Oral Nigella sativa seed oil as adjunctive therapy × Improved ACT symptom control in adults continuing inhaled asthma therapy

Required evidence, verification status and materials actually read
Item	AVerification status	BReading scope	CReview item	DCurrent findings	EWhy unverified	FRequired materials and conditions	GFurther research
1	Partly verified	Full text not readStored summary read	N01 · Evidence conditionWhat is the exact original claim scope?Required	The selected claim is improved ACT symptom control in adults continuing inhaled asthma therapy. It concerns adjunctive oral seed oil. S01 S02	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.	Seed oil, adults with asthma on inhaled maintenance therapy,4-week ACT and placebo add-on question	Material needed: Original material for the same population, formulation, comparison and endpoint This records needed materials; no new research was executed.
2	Partly verified	Full text not readStored summary read	N02 · Evidence conditionWhat material was actually read?Required	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. S01 S02	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.	Distinguishing stored summaries from external papers, registration and plans	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.
3	Partly verified	Full text not readStored summary read	N03 · Evidence conditionWhat identifies the seed-oil report?Required	Koshak A et al., Phytother Res2017, PMID28093815, DOI10.1002/ptr.5761 and NCT02407262 are preserved. S01	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.	Title, authors, year, PMID/DOI and registration identity	Material needed: Complete original citation, registration history and related-report list This records needed materials; no new research was executed.
4	Partly verified	Full text not readStored summary read	N04 · Evidence conditionIs the seed-powder report the same oil replication?Required	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. S02	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.	Distinguishing powder, dose,12 weeks, registration and study families	Material needed: Study specifications and registration/report mapping for each formulation This records needed materials; no new research was executed.
5	Partly verified	Full text not readStored summary read	N05 · Evidence conditionAre reports, trials and participants kept separate?Required	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. S01 S02	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.	Report/family relationships for80-person oil and76-person powder studies	Material needed: Study-specific participant flow and related-report relationships This records needed materials; no new research was executed.
6	Partly verified	Full text not readStored summary read	N06 · Evidence conditionWhich adults with asthma are represented?Required	Participants are adults with asthma continuing inhaled maintenance therapy. S01	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.	Asthma diagnosis, severity, baseline control, age and inclusion/exclusion	Material needed: Population/baseline characteristics and selection tables This records needed materials; no new research was executed.
7	Partly verified	Full text not readStored summary read	N07 · Evidence conditionWhich seed oil is represented?Required	Oral capsules of fixed oil from Nigella sativa L. seeds are selected. S01	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.	Fixed seed-oil capsules, composition, extraction/manufacture and batch	Material needed: Product, manufacturing, composition and batch specifications This records needed materials; no new research was executed.
8	Partly verified	Full text not readStored summary read	N08 · Evidence conditionWhat were the oil dose and actual use?Required	The preserved oil dose is500 mg2 times daily. Powder doses of1·2 g/day are not applied to oil. S01 S02	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.	500 mg2 times daily, dosing interval, actual amount and adherence	Material needed: Arm-specific use, adherence and product-composition records This records needed materials; no new research was executed.
9	Partly verified	Full text not readStored summary read	N09 · Evidence conditionIs this an effect added to inhaled maintenance therapy?Required	Oil or placebo was added for4 weeks while inhaled maintenance therapy continued. S01	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.	Common inhaled medicines, doses, arm-specific changes and adjunctive contribution	Material needed: Inhaled medicines, changes, rescue treatment and adherence tables This records needed materials; no new research was executed.
10	Partly verified	Full text not readStored summary read	N10 · Evidence conditionWhat were the placebo conditions?Required	The original wording describes matched-appearance placebo added to standard treatment. S01	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.	Matched appearance, ingredients, administration, common therapy and masking	Material needed: Placebo specifications and masking/unmasking records This records needed materials; no new research was executed.
11	Partly verified	Full text not readStored summary read	N11 · Evidence conditionWhat was the actual allocation process?Required	The original design is randomized, double-blind and placebo-controlled, with80 randomized people. S01	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.	Random sequence generation, concealment, baseline balance and allocation denominators	Material needed: Allocation methods, baseline tables and participant flow This records needed materials; no new research was executed.
12	Partly verified	Full text not readStored summary read	N12 · Evidence conditionHow are treatment and follow-up periods defined?Required	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. S01	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.	Treatment4 weeks, follow-up4 weeks, assessment schedules and post-discontinuation observation	Material needed: Visit, dosing, discontinuation and follow-up schedules This records needed materials; no new research was executed.
13	Partly verified	Full text not readStored summary read	N13 · Evidence conditionWhat does ACT measure?Required	The endpoint is patient-reported symptom control on the4-week Asthma Control Test. S01	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.	Asthma Control Test, scale/direction, respondents, final values/changes and timing	Material needed: ACT methods, baseline/4-week results and respondent denominators This records needed materials; no new research was executed.
14	Partly verified	Full text not readStored summary read	N14 · Evidence conditionWhat are the4-week ACT results?Required	ACT21.1±2.6 versus19.6±3.7, P=.044 is retained as originally recorded. S01	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.	Oil/placebo final values, dispersion, denominators and testing	Material needed: Endpoint-specific result tables, dispersion, adjustment and intervals This records needed materials; no new research was executed.
15	Unverified	Full text not readStored summary read	N15 · Evidence conditionWhat is the clinical importance of the small ACT contrast?Required	The original account describes a small absolute ACT contrast and a signal with limited robustness after attrition. S01	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.	Effect/CI, justified important difference and responder criteria	Material needed: Original effect/CI, important-difference rationale and responder results This records needed materials; no new research was executed.
16	Partly verified	Full text not readStored summary read	N16 · Evidence conditionIs the FEV1 result preserved alongside ACT?Required	FEV1 P=.170 and the original nonsignificant result remain alongside positive ACT. S01	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.	Separate FEV1 and ACT endpoints, units, denominators and timing	Material needed: Original FEV1 results, denominators, intervals and plans This records needed materials; no new research was executed.
17	Unverified	Full text not readStored summary read	N17 · Evidence conditionWhat is the prespecified ACT/FEV1 hierarchy?Required	The selected account’s main endpoint is4-week ACT, with FEV1 kept separate. NCT02407262 appears in the original material. S01	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.	Registry, protocol and SAP endpoints, timing, analysis and changes	Material needed: Registration history, protocol, SAP and all endpoints This records needed materials; no new research was executed.
18	Partly verified	Full text not readStored summary read	N18 · Evidence conditionWhat are the80-person allocation and post-attrition denominators?Required	80 randomized people and10 withdrawals per arm are preserved; the account’s25% attrition remains historical wording. S01	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.	Arm-specific allocation, measurement, completion, ACT/FEV1 and ITT denominators	Material needed: Arm-specific participant flow and endpoint analysis tables This records needed materials; no new research was executed.
19	Unverified	Full text not readStored summary read	N19 · Evidence conditionHow were missing data handled in the reported ITT?Required	The original design reports ITT, but there were10 withdrawals per arm. S01	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.	ITT definition, imputation/estimation, withdrawal reasons and sensitivity analysis	Material needed: ITT/missing-data methods, withdrawal reasons and sensitivity results This records needed materials; no new research was executed.
20	Unverified	Full text not readStored summary read	N20 · Evidence conditionWhat are adherence, rescue medicines and treatment deviations?Required	The description of adjunctive use with common inhaled maintenance therapy is retained. S01	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.	Oil/placebo adherence, inhaled-therapy changes, rescue medication and exacerbations	Material needed: Adherence, rescue-medication and treatment-change tables This records needed materials; no new research was executed.
21	Partly verified	Full text not readStored summary read	N21 · Evidence conditionWhat do the powder-study results cover?Required	The single-blind3-arm placebo study records76 randomized people,24/26/26 and ACT improvement at12 weeks in1·2 g/day powder groups. S02	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.	Powder1/2 g,12-week ACT,3 arms, denominators and plans	Material needed: Powder-study results, group composition, denominators and plans This records needed materials; no new research was executed.
22	Unverified	Full text not readStored summary read	N22 · Evidence conditionWhat independent replication concerns the same oil?Required	The account does not count powder as independent oil replication because formulation, dose and duration differ. S01 S02	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.	Unique families for the same formulation, population, comparison and4-week ACT	Material needed: Direct same-oil trials and related-report list This records needed materials; no new research was executed.
23	Unverified	Full text not readStored summary read	N23 · Evidence conditionWhat would answer dose and long-term persistence questions?Required	The selected oil question is500 mg2 times daily and4-week ACT. 12-week powder results are not substituted for long-term oil data. S01 S02	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.	Direct oil dose, long-term/post-discontinuation outcomes and subgroups	Material needed: Same-oil dose/follow-up and prespecified-subgroup material This records needed materials; no new research was executed.
24	Unverified	Full text not readStored summary read	N24 · Evidence conditionDoes this establish exacerbation, attack or admission prevention or inhaler replacement?Required	The account says ACT is not the same as preventing exacerbations/admissions and that inhaler replacement or attack/admission prevention was not tested. S01	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.	Boundaries between ACT, separate clinical events and replacement treatment	Material needed: Separate clinical events, periods, denominators and replacement designs This records needed materials; no new research was executed.
25	Partly verified	Full text not readStored summary read	N25 · Evidence conditionWhat records the oil-study funding?Required	UK Medical Research Council grant G106/1249 is preserved. The account’s independent-funding description is a historical verdict record. S01	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.	Reported funding, sponsor roles and independence level	Material needed: Original funding and sponsor-role documents This records needed materials; no new research was executed.
26	Unverified	Full text not readStored summary read	N26 · Evidence conditionWhat are powder funding and product support/COI for both reports?Required	Powder funding has limited verification. General English wording for both reports is preserved in its original form. S01 S02	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.	Separate original funding, product provision, employee authorship, patent and COI records	Material needed: Support, manufacture, employment and COI specifications for each report This records needed materials; no new research was executed.
27	Unverified	Full text not readStored summary read	N27 · Evidence conditionHow were adverse events collected?Supplementary	The original Caution state and statement that small studies cannot exclude rare/long-term harms are retained. S01	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.	Events, collection, discontinuation and denominators for the same adult oil exposure	Material needed: Arm-specific event/discontinuation tables and collection methods This records needed materials; no new research was executed.
28	Unverified	Full text not readStored summary read	N28 · Evidence conditionWhat are co-medication, event timing and harm attribution?Supplementary	Inhaled maintenance therapy is linked to the original product/medication caution wording. S01	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.	Inhaled medicines, baseline asthma, cointerventions, onset/recovery and alternatives	Material needed: Cointerventions, event timelines, withdrawal/recovery and alternative-cause material This records needed materials; no new research was executed.
29	Unverified	Full text not readStored summary read	N29 · Evidence conditionWhat are long-term/rare harms and other vulnerable groups?Supplementary	Original wording on product differences, vulnerable groups, surgery and medicines is preserved. S01	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.	Direct long-term exposure, pregnancy/breastfeeding, children and liver/kidney material	Material needed: Long-term/population-specific exposure, harm and interaction material This records needed materials; no new research was executed.
30	Partly verified	Full text not readStored summary read	N30 · Evidence conditionWhat is the history of C50, assessment values and past validation?Required	C50, original assessment values, historical independent cross-checking wording and empty subclaim/deliberation records are preserved. S01 S02	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.	Original grade, score, assessment values, original states and change history	Material needed: Separate history of original verdict and change events This records needed materials; no new research was executed.
31	Partly verified	Full text not readStored summary read	N31 · Evidence conditionWhat are the boundaries of English wording, corrections and the original evidence date?Required	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. S01 S02	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.	Korean/English wording,2026-09-08,09-14 correction and production-date distinctions	Material needed: Before/after correction records, additional material and user comments This records needed materials; no new research was executed.

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31 itemsWhat the statuses mean

Assessment scope

Stored-material review date: Not recorded
Original evidence cut-off: 2026-09-08
Scope actually checked: Existing review summaries and stored records of methodological application. Full papers, supplements, registrations, plans and original data were not read.
What the dates mean: This is the date the stored materials were checked, not the date of a new search of the clinical literature.
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.
Ingredient, formulation and route: 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.
Measured outcome: 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.
Questions outside this scope: 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.

Evidence and sources

The links below lead to the sources. A link alone does not mean the original source was read or its latest publication status verified.

S01 · Koshak et al. 2017 · Adjunctive seed-oil trial

PubMed

Material type: Randomized double-blind placebo-controlled trial; ITT reported
Materials actually read: Summary read; external material unread
Findings recorded in the stored summary: ACT 21.1±2.6 versus 19.6±3.7, P=.044; FEV1 P=.170
Record level: 80 people were randomized, with 10 withdrawals per arm. Completer, endpoint-specific and imputed-data denominators remain unverified.
Study overlap and independent replication: 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.

Public availability, access and reading status by material
Material	Public availability	Access status	Actually read	Notes
Stored existing review summary	Preserved copy of the complete existing review summary	Stored summary	Summary read	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.
External paper	Original bibliographic link or needed material; external public availability/access status unverified	Unread; access not attempted	Not read	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.
Registration material	Original bibliographic link or needed material; external public availability/access status unverified	Unread; access not attempted	Not read	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.
Protocol	Original bibliographic link or needed material; external public availability/access status unverified	Unread; access not attempted	Not read	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.
Statistical analysis plan	Original bibliographic link or needed material; external public availability/access status unverified	Unread; access not attempted	Not read	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.
Funding, product support and COI material	Original bibliographic link or needed material; external public availability/access status unverified	Unread; access not attempted	Not read	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.

S02 · Salem et al. 2017 · Separate seed-powder study

PubMed

Material type: Single-blind 3-arm placebo-controlled study
Materials actually read: Summary read; external material unread
Findings recorded in the stored summary: ACT improvement reported in the 1·2 g/day powder groups; not direct seed-oil replication
Record level: The original record is 76 randomized people; 24/26/26. Arm mapping and endpoint analysis denominators remain unverified.
Study overlap and independent replication: 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.

Public availability, access and reading status by material
Material	Public availability	Access status	Actually read	Notes
Stored existing review summary	Preserved copy of the complete existing review summary	Stored summary	Summary read	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.
External paper	Original bibliographic link or needed material; external public availability/access status unverified	Unread; access not attempted	Not read	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.
Registration material	Original bibliographic link or needed material; external public availability/access status unverified	Unread; access not attempted	Not read	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.
Protocol	Original bibliographic link or needed material; external public availability/access status unverified	Unread; access not attempted	Not read	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.
Statistical analysis plan	Original bibliographic link or needed material; external public availability/access status unverified	Unread; access not attempted	Not read	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.
Funding, product support and COI material	Original bibliographic link or needed material; external public availability/access status unverified	Unread; access not attempted	Not read	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.

Report counts versus independent study counts

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.

Review criteria

Version 1.0 · Criteria record date 2026-10-06. These are Chamgap's own application conditions, informed by the referenced methods. They do not constitute official assessment-tool certification or a new efficacy score.

N01 · What is the exact original claim scope?

Required materials and conditions: Seed oil, adults with asthma on inhaled maintenance therapy,4-week ACT and placebo add-on question
Conditions for verification: 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.
Requirement and applicability: Required
Application exceptions: 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.
Why this condition is needed: 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.
Referenced methods: 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.

N02 · What material was actually read?

Required materials and conditions: Distinguishing stored summaries from external papers, registration and plans
Conditions for verification: 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.
Requirement and applicability: Required
Application exceptions: 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.
Why this condition is needed: 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.
Referenced methods: 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.

N03 · What identifies the seed-oil report?

Required materials and conditions: Title, authors, year, PMID/DOI and registration identity
Conditions for verification: 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.
Requirement and applicability: Required
Application exceptions: 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.
Why this condition is needed: 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.
Referenced methods: 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.

N04 · Is the seed-powder report the same oil replication?

Required materials and conditions: Distinguishing powder, dose,12 weeks, registration and study families
Conditions for verification: 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.
Requirement and applicability: Required
Application exceptions: 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.
Why this condition is needed: 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.
Referenced methods: 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.

N05 · Are reports, trials and participants kept separate?

Required materials and conditions: Report/family relationships for80-person oil and76-person powder studies
Conditions for verification: 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.
Requirement and applicability: Required
Application exceptions: 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.
Why this condition is needed: 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.
Referenced methods: 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.

N06 · Which adults with asthma are represented?

Required materials and conditions: Asthma diagnosis, severity, baseline control, age and inclusion/exclusion
Conditions for verification: 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.
Requirement and applicability: Required
Application exceptions: 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.
Why this condition is needed: 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.
Referenced methods: 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.

N07 · Which seed oil is represented?

Required materials and conditions: Fixed seed-oil capsules, composition, extraction/manufacture and batch
Conditions for verification: 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.
Requirement and applicability: Required
Application exceptions: 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.
Why this condition is needed: 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.
Referenced methods: 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.

N08 · What were the oil dose and actual use?

Required materials and conditions: 500 mg2 times daily, dosing interval, actual amount and adherence
Conditions for verification: 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.
Requirement and applicability: Required
Application exceptions: 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.
Why this condition is needed: 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.
Referenced methods: 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.

N09 · Is this an effect added to inhaled maintenance therapy?

Required materials and conditions: Common inhaled medicines, doses, arm-specific changes and adjunctive contribution
Conditions for verification: 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.
Requirement and applicability: Required
Application exceptions: 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.
Why this condition is needed: 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.
Referenced methods: 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.

N10 · What were the placebo conditions?

Required materials and conditions: Matched appearance, ingredients, administration, common therapy and masking
Conditions for verification: 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.
Requirement and applicability: Required
Application exceptions: 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.
Why this condition is needed: 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.
Referenced methods: 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.

N11 · What was the actual allocation process?

Required materials and conditions: Random sequence generation, concealment, baseline balance and allocation denominators
Conditions for verification: 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.
Requirement and applicability: Required
Application exceptions: 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.
Why this condition is needed: 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.
Referenced methods: 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.

N12 · How are treatment and follow-up periods defined?

Required materials and conditions: Treatment4 weeks, follow-up4 weeks, assessment schedules and post-discontinuation observation
Conditions for verification: 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.
Requirement and applicability: Required
Application exceptions: 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.
Why this condition is needed: 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.
Referenced methods: 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.

N13 · What does ACT measure?

Required materials and conditions: Asthma Control Test, scale/direction, respondents, final values/changes and timing
Conditions for verification: 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.
Requirement and applicability: Required
Application exceptions: 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.
Why this condition is needed: 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.
Referenced methods: 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.

N14 · What are the4-week ACT results?

Required materials and conditions: Oil/placebo final values, dispersion, denominators and testing
Conditions for verification: 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.
Requirement and applicability: Required
Application exceptions: 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.
Why this condition is needed: 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.
Referenced methods: 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.

N15 · What is the clinical importance of the small ACT contrast?

Required materials and conditions: Effect/CI, justified important difference and responder criteria
Conditions for verification: 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.
Requirement and applicability: Required
Application exceptions: 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.
Why this condition is needed: 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.
Referenced methods: 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.

N16 · Is the FEV1 result preserved alongside ACT?

Required materials and conditions: Separate FEV1 and ACT endpoints, units, denominators and timing
Conditions for verification: 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.
Requirement and applicability: Required
Application exceptions: 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.
Why this condition is needed: 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.
Referenced methods: 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.

N17 · What is the prespecified ACT/FEV1 hierarchy?

Required materials and conditions: Registry, protocol and SAP endpoints, timing, analysis and changes
Conditions for verification: 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.
Requirement and applicability: Required
Application exceptions: 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.
Why this condition is needed: 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.
Referenced methods: 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.

N18 · What are the80-person allocation and post-attrition denominators?

Required materials and conditions: Arm-specific allocation, measurement, completion, ACT/FEV1 and ITT denominators
Conditions for verification: 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.
Requirement and applicability: Required
Application exceptions: 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.
Why this condition is needed: 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.
Referenced methods: 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.

N19 · How were missing data handled in the reported ITT?

Required materials and conditions: ITT definition, imputation/estimation, withdrawal reasons and sensitivity analysis
Conditions for verification: 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.
Requirement and applicability: Required
Application exceptions: 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.
Why this condition is needed: 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.
Referenced methods: 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.

N20 · What are adherence, rescue medicines and treatment deviations?

Required materials and conditions: Oil/placebo adherence, inhaled-therapy changes, rescue medication and exacerbations
Conditions for verification: 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.
Requirement and applicability: Required
Application exceptions: 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.
Why this condition is needed: 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.
Referenced methods: 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.

N21 · What do the powder-study results cover?

Required materials and conditions: Powder1/2 g,12-week ACT,3 arms, denominators and plans
Conditions for verification: 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.
Requirement and applicability: Required
Application exceptions: 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.
Why this condition is needed: 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.
Referenced methods: 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.

N22 · What independent replication concerns the same oil?

Required materials and conditions: Unique families for the same formulation, population, comparison and4-week ACT
Conditions for verification: 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.
Requirement and applicability: Required
Application exceptions: 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.
Why this condition is needed: 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.
Referenced methods: 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.

N23 · What would answer dose and long-term persistence questions?

Required materials and conditions: Direct oil dose, long-term/post-discontinuation outcomes and subgroups
Conditions for verification: 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.
Requirement and applicability: Required
Application exceptions: 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.
Why this condition is needed: 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.
Referenced methods: 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.

N24 · Does this establish exacerbation, attack or admission prevention or inhaler replacement?

Required materials and conditions: Boundaries between ACT, separate clinical events and replacement treatment
Conditions for verification: 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.
Requirement and applicability: Required
Application exceptions: 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.
Why this condition is needed: 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.
Referenced methods: 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.

N25 · What records the oil-study funding?

Required materials and conditions: Reported funding, sponsor roles and independence level
Conditions for verification: 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.
Requirement and applicability: Required
Application exceptions: 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.
Why this condition is needed: 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.
Referenced methods: 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.

N26 · What are powder funding and product support/COI for both reports?

Required materials and conditions: Separate original funding, product provision, employee authorship, patent and COI records
Conditions for verification: 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.
Requirement and applicability: Required
Application exceptions: 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.
Why this condition is needed: 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.
Referenced methods: 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.

N27 · How were adverse events collected?

Required materials and conditions: Events, collection, discontinuation and denominators for the same adult oil exposure
Conditions for verification: 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.
Requirement and applicability: Supplementary
Application exceptions: 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.
Why this condition is needed: 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.
Referenced methods: 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.

N28 · What are co-medication, event timing and harm attribution?

Required materials and conditions: Inhaled medicines, baseline asthma, cointerventions, onset/recovery and alternatives
Conditions for verification: 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.
Requirement and applicability: Supplementary
Application exceptions: 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.
Why this condition is needed: 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.
Referenced methods: 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.

N29 · What are long-term/rare harms and other vulnerable groups?

Required materials and conditions: Direct long-term exposure, pregnancy/breastfeeding, children and liver/kidney material
Conditions for verification: 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.
Requirement and applicability: Supplementary
Application exceptions: 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.
Why this condition is needed: 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.
Referenced methods: 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.

N30 · What is the history of C50, assessment values and past validation?

Required materials and conditions: Original grade, score, assessment values, original states and change history
Conditions for verification: 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.
Requirement and applicability: Required
Application exceptions: 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.
Why this condition is needed: 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.
Referenced methods: 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.

N31 · What are the boundaries of English wording, corrections and the original evidence date?

Required materials and conditions: Korean/English wording,2026-09-08,09-14 correction and production-date distinctions
Conditions for verification: 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.
Requirement and applicability: Required
Application exceptions: 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.
Why this condition is needed: 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.
Referenced methods: 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.

Referenced methods and the sections actually reviewed

M03 · Cochrane Handbook 6.5 (2024), chapter updated 2023-08

Official methodology · §3.1, §3.2.1–3.2.3, MECIR C5/C7/C13

Referenced principle: Clearly record the question, eligibility conditions and reasons for changes, and distinguish variations in interventions.
Extent of review: Existing methodological links were reused for production. External originals were not reread and methodological content was not reassessed.

M04 · Cochrane Handbook 6.5.1 (2025), chapter updated 2025-03

Official methodology · §4.5, §4.6.1–4.6.3, MECIR C42

Referenced principle: Distinguish studies from reports and link them; do not omit a study solely because results are unreported.
Extent of review: Existing methodological links were reused for production. External originals were not reread and methodological content was not reassessed.

M08 · Cochrane Handbook 6.5 (2024), chapter updated 2019-10

Official methodology · §8.1–8.2.3, Table 8.2.a

Referenced principle: Define the outcome and effect of interest, then examine randomization, deviations, missing data, measurement and selective reporting.
Extent of review: Existing methodological links were reused for production. External originals were not reread and methodological content was not reassessed.

M15 · Cochrane Handbook 6.5 (2024), chapter updated 2023-08

Official methodology · §15.2.4, §15.3.1–15.3.3

Referenced principle: Distinguish effect estimates, intervals, importance and applicability. Sample size alone does not determine precision.
Extent of review: Existing methodological links were reused for production. External originals were not reread and methodological content was not reassessed.

M19 · Cochrane Handbook 6.5 (2024), chapter updated 2019-10

Official methodology · §19.1.2, §19.2.1–19.2.4

Referenced principle: Harm questions may require different designs, populations and follow-up from efficacy questions. Case reports do not establish incidence rates.
Extent of review: Existing methodological links were reused for production. External originals were not reread and methodological content was not reassessed.

What the statuses mean

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.

Change history

2026-10-23 · Public page/material version 1.0

The public view and materials were prepared from the existing 31 items. No new clinical search, verification-state change or scoring was performed.

The stored-material review date (Not recorded) and original evidence cut-off (2026-09-08) were retained unchanged.

Researcher downloads

These materials provide the same evidence, scope and verification status as this page.

View all item details

N01 · What is the exact original claim scope?

Current findings: The selected claim is improved ACT symptom control in adults continuing inhaled asthma therapy. It concerns adjunctive oral seed oil.
Verification status: Partly verified
Materials actually 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
Why unverified: 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.
Reason for missing information: Powder, inhaler replacement and exacerbation/admission prevention are not substituted for this question.
Required materials and conditions: Seed oil, adults with asthma on inhaled maintenance therapy,4-week ACT and placebo add-on question
Materials to obtain first: Original material for the same population, formulation, comparison and endpoint
Further research: Material needed: Original material for the same population, formulation, comparison and endpoint This records needed materials; no new research was executed.
Remaining 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.
Conditions for verification: 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.
Why this condition is needed: 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 exceptions: 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.
Referenced methods: 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.

Related sources S01 S02

N02 · What material was actually read?

Current findings: 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.
Verification status: Partly verified
Materials actually 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
Why unverified: 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.
Reason for missing information: Links, registration identifiers and historical registered-trial wording are not promoted to actual current reading.
Required materials and conditions: Distinguishing stored summaries from external papers, registration and plans
Materials to obtain first: Original material and access history provided by the user or acquired in follow-up work
Further 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.
Remaining 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.
Conditions for verification: 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.
Why this condition is needed: 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 exceptions: 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.
Referenced methods: 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.

Related sources S01 S02

N03 · What identifies the seed-oil report?

Current findings: Koshak A et al., Phytother Res2017, PMID28093815, DOI10.1002/ptr.5761 and NCT02407262 are preserved.
Verification status: Partly verified
Materials actually 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
Why unverified: 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.
Reason for missing information: Actual external paper/registry content and related-report mapping remain unverified here.
Required materials and conditions: Title, authors, year, PMID/DOI and registration identity
Materials to obtain first: Complete original citation, registration history and related-report list
Further research: Material needed: Complete original citation, registration history and related-report list This records needed materials; no new research was executed.
Remaining 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.
Conditions for verification: 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.
Why this condition is needed: 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 exceptions: 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.
Referenced methods: 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.

Related sources S01

N04 · Is the seed-powder report the same oil replication?

Current findings: 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.
Verification status: Partly verified
Materials actually 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
Why unverified: 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.
Reason for missing information: Sharing the ACT name does not erase formulation, dose and duration differences or establish independent replication.
Required materials and conditions: Distinguishing powder, dose,12 weeks, registration and study families
Materials to obtain first: Study specifications and registration/report mapping for each formulation
Further research: Material needed: Study specifications and registration/report mapping for each formulation This records needed materials; no new research was executed.
Remaining 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.
Conditions for verification: 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.
Why this condition is needed: 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 exceptions: 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.
Referenced methods: 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.

Related sources S02

N05 · Are reports, trials and participants kept separate?

Current findings: 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.
Verification status: Partly verified
Materials actually 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
Why unverified: 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.
Reason for missing information: Unique trial, participant and independent-replication totals are not established; external related-report/overlap material remains unread.
Required materials and conditions: Report/family relationships for80-person oil and76-person powder studies
Materials to obtain first: Study-specific participant flow and related-report relationships
Further research: Material needed: Study-specific participant flow and related-report relationships This records needed materials; no new research was executed.
Remaining 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.
Conditions for verification: 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.
Why this condition is needed: 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 exceptions: 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.
Referenced methods: 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.

Related sources S01 S02

N06 · Which adults with asthma are represented?

Current findings: Participants are adults with asthma continuing inhaled maintenance therapy.
Verification status: Partly verified
Materials actually 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
Why unverified: 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.
Reason for missing information: Detailed age, severity, baseline ACT, smoking, comorbidity, inclusion/exclusion and applicability to children remain unverified.
Required materials and conditions: Asthma diagnosis, severity, baseline control, age and inclusion/exclusion
Materials to obtain first: Population/baseline characteristics and selection tables
Further research: Material needed: Population/baseline characteristics and selection tables This records needed materials; no new research was executed.
Remaining 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.
Conditions for verification: 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.
Why this condition is needed: 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 exceptions: 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.
Referenced methods: 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.

Related sources S01

N07 · Which seed oil is represented?

Current findings: Oral capsules of fixed oil from Nigella sativa L. seeds are selected.
Verification status: Partly verified
Materials actually 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
Why unverified: 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.
Reason for missing information: Composition specifications, extraction/manufacture, batch and marketed-product identity remain unverified; powder and purified thymoquinone are not substituted.
Required materials and conditions: Fixed seed-oil capsules, composition, extraction/manufacture and batch
Materials to obtain first: Product, manufacturing, composition and batch specifications
Further research: Material needed: Product, manufacturing, composition and batch specifications This records needed materials; no new research was executed.
Remaining 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.
Conditions for verification: 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.
Why this condition is needed: 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 exceptions: 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.
Referenced methods: 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.

Related sources S01

N08 · What were the oil dose and actual use?

Current findings: The preserved oil dose is500 mg2 times daily. Powder doses of1·2 g/day are not applied to oil.
Verification status: Partly verified
Materials actually 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
Why unverified: 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.
Reason for missing information: Missed doses, adjustments and constituent exposure remain unverified; no new daily total is calculated.
Required materials and conditions: 500 mg2 times daily, dosing interval, actual amount and adherence
Materials to obtain first: Arm-specific use, adherence and product-composition records
Further research: Material needed: Arm-specific use, adherence and product-composition records This records needed materials; no new research was executed.
Remaining 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.
Conditions for verification: 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.
Why this condition is needed: 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 exceptions: 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.
Referenced methods: 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.

Related sources S01 S02

N09 · Is this an effect added to inhaled maintenance therapy?

Current findings: Oil or placebo was added for4 weeks while inhaled maintenance therapy continued.
Verification status: Partly verified
Materials actually 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
Why unverified: 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.
Reason for missing information: Specific inhalers, doses, changes, rescue treatment and arm-specific balance remain unverified; results are not attributed to oil monotherapy.
Required materials and conditions: Common inhaled medicines, doses, arm-specific changes and adjunctive contribution
Materials to obtain first: Inhaled medicines, changes, rescue treatment and adherence tables
Further research: Material needed: Inhaled medicines, changes, rescue treatment and adherence tables This records needed materials; no new research was executed.
Remaining 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.
Conditions for verification: 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.
Why this condition is needed: 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 exceptions: 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.
Referenced methods: 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.

Related sources S01

N10 · What were the placebo conditions?

Current findings: The original wording describes matched-appearance placebo added to standard treatment.
Verification status: Partly verified
Materials actually 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
Why unverified: 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.
Reason for missing information: Placebo ingredients, taste/smell, actual administration matching, maintained masking and unmasking remain unverified.
Required materials and conditions: Matched appearance, ingredients, administration, common therapy and masking
Materials to obtain first: Placebo specifications and masking/unmasking records
Further research: Material needed: Placebo specifications and masking/unmasking records This records needed materials; no new research was executed.
Remaining 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.
Conditions for verification: 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.
Why this condition is needed: 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 exceptions: 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.
Referenced methods: 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.

Related sources S01

N11 · What was the actual allocation process?

Current findings: The original design is randomized, double-blind and placebo-controlled, with80 randomized people.
Verification status: Partly verified
Materials actually 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
Why unverified: 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.
Reason for missing information: Sequence generation, concealment, arm-specific baseline differences and initial allocation denominators remain unverified in the summary.
Required materials and conditions: Random sequence generation, concealment, baseline balance and allocation denominators
Materials to obtain first: Allocation methods, baseline tables and participant flow
Further research: Material needed: Allocation methods, baseline tables and participant flow This records needed materials; no new research was executed.
Remaining 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.
Conditions for verification: 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.
Why this condition is needed: 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 exceptions: 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.
Referenced methods: 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.

Related sources S01

N12 · How are treatment and follow-up periods defined?

Current findings: 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.
Verification status: Partly verified
Materials actually 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
Why unverified: 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.
Reason for missing information: No separate additional4 weeks or total8 weeks is newly calculated; follow-up definitions and post-discontinuation schedules remain unverified.
Required materials and conditions: Treatment4 weeks, follow-up4 weeks, assessment schedules and post-discontinuation observation
Materials to obtain first: Visit, dosing, discontinuation and follow-up schedules
Further research: Material needed: Visit, dosing, discontinuation and follow-up schedules This records needed materials; no new research was executed.
Remaining 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.
Conditions for verification: 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.
Why this condition is needed: 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 exceptions: 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.
Referenced methods: 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.

Related sources S01

N13 · What does ACT measure?

Current findings: The endpoint is patient-reported symptom control on the4-week Asthma Control Test.
Verification status: Partly verified
Materials actually 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
Why unverified: 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.
Reason for missing information: Version, baseline score, change, original explanation of scale direction and measurement completeness remain unverified; final values are not converted into changes.
Required materials and conditions: Asthma Control Test, scale/direction, respondents, final values/changes and timing
Materials to obtain first: ACT methods, baseline/4-week results and respondent denominators
Further research: Material needed: ACT methods, baseline/4-week results and respondent denominators This records needed materials; no new research was executed.
Remaining 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.
Conditions for verification: 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.
Why this condition is needed: 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 exceptions: 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.
Referenced methods: 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.

Related sources S01

N14 · What are the4-week ACT results?

Current findings: ACT21.1±2.6 versus19.6±3.7, P=.044 is retained as originally recorded.
Verification status: Partly verified
Materials actually 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
Why unverified: 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.
Reason for missing information: The original ± definition, ACT analysis denominator, baseline adjustment, change and original CI remain unverified; no new difference or CI is calculated.
Required materials and conditions: Oil/placebo final values, dispersion, denominators and testing
Materials to obtain first: Endpoint-specific result tables, dispersion, adjustment and intervals
Further research: Material needed: Endpoint-specific result tables, dispersion, adjustment and intervals This records needed materials; no new research was executed.
Remaining 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.
Conditions for verification: 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.
Why this condition is needed: 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 exceptions: 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.
Referenced methods: 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.

Related sources S01

N15 · What is the clinical importance of the small ACT contrast?

Current findings: The original account describes a small absolute ACT contrast and a signal with limited robustness after attrition.
Verification status: Unverified
Materials actually 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
Why unverified: 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.
Reason for missing information: Exact CI, minimum important difference and responder denominators/intervals remain unverified; a significant P value alone does not establish a large effect.
Required materials and conditions: Effect/CI, justified important difference and responder criteria
Materials to obtain first: Original effect/CI, important-difference rationale and responder results
Further research: Material needed: Original effect/CI, important-difference rationale and responder results This records needed materials; no new research was executed.
Remaining 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.
Conditions for verification: 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.
Why this condition is needed: 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 exceptions: 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.
Referenced methods: 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.

Related sources S01

N16 · Is the FEV1 result preserved alongside ACT?

Current findings: FEV1 P=.170 and the original nonsignificant result remain alongside positive ACT.
Verification status: Partly verified
Materials actually 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
Why unverified: 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.
Reason for missing information: FEV1 means, changes, units, denominators, CI and prespecified hierarchy remain unverified; nonsignificance is not converted into effect0 or equivalence.
Required materials and conditions: Separate FEV1 and ACT endpoints, units, denominators and timing
Materials to obtain first: Original FEV1 results, denominators, intervals and plans
Further research: Material needed: Original FEV1 results, denominators, intervals and plans This records needed materials; no new research was executed.
Remaining 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.
Conditions for verification: 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.
Why this condition is needed: 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 exceptions: 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.
Referenced methods: 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.

Related sources S01

N17 · What is the prespecified ACT/FEV1 hierarchy?

Current findings: The selected account’s main endpoint is4-week ACT, with FEV1 kept separate. NCT02407262 appears in the original material.
Verification status: Unverified
Materials actually 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
Why unverified: 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.
Reason for missing information: An identifier alone does not verify a prespecified1st endpoint or matching analysis; registry documents and original plans remain unread.
Required materials and conditions: Registry, protocol and SAP endpoints, timing, analysis and changes
Materials to obtain first: Registration history, protocol, SAP and all endpoints
Further research: Material needed: Registration history, protocol, SAP and all endpoints This records needed materials; no new research was executed.
Remaining 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.
Conditions for verification: 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.
Why this condition is needed: 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 exceptions: 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.
Referenced methods: 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.

Related sources S01

N18 · What are the80-person allocation and post-attrition denominators?

Current findings: 80 randomized people and10 withdrawals per arm are preserved; the account’s25% attrition remains historical wording.
Verification status: Partly verified
Materials actually 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
Why unverified: 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.
Reason for missing information: Completer/endpoint-specific denominators are not newly derived; arm-specific allocation, observed-data and imputed-data denominators remain unverified.
Required materials and conditions: Arm-specific allocation, measurement, completion, ACT/FEV1 and ITT denominators
Materials to obtain first: Arm-specific participant flow and endpoint analysis tables
Further research: Material needed: Arm-specific participant flow and endpoint analysis tables This records needed materials; no new research was executed.
Remaining 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.
Conditions for verification: 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.
Why this condition is needed: 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 exceptions: 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.
Referenced methods: 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.

Related sources S01

N19 · How were missing data handled in the reported ITT?

Current findings: The original design reports ITT, but there were10 withdrawals per arm.
Verification status: Unverified
Materials actually 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
Why unverified: 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.
Reason for missing information: An ITT label does not establish robustness; specific missing-data handling, withdrawal reasons and sensitivity remain unverified.
Required materials and conditions: ITT definition, imputation/estimation, withdrawal reasons and sensitivity analysis
Materials to obtain first: ITT/missing-data methods, withdrawal reasons and sensitivity results
Further research: Material needed: ITT/missing-data methods, withdrawal reasons and sensitivity results This records needed materials; no new research was executed.
Remaining 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.
Conditions for verification: 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.
Why this condition is needed: 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 exceptions: 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.
Referenced methods: 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.

Related sources S01

N20 · What are adherence, rescue medicines and treatment deviations?

Current findings: The description of adjunctive use with common inhaled maintenance therapy is retained.
Verification status: Unverified
Materials actually 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
Why unverified: 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.
Reason for missing information: Rescue medication, actual adherence, deviations, exacerbation-related changes and analytical handling remain unverified.
Required materials and conditions: Oil/placebo adherence, inhaled-therapy changes, rescue medication and exacerbations
Materials to obtain first: Adherence, rescue-medication and treatment-change tables
Further research: Material needed: Adherence, rescue-medication and treatment-change tables This records needed materials; no new research was executed.
Remaining 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.
Conditions for verification: 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.
Why this condition is needed: 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 exceptions: 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.
Referenced methods: 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.

Related sources S01

N21 · What do the powder-study results cover?

Current findings: The single-blind3-arm placebo study records76 randomized people,24/26/26 and ACT improvement at12 weeks in1·2 g/day powder groups.
Verification status: Partly verified
Materials actually 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
Why unverified: 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.
Reason for missing information: Exact effects/CI, arm mapping, endpoint denominators and funding verification remain limited;4-week oil values are not used to fill them.
Required materials and conditions: Powder1/2 g,12-week ACT,3 arms, denominators and plans
Materials to obtain first: Powder-study results, group composition, denominators and plans
Further research: Material needed: Powder-study results, group composition, denominators and plans This records needed materials; no new research was executed.
Remaining 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.
Conditions for verification: 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.
Why this condition is needed: 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 exceptions: 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.
Referenced methods: 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.

Related sources S02

N22 · What independent replication concerns the same oil?

Current findings: The account does not count powder as independent oil replication because formulation, dose and duration differ.
Verification status: Unverified
Materials actually 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
Why unverified: 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.
Reason for missing information: The current two reports are not converted into same-formulation replication counts or a current complete study total.
Required materials and conditions: Unique families for the same formulation, population, comparison and4-week ACT
Materials to obtain first: Direct same-oil trials and related-report list
Further research: Material needed: Direct same-oil trials and related-report list This records needed materials; no new research was executed.
Remaining 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.
Conditions for verification: 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.
Why this condition is needed: 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 exceptions: 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.
Referenced methods: 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.

Related sources S01 S02

N23 · What would answer dose and long-term persistence questions?

Current findings: The selected oil question is500 mg2 times daily and4-week ACT. 12-week powder results are not substituted for long-term oil data.
Verification status: Unverified
Materials actually 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
Why unverified: 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.
Reason for missing information: Other oil doses, long-term persistence, post-discontinuation effects and prespecified subgroups remain unverified.
Required materials and conditions: Direct oil dose, long-term/post-discontinuation outcomes and subgroups
Materials to obtain first: Same-oil dose/follow-up and prespecified-subgroup material
Further research: Material needed: Same-oil dose/follow-up and prespecified-subgroup material This records needed materials; no new research was executed.
Remaining 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.
Conditions for verification: 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.
Why this condition is needed: 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 exceptions: 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.
Referenced methods: 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.

Related sources S01 S02

N24 · Does this establish exacerbation, attack or admission prevention or inhaler replacement?

Current findings: The account says ACT is not the same as preventing exacerbations/admissions and that inhaler replacement or attack/admission prevention was not tested.
Verification status: Unverified
Materials actually 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
Why unverified: 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.
Reason for missing information: Positive ACT is not extended into evidence for fewer exacerbations/admissions or stopping inhalers.
Required materials and conditions: Boundaries between ACT, separate clinical events and replacement treatment
Materials to obtain first: Separate clinical events, periods, denominators and replacement designs
Further research: Material needed: Separate clinical events, periods, denominators and replacement designs This records needed materials; no new research was executed.
Remaining 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.
Conditions for verification: 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.
Why this condition is needed: 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 exceptions: 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.
Referenced methods: 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.

Related sources S01

N25 · What records the oil-study funding?

Current findings: UK Medical Research Council grant G106/1249 is preserved. The account’s independent-funding description is a historical verdict record.
Verification status: Partly verified
Materials actually 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
Why unverified: 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.
Reason for missing information: Original funding documents, sponsor roles and current independence comparisons remain unread; funding alone does not establish absence of bias.
Required materials and conditions: Reported funding, sponsor roles and independence level
Materials to obtain first: Original funding and sponsor-role documents
Further research: Material needed: Original funding and sponsor-role documents This records needed materials; no new research was executed.
Remaining 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.
Conditions for verification: 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.
Why this condition is needed: 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 exceptions: 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.
Referenced methods: 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.

Related sources S01

N26 · What are powder funding and product support/COI for both reports?

Current findings: Powder funding has limited verification. General English wording for both reports is preserved in its original form.
Verification status: Unverified
Materials actually 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
Why unverified: 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.
Reason for missing information: Product/free support, employee authors, patents and COI are not verified merely by the MRC grant or assessed separately wording.
Required materials and conditions: Separate original funding, product provision, employee authorship, patent and COI records
Materials to obtain first: Support, manufacture, employment and COI specifications for each report
Further research: Material needed: Support, manufacture, employment and COI specifications for each report This records needed materials; no new research was executed.
Remaining 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.
Conditions for verification: 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.
Why this condition is needed: 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 exceptions: 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.
Referenced methods: 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.

Related sources S01 S02

N27 · How were adverse events collected?

Current findings: The original Caution state and statement that small studies cannot exclude rare/long-term harms are retained.
Verification status: Unverified
Materials actually 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
Why unverified: 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.
Reason for missing information: Arm-specific adverse events, collection, severity, discontinuation and denominators remain unverified; ACT improvement does not establish safety.
Required materials and conditions: Events, collection, discontinuation and denominators for the same adult oil exposure
Materials to obtain first: Arm-specific event/discontinuation tables and collection methods
Further research: Material needed: Arm-specific event/discontinuation tables and collection methods This records needed materials; no new research was executed.
Remaining 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.
Conditions for verification: 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.
Why this condition is needed: 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 exceptions: 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.
Referenced methods: 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.

Related sources S01

N28 · What are co-medication, event timing and harm attribution?

Current findings: Inhaled maintenance therapy is linked to the original product/medication caution wording.
Verification status: Unverified
Materials actually 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
Why unverified: 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.
Reason for missing information: Specific interactions, improvement after withdrawal, re-exposure, causality and comparative risk remain unverified; no new harm judgment is created.
Required materials and conditions: Inhaled medicines, baseline asthma, cointerventions, onset/recovery and alternatives
Materials to obtain first: Cointerventions, event timelines, withdrawal/recovery and alternative-cause material
Further research: Material needed: Cointerventions, event timelines, withdrawal/recovery and alternative-cause material This records needed materials; no new research was executed.
Remaining 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.
Conditions for verification: 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.
Why this condition is needed: 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 exceptions: 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.
Referenced methods: 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.

Related sources S01

N29 · What are long-term/rare harms and other vulnerable groups?

Current findings: Original wording on product differences, vulnerable groups, surgery and medicines is preserved.
Verification status: Unverified
Materials actually 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
Why unverified: 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.
Reason for missing information: Adult4-week material is not extended to safety in all vulnerable groups or absence of rare/long-term harms.
Required materials and conditions: Direct long-term exposure, pregnancy/breastfeeding, children and liver/kidney material
Materials to obtain first: Long-term/population-specific exposure, harm and interaction material
Further research: Material needed: Long-term/population-specific exposure, harm and interaction material This records needed materials; no new research was executed.
Remaining 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.
Conditions for verification: 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.
Why this condition is needed: 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 exceptions: 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.
Referenced methods: 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.

Related sources S01

N30 · What is the history of C50, assessment values and past validation?

Current findings: C50, original assessment values, historical independent cross-checking wording and empty subclaim/deliberation records are preserved.
Verification status: Partly verified
Materials actually 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
Why unverified: 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.
Reason for missing information: Past I2/R1 values are not inherited as current condition fulfilment, completed user review or independent-replication certification.
Required materials and conditions: Original grade, score, assessment values, original states and change history
Materials to obtain first: Separate history of original verdict and change events
Further research: Material needed: Separate history of original verdict and change events This records needed materials; no new research was executed.
Remaining 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.
Conditions for verification: 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.
Why this condition is needed: 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 exceptions: 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.
Referenced methods: 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.

Related sources S01 S02

N31 · What are the boundaries of English wording, corrections and the original evidence date?

Current findings: 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.
Verification status: Partly verified
Materials actually 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
Why unverified: 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.
Reason for missing information: General verified/assessed expressions are not inherited as current full-text verification; withdrawals, new literature and registrations have not been searched.
Required materials and conditions: Korean/English wording,2026-09-08,09-14 correction and production-date distinctions
Materials to obtain first: Before/after correction records, additional material and user comments
Further research: Material needed: Before/after correction records, additional material and user comments This records needed materials; no new research was executed.
Remaining 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.
Conditions for verification: 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.
Why this condition is needed: 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 exceptions: 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.
Referenced methods: 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.

Related sources S01 S02