# Combination of 5%-thymoquinone standardized Nigella seed oil and piperine × Relief of total nasal symptoms in adults with seasonal allergic rhinitis Verdict 3028 · Evidence Check Stored-material review date: Not recorded Original evidence cut-off: 2026-09-08 Review-criteria version: 1.0 Public page/material preparation date: 2026-10-23 Clinical papers were not read directly; existing review summaries were checked. No new clinical-literature search was performed. Unverified does not mean that research is absent or that there is no effect. ## Assessment scope - 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. ## Checklist items ### N01 · Which combination and rhinitis outcome does this sheet address? Verification status: Partly verified Reading scope: Existing Korean and English stored summaries and bibliography for the combination-product report read; external abstracts, full text, registration, protocols and analysis plans unread - 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. - 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. - 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. - 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. - 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? Verification status: Partly verified Reading scope: Existing Korean and English stored summaries and bibliography for the combination-product report read; external abstracts, full text, registration, protocols and analysis plans unread - Current findings: The original record is a combination capsule of supercritical Nigellin Amber(5% thymoquinone) and BioPerine 2.5 mg. - 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. - 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. - 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. - 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? Verification status: Partly verified Reading scope: Existing Korean and English stored summaries and bibliography for the combination-product report read; external abstracts, full text, registration, protocols and analysis plans unread - Current findings: The original formulation records 5% thymoquinone-standardized seed oil and BioPerine. - 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. - 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. - 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. - 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? Verification status: Partly verified Reading scope: Existing Korean and English stored summaries and bibliography for the combination-product report read; external abstracts, full text, registration, protocols and analysis plans unread - Current findings: The original dose record is 250 mg seed oil and 2.5 mg piperine 2 times daily. - 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. - 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. - 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. - 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? Verification status: Partly verified Reading scope: Existing Korean and English stored summaries and bibliography for the combination-product report read; external abstracts, full text, registration, protocols and analysis plans unread - Current findings: The original explanation that both constituents were administered together and Nigella oil's isolated contribution was not separated is retained. - 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. - 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. - 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. - 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? Verification status: Partly verified Reading scope: Existing Korean and English stored summaries and bibliography for the combination-product report read; external abstracts, full text, registration, protocols and analysis plans unread - Current findings: The original route is oral. Existing wording distinguishes formulations rather than treating them as interchangeable. - 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. - 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. - 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. - 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? Verification status: Partly verified Reading scope: Existing Korean and English stored summaries and bibliography for the combination-product report read; external abstracts, full text, registration, protocols and analysis plans unread - 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. - 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. - 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. - 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. - 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? Verification status: Unverified Reading scope: Existing Korean and English stored summaries and bibliography for the combination-product report read; external abstracts, full text, registration, protocols and analysis plans unread - Current findings: The original population has seasonal allergic rhinitis and the stored result includes starting TNSS 8.45 versus 7.69. - 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. - 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. - 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. - 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? Verification status: Unverified Reading scope: Existing Korean and English stored summaries and bibliography for the combination-product report read; external abstracts, full text, registration, protocols and analysis plans unread - Current findings: The stored account describes a 15-day seasonal-rhinitis trial. - 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. - 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. - 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. - 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? Verification status: Partly verified Reading scope: Existing Korean and English stored summaries and bibliography for the combination-product report read; external abstracts, full text, registration, protocols and analysis plans unread - Current findings: The original description of a fixed standardized seed-oil/piperine combination compared with matched-appearance placebo is retained. - 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. - 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. - 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. - 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? Verification status: Unverified Reading scope: Existing Korean and English stored summaries and bibliography for the combination-product report read; external abstracts, full text, registration, protocols and analysis plans unread - Current findings: The original explanation distinguishes 15-day TNSS from medication sparing. - 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. - 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. - 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. - 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? Verification status: Partly verified Reading scope: Existing Korean and English stored summaries and bibliography for the combination-product report read; external abstracts, full text, registration, protocols and analysis plans unread - Current findings: The original duration is 15 days of treatment/follow-up and the selected endpoint is 15-day TNSS change. - 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. - 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. - 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. - 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? Verification status: Unverified Reading scope: Existing Korean and English stored summaries and bibliography for the combination-product report read; external abstracts, full text, registration, protocols and analysis plans unread - Current findings: The original endpoint is 15-day TNSS change. - 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. - 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. - 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. - 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? Verification status: Partly verified Reading scope: Existing Korean and English stored summaries and bibliography for the combination-product report read; external abstracts, full text, registration, protocols and analysis plans unread - 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. - 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. - 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. - 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. - 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? Verification status: Partly verified Reading scope: Existing Korean and English stored summaries and bibliography for the combination-product report read; external abstracts, full text, registration, protocols and analysis plans unread - Current findings: The existing result record contains TNSS 8.45→4.94 versus 7.69→6.66. - 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. - 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. - 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. - 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? Verification status: Partly verified Reading scope: Existing Korean and English stored summaries and bibliography for the combination-product report read; external abstracts, full text, registration, protocols and analysis plans unread - 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. - 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. - 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. - 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. - 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? Verification status: Unverified Reading scope: Existing Korean and English stored summaries and bibliography for the combination-product report read; external abstracts, full text, registration, protocols and analysis plans unread - Current findings: The original result says that the change CI was not reported. - 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. - 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. - 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. - 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? Verification status: Unverified Reading scope: Existing Korean and English stored summaries and bibliography for the combination-product report read; external abstracts, full text, registration, protocols and analysis plans unread - Current findings: The existing result separately reports starting TNSS 8.45 versus 7.69. - 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. - 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. - 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. - 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? Verification status: Partly verified Reading scope: Existing Korean and English stored summaries and bibliography for the combination-product report read; external abstracts, full text, registration, protocols and analysis plans unread - Current findings: The evidence summary records 65 people,33 versus 32, all completed and all male. - 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. - 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. - 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. - 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? Verification status: Partly verified Reading scope: Existing Korean and English stored summaries and bibliography for the combination-product report read; external abstracts, full text, registration, protocols and analysis plans unread - Current findings: The existing account and sample record both state that all participants completed. - 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. - 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. - 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. - 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? Verification status: Unverified Reading scope: Existing Korean and English stored summaries and bibliography for the combination-product report read; external abstracts, full text, registration, protocols and analysis plans unread - Current findings: The original design is a randomized double-blind placebo trial. - 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. - 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. - 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. - 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? Verification status: Unverified Reading scope: Existing Korean and English stored summaries and bibliography for the combination-product report read; external abstracts, full text, registration, protocols and analysis plans unread - Current findings: The original design is double-blind and the comparator is matched-appearance placebo. - 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. - 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. - 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. - 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? Verification status: Unverified Reading scope: Existing Korean and English stored summaries and bibliography for the combination-product report read; external abstracts, full text, registration, protocols and analysis plans unread - Current findings: The original formulation/dose records a fixed combination 2 times daily for 15 days and describes all participants completing. - 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. - 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. - 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. - 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? Verification status: Partly verified Reading scope: Existing Korean and English stored summaries and bibliography for the combination-product report read; external abstracts, full text, registration, protocols and analysis plans unread - Current findings: Stored evidence and the citation include CTRI/2022/07/044180, and the existing account describes a preregistered placebo comparison. - 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. - 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. - 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. - 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? Verification status: Unverified Reading scope: Existing Korean and English stored summaries and bibliography for the combination-product report read; external abstracts, full text, registration, protocols and analysis plans unread - Current findings: The evidence summary records TNSS and symptom duration as coprimary outcomes, while the selected question is TNSS. - 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. - 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. - 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. - 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? Verification status: Unverified Reading scope: Existing Korean and English stored summaries and bibliography for the combination-product report read; external abstracts, full text, registration, protocols and analysis plans unread - Current findings: The original endpoint description only identifies symptom duration as coprimary. - 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. - 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. - 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. - 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? Verification status: Unverified Reading scope: Existing Korean and English stored summaries and bibliography for the combination-product report read; external abstracts, full text, registration, protocols and analysis plans unread - Current findings: The original explanation states that 15-day TNSS differs from long-term seasonal management or medication sparing. - 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. - 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. - 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. - 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? Verification status: Partly verified Reading scope: Existing Korean and English stored summaries and bibliography for the combination-product report read; external abstracts, full text, registration, protocols and analysis plans unread - Current findings: The existing account and grade rationale describe a large short-term between-group contrast. - 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. - 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. - 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. - 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? Verification status: Partly verified Reading scope: Existing Korean and English stored summaries and bibliography for the combination-product report read; external abstracts, full text, registration, protocols and analysis plans unread - 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. - 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. - 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. - 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. - 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? Verification status: Partly verified Reading scope: Existing Korean and English stored summaries and bibliography for the combination-product report read; external abstracts, full text, registration, protocols and analysis plans unread - Current findings: The existing funding record includes both the authors' no-funding statement and Sami-Sabinsa/Sabinsa employee authorship and product involvement. - 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. - 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. - 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. - 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? Verification status: Partly verified Reading scope: Existing Korean and English stored summaries and bibliography for the combination-product report read; external abstracts, full text, registration, protocols and analysis plans unread - 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. - 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. - 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. - 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. - 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? Verification status: Partly verified Reading scope: Existing Korean and English stored summaries and bibliography for the combination-product report read; external abstracts, full text, registration, protocols and analysis plans unread - Current findings: The clinical production material actually read was the whole stored summary. The original PubMed address is linked and the PMCID entry retained. - 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. - 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. - 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. - 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? Verification status: Partly verified Reading scope: Existing Korean and English stored summaries and bibliography for the combination-product report read; external abstracts, full text, registration, protocols and analysis plans unread - Current findings: The existing original-record date is 2026-09-08, the correction date is 2026-09-14 and the citation is from 2024. - 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. - 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. - 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. - 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 ### N34 · What is the status of generic English wording and the 1-field correction? Verification status: Partly verified Reading scope: Existing Korean and English stored summaries and bibliography for the combination-product report read; external abstracts, full text, registration, protocols and analysis plans unread - 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. - 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. - 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. - 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. - 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? Verification status: Partly verified Reading scope: Existing Korean and English stored summaries and bibliography for the combination-product report read; external abstracts, full text, registration, protocols and analysis plans unread - 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. - 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. - 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. - 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. - 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? Verification status: Partly verified Reading scope: Existing Korean and English stored summaries and bibliography for the combination-product report read; external abstracts, full text, registration, protocols and analysis plans unread - Current findings: The study title mentions efficacy/safety, but the original safety wording cautions that small trials cannot exclude rare or long-term harms. - 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. - 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. - 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. - 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? Verification status: Unverified Reading scope: Existing Korean and English stored summaries and bibliography for the combination-product report read; external abstracts, full text, registration, protocols and analysis plans unread - Current findings: The original formulation combines piperine and the safety wording retains caution for glucose, blood-pressure, anticoagulant, antiseizure and immune-modifying medicines. - 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. - 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. - 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. - 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? Verification status: Partly verified Reading scope: Existing Korean and English stored summaries and bibliography for the combination-product report read; external abstracts, full text, registration, protocols and analysis plans unread - 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. - 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. - 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. - 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. - 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? Verification status: Unverified Reading scope: Existing Korean and English stored summaries and bibliography for the combination-product report read; external abstracts, full text, registration, protocols and analysis plans unread - Current findings: The original material records 15-day use and general caution wording. - 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. - 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. - 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. - 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? Verification status: Unverified Reading scope: Existing Korean and English stored summaries and bibliography for the combination-product report read; external abstracts, full text, registration, protocols and analysis plans unread - Current findings: The current stored account records general caution wording and does not present a list of independent cases. - 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. - 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. - 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. - 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? Verification status: Partly verified Reading scope: Existing Korean and English stored summaries and bibliography for the combination-product report read; external abstracts, full text, registration, protocols and analysis plans unread - Current findings: The stored summary is read for production and external material remains unread with access unattempted. - 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. - 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. - 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. - 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 ## Evidence and sources ### R01 Majeed et al. 2024 · Standardized seed-oil/piperine combination-product trial [PubMed](https://pubmed.ncbi.nlm.nih.gov/39121267/) Materials actually read: Stored summary read; external abstracts, full text, registration and plans unread; access unattempted Findings recorded in the 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. 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. | 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. | ## Review criteria and methods These are Chamgap's own application conditions, informed by the relevant sections of official methodological guidance. They do not constitute official assessment-tool certification or a new efficacy score. - M03 [Cochrane Handbook 6.5 (2024), chapter updated 2023-08](https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-03) · §3.1, §3.2.1–3.2.3, MECIR C5/C7/C13 · Clearly record the question, eligibility conditions and reasons for changes, and distinguish variations in interventions. · 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](https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-04) · §4.5, §4.6.1–4.6.3, MECIR C42 · Distinguish studies from reports and link them; do not omit a study solely because results are unreported. · 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](https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-08) · §8.1–8.2.3, Table 8.2.a · Define the outcome and effect of interest, then examine randomization, deviations, missing data, measurement and selective reporting. · 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](https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-15) · §15.2.4, §15.3.1–15.3.3 · Distinguish effect estimates, intervals, importance and applicability. Sample size alone does not determine precision. · 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](https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-19) · §19.1.2, §19.2.1–19.2.4 · Harm questions may require different designs, populations and follow-up from efficacy questions. Case reports do not establish incidence rates. · 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/materials 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.