Combination of 5%-thymoquinone standardized Nigella seed oil and piperine × Relief of total nasal symptoms in adults with seasonal allergic rhinitis

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 conditionWhich combination and rhinitis outcome does this sheet address?Required	The selected claim is relief of TNSS in adult seasonal allergic rhinitis. The original population is adult men and the question concerns the combination product rather than Nigella alone. R01	Stored information is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.	Standardized Nigella oil and piperine, men with seasonal rhinitis,15-day TNSS and placebo	Material needed: Trial question, eligibility, intervention and TNSS definition This records needed materials; no new research was executed.
2	Partly verified	Full text not readStored summary read	N02 · Evidence conditionWhat intervention combines Nigellin Amber and BioPerine?Required	The original record is a combination capsule of supercritical Nigellin Amber(5% thymoquinone) and BioPerine 2.5 mg. R01	Stored information is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.	Supercritical seed fixed oil,5% thymoquinone and 2.5 mg piperine combination	Material needed: Product composition, extraction, standardization and batch analysis This records needed materials; no new research was executed.
3	Partly verified	Full text not readStored summary read	N03 · Evidence conditionWhat quality evidence supports 5% thymoquinone standardization?Required	The original formulation records 5% thymoquinone-standardized seed oil and BioPerine. R01	Stored information is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.	Seed-oil standardization, measurement, quality, piperine content and product preservation	Material needed: Standardization, composition analysis, batch quality and stability material This records needed materials; no new research was executed.
4	Partly verified	Full text not readStored summary read	N04 · Evidence conditionHow were 250 mg oil+2.5 mg piperine used 2 times daily?Required	The original dose record is 250 mg seed oil and 2.5 mg piperine 2 times daily. R01	Stored information is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.	Constituents per 1 dose, frequency, use, adherence and actual exposure	Material needed: Product contents, dosing procedures and use diaries This records needed materials; no new research was executed.
5	Partly verified	Full text not readStored summary read	N05 · Evidence conditionCan the combination result establish a Nigella-oil-only effect?Required	The original explanation that both constituents were administered together and Nigella oil's isolated contribution was not separated is retained. R01	Stored information is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.	Nigella-only and piperine-only arms, combination arm, factorial design and isolated contribution	Material needed: Direct studies with constituent-specific arms and composition tables This records needed materials; no new research was executed.
6	Partly verified	Full text not readStored summary read	N06 · Evidence conditionDo other Nigella products answer the same question?Required	The original route is oral. Existing wording distinguishes formulations rather than treating them as interchangeable. R01	Stored information is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.	Seed powder, fixed oil, aqueous extracts, topical products, purified constituents, combinations and oral route	Material needed: Direct rhinitis studies for the exact formulation and route This records needed materials; no new research was executed.
7	Partly verified	Full text not readStored summary read	N07 · Evidence conditionHow far do adult-male results apply?Required	The original population is adult men with seasonal rhinitis, with all participants described as male. Results are not extended to women, children, single constituents or long-term prevention. R01	Stored information is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.	Adult men, seasonal-rhinitis eligibility, and distinctions from women, children and other populations	Material needed: Eligibility, baseline characteristics and population-specific direct material This records needed materials; no new research was executed.
8	Unverified	Full text not readStored summary read	N08 · Evidence conditionHow were seasonal rhinitis and severity diagnosed?Required	The original population has seasonal allergic rhinitis and the stored result includes starting TNSS 8.45 versus 7.69. R01	Stored information is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.	Diagnosis, allergens, baseline TNSS, duration, eligibility and baseline medicines	Material needed: Diagnosis, eligibility, allergens and baseline-characteristics tables This records needed materials; no new research was executed.
9	Unverified	Full text not readStored summary read	N09 · Evidence conditionHow did seasonal and allergen exposure compare over 15 days?Required	The stored account describes a 15-day seasonal-rhinitis trial. R01	Stored information is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.	Actual season, region, pollen, environment, exposure differences and concurrent changes	Material needed: Trial dates, region, environment, exposure and common-management records This records needed materials; no new research was executed.
10	Partly verified	Full text not readStored summary read	N10 · Evidence conditionWhat placebo and common management were compared?Required	The original description of a fixed standardized seed-oil/piperine combination compared with matched-appearance placebo is retained. R01	Stored information is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.	Placebo composition/appearance, common treatment and product distinguishability	Material needed: Placebo composition, product appearance and common-treatment tables This records needed materials; no new research was executed.
11	Unverified	Full text not readStored summary read	N11 · Evidence conditionWhat concurrent effects might rhinitis medicines, rescue treatment and avoidance have?Required	The original explanation distinguishes 15-day TNSS from medication sparing. R01	Stored information is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.	Concomitant medicines, washout, rescue antihistamines, other medicines, avoidance and arm-specific use	Material needed: Concomitant/rescue-medication plans, arm-specific use and avoidance material This records needed materials; no new research was executed.
12	Partly verified	Full text not readStored summary read	N12 · Evidence conditionWhat are the exact 15-day treatment and follow-up time points?Required	The original duration is 15 days of treatment/follow-up and the selected endpoint is 15-day TNSS change. R01	Stored information is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.	Treatment, visits, starting/final assessments,15-day TNSS and post-discontinuation follow-up	Material needed: Visits, dosing, symptom-recording schedules and subsequent follow-up This records needed materials; no new research was executed.
13	Unverified	Full text not readStored summary read	N13 · Evidence conditionWhat TNSS scale and measurement methods were used?Required	The original endpoint is 15-day TNSS change. R01	Stored information is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.	Components, range, score direction, recall period, assessors and diaries	Material needed: TNSS definition, measurement tools, diaries and aggregation procedures This records needed materials; no new research was executed.
14	Partly verified	Full text not readStored summary read	N14 · Evidence conditionWhat was the original TNSS and symptom-duration hierarchy?Required	The evidence summary records TNSS and symptom duration as coprimary outcomes. The selected question is 15-day TNSS change and the existing coprimary separation setting is off. R01	Stored information is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.	TNSS/symptom-duration coprimary wording, plans and success criteria	Material needed: Registration, protocol, analysis plan, endpoint hierarchy and analysis list This records needed materials; no new research was executed.
15	Partly verified	Full text not readStored summary read	N15 · Evidence conditionWhat do 8.45→4.94 versus 7.69→6.66 represent?Required	The existing result record contains TNSS 8.45→4.94 versus 7.69→6.66. R01	Stored information is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.	Arm-specific starting/final TNSS, means, dispersion, timing and denominators	Material needed: Arm-specific starting/final TNSS, raw values, dispersion and denominators This records needed materials; no new research was executed.
16	Partly verified	Full text not readStored summary read	N16 · Evidence conditionHow should −3.52 versus −1.03 points and P<.001 be read?Required	The existing answer records −3.52 points with the combination and −1.03 with placebo(P<.001); the evidence summary records the same reported changes and P value. R01	Stored information is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.	Arm-specific changes, tested comparison, effect of interest and precision	Material needed: Arm-specific changes, between-group test results, dispersion and models This records needed materials; no new research was executed.
17	Unverified	Full text not readStored summary read	N17 · Evidence conditionWhat is missing about the change CI?Required	The original result says that the change CI was not reported. R01	Stored information is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.	Change/between-group-effect CI, dispersion, denominators and models	Material needed: Original changes, between-group effects, CI and dispersion tables This records needed materials; no new research was executed.
18	Unverified	Full text not readStored summary read	N18 · Evidence conditionHow were baseline TNSS and other differences considered?Required	The existing result separately reports starting TNSS 8.45 versus 7.69. R01	Stored information is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.	Baseline scores/characteristics, adjustment, regression, between-group analysis and alternatives	Material needed: Baseline tables, adjustment, analysis plans and sensitivity material This records needed materials; no new research was executed.
19	Partly verified	Full text not readStored summary read	N19 · Evidence conditionWhat denominators do 65 people and 33 versus 32 represent?Required	The evidence summary records 65 people,33 versus 32, all completed and all male. R01	Stored information is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.	Allocation, analysis, completion, arm mapping, TNSS, symptom-duration and harm denominators	Material needed: Participant flow and arm-specific allocation, analysis and endpoint tables This records needed materials; no new research was executed.
20	Partly verified	Full text not readStored summary read	N20 · Evidence conditionDoes completion establish complete outcomes and ITT analysis?Required	The existing account and sample record both state that all participants completed. R01	Stored information is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.	Completion, attrition, missing data, ITT, PP, outcome availability and effect of interest	Material needed: Participant flow, analysis definitions and endpoint/diary missingness tables This records needed materials; no new research was executed.
21	Unverified	Full text not readStored summary read	N21 · Evidence conditionWhat were the allocation sequence, concealment and baseline characteristics?Required	The original design is a randomized double-blind placebo trial. R01	Stored information is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.	Random sequence generation, concealment, allocation and baseline balance	Material needed: Allocation procedures and baseline tables This records needed materials; no new research was executed.
22	Unverified	Full text not readStored summary read	N22 · Evidence conditionWho was masked and could the products be distinguished?Required	The original design is double-blind and the comparator is matched-appearance placebo. R01	Stored information is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.	Role-specific masking, appearance, sensory properties, maintenance, unmasking and measurement	Material needed: Masking/placebo procedures and measurement methods This records needed materials; no new research was executed.
23	Unverified	Full text not readStored summary read	N23 · Evidence conditionHow were product use and treatment deviations handled?Required	The original formulation/dose records a fixed combination 2 times daily for 15 days and describes all participants completing. R01	Stored information is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.	Actual use, adherence, discontinuation, crossover, rescue medicines and effect of interest	Material needed: Use diaries, rescue medicines, deviations and analysis plans This records needed materials; no new research was executed.
24	Partly verified	Full text not readStored summary read	N24 · Evidence conditionHow much is verified about CTRI/2022/07/044180?Required	Stored evidence and the citation include CTRI/2022/07/044180, and the existing account describes a preregistered placebo comparison. R01	Stored information is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.	Original-record/citation registration identifiers versus registry contents, dates and actual reading	Material needed: CTRI text/history, protocol and report mapping This records needed materials; no new research was executed.
25	Unverified	Full text not readStored summary read	N25 · Evidence conditionHow were TNSS/symptom-duration success and multiplicity planned?Required	The evidence summary records TNSS and symptom duration as coprimary outcomes, while the selected question is TNSS. R01	Stored information is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.	Coprimary outcomes, planned analyses, timing, success criteria and adjustment	Material needed: Analysis plans, planned comparisons and all primary-outcome tables This records needed materials; no new research was executed.
26	Unverified	Full text not readStored summary read	N26 · Evidence conditionWhat remains unknown for the coprimary symptom-duration outcome?Required	The original endpoint description only identifies symptom duration as coprimary. R01	Stored information is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.	Symptom-duration definition, units, timing, arm-specific values, effects and denominators	Material needed: Symptom-duration definitions, results and denominator tables This records needed materials; no new research was executed.
27	Unverified	Full text not readStored summary read	N27 · Evidence conditionDoes 15-day TNSS establish medication sparing or management across the season?Supplementary; required for claims about long-term management or medication sparing	The original explanation states that 15-day TNSS differs from long-term seasonal management or medication sparing. R01	Stored information is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.	Rescue/regular medicines, seasonal/long-term follow-up, treatment strategies and recurrence	Material needed: Medication-use outcomes and long-term/seasonal follow-up This records needed materials; no new research was executed.
28	Partly verified	Full text not readStored summary read	N28 · Evidence conditionWhat is the scope of the original large-TNSS-change interpretation?Required	The existing account and grade rationale describe a large short-term between-group contrast. R01	Stored information is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.	Effects, CI, prespecified important difference, patient-important outcomes and responders	Material needed: Importance plans, effect intervals and patient-important outcomes This records needed materials; no new research was executed.
29	Partly verified	Full text not readStored summary read	N29 · Evidence conditionWhich report do the stored summary and PMID/PMCID/DOI identify?Required	The original citation records Majeed M et al., Medicine(Baltimore).2024, PMID 39121267, PMCID PMC11315530, DOI 10.1097/MD.0000000000039243 and a CTRI identifier. R01	Stored information is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.	Research reports, same-trial/registration families and original citation	Material needed: Original papers, registration and subsequent reports from the same trial This records needed materials; no new research was executed.
30	Partly verified	Full text not readStored summary read	N30 · Evidence conditionHow do the no-funding statement and company involvement differ?Required	The existing funding record includes both the authors' no-funding statement and Sami-Sabinsa/Sabinsa employee authorship and product involvement. R01	Stored information is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.	Cash funding, product support, employee authorship, COI and company roles	Material needed: Original funding/COI, affiliations and product/company-role material This records needed materials; no new research was executed.
31	Partly verified	Full text not readStored summary read	N31 · Evidence conditionWhat remains unknown about independent replication of the same product?Required	The account records the company product trial/employee-author limitation and a product-specific short-term signal. The original assessment record is R1/I0. R01	Stored information is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.	Product/question matching, teams, support, report families and independent replication	Material needed: Separate original trials for the same product/question and team/support relationships This records needed materials; no new research was executed.
32	Partly verified	Full text not readStored summary read	N32 · Evidence conditionWere the original paper, PMCID text and registration actually read?Required	The clinical production material actually read was the whole stored summary. The original PubMed address is linked and the PMCID entry retained. R01	Stored information is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.	Stored summary, PubMed link, PMCID citation and external content reading	Material needed: Original material corresponding to the citation and registration This records needed materials; no new research was executed.
33	Partly verified	Full text not readStored summary read	N33 · Evidence conditionAre the original evidence date and current production time distinguished?Required	The existing original-record date is 2026-09-08, the correction date is 2026-09-14 and the citation is from 2024. R01	Stored information is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.	Original-record date, correction date,2024 citation, actual reading, searches and production	Material needed: Original publication, search, receipt and correction records This records needed materials; no new research was executed.
34	Partly verified	Full text not readStored summary read	N34 · Evidence conditionWhat is the status of generic English wording and the 1-field correction?Required	The English answer records 65 men,15 days and −3.52/−1.03/P<.001. English evidence-summary descriptions of denominators, funding, endpoints and results remain generic, while the evidence type specifically identifies product-combination evidence. The correction record describes replacing 1 field. R01	Stored information is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.	Korean/English reported values, generic English explanations and before/after correction originals	Material needed: Before/after correction originals and English correspondence for original results/endpoints This records needed materials; no new research was executed.
35	Partly verified	Full text not readStored summary read	N35 · Evidence conditionWhat historical records are C50, I0 and the existing settings?Required	The original preserves C50, Caution, assessment record B/P/R1/I0/E+/B2/C0, the off coprimary-separation setting and historical independent cross-checking wording. R01	Stored information is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.	Original grade, score, safety label, assessment records, grade rationale and empty values	Material needed: Original verdict and permitted subsequent correction events This records needed materials; no new research was executed.
36	Partly verified	Full text not readStored summary read	N36 · Evidence conditionWhat denominators supported collection of actual 15-day combination harms?Required	The study title mentions efficacy/safety, but the original safety wording cautions that small trials cannot exclude rare or long-term harms. R01	Stored information is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.	Event definitions, collection, arm-specific events, denominators, discontinuation, missingness and timing	Material needed: Adverse-event/discontinuation records, harm collection and arm-specific denominators This records needed materials; no new research was executed.
37	Unverified	Full text not readStored summary read	N37 · Evidence conditionAre harms of the piperine combination and caution-listed medicines verified?Supplementary; required within concomitant-use or combination-harm scope	The original formulation combines piperine and the safety wording retains caution for glucose, blood-pressure, anticoagulant, antiseizure and immune-modifying medicines. R01	Stored information is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.	Combined/isolated exposure, concomitant medicines, interaction events, denominators and contribution	Material needed: Formulation/medicine-specific exposure, interaction and concomitant-use material This records needed materials; no new research was executed.
38	Partly verified	Full text not readStored summary read	N38 · Evidence conditionWhat about safety beyond a short male trial?Supplementary; required for long-term or vulnerable-group safety claims	The original safety wording records composition differences by formulation/extraction, vulnerable-group/surgical cautions and inability to exclude rare or long-term harms. R01	Stored information is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.	Formulation-specific long-term/rare harms, pregnancy, breastfeeding, children, liver/kidney disease and surgery	Material needed: Long-term, rare, formulation-specific and population-specific original harm material This records needed materials; no new research was executed.
39	Unverified	Full text not readStored summary read	N39 · Evidence conditionWhat are individual event timelines and alternative causes?Required	The original material records 15-day use and general caution wording. R01	Stored information is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.	Onset, recovery, discontinuation, re-exposure, concomitant medicines, underlying illness and alternatives	Material needed: Event timelines, co-medication, alternatives and original harm material This records needed materials; no new research was executed.
40	Unverified	Full text not readStored summary read	N40 · Evidence conditionWere events with the same combination repeated in independent material?Supplementary; required for repeated-harm claims	The current stored account records general caution wording and does not present a list of independent cases. R01	Stored information is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.	Unique cases, formulation/exposure/event matching, report families and repeated citations	Material needed: Unique cases, report families and exposure material This records needed materials; no new research was executed.
41	Partly verified	Full text not readStored summary read	N41 · Evidence conditionHow are the read summary, unread material and later changes linked?Required	The stored summary is read for production and external material remains unread with access unattempted. R01	Stored information is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.	Material-specific availability/reading, original citation links and condition/evidence-change events	Material needed: Provided or separately permitted original material and corrections This records needed materials; no new research was executed.

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41 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 adult men with seasonal allergic rhinitis. Specific age, diagnosis, sensitization testing, allergen, eligibility and baseline characteristics remain unverified. Applicability to women, children or perennial rhinitis is not assumed.
Ingredient, formulation and route: This is an oral combination capsule of supercritical-extracted Nigellin Amber seed oil standardized to 5% thymoquinone and BioPerine piperine. Batch measurements, excipients, quality and product identity remain unverified.
Dose: The original record is 250 mg seed oil and 2.5 mg piperine 2 times daily. Dosing times, adherence and actual exposure remain unverified. No new constituent daily total, cumulative dose, optimal dose or individual dosing guidance is created.
Comparator: The comparison is matched-appearance placebo. Placebo ingredients, taste/smell, maintained masking, common management and permitted/arm-specific rhinitis or rescue medicines remain unverified. This is not converted into a comparison with Nigella-oil-only or piperine-only arms.
Measured outcome: The selected question is change in TNSS at 15 days. The original description of TNSS and symptom duration as coprimary outcomes is retained without filling the symptom-duration result. Scale range, measurement methods, prespecified success criteria, important difference and original intervals remain unverified.
Duration: The original record is 15 days of treatment and follow-up. Interim visits, persistence after discontinuation, management across the season and long-term follow-up remain unverified. This is not converted into a numerical improvement in symptom duration or long-term prevention.
Questions outside this scope: The selected question concerns the fixed standardized Nigella-oil and piperine combination product. The separate contributions of Nigella oil, piperine and thymoquinone, and effects of other formulations, remain distinctly unverified.; The existing C·50 points·Caution, B/P/R1/I0/E+/B2/C0 and evidence date 2026-09-08 are retained. Historical cross-checking wording and assessment records do not establish new independent clinical validation or completed review here.; TNSS 8.45→4.94 versus 7.69→6.66 and the reported changes −3.52 versus −1.03, P<.001 are separately retained. Starting/final values are not subtracted to revise reported changes or calculate new between-group effects, intervals, percentages or NNT.; The original record of 65 people, 33 versus 32, all completing and all male is retained. Direct arm mapping and endpoint-specific analysis denominators remain unverified; completion is not converted into no missing results, verified ITT or no adverse events.; The original TNSS/symptom-duration coprimary wording and existing separation setting are both retained. TNSS significance alone does not establish overall success or fill the symptom-duration result.; The original citation’s CTRI/2022/07/044180 and PMCIDPMC11315530 are separate from content reading. The English-placeholder correction date 2026-09-14 is not converted into current external verification or a new verdict date.; The no-funding statement remains separate from Sami-Sabinsa/Sabinsa employee authorship and product involvement. Company-related records are not converted into new independence certification or proof of no effect.; Short-term male combination-product results are not extended to women, children, perennial rhinitis, medication sparing, management across the season, prevention or treatment replacement. Original caution about product differences, vulnerable groups, surgery and medicines remains; no new harm rate, causality, contraindication or overall safety judgment is made.

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.

R01 · Majeed et al. 2024 · Standardized seed-oil/piperine combination-product trial

PubMed

Material type: Randomized double-blind placebo-controlled trial
Materials actually read: Stored summary read; external abstracts, full text, registration and plans unread; access unattempted
Findings recorded in the stored summary: TNSS 8.45→4.94 versus 7.69→6.66; changes −3.52 versus −1.03, P<.001; change CI not reported in the stored summary
Record level: The original record is 65 people, 33 versus 32; all completed and all were male. Original allocation/analysis stages, direct arm mapping, and endpoint-specific or harm denominators remain unverified.
Study overlap and independent replication: The stored summary and citation link to the same combination-product report. Family relationships among external papers, registration and subsequent reports, and unique trial, participant or independent-replication totals remain unverified. Report counts are not converted into unique trials or 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	PMID39121267; PMCIDPMC11315530; DOI10.1097/MD.0000000000039243; CTRI/2022/07/044180 are retained. External abstracts, full text, registration, protocols, analysis plans and original result tables are unread; the original no-funding statement and company employee authorship/product involvement remain separate. Original material-specific dates and unverified states are retained without conversion into current external-reading dates.
External paper identity link	Original bibliographic link or needed material; external public availability/access status unverified	Unread; access not attempted	Not read	PMID39121267; PMCIDPMC11315530; DOI10.1097/MD.0000000000039243; CTRI/2022/07/044180 are retained. External abstracts, full text, registration, protocols, analysis plans and original result tables are unread; the original no-funding statement and company employee authorship/product involvement remain separate. Original material-specific dates and unverified states are retained without conversion into current external-reading dates.
External full text	Original bibliographic link or needed material; external public availability/access status unverified	Unread; access not attempted	Not read	PMID39121267; PMCIDPMC11315530; DOI10.1097/MD.0000000000039243; CTRI/2022/07/044180 are retained. External abstracts, full text, registration, protocols, analysis plans and original result tables are unread; the original no-funding statement and company employee authorship/product involvement remain separate. Original material-specific dates and unverified states 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	PMID39121267; PMCIDPMC11315530; DOI10.1097/MD.0000000000039243; CTRI/2022/07/044180 are retained. External abstracts, full text, registration, protocols, analysis plans and original result tables are unread; the original no-funding statement and company employee authorship/product involvement remain separate. Original material-specific dates and unverified states are retained without conversion into current external-reading dates.
Additional material needed	Original bibliographic link or needed material; external public availability/access status unverified	Unread; access not attempted	Not read	PMID39121267; PMCIDPMC11315530; DOI10.1097/MD.0000000000039243; CTRI/2022/07/044180 are retained. External abstracts, full text, registration, protocols, analysis plans and original result tables are unread; the original no-funding statement and company employee authorship/product involvement remain separate. Original material-specific dates and unverified states are retained without conversion into current external-reading dates.
Additional material needed	Original bibliographic link or needed material; external public availability/access status unverified	Unread; access not attempted	Not read	PMID39121267; PMCIDPMC11315530; DOI10.1097/MD.0000000000039243; CTRI/2022/07/044180 are retained. External abstracts, full text, registration, protocols, analysis plans and original result tables are unread; the original no-funding statement and company employee authorship/product involvement remain separate. Original material-specific dates and unverified states are retained without conversion into current external-reading dates.
Additional material needed	Original bibliographic link or needed material; external public availability/access status unverified	Unread; access not attempted	Not read	PMID39121267; PMCIDPMC11315530; DOI10.1097/MD.0000000000039243; CTRI/2022/07/044180 are retained. External abstracts, full text, registration, protocols, analysis plans and original result tables are unread; the original no-funding statement and company employee authorship/product involvement remain separate. Original material-specific dates and unverified states are retained without conversion into current external-reading dates.
Additional material needed	Original bibliographic link or needed material; external public availability/access status unverified	Unread; access not attempted	Not read	PMID39121267; PMCIDPMC11315530; DOI10.1097/MD.0000000000039243; CTRI/2022/07/044180 are retained. External abstracts, full text, registration, protocols, analysis plans and original result tables are unread; the original no-funding statement and company employee authorship/product involvement remain separate. Original material-specific dates and unverified states are retained without conversion into current external-reading dates.
Additional material needed	Original bibliographic link or needed material; external public availability/access status unverified	Unread; access not attempted	Not read	PMID39121267; PMCIDPMC11315530; DOI10.1097/MD.0000000000039243; CTRI/2022/07/044180 are retained. External abstracts, full text, registration, protocols, analysis plans and original result tables are unread; the original no-funding statement and company employee authorship/product involvement remain separate. Original material-specific dates and unverified states are retained without conversion into current external-reading dates.
Additional material needed	Original bibliographic link or needed material; external public availability/access status unverified	Unread; access not attempted	Not read	PMID39121267; PMCIDPMC11315530; DOI10.1097/MD.0000000000039243; CTRI/2022/07/044180 are retained. External abstracts, full text, registration, protocols, analysis plans and original result tables are unread; the original no-funding statement and company employee authorship/product involvement remain separate. Original material-specific dates and unverified states are retained without conversion into current external-reading dates.

Report counts versus independent study counts

The stored summary and citation link to the same combination-product report. Family relationships among external papers, registration and subsequent reports, and unique trial, participant or independent-replication totals remain unverified. Report counts are not converted into unique trials or 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 · Which combination and rhinitis outcome does this sheet address?

Required materials and conditions: Standardized Nigella oil and piperine, men with seasonal rhinitis,15-day TNSS and placebo
Conditions for verification: Original records on Standardized Nigella oil and piperine, men with seasonal rhinitis,15-day TNSS and placebo must link to the same product, question, population, comparison, endpoint, timing and analysis denominator, distinguishing recorded information from gaps.
Requirement and applicability: Required
Application exceptions: Combination-product results are not extended to the isolated effects of Nigella oil, piperine or purified thymoquinone, or to other products, populations or periods. Reported starting/final values and changes remain separate; no new effects, intervals, denominators, harm rates or dose totals are calculated.
Why this condition is needed: Material on Standardized Nigella oil and piperine, men with seasonal rhinitis,15-day TNSS and placebo is needed to connect the combination-product question to its population, formulation, comparison, endpoint, timing, denominator or harms.
Referenced methods: Existing principles distinguish the exact combination product, adult men, seasonal rhinitis, placebo, TNSS and symptom duration, timing, original reported values, denominators, company involvement and harms.

N02 · What intervention combines Nigellin Amber and BioPerine?

Required materials and conditions: Supercritical seed fixed oil,5% thymoquinone and 2.5 mg piperine combination
Conditions for verification: Original records on Supercritical seed fixed oil,5% thymoquinone and 2.5 mg piperine combination must link to the same product, question, population, comparison, endpoint, timing and analysis denominator, distinguishing recorded information from gaps.
Requirement and applicability: Required
Application exceptions: Combination-product results are not extended to the isolated effects of Nigella oil, piperine or purified thymoquinone, or to other products, populations or periods. Reported starting/final values and changes remain separate; no new effects, intervals, denominators, harm rates or dose totals are calculated.
Why this condition is needed: Material on Supercritical seed fixed oil,5% thymoquinone and 2.5 mg piperine combination is needed to connect the combination-product question to its population, formulation, comparison, endpoint, timing, denominator or harms.
Referenced methods: Existing principles distinguish the exact combination product, adult men, seasonal rhinitis, placebo, TNSS and symptom duration, timing, original reported values, denominators, company involvement and harms.

N03 · What quality evidence supports 5% thymoquinone standardization?

Required materials and conditions: Seed-oil standardization, measurement, quality, piperine content and product preservation
Conditions for verification: Original records on Seed-oil standardization, measurement, quality, piperine content and product preservation must link to the same product, question, population, comparison, endpoint, timing and analysis denominator, distinguishing recorded information from gaps.
Requirement and applicability: Required
Application exceptions: Combination-product results are not extended to the isolated effects of Nigella oil, piperine or purified thymoquinone, or to other products, populations or periods. Reported starting/final values and changes remain separate; no new effects, intervals, denominators, harm rates or dose totals are calculated.
Why this condition is needed: Material on Seed-oil standardization, measurement, quality, piperine content and product preservation is needed to connect the combination-product question to its population, formulation, comparison, endpoint, timing, denominator or harms.
Referenced methods: Existing principles distinguish the exact combination product, adult men, seasonal rhinitis, placebo, TNSS and symptom duration, timing, original reported values, denominators, company involvement and harms.

N04 · How were 250 mg oil+2.5 mg piperine used 2 times daily?

Required materials and conditions: Constituents per 1 dose, frequency, use, adherence and actual exposure
Conditions for verification: Original records on Constituents per 1 dose, frequency, use, adherence and actual exposure must link to the same product, question, population, comparison, endpoint, timing and analysis denominator, distinguishing recorded information from gaps.
Requirement and applicability: Required
Application exceptions: Combination-product results are not extended to the isolated effects of Nigella oil, piperine or purified thymoquinone, or to other products, populations or periods. Reported starting/final values and changes remain separate; no new effects, intervals, denominators, harm rates or dose totals are calculated.
Why this condition is needed: Material on Constituents per 1 dose, frequency, use, adherence and actual exposure is needed to connect the combination-product question to its population, formulation, comparison, endpoint, timing, denominator or harms.
Referenced methods: Existing principles distinguish the exact combination product, adult men, seasonal rhinitis, placebo, TNSS and symptom duration, timing, original reported values, denominators, company involvement and harms.

N05 · Can the combination result establish a Nigella-oil-only effect?

Required materials and conditions: Nigella-only and piperine-only arms, combination arm, factorial design and isolated contribution
Conditions for verification: Original records on Nigella-only and piperine-only arms, combination arm, factorial design and isolated contribution must link to the same product, question, population, comparison, endpoint, timing and analysis denominator, distinguishing recorded information from gaps.
Requirement and applicability: Required
Application exceptions: Combination-product results are not extended to the isolated effects of Nigella oil, piperine or purified thymoquinone, or to other products, populations or periods. Reported starting/final values and changes remain separate; no new effects, intervals, denominators, harm rates or dose totals are calculated.
Why this condition is needed: Material on Nigella-only and piperine-only arms, combination arm, factorial design and isolated contribution is needed to connect the combination-product question to its population, formulation, comparison, endpoint, timing, denominator or harms.
Referenced methods: Existing principles distinguish the exact combination product, adult men, seasonal rhinitis, placebo, TNSS and symptom duration, timing, original reported values, denominators, company involvement and harms.

N06 · Do other Nigella products answer the same question?

Required materials and conditions: Seed powder, fixed oil, aqueous extracts, topical products, purified constituents, combinations and oral route
Conditions for verification: Original records on Seed powder, fixed oil, aqueous extracts, topical products, purified constituents, combinations and oral route must link to the same product, question, population, comparison, endpoint, timing and analysis denominator, distinguishing recorded information from gaps.
Requirement and applicability: Required
Application exceptions: Combination-product results are not extended to the isolated effects of Nigella oil, piperine or purified thymoquinone, or to other products, populations or periods. Reported starting/final values and changes remain separate; no new effects, intervals, denominators, harm rates or dose totals are calculated.
Why this condition is needed: Material on Seed powder, fixed oil, aqueous extracts, topical products, purified constituents, combinations and oral route is needed to connect the combination-product question to its population, formulation, comparison, endpoint, timing, denominator or harms.
Referenced methods: Existing principles distinguish the exact combination product, adult men, seasonal rhinitis, placebo, TNSS and symptom duration, timing, original reported values, denominators, company involvement and harms.

N07 · How far do adult-male results apply?

Required materials and conditions: Adult men, seasonal-rhinitis eligibility, and distinctions from women, children and other populations
Conditions for verification: Original records on Adult men, seasonal-rhinitis eligibility, and distinctions from women, children and other populations must link to the same product, question, population, comparison, endpoint, timing and analysis denominator, distinguishing recorded information from gaps.
Requirement and applicability: Required
Application exceptions: Combination-product results are not extended to the isolated effects of Nigella oil, piperine or purified thymoquinone, or to other products, populations or periods. Reported starting/final values and changes remain separate; no new effects, intervals, denominators, harm rates or dose totals are calculated.
Why this condition is needed: Material on Adult men, seasonal-rhinitis eligibility, and distinctions from women, children and other populations is needed to connect the combination-product question to its population, formulation, comparison, endpoint, timing, denominator or harms.
Referenced methods: Existing principles distinguish the exact combination product, adult men, seasonal rhinitis, placebo, TNSS and symptom duration, timing, original reported values, denominators, company involvement and harms.

N08 · How were seasonal rhinitis and severity diagnosed?

Required materials and conditions: Diagnosis, allergens, baseline TNSS, duration, eligibility and baseline medicines
Conditions for verification: Original records on Diagnosis, allergens, baseline TNSS, duration, eligibility and baseline medicines must link to the same product, question, population, comparison, endpoint, timing and analysis denominator, distinguishing recorded information from gaps.
Requirement and applicability: Required
Application exceptions: Combination-product results are not extended to the isolated effects of Nigella oil, piperine or purified thymoquinone, or to other products, populations or periods. Reported starting/final values and changes remain separate; no new effects, intervals, denominators, harm rates or dose totals are calculated.
Why this condition is needed: Material on Diagnosis, allergens, baseline TNSS, duration, eligibility and baseline medicines is needed to connect the combination-product question to its population, formulation, comparison, endpoint, timing, denominator or harms.
Referenced methods: Existing principles distinguish the exact combination product, adult men, seasonal rhinitis, placebo, TNSS and symptom duration, timing, original reported values, denominators, company involvement and harms.

N09 · How did seasonal and allergen exposure compare over 15 days?

Required materials and conditions: Actual season, region, pollen, environment, exposure differences and concurrent changes
Conditions for verification: Original records on Actual season, region, pollen, environment, exposure differences and concurrent changes must link to the same product, question, population, comparison, endpoint, timing and analysis denominator, distinguishing recorded information from gaps.
Requirement and applicability: Required
Application exceptions: Combination-product results are not extended to the isolated effects of Nigella oil, piperine or purified thymoquinone, or to other products, populations or periods. Reported starting/final values and changes remain separate; no new effects, intervals, denominators, harm rates or dose totals are calculated.
Why this condition is needed: Material on Actual season, region, pollen, environment, exposure differences and concurrent changes is needed to connect the combination-product question to its population, formulation, comparison, endpoint, timing, denominator or harms.
Referenced methods: Existing principles distinguish the exact combination product, adult men, seasonal rhinitis, placebo, TNSS and symptom duration, timing, original reported values, denominators, company involvement and harms.

N10 · What placebo and common management were compared?

Required materials and conditions: Placebo composition/appearance, common treatment and product distinguishability
Conditions for verification: Original records on Placebo composition/appearance, common treatment and product distinguishability must link to the same product, question, population, comparison, endpoint, timing and analysis denominator, distinguishing recorded information from gaps.
Requirement and applicability: Required
Application exceptions: Combination-product results are not extended to the isolated effects of Nigella oil, piperine or purified thymoquinone, or to other products, populations or periods. Reported starting/final values and changes remain separate; no new effects, intervals, denominators, harm rates or dose totals are calculated.
Why this condition is needed: Material on Placebo composition/appearance, common treatment and product distinguishability is needed to connect the combination-product question to its population, formulation, comparison, endpoint, timing, denominator or harms.
Referenced methods: Existing principles distinguish the exact combination product, adult men, seasonal rhinitis, placebo, TNSS and symptom duration, timing, original reported values, denominators, company involvement and harms.

N11 · What concurrent effects might rhinitis medicines, rescue treatment and avoidance have?

Required materials and conditions: Concomitant medicines, washout, rescue antihistamines, other medicines, avoidance and arm-specific use
Conditions for verification: Original records on Concomitant medicines, washout, rescue antihistamines, other medicines, avoidance and arm-specific use must link to the same product, question, population, comparison, endpoint, timing and analysis denominator, distinguishing recorded information from gaps.
Requirement and applicability: Required
Application exceptions: Combination-product results are not extended to the isolated effects of Nigella oil, piperine or purified thymoquinone, or to other products, populations or periods. Reported starting/final values and changes remain separate; no new effects, intervals, denominators, harm rates or dose totals are calculated.
Why this condition is needed: Material on Concomitant medicines, washout, rescue antihistamines, other medicines, avoidance and arm-specific use is needed to connect the combination-product question to its population, formulation, comparison, endpoint, timing, denominator or harms.
Referenced methods: Existing principles distinguish the exact combination product, adult men, seasonal rhinitis, placebo, TNSS and symptom duration, timing, original reported values, denominators, company involvement and harms.

N12 · What are the exact 15-day treatment and follow-up time points?

Required materials and conditions: Treatment, visits, starting/final assessments,15-day TNSS and post-discontinuation follow-up
Conditions for verification: Original records on Treatment, visits, starting/final assessments,15-day TNSS and post-discontinuation follow-up must link to the same product, question, population, comparison, endpoint, timing and analysis denominator, distinguishing recorded information from gaps.
Requirement and applicability: Required
Application exceptions: Combination-product results are not extended to the isolated effects of Nigella oil, piperine or purified thymoquinone, or to other products, populations or periods. Reported starting/final values and changes remain separate; no new effects, intervals, denominators, harm rates or dose totals are calculated.
Why this condition is needed: Material on Treatment, visits, starting/final assessments,15-day TNSS and post-discontinuation follow-up is needed to connect the combination-product question to its population, formulation, comparison, endpoint, timing, denominator or harms.
Referenced methods: Existing principles distinguish the exact combination product, adult men, seasonal rhinitis, placebo, TNSS and symptom duration, timing, original reported values, denominators, company involvement and harms.

N13 · What TNSS scale and measurement methods were used?

Required materials and conditions: Components, range, score direction, recall period, assessors and diaries
Conditions for verification: Original records on Components, range, score direction, recall period, assessors and diaries must link to the same product, question, population, comparison, endpoint, timing and analysis denominator, distinguishing recorded information from gaps.
Requirement and applicability: Required
Application exceptions: Combination-product results are not extended to the isolated effects of Nigella oil, piperine or purified thymoquinone, or to other products, populations or periods. Reported starting/final values and changes remain separate; no new effects, intervals, denominators, harm rates or dose totals are calculated.
Why this condition is needed: Material on Components, range, score direction, recall period, assessors and diaries is needed to connect the combination-product question to its population, formulation, comparison, endpoint, timing, denominator or harms.
Referenced methods: Existing principles distinguish the exact combination product, adult men, seasonal rhinitis, placebo, TNSS and symptom duration, timing, original reported values, denominators, company involvement and harms.

N14 · What was the original TNSS and symptom-duration hierarchy?

Required materials and conditions: TNSS/symptom-duration coprimary wording, plans and success criteria
Conditions for verification: Original records on TNSS/symptom-duration coprimary wording, plans and success criteria must link to the same product, question, population, comparison, endpoint, timing and analysis denominator, distinguishing recorded information from gaps.
Requirement and applicability: Required
Application exceptions: Combination-product results are not extended to the isolated effects of Nigella oil, piperine or purified thymoquinone, or to other products, populations or periods. Reported starting/final values and changes remain separate; no new effects, intervals, denominators, harm rates or dose totals are calculated.
Why this condition is needed: Material on TNSS/symptom-duration coprimary wording, plans and success criteria is needed to connect the combination-product question to its population, formulation, comparison, endpoint, timing, denominator or harms.
Referenced methods: Existing principles distinguish the exact combination product, adult men, seasonal rhinitis, placebo, TNSS and symptom duration, timing, original reported values, denominators, company involvement and harms.

N15 · What do 8.45→4.94 versus 7.69→6.66 represent?

Required materials and conditions: Arm-specific starting/final TNSS, means, dispersion, timing and denominators
Conditions for verification: Original records on Arm-specific starting/final TNSS, means, dispersion, timing and denominators must link to the same product, question, population, comparison, endpoint, timing and analysis denominator, distinguishing recorded information from gaps.
Requirement and applicability: Required
Application exceptions: Combination-product results are not extended to the isolated effects of Nigella oil, piperine or purified thymoquinone, or to other products, populations or periods. Reported starting/final values and changes remain separate; no new effects, intervals, denominators, harm rates or dose totals are calculated.
Why this condition is needed: Material on Arm-specific starting/final TNSS, means, dispersion, timing and denominators is needed to connect the combination-product question to its population, formulation, comparison, endpoint, timing, denominator or harms.
Referenced methods: Existing principles distinguish the exact combination product, adult men, seasonal rhinitis, placebo, TNSS and symptom duration, timing, original reported values, denominators, company involvement and harms.

N16 · How should −3.52 versus −1.03 points and P<.001 be read?

Required materials and conditions: Arm-specific changes, tested comparison, effect of interest and precision
Conditions for verification: Original records on Arm-specific changes, tested comparison, effect of interest and precision must link to the same product, question, population, comparison, endpoint, timing and analysis denominator, distinguishing recorded information from gaps.
Requirement and applicability: Required
Application exceptions: Combination-product results are not extended to the isolated effects of Nigella oil, piperine or purified thymoquinone, or to other products, populations or periods. Reported starting/final values and changes remain separate; no new effects, intervals, denominators, harm rates or dose totals are calculated.
Why this condition is needed: Material on Arm-specific changes, tested comparison, effect of interest and precision is needed to connect the combination-product question to its population, formulation, comparison, endpoint, timing, denominator or harms.
Referenced methods: Existing principles distinguish the exact combination product, adult men, seasonal rhinitis, placebo, TNSS and symptom duration, timing, original reported values, denominators, company involvement and harms.

N17 · What is missing about the change CI?

Required materials and conditions: Change/between-group-effect CI, dispersion, denominators and models
Conditions for verification: Original records on Change/between-group-effect CI, dispersion, denominators and models must link to the same product, question, population, comparison, endpoint, timing and analysis denominator, distinguishing recorded information from gaps.
Requirement and applicability: Required
Application exceptions: Combination-product results are not extended to the isolated effects of Nigella oil, piperine or purified thymoquinone, or to other products, populations or periods. Reported starting/final values and changes remain separate; no new effects, intervals, denominators, harm rates or dose totals are calculated.
Why this condition is needed: Material on Change/between-group-effect CI, dispersion, denominators and models is needed to connect the combination-product question to its population, formulation, comparison, endpoint, timing, denominator or harms.
Referenced methods: Existing principles distinguish the exact combination product, adult men, seasonal rhinitis, placebo, TNSS and symptom duration, timing, original reported values, denominators, company involvement and harms.

N18 · How were baseline TNSS and other differences considered?

Required materials and conditions: Baseline scores/characteristics, adjustment, regression, between-group analysis and alternatives
Conditions for verification: Original records on Baseline scores/characteristics, adjustment, regression, between-group analysis and alternatives must link to the same product, question, population, comparison, endpoint, timing and analysis denominator, distinguishing recorded information from gaps.
Requirement and applicability: Required
Application exceptions: Combination-product results are not extended to the isolated effects of Nigella oil, piperine or purified thymoquinone, or to other products, populations or periods. Reported starting/final values and changes remain separate; no new effects, intervals, denominators, harm rates or dose totals are calculated.
Why this condition is needed: Material on Baseline scores/characteristics, adjustment, regression, between-group analysis and alternatives is needed to connect the combination-product question to its population, formulation, comparison, endpoint, timing, denominator or harms.
Referenced methods: Existing principles distinguish the exact combination product, adult men, seasonal rhinitis, placebo, TNSS and symptom duration, timing, original reported values, denominators, company involvement and harms.

N19 · What denominators do 65 people and 33 versus 32 represent?

Required materials and conditions: Allocation, analysis, completion, arm mapping, TNSS, symptom-duration and harm denominators
Conditions for verification: Original records on Allocation, analysis, completion, arm mapping, TNSS, symptom-duration and harm denominators must link to the same product, question, population, comparison, endpoint, timing and analysis denominator, distinguishing recorded information from gaps.
Requirement and applicability: Required
Application exceptions: Combination-product results are not extended to the isolated effects of Nigella oil, piperine or purified thymoquinone, or to other products, populations or periods. Reported starting/final values and changes remain separate; no new effects, intervals, denominators, harm rates or dose totals are calculated.
Why this condition is needed: Material on Allocation, analysis, completion, arm mapping, TNSS, symptom-duration and harm denominators is needed to connect the combination-product question to its population, formulation, comparison, endpoint, timing, denominator or harms.
Referenced methods: Existing principles distinguish the exact combination product, adult men, seasonal rhinitis, placebo, TNSS and symptom duration, timing, original reported values, denominators, company involvement and harms.

N20 · Does completion establish complete outcomes and ITT analysis?

Required materials and conditions: Completion, attrition, missing data, ITT, PP, outcome availability and effect of interest
Conditions for verification: Original records on Completion, attrition, missing data, ITT, PP, outcome availability and effect of interest must link to the same product, question, population, comparison, endpoint, timing and analysis denominator, distinguishing recorded information from gaps.
Requirement and applicability: Required
Application exceptions: Combination-product results are not extended to the isolated effects of Nigella oil, piperine or purified thymoquinone, or to other products, populations or periods. Reported starting/final values and changes remain separate; no new effects, intervals, denominators, harm rates or dose totals are calculated.
Why this condition is needed: Material on Completion, attrition, missing data, ITT, PP, outcome availability and effect of interest is needed to connect the combination-product question to its population, formulation, comparison, endpoint, timing, denominator or harms.
Referenced methods: Existing principles distinguish the exact combination product, adult men, seasonal rhinitis, placebo, TNSS and symptom duration, timing, original reported values, denominators, company involvement and harms.

N21 · What were the allocation sequence, concealment and baseline characteristics?

Required materials and conditions: Random sequence generation, concealment, allocation and baseline balance
Conditions for verification: Original records on Random sequence generation, concealment, allocation and baseline balance must link to the same product, question, population, comparison, endpoint, timing and analysis denominator, distinguishing recorded information from gaps.
Requirement and applicability: Required
Application exceptions: Combination-product results are not extended to the isolated effects of Nigella oil, piperine or purified thymoquinone, or to other products, populations or periods. Reported starting/final values and changes remain separate; no new effects, intervals, denominators, harm rates or dose totals are calculated.
Why this condition is needed: Material on Random sequence generation, concealment, allocation and baseline balance is needed to connect the combination-product question to its population, formulation, comparison, endpoint, timing, denominator or harms.
Referenced methods: Existing principles distinguish the exact combination product, adult men, seasonal rhinitis, placebo, TNSS and symptom duration, timing, original reported values, denominators, company involvement and harms.

N22 · Who was masked and could the products be distinguished?

Required materials and conditions: Role-specific masking, appearance, sensory properties, maintenance, unmasking and measurement
Conditions for verification: Original records on Role-specific masking, appearance, sensory properties, maintenance, unmasking and measurement must link to the same product, question, population, comparison, endpoint, timing and analysis denominator, distinguishing recorded information from gaps.
Requirement and applicability: Required
Application exceptions: Combination-product results are not extended to the isolated effects of Nigella oil, piperine or purified thymoquinone, or to other products, populations or periods. Reported starting/final values and changes remain separate; no new effects, intervals, denominators, harm rates or dose totals are calculated.
Why this condition is needed: Material on Role-specific masking, appearance, sensory properties, maintenance, unmasking and measurement is needed to connect the combination-product question to its population, formulation, comparison, endpoint, timing, denominator or harms.
Referenced methods: Existing principles distinguish the exact combination product, adult men, seasonal rhinitis, placebo, TNSS and symptom duration, timing, original reported values, denominators, company involvement and harms.

N23 · How were product use and treatment deviations handled?

Required materials and conditions: Actual use, adherence, discontinuation, crossover, rescue medicines and effect of interest
Conditions for verification: Original records on Actual use, adherence, discontinuation, crossover, rescue medicines and effect of interest must link to the same product, question, population, comparison, endpoint, timing and analysis denominator, distinguishing recorded information from gaps.
Requirement and applicability: Required
Application exceptions: Combination-product results are not extended to the isolated effects of Nigella oil, piperine or purified thymoquinone, or to other products, populations or periods. Reported starting/final values and changes remain separate; no new effects, intervals, denominators, harm rates or dose totals are calculated.
Why this condition is needed: Material on Actual use, adherence, discontinuation, crossover, rescue medicines and effect of interest is needed to connect the combination-product question to its population, formulation, comparison, endpoint, timing, denominator or harms.
Referenced methods: Existing principles distinguish the exact combination product, adult men, seasonal rhinitis, placebo, TNSS and symptom duration, timing, original reported values, denominators, company involvement and harms.

N24 · How much is verified about CTRI/2022/07/044180?

Required materials and conditions: Original-record/citation registration identifiers versus registry contents, dates and actual reading
Conditions for verification: Original records on Original-record/citation registration identifiers versus registry contents, dates and actual reading must link to the same product, question, population, comparison, endpoint, timing and analysis denominator, distinguishing recorded information from gaps.
Requirement and applicability: Required
Application exceptions: Combination-product results are not extended to the isolated effects of Nigella oil, piperine or purified thymoquinone, or to other products, populations or periods. Reported starting/final values and changes remain separate; no new effects, intervals, denominators, harm rates or dose totals are calculated.
Why this condition is needed: Material on Original-record/citation registration identifiers versus registry contents, dates and actual reading is needed to connect the combination-product question to its population, formulation, comparison, endpoint, timing, denominator or harms.
Referenced methods: Existing principles distinguish the exact combination product, adult men, seasonal rhinitis, placebo, TNSS and symptom duration, timing, original reported values, denominators, company involvement and harms.

N25 · How were TNSS/symptom-duration success and multiplicity planned?

Required materials and conditions: Coprimary outcomes, planned analyses, timing, success criteria and adjustment
Conditions for verification: Original records on Coprimary outcomes, planned analyses, timing, success criteria and adjustment must link to the same product, question, population, comparison, endpoint, timing and analysis denominator, distinguishing recorded information from gaps.
Requirement and applicability: Required
Application exceptions: Combination-product results are not extended to the isolated effects of Nigella oil, piperine or purified thymoquinone, or to other products, populations or periods. Reported starting/final values and changes remain separate; no new effects, intervals, denominators, harm rates or dose totals are calculated.
Why this condition is needed: Material on Coprimary outcomes, planned analyses, timing, success criteria and adjustment is needed to connect the combination-product question to its population, formulation, comparison, endpoint, timing, denominator or harms.
Referenced methods: Existing principles distinguish the exact combination product, adult men, seasonal rhinitis, placebo, TNSS and symptom duration, timing, original reported values, denominators, company involvement and harms.

N26 · What remains unknown for the coprimary symptom-duration outcome?

Required materials and conditions: Symptom-duration definition, units, timing, arm-specific values, effects and denominators
Conditions for verification: Original records on Symptom-duration definition, units, timing, arm-specific values, effects and denominators must link to the same product, question, population, comparison, endpoint, timing and analysis denominator, distinguishing recorded information from gaps.
Requirement and applicability: Required
Application exceptions: Combination-product results are not extended to the isolated effects of Nigella oil, piperine or purified thymoquinone, or to other products, populations or periods. Reported starting/final values and changes remain separate; no new effects, intervals, denominators, harm rates or dose totals are calculated.
Why this condition is needed: Material on Symptom-duration definition, units, timing, arm-specific values, effects and denominators is needed to connect the combination-product question to its population, formulation, comparison, endpoint, timing, denominator or harms.
Referenced methods: Existing principles distinguish the exact combination product, adult men, seasonal rhinitis, placebo, TNSS and symptom duration, timing, original reported values, denominators, company involvement and harms.

N27 · Does 15-day TNSS establish medication sparing or management across the season?

Required materials and conditions: Rescue/regular medicines, seasonal/long-term follow-up, treatment strategies and recurrence
Conditions for verification: Original records on Rescue/regular medicines, seasonal/long-term follow-up, treatment strategies and recurrence must link to the same product, question, population, comparison, endpoint, timing and analysis denominator, distinguishing recorded information from gaps.
Requirement and applicability: Supplementary; required for claims about long-term management or medication sparing
Application exceptions: Combination-product results are not extended to the isolated effects of Nigella oil, piperine or purified thymoquinone, or to other products, populations or periods. Reported starting/final values and changes remain separate; no new effects, intervals, denominators, harm rates or dose totals are calculated.
Why this condition is needed: Material on Rescue/regular medicines, seasonal/long-term follow-up, treatment strategies and recurrence is needed to connect the combination-product question to its population, formulation, comparison, endpoint, timing, denominator or harms.
Referenced methods: Existing principles distinguish the exact combination product, adult men, seasonal rhinitis, placebo, TNSS and symptom duration, timing, original reported values, denominators, company involvement and harms.

N28 · What is the scope of the original large-TNSS-change interpretation?

Required materials and conditions: Effects, CI, prespecified important difference, patient-important outcomes and responders
Conditions for verification: Original records on Effects, CI, prespecified important difference, patient-important outcomes and responders must link to the same product, question, population, comparison, endpoint, timing and analysis denominator, distinguishing recorded information from gaps.
Requirement and applicability: Required
Application exceptions: Combination-product results are not extended to the isolated effects of Nigella oil, piperine or purified thymoquinone, or to other products, populations or periods. Reported starting/final values and changes remain separate; no new effects, intervals, denominators, harm rates or dose totals are calculated.
Why this condition is needed: Material on Effects, CI, prespecified important difference, patient-important outcomes and responders is needed to connect the combination-product question to its population, formulation, comparison, endpoint, timing, denominator or harms.
Referenced methods: Existing principles distinguish the exact combination product, adult men, seasonal rhinitis, placebo, TNSS and symptom duration, timing, original reported values, denominators, company involvement and harms.

N29 · Which report do the stored summary and PMID/PMCID/DOI identify?

Required materials and conditions: Research reports, same-trial/registration families and original citation
Conditions for verification: Original records on Research reports, same-trial/registration families and original citation must link to the same product, question, population, comparison, endpoint, timing and analysis denominator, distinguishing recorded information from gaps.
Requirement and applicability: Required
Application exceptions: Combination-product results are not extended to the isolated effects of Nigella oil, piperine or purified thymoquinone, or to other products, populations or periods. Reported starting/final values and changes remain separate; no new effects, intervals, denominators, harm rates or dose totals are calculated.
Why this condition is needed: Material on Research reports, same-trial/registration families and original citation is needed to connect the combination-product question to its population, formulation, comparison, endpoint, timing, denominator or harms.
Referenced methods: Existing principles distinguish the exact combination product, adult men, seasonal rhinitis, placebo, TNSS and symptom duration, timing, original reported values, denominators, company involvement and harms.

N30 · How do the no-funding statement and company involvement differ?

Required materials and conditions: Cash funding, product support, employee authorship, COI and company roles
Conditions for verification: Original records on Cash funding, product support, employee authorship, COI and company roles must link to the same product, question, population, comparison, endpoint, timing and analysis denominator, distinguishing recorded information from gaps.
Requirement and applicability: Required
Application exceptions: Combination-product results are not extended to the isolated effects of Nigella oil, piperine or purified thymoquinone, or to other products, populations or periods. Reported starting/final values and changes remain separate; no new effects, intervals, denominators, harm rates or dose totals are calculated.
Why this condition is needed: Material on Cash funding, product support, employee authorship, COI and company roles is needed to connect the combination-product question to its population, formulation, comparison, endpoint, timing, denominator or harms.
Referenced methods: Existing principles distinguish the exact combination product, adult men, seasonal rhinitis, placebo, TNSS and symptom duration, timing, original reported values, denominators, company involvement and harms.

N31 · What remains unknown about independent replication of the same product?

Required materials and conditions: Product/question matching, teams, support, report families and independent replication
Conditions for verification: Original records on Product/question matching, teams, support, report families and independent replication must link to the same product, question, population, comparison, endpoint, timing and analysis denominator, distinguishing recorded information from gaps.
Requirement and applicability: Required
Application exceptions: Combination-product results are not extended to the isolated effects of Nigella oil, piperine or purified thymoquinone, or to other products, populations or periods. Reported starting/final values and changes remain separate; no new effects, intervals, denominators, harm rates or dose totals are calculated.
Why this condition is needed: Material on Product/question matching, teams, support, report families and independent replication is needed to connect the combination-product question to its population, formulation, comparison, endpoint, timing, denominator or harms.
Referenced methods: Existing principles distinguish the exact combination product, adult men, seasonal rhinitis, placebo, TNSS and symptom duration, timing, original reported values, denominators, company involvement and harms.

N32 · Were the original paper, PMCID text and registration actually read?

Required materials and conditions: Stored summary, PubMed link, PMCID citation and external content reading
Conditions for verification: Original records on Stored summary, PubMed link, PMCID citation and external content reading must link to the same product, question, population, comparison, endpoint, timing and analysis denominator, distinguishing recorded information from gaps.
Requirement and applicability: Required
Application exceptions: Combination-product results are not extended to the isolated effects of Nigella oil, piperine or purified thymoquinone, or to other products, populations or periods. Reported starting/final values and changes remain separate; no new effects, intervals, denominators, harm rates or dose totals are calculated.
Why this condition is needed: Material on Stored summary, PubMed link, PMCID citation and external content reading is needed to connect the combination-product question to its population, formulation, comparison, endpoint, timing, denominator or harms.
Referenced methods: Existing principles distinguish the exact combination product, adult men, seasonal rhinitis, placebo, TNSS and symptom duration, timing, original reported values, denominators, company involvement and harms.

N33 · Are the original evidence date and current production time distinguished?

Required materials and conditions: Original-record date, correction date,2024 citation, actual reading, searches and production
Conditions for verification: Original records on Original-record date, correction date,2024 citation, actual reading, searches and production must link to the same product, question, population, comparison, endpoint, timing and analysis denominator, distinguishing recorded information from gaps.
Requirement and applicability: Required
Application exceptions: Combination-product results are not extended to the isolated effects of Nigella oil, piperine or purified thymoquinone, or to other products, populations or periods. Reported starting/final values and changes remain separate; no new effects, intervals, denominators, harm rates or dose totals are calculated.
Why this condition is needed: Material on Original-record date, correction date,2024 citation, actual reading, searches and production is needed to connect the combination-product question to its population, formulation, comparison, endpoint, timing, denominator or harms.
Referenced methods: Existing principles distinguish the exact combination product, adult men, seasonal rhinitis, placebo, TNSS and symptom duration, timing, original reported values, denominators, company involvement and harms.

N34 · What is the status of generic English wording and the 1-field correction?

Required materials and conditions: Korean/English reported values, generic English explanations and before/after correction originals
Conditions for verification: Original records on Korean/English reported values, generic English explanations and before/after correction originals must link to the same product, question, population, comparison, endpoint, timing and analysis denominator, distinguishing recorded information from gaps.
Requirement and applicability: Required
Application exceptions: Combination-product results are not extended to the isolated effects of Nigella oil, piperine or purified thymoquinone, or to other products, populations or periods. Reported starting/final values and changes remain separate; no new effects, intervals, denominators, harm rates or dose totals are calculated.
Why this condition is needed: Material on Korean/English reported values, generic English explanations and before/after correction originals is needed to connect the combination-product question to its population, formulation, comparison, endpoint, timing, denominator or harms.
Referenced methods: Existing principles distinguish the exact combination product, adult men, seasonal rhinitis, placebo, TNSS and symptom duration, timing, original reported values, denominators, company involvement and harms.

N35 · What historical records are C50, I0 and the existing settings?

Required materials and conditions: Original grade, score, safety label, assessment records, grade rationale and empty values
Conditions for verification: Original records on Original grade, score, safety label, assessment records, grade rationale and empty values must link to the same product, question, population, comparison, endpoint, timing and analysis denominator, distinguishing recorded information from gaps.
Requirement and applicability: Required
Application exceptions: Combination-product results are not extended to the isolated effects of Nigella oil, piperine or purified thymoquinone, or to other products, populations or periods. Reported starting/final values and changes remain separate; no new effects, intervals, denominators, harm rates or dose totals are calculated.
Why this condition is needed: Material on Original grade, score, safety label, assessment records, grade rationale and empty values is needed to connect the combination-product question to its population, formulation, comparison, endpoint, timing, denominator or harms.
Referenced methods: Existing principles distinguish the exact combination product, adult men, seasonal rhinitis, placebo, TNSS and symptom duration, timing, original reported values, denominators, company involvement and harms.

N36 · What denominators supported collection of actual 15-day combination harms?

Required materials and conditions: Event definitions, collection, arm-specific events, denominators, discontinuation, missingness and timing
Conditions for verification: Original records on Event definitions, collection, arm-specific events, denominators, discontinuation, missingness and timing must link to the same product, question, population, comparison, endpoint, timing and analysis denominator, distinguishing recorded information from gaps.
Requirement and applicability: Required
Application exceptions: Combination-product results are not extended to the isolated effects of Nigella oil, piperine or purified thymoquinone, or to other products, populations or periods. Reported starting/final values and changes remain separate; no new effects, intervals, denominators, harm rates or dose totals are calculated.
Why this condition is needed: Material on Event definitions, collection, arm-specific events, denominators, discontinuation, missingness and timing is needed to connect the combination-product question to its population, formulation, comparison, endpoint, timing, denominator or harms.
Referenced methods: Existing principles distinguish the exact combination product, adult men, seasonal rhinitis, placebo, TNSS and symptom duration, timing, original reported values, denominators, company involvement and harms.

N37 · Are harms of the piperine combination and caution-listed medicines verified?

Required materials and conditions: Combined/isolated exposure, concomitant medicines, interaction events, denominators and contribution
Conditions for verification: Original records on Combined/isolated exposure, concomitant medicines, interaction events, denominators and contribution must link to the same product, question, population, comparison, endpoint, timing and analysis denominator, distinguishing recorded information from gaps.
Requirement and applicability: Supplementary; required within concomitant-use or combination-harm scope
Application exceptions: Combination-product results are not extended to the isolated effects of Nigella oil, piperine or purified thymoquinone, or to other products, populations or periods. Reported starting/final values and changes remain separate; no new effects, intervals, denominators, harm rates or dose totals are calculated.
Why this condition is needed: Material on Combined/isolated exposure, concomitant medicines, interaction events, denominators and contribution is needed to connect the combination-product question to its population, formulation, comparison, endpoint, timing, denominator or harms.
Referenced methods: Existing principles distinguish the exact combination product, adult men, seasonal rhinitis, placebo, TNSS and symptom duration, timing, original reported values, denominators, company involvement and harms.

N38 · What about safety beyond a short male trial?

Required materials and conditions: Formulation-specific long-term/rare harms, pregnancy, breastfeeding, children, liver/kidney disease and surgery
Conditions for verification: Original records on Formulation-specific long-term/rare harms, pregnancy, breastfeeding, children, liver/kidney disease and surgery must link to the same product, question, population, comparison, endpoint, timing and analysis denominator, distinguishing recorded information from gaps.
Requirement and applicability: Supplementary; required for long-term or vulnerable-group safety claims
Application exceptions: Combination-product results are not extended to the isolated effects of Nigella oil, piperine or purified thymoquinone, or to other products, populations or periods. Reported starting/final values and changes remain separate; no new effects, intervals, denominators, harm rates or dose totals are calculated.
Why this condition is needed: Material on Formulation-specific long-term/rare harms, pregnancy, breastfeeding, children, liver/kidney disease and surgery is needed to connect the combination-product question to its population, formulation, comparison, endpoint, timing, denominator or harms.
Referenced methods: Existing principles distinguish the exact combination product, adult men, seasonal rhinitis, placebo, TNSS and symptom duration, timing, original reported values, denominators, company involvement and harms.

N39 · What are individual event timelines and alternative causes?

Required materials and conditions: Onset, recovery, discontinuation, re-exposure, concomitant medicines, underlying illness and alternatives
Conditions for verification: Original records on Onset, recovery, discontinuation, re-exposure, concomitant medicines, underlying illness and alternatives must link to the same product, question, population, comparison, endpoint, timing and analysis denominator, distinguishing recorded information from gaps.
Requirement and applicability: Required
Application exceptions: Combination-product results are not extended to the isolated effects of Nigella oil, piperine or purified thymoquinone, or to other products, populations or periods. Reported starting/final values and changes remain separate; no new effects, intervals, denominators, harm rates or dose totals are calculated.
Why this condition is needed: Material on Onset, recovery, discontinuation, re-exposure, concomitant medicines, underlying illness and alternatives is needed to connect the combination-product question to its population, formulation, comparison, endpoint, timing, denominator or harms.
Referenced methods: Existing principles distinguish the exact combination product, adult men, seasonal rhinitis, placebo, TNSS and symptom duration, timing, original reported values, denominators, company involvement and harms.

N40 · Were events with the same combination repeated in independent material?

Required materials and conditions: Unique cases, formulation/exposure/event matching, report families and repeated citations
Conditions for verification: Original records on Unique cases, formulation/exposure/event matching, report families and repeated citations must link to the same product, question, population, comparison, endpoint, timing and analysis denominator, distinguishing recorded information from gaps.
Requirement and applicability: Supplementary; required for repeated-harm claims
Application exceptions: Combination-product results are not extended to the isolated effects of Nigella oil, piperine or purified thymoquinone, or to other products, populations or periods. Reported starting/final values and changes remain separate; no new effects, intervals, denominators, harm rates or dose totals are calculated.
Why this condition is needed: Material on Unique cases, formulation/exposure/event matching, report families and repeated citations is needed to connect the combination-product question to its population, formulation, comparison, endpoint, timing, denominator or harms.
Referenced methods: Existing principles distinguish the exact combination product, adult men, seasonal rhinitis, placebo, TNSS and symptom duration, timing, original reported values, denominators, company involvement and harms.

N41 · How are the read summary, unread material and later changes linked?

Required materials and conditions: Material-specific availability/reading, original citation links and condition/evidence-change events
Conditions for verification: Original records on Material-specific availability/reading, original citation links and condition/evidence-change events must link to the same product, question, population, comparison, endpoint, timing and analysis denominator, distinguishing recorded information from gaps.
Requirement and applicability: Required
Application exceptions: Combination-product results are not extended to the isolated effects of Nigella oil, piperine or purified thymoquinone, or to other products, populations or periods. Reported starting/final values and changes remain separate; no new effects, intervals, denominators, harm rates or dose totals are calculated.
Why this condition is needed: Material on Material-specific availability/reading, original citation links and condition/evidence-change events is needed to connect the combination-product question to its population, formulation, comparison, endpoint, timing, denominator or harms.
Referenced methods: Existing principles distinguish the exact combination product, adult men, seasonal rhinitis, placebo, TNSS and symptom duration, timing, original reported values, denominators, company involvement 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 41 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 · Which combination and rhinitis outcome does this sheet address?

Current findings: The selected claim is relief of TNSS in adult seasonal allergic rhinitis. The original population is adult men and the question concerns the combination product rather than Nigella alone.
Verification status: Partly verified
Materials actually read: Existing Korean and English stored summaries and bibliography for the combination-product report read; external abstracts, full text, registration, protocols and analysis plans unread
Why unverified: Stored information is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.
Reason for missing information: Review of the independent-question boundary remains incomplete and the subclaim list is empty.
Required materials and conditions: Standardized Nigella oil and piperine, men with seasonal rhinitis,15-day TNSS and placebo
Materials to obtain first: Trial question, eligibility, intervention and TNSS definition
Further research: Material needed: Trial question, eligibility, intervention and TNSS definition This records needed materials; no new research was executed.
Remaining uncertainty: Gaps in product quality, seasonal exposure, concomitant medicines, scale, analysis denominators, plans, company roles and harms remain. Significance is not converted into clinical importance or success across all coprimary outcomes, or complete follow-up into absence of missing data or adverse events.
Conditions for verification: Original records on Standardized Nigella oil and piperine, men with seasonal rhinitis,15-day TNSS and placebo must link to the same product, question, population, comparison, endpoint, timing and analysis denominator, distinguishing recorded information from gaps.
Why this condition is needed: Material on Standardized Nigella oil and piperine, men with seasonal rhinitis,15-day TNSS and placebo is needed to connect the combination-product question to its population, formulation, comparison, endpoint, timing, denominator or harms.
Application exceptions: Combination-product results are not extended to the isolated effects of Nigella oil, piperine or purified thymoquinone, or to other products, populations or periods. Reported starting/final values and changes remain separate; no new effects, intervals, denominators, harm rates or dose totals are calculated.
Referenced methods: Existing principles distinguish the exact combination product, adult men, seasonal rhinitis, placebo, TNSS and symptom duration, timing, original reported values, denominators, company involvement and harms.

Related sources R01

N02 · What intervention combines Nigellin Amber and BioPerine?

Current findings: The original record is a combination capsule of supercritical Nigellin Amber(5% thymoquinone) and BioPerine 2.5 mg.
Verification status: Partly verified
Materials actually read: Existing Korean and English stored summaries and bibliography for the combination-product report read; external abstracts, full text, registration, protocols and analysis plans unread
Why unverified: Stored information is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.
Reason for missing information: Complete composition, excipients, raw material, batch, constituent measurements and quality remain unverified.
Required materials and conditions: Supercritical seed fixed oil,5% thymoquinone and 2.5 mg piperine combination
Materials to obtain first: Product composition, extraction, standardization and batch analysis
Further research: Material needed: Product composition, extraction, standardization and batch analysis This records needed materials; no new research was executed.
Remaining uncertainty: Gaps in product quality, seasonal exposure, concomitant medicines, scale, analysis denominators, plans, company roles and harms remain. Significance is not converted into clinical importance or success across all coprimary outcomes, or complete follow-up into absence of missing data or adverse events.
Conditions for verification: Original records on Supercritical seed fixed oil,5% thymoquinone and 2.5 mg piperine combination must link to the same product, question, population, comparison, endpoint, timing and analysis denominator, distinguishing recorded information from gaps.
Why this condition is needed: Material on Supercritical seed fixed oil,5% thymoquinone and 2.5 mg piperine combination is needed to connect the combination-product question to its population, formulation, comparison, endpoint, timing, denominator or harms.
Application exceptions: Combination-product results are not extended to the isolated effects of Nigella oil, piperine or purified thymoquinone, or to other products, populations or periods. Reported starting/final values and changes remain separate; no new effects, intervals, denominators, harm rates or dose totals are calculated.
Referenced methods: Existing principles distinguish the exact combination product, adult men, seasonal rhinitis, placebo, TNSS and symptom duration, timing, original reported values, denominators, company involvement and harms.

Related sources R01

N03 · What quality evidence supports 5% thymoquinone standardization?

Current findings: The original formulation records 5% thymoquinone-standardized seed oil and BioPerine.
Verification status: Partly verified
Materials actually read: Existing Korean and English stored summaries and bibliography for the combination-product report read; external abstracts, full text, registration, protocols and analysis plans unread
Why unverified: Stored information is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.
Reason for missing information: Original batch measurements, analytical methods, tolerances, storage, contaminants and uniformity remain unverified.
Required materials and conditions: Seed-oil standardization, measurement, quality, piperine content and product preservation
Materials to obtain first: Standardization, composition analysis, batch quality and stability material
Further research: Material needed: Standardization, composition analysis, batch quality and stability material This records needed materials; no new research was executed.
Remaining uncertainty: Gaps in product quality, seasonal exposure, concomitant medicines, scale, analysis denominators, plans, company roles and harms remain. Significance is not converted into clinical importance or success across all coprimary outcomes, or complete follow-up into absence of missing data or adverse events.
Conditions for verification: Original records on Seed-oil standardization, measurement, quality, piperine content and product preservation must link to the same product, question, population, comparison, endpoint, timing and analysis denominator, distinguishing recorded information from gaps.
Why this condition is needed: Material on Seed-oil standardization, measurement, quality, piperine content and product preservation is needed to connect the combination-product question to its population, formulation, comparison, endpoint, timing, denominator or harms.
Application exceptions: Combination-product results are not extended to the isolated effects of Nigella oil, piperine or purified thymoquinone, or to other products, populations or periods. Reported starting/final values and changes remain separate; no new effects, intervals, denominators, harm rates or dose totals are calculated.
Referenced methods: Existing principles distinguish the exact combination product, adult men, seasonal rhinitis, placebo, TNSS and symptom duration, timing, original reported values, denominators, company involvement and harms.

Related sources R01

N04 · How were 250 mg oil+2.5 mg piperine used 2 times daily?

Current findings: The original dose record is 250 mg seed oil and 2.5 mg piperine 2 times daily.
Verification status: Partly verified
Materials actually read: Existing Korean and English stored summaries and bibliography for the combination-product report read; external abstracts, full text, registration, protocols and analysis plans unread
Why unverified: Stored information is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.
Reason for missing information: Dosing time, relation to food, actual use/adherence, omissions, excess use and exposure remain unverified.
Required materials and conditions: Constituents per 1 dose, frequency, use, adherence and actual exposure
Materials to obtain first: Product contents, dosing procedures and use diaries
Further research: Material needed: Product contents, dosing procedures and use diaries This records needed materials; no new research was executed.
Remaining uncertainty: Gaps in product quality, seasonal exposure, concomitant medicines, scale, analysis denominators, plans, company roles and harms remain. Significance is not converted into clinical importance or success across all coprimary outcomes, or complete follow-up into absence of missing data or adverse events.
Conditions for verification: Original records on Constituents per 1 dose, frequency, use, adherence and actual exposure must link to the same product, question, population, comparison, endpoint, timing and analysis denominator, distinguishing recorded information from gaps.
Why this condition is needed: Material on Constituents per 1 dose, frequency, use, adherence and actual exposure is needed to connect the combination-product question to its population, formulation, comparison, endpoint, timing, denominator or harms.
Application exceptions: Combination-product results are not extended to the isolated effects of Nigella oil, piperine or purified thymoquinone, or to other products, populations or periods. Reported starting/final values and changes remain separate; no new effects, intervals, denominators, harm rates or dose totals are calculated.
Referenced methods: Existing principles distinguish the exact combination product, adult men, seasonal rhinitis, placebo, TNSS and symptom duration, timing, original reported values, denominators, company involvement and harms.

Related sources R01

N05 · Can the combination result establish a Nigella-oil-only effect?

Current findings: The original explanation that both constituents were administered together and Nigella oil's isolated contribution was not separated is retained.
Verification status: Partly verified
Materials actually read: Existing Korean and English stored summaries and bibliography for the combination-product report read; external abstracts, full text, registration, protocols and analysis plans unread
Why unverified: Stored information is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.
Reason for missing information: Constituent-only arms, factorial effects, interactions and quantified contributions remain unverified.
Required materials and conditions: Nigella-only and piperine-only arms, combination arm, factorial design and isolated contribution
Materials to obtain first: Direct studies with constituent-specific arms and composition tables
Further research: Material needed: Direct studies with constituent-specific arms and composition tables This records needed materials; no new research was executed.
Remaining uncertainty: Gaps in product quality, seasonal exposure, concomitant medicines, scale, analysis denominators, plans, company roles and harms remain. Significance is not converted into clinical importance or success across all coprimary outcomes, or complete follow-up into absence of missing data or adverse events.
Conditions for verification: Original records on Nigella-only and piperine-only arms, combination arm, factorial design and isolated contribution must link to the same product, question, population, comparison, endpoint, timing and analysis denominator, distinguishing recorded information from gaps.
Why this condition is needed: Material on Nigella-only and piperine-only arms, combination arm, factorial design and isolated contribution is needed to connect the combination-product question to its population, formulation, comparison, endpoint, timing, denominator or harms.
Application exceptions: Combination-product results are not extended to the isolated effects of Nigella oil, piperine or purified thymoquinone, or to other products, populations or periods. Reported starting/final values and changes remain separate; no new effects, intervals, denominators, harm rates or dose totals are calculated.
Referenced methods: Existing principles distinguish the exact combination product, adult men, seasonal rhinitis, placebo, TNSS and symptom duration, timing, original reported values, denominators, company involvement and harms.

Related sources R01

N06 · Do other Nigella products answer the same question?

Current findings: The original route is oral. Existing wording distinguishes formulations rather than treating them as interchangeable.
Verification status: Partly verified
Materials actually read: Existing Korean and English stored summaries and bibliography for the combination-product report read; external abstracts, full text, registration, protocols and analysis plans unread
Why unverified: Stored information is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.
Reason for missing information: Direct effects of piperine-free oil, seeds, topical products or products with other extraction methods or contents remain unverified.
Required materials and conditions: Seed powder, fixed oil, aqueous extracts, topical products, purified constituents, combinations and oral route
Materials to obtain first: Direct rhinitis studies for the exact formulation and route
Further research: Material needed: Direct rhinitis studies for the exact formulation and route This records needed materials; no new research was executed.
Remaining uncertainty: Gaps in product quality, seasonal exposure, concomitant medicines, scale, analysis denominators, plans, company roles and harms remain. Significance is not converted into clinical importance or success across all coprimary outcomes, or complete follow-up into absence of missing data or adverse events.
Conditions for verification: Original records on Seed powder, fixed oil, aqueous extracts, topical products, purified constituents, combinations and oral route must link to the same product, question, population, comparison, endpoint, timing and analysis denominator, distinguishing recorded information from gaps.
Why this condition is needed: Material on Seed powder, fixed oil, aqueous extracts, topical products, purified constituents, combinations and oral route is needed to connect the combination-product question to its population, formulation, comparison, endpoint, timing, denominator or harms.
Application exceptions: Combination-product results are not extended to the isolated effects of Nigella oil, piperine or purified thymoquinone, or to other products, populations or periods. Reported starting/final values and changes remain separate; no new effects, intervals, denominators, harm rates or dose totals are calculated.
Referenced methods: Existing principles distinguish the exact combination product, adult men, seasonal rhinitis, placebo, TNSS and symptom duration, timing, original reported values, denominators, company involvement and harms.

Related sources R01

N07 · How far do adult-male results apply?

Current findings: The original population is adult men with seasonal rhinitis, with all participants described as male. Results are not extended to women, children, single constituents or long-term prevention.
Verification status: Partly verified
Materials actually read: Existing Korean and English stored summaries and bibliography for the combination-product report read; external abstracts, full text, registration, protocols and analysis plans unread
Why unverified: Stored information is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.
Reason for missing information: Specific ages, eligibility, women, children, perennial rhinitis and effects in other populations remain unverified.
Required materials and conditions: Adult men, seasonal-rhinitis eligibility, and distinctions from women, children and other populations
Materials to obtain first: Eligibility, baseline characteristics and population-specific direct material
Further research: Material needed: Eligibility, baseline characteristics and population-specific direct material This records needed materials; no new research was executed.
Remaining uncertainty: Gaps in product quality, seasonal exposure, concomitant medicines, scale, analysis denominators, plans, company roles and harms remain. Significance is not converted into clinical importance or success across all coprimary outcomes, or complete follow-up into absence of missing data or adverse events.
Conditions for verification: Original records on Adult men, seasonal-rhinitis eligibility, and distinctions from women, children and other populations must link to the same product, question, population, comparison, endpoint, timing and analysis denominator, distinguishing recorded information from gaps.
Why this condition is needed: Material on Adult men, seasonal-rhinitis eligibility, and distinctions from women, children and other populations is needed to connect the combination-product question to its population, formulation, comparison, endpoint, timing, denominator or harms.
Application exceptions: Combination-product results are not extended to the isolated effects of Nigella oil, piperine or purified thymoquinone, or to other products, populations or periods. Reported starting/final values and changes remain separate; no new effects, intervals, denominators, harm rates or dose totals are calculated.
Referenced methods: Existing principles distinguish the exact combination product, adult men, seasonal rhinitis, placebo, TNSS and symptom duration, timing, original reported values, denominators, company involvement and harms.

Related sources R01

N08 · How were seasonal rhinitis and severity diagnosed?

Current findings: The original population has seasonal allergic rhinitis and the stored result includes starting TNSS 8.45 versus 7.69.
Verification status: Unverified
Materials actually read: Existing Korean and English stored summaries and bibliography for the combination-product report read; external abstracts, full text, registration, protocols and analysis plans unread
Why unverified: Stored information is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.
Reason for missing information: Diagnosis, sensitization tests, allergens, baseline severity criteria, symptom duration, medicines and exclusion criteria remain unverified.
Required materials and conditions: Diagnosis, allergens, baseline TNSS, duration, eligibility and baseline medicines
Materials to obtain first: Diagnosis, eligibility, allergens and baseline-characteristics tables
Further research: Material needed: Diagnosis, eligibility, allergens and baseline-characteristics tables This records needed materials; no new research was executed.
Remaining uncertainty: Gaps in product quality, seasonal exposure, concomitant medicines, scale, analysis denominators, plans, company roles and harms remain. Significance is not converted into clinical importance or success across all coprimary outcomes, or complete follow-up into absence of missing data or adverse events.
Conditions for verification: Original records on Diagnosis, allergens, baseline TNSS, duration, eligibility and baseline medicines must link to the same product, question, population, comparison, endpoint, timing and analysis denominator, distinguishing recorded information from gaps.
Why this condition is needed: Material on Diagnosis, allergens, baseline TNSS, duration, eligibility and baseline medicines is needed to connect the combination-product question to its population, formulation, comparison, endpoint, timing, denominator or harms.
Application exceptions: Combination-product results are not extended to the isolated effects of Nigella oil, piperine or purified thymoquinone, or to other products, populations or periods. Reported starting/final values and changes remain separate; no new effects, intervals, denominators, harm rates or dose totals are calculated.
Referenced methods: Existing principles distinguish the exact combination product, adult men, seasonal rhinitis, placebo, TNSS and symptom duration, timing, original reported values, denominators, company involvement and harms.

Related sources R01

N09 · How did seasonal and allergen exposure compare over 15 days?

Current findings: The stored account describes a 15-day seasonal-rhinitis trial.
Verification status: Unverified
Materials actually read: Existing Korean and English stored summaries and bibliography for the combination-product report read; external abstracts, full text, registration, protocols and analysis plans unread
Why unverified: Stored information is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.
Reason for missing information: Season, region, allergen intensity, avoidance, environmental changes and balance of exposure across arms remain unverified.
Required materials and conditions: Actual season, region, pollen, environment, exposure differences and concurrent changes
Materials to obtain first: Trial dates, region, environment, exposure and common-management records
Further research: Material needed: Trial dates, region, environment, exposure and common-management records This records needed materials; no new research was executed.
Remaining uncertainty: Gaps in product quality, seasonal exposure, concomitant medicines, scale, analysis denominators, plans, company roles and harms remain. Significance is not converted into clinical importance or success across all coprimary outcomes, or complete follow-up into absence of missing data or adverse events.
Conditions for verification: Original records on Actual season, region, pollen, environment, exposure differences and concurrent changes must link to the same product, question, population, comparison, endpoint, timing and analysis denominator, distinguishing recorded information from gaps.
Why this condition is needed: Material on Actual season, region, pollen, environment, exposure differences and concurrent changes is needed to connect the combination-product question to its population, formulation, comparison, endpoint, timing, denominator or harms.
Application exceptions: Combination-product results are not extended to the isolated effects of Nigella oil, piperine or purified thymoquinone, or to other products, populations or periods. Reported starting/final values and changes remain separate; no new effects, intervals, denominators, harm rates or dose totals are calculated.
Referenced methods: Existing principles distinguish the exact combination product, adult men, seasonal rhinitis, placebo, TNSS and symptom duration, timing, original reported values, denominators, company involvement and harms.

Related sources R01

N10 · What placebo and common management were compared?

Current findings: The original description of a fixed standardized seed-oil/piperine combination compared with matched-appearance placebo is retained.
Verification status: Partly verified
Materials actually read: Existing Korean and English stored summaries and bibliography for the combination-product report read; external abstracts, full text, registration, protocols and analysis plans unread
Why unverified: Stored information is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.
Reason for missing information: Placebo contents, appearance, taste, common management and maintained masking remain unverified.
Required materials and conditions: Placebo composition/appearance, common treatment and product distinguishability
Materials to obtain first: Placebo composition, product appearance and common-treatment tables
Further research: Material needed: Placebo composition, product appearance and common-treatment tables This records needed materials; no new research was executed.
Remaining uncertainty: Gaps in product quality, seasonal exposure, concomitant medicines, scale, analysis denominators, plans, company roles and harms remain. Significance is not converted into clinical importance or success across all coprimary outcomes, or complete follow-up into absence of missing data or adverse events.
Conditions for verification: Original records on Placebo composition/appearance, common treatment and product distinguishability must link to the same product, question, population, comparison, endpoint, timing and analysis denominator, distinguishing recorded information from gaps.
Why this condition is needed: Material on Placebo composition/appearance, common treatment and product distinguishability is needed to connect the combination-product question to its population, formulation, comparison, endpoint, timing, denominator or harms.
Application exceptions: Combination-product results are not extended to the isolated effects of Nigella oil, piperine or purified thymoquinone, or to other products, populations or periods. Reported starting/final values and changes remain separate; no new effects, intervals, denominators, harm rates or dose totals are calculated.
Referenced methods: Existing principles distinguish the exact combination product, adult men, seasonal rhinitis, placebo, TNSS and symptom duration, timing, original reported values, denominators, company involvement and harms.

Related sources R01

N11 · What concurrent effects might rhinitis medicines, rescue treatment and avoidance have?

Current findings: The original explanation distinguishes 15-day TNSS from medication sparing.
Verification status: Unverified
Materials actually read: Existing Korean and English stored summaries and bibliography for the combination-product report read; external abstracts, full text, registration, protocols and analysis plans unread
Why unverified: Stored information is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.
Reason for missing information: Permitted use, washout and arm-specific use of rhinitis/rescue medicines, allergen avoidance and medicine changes remain unverified.
Required materials and conditions: Concomitant medicines, washout, rescue antihistamines, other medicines, avoidance and arm-specific use
Materials to obtain first: Concomitant/rescue-medication plans, arm-specific use and avoidance material
Further research: Material needed: Concomitant/rescue-medication plans, arm-specific use and avoidance material This records needed materials; no new research was executed.
Remaining uncertainty: Gaps in product quality, seasonal exposure, concomitant medicines, scale, analysis denominators, plans, company roles and harms remain. Significance is not converted into clinical importance or success across all coprimary outcomes, or complete follow-up into absence of missing data or adverse events.
Conditions for verification: Original records on Concomitant medicines, washout, rescue antihistamines, other medicines, avoidance and arm-specific use must link to the same product, question, population, comparison, endpoint, timing and analysis denominator, distinguishing recorded information from gaps.
Why this condition is needed: Material on Concomitant medicines, washout, rescue antihistamines, other medicines, avoidance and arm-specific use is needed to connect the combination-product question to its population, formulation, comparison, endpoint, timing, denominator or harms.
Application exceptions: Combination-product results are not extended to the isolated effects of Nigella oil, piperine or purified thymoquinone, or to other products, populations or periods. Reported starting/final values and changes remain separate; no new effects, intervals, denominators, harm rates or dose totals are calculated.
Referenced methods: Existing principles distinguish the exact combination product, adult men, seasonal rhinitis, placebo, TNSS and symptom duration, timing, original reported values, denominators, company involvement and harms.

Related sources R01

N12 · What are the exact 15-day treatment and follow-up time points?

Current findings: The original duration is 15 days of treatment/follow-up and the selected endpoint is 15-day TNSS change.
Verification status: Partly verified
Materials actually read: Existing Korean and English stored summaries and bibliography for the combination-product report read; external abstracts, full text, registration, protocols and analysis plans unread
Why unverified: Stored information is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.
Reason for missing information: Interim assessments, persistence, post-discontinuation follow-up and management across the season remain unverified.
Required materials and conditions: Treatment, visits, starting/final assessments,15-day TNSS and post-discontinuation follow-up
Materials to obtain first: Visits, dosing, symptom-recording schedules and subsequent follow-up
Further research: Material needed: Visits, dosing, symptom-recording schedules and subsequent follow-up This records needed materials; no new research was executed.
Remaining uncertainty: Gaps in product quality, seasonal exposure, concomitant medicines, scale, analysis denominators, plans, company roles and harms remain. Significance is not converted into clinical importance or success across all coprimary outcomes, or complete follow-up into absence of missing data or adverse events.
Conditions for verification: Original records on Treatment, visits, starting/final assessments,15-day TNSS and post-discontinuation follow-up must link to the same product, question, population, comparison, endpoint, timing and analysis denominator, distinguishing recorded information from gaps.
Why this condition is needed: Material on Treatment, visits, starting/final assessments,15-day TNSS and post-discontinuation follow-up is needed to connect the combination-product question to its population, formulation, comparison, endpoint, timing, denominator or harms.
Application exceptions: Combination-product results are not extended to the isolated effects of Nigella oil, piperine or purified thymoquinone, or to other products, populations or periods. Reported starting/final values and changes remain separate; no new effects, intervals, denominators, harm rates or dose totals are calculated.
Referenced methods: Existing principles distinguish the exact combination product, adult men, seasonal rhinitis, placebo, TNSS and symptom duration, timing, original reported values, denominators, company involvement and harms.

Related sources R01

N13 · What TNSS scale and measurement methods were used?

Current findings: The original endpoint is 15-day TNSS change.
Verification status: Unverified
Materials actually read: Existing Korean and English stored summaries and bibliography for the combination-product report read; external abstracts, full text, registration, protocols and analysis plans unread
Why unverified: Stored information is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.
Reason for missing information: TNSS range, components, scoring, recall period, diaries, assessors and aggregation methods remain unverified.
Required materials and conditions: Components, range, score direction, recall period, assessors and diaries
Materials to obtain first: TNSS definition, measurement tools, diaries and aggregation procedures
Further research: Material needed: TNSS definition, measurement tools, diaries and aggregation procedures This records needed materials; no new research was executed.
Remaining uncertainty: Gaps in product quality, seasonal exposure, concomitant medicines, scale, analysis denominators, plans, company roles and harms remain. Significance is not converted into clinical importance or success across all coprimary outcomes, or complete follow-up into absence of missing data or adverse events.
Conditions for verification: Original records on Components, range, score direction, recall period, assessors and diaries must link to the same product, question, population, comparison, endpoint, timing and analysis denominator, distinguishing recorded information from gaps.
Why this condition is needed: Material on Components, range, score direction, recall period, assessors and diaries is needed to connect the combination-product question to its population, formulation, comparison, endpoint, timing, denominator or harms.
Application exceptions: Combination-product results are not extended to the isolated effects of Nigella oil, piperine or purified thymoquinone, or to other products, populations or periods. Reported starting/final values and changes remain separate; no new effects, intervals, denominators, harm rates or dose totals are calculated.
Referenced methods: Existing principles distinguish the exact combination product, adult men, seasonal rhinitis, placebo, TNSS and symptom duration, timing, original reported values, denominators, company involvement and harms.

Related sources R01

N14 · What was the original TNSS and symptom-duration hierarchy?

Current findings: The evidence summary records TNSS and symptom duration as coprimary outcomes. The selected question is 15-day TNSS change and the existing coprimary separation setting is off.
Verification status: Partly verified
Materials actually read: Existing Korean and English stored summaries and bibliography for the combination-product report read; external abstracts, full text, registration, protocols and analysis plans unread
Why unverified: Stored information is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.
Reason for missing information: External registration/plan hierarchy, joint success criteria, multiplicity and separation decisions remain unverified.
Required materials and conditions: TNSS/symptom-duration coprimary wording, plans and success criteria
Materials to obtain first: Registration, protocol, analysis plan, endpoint hierarchy and analysis list
Further research: Material needed: Registration, protocol, analysis plan, endpoint hierarchy and analysis list This records needed materials; no new research was executed.
Remaining uncertainty: Gaps in product quality, seasonal exposure, concomitant medicines, scale, analysis denominators, plans, company roles and harms remain. Significance is not converted into clinical importance or success across all coprimary outcomes, or complete follow-up into absence of missing data or adverse events.
Conditions for verification: Original records on TNSS/symptom-duration coprimary wording, plans and success criteria must link to the same product, question, population, comparison, endpoint, timing and analysis denominator, distinguishing recorded information from gaps.
Why this condition is needed: Material on TNSS/symptom-duration coprimary wording, plans and success criteria is needed to connect the combination-product question to its population, formulation, comparison, endpoint, timing, denominator or harms.
Application exceptions: Combination-product results are not extended to the isolated effects of Nigella oil, piperine or purified thymoquinone, or to other products, populations or periods. Reported starting/final values and changes remain separate; no new effects, intervals, denominators, harm rates or dose totals are calculated.
Referenced methods: Existing principles distinguish the exact combination product, adult men, seasonal rhinitis, placebo, TNSS and symptom duration, timing, original reported values, denominators, company involvement and harms.

Related sources R01

N15 · What do 8.45→4.94 versus 7.69→6.66 represent?

Current findings: The existing result record contains TNSS 8.45→4.94 versus 7.69→6.66.
Verification status: Partly verified
Materials actually read: Existing Korean and English stored summaries and bibliography for the combination-product report read; external abstracts, full text, registration, protocols and analysis plans unread
Why unverified: Stored information is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.
Reason for missing information: Original-table means, dispersion, raw values, timing, denominators, adjustment and decimal precision remain unverified.
Required materials and conditions: Arm-specific starting/final TNSS, means, dispersion, timing and denominators
Materials to obtain first: Arm-specific starting/final TNSS, raw values, dispersion and denominators
Further research: Material needed: Arm-specific starting/final TNSS, raw values, dispersion and denominators This records needed materials; no new research was executed.
Remaining uncertainty: Gaps in product quality, seasonal exposure, concomitant medicines, scale, analysis denominators, plans, company roles and harms remain. Significance is not converted into clinical importance or success across all coprimary outcomes, or complete follow-up into absence of missing data or adverse events.
Conditions for verification: Original records on Arm-specific starting/final TNSS, means, dispersion, timing and denominators must link to the same product, question, population, comparison, endpoint, timing and analysis denominator, distinguishing recorded information from gaps.
Why this condition is needed: Material on Arm-specific starting/final TNSS, means, dispersion, timing and denominators is needed to connect the combination-product question to its population, formulation, comparison, endpoint, timing, denominator or harms.
Application exceptions: Combination-product results are not extended to the isolated effects of Nigella oil, piperine or purified thymoquinone, or to other products, populations or periods. Reported starting/final values and changes remain separate; no new effects, intervals, denominators, harm rates or dose totals are calculated.
Referenced methods: Existing principles distinguish the exact combination product, adult men, seasonal rhinitis, placebo, TNSS and symptom duration, timing, original reported values, denominators, company involvement and harms.

Related sources R01

N16 · How should −3.52 versus −1.03 points and P<.001 be read?

Current findings: The existing answer records −3.52 points with the combination and −1.03 with placebo(P<.001); the evidence summary records the same reported changes and P value.
Verification status: Partly verified
Materials actually read: Existing Korean and English stored summaries and bibliography for the combination-product report read; external abstracts, full text, registration, protocols and analysis plans unread
Why unverified: Stored information is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.
Reason for missing information: Original dispersion, between-group effects, test models and targets, adjustment, decimals and change definitions remain unverified.
Required materials and conditions: Arm-specific changes, tested comparison, effect of interest and precision
Materials to obtain first: Arm-specific changes, between-group test results, dispersion and models
Further research: Material needed: Arm-specific changes, between-group test results, dispersion and models This records needed materials; no new research was executed.
Remaining uncertainty: Gaps in product quality, seasonal exposure, concomitant medicines, scale, analysis denominators, plans, company roles and harms remain. Significance is not converted into clinical importance or success across all coprimary outcomes, or complete follow-up into absence of missing data or adverse events.
Conditions for verification: Original records on Arm-specific changes, tested comparison, effect of interest and precision must link to the same product, question, population, comparison, endpoint, timing and analysis denominator, distinguishing recorded information from gaps.
Why this condition is needed: Material on Arm-specific changes, tested comparison, effect of interest and precision is needed to connect the combination-product question to its population, formulation, comparison, endpoint, timing, denominator or harms.
Application exceptions: Combination-product results are not extended to the isolated effects of Nigella oil, piperine or purified thymoquinone, or to other products, populations or periods. Reported starting/final values and changes remain separate; no new effects, intervals, denominators, harm rates or dose totals are calculated.
Referenced methods: Existing principles distinguish the exact combination product, adult men, seasonal rhinitis, placebo, TNSS and symptom duration, timing, original reported values, denominators, company involvement and harms.

Related sources R01

N17 · What is missing about the change CI?

Current findings: The original result says that the change CI was not reported.
Verification status: Unverified
Materials actually read: Existing Korean and English stored summaries and bibliography for the combination-product report read; external abstracts, full text, registration, protocols and analysis plans unread
Why unverified: Stored information is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.
Reason for missing information: CI, dispersion, exact effects and reporting scope outside the stored summary remain unverified because original tables and appendices are unread.
Required materials and conditions: Change/between-group-effect CI, dispersion, denominators and models
Materials to obtain first: Original changes, between-group effects, CI and dispersion tables
Further research: Material needed: Original changes, between-group effects, CI and dispersion tables This records needed materials; no new research was executed.
Remaining uncertainty: Gaps in product quality, seasonal exposure, concomitant medicines, scale, analysis denominators, plans, company roles and harms remain. Significance is not converted into clinical importance or success across all coprimary outcomes, or complete follow-up into absence of missing data or adverse events.
Conditions for verification: Original records on Change/between-group-effect CI, dispersion, denominators and models must link to the same product, question, population, comparison, endpoint, timing and analysis denominator, distinguishing recorded information from gaps.
Why this condition is needed: Material on Change/between-group-effect CI, dispersion, denominators and models is needed to connect the combination-product question to its population, formulation, comparison, endpoint, timing, denominator or harms.
Application exceptions: Combination-product results are not extended to the isolated effects of Nigella oil, piperine or purified thymoquinone, or to other products, populations or periods. Reported starting/final values and changes remain separate; no new effects, intervals, denominators, harm rates or dose totals are calculated.
Referenced methods: Existing principles distinguish the exact combination product, adult men, seasonal rhinitis, placebo, TNSS and symptom duration, timing, original reported values, denominators, company involvement and harms.

Related sources R01

N18 · How were baseline TNSS and other differences considered?

Current findings: The existing result separately reports starting TNSS 8.45 versus 7.69.
Verification status: Unverified
Materials actually read: Existing Korean and English stored summaries and bibliography for the combination-product report read; external abstracts, full text, registration, protocols and analysis plans unread
Why unverified: Stored information is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.
Reason for missing information: Arm-specific baseline dispersion, balance of characteristics, baseline adjustment, analytical models and sensitivity analyses remain unverified.
Required materials and conditions: Baseline scores/characteristics, adjustment, regression, between-group analysis and alternatives
Materials to obtain first: Baseline tables, adjustment, analysis plans and sensitivity material
Further research: Material needed: Baseline tables, adjustment, analysis plans and sensitivity material This records needed materials; no new research was executed.
Remaining uncertainty: Gaps in product quality, seasonal exposure, concomitant medicines, scale, analysis denominators, plans, company roles and harms remain. Significance is not converted into clinical importance or success across all coprimary outcomes, or complete follow-up into absence of missing data or adverse events.
Conditions for verification: Original records on Baseline scores/characteristics, adjustment, regression, between-group analysis and alternatives must link to the same product, question, population, comparison, endpoint, timing and analysis denominator, distinguishing recorded information from gaps.
Why this condition is needed: Material on Baseline scores/characteristics, adjustment, regression, between-group analysis and alternatives is needed to connect the combination-product question to its population, formulation, comparison, endpoint, timing, denominator or harms.
Application exceptions: Combination-product results are not extended to the isolated effects of Nigella oil, piperine or purified thymoquinone, or to other products, populations or periods. Reported starting/final values and changes remain separate; no new effects, intervals, denominators, harm rates or dose totals are calculated.
Referenced methods: Existing principles distinguish the exact combination product, adult men, seasonal rhinitis, placebo, TNSS and symptom duration, timing, original reported values, denominators, company involvement and harms.

Related sources R01

N19 · What denominators do 65 people and 33 versus 32 represent?

Current findings: The evidence summary records 65 people,33 versus 32, all completed and all male.
Verification status: Partly verified
Materials actually read: Existing Korean and English stored summaries and bibliography for the combination-product report read; external abstracts, full text, registration, protocols and analysis plans unread
Why unverified: Stored information is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.
Reason for missing information: Original allocation/analysis stages, direct arm mapping, endpoint-specific/harm denominators and aggregation procedures remain unverified.
Required materials and conditions: Allocation, analysis, completion, arm mapping, TNSS, symptom-duration and harm denominators
Materials to obtain first: Participant flow and arm-specific allocation, analysis and endpoint tables
Further research: Material needed: Participant flow and arm-specific allocation, analysis and endpoint tables This records needed materials; no new research was executed.
Remaining uncertainty: Gaps in product quality, seasonal exposure, concomitant medicines, scale, analysis denominators, plans, company roles and harms remain. Significance is not converted into clinical importance or success across all coprimary outcomes, or complete follow-up into absence of missing data or adverse events.
Conditions for verification: Original records on Allocation, analysis, completion, arm mapping, TNSS, symptom-duration and harm denominators must link to the same product, question, population, comparison, endpoint, timing and analysis denominator, distinguishing recorded information from gaps.
Why this condition is needed: Material on Allocation, analysis, completion, arm mapping, TNSS, symptom-duration and harm denominators is needed to connect the combination-product question to its population, formulation, comparison, endpoint, timing, denominator or harms.
Application exceptions: Combination-product results are not extended to the isolated effects of Nigella oil, piperine or purified thymoquinone, or to other products, populations or periods. Reported starting/final values and changes remain separate; no new effects, intervals, denominators, harm rates or dose totals are calculated.
Referenced methods: Existing principles distinguish the exact combination product, adult men, seasonal rhinitis, placebo, TNSS and symptom duration, timing, original reported values, denominators, company involvement and harms.

Related sources R01

N20 · Does completion establish complete outcomes and ITT analysis?

Current findings: The existing account and sample record both state that all participants completed.
Verification status: Partly verified
Materials actually read: Existing Korean and English stored summaries and bibliography for the combination-product report read; external abstracts, full text, registration, protocols and analysis plans unread
Why unverified: Stored information is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.
Reason for missing information: ITT/PP definitions, availability of all TNSS/symptom-duration/harm data, diary missingness and analysis-inclusion rules remain unverified.
Required materials and conditions: Completion, attrition, missing data, ITT, PP, outcome availability and effect of interest
Materials to obtain first: Participant flow, analysis definitions and endpoint/diary missingness tables
Further research: Material needed: Participant flow, analysis definitions and endpoint/diary missingness tables This records needed materials; no new research was executed.
Remaining uncertainty: Gaps in product quality, seasonal exposure, concomitant medicines, scale, analysis denominators, plans, company roles and harms remain. Significance is not converted into clinical importance or success across all coprimary outcomes, or complete follow-up into absence of missing data or adverse events.
Conditions for verification: Original records on Completion, attrition, missing data, ITT, PP, outcome availability and effect of interest must link to the same product, question, population, comparison, endpoint, timing and analysis denominator, distinguishing recorded information from gaps.
Why this condition is needed: Material on Completion, attrition, missing data, ITT, PP, outcome availability and effect of interest is needed to connect the combination-product question to its population, formulation, comparison, endpoint, timing, denominator or harms.
Application exceptions: Combination-product results are not extended to the isolated effects of Nigella oil, piperine or purified thymoquinone, or to other products, populations or periods. Reported starting/final values and changes remain separate; no new effects, intervals, denominators, harm rates or dose totals are calculated.
Referenced methods: Existing principles distinguish the exact combination product, adult men, seasonal rhinitis, placebo, TNSS and symptom duration, timing, original reported values, denominators, company involvement and harms.

Related sources R01

N21 · What were the allocation sequence, concealment and baseline characteristics?

Current findings: The original design is a randomized double-blind placebo trial.
Verification status: Unverified
Materials actually read: Existing Korean and English stored summaries and bibliography for the combination-product report read; external abstracts, full text, registration, protocols and analysis plans unread
Why unverified: Stored information is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.
Reason for missing information: Allocation sequence, concealment, assignment, baseline characteristics and changes remain unverified.
Required materials and conditions: Random sequence generation, concealment, allocation and baseline balance
Materials to obtain first: Allocation procedures and baseline tables
Further research: Material needed: Allocation procedures and baseline tables This records needed materials; no new research was executed.
Remaining uncertainty: Gaps in product quality, seasonal exposure, concomitant medicines, scale, analysis denominators, plans, company roles and harms remain. Significance is not converted into clinical importance or success across all coprimary outcomes, or complete follow-up into absence of missing data or adverse events.
Conditions for verification: Original records on Random sequence generation, concealment, allocation and baseline balance must link to the same product, question, population, comparison, endpoint, timing and analysis denominator, distinguishing recorded information from gaps.
Why this condition is needed: Material on Random sequence generation, concealment, allocation and baseline balance is needed to connect the combination-product question to its population, formulation, comparison, endpoint, timing, denominator or harms.
Application exceptions: Combination-product results are not extended to the isolated effects of Nigella oil, piperine or purified thymoquinone, or to other products, populations or periods. Reported starting/final values and changes remain separate; no new effects, intervals, denominators, harm rates or dose totals are calculated.
Referenced methods: Existing principles distinguish the exact combination product, adult men, seasonal rhinitis, placebo, TNSS and symptom duration, timing, original reported values, denominators, company involvement and harms.

Related sources R01

N22 · Who was masked and could the products be distinguished?

Current findings: The original design is double-blind and the comparator is matched-appearance placebo.
Verification status: Unverified
Materials actually read: Existing Korean and English stored summaries and bibliography for the combination-product report read; external abstracts, full text, registration, protocols and analysis plans unread
Why unverified: Stored information is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.
Reason for missing information: Specific roles, taste, smell, maintained masking and effects on assessment/diaries remain unverified.
Required materials and conditions: Role-specific masking, appearance, sensory properties, maintenance, unmasking and measurement
Materials to obtain first: Masking/placebo procedures and measurement methods
Further research: Material needed: Masking/placebo procedures and measurement methods This records needed materials; no new research was executed.
Remaining uncertainty: Gaps in product quality, seasonal exposure, concomitant medicines, scale, analysis denominators, plans, company roles and harms remain. Significance is not converted into clinical importance or success across all coprimary outcomes, or complete follow-up into absence of missing data or adverse events.
Conditions for verification: Original records on Role-specific masking, appearance, sensory properties, maintenance, unmasking and measurement must link to the same product, question, population, comparison, endpoint, timing and analysis denominator, distinguishing recorded information from gaps.
Why this condition is needed: Material on Role-specific masking, appearance, sensory properties, maintenance, unmasking and measurement is needed to connect the combination-product question to its population, formulation, comparison, endpoint, timing, denominator or harms.
Application exceptions: Combination-product results are not extended to the isolated effects of Nigella oil, piperine or purified thymoquinone, or to other products, populations or periods. Reported starting/final values and changes remain separate; no new effects, intervals, denominators, harm rates or dose totals are calculated.
Referenced methods: Existing principles distinguish the exact combination product, adult men, seasonal rhinitis, placebo, TNSS and symptom duration, timing, original reported values, denominators, company involvement and harms.

Related sources R01

N23 · How were product use and treatment deviations handled?

Current findings: The original formulation/dose records a fixed combination 2 times daily for 15 days and describes all participants completing.
Verification status: Unverified
Materials actually read: Existing Korean and English stored summaries and bibliography for the combination-product report read; external abstracts, full text, registration, protocols and analysis plans unread
Why unverified: Stored information is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.
Reason for missing information: Actual adherence, missed doses, rescue medicines and analysis of treatment deviations remain unverified.
Required materials and conditions: Actual use, adherence, discontinuation, crossover, rescue medicines and effect of interest
Materials to obtain first: Use diaries, rescue medicines, deviations and analysis plans
Further research: Material needed: Use diaries, rescue medicines, deviations and analysis plans This records needed materials; no new research was executed.
Remaining uncertainty: Gaps in product quality, seasonal exposure, concomitant medicines, scale, analysis denominators, plans, company roles and harms remain. Significance is not converted into clinical importance or success across all coprimary outcomes, or complete follow-up into absence of missing data or adverse events.
Conditions for verification: Original records on Actual use, adherence, discontinuation, crossover, rescue medicines and effect of interest must link to the same product, question, population, comparison, endpoint, timing and analysis denominator, distinguishing recorded information from gaps.
Why this condition is needed: Material on Actual use, adherence, discontinuation, crossover, rescue medicines and effect of interest is needed to connect the combination-product question to its population, formulation, comparison, endpoint, timing, denominator or harms.
Application exceptions: Combination-product results are not extended to the isolated effects of Nigella oil, piperine or purified thymoquinone, or to other products, populations or periods. Reported starting/final values and changes remain separate; no new effects, intervals, denominators, harm rates or dose totals are calculated.
Referenced methods: Existing principles distinguish the exact combination product, adult men, seasonal rhinitis, placebo, TNSS and symptom duration, timing, original reported values, denominators, company involvement and harms.

Related sources R01

N24 · How much is verified about CTRI/2022/07/044180?

Current findings: Stored evidence and the citation include CTRI/2022/07/044180, and the existing account describes a preregistered placebo comparison.
Verification status: Partly verified
Materials actually read: Existing Korean and English stored summaries and bibliography for the combination-product report read; external abstracts, full text, registration, protocols and analysis plans unread
Why unverified: Stored information is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.
Reason for missing information: Registry text/history, registration and first-recruitment dates, and endpoint, denominator and plan correspondence remain unverified.
Required materials and conditions: Original-record/citation registration identifiers versus registry contents, dates and actual reading
Materials to obtain first: CTRI text/history, protocol and report mapping
Further research: Material needed: CTRI text/history, protocol and report mapping This records needed materials; no new research was executed.
Remaining uncertainty: Gaps in product quality, seasonal exposure, concomitant medicines, scale, analysis denominators, plans, company roles and harms remain. Significance is not converted into clinical importance or success across all coprimary outcomes, or complete follow-up into absence of missing data or adverse events.
Conditions for verification: Original records on Original-record/citation registration identifiers versus registry contents, dates and actual reading must link to the same product, question, population, comparison, endpoint, timing and analysis denominator, distinguishing recorded information from gaps.
Why this condition is needed: Material on Original-record/citation registration identifiers versus registry contents, dates and actual reading is needed to connect the combination-product question to its population, formulation, comparison, endpoint, timing, denominator or harms.
Application exceptions: Combination-product results are not extended to the isolated effects of Nigella oil, piperine or purified thymoquinone, or to other products, populations or periods. Reported starting/final values and changes remain separate; no new effects, intervals, denominators, harm rates or dose totals are calculated.
Referenced methods: Existing principles distinguish the exact combination product, adult men, seasonal rhinitis, placebo, TNSS and symptom duration, timing, original reported values, denominators, company involvement and harms.

Related sources R01

N25 · How were TNSS/symptom-duration success and multiplicity planned?

Current findings: The evidence summary records TNSS and symptom duration as coprimary outcomes, while the selected question is TNSS.
Verification status: Unverified
Materials actually read: Existing Korean and English stored summaries and bibliography for the combination-product report read; external abstracts, full text, registration, protocols and analysis plans unread
Why unverified: Stored information is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.
Reason for missing information: Joint success/multiplicity criteria, planned tests, analysis changes and endpoint hierarchy remain unverified.
Required materials and conditions: Coprimary outcomes, planned analyses, timing, success criteria and adjustment
Materials to obtain first: Analysis plans, planned comparisons and all primary-outcome tables
Further research: Material needed: Analysis plans, planned comparisons and all primary-outcome tables This records needed materials; no new research was executed.
Remaining uncertainty: Gaps in product quality, seasonal exposure, concomitant medicines, scale, analysis denominators, plans, company roles and harms remain. Significance is not converted into clinical importance or success across all coprimary outcomes, or complete follow-up into absence of missing data or adverse events.
Conditions for verification: Original records on Coprimary outcomes, planned analyses, timing, success criteria and adjustment must link to the same product, question, population, comparison, endpoint, timing and analysis denominator, distinguishing recorded information from gaps.
Why this condition is needed: Material on Coprimary outcomes, planned analyses, timing, success criteria and adjustment is needed to connect the combination-product question to its population, formulation, comparison, endpoint, timing, denominator or harms.
Application exceptions: Combination-product results are not extended to the isolated effects of Nigella oil, piperine or purified thymoquinone, or to other products, populations or periods. Reported starting/final values and changes remain separate; no new effects, intervals, denominators, harm rates or dose totals are calculated.
Referenced methods: Existing principles distinguish the exact combination product, adult men, seasonal rhinitis, placebo, TNSS and symptom duration, timing, original reported values, denominators, company involvement and harms.

Related sources R01

N26 · What remains unknown for the coprimary symptom-duration outcome?

Current findings: The original endpoint description only identifies symptom duration as coprimary.
Verification status: Unverified
Materials actually read: Existing Korean and English stored summaries and bibliography for the combination-product report read; external abstracts, full text, registration, protocols and analysis plans unread
Why unverified: Stored information is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.
Reason for missing information: Duration definitions, units, reported values, between-group effects, CI, denominators and plans remain unverified.
Required materials and conditions: Symptom-duration definition, units, timing, arm-specific values, effects and denominators
Materials to obtain first: Symptom-duration definitions, results and denominator tables
Further research: Material needed: Symptom-duration definitions, results and denominator tables This records needed materials; no new research was executed.
Remaining uncertainty: Gaps in product quality, seasonal exposure, concomitant medicines, scale, analysis denominators, plans, company roles and harms remain. Significance is not converted into clinical importance or success across all coprimary outcomes, or complete follow-up into absence of missing data or adverse events.
Conditions for verification: Original records on Symptom-duration definition, units, timing, arm-specific values, effects and denominators must link to the same product, question, population, comparison, endpoint, timing and analysis denominator, distinguishing recorded information from gaps.
Why this condition is needed: Material on Symptom-duration definition, units, timing, arm-specific values, effects and denominators is needed to connect the combination-product question to its population, formulation, comparison, endpoint, timing, denominator or harms.
Application exceptions: Combination-product results are not extended to the isolated effects of Nigella oil, piperine or purified thymoquinone, or to other products, populations or periods. Reported starting/final values and changes remain separate; no new effects, intervals, denominators, harm rates or dose totals are calculated.
Referenced methods: Existing principles distinguish the exact combination product, adult men, seasonal rhinitis, placebo, TNSS and symptom duration, timing, original reported values, denominators, company involvement and harms.

Related sources R01

N27 · Does 15-day TNSS establish medication sparing or management across the season?

Current findings: The original explanation states that 15-day TNSS differs from long-term seasonal management or medication sparing.
Verification status: Unverified
Materials actually read: Existing Korean and English stored summaries and bibliography for the combination-product report read; external abstracts, full text, registration, protocols and analysis plans unread
Why unverified: Stored information is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.
Reason for missing information: Medicine use, reduction, management across the season, recurrence and post-discontinuation persistence remain unverified.
Required materials and conditions: Rescue/regular medicines, seasonal/long-term follow-up, treatment strategies and recurrence
Materials to obtain first: Medication-use outcomes and long-term/seasonal follow-up
Further research: Material needed: Medication-use outcomes and long-term/seasonal follow-up This records needed materials; no new research was executed.
Remaining uncertainty: Gaps in product quality, seasonal exposure, concomitant medicines, scale, analysis denominators, plans, company roles and harms remain. Significance is not converted into clinical importance or success across all coprimary outcomes, or complete follow-up into absence of missing data or adverse events.
Conditions for verification: Original records on Rescue/regular medicines, seasonal/long-term follow-up, treatment strategies and recurrence must link to the same product, question, population, comparison, endpoint, timing and analysis denominator, distinguishing recorded information from gaps.
Why this condition is needed: Material on Rescue/regular medicines, seasonal/long-term follow-up, treatment strategies and recurrence is needed to connect the combination-product question to its population, formulation, comparison, endpoint, timing, denominator or harms.
Application exceptions: Combination-product results are not extended to the isolated effects of Nigella oil, piperine or purified thymoquinone, or to other products, populations or periods. Reported starting/final values and changes remain separate; no new effects, intervals, denominators, harm rates or dose totals are calculated.
Referenced methods: Existing principles distinguish the exact combination product, adult men, seasonal rhinitis, placebo, TNSS and symptom duration, timing, original reported values, denominators, company involvement and harms.

Related sources R01

N28 · What is the scope of the original large-TNSS-change interpretation?

Current findings: The existing account and grade rationale describe a large short-term between-group contrast.
Verification status: Partly verified
Materials actually read: Existing Korean and English stored summaries and bibliography for the combination-product report read; external abstracts, full text, registration, protocols and analysis plans unread
Why unverified: Stored information is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.
Reason for missing information: Prespecified MCID, responder criteria/rates, exact effect intervals and patient-important outcomes such as quality of life or sleep remain unverified.
Required materials and conditions: Effects, CI, prespecified important difference, patient-important outcomes and responders
Materials to obtain first: Importance plans, effect intervals and patient-important outcomes
Further research: Material needed: Importance plans, effect intervals and patient-important outcomes This records needed materials; no new research was executed.
Remaining uncertainty: Gaps in product quality, seasonal exposure, concomitant medicines, scale, analysis denominators, plans, company roles and harms remain. Significance is not converted into clinical importance or success across all coprimary outcomes, or complete follow-up into absence of missing data or adverse events.
Conditions for verification: Original records on Effects, CI, prespecified important difference, patient-important outcomes and responders must link to the same product, question, population, comparison, endpoint, timing and analysis denominator, distinguishing recorded information from gaps.
Why this condition is needed: Material on Effects, CI, prespecified important difference, patient-important outcomes and responders is needed to connect the combination-product question to its population, formulation, comparison, endpoint, timing, denominator or harms.
Application exceptions: Combination-product results are not extended to the isolated effects of Nigella oil, piperine or purified thymoquinone, or to other products, populations or periods. Reported starting/final values and changes remain separate; no new effects, intervals, denominators, harm rates or dose totals are calculated.
Referenced methods: Existing principles distinguish the exact combination product, adult men, seasonal rhinitis, placebo, TNSS and symptom duration, timing, original reported values, denominators, company involvement and harms.

Related sources R01

N29 · Which report do the stored summary and PMID/PMCID/DOI identify?

Current findings: The original citation records Majeed M et al., Medicine(Baltimore).2024, PMID 39121267, PMCID PMC11315530, DOI 10.1097/MD.0000000000039243 and a CTRI identifier.
Verification status: Partly verified
Materials actually read: Existing Korean and English stored summaries and bibliography for the combination-product report read; external abstracts, full text, registration, protocols and analysis plans unread
Why unverified: Stored information is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.
Reason for missing information: External paper/registry identity, subsequent-report families and unique trial/participant totals remain unverified.
Required materials and conditions: Research reports, same-trial/registration families and original citation
Materials to obtain first: Original papers, registration and subsequent reports from the same trial
Further research: Material needed: Original papers, registration and subsequent reports from the same trial This records needed materials; no new research was executed.
Remaining uncertainty: Gaps in product quality, seasonal exposure, concomitant medicines, scale, analysis denominators, plans, company roles and harms remain. Significance is not converted into clinical importance or success across all coprimary outcomes, or complete follow-up into absence of missing data or adverse events.
Conditions for verification: Original records on Research reports, same-trial/registration families and original citation must link to the same product, question, population, comparison, endpoint, timing and analysis denominator, distinguishing recorded information from gaps.
Why this condition is needed: Material on Research reports, same-trial/registration families and original citation is needed to connect the combination-product question to its population, formulation, comparison, endpoint, timing, denominator or harms.
Application exceptions: Combination-product results are not extended to the isolated effects of Nigella oil, piperine or purified thymoquinone, or to other products, populations or periods. Reported starting/final values and changes remain separate; no new effects, intervals, denominators, harm rates or dose totals are calculated.
Referenced methods: Existing principles distinguish the exact combination product, adult men, seasonal rhinitis, placebo, TNSS and symptom duration, timing, original reported values, denominators, company involvement and harms.

Related sources R01

N30 · How do the no-funding statement and company involvement differ?

Current findings: The existing funding record includes both the authors' no-funding statement and Sami-Sabinsa/Sabinsa employee authorship and product involvement.
Verification status: Partly verified
Materials actually read: Existing Korean and English stored summaries and bibliography for the combination-product report read; external abstracts, full text, registration, protocols and analysis plans unread
Why unverified: Stored information is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.
Reason for missing information: Details of cash/product support, employment, roles, original COI and involvement in design, analysis or reporting remain unverified.
Required materials and conditions: Cash funding, product support, employee authorship, COI and company roles
Materials to obtain first: Original funding/COI, affiliations and product/company-role material
Further research: Material needed: Original funding/COI, affiliations and product/company-role material This records needed materials; no new research was executed.
Remaining uncertainty: Gaps in product quality, seasonal exposure, concomitant medicines, scale, analysis denominators, plans, company roles and harms remain. Significance is not converted into clinical importance or success across all coprimary outcomes, or complete follow-up into absence of missing data or adverse events.
Conditions for verification: Original records on Cash funding, product support, employee authorship, COI and company roles must link to the same product, question, population, comparison, endpoint, timing and analysis denominator, distinguishing recorded information from gaps.
Why this condition is needed: Material on Cash funding, product support, employee authorship, COI and company roles is needed to connect the combination-product question to its population, formulation, comparison, endpoint, timing, denominator or harms.
Application exceptions: Combination-product results are not extended to the isolated effects of Nigella oil, piperine or purified thymoquinone, or to other products, populations or periods. Reported starting/final values and changes remain separate; no new effects, intervals, denominators, harm rates or dose totals are calculated.
Referenced methods: Existing principles distinguish the exact combination product, adult men, seasonal rhinitis, placebo, TNSS and symptom duration, timing, original reported values, denominators, company involvement and harms.

Related sources R01

N31 · What remains unknown about independent replication of the same product?

Current findings: The account records the company product trial/employee-author limitation and a product-specific short-term signal. The original assessment record is R1/I0.
Verification status: Partly verified
Materials actually read: Existing Korean and English stored summaries and bibliography for the combination-product report read; external abstracts, full text, registration, protocols and analysis plans unread
Why unverified: Stored information is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.
Reason for missing information: Independent teams/trials, long-term or other-sex replication of the same combination, and unique totals remain unverified.
Required materials and conditions: Product/question matching, teams, support, report families and independent replication
Materials to obtain first: Separate original trials for the same product/question and team/support relationships
Further research: Material needed: Separate original trials for the same product/question and team/support relationships This records needed materials; no new research was executed.
Remaining uncertainty: Gaps in product quality, seasonal exposure, concomitant medicines, scale, analysis denominators, plans, company roles and harms remain. Significance is not converted into clinical importance or success across all coprimary outcomes, or complete follow-up into absence of missing data or adverse events.
Conditions for verification: Original records on Product/question matching, teams, support, report families and independent replication must link to the same product, question, population, comparison, endpoint, timing and analysis denominator, distinguishing recorded information from gaps.
Why this condition is needed: Material on Product/question matching, teams, support, report families and independent replication is needed to connect the combination-product question to its population, formulation, comparison, endpoint, timing, denominator or harms.
Application exceptions: Combination-product results are not extended to the isolated effects of Nigella oil, piperine or purified thymoquinone, or to other products, populations or periods. Reported starting/final values and changes remain separate; no new effects, intervals, denominators, harm rates or dose totals are calculated.
Referenced methods: Existing principles distinguish the exact combination product, adult men, seasonal rhinitis, placebo, TNSS and symptom duration, timing, original reported values, denominators, company involvement and harms.

Related sources R01

N32 · Were the original paper, PMCID text and registration actually read?

Current findings: The clinical production material actually read was the whole stored summary. The original PubMed address is linked and the PMCID entry retained.
Verification status: Partly verified
Materials actually read: Existing Korean and English stored summaries and bibliography for the combination-product report read; external abstracts, full text, registration, protocols and analysis plans unread
Why unverified: Stored information is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.
Reason for missing information: Abstracts, PMCID full text, registration, plans and appendices remain unread and access unattempted.
Required materials and conditions: Stored summary, PubMed link, PMCID citation and external content reading
Materials to obtain first: Original material corresponding to the citation and registration
Further research: Material needed: Original material corresponding to the citation and registration This records needed materials; no new research was executed.
Remaining uncertainty: Gaps in product quality, seasonal exposure, concomitant medicines, scale, analysis denominators, plans, company roles and harms remain. Significance is not converted into clinical importance or success across all coprimary outcomes, or complete follow-up into absence of missing data or adverse events.
Conditions for verification: Original records on Stored summary, PubMed link, PMCID citation and external content reading must link to the same product, question, population, comparison, endpoint, timing and analysis denominator, distinguishing recorded information from gaps.
Why this condition is needed: Material on Stored summary, PubMed link, PMCID citation and external content reading is needed to connect the combination-product question to its population, formulation, comparison, endpoint, timing, denominator or harms.
Application exceptions: Combination-product results are not extended to the isolated effects of Nigella oil, piperine or purified thymoquinone, or to other products, populations or periods. Reported starting/final values and changes remain separate; no new effects, intervals, denominators, harm rates or dose totals are calculated.
Referenced methods: Existing principles distinguish the exact combination product, adult men, seasonal rhinitis, placebo, TNSS and symptom duration, timing, original reported values, denominators, company involvement and harms.

Related sources R01

N33 · Are the original evidence date and current production time distinguished?

Current findings: The existing original-record date is 2026-09-08, the correction date is 2026-09-14 and the citation is from 2024.
Verification status: Partly verified
Materials actually read: Existing Korean and English stored summaries and bibliography for the combination-product report read; external abstracts, full text, registration, protocols and analysis plans unread
Why unverified: Stored information is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.
Reason for missing information: An actual latest-search cutoff, current external-reading date and completed-review date are absent or unverified.
Required materials and conditions: Original-record date, correction date,2024 citation, actual reading, searches and production
Materials to obtain first: Original publication, search, receipt and correction records
Further research: Material needed: Original publication, search, receipt and correction records This records needed materials; no new research was executed.
Remaining uncertainty: Gaps in product quality, seasonal exposure, concomitant medicines, scale, analysis denominators, plans, company roles and harms remain. Significance is not converted into clinical importance or success across all coprimary outcomes, or complete follow-up into absence of missing data or adverse events.
Conditions for verification: Original records on Original-record date, correction date,2024 citation, actual reading, searches and production must link to the same product, question, population, comparison, endpoint, timing and analysis denominator, distinguishing recorded information from gaps.
Why this condition is needed: Material on Original-record date, correction date,2024 citation, actual reading, searches and production is needed to connect the combination-product question to its population, formulation, comparison, endpoint, timing, denominator or harms.
Application exceptions: Combination-product results are not extended to the isolated effects of Nigella oil, piperine or purified thymoquinone, or to other products, populations or periods. Reported starting/final values and changes remain separate; no new effects, intervals, denominators, harm rates or dose totals are calculated.
Referenced methods: Existing principles distinguish the exact combination product, adult men, seasonal rhinitis, placebo, TNSS and symptom duration, timing, original reported values, denominators, company involvement and harms.

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N34 · What is the status of generic English wording and the 1-field correction?

Current findings: The English answer records 65 men,15 days and −3.52/−1.03/P<.001. English evidence-summary descriptions of denominators, funding, endpoints and results remain generic, while the evidence type specifically identifies product-combination evidence. The correction record describes replacing 1 field.
Verification status: Partly verified
Materials actually read: Existing Korean and English stored summaries and bibliography for the combination-product report read; external abstracts, full text, registration, protocols and analysis plans unread
Why unverified: Stored information is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.
Reason for missing information: Which field's before/after original and review of detailed English/coprimary correspondence remain unverified.
Required materials and conditions: Korean/English reported values, generic English explanations and before/after correction originals
Materials to obtain first: Before/after correction originals and English correspondence for original results/endpoints
Further research: Material needed: Before/after correction originals and English correspondence for original results/endpoints This records needed materials; no new research was executed.
Remaining uncertainty: Gaps in product quality, seasonal exposure, concomitant medicines, scale, analysis denominators, plans, company roles and harms remain. Significance is not converted into clinical importance or success across all coprimary outcomes, or complete follow-up into absence of missing data or adverse events.
Conditions for verification: Original records on Korean/English reported values, generic English explanations and before/after correction originals must link to the same product, question, population, comparison, endpoint, timing and analysis denominator, distinguishing recorded information from gaps.
Why this condition is needed: Material on Korean/English reported values, generic English explanations and before/after correction originals is needed to connect the combination-product question to its population, formulation, comparison, endpoint, timing, denominator or harms.
Application exceptions: Combination-product results are not extended to the isolated effects of Nigella oil, piperine or purified thymoquinone, or to other products, populations or periods. Reported starting/final values and changes remain separate; no new effects, intervals, denominators, harm rates or dose totals are calculated.
Referenced methods: Existing principles distinguish the exact combination product, adult men, seasonal rhinitis, placebo, TNSS and symptom duration, timing, original reported values, denominators, company involvement and harms.

Related sources R01

N35 · What historical records are C50, I0 and the existing settings?

Current findings: The original preserves C50, Caution, assessment record B/P/R1/I0/E+/B2/C0, the off coprimary-separation setting and historical independent cross-checking wording.
Verification status: Partly verified
Materials actually read: Existing Korean and English stored summaries and bibliography for the combination-product report read; external abstracts, full text, registration, protocols and analysis plans unread
Why unverified: Stored information is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.
Reason for missing information: Current content review, external clinical validation and official assessment certification remain incomplete.
Required materials and conditions: Original grade, score, safety label, assessment records, grade rationale and empty values
Materials to obtain first: Original verdict and permitted subsequent correction events
Further research: Material needed: Original verdict and permitted subsequent correction events This records needed materials; no new research was executed.
Remaining uncertainty: Gaps in product quality, seasonal exposure, concomitant medicines, scale, analysis denominators, plans, company roles and harms remain. Significance is not converted into clinical importance or success across all coprimary outcomes, or complete follow-up into absence of missing data or adverse events.
Conditions for verification: Original records on Original grade, score, safety label, assessment records, grade rationale and empty values must link to the same product, question, population, comparison, endpoint, timing and analysis denominator, distinguishing recorded information from gaps.
Why this condition is needed: Material on Original grade, score, safety label, assessment records, grade rationale and empty values is needed to connect the combination-product question to its population, formulation, comparison, endpoint, timing, denominator or harms.
Application exceptions: Combination-product results are not extended to the isolated effects of Nigella oil, piperine or purified thymoquinone, or to other products, populations or periods. Reported starting/final values and changes remain separate; no new effects, intervals, denominators, harm rates or dose totals are calculated.
Referenced methods: Existing principles distinguish the exact combination product, adult men, seasonal rhinitis, placebo, TNSS and symptom duration, timing, original reported values, denominators, company involvement and harms.

Related sources R01

N36 · What denominators supported collection of actual 15-day combination harms?

Current findings: The study title mentions efficacy/safety, but the original safety wording cautions that small trials cannot exclude rare or long-term harms.
Verification status: Partly verified
Materials actually read: Existing Korean and English stored summaries and bibliography for the combination-product report read; external abstracts, full text, registration, protocols and analysis plans unread
Why unverified: Stored information is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.
Reason for missing information: Specific event counts, arm-specific harm denominators, collection, discontinuation, missingness and timing remain unverified.
Required materials and conditions: Event definitions, collection, arm-specific events, denominators, discontinuation, missingness and timing
Materials to obtain first: Adverse-event/discontinuation records, harm collection and arm-specific denominators
Further research: Material needed: Adverse-event/discontinuation records, harm collection and arm-specific denominators This records needed materials; no new research was executed.
Remaining uncertainty: Gaps in product quality, seasonal exposure, concomitant medicines, scale, analysis denominators, plans, company roles and harms remain. Significance is not converted into clinical importance or success across all coprimary outcomes, or complete follow-up into absence of missing data or adverse events.
Conditions for verification: Original records on Event definitions, collection, arm-specific events, denominators, discontinuation, missingness and timing must link to the same product, question, population, comparison, endpoint, timing and analysis denominator, distinguishing recorded information from gaps.
Why this condition is needed: Material on Event definitions, collection, arm-specific events, denominators, discontinuation, missingness and timing is needed to connect the combination-product question to its population, formulation, comparison, endpoint, timing, denominator or harms.
Application exceptions: Combination-product results are not extended to the isolated effects of Nigella oil, piperine or purified thymoquinone, or to other products, populations or periods. Reported starting/final values and changes remain separate; no new effects, intervals, denominators, harm rates or dose totals are calculated.
Referenced methods: Existing principles distinguish the exact combination product, adult men, seasonal rhinitis, placebo, TNSS and symptom duration, timing, original reported values, denominators, company involvement and harms.

Related sources R01

N37 · Are harms of the piperine combination and caution-listed medicines verified?

Current findings: The original formulation combines piperine and the safety wording retains caution for glucose, blood-pressure, anticoagulant, antiseizure and immune-modifying medicines.
Verification status: Unverified
Materials actually read: Existing Korean and English stored summaries and bibliography for the combination-product report read; external abstracts, full text, registration, protocols and analysis plans unread
Why unverified: Stored information is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.
Reason for missing information: Isolated piperine/oil contributions, concomitant use, exclusions, actual interaction events, denominators and causality remain unverified.
Required materials and conditions: Combined/isolated exposure, concomitant medicines, interaction events, denominators and contribution
Materials to obtain first: Formulation/medicine-specific exposure, interaction and concomitant-use material
Further research: Material needed: Formulation/medicine-specific exposure, interaction and concomitant-use material This records needed materials; no new research was executed.
Remaining uncertainty: Gaps in product quality, seasonal exposure, concomitant medicines, scale, analysis denominators, plans, company roles and harms remain. Significance is not converted into clinical importance or success across all coprimary outcomes, or complete follow-up into absence of missing data or adverse events.
Conditions for verification: Original records on Combined/isolated exposure, concomitant medicines, interaction events, denominators and contribution must link to the same product, question, population, comparison, endpoint, timing and analysis denominator, distinguishing recorded information from gaps.
Why this condition is needed: Material on Combined/isolated exposure, concomitant medicines, interaction events, denominators and contribution is needed to connect the combination-product question to its population, formulation, comparison, endpoint, timing, denominator or harms.
Application exceptions: Combination-product results are not extended to the isolated effects of Nigella oil, piperine or purified thymoquinone, or to other products, populations or periods. Reported starting/final values and changes remain separate; no new effects, intervals, denominators, harm rates or dose totals are calculated.
Referenced methods: Existing principles distinguish the exact combination product, adult men, seasonal rhinitis, placebo, TNSS and symptom duration, timing, original reported values, denominators, company involvement and harms.

Related sources R01

N38 · What about safety beyond a short male trial?

Current findings: The original safety wording records composition differences by formulation/extraction, vulnerable-group/surgical cautions and inability to exclude rare or long-term harms.
Verification status: Partly verified
Materials actually read: Existing Korean and English stored summaries and bibliography for the combination-product report read; external abstracts, full text, registration, protocols and analysis plans unread
Why unverified: Stored information is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.
Reason for missing information: Direct harm material for the combination's long-term/rare outcomes, women, children, vulnerable groups and surgery remains unverified.
Required materials and conditions: Formulation-specific long-term/rare harms, pregnancy, breastfeeding, children, liver/kidney disease and surgery
Materials to obtain first: Long-term, rare, formulation-specific and population-specific original harm material
Further research: Material needed: Long-term, rare, formulation-specific and population-specific original harm material This records needed materials; no new research was executed.
Remaining uncertainty: Gaps in product quality, seasonal exposure, concomitant medicines, scale, analysis denominators, plans, company roles and harms remain. Significance is not converted into clinical importance or success across all coprimary outcomes, or complete follow-up into absence of missing data or adverse events.
Conditions for verification: Original records on Formulation-specific long-term/rare harms, pregnancy, breastfeeding, children, liver/kidney disease and surgery must link to the same product, question, population, comparison, endpoint, timing and analysis denominator, distinguishing recorded information from gaps.
Why this condition is needed: Material on Formulation-specific long-term/rare harms, pregnancy, breastfeeding, children, liver/kidney disease and surgery is needed to connect the combination-product question to its population, formulation, comparison, endpoint, timing, denominator or harms.
Application exceptions: Combination-product results are not extended to the isolated effects of Nigella oil, piperine or purified thymoquinone, or to other products, populations or periods. Reported starting/final values and changes remain separate; no new effects, intervals, denominators, harm rates or dose totals are calculated.
Referenced methods: Existing principles distinguish the exact combination product, adult men, seasonal rhinitis, placebo, TNSS and symptom duration, timing, original reported values, denominators, company involvement and harms.

Related sources R01

N39 · What are individual event timelines and alternative causes?

Current findings: The original material records 15-day use and general caution wording.
Verification status: Unverified
Materials actually read: Existing Korean and English stored summaries and bibliography for the combination-product report read; external abstracts, full text, registration, protocols and analysis plans unread
Why unverified: Stored information is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.
Reason for missing information: Individual event timing, recovery after withdrawal, re-exposure, concomitant medicines, underlying illness and alternative causes remain unverified.
Required materials and conditions: Onset, recovery, discontinuation, re-exposure, concomitant medicines, underlying illness and alternatives
Materials to obtain first: Event timelines, co-medication, alternatives and original harm material
Further research: Material needed: Event timelines, co-medication, alternatives and original harm material This records needed materials; no new research was executed.
Remaining uncertainty: Gaps in product quality, seasonal exposure, concomitant medicines, scale, analysis denominators, plans, company roles and harms remain. Significance is not converted into clinical importance or success across all coprimary outcomes, or complete follow-up into absence of missing data or adverse events.
Conditions for verification: Original records on Onset, recovery, discontinuation, re-exposure, concomitant medicines, underlying illness and alternatives must link to the same product, question, population, comparison, endpoint, timing and analysis denominator, distinguishing recorded information from gaps.
Why this condition is needed: Material on Onset, recovery, discontinuation, re-exposure, concomitant medicines, underlying illness and alternatives is needed to connect the combination-product question to its population, formulation, comparison, endpoint, timing, denominator or harms.
Application exceptions: Combination-product results are not extended to the isolated effects of Nigella oil, piperine or purified thymoquinone, or to other products, populations or periods. Reported starting/final values and changes remain separate; no new effects, intervals, denominators, harm rates or dose totals are calculated.
Referenced methods: Existing principles distinguish the exact combination product, adult men, seasonal rhinitis, placebo, TNSS and symptom duration, timing, original reported values, denominators, company involvement and harms.

Related sources R01

N40 · Were events with the same combination repeated in independent material?

Current findings: The current stored account records general caution wording and does not present a list of independent cases.
Verification status: Unverified
Materials actually read: Existing Korean and English stored summaries and bibliography for the combination-product report read; external abstracts, full text, registration, protocols and analysis plans unread
Why unverified: Stored information is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.
Reason for missing information: Unique harm cases/report families, independent repetition and frequencies for the same combination remain unverified.
Required materials and conditions: Unique cases, formulation/exposure/event matching, report families and repeated citations
Materials to obtain first: Unique cases, report families and exposure material
Further research: Material needed: Unique cases, report families and exposure material This records needed materials; no new research was executed.
Remaining uncertainty: Gaps in product quality, seasonal exposure, concomitant medicines, scale, analysis denominators, plans, company roles and harms remain. Significance is not converted into clinical importance or success across all coprimary outcomes, or complete follow-up into absence of missing data or adverse events.
Conditions for verification: Original records on Unique cases, formulation/exposure/event matching, report families and repeated citations must link to the same product, question, population, comparison, endpoint, timing and analysis denominator, distinguishing recorded information from gaps.
Why this condition is needed: Material on Unique cases, formulation/exposure/event matching, report families and repeated citations is needed to connect the combination-product question to its population, formulation, comparison, endpoint, timing, denominator or harms.
Application exceptions: Combination-product results are not extended to the isolated effects of Nigella oil, piperine or purified thymoquinone, or to other products, populations or periods. Reported starting/final values and changes remain separate; no new effects, intervals, denominators, harm rates or dose totals are calculated.
Referenced methods: Existing principles distinguish the exact combination product, adult men, seasonal rhinitis, placebo, TNSS and symptom duration, timing, original reported values, denominators, company involvement and harms.

Related sources R01

N41 · How are the read summary, unread material and later changes linked?

Current findings: The stored summary is read for production and external material remains unread with access unattempted.
Verification status: Partly verified
Materials actually read: Existing Korean and English stored summaries and bibliography for the combination-product report read; external abstracts, full text, registration, protocols and analysis plans unread
Why unverified: Stored information is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.
Reason for missing information: Original plans, denominators, CI, product, season, concomitant use, harms, COI and content review remain outstanding.
Required materials and conditions: Material-specific availability/reading, original citation links and condition/evidence-change events
Materials to obtain first: Provided or separately permitted original material and corrections
Further research: Material needed: Provided or separately permitted original material and corrections This records needed materials; no new research was executed.
Remaining uncertainty: Gaps in product quality, seasonal exposure, concomitant medicines, scale, analysis denominators, plans, company roles and harms remain. Significance is not converted into clinical importance or success across all coprimary outcomes, or complete follow-up into absence of missing data or adverse events.
Conditions for verification: Original records on Material-specific availability/reading, original citation links and condition/evidence-change events must link to the same product, question, population, comparison, endpoint, timing and analysis denominator, distinguishing recorded information from gaps.
Why this condition is needed: Material on Material-specific availability/reading, original citation links and condition/evidence-change events is needed to connect the combination-product question to its population, formulation, comparison, endpoint, timing, denominator or harms.
Application exceptions: Combination-product results are not extended to the isolated effects of Nigella oil, piperine or purified thymoquinone, or to other products, populations or periods. Reported starting/final values and changes remain separate; no new effects, intervals, denominators, harm rates or dose totals are calculated.
Referenced methods: Existing principles distinguish the exact combination product, adult men, seasonal rhinitis, placebo, TNSS and symptom duration, timing, original reported values, denominators, company involvement and harms.

Related sources R01