support and harms remain. Significance is not converted into a large effect, nonsignificance into absence of effect or equivalence, or limited harm records into overall safety.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Complete original citation, registration history and related-report list" }, { "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.", "current_reports": [ "S02" ], "existence": "The information is recorded in stored summaries and citations for the seed-oil trial and separate seed-powder study. Current reading of external abstracts, full text, registrations and plans remains separately unverified.", "acquired_read": "Existing Korean and English stored summaries and bibliography for the oil and powder reports read; external abstracts, full text, registrations, protocols and analysis plans unread", "observation": "This is the powder study by Salem AM et al., Ann Saudi Med2017, PMID28151459, PMCIDPMC6148976, DOI10.5144/0256-4947.2017.64 and ISRCTN48853858. It is not direct seed-oil replication.", "condition_status": "Partly verified", "status_reason": "Stored information is linked to gaps in detailed material. External verification and clinical content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.", "missingness": "Sharing the ACT name does not erase formulation, dose and duration differences or establish independent replication.", "uncertainty": "Gaps in product specifications, inhaled medicines, baseline scores, analysis denominators, missing-data handling, plans, support and harms remain. Significance is not converted into a large effect, nonsignificance into absence of effect or equivalence, or limited harm records into overall safety.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Study specifications and registration/report mapping for each formulation" }, { "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.", "current_reports": [ "S01", "S02" ], "existence": "The information is recorded in stored summaries and citations for the seed-oil trial and separate seed-powder study. Current reading of external abstracts, full text, registrations and plans remains separately unverified.", "acquired_read": "Existing Korean and English stored summaries and bibliography for the oil and powder reports read; external abstracts, full text, registrations, protocols and analysis plans unread", "observation": "The oil trial and different-formulation powder study remain linked to their own reports. 80 and76 people or powder24/26/26 are not newly summed into an oil-efficacy denominator.", "condition_status": "Partly verified", "status_reason": "Stored information is linked to gaps in detailed material. External verification and clinical content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.", "missingness": "Unique trial, participant and independent-replication totals are not established; external related-report/overlap material remains unread.", "uncertainty": "Gaps in product specifications, inhaled medicines, baseline scores, analysis denominators, missing-data handling, plans, support and harms remain. Significance is not converted into a large effect, nonsignificance into absence of effect or equivalence, or limited harm records into overall safety.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Study-specific participant flow and related-report relationships" }, { "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.", "current_reports": [ "S01" ], "existence": "The information is recorded in stored summaries and citations for the seed-oil trial and separate seed-powder study. Current reading of external abstracts, full text, registrations and plans remains separately unverified.", "acquired_read": "Existing Korean and English stored summaries and bibliography for the oil and powder reports read; external abstracts, full text, registrations, protocols and analysis plans unread", "observation": "Participants are adults with asthma continuing inhaled maintenance therapy.", "condition_status": "Partly verified", "status_reason": "Stored information is linked to gaps in detailed material. External verification and clinical content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.", "missingness": "Detailed age, severity, baseline ACT, smoking, comorbidity, inclusion/exclusion and applicability to children remain unverified.", "uncertainty": "Gaps in product specifications, inhaled medicines, baseline scores, analysis denominators, missing-data handling, plans, support and harms remain. Significance is not converted into a large effect, nonsignificance into absence of effect or equivalence, or limited harm records into overall safety.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Population/baseline characteristics and selection tables" }, { "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.", "current_reports": [ "S01" ], "existence": "The information is recorded in stored summaries and citations for the seed-oil trial and separate seed-powder study. Current reading of external abstracts, full text, registrations and plans remains separately unverified.", "acquired_read": "Existing Korean and English stored summaries and bibliography for the oil and powder reports read; external abstracts, full text, registrations, protocols and analysis plans unread", "observation": "Oral capsules of fixed oil from Nigella sativa L. seeds are selected.", "condition_status": "Partly verified", "status_reason": "Stored information is linked to gaps in detailed material. External verification and clinical content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.", "missingness": "Composition specifications, extraction/manufacture, batch and marketed-product identity remain unverified; powder and purified thymoquinone are not substituted.", "uncertainty": "Gaps in product specifications, inhaled medicines, baseline scores, analysis denominators, missing-data handling, plans, support and harms remain. Significance is not converted into a large effect, nonsignificance into absence of effect or equivalence, or limited harm records into overall safety.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Product, manufacturing, composition and batch specifications" }, { "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.", "current_reports": [ "S01", "S02" ], "existence": "The information is recorded in stored summaries and citations for the seed-oil trial and separate seed-powder study. Current reading of external abstracts, full text, registrations and plans remains separately unverified.", "acquired_read": "Existing Korean and English stored summaries and bibliography for the oil and powder reports read; external abstracts, full text, registrations, protocols and analysis plans unread", "observation": "The preserved oil dose is500 mg2 times daily. Powder doses of1·2 g/day are not applied to oil.", "condition_status": "Partly verified", "status_reason": "Stored information is linked to gaps in detailed material. External verification and clinical content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.", "missingness": "Missed doses, adjustments and constituent exposure remain unverified; no new daily total is calculated.", "uncertainty": "Gaps in product specifications, inhaled medicines, baseline scores, analysis denominators, missing-data handling, plans, support and harms remain. Significance is not converted into a large effect, nonsignificance into absence of effect or equivalence, or limited harm records into overall safety.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Arm-specific use, adherence and product-composition records" }, { "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.", "current_reports": [ "S01" ], "existence": "The information is recorded in stored summaries and citations for the seed-oil trial and separate seed-powder study. Current reading of external abstracts, full text, registrations and plans remains separately unverified.", "acquired_read": "Existing Korean and English stored summaries and bibliography for the oil and powder reports read; external abstracts, full text, registrations, protocols and analysis plans unread", "observation": "Oil or placebo was added for4 weeks while inhaled maintenance therapy continued.", "condition_status": "Partly verified", "status_reason": "Stored information is linked to gaps in detailed material. External verification and clinical content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.", "missingness": "Specific inhalers, doses, changes, rescue treatment and arm-specific balance remain unverified; results are not attributed to oil monotherapy.", "uncertainty": "Gaps in product specifications, inhaled medicines, baseline scores, analysis denominators, missing-data handling, plans, support and harms remain. Significance is not converted into a large effect, nonsignificance into absence of effect or equivalence, or limited harm records into overall safety.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Inhaled medicines, changes, rescue treatment and adherence tables" }, { "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.", "current_reports": [ "S01" ], "existence": "The information is recorded in stored summaries and citations for the seed-oil trial and separate seed-powder study. Current reading of external abstracts, full text, registrations and plans remains separately unverified.", "acquired_read": "Existing Korean and English stored summaries and bibliography for the oil and powder reports read; external abstracts, full text, registrations, protocols and analysis plans unread", "observation": "The original wording describes matched-appearance placebo added to standard treatment.", "condition_status": "Partly verified", "status_reason": "Stored information is linked to gaps in detailed material. External verification and clinical content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.", "missingness": "Placebo ingredients, taste/smell, actual administration matching, maintained masking and unmasking remain unverified.", "uncertainty": "Gaps in product specifications, inhaled medicines, baseline scores, analysis denominators, missing-data handling, plans, support and harms remain. Significance is not converted into a large effect, nonsignificance into absence of effect or equivalence, or limited harm records into overall safety.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Placebo specifications and masking/unmasking records" }, { "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.", "current_reports": [ "S01" ], "existence": "The information is recorded in stored summaries and citations for the seed-oil trial and separate seed-powder study. Current reading of external abstracts, full text, registrations and plans remains separately unverified.", "acquired_read": "Existing Korean and English stored summaries and bibliography for the oil and powder reports read; external abstracts, full text, registrations, protocols and analysis plans unread", "observation": "The original design is randomized, double-blind and placebo-controlled, with80 randomized people.", "condition_status": "Partly verified", "status_reason": "Stored information is linked to gaps in detailed material. External verification and clinical content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.", "missingness": "Sequence generation, concealment, arm-specific baseline differences and initial allocation denominators remain unverified in the summary.", "uncertainty": "Gaps in product specifications, inhaled medicines, baseline scores, analysis denominators, missing-data handling, plans, support and harms remain. Significance is not converted into a large effect, nonsignificance into absence of effect or equivalence, or limited harm records into overall safety.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Allocation methods, baseline tables and participant flow" }, { "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.", "current_reports": [ "S01" ], "existence": "The information is recorded in stored summaries and citations for the seed-oil trial and separate seed-powder study. Current reading of external abstracts, full text, registrations and plans remains separately unverified.", "acquired_read": "Existing Korean and English stored summaries and bibliography for the oil and powder reports read; external abstracts, full text, registrations, protocols and analysis plans unread", "observation": "The selected endpoint is4-week ACT. The original Korean treatment4 weeks/follow-up4 weeks and English Four weeks of treatment and follow-up wording are retained.", "condition_status": "Partly verified", "status_reason": "Stored information is linked to gaps in detailed material. External verification and clinical content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.", "missingness": "No separate additional4 weeks or total8 weeks is newly calculated; follow-up definitions and post-discontinuation schedules remain unverified.", "uncertainty": "Gaps in product specifications, inhaled medicines, baseline scores, analysis denominators, missing-data handling, plans, support and harms remain. Significance is not converted into a large effect, nonsignificance into absence of effect or equivalence, or limited harm records into overall safety.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Visit, dosing, discontinuation and follow-up schedules" }, { "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.", "current_reports": [ "S01" ], "existence": "The information is recorded in stored summaries and citations for the seed-oil trial and separate seed-powder study. Current reading of external abstracts, full text, registrations and plans remains separately unverified.", "acquired_read": "Existing Korean and English stored summaries and bibliography for the oil and powder reports read; external abstracts, full text, registrations, protocols and analysis plans unread", "observation": "The endpoint is patient-reported symptom control on the4-week Asthma Control Test.", "condition_status": "Partly verified", "status_reason": "Stored information is linked to gaps in detailed material. External verification and clinical content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.", "missingness": "Version, baseline score, change, original explanation of scale direction and measurement completeness remain unverified; final values are not converted into changes.", "uncertainty": "Gaps in product specifications, inhaled medicines, baseline scores, analysis denominators, missing-data handling, plans, support and harms remain. Significance is not converted into a large effect, nonsignificance into absence of effect or equivalence, or limited harm records into overall safety.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "ACT methods, baseline/4-week results and respondent denominators" }, { "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.", "current_reports": [ "S01" ], "existence": "The information is recorded in stored summaries and citations for the seed-oil trial and separate seed-powder study. Current reading of external abstracts, full text, registrations and plans remains separately unverified.", "acquired_read": "Existing Korean and English stored summaries and bibliography for the oil and powder reports read; external abstracts, full text, registrations, protocols and analysis plans unread", "observation": "ACT21.1±2.6 versus19.6±3.7, P=.044 is retained as originally recorded.", "condition_status": "Partly verified", "status_reason": "Stored information is linked to gaps in detailed material. External verification and clinical content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.", "missingness": "The original ± definition, ACT analysis denominator, baseline adjustment, change and original CI remain unverified; no new difference or CI is calculated.", "uncertainty": "Gaps in product specifications, inhaled medicines, baseline scores, analysis denominators, missing-data handling, plans, support and harms remain. Significance is not converted into a large effect, nonsignificance into absence of effect or equivalence, or limited harm records into overall safety.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Endpoint-specific result tables, dispersion, adjustment and intervals" }, { "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.", "current_reports": [ "S01" ], "existence": "The information is recorded in stored summaries and citations for the seed-oil trial and separate seed-powder study. Current reading of external abstracts, full text, registrations and plans remains separately unverified.", "acquired_read": "Existing Korean and English stored summaries and bibliography for the oil and powder reports read; external abstracts, full text, registrations, protocols and analysis plans unread", "observation": "The original account describes a small absolute ACT contrast and a signal with limited robustness after attrition.", "condition_status": "Unverified", "status_reason": "Stored information is linked to gaps in detailed material. External verification and clinical content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.", "missingness": "Exact CI, minimum important difference and responder denominators/intervals remain unverified; a significant P value alone does not establish a large effect.", "uncertainty": "Gaps in product specifications, inhaled medicines, baseline scores, analysis denominators, missing-data handling, plans, support and harms remain. Significance is not converted into a large effect, nonsignificance into absence of effect or equivalence, or limited harm records into overall safety.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original effect/CI, important-difference rationale and responder results" }, { "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.", "current_reports": [ "S01" ], "existence": "The information is recorded in stored summaries and citations for the seed-oil trial and separate seed-powder study. Current reading of external abstracts, full text, registrations and plans remains separately unverified.", "acquired_read": "Existing Korean and English stored summaries and bibliography for the oil and powder reports read; external abstracts, full text, registrations, protocols and analysis plans unread", "observation": "FEV1 P=.170 and the original nonsignificant result remain alongside positive ACT.", "condition_status": "Partly verified", "status_reason": "Stored information is linked to gaps in detailed material. External verification and clinical content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.", "missingness": "FEV1 means, changes, units, denominators, CI and prespecified hierarchy remain unverified; nonsignificance is not converted into effect0 or equivalence.", "uncertainty": "Gaps in product specifications, inhaled medicines, baseline scores, analysis denominators, missing-data handling, plans, support and harms remain. Significance is not converted into a large effect, nonsignificance into absence of effect or equivalence, or limited harm records into overall safety.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original FEV1 results, denominators, intervals and plans" }, { "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.", "current_reports": [ "S01" ], "existence": "The information is recorded in stored summaries and citations for the seed-oil trial and separate seed-powder study. Current reading of external abstracts, full text, registrations and plans remains separately unverified.", "acquired_read": "Existing Korean and English stored summaries and bibliography for the oil and powder reports read; external abstracts, full text, registrations, protocols and analysis plans unread", "observation": "The selected account’s main endpoint is4-week ACT, with FEV1 kept separate. NCT02407262 appears in the original material.", "condition_status": "Unverified", "status_reason": "Stored information is linked to gaps in detailed material. External verification and clinical content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.", "missingness": "An identifier alone does not verify a prespecified1st endpoint or matching analysis; registry documents and original plans remain unread.", "uncertainty": "Gaps in product specifications, inhaled medicines, baseline scores, analysis denominators, missing-data handling, plans, support and harms remain. Significance is not converted into a large effect, nonsignificance into absence of effect or equivalence, or limited harm records into overall safety.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Registration history, protocol, SAP and all endpoints" }, { "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.", "current_reports": [ "S01" ], "existence": "The information is recorded in stored summaries and citations for the seed-oil trial and separate seed-powder study. Current reading of external abstracts, full text, registrations and plans remains separately unverified.", "acquired_read": "Existing Korean and English stored summaries and bibliography for the oil and powder reports read; external abstracts, full text, registrations, protocols and analysis plans unread", "observation": "80 randomized people and10 withdrawals per arm are preserved; the account’s25% attrition remains historical wording.", "condition_status": "Partly verified", "status_reason": "Stored information is linked to gaps in detailed material. External verification and clinical content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.", "missingness": "Completer/endpoint-specific denominators are not newly derived; arm-specific allocation, observed-data and imputed-data denominators remain unverified.", "uncertainty": "Gaps in product specifications, inhaled medicines, baseline scores, analysis denominators, missing-data handling, plans, support and harms remain. Significance is not converted into a large effect, nonsignificance into absence of effect or equivalence, or limited harm records into overall safety.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Arm-specific participant flow and endpoint analysis tables" }, { "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.", "current_reports": [ "S01" ], "existence": "The information is recorded in stored summaries and citations for the seed-oil trial and separate seed-powder study. Current reading of external abstracts, full text, registrations and plans remains separately unverified.", "acquired_read": "Existing Korean and English stored summaries and bibliography for the oil and powder reports read; external abstracts, full text, registrations, protocols and analysis plans unread", "observation": "The original design reports ITT, but there were10 withdrawals per arm.", "condition_status": "Unverified", "status_reason": "Stored information is linked to gaps in detailed material. External verification and clinical content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.", "missingness": "An ITT label does not establish robustness; specific missing-data handling, withdrawal reasons and sensitivity remain unverified.", "uncertainty": "Gaps in product specifications, inhaled medicines, baseline scores, analysis denominators, missing-data handling, plans, support and harms remain. Significance is not converted into a large effect, nonsignificance into absence of effect or equivalence, or limited harm records into overall safety.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "ITT/missing-data methods, withdrawal reasons and sensitivity results" }, { "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.", "current_reports": [ "S01" ], "existence": "The information is recorded in stored summaries and citations for the seed-oil trial and separate seed-powder study. Current reading of external abstracts, full text, registrations and plans remains separately unverified.", "acquired_read": "Existing Korean and English stored summaries and bibliography for the oil and powder reports read; external abstracts, full text, registrations, protocols and analysis plans unread", "observation": "The description of adjunctive use with common inhaled maintenance therapy is retained.", "condition_status": "Unverified", "status_reason": "Stored information is linked to gaps in detailed material. External verification and clinical content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.", "missingness": "Rescue medication, actual adherence, deviations, exacerbation-related changes and analytical handling remain unverified.", "uncertainty": "Gaps in product specifications, inhaled medicines, baseline scores, analysis denominators, missing-data handling, plans, support and harms remain. Significance is not converted into a large effect, nonsignificance into absence of effect or equivalence, or limited harm records into overall safety.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Adherence, rescue-medication and treatment-change tables" }, { "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.", "current_reports": [ "S02" ], "existence": "The information is recorded in stored summaries and citations for the seed-oil trial and separate seed-powder study. Current reading of external abstracts, full text, registrations and plans remains separately unverified.", "acquired_read": "Existing Korean and English stored summaries and bibliography for the oil and powder reports read; external abstracts, full text, registrations, protocols and analysis plans unread", "observation": "The single-blind3-arm placebo study records76 randomized people,24/26/26 and ACT improvement at12 weeks in1·2 g/day powder groups.", "condition_status": "Partly verified", "status_reason": "Stored information is linked to gaps in detailed material. External verification and clinical content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.", "missingness": "Exact effects/CI, arm mapping, endpoint denominators and funding verification remain limited;4-week oil values are not used to fill them.", "uncertainty": "Gaps in product specifications, inhaled medicines, baseline scores, analysis denominators, missing-data handling, plans, support and harms remain. Significance is not converted into a large effect, nonsignificance into absence of effect or equivalence, or limited harm records into overall safety.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Powder-study results, group composition, denominators and plans" }, { "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.", "current_reports": [ "S01", "S02" ], "existence": "The information is recorded in stored summaries and citations for the seed-oil trial and separate seed-powder study. Current reading of external abstracts, full text, registrations and plans remains separately unverified.", "acquired_read": "Existing Korean and English stored summaries and bibliography for the oil and powder reports read; external abstracts, full text, registrations, protocols and analysis plans unread", "observation": "The account does not count powder as independent oil replication because formulation, dose and duration differ.", "condition_status": "Unverified", "status_reason": "Stored information is linked to gaps in detailed material. External verification and clinical content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.", "missingness": "The current two reports are not converted into same-formulation replication counts or a current complete study total.", "uncertainty": "Gaps in product specifications, inhaled medicines, baseline scores, analysis denominators, missing-data handling, plans, support and harms remain. Significance is not converted into a large effect, nonsignificance into absence of effect or equivalence, or limited harm records into overall safety.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Direct same-oil trials and related-report list" }, { "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.", "current_reports": [ "S01", "S02" ], "existence": "The information is recorded in stored summaries and citations for the seed-oil trial and separate seed-powder study. Current reading of external abstracts, full text, registrations and plans remains separately unverified.", "acquired_read": "Existing Korean and English stored summaries and bibliography for the oil and powder reports read; external abstracts, full text, registrations, protocols and analysis plans unread", "observation": "The selected oil question is500 mg2 times daily and4-week ACT. 12-week powder results are not substituted for long-term oil data.", "condition_status": "Unverified", "status_reason": "Stored information is linked to gaps in detailed material. External verification and clinical content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.", "missingness": "Other oil doses, long-term persistence, post-discontinuation effects and prespecified subgroups remain unverified.", "uncertainty": "Gaps in product specifications, inhaled medicines, baseline scores, analysis denominators, missing-data handling, plans, support and harms remain. Significance is not converted into a large effect, nonsignificance into absence of effect or equivalence, or limited harm records into overall safety.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Same-oil dose/follow-up and prespecified-subgroup material" }, { "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.", "current_reports": [ "S01" ], "existence": "The information is recorded in stored summaries and citations for the seed-oil trial and separate seed-powder study. Current reading of external abstracts, full text, registrations and plans remains separately unverified.", "acquired_read": "Existing Korean and English stored summaries and bibliography for the oil and powder reports read; external abstracts, full text, registrations, protocols and analysis plans unread", "observation": "The account says ACT is not the same as preventing exacerbations/admissions and that inhaler replacement or attack/admission prevention was not tested.", "condition_status": "Unverified", "status_reason": "Stored information is linked to gaps in detailed material. External verification and clinical content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.", "missingness": "Positive ACT is not extended into evidence for fewer exacerbations/admissions or stopping inhalers.", "uncertainty": "Gaps in product specifications, inhaled medicines, baseline scores, analysis denominators, missing-data handling, plans, support and harms remain. Significance is not converted into a large effect, nonsignificance into absence of effect or equivalence, or limited harm records into overall safety.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Separate clinical events, periods, denominators and replacement designs" }, { "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.", "current_reports": [ "S01" ], "existence": "The information is recorded in stored summaries and citations for the seed-oil trial and separate seed-powder study. Current reading of external abstracts, full text, registrations and plans remains separately unverified.", "acquired_read": "Existing Korean and English stored summaries and bibliography for the oil and powder reports read; external abstracts, full text, registrations, protocols and analysis plans unread", "observation": "UK Medical Research Council grant G106/1249 is preserved. The account’s independent-funding description is a historical verdict record.", "condition_status": "Partly verified", "status_reason": "Stored information is linked to gaps in detailed material. External verification and clinical content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.", "missingness": "Original funding documents, sponsor roles and current independence comparisons remain unread; funding alone does not establish absence of bias.", "uncertainty": "Gaps in product specifications, inhaled medicines, baseline scores, analysis denominators, missing-data handling, plans, support and harms remain. Significance is not converted into a large effect, nonsignificance into absence of effect or equivalence, or limited harm records into overall safety.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original funding and sponsor-role documents" }, { "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.", "current_reports": [ "S01", "S02" ], "existence": "The information is recorded in stored summaries and citations for the seed-oil trial and separate seed-powder study. Current reading of external abstracts, full text, registrations and plans remains separately unverified.", "acquired_read": "Existing Korean and English stored summaries and bibliography for the oil and powder reports read; external abstracts, full text, registrations, protocols and analysis plans unread", "observation": "Powder funding has limited verification. General English wording for both reports is preserved in its original form.", "condition_status": "Unverified", "status_reason": "Stored information is linked to gaps in detailed material. External verification and clinical content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.", "missingness": "Product/free support, employee authors, patents and COI are not verified merely by the MRC grant or assessed separately wording.", "uncertainty": "Gaps in product specifications, inhaled medicines, baseline scores, analysis denominators, missing-data handling, plans, support and harms remain. Significance is not converted into a large effect, nonsignificance into absence of effect or equivalence, or limited harm records into overall safety.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Support, manufacture, employment and COI specifications for each report" }, { "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.", "current_reports": [ "S01" ], "existence": "The information is recorded in stored summaries and citations for the seed-oil trial and separate seed-powder study. Current reading of external abstracts, full text, registrations and plans remains separately unverified.", "acquired_read": "Existing Korean and English stored summaries and bibliography for the oil and powder reports read; external abstracts, full text, registrations, protocols and analysis plans unread", "observation": "The original Caution state and statement that small studies cannot exclude rare/long-term harms are retained.", "condition_status": "Unverified", "status_reason": "Stored information is linked to gaps in detailed material. External verification and clinical content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.", "missingness": "Arm-specific adverse events, collection, severity, discontinuation and denominators remain unverified; ACT improvement does not establish safety.", "uncertainty": "Gaps in product specifications, inhaled medicines, baseline scores, analysis denominators, missing-data handling, plans, support and harms remain. Significance is not converted into a large effect, nonsignificance into absence of effect or equivalence, or limited harm records into overall safety.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Arm-specific event/discontinuation tables and collection methods" }, { "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.", "current_reports": [ "S01" ], "existence": "The information is recorded in stored summaries and citations for the seed-oil trial and separate seed-powder study. Current reading of external abstracts, full text, registrations and plans remains separately unverified.", "acquired_read": "Existing Korean and English stored summaries and bibliography for the oil and powder reports read; external abstracts, full text, registrations, protocols and analysis plans unread", "observation": "Inhaled maintenance therapy is linked to the original product/medication caution wording.", "condition_status": "Unverified", "status_reason": "Stored information is linked to gaps in detailed material. External verification and clinical content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.", "missingness": "Specific interactions, improvement after withdrawal, re-exposure, causality and comparative risk remain unverified; no new harm judgment is created.", "uncertainty": "Gaps in product specifications, inhaled medicines, baseline scores, analysis denominators, missing-data handling, plans, support and harms remain. Significance is not converted into a large effect, nonsignificance into absence of effect or equivalence, or limited harm records into overall safety.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Cointerventions, event timelines, withdrawal/recovery and alternative-cause material" }, { "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.", "current_reports": [ "S01" ], "existence": "The information is recorded in stored summaries and citations for the seed-oil trial and separate seed-powder study. Current reading of external abstracts, full text, registrations and plans remains separately unverified.", "acquired_read": "Existing Korean and English stored summaries and bibliography for the oil and powder reports read; external abstracts, full text, registrations, protocols and analysis plans unread", "observation": "Original wording on product differences, vulnerable groups, surgery and medicines is preserved.", "condition_status": "Unverified", "status_reason": "Stored information is linked to gaps in detailed material. External verification and clinical content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.", "missingness": "Adult4-week material is not extended to safety in all vulnerable groups or absence of rare/long-term harms.", "uncertainty": "Gaps in product specifications, inhaled medicines, baseline scores, analysis denominators, missing-data handling, plans, support and harms remain. Significance is not converted into a large effect, nonsignificance into absence of effect or equivalence, or limited harm records into overall safety.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Long-term/population-specific exposure, harm and interaction material" }, { "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.", "current_reports": [ "S01", "S02" ], "existence": "The information is recorded in stored summaries and citations for the seed-oil trial and separate seed-powder study. Current reading of external abstracts, full text, registrations and plans remains separately unverified.", "acquired_read": "Existing Korean and English stored summaries and bibliography for the oil and powder reports read; external abstracts, full text, registrations, protocols and analysis plans unread", "observation": "C50, original assessment values, historical independent cross-checking wording and empty subclaim/deliberation records are preserved.", "condition_status": "Partly verified", "status_reason": "Stored information is linked to gaps in detailed material. External verification and clinical content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.", "missingness": "Past I2/R1 values are not inherited as current condition fulfilment, completed user review or independent-replication certification.", "uncertainty": "Gaps in product specifications, inhaled medicines, baseline scores, analysis denominators, missing-data handling, plans, support and harms remain. Significance is not converted into a large effect, nonsignificance into absence of effect or equivalence, or limited harm records into overall safety.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Separate history of original verdict and change events" }, { "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.", "current_reports": [ "S01", "S02" ], "existence": "The information is recorded in stored summaries and citations for the seed-oil trial and separate seed-powder study. Current reading of external abstracts, full text, registrations and plans remains separately unverified.", "acquired_read": "Existing Korean and English stored summaries and bibliography for the oil and powder reports read; external abstracts, full text, registrations, protocols and analysis plans unread", "observation": "The original verdict date2026-09-08,2-field English correction2026-09-14 with C retained, and current specific/general English wording are preserved. This is a production date with user review pending.", "condition_status": "Partly verified", "status_reason": "Stored information is linked to gaps in detailed material. External verification and clinical content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.", "missingness": "General verified/assessed expressions are not inherited as current full-text verification; withdrawals, new literature and registrations have not been searched.", "uncertainty": "Gaps in product specifications, inhaled medicines, baseline scores, analysis denominators, missing-data handling, plans, support and harms remain. Significance is not converted into a large effect, nonsignificance into absence of effect or equivalence, or limited harm records into overall safety.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Before/after correction records, additional material and user comments" } ], "reports": [ { "report_id": "S01", "title": "Koshak et al. 2017 · Adjunctive seed-oil trial", "url": "https://pubmed.ncbi.nlm.nih.gov/28093815/", "report_type": "Randomized double-blind placebo-controlled trial; ITT reported", "existence": "The information is recorded in stored summaries and citations for the seed-oil trial and separate seed-powder study. Current reading of external abstracts, full text, registrations and plans remains separately unverified.", "acquired_read": "Summary read; external material unread", "study_family": "TF3027-01", "independent_replication": null, "observed_result": "ACT 21.1±2.6 versus 19.6±3.7, P=.044; FEV1 P=.170", "result_level": "80 people were randomized, with 10 withdrawals per arm. Completer, endpoint-specific and imputed-data denominators remain unverified.", "source_evidence_date": "2026-09-08", "materials": [ { "material_type": "Stored existing review summary", "public_status": "Preserved copy of the complete existing review summary", "access_status": "Stored summary", "acquired": true, "actually_read": "Summary read", "as_of": "2026-09-08", "qualification": "PMID28093815; DOI10.1002/ptr.5761; the citation’s NCT02407262 identifier is retained. Registry documents, prespecified hierarchy, external abstracts, full text and plans remain unread here. MRC grant G106/1249 is an original record, not a substitute for verifying product support, employee authors or COI. Original material-specific dates and absent dates are retained without conversion into current external-reading dates." }, { "material_type": "External paper", "public_status": "Original bibliographic link or needed material; external public availability/access status unverified", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-09-08", "qualification": "PMID28093815; DOI10.1002/ptr.5761; the citation’s NCT02407262 identifier is retained. Registry documents, prespecified hierarchy, external abstracts, full text and plans remain unread here. MRC grant G106/1249 is an original record, not a substitute for verifying product support, employee authors or COI. Original material-specific dates and absent dates are retained without conversion into current external-reading dates." }, { "material_type": "Registration material", "public_status": "Original bibliographic link or needed material; external public availability/access status unverified", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-09-08", "qualification": "PMID28093815; DOI10.1002/ptr.5761; the citation’s NCT02407262 identifier is retained. Registry documents, prespecified hierarchy, external abstracts, full text and plans remain unread here. MRC grant G106/1249 is an original record, not a substitute for verifying product support, employee authors or COI. Original material-specific dates and absent dates are retained without conversion into current external-reading dates." }, { "material_type": "Protocol", "public_status": "Original bibliographic link or needed material; external public availability/access status unverified", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-09-08", "qualification": "PMID28093815; DOI10.1002/ptr.5761; the citation’s NCT02407262 identifier is retained. Registry documents, prespecified hierarchy, external abstracts, full text and plans remain unread here. MRC grant G106/1249 is an original record, not a substitute for verifying product support, employee authors or COI. Original material-specific dates and absent dates are retained without conversion into current external-reading dates." }, { "material_type": "Statistical analysis plan", "public_status": "Original bibliographic link or needed material; external public availability/access status unverified", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-09-08", "qualification": "PMID28093815; DOI10.1002/ptr.5761; the citation’s NCT02407262 identifier is retained. Registry documents, prespecified hierarchy, external abstracts, full text and plans remain unread here. MRC grant G106/1249 is an original record, not a substitute for verifying product support, employee authors or COI. Original material-specific dates and absent dates are retained without conversion into current external-reading dates." }, { "material_type": "Funding, product support and COI material", "public_status": "Original bibliographic link or needed material; external public availability/access status unverified", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-09-08", "qualification": "PMID28093815; DOI10.1002/ptr.5761; the citation’s NCT02407262 identifier is retained. Registry documents, prespecified hierarchy, external abstracts, full text and plans remain unread here. MRC grant G106/1249 is an original record, not a substitute for verifying product support, employee authors or COI. Original material-specific dates and absent dates are retained without conversion into current external-reading dates." } ], "links": [ { "label": "PubMed", "url": "https://pubmed.ncbi.nlm.nih.gov/28093815/" } ] }, { "report_id": "S02", "title": "Salem et al. 2017 · Separate seed-powder study", "url": "https://pubmed.ncbi.nlm.nih.gov/28151459/", "report_type": "Single-blind 3-arm placebo-controlled study", "existence": "The information is recorded in stored summaries and citations for the seed-oil trial and separate seed-powder study. Current reading of external abstracts, full text, registrations and plans remains separately unverified.", "acquired_read": "Summary read; external material unread", "study_family": "TF3027-02", "independent_replication": null, "observed_result": "ACT improvement reported in the 1·2 g/day powder groups; not direct seed-oil replication", "result_level": "The original record is 76 randomized people; 24/26/26. Arm mapping and endpoint analysis denominators remain unverified.", "source_evidence_date": "2026-09-08", "materials": [ { "material_type": "Stored existing review summary", "public_status": "Preserved copy of the complete existing review summary", "access_status": "Stored summary", "acquired": true, "actually_read": "Summary read", "as_of": "2026-09-08", "qualification": "PMID28151459; PMCIDPMC6148976; DOI10.5144/0256-4947.2017.64; the citation’s ISRCTN48853858 identifier is retained. This is a powder report; current registry documents, abstracts, full text, plans, funding, product support and COI remain unread. Original material-specific dates and absent dates are retained without conversion into current external-reading dates." }, { "material_type": "External paper", "public_status": "Original bibliographic link or needed material; external public availability/access status unverified", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-09-08", "qualification": "PMID28151459; PMCIDPMC6148976; DOI10.5144/0256-4947.2017.64; the citation’s ISRCTN48853858 identifier is retained. This is a powder report; current registry documents, abstracts, full text, plans, funding, product support and COI remain unread. Original material-specific dates and absent dates are retained without conversion into current external-reading dates." }, { "material_type": "Registration material", "public_status": "Original bibliographic link or needed material; external public availability/access status unverified", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-09-08", "qualification": "PMID28151459; PMCIDPMC6148976; DOI10.5144/0256-4947.2017.64; the citation’s ISRCTN48853858 identifier is retained. This is a powder report; current registry documents, abstracts, full text, plans, funding, product support and COI remain unread. Original material-specific dates and absent dates are retained without conversion into current external-reading dates." }, { "material_type": "Protocol", "public_status": "Original bibliographic link or needed material; external public availability/access status unverified", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-09-08", "qualification": "PMID28151459; PMCIDPMC6148976; DOI10.5144/0256-4947.2017.64; the citation’s ISRCTN48853858 identifier is retained. This is a powder report; current registry documents, abstracts, full text, plans, funding, product support and COI remain unread. Original material-specific dates and absent dates are retained without conversion into current external-reading dates." }, { "material_type": "Statistical analysis plan", "public_status": "Original bibliographic link or needed material; external public availability/access status unverified", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-09-08", "qualification": "PMID28151459; PMCIDPMC6148976; DOI10.5144/0256-4947.2017.64; the citation’s ISRCTN48853858 identifier is retained. This is a powder report; current registry documents, abstracts, full text, plans, funding, product support and COI remain unread. Original material-specific dates and absent dates are retained without conversion into current external-reading dates." }, { "material_type": "Funding, product support and COI material", "public_status": "Original bibliographic link or needed material; external public availability/access status unverified", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-09-08", "qualification": "PMID28151459; PMCIDPMC6148976; DOI10.5144/0256-4947.2017.64; the citation’s ISRCTN48853858 identifier is retained. This is a powder report; current registry documents, abstracts, full text, plans, funding, product support and COI remain unread. Original material-specific dates and absent dates are retained without conversion into current external-reading dates." } ], "links": [ { "label": "PubMed", "url": "https://pubmed.ncbi.nlm.nih.gov/28151459/" } ] } ], "method_sources": [ { "id": "M03", "version": "Cochrane Handbook 6.5 (2024), chapter updated 2023-08", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-03", "section": "§3.1, §3.2.1–3.2.3, MECIR C5/C7/C13", "official_principle": "Clearly record the question, eligibility conditions and reasons for changes, and distinguish variations in interventions.", "review_level": "Existing methodological links were reused for production. External originals were not reread and methodological content was not reassessed." }, { "id": "M04", "version": "Cochrane Handbook 6.5.1 (2025), chapter updated 2025-03", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-04", "section": "§4.5, §4.6.1–4.6.3, MECIR C42", "official_principle": "Distinguish studies from reports and link them; do not omit a study solely because results are unreported.", "review_level": "Existing methodological links were reused for production. External originals were not reread and methodological content was not reassessed." }, { "id": "M08", "version": "Cochrane Handbook 6.5 (2024), chapter updated 2019-10", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-08", "section": "§8.1–8.2.3, Table 8.2.a", "official_principle": "Define the outcome and effect of interest, then examine randomization, deviations, missing data, measurement and selective reporting.", "review_level": "Existing methodological links were reused for production. External originals were not reread and methodological content was not reassessed." }, { "id": "M15", "version": "Cochrane Handbook 6.5 (2024), chapter updated 2023-08", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-15", "section": "§15.2.4, §15.3.1–15.3.3", "official_principle": "Distinguish effect estimates, intervals, importance and applicability. Sample size alone does not determine precision.", "review_level": "Existing methodological links were reused for production. External originals were not reread and methodological content was not reassessed." }, { "id": "M19", "version": "Cochrane Handbook 6.5 (2024), chapter updated 2019-10", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-19", "section": "§19.1.2, §19.2.1–19.2.4", "official_principle": "Harm questions may require different designs, populations and follow-up from efficacy questions. Case reports do not establish incidence rates.", "review_level": "Existing methodological links were reused for production. External originals were not reread and methodological content was not reassessed." } ], "status_dictionary": { "Partly verified": "Partial information from the stored summary is linked; detailed originals and content review remain incomplete.", "Unverified": "Required details cannot be established within the preserved scope. This does not establish absence of effects or studies, or safety.", "Review incomplete": "Review of existing content remains incomplete.", "Met": "This state is used only within the relevant conditions after material verification and content review. It was not automatically assigned in this work.", "Not reported": "Unreported within material actually read. Unread external material is not relabeled as unreported.", "Inaccessible": "This means actual access failure. External access was not attempted in this work, so this state was not assigned.", "Not applicable": "Used only with an application exception and reason based on the question scope.", "Conflicting data": "This requires actual comparison of materials; no new conflict judgment was made in this work.", "Insufficient evidence for the conditions": "This indicates gaps in additional material for the selected conditions. Unread material as a whole is not converted into an efficacy grade." }, "study_overlap": { "state": "Unverified", "unique_trial_count": null, "unique_participant_count": null, "reason": "The two reports remain distinct as adjunctive seed oil and seed powder with a different formulation, dose and duration. Sharing the ACT name does not establish independent oil replication or unique trial/participant totals." }, "history": [ { "date": "2026-10-23", "kind": "Separation of public-facing pages and materials", "view_version": "1.0", "change": "The public view and materials were prepared from the existing 31 items. No new clinical search, verification-state change or scoring was performed." } ], "language": "en", "translation_date": "2026-10-23" }