{ "schema_version": "chamgap-public-evidence-check-1.0", "public_id": "v3028-main", "verdict_number": "3028", "title": "Combination of 5%-thymoquinone standardized Nigella seed oil and piperine × Relief of total nasal symptoms in adults with seasonal allergic rhinitis", "view_version": "1.0", "view_created_date": "2026-10-23", "criteria_version": "1.0", "criteria_date": "2026-10-06", "review_date": null, "legacy_evidence_date": "2026-09-08", "review_scope": { "materials_read": "Existing review summaries and stored records of methodological application", "clinical_papers_directly_read": false, "new_clinical_search": false, "limitation": "Existing stored summary and preserved methodology application records. External papers, abstracts, registration, protocols, SAPs, original result tables and support disclosures are unread, and review of existing content remains incomplete.", "date_meaning": "This is the date the stored materials were checked, not the date of a new search of the clinical literature." }, "claim_context": { "population": "The population is 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.", "intervention": "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.", "endpoint": "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.", "excluded_extensions": [ "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." ] }, "requirements": [ { "item_id": "N01", "question_type": "Evidence condition", "question": "Which combination and rhinitis outcome does this sheet address?", "needed": "Standardized Nigella oil and piperine, men with seasonal rhinitis,15-day TNSS and placebo", "role": "Required", "role_reason": "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_exception": "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.", "criterion": "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.", "basis": "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.", "condition_origin": "These existing conditions are linked to seasonal rhinitis with the standardized Nigella-oil and piperine combination. They explain stored information and gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Trial question, eligibility, intervention and TNSS definition This records needed materials; no new research was executed.", "current_reports": [ "R01" ], "existence": "The information is recorded in the stored combination-product trial summary and citation. Actual reading of external abstracts, full text, registration and plans remains separately unverified.", "acquired_read": "Existing Korean and English stored summaries and bibliography for the combination-product report read; external abstracts, full text, registration, protocols and analysis plans unread", "observation": "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.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Review of the independent-question boundary remains incomplete and the subclaim list is empty.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Trial question, eligibility, intervention and TNSS definition" }, { "item_id": "N02", "question_type": "Evidence condition", "question": "What intervention combines Nigellin Amber and BioPerine?", "needed": "Supercritical seed fixed oil,5% thymoquinone and 2.5 mg piperine combination", "role": "Required", "role_reason": "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_exception": "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.", "criterion": "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.", "basis": "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.", "condition_origin": "These existing conditions are linked to seasonal rhinitis with the standardized Nigella-oil and piperine combination. They explain stored information and gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Product composition, extraction, standardization and batch analysis This records needed materials; no new research was executed.", "current_reports": [ "R01" ], "existence": "The information is recorded in the stored combination-product trial summary and citation. Actual reading of external abstracts, full text, registration and plans remains separately unverified.", "acquired_read": "Existing Korean and English stored summaries and bibliography for the combination-product report read; external abstracts, full text, registration, protocols and analysis plans unread", "observation": "The original record is a combination capsule of supercritical Nigellin Amber(5% thymoquinone) and BioPerine 2.5 mg.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Complete composition, excipients, raw material, batch, constituent measurements and quality remain unverified.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Product composition, extraction, standardization and batch analysis" }, { "item_id": "N03", "question_type": "Evidence condition", "question": "What quality evidence supports 5% thymoquinone standardization?", "needed": "Seed-oil standardization, measurement, quality, piperine content and product preservation", "role": "Required", "role_reason": "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_exception": "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.", "criterion": "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.", "basis": "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.", "condition_origin": "These existing conditions are linked to seasonal rhinitis with the standardized Nigella-oil and piperine combination. They explain stored information and gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Standardization, composition analysis, batch quality and stability material This records needed materials; no new research was executed.", "current_reports": [ "R01" ], "existence": "The information is recorded in the stored combination-product trial summary and citation. Actual reading of external abstracts, full text, registration and plans remains separately unverified.", "acquired_read": "Existing Korean and English stored summaries and bibliography for the combination-product report read; external abstracts, full text, registration, protocols and analysis plans unread", "observation": "The original formulation records 5% thymoquinone-standardized seed oil and BioPerine.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Original batch measurements, analytical methods, tolerances, storage, contaminants and uniformity remain unverified.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Standardization, composition analysis, batch quality and stability material" }, { "item_id": "N04", "question_type": "Evidence condition", "question": "How were 250 mg oil+2.5 mg piperine used 2 times daily?", "needed": "Constituents per 1 dose, frequency, use, adherence and actual exposure", "role": "Required", "role_reason": "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_exception": "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.", "criterion": "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.", "basis": "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.", "condition_origin": "These existing conditions are linked to seasonal rhinitis with the standardized Nigella-oil and piperine combination. They explain stored information and gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Product contents, dosing procedures and use diaries This records needed materials; no new research was executed.", "current_reports": [ "R01" ], "existence": "The information is recorded in the stored combination-product trial summary and citation. Actual reading of external abstracts, full text, registration and plans remains separately unverified.", "acquired_read": "Existing Korean and English stored summaries and bibliography for the combination-product report read; external abstracts, full text, registration, protocols and analysis plans unread", "observation": "The original dose record is 250 mg seed oil and 2.5 mg piperine 2 times daily.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Dosing time, relation to food, actual use/adherence, omissions, excess use and exposure remain unverified.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Product contents, dosing procedures and use diaries" }, { "item_id": "N05", "question_type": "Evidence condition", "question": "Can the combination result establish a Nigella-oil-only effect?", "needed": "Nigella-only and piperine-only arms, combination arm, factorial design and isolated contribution", "role": "Required", "role_reason": "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_exception": "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.", "criterion": "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.", "basis": "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.", "condition_origin": "These existing conditions are linked to seasonal rhinitis with the standardized Nigella-oil and piperine combination. They explain stored information and gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Direct studies with constituent-specific arms and composition tables This records needed materials; no new research was executed.", "current_reports": [ "R01" ], "existence": "The information is recorded in the stored combination-product trial summary and citation. Actual reading of external abstracts, full text, registration and plans remains separately unverified.", "acquired_read": "Existing Korean and English stored summaries and bibliography for the combination-product report read; external abstracts, full text, registration, protocols and analysis plans unread", "observation": "The original explanation that both constituents were administered together and Nigella oil's isolated contribution was not separated is retained.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Constituent-only arms, factorial effects, interactions and quantified contributions remain unverified.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Direct studies with constituent-specific arms and composition tables" }, { "item_id": "N06", "question_type": "Evidence condition", "question": "Do other Nigella products answer the same question?", "needed": "Seed powder, fixed oil, aqueous extracts, topical products, purified constituents, combinations and oral route", "role": "Required", "role_reason": "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_exception": "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.", "criterion": "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.", "basis": "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.", "condition_origin": "These existing conditions are linked to seasonal rhinitis with the standardized Nigella-oil and piperine combination. They explain stored information and gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Direct rhinitis studies for the exact formulation and route This records needed materials; no new research was executed.", "current_reports": [ "R01" ], "existence": "The information is recorded in the stored combination-product trial summary and citation. Actual reading of external abstracts, full text, registration and plans remains separately unverified.", "acquired_read": "Existing Korean and English stored summaries and bibliography for the combination-product report read; external abstracts, full text, registration, protocols and analysis plans unread", "observation": "The original route is oral. Existing wording distinguishes formulations rather than treating them as interchangeable.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Direct effects of piperine-free oil, seeds, topical products or products with other extraction methods or contents remain unverified.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Direct rhinitis studies for the exact formulation and route" }, { "item_id": "N07", "question_type": "Evidence condition", "question": "How far do adult-male results apply?", "needed": "Adult men, seasonal-rhinitis eligibility, and distinctions from women, children and other populations", "role": "Required", "role_reason": "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_exception": "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.", "criterion": "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.", "basis": "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.", "condition_origin": "These existing conditions are linked to seasonal rhinitis with the standardized Nigella-oil and piperine combination. They explain stored information and gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Eligibility, baseline characteristics and population-specific direct material This records needed materials; no new research was executed.", "current_reports": [ "R01" ], "existence": "The information is recorded in the stored combination-product trial summary and citation. Actual reading of external abstracts, full text, registration and plans remains separately unverified.", "acquired_read": "Existing Korean and English stored summaries and bibliography for the combination-product report read; external abstracts, full text, registration, protocols and analysis plans unread", "observation": "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.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Specific ages, eligibility, women, children, perennial rhinitis and effects in other populations remain unverified.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Eligibility, baseline characteristics and population-specific direct material" }, { "item_id": "N08", "question_type": "Evidence condition", "question": "How were seasonal rhinitis and severity diagnosed?", "needed": "Diagnosis, allergens, baseline TNSS, duration, eligibility and baseline medicines", "role": "Required", "role_reason": "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_exception": "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.", "criterion": "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.", "basis": "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.", "condition_origin": "These existing conditions are linked to seasonal rhinitis with the standardized Nigella-oil and piperine combination. They explain stored information and gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Diagnosis, eligibility, allergens and baseline-characteristics tables This records needed materials; no new research was executed.", "current_reports": [ "R01" ], "existence": "The information is recorded in the stored combination-product trial summary and citation. Actual reading of external abstracts, full text, registration and plans remains separately unverified.", "acquired_read": "Existing Korean and English stored summaries and bibliography for the combination-product report read; external abstracts, full text, registration, protocols and analysis plans unread", "observation": "The original population has seasonal allergic rhinitis and the stored result includes starting TNSS 8.45 versus 7.69.", "condition_status": "Unverified", "status_reason": "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.", "missingness": "Diagnosis, sensitization tests, allergens, baseline severity criteria, symptom duration, medicines and exclusion criteria remain unverified.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Diagnosis, eligibility, allergens and baseline-characteristics tables" }, { "item_id": "N09", "question_type": "Evidence condition", "question": "How did seasonal and allergen exposure compare over 15 days?", "needed": "Actual season, region, pollen, environment, exposure differences and concurrent changes", "role": "Required", "role_reason": "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_exception": "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.", "criterion": "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.", "basis": "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.", "condition_origin": "These existing conditions are linked to seasonal rhinitis with the standardized Nigella-oil and piperine combination. They explain stored information and gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Trial dates, region, environment, exposure and common-management records This records needed materials; no new research was executed.", "current_reports": [ "R01" ], "existence": "The information is recorded in the stored combination-product trial summary and citation. Actual reading of external abstracts, full text, registration and plans remains separately unverified.", "acquired_read": "Existing Korean and English stored summaries and bibliography for the combination-product report read; external abstracts, full text, registration, protocols and analysis plans unread", "observation": "The stored account describes a 15-day seasonal-rhinitis trial.", "condition_status": "Unverified", "status_reason": "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.", "missingness": "Season, region, allergen intensity, avoidance, environmental changes and balance of exposure across arms remain unverified.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Trial dates, region, environment, exposure and common-management records" }, { "item_id": "N10", "question_type": "Evidence condition", "question": "What placebo and common management were compared?", "needed": "Placebo composition/appearance, common treatment and product distinguishability", "role": "Required", "role_reason": "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_exception": "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.", "criterion": "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.", "basis": "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.", "condition_origin": "These existing conditions are linked to seasonal rhinitis with the standardized Nigella-oil and piperine combination. They explain stored information and gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Placebo composition, product appearance and common-treatment tables This records needed materials; no new research was executed.", "current_reports": [ "R01" ], "existence": "The information is recorded in the stored combination-product trial summary and citation. Actual reading of external abstracts, full text, registration and plans remains separately unverified.", "acquired_read": "Existing Korean and English stored summaries and bibliography for the combination-product report read; external abstracts, full text, registration, protocols and analysis plans unread", "observation": "The original description of a fixed standardized seed-oil/piperine combination compared with matched-appearance placebo is retained.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Placebo contents, appearance, taste, common management and maintained masking remain unverified.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Placebo composition, product appearance and common-treatment tables" }, { "item_id": "N11", "question_type": "Evidence condition", "question": "What concurrent effects might rhinitis medicines, rescue treatment and avoidance have?", "needed": "Concomitant medicines, washout, rescue antihistamines, other medicines, avoidance and arm-specific use", "role": "Required", "role_reason": "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_exception": "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.", "criterion": "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.", "basis": "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.", "condition_origin": "These existing conditions are linked to seasonal rhinitis with the standardized Nigella-oil and piperine combination. They explain stored information and gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Concomitant/rescue-medication plans, arm-specific use and avoidance material This records needed materials; no new research was executed.", "current_reports": [ "R01" ], "existence": "The information is recorded in the stored combination-product trial summary and citation. Actual reading of external abstracts, full text, registration and plans remains separately unverified.", "acquired_read": "Existing Korean and English stored summaries and bibliography for the combination-product report read; external abstracts, full text, registration, protocols and analysis plans unread", "observation": "The original explanation distinguishes 15-day TNSS from medication sparing.", "condition_status": "Unverified", "status_reason": "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.", "missingness": "Permitted use, washout and arm-specific use of rhinitis/rescue medicines, allergen avoidance and medicine changes remain unverified.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Concomitant/rescue-medication plans, arm-specific use and avoidance material" }, { "item_id": "N12", "question_type": "Evidence condition", "question": "What are the exact 15-day treatment and follow-up time points?", "needed": "Treatment, visits, starting/final assessments,15-day TNSS and post-discontinuation follow-up", "role": "Required", "role_reason": "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_exception": "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.", "criterion": "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.", "basis": "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.", "condition_origin": "These existing conditions are linked to seasonal rhinitis with the standardized Nigella-oil and piperine combination. They explain stored information and gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Visits, dosing, symptom-recording schedules and subsequent follow-up This records needed materials; no new research was executed.", "current_reports": [ "R01" ], "existence": "The information is recorded in the stored combination-product trial summary and citation. Actual reading of external abstracts, full text, registration and plans remains separately unverified.", "acquired_read": "Existing Korean and English stored summaries and bibliography for the combination-product report read; external abstracts, full text, registration, protocols and analysis plans unread", "observation": "The original duration is 15 days of treatment/follow-up and the selected endpoint is 15-day TNSS change.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Interim assessments, persistence, post-discontinuation follow-up and management across the season remain unverified.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Visits, dosing, symptom-recording schedules and subsequent follow-up" }, { "item_id": "N13", "question_type": "Evidence condition", "question": "What TNSS scale and measurement methods were used?", "needed": "Components, range, score direction, recall period, assessors and diaries", "role": "Required", "role_reason": "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_exception": "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.", "criterion": "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.", "basis": "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.", "condition_origin": "These existing conditions are linked to seasonal rhinitis with the standardized Nigella-oil and piperine combination. They explain stored information and gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: TNSS definition, measurement tools, diaries and aggregation procedures This records needed materials; no new research was executed.", "current_reports": [ "R01" ], "existence": "The information is recorded in the stored combination-product trial summary and citation. Actual reading of external abstracts, full text, registration and plans remains separately unverified.", "acquired_read": "Existing Korean and English stored summaries and bibliography for the combination-product report read; external abstracts, full text, registration, protocols and analysis plans unread", "observation": "The original endpoint is 15-day TNSS change.", "condition_status": "Unverified", "status_reason": "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.", "missingness": "TNSS range, components, scoring, recall period, diaries, assessors and aggregation methods remain unverified.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "TNSS definition, measurement tools, diaries and aggregation procedures" }, { "item_id": "N14", "question_type": "Evidence condition", "question": "What was the original TNSS and symptom-duration hierarchy?", "needed": "TNSS/symptom-duration coprimary wording, plans and success criteria", "role": "Required", "role_reason": "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_exception": "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.", "criterion": "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.", "basis": "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.", "condition_origin": "These existing conditions are linked to seasonal rhinitis with the standardized Nigella-oil and piperine combination. They explain stored information and gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Registration, protocol, analysis plan, endpoint hierarchy and analysis list This records needed materials; no new research was executed.", "current_reports": [ "R01" ], "existence": "The information is recorded in the stored combination-product trial summary and citation. Actual reading of external abstracts, full text, registration and plans remains separately unverified.", "acquired_read": "Existing Korean and English stored summaries and bibliography for the combination-product report read; external abstracts, full text, registration, protocols and analysis plans unread", "observation": "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.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "External registration/plan hierarchy, joint success criteria, multiplicity and separation decisions remain unverified.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Registration, protocol, analysis plan, endpoint hierarchy and analysis list" }, { "item_id": "N15", "question_type": "Evidence condition", "question": "What do 8.45→4.94 versus 7.69→6.66 represent?", "needed": "Arm-specific starting/final TNSS, means, dispersion, timing and denominators", "role": "Required", "role_reason": "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_exception": "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.", "criterion": "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.", "basis": "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.", "condition_origin": "These existing conditions are linked to seasonal rhinitis with the standardized Nigella-oil and piperine combination. They explain stored information and gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Arm-specific starting/final TNSS, raw values, dispersion and denominators This records needed materials; no new research was executed.", "current_reports": [ "R01" ], "existence": "The information is recorded in the stored combination-product trial summary and citation. Actual reading of external abstracts, full text, registration and plans remains separately unverified.", "acquired_read": "Existing Korean and English stored summaries and bibliography for the combination-product report read; external abstracts, full text, registration, protocols and analysis plans unread", "observation": "The existing result record contains TNSS 8.45→4.94 versus 7.69→6.66.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Original-table means, dispersion, raw values, timing, denominators, adjustment and decimal precision remain unverified.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Arm-specific starting/final TNSS, raw values, dispersion and denominators" }, { "item_id": "N16", "question_type": "Evidence condition", "question": "How should −3.52 versus −1.03 points and P<.001 be read?", "needed": "Arm-specific changes, tested comparison, effect of interest and precision", "role": "Required", "role_reason": "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_exception": "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.", "criterion": "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.", "basis": "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.", "condition_origin": "These existing conditions are linked to seasonal rhinitis with the standardized Nigella-oil and piperine combination. They explain stored information and gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Arm-specific changes, between-group test results, dispersion and models This records needed materials; no new research was executed.", "current_reports": [ "R01" ], "existence": "The information is recorded in the stored combination-product trial summary and citation. Actual reading of external abstracts, full text, registration and plans remains separately unverified.", "acquired_read": "Existing Korean and English stored summaries and bibliography for the combination-product report read; external abstracts, full text, registration, protocols and analysis plans unread", "observation": "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.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Original dispersion, between-group effects, test models and targets, adjustment, decimals and change definitions remain unverified.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Arm-specific changes, between-group test results, dispersion and models" }, { "item_id": "N17", "question_type": "Evidence condition", "question": "What is missing about the change CI?", "needed": "Change/between-group-effect CI, dispersion, denominators and models", "role": "Required", "role_reason": "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_exception": "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.", "criterion": "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.", "basis": "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.", "condition_origin": "These existing conditions are linked to seasonal rhinitis with the standardized Nigella-oil and piperine combination. They explain stored information and gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Original changes, between-group effects, CI and dispersion tables This records needed materials; no new research was executed.", "current_reports": [ "R01" ], "existence": "The information is recorded in the stored combination-product trial summary and citation. Actual reading of external abstracts, full text, registration and plans remains separately unverified.", "acquired_read": "Existing Korean and English stored summaries and bibliography for the combination-product report read; external abstracts, full text, registration, protocols and analysis plans unread", "observation": "The original result says that the change CI was not reported.", "condition_status": "Unverified", "status_reason": "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.", "missingness": "CI, dispersion, exact effects and reporting scope outside the stored summary remain unverified because original tables and appendices are unread.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original changes, between-group effects, CI and dispersion tables" }, { "item_id": "N18", "question_type": "Evidence condition", "question": "How were baseline TNSS and other differences considered?", "needed": "Baseline scores/characteristics, adjustment, regression, between-group analysis and alternatives", "role": "Required", "role_reason": "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_exception": "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.", "criterion": "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.", "basis": "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.", "condition_origin": "These existing conditions are linked to seasonal rhinitis with the standardized Nigella-oil and piperine combination. They explain stored information and gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Baseline tables, adjustment, analysis plans and sensitivity material This records needed materials; no new research was executed.", "current_reports": [ "R01" ], "existence": "The information is recorded in the stored combination-product trial summary and citation. Actual reading of external abstracts, full text, registration and plans remains separately unverified.", "acquired_read": "Existing Korean and English stored summaries and bibliography for the combination-product report read; external abstracts, full text, registration, protocols and analysis plans unread", "observation": "The existing result separately reports starting TNSS 8.45 versus 7.69.", "condition_status": "Unverified", "status_reason": "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.", "missingness": "Arm-specific baseline dispersion, balance of characteristics, baseline adjustment, analytical models and sensitivity analyses remain unverified.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Baseline tables, adjustment, analysis plans and sensitivity material" }, { "item_id": "N19", "question_type": "Evidence condition", "question": "What denominators do 65 people and 33 versus 32 represent?", "needed": "Allocation, analysis, completion, arm mapping, TNSS, symptom-duration and harm denominators", "role": "Required", "role_reason": "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_exception": "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.", "criterion": "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.", "basis": "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.", "condition_origin": "These existing conditions are linked to seasonal rhinitis with the standardized Nigella-oil and piperine combination. They explain stored information and gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Participant flow and arm-specific allocation, analysis and endpoint tables This records needed materials; no new research was executed.", "current_reports": [ "R01" ], "existence": "The information is recorded in the stored combination-product trial summary and citation. Actual reading of external abstracts, full text, registration and plans remains separately unverified.", "acquired_read": "Existing Korean and English stored summaries and bibliography for the combination-product report read; external abstracts, full text, registration, protocols and analysis plans unread", "observation": "The evidence summary records 65 people,33 versus 32, all completed and all male.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Original allocation/analysis stages, direct arm mapping, endpoint-specific/harm denominators and aggregation procedures remain unverified.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Participant flow and arm-specific allocation, analysis and endpoint tables" }, { "item_id": "N20", "question_type": "Evidence condition", "question": "Does completion establish complete outcomes and ITT analysis?", "needed": "Completion, attrition, missing data, ITT, PP, outcome availability and effect of interest", "role": "Required", "role_reason": "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_exception": "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.", "criterion": "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.", "basis": "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.", "condition_origin": "These existing conditions are linked to seasonal rhinitis with the standardized Nigella-oil and piperine combination. They explain stored information and gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Participant flow, analysis definitions and endpoint/diary missingness tables This records needed materials; no new research was executed.", "current_reports": [ "R01" ], "existence": "The information is recorded in the stored combination-product trial summary and citation. Actual reading of external abstracts, full text, registration and plans remains separately unverified.", "acquired_read": "Existing Korean and English stored summaries and bibliography for the combination-product report read; external abstracts, full text, registration, protocols and analysis plans unread", "observation": "The existing account and sample record both state that all participants completed.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "ITT/PP definitions, availability of all TNSS/symptom-duration/harm data, diary missingness and analysis-inclusion rules remain unverified.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Participant flow, analysis definitions and endpoint/diary missingness tables" }, { "item_id": "N21", "question_type": "Evidence condition", "question": "What were the allocation sequence, concealment and baseline characteristics?", "needed": "Random sequence generation, concealment, allocation and baseline balance", "role": "Required", "role_reason": "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_exception": "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.", "criterion": "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.", "basis": "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.", "condition_origin": "These existing conditions are linked to seasonal rhinitis with the standardized Nigella-oil and piperine combination. They explain stored information and gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Allocation procedures and baseline tables This records needed materials; no new research was executed.", "current_reports": [ "R01" ], "existence": "The information is recorded in the stored combination-product trial summary and citation. Actual reading of external abstracts, full text, registration and plans remains separately unverified.", "acquired_read": "Existing Korean and English stored summaries and bibliography for the combination-product report read; external abstracts, full text, registration, protocols and analysis plans unread", "observation": "The original design is a randomized double-blind placebo trial.", "condition_status": "Unverified", "status_reason": "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.", "missingness": "Allocation sequence, concealment, assignment, baseline characteristics and changes remain unverified.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Allocation procedures and baseline tables" }, { "item_id": "N22", "question_type": "Evidence condition", "question": "Who was masked and could the products be distinguished?", "needed": "Role-specific masking, appearance, sensory properties, maintenance, unmasking and measurement", "role": "Required", "role_reason": "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_exception": "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.", "criterion": "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.", "basis": "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.", "condition_origin": "These existing conditions are linked to seasonal rhinitis with the standardized Nigella-oil and piperine combination. They explain stored information and gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Masking/placebo procedures and measurement methods This records needed materials; no new research was executed.", "current_reports": [ "R01" ], "existence": "The information is recorded in the stored combination-product trial summary and citation. Actual reading of external abstracts, full text, registration and plans remains separately unverified.", "acquired_read": "Existing Korean and English stored summaries and bibliography for the combination-product report read; external abstracts, full text, registration, protocols and analysis plans unread", "observation": "The original design is double-blind and the comparator is matched-appearance placebo.", "condition_status": "Unverified", "status_reason": "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.", "missingness": "Specific roles, taste, smell, maintained masking and effects on assessment/diaries remain unverified.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Masking/placebo procedures and measurement methods" }, { "item_id": "N23", "question_type": "Evidence condition", "question": "How were product use and treatment deviations handled?", "needed": "Actual use, adherence, discontinuation, crossover, rescue medicines and effect of interest", "role": "Required", "role_reason": "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_exception": "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.", "criterion": "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.", "basis": "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.", "condition_origin": "These existing conditions are linked to seasonal rhinitis with the standardized Nigella-oil and piperine combination. They explain stored information and gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Use diaries, rescue medicines, deviations and analysis plans This records needed materials; no new research was executed.", "current_reports": [ "R01" ], "existence": "The information is recorded in the stored combination-product trial summary and citation. Actual reading of external abstracts, full text, registration and plans remains separately unverified.", "acquired_read": "Existing Korean and English stored summaries and bibliography for the combination-product report read; external abstracts, full text, registration, protocols and analysis plans unread", "observation": "The original formulation/dose records a fixed combination 2 times daily for 15 days and describes all participants completing.", "condition_status": "Unverified", "status_reason": "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.", "missingness": "Actual adherence, missed doses, rescue medicines and analysis of treatment deviations remain unverified.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Use diaries, rescue medicines, deviations and analysis plans" }, { "item_id": "N24", "question_type": "Evidence condition", "question": "How much is verified about CTRI/2022/07/044180?", "needed": "Original-record/citation registration identifiers versus registry contents, dates and actual reading", "role": "Required", "role_reason": "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_exception": "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.", "criterion": "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.", "basis": "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.", "condition_origin": "These existing conditions are linked to seasonal rhinitis with the standardized Nigella-oil and piperine combination. They explain stored information and gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: CTRI text/history, protocol and report mapping This records needed materials; no new research was executed.", "current_reports": [ "R01" ], "existence": "The information is recorded in the stored combination-product trial summary and citation. Actual reading of external abstracts, full text, registration and plans remains separately unverified.", "acquired_read": "Existing Korean and English stored summaries and bibliography for the combination-product report read; external abstracts, full text, registration, protocols and analysis plans unread", "observation": "Stored evidence and the citation include CTRI/2022/07/044180, and the existing account describes a preregistered placebo comparison.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Registry text/history, registration and first-recruitment dates, and endpoint, denominator and plan correspondence remain unverified.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "CTRI text/history, protocol and report mapping" }, { "item_id": "N25", "question_type": "Evidence condition", "question": "How were TNSS/symptom-duration success and multiplicity planned?", "needed": "Coprimary outcomes, planned analyses, timing, success criteria and adjustment", "role": "Required", "role_reason": "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_exception": "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.", "criterion": "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.", "basis": "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.", "condition_origin": "These existing conditions are linked to seasonal rhinitis with the standardized Nigella-oil and piperine combination. They explain stored information and gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Analysis plans, planned comparisons and all primary-outcome tables This records needed materials; no new research was executed.", "current_reports": [ "R01" ], "existence": "The information is recorded in the stored combination-product trial summary and citation. Actual reading of external abstracts, full text, registration and plans remains separately unverified.", "acquired_read": "Existing Korean and English stored summaries and bibliography for the combination-product report read; external abstracts, full text, registration, protocols and analysis plans unread", "observation": "The evidence summary records TNSS and symptom duration as coprimary outcomes, while the selected question is TNSS.", "condition_status": "Unverified", "status_reason": "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.", "missingness": "Joint success/multiplicity criteria, planned tests, analysis changes and endpoint hierarchy remain unverified.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Analysis plans, planned comparisons and all primary-outcome tables" }, { "item_id": "N26", "question_type": "Evidence condition", "question": "What remains unknown for the coprimary symptom-duration outcome?", "needed": "Symptom-duration definition, units, timing, arm-specific values, effects and denominators", "role": "Required", "role_reason": "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_exception": "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.", "criterion": "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.", "basis": "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.", "condition_origin": "These existing conditions are linked to seasonal rhinitis with the standardized Nigella-oil and piperine combination. They explain stored information and gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Symptom-duration definitions, results and denominator tables This records needed materials; no new research was executed.", "current_reports": [ "R01" ], "existence": "The information is recorded in the stored combination-product trial summary and citation. Actual reading of external abstracts, full text, registration and plans remains separately unverified.", "acquired_read": "Existing Korean and English stored summaries and bibliography for the combination-product report read; external abstracts, full text, registration, protocols and analysis plans unread", "observation": "The original endpoint description only identifies symptom duration as coprimary.", "condition_status": "Unverified", "status_reason": "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.", "missingness": "Duration definitions, units, reported values, between-group effects, CI, denominators and plans remain unverified.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Symptom-duration definitions, results and denominator tables" }, { "item_id": "N27", "question_type": "Evidence condition", "question": "Does 15-day TNSS establish medication sparing or management across the season?", "needed": "Rescue/regular medicines, seasonal/long-term follow-up, treatment strategies and recurrence", "role": "Supplementary; required for claims about long-term management or medication sparing", "role_reason": "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_exception": "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.", "criterion": "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.", "basis": "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.", "condition_origin": "These existing conditions are linked to seasonal rhinitis with the standardized Nigella-oil and piperine combination. They explain stored information and gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Medication-use outcomes and long-term/seasonal follow-up This records needed materials; no new research was executed.", "current_reports": [ "R01" ], "existence": "The information is recorded in the stored combination-product trial summary and citation. Actual reading of external abstracts, full text, registration and plans remains separately unverified.", "acquired_read": "Existing Korean and English stored summaries and bibliography for the combination-product report read; external abstracts, full text, registration, protocols and analysis plans unread", "observation": "The original explanation states that 15-day TNSS differs from long-term seasonal management or medication sparing.", "condition_status": "Unverified", "status_reason": "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.", "missingness": "Medicine use, reduction, management across the season, recurrence and post-discontinuation persistence remain unverified.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Medication-use outcomes and long-term/seasonal follow-up" }, { "item_id": "N28", "question_type": "Evidence condition", "question": "What is the scope of the original large-TNSS-change interpretation?", "needed": "Effects, CI, prespecified important difference, patient-important outcomes and responders", "role": "Required", "role_reason": "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_exception": "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.", "criterion": "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.", "basis": "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.", "condition_origin": "These existing conditions are linked to seasonal rhinitis with the standardized Nigella-oil and piperine combination. They explain stored information and gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Importance plans, effect intervals and patient-important outcomes This records needed materials; no new research was executed.", "current_reports": [ "R01" ], "existence": "The information is recorded in the stored combination-product trial summary and citation. Actual reading of external abstracts, full text, registration and plans remains separately unverified.", "acquired_read": "Existing Korean and English stored summaries and bibliography for the combination-product report read; external abstracts, full text, registration, protocols and analysis plans unread", "observation": "The existing account and grade rationale describe a large short-term between-group contrast.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Prespecified MCID, responder criteria/rates, exact effect intervals and patient-important outcomes such as quality of life or sleep remain unverified.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Importance plans, effect intervals and patient-important outcomes" }, { "item_id": "N29", "question_type": "Evidence condition", "question": "Which report do the stored summary and PMID/PMCID/DOI identify?", "needed": "Research reports, same-trial/registration families and original citation", "role": "Required", "role_reason": "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_exception": "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.", "criterion": "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.", "basis": "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.", "condition_origin": "These existing conditions are linked to seasonal rhinitis with the standardized Nigella-oil and piperine combination. They explain stored information and gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Original papers, registration and subsequent reports from the same trial This records needed materials; no new research was executed.", "current_reports": [ "R01" ], "existence": "The information is recorded in the stored combination-product trial summary and citation. Actual reading of external abstracts, full text, registration and plans remains separately unverified.", "acquired_read": "Existing Korean and English stored summaries and bibliography for the combination-product report read; external abstracts, full text, registration, protocols and analysis plans unread", "observation": "The original citation records Majeed M et al., Medicine(Baltimore).2024, PMID 39121267, PMCID PMC11315530, DOI 10.1097/MD.0000000000039243 and a CTRI identifier.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "External paper/registry identity, subsequent-report families and unique trial/participant totals remain unverified.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original papers, registration and subsequent reports from the same trial" }, { "item_id": "N30", "question_type": "Evidence condition", "question": "How do the no-funding statement and company involvement differ?", "needed": "Cash funding, product support, employee authorship, COI and company roles", "role": "Required", "role_reason": "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_exception": "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.", "criterion": "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.", "basis": "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.", "condition_origin": "These existing conditions are linked to seasonal rhinitis with the standardized Nigella-oil and piperine combination. They explain stored information and gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Original funding/COI, affiliations and product/company-role material This records needed materials; no new research was executed.", "current_reports": [ "R01" ], "existence": "The information is recorded in the stored combination-product trial summary and citation. Actual reading of external abstracts, full text, registration and plans remains separately unverified.", "acquired_read": "Existing Korean and English stored summaries and bibliography for the combination-product report read; external abstracts, full text, registration, protocols and analysis plans unread", "observation": "The existing funding record includes both the authors' no-funding statement and Sami-Sabinsa/Sabinsa employee authorship and product involvement.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Details of cash/product support, employment, roles, original COI and involvement in design, analysis or reporting remain unverified.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original funding/COI, affiliations and product/company-role material" }, { "item_id": "N31", "question_type": "Evidence condition", "question": "What remains unknown about independent replication of the same product?", "needed": "Product/question matching, teams, support, report families and independent replication", "role": "Required", "role_reason": "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_exception": "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.", "criterion": "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.", "basis": "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.", "condition_origin": "These existing conditions are linked to seasonal rhinitis with the standardized Nigella-oil and piperine combination. They explain stored information and gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Separate original trials for the same product/question and team/support relationships This records needed materials; no new research was executed.", "current_reports": [ "R01" ], "existence": "The information is recorded in the stored combination-product trial summary and citation. Actual reading of external abstracts, full text, registration and plans remains separately unverified.", "acquired_read": "Existing Korean and English stored summaries and bibliography for the combination-product report read; external abstracts, full text, registration, protocols and analysis plans unread", "observation": "The account records the company product trial/employee-author limitation and a product-specific short-term signal. The original assessment record is R1/I0.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Independent teams/trials, long-term or other-sex replication of the same combination, and unique totals remain unverified.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Separate original trials for the same product/question and team/support relationships" }, { "item_id": "N32", "question_type": "Evidence condition", "question": "Were the original paper, PMCID text and registration actually read?", "needed": "Stored summary, PubMed link, PMCID citation and external content reading", "role": "Required", "role_reason": "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_exception": "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.", "criterion": "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.", "basis": "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.", "condition_origin": "These existing conditions are linked to seasonal rhinitis with the standardized Nigella-oil and piperine combination. They explain stored information and gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Original material corresponding to the citation and registration This records needed materials; no new research was executed.", "current_reports": [ "R01" ], "existence": "The information is recorded in the stored combination-product trial summary and citation. Actual reading of external abstracts, full text, registration and plans remains separately unverified.", "acquired_read": "Existing Korean and English stored summaries and bibliography for the combination-product report read; external abstracts, full text, registration, protocols and analysis plans unread", "observation": "The clinical production material actually read was the whole stored summary. The original PubMed address is linked and the PMCID entry retained.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Abstracts, PMCID full text, registration, plans and appendices remain unread and access unattempted.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original material corresponding to the citation and registration" }, { "item_id": "N33", "question_type": "Evidence condition", "question": "Are the original evidence date and current production time distinguished?", "needed": "Original-record date, correction date,2024 citation, actual reading, searches and production", "role": "Required", "role_reason": "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_exception": "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.", "criterion": "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.", "basis": "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.", "condition_origin": "These existing conditions are linked to seasonal rhinitis with the standardized Nigella-oil and piperine combination. They explain stored information and gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Original publication, search, receipt and correction records This records needed materials; no new research was executed.", "current_reports": [ "R01" ], "existence": "The information is recorded in the stored combination-product trial summary and citation. Actual reading of external abstracts, full text, registration and plans remains separately unverified.", "acquired_read": "Existing Korean and English stored summaries and bibliography for the combination-product report read; external abstracts, full text, registration, protocols and analysis plans unread", "observation": "The existing original-record date is 2026-09-08, the correction date is 2026-09-14 and the citation is from 2024.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "An actual latest-search cutoff, current external-reading date and completed-review date are absent or unverified.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original publication, search, receipt and correction records" }, { "item_id": "N34", "question_type": "Evidence condition", "question": "What is the status of generic English wording and the 1-field correction?", "needed": "Korean/English reported values, generic English explanations and before/after correction originals", "role": "Required", "role_reason": "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_exception": "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.", "criterion": "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.", "basis": "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.", "condition_origin": "These existing conditions are linked to seasonal rhinitis with the standardized Nigella-oil and piperine combination. They explain stored information and gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Before/after correction originals and English correspondence for original results/endpoints This records needed materials; no new research was executed.", "current_reports": [ "R01" ], "existence": "The information is recorded in the stored combination-product trial summary and citation. Actual reading of external abstracts, full text, registration and plans remains separately unverified.", "acquired_read": "Existing Korean and English stored summaries and bibliography for the combination-product report read; external abstracts, full text, registration, protocols and analysis plans unread", "observation": "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.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Which field's before/after original and review of detailed English/coprimary correspondence remain unverified.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Before/after correction originals and English correspondence for original results/endpoints" }, { "item_id": "N35", "question_type": "Evidence condition", "question": "What historical records are C50, I0 and the existing settings?", "needed": "Original grade, score, safety label, assessment records, grade rationale and empty values", "role": "Required", "role_reason": "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_exception": "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.", "criterion": "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.", "basis": "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.", "condition_origin": "These existing conditions are linked to seasonal rhinitis with the standardized Nigella-oil and piperine combination. They explain stored information and gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Original verdict and permitted subsequent correction events This records needed materials; no new research was executed.", "current_reports": [ "R01" ], "existence": "The information is recorded in the stored combination-product trial summary and citation. Actual reading of external abstracts, full text, registration and plans remains separately unverified.", "acquired_read": "Existing Korean and English stored summaries and bibliography for the combination-product report read; external abstracts, full text, registration, protocols and analysis plans unread", "observation": "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.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Current content review, external clinical validation and official assessment certification remain incomplete.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original verdict and permitted subsequent correction events" }, { "item_id": "N36", "question_type": "Evidence condition", "question": "What denominators supported collection of actual 15-day combination harms?", "needed": "Event definitions, collection, arm-specific events, denominators, discontinuation, missingness and timing", "role": "Required", "role_reason": "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_exception": "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.", "criterion": "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.", "basis": "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.", "condition_origin": "These existing conditions are linked to seasonal rhinitis with the standardized Nigella-oil and piperine combination. They explain stored information and gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Adverse-event/discontinuation records, harm collection and arm-specific denominators This records needed materials; no new research was executed.", "current_reports": [ "R01" ], "existence": "The information is recorded in the stored combination-product trial summary and citation. Actual reading of external abstracts, full text, registration and plans remains separately unverified.", "acquired_read": "Existing Korean and English stored summaries and bibliography for the combination-product report read; external abstracts, full text, registration, protocols and analysis plans unread", "observation": "The study title mentions efficacy/safety, but the original safety wording cautions that small trials cannot exclude rare or long-term harms.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Specific event counts, arm-specific harm denominators, collection, discontinuation, missingness and timing remain unverified.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Adverse-event/discontinuation records, harm collection and arm-specific denominators" }, { "item_id": "N37", "question_type": "Evidence condition", "question": "Are harms of the piperine combination and caution-listed medicines verified?", "needed": "Combined/isolated exposure, concomitant medicines, interaction events, denominators and contribution", "role": "Supplementary; required within concomitant-use or combination-harm scope", "role_reason": "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_exception": "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.", "criterion": "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.", "basis": "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.", "condition_origin": "These existing conditions are linked to seasonal rhinitis with the standardized Nigella-oil and piperine combination. They explain stored information and gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Formulation/medicine-specific exposure, interaction and concomitant-use material This records needed materials; no new research was executed.", "current_reports": [ "R01" ], "existence": "The information is recorded in the stored combination-product trial summary and citation. Actual reading of external abstracts, full text, registration and plans remains separately unverified.", "acquired_read": "Existing Korean and English stored summaries and bibliography for the combination-product report read; external abstracts, full text, registration, protocols and analysis plans unread", "observation": "The original formulation combines piperine and the safety wording retains caution for glucose, blood-pressure, anticoagulant, antiseizure and immune-modifying medicines.", "condition_status": "Unverified", "status_reason": "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.", "missingness": "Isolated piperine/oil contributions, concomitant use, exclusions, actual interaction events, denominators and causality remain unverified.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Formulation/medicine-specific exposure, interaction and concomitant-use material" }, { "item_id": "N38", "question_type": "Evidence condition", "question": "What about safety beyond a short male trial?", "needed": "Formulation-specific long-term/rare harms, pregnancy, breastfeeding, children, liver/kidney disease and surgery", "role": "Supplementary; required for long-term or vulnerable-group safety claims", "role_reason": "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_exception": "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.", "criterion": "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.", "basis": "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.", "condition_origin": "These existing conditions are linked to seasonal rhinitis with the standardized Nigella-oil and piperine combination. They explain stored information and gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Long-term, rare, formulation-specific and population-specific original harm material This records needed materials; no new research was executed.", "current_reports": [ "R01" ], "existence": "The information is recorded in the stored combination-product trial summary and citation. Actual reading of external abstracts, full text, registration and plans remains separately unverified.", "acquired_read": "Existing Korean and English stored summaries and bibliography for the combination-product report read; external abstracts, full text, registration, protocols and analysis plans unread", "observation": "The original safety wording records composition differences by formulation/extraction, vulnerable-group/surgical cautions and inability to exclude rare or long-term harms.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Direct harm material for the combination's long-term/rare outcomes, women, children, vulnerable groups and surgery remains unverified.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Long-term, rare, formulation-specific and population-specific original harm material" }, { "item_id": "N39", "question_type": "Evidence condition", "question": "What are individual event timelines and alternative causes?", "needed": "Onset, recovery, discontinuation, re-exposure, concomitant medicines, underlying illness and alternatives", "role": "Required", "role_reason": "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_exception": "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.", "criterion": "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.", "basis": "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.", "condition_origin": "These existing conditions are linked to seasonal rhinitis with the standardized Nigella-oil and piperine combination. They explain stored information and gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Event timelines, co-medication, alternatives and original harm material This records needed materials; no new research was executed.", "current_reports": [ "R01" ], "existence": "The information is recorded in the stored combination-product trial summary and citation. Actual reading of external abstracts, full text, registration and plans remains separately unverified.", "acquired_read": "Existing Korean and English stored summaries and bibliography for the combination-product report read; external abstracts, full text, registration, protocols and analysis plans unread", "observation": "The original material records 15-day use and general caution wording.", "condition_status": "Unverified", "status_reason": "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.", "missingness": "Individual event timing, recovery after withdrawal, re-exposure, concomitant medicines, underlying illness and alternative causes remain unverified.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Event timelines, co-medication, alternatives and original harm material" }, { "item_id": "N40", "question_type": "Evidence condition", "question": "Were events with the same combination repeated in independent material?", "needed": "Unique cases, formulation/exposure/event matching, report families and repeated citations", "role": "Supplementary; required for repeated-harm claims", "role_reason": "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_exception": "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.", "criterion": "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.", "basis": "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.", "condition_origin": "These existing conditions are linked to seasonal rhinitis with the standardized Nigella-oil and piperine combination. They explain stored information and gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Unique cases, report families and exposure material This records needed materials; no new research was executed.", "current_reports": [ "R01" ], "existence": "The information is recorded in the stored combination-product trial summary and citation. Actual reading of external abstracts, full text, registration and plans remains separately unverified.", "acquired_read": "Existing Korean and English stored summaries and bibliography for the combination-product report read; external abstracts, full text, registration, protocols and analysis plans unread", "observation": "The current stored account records general caution wording and does not present a list of independent cases.", "condition_status": "Unverified", "status_reason": "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.", "missingness": "Unique harm cases/report families, independent repetition and frequencies for the same combination remain unverified.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Unique cases, report families and exposure material" }, { "item_id": "N41", "question_type": "Evidence condition", "question": "How are the read summary, unread material and later changes linked?", "needed": "Material-specific availability/reading, original citation links and condition/evidence-change events", "role": "Required", "role_reason": "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_exception": "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.", "criterion": "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.", "basis": "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.", "condition_origin": "These existing conditions are linked to seasonal rhinitis with the standardized Nigella-oil and piperine combination. They explain stored information and gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Provided or separately permitted original material and corrections This records needed materials; no new research was executed.", "current_reports": [ "R01" ], "existence": "The information is recorded in the stored combination-product trial summary and citation. Actual reading of external abstracts, full text, registration and plans remains separately unverified.", "acquired_read": "Existing Korean and English stored summaries and bibliography for the combination-product report read; external abstracts, full text, registration, protocols and analysis plans unread", "observation": "The stored summary is read for production and external material remains unread with access unattempted.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Original plans, denominators, CI, product, season, concomitant use, harms, COI and content review remain outstanding.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Provided or separately permitted original material and corrections" } ], "reports": [ { "report_id": "R01", "title": "Majeed et al. 2024 · Standardized seed-oil/piperine combination-product trial", "url": "https://pubmed.ncbi.nlm.nih.gov/39121267/", "report_type": "Randomized double-blind placebo-controlled trial", "existence": "The information is recorded in the stored combination-product trial summary and citation. Actual reading of external abstracts, full text, registration and plans remains separately unverified.", "acquired_read": "Stored summary read; external abstracts, full text, registration and plans unread; access unattempted", "study_family": "SF01-Majeed-2024-oil-piperine-rhinitis-native", "independent_replication": "Original company-involvement/I0/R1 records retained; no new independent-replication or unique-total certification", "observed_result": "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", "result_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.", "source_evidence_date": "2026-09-08", "materials": [ { "material_type": "Stored existing review summary", "public_status": "Preserved copy of the complete existing review summary", "access_status": "Stored summary", "acquired": true, "actually_read": "Summary read", "as_of": "2026-09-08 (date of the original record, not a new external reading date)", "qualification": "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." }, { "material_type": "External paper identity link", "public_status": "Original bibliographic link or needed material; external public availability/access status unverified", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-09-08 (date of the original record, not a new external reading date)", "qualification": "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." }, { "material_type": "External full text", "public_status": "Original bibliographic link or needed material; external public availability/access status unverified", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-09-08 (date of the original record, not a new external reading date)", "qualification": "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." }, { "material_type": "Registration material", "public_status": "Original bibliographic link or needed material; external public availability/access status unverified", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-09-08 (date of the original record, not a new external reading date)", "qualification": "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." }, { "material_type": "Additional material needed", "public_status": "Original bibliographic link or needed material; external public availability/access status unverified", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-09-08 (date of the original record, not a new external reading date)", "qualification": "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." }, { "material_type": "Additional material needed", "public_status": "Original bibliographic link or needed material; external public availability/access status unverified", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-09-08 (date of the original record, not a new external reading date)", "qualification": "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." }, { "material_type": "Additional material needed", "public_status": "Original bibliographic link or needed material; external public availability/access status unverified", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-09-08 (date of the original record, not a new external reading date)", "qualification": "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." }, { "material_type": "Additional material needed", "public_status": "Original bibliographic link or needed material; external public availability/access status unverified", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-09-08 (date of the original record, not a new external reading date)", "qualification": "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." }, { "material_type": "Additional material needed", "public_status": "Original bibliographic link or needed material; external public availability/access status unverified", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-09-08 (date of the original record, not a new external reading date)", "qualification": "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." }, { "material_type": "Additional material needed", "public_status": "Original bibliographic link or needed material; external public availability/access status unverified", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-09-08 (date of the original record, not a new external reading date)", "qualification": "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." } ], "links": [ { "label": "PubMed", "url": "https://pubmed.ncbi.nlm.nih.gov/39121267/" } ] } ], "method_sources": [ { "id": "M03", "version": "Cochrane Handbook 6.5 (2024), chapter updated 2023-08", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-03", "section": "§3.1, §3.2.1–3.2.3, MECIR C5/C7/C13", "official_principle": "Clearly record the question, eligibility conditions and reasons for changes, and distinguish variations in interventions.", "review_level": "Existing methodological links were reused for production. External originals were not reread and methodological content was not reassessed." }, { "id": "M04", "version": "Cochrane Handbook 6.5.1 (2025), chapter updated 2025-03", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-04", "section": "§4.5, §4.6.1–4.6.3, MECIR C42", "official_principle": "Distinguish studies from reports and link them; do not omit a study solely because results are unreported.", "review_level": "Existing methodological links were reused for production. External originals were not reread and methodological content was not reassessed." }, { "id": "M08", "version": "Cochrane Handbook 6.5 (2024), chapter updated 2019-10", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-08", "section": "§8.1–8.2.3, Table 8.2.a", "official_principle": "Define the outcome and effect of interest, then examine randomization, deviations, missing data, measurement and selective reporting.", "review_level": "Existing methodological links were reused for production. External originals were not reread and methodological content was not reassessed." }, { "id": "M15", "version": "Cochrane Handbook 6.5 (2024), chapter updated 2023-08", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-15", "section": "§15.2.4, §15.3.1–15.3.3", "official_principle": "Distinguish effect estimates, intervals, importance and applicability. Sample size alone does not determine precision.", "review_level": "Existing methodological links were reused for production. External originals were not reread and methodological content was not reassessed." }, { "id": "M19", "version": "Cochrane Handbook 6.5 (2024), chapter updated 2019-10", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-19", "section": "§19.1.2, §19.2.1–19.2.4", "official_principle": "Harm questions may require different designs, populations and follow-up from efficacy questions. Case reports do not establish incidence rates.", "review_level": "Existing methodological links were reused for production. External originals were not reread and methodological content was not reassessed." } ], "status_dictionary": { "Partly verified": "Partial information from the stored summary is linked; detailed originals and content review remain incomplete.", "Unverified": "Required details cannot be established within the preserved scope. This does not establish absence of effects or studies, or safety.", "Review incomplete": "Review of existing content remains incomplete.", "Met": "This state is used only within the relevant conditions after material verification and content review. It was not automatically assigned in this work.", "Not reported": "Unreported within material actually read. Unread external material is not relabeled as unreported.", "Inaccessible": "This means actual access failure. External access was not attempted in this work, so this state was not assigned.", "Not applicable": "Used only with an application exception and reason based on the question scope.", "Conflicting data": "This requires actual comparison of materials; no new conflict judgment was made in this work.", "Insufficient evidence for the conditions": "This indicates gaps in additional material for the selected conditions. Unread material as a whole is not converted into an efficacy grade." }, "study_overlap": { "state": "Unverified", "unique_trial_count": null, "unique_participant_count": null, "reason": "The 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." }, "history": [ { "date": "2026-10-23", "kind": "Separation of public-facing pages and materials", "view_version": "1.0", "change": "The public view and materials were prepared from the existing 41 items. No new clinical search, verification-state change or scoring was performed." } ], "language": "en", "translation_date": "2026-10-23" }