{ "schema_version": "chamgap-public-evidence-check-1.0", "public_id": "v3032-main", "verdict_number": "3032", "title": "Oral aqueous Nigella sativa seed extract as adjunctive therapy × Reduced seizure frequency in pediatric refractory epilepsy", "view_version": "1.0", "view_created_date": "2026-10-24", "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": "The date 2026-09-08 retained in every material item is the original evidence date, not a date of external reading. The date 2026-10-06 is the original production date, not a completed-content-review date. Pending-review wording is not a verification date." }, "claim_context": { "population": "The population is children with refractory epilepsy continuing antiseizure medication. Detailed ages, seizure types, the definition of refractoriness, baseline severity and inclusion/exclusion criteria remain unverified. Applicability to adults, children with epilepsy generally or other clinical questions is not assumed.", "intervention": "The adjunctive intervention is oral Soxhlet-prepared aqueous extract of Nigella sativa L. seeds added to background antiseizure medication. It is not purified thymoquinone; composition, yield, batch, standardization and equivalence to marketed preparations remain unverified.", "dose": "The retained oral dose is 40 mg/kg every 8 hours. No new daily total, cumulative dose or optimal dose is calculated. Reference body weight, actual administered amounts, missed doses, adjustments and adherence remain unverified.", "comparator": "The crossover comparator is placebo added to common background antiseizure medication. Placebo composition, appearance and taste, matching administration, specific concomitant drugs and doses, changes and rescue treatment remain unverified. This is not converted into an extract-alone effect or an effect of stopping background medication.", "endpoint": "The principal endpoint is parent-recorded seizures per day. Seizure definitions, recording instruction, objective confirmation, missing-diary handling and prospective endpoint and analysis hierarchies remain unverified. It is not substituted for developmental, quality-of-life, hospitalization, medication-withdrawal or durable-remission outcomes.", "duration": "The record distinguishes 4 weeks per intervention period from a 2-week washout. Baseline recording duration, period-specific measurement schedules, seizures and treatment during washout, and long-term persistence remain unverified. No new total duration is summed, and washout alone does not establish removal of carryover.", "excluded_extensions": [ "The selected question concerns seizure frequency with adjunctive oral aqueous seed extract in children with refractory epilepsy continuing antiseizure medication. It is not extended to adults, animals, powder, fixed oil, other extracts, purified thymoquinone, medication withdrawal or durable remission.", "The existing C·54 points·Caution and B/H/R1/I1/E+/B2/C0 are retained. Historical independent Codex cross-check wording does not establish completed content review, certified independent replication or new confirmation of independence here.", "The records of 23 enrolled participants and 20 completers remain distinct. Enrollment is not converted into a randomized count, nor completion into an analysis denominator for every period, endpoint or harm. The same participants' crossover periods are not pooled as independent trials or new participants, and no new dropout count or ITT set is created.", "The retained values are baseline 5.78±7.20, extract 4.21±5.77, placebo 6.14±6.75 and 65% versus 20% improvement. The definition of ±, paired period- and sequence-specific values, response criteria, participant counts and denominators, and intervals remain unverified. No new change score, treatment effect, total seizure-event count or responder count is calculated.", "The overall Friedman P<.001 is not a fully reported period-specific treatment contrast. Prospective contrasts, period and sequence adjustment, exact treatment-contrast P values, paired CIs, important differences and multiplicity handling remain unverified. The presence of washout does not establish that carryover, period or sequence effects were addressed.", "The original record of 40 mg/kg every 8 hours, 4 weeks per intervention period and a 2-week washout is retained. Differences in background drugs, rescue treatment and adherence, and actual exposure remain unverified. No new daily total, total duration, long-term effect or effect of another dose is created.", "Funding is recorded as unconfirmed in the original. Unverified product provision, employee authorship, patents and conflicts are not converted into absence or new confirmation of independence. Period-specific harm collection, withdrawal, denominators, causality and long-term or vulnerable-population safety also remain unverified.", "PMID18049435, the original evidence date 2026-09-08 and the English-placeholder correction date 2026-09-14 for 1 field are retained. The date 2026-10-06 is the original production date. Unrecorded DOI, PMCID and registration identifiers and the original unconfirmed nct field are not converted into verified absence; identifiers or historical generic wording are not promoted to current external reading." ] }, "requirements": [ { "item_id": "N01", "question_type": "Evidence condition", "question": "What is the selected claim?", "needed": "The exact question on aqueous seed extract, pediatric refractory epilepsy, seizure frequency, continued antiseizure medication and added placebo", "role": "Required", "role_reason": "Material on The exact question on aqueous seed extract, pediatric refractory epilepsy, seizure frequency, continued antiseizure medication and added placebo is needed to connect the pediatric population to formulation, dose, background treatment, placebo, seizure recording, crossover periods and sequences, denominators, intervals or harms.", "application_exception": "The records of 23 enrolled participants and 20 completers are not converted into randomized, period-specific analysis or safety denominators, and no new dropout count is calculated. Crossover periods are not pooled as independent trials or new participants, and an overall test is not converted into an effect between treatment periods.", "criterion": "Original records on The exact question on aqueous seed extract, pediatric refractory epilepsy, seizure frequency, continued antiseizure medication and added placebo must link to the relevant report, crossover design, concomitant medication, measurement, timing and denominator, distinguishing recorded information from what remains unverified.", "basis": "Existing principles distinguish formulation, population, background antiseizure medication, placebo, seizure recording, crossover periods and sequences, denominators, effect intervals, support and harms for adjunctive aqueous seed extract in children.", "condition_origin": "These existing conditions are linked to the crossover comparison of aqueous seed extract and placebo in children continuing antiseizure medication. They explain stored summaries and material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Original material specifying formulation, population, comparison and duration for this question This records needed materials; no new research was executed.", "current_reports": [ "S01" ], "existence": "The information is recorded in a stored pediatric crossover report, citation and existing Korean and English summaries. Actual reading of external articles, registration, plans and support disclosures remains separately unverified.", "acquired_read": "Existing Korean and English stored summaries and the S01 citation read; external articles, registration, protocols, analysis plans and support disclosures unread", "observation": "The original claim is reduced seizure frequency in pediatric refractory epilepsy. Only adjunctive oral aqueous seed extract in children continuing antiseizure medication is linked.", "condition_status": "Partly verified", "status_reason": "Information retained in stored summaries 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": "Material supporting application of adult, purified-thymoquinone or other Nigella-formulation effects to this question remains unverified.", "uncertainty": "Gaps in extract specifications, background drugs, adherence, allocation, masking, parent diaries, crossover periods and sequences, carryover, missing data, effect intervals, support roles and harms remain. A short seizure-frequency signal is not converted into medication withdrawal, durable remission, efficacy of other formulations or long-term safety.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original material specifying formulation, population, comparison and duration for this question" }, { "item_id": "N02", "question_type": "Evidence condition", "question": "Which materials were actually read here?", "needed": "Separate reading levels for the stored JSON summary and external articles, registration and plans", "role": "Required", "role_reason": "Material on Separate reading levels for the stored JSON summary and external articles, registration and plans is needed to connect the pediatric population to formulation, dose, background treatment, placebo, seizure recording, crossover periods and sequences, denominators, intervals or harms.", "application_exception": "The records of 23 enrolled participants and 20 completers are not converted into randomized, period-specific analysis or safety denominators, and no new dropout count is calculated. Crossover periods are not pooled as independent trials or new participants, and an overall test is not converted into an effect between treatment periods.", "criterion": "Original records on Separate reading levels for the stored JSON summary and external articles, registration and plans must link to the relevant report, crossover design, concomitant medication, measurement, timing and denominator, distinguishing recorded information from what remains unverified.", "basis": "Existing principles distinguish formulation, population, background antiseizure medication, placebo, seizure recording, crossover periods and sequences, denominators, effect intervals, support and harms for adjunctive aqueous seed extract in children.", "condition_origin": "These existing conditions are linked to the crossover comparison of aqueous seed extract and placebo in children continuing antiseizure medication. They explain stored summaries and material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Original material and access histories supplied by the user or obtained in subsequent work This records needed materials; no new research was executed.", "current_reports": [ "S01" ], "existence": "The information is recorded in a stored pediatric crossover report, citation and existing Korean and English summaries. Actual reading of external articles, registration, plans and support disclosures remains separately unverified.", "acquired_read": "Existing Korean and English stored summaries and the S01 citation read; external articles, registration, protocols, analysis plans and support disclosures unread", "observation": "Existing Korean and English stored summaries, 1 evidence entry and 1 citation were used for preparation. The article URL is copied from the original record; external abstracts, full text, registration, protocols and SAP were unread, with no access attempted.", "condition_status": "Partly verified", "status_reason": "Information retained in stored summaries 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": "Existence of a link does not establish full-text reading or completed content review.", "uncertainty": "Gaps in extract specifications, background drugs, adherence, allocation, masking, parent diaries, crossover periods and sequences, carryover, missing data, effect intervals, support roles and harms remain. A short seizure-frequency signal is not converted into medication withdrawal, durable remission, efficacy of other formulations or long-term safety.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original material and access histories supplied by the user or obtained in subsequent work" }, { "item_id": "N03", "question_type": "Evidence condition", "question": "What is the identity of the report?", "needed": "Link authors, year, title and PMID to the direct report", "role": "Required", "role_reason": "Material on Link authors, year, title and PMID to the direct report is needed to connect the pediatric population to formulation, dose, background treatment, placebo, seizure recording, crossover periods and sequences, denominators, intervals or harms.", "application_exception": "The records of 23 enrolled participants and 20 completers are not converted into randomized, period-specific analysis or safety denominators, and no new dropout count is calculated. Crossover periods are not pooled as independent trials or new participants, and an overall test is not converted into an effect between treatment periods.", "criterion": "Original records on Link authors, year, title and PMID to the direct report must link to the relevant report, crossover design, concomitant medication, measurement, timing and denominator, distinguishing recorded information from what remains unverified.", "basis": "Existing principles distinguish formulation, population, background antiseizure medication, placebo, seizure recording, crossover periods and sequences, denominators, effect intervals, support and harms for adjunctive aqueous seed extract in children.", "condition_origin": "These existing conditions are linked to the crossover comparison of aqueous seed extract and placebo in children continuing antiseizure medication. They explain stored summaries and material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Full article bibliography and lists of related registrations and reports This records needed materials; no new research was executed.", "current_reports": [ "S01" ], "existence": "The information is recorded in a stored pediatric crossover report, citation and existing Korean and English summaries. Actual reading of external articles, registration, plans and support disclosures remains separately unverified.", "acquired_read": "Existing Korean and English stored summaries and the S01 citation read; external articles, registration, protocols, analysis plans and support disclosures unread", "observation": "A stored report by Akhondian J et al. in Med Sci Monit 2007, PMID 18049435, concerns pediatric intractable seizures.", "condition_status": "Partly verified", "status_reason": "Information retained in stored summaries 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": "The original article, DOI and registration identity were not reconciled here.", "uncertainty": "Gaps in extract specifications, background drugs, adherence, allocation, masking, parent diaries, crossover periods and sequences, carryover, missing data, effect intervals, support roles and harms remain. A short seizure-frequency signal is not converted into medication withdrawal, durable remission, efficacy of other formulations or long-term safety.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Full article bibliography and lists of related registrations and reports" }, { "item_id": "N04", "question_type": "Evidence condition", "question": "Are crossover periods kept distinct from independent studies or people?", "needed": "Relationships among the single trial, its sequences/periods, participants and reports", "role": "Required", "role_reason": "Material on Relationships among the single trial, its sequences/periods, participants and reports is needed to connect the pediatric population to formulation, dose, background treatment, placebo, seizure recording, crossover periods and sequences, denominators, intervals or harms.", "application_exception": "The records of 23 enrolled participants and 20 completers are not converted into randomized, period-specific analysis or safety denominators, and no new dropout count is calculated. Crossover periods are not pooled as independent trials or new participants, and an overall test is not converted into an effect between treatment periods.", "criterion": "Original records on Relationships among the single trial, its sequences/periods, participants and reports must link to the relevant report, crossover design, concomitant medication, measurement, timing and denominator, distinguishing recorded information from what remains unverified.", "basis": "Existing principles distinguish formulation, population, background antiseizure medication, placebo, seizure recording, crossover periods and sequences, denominators, effect intervals, support and harms for adjunctive aqueous seed extract in children.", "condition_origin": "These existing conditions are linked to the crossover comparison of aqueous seed extract and placebo in children continuing antiseizure medication. They explain stored summaries and material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Participant flow, sequence/period tables and related report lists This records needed materials; no new research was executed.", "current_reports": [ "S01" ], "existence": "The information is recorded in a stored pediatric crossover report, citation and existing Korean and English summaries. Actual reading of external articles, registration, plans and support disclosures remains separately unverified.", "acquired_read": "Existing Korean and English stored summaries and the S01 citation read; external articles, registration, protocols, analysis plans and support disclosures unread", "observation": "The stored report describes a double-blind placebo crossover. Extract and placebo periods are not pooled as separate independent trials or separate participants.", "condition_status": "Partly verified", "status_reason": "Information retained in stored summaries 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": "Sequence allocation, period-specific participant matching and related report families remain unverified; a unique clinical total is not established.", "uncertainty": "Gaps in extract specifications, background drugs, adherence, allocation, masking, parent diaries, crossover periods and sequences, carryover, missing data, effect intervals, support roles and harms remain. A short seizure-frequency signal is not converted into medication withdrawal, durable remission, efficacy of other formulations or long-term safety.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Participant flow, sequence/period tables and related report lists" }, { "item_id": "N05", "question_type": "Evidence condition", "question": "Which children does the record concern?", "needed": "Refractory diagnosis, age, seizure type, baseline severity and inclusion/exclusion criteria", "role": "Required", "role_reason": "Material on Refractory diagnosis, age, seizure type, baseline severity and inclusion/exclusion criteria is needed to connect the pediatric population to formulation, dose, background treatment, placebo, seizure recording, crossover periods and sequences, denominators, intervals or harms.", "application_exception": "The records of 23 enrolled participants and 20 completers are not converted into randomized, period-specific analysis or safety denominators, and no new dropout count is calculated. Crossover periods are not pooled as independent trials or new participants, and an overall test is not converted into an effect between treatment periods.", "criterion": "Original records on Refractory diagnosis, age, seizure type, baseline severity and inclusion/exclusion criteria must link to the relevant report, crossover design, concomitant medication, measurement, timing and denominator, distinguishing recorded information from what remains unverified.", "basis": "Existing principles distinguish formulation, population, background antiseizure medication, placebo, seizure recording, crossover periods and sequences, denominators, effect intervals, support and harms for adjunctive aqueous seed extract in children.", "condition_origin": "These existing conditions are linked to the crossover comparison of aqueous seed extract and placebo in children continuing antiseizure medication. They explain stored summaries and material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Eligibility tables, baseline characteristics and seizure-type-specific material This records needed materials; no new research was executed.", "current_reports": [ "S01" ], "existence": "The information is recorded in a stored pediatric crossover report, citation and existing Korean and English summaries. Actual reading of external articles, registration, plans and support disclosures remains separately unverified.", "acquired_read": "Existing Korean and English stored summaries and the S01 citation read; external articles, registration, protocols, analysis plans and support disclosures unread", "observation": "The retained population is children with refractory epilepsy continuing antiseizure medication.", "condition_status": "Partly verified", "status_reason": "Information retained in stored summaries 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": "Detailed ages, seizure types, the definition of refractoriness, inclusion/exclusion criteria and applicability to children with epilepsy generally remain unverified.", "uncertainty": "Gaps in extract specifications, background drugs, adherence, allocation, masking, parent diaries, crossover periods and sequences, carryover, missing data, effect intervals, support roles and harms remain. A short seizure-frequency signal is not converted into medication withdrawal, durable remission, efficacy of other formulations or long-term safety.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Eligibility tables, baseline characteristics and seizure-type-specific material" }, { "item_id": "N06", "question_type": "Evidence condition", "question": "Which extract was used?", "needed": "Identity of the seed, Soxhlet aqueous extraction, composition/batch and formulation", "role": "Required", "role_reason": "Material on Identity of the seed, Soxhlet aqueous extraction, composition/batch and formulation is needed to connect the pediatric population to formulation, dose, background treatment, placebo, seizure recording, crossover periods and sequences, denominators, intervals or harms.", "application_exception": "The records of 23 enrolled participants and 20 completers are not converted into randomized, period-specific analysis or safety denominators, and no new dropout count is calculated. Crossover periods are not pooled as independent trials or new participants, and an overall test is not converted into an effect between treatment periods.", "criterion": "Original records on Identity of the seed, Soxhlet aqueous extraction, composition/batch and formulation must link to the relevant report, crossover design, concomitant medication, measurement, timing and denominator, distinguishing recorded information from what remains unverified.", "basis": "Existing principles distinguish formulation, population, background antiseizure medication, placebo, seizure recording, crossover periods and sequences, denominators, effect intervals, support and harms for adjunctive aqueous seed extract in children.", "condition_origin": "These existing conditions are linked to the crossover comparison of aqueous seed extract and placebo in children continuing antiseizure medication. They explain stored summaries and material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Extraction, quality, constituent-amount and trial-preparation specifications This records needed materials; no new research was executed.", "current_reports": [ "S01" ], "existence": "The information is recorded in a stored pediatric crossover report, citation and existing Korean and English summaries. Actual reading of external articles, registration, plans and support disclosures remains separately unverified.", "acquired_read": "Existing Korean and English stored summaries and the S01 citation read; external articles, registration, protocols, analysis plans and support disclosures unread", "observation": "The preparation is a Soxhlet-produced aqueous extract of Nigella sativa L. seeds, not purified thymoquinone.", "condition_status": "Partly verified", "status_reason": "Information retained in stored summaries 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": "Composition, yield, batch, standardization and equivalence to marketed products remain unverified.", "uncertainty": "Gaps in extract specifications, background drugs, adherence, allocation, masking, parent diaries, crossover periods and sequences, carryover, missing data, effect intervals, support roles and harms remain. A short seizure-frequency signal is not converted into medication withdrawal, durable remission, efficacy of other formulations or long-term safety.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Extraction, quality, constituent-amount and trial-preparation specifications" }, { "item_id": "N07", "question_type": "Evidence condition", "question": "What record specifies the dose and frequency?", "needed": "Weight-based amount per 1 administration, interval, actual dosing and adherence", "role": "Required", "role_reason": "Material on Weight-based amount per 1 administration, interval, actual dosing and adherence is needed to connect the pediatric population to formulation, dose, background treatment, placebo, seizure recording, crossover periods and sequences, denominators, intervals or harms.", "application_exception": "The records of 23 enrolled participants and 20 completers are not converted into randomized, period-specific analysis or safety denominators, and no new dropout count is calculated. Crossover periods are not pooled as independent trials or new participants, and an overall test is not converted into an effect between treatment periods.", "criterion": "Original records on Weight-based amount per 1 administration, interval, actual dosing and adherence must link to the relevant report, crossover design, concomitant medication, measurement, timing and denominator, distinguishing recorded information from what remains unverified.", "basis": "Existing principles distinguish formulation, population, background antiseizure medication, placebo, seizure recording, crossover periods and sequences, denominators, effect intervals, support and harms for adjunctive aqueous seed extract in children.", "condition_origin": "These existing conditions are linked to the crossover comparison of aqueous seed extract and placebo in children continuing antiseizure medication. They explain stored summaries and material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Dosing schedules, adherence and adjustment records This records needed materials; no new research was executed.", "current_reports": [ "S01" ], "existence": "The information is recorded in a stored pediatric crossover report, citation and existing Korean and English summaries. Actual reading of external articles, registration, plans and support disclosures remains separately unverified.", "acquired_read": "Existing Korean and English stored summaries and the S01 citation read; external articles, registration, protocols, analysis plans and support disclosures unread", "observation": "The retained oral dose is 40 mg/kg every 8 hours. A daily total is not newly calculated.", "condition_status": "Partly verified", "status_reason": "Information retained in stored summaries 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": "Reference body weight, actual administered amounts, missed doses and dose adjustments remain unverified.", "uncertainty": "Gaps in extract specifications, background drugs, adherence, allocation, masking, parent diaries, crossover periods and sequences, carryover, missing data, effect intervals, support roles and harms remain. A short seizure-frequency signal is not converted into medication withdrawal, durable remission, efficacy of other formulations or long-term safety.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Dosing schedules, adherence and adjustment records" }, { "item_id": "N08", "question_type": "Evidence condition", "question": "Is this an adjunctive effect above background antiseizure medication?", "needed": "Background drugs, maintenance, changes and attribution of concomitant treatment by group/period", "role": "Required", "role_reason": "Material on Background drugs, maintenance, changes and attribution of concomitant treatment by group/period is needed to connect the pediatric population to formulation, dose, background treatment, placebo, seizure recording, crossover periods and sequences, denominators, intervals or harms.", "application_exception": "The records of 23 enrolled participants and 20 completers are not converted into randomized, period-specific analysis or safety denominators, and no new dropout count is calculated. Crossover periods are not pooled as independent trials or new participants, and an overall test is not converted into an effect between treatment periods.", "criterion": "Original records on Background drugs, maintenance, changes and attribution of concomitant treatment by group/period must link to the relevant report, crossover design, concomitant medication, measurement, timing and denominator, distinguishing recorded information from what remains unverified.", "basis": "Existing principles distinguish formulation, population, background antiseizure medication, placebo, seizure recording, crossover periods and sequences, denominators, effect intervals, support and harms for adjunctive aqueous seed extract in children.", "condition_origin": "These existing conditions are linked to the crossover comparison of aqueous seed extract and placebo in children continuing antiseizure medication. They explain stored summaries and material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Background drug lists, changes and rescue-treatment tables This records needed materials; no new research was executed.", "current_reports": [ "S01" ], "existence": "The information is recorded in a stored pediatric crossover report, citation and existing Korean and English summaries. Actual reading of external articles, registration, plans and support disclosures remains separately unverified.", "acquired_read": "Existing Korean and English stored summaries and the S01 citation read; external articles, registration, protocols, analysis plans and support disclosures unread", "observation": "The original text describes extract or placebo added while existing antiseizure medication was maintained.", "condition_status": "Partly verified", "status_reason": "Information retained in stored summaries 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 drugs, doses, changes during periods, rescue treatment and their balance remain unverified.", "uncertainty": "Gaps in extract specifications, background drugs, adherence, allocation, masking, parent diaries, crossover periods and sequences, carryover, missing data, effect intervals, support roles and harms remain. A short seizure-frequency signal is not converted into medication withdrawal, durable remission, efficacy of other formulations or long-term safety.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Background drug lists, changes and rescue-treatment tables" }, { "item_id": "N09", "question_type": "Evidence condition", "question": "How was placebo actually compared?", "needed": "Placebo composition, appearance, administration and adjunctive-treatment conditions", "role": "Required", "role_reason": "Material on Placebo composition, appearance, administration and adjunctive-treatment conditions is needed to connect the pediatric population to formulation, dose, background treatment, placebo, seizure recording, crossover periods and sequences, denominators, intervals or harms.", "application_exception": "The records of 23 enrolled participants and 20 completers are not converted into randomized, period-specific analysis or safety denominators, and no new dropout count is calculated. Crossover periods are not pooled as independent trials or new participants, and an overall test is not converted into an effect between treatment periods.", "criterion": "Original records on Placebo composition, appearance, administration and adjunctive-treatment conditions must link to the relevant report, crossover design, concomitant medication, measurement, timing and denominator, distinguishing recorded information from what remains unverified.", "basis": "Existing principles distinguish formulation, population, background antiseizure medication, placebo, seizure recording, crossover periods and sequences, denominators, effect intervals, support and harms for adjunctive aqueous seed extract in children.", "condition_origin": "These existing conditions are linked to the crossover comparison of aqueous seed extract and placebo in children continuing antiseizure medication. They explain stored summaries and material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Placebo specifications, preparation images/descriptions and administration records This records needed materials; no new research was executed.", "current_reports": [ "S01" ], "existence": "The information is recorded in a stored pediatric crossover report, citation and existing Korean and English summaries. Actual reading of external articles, registration, plans and support disclosures remains separately unverified.", "acquired_read": "Existing Korean and English stored summaries and the S01 citation read; external articles, registration, protocols, analysis plans and support disclosures unread", "observation": "The retained comparison is a crossover with placebo added to background antiseizure medication.", "condition_status": "Partly verified", "status_reason": "Information retained in stored summaries 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 composition, appearance/taste, matched administration and actual differences in use remain unverified.", "uncertainty": "Gaps in extract specifications, background drugs, adherence, allocation, masking, parent diaries, crossover periods and sequences, carryover, missing data, effect intervals, support roles and harms remain. A short seizure-frequency signal is not converted into medication withdrawal, durable remission, efficacy of other formulations or long-term safety.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Placebo specifications, preparation images/descriptions and administration records" }, { "item_id": "N10", "question_type": "Evidence condition", "question": "What was the allocation process in the crossover design?", "needed": "Sequence allocation, concealment, randomization methods and baseline balance", "role": "Required", "role_reason": "Material on Sequence allocation, concealment, randomization methods and baseline balance is needed to connect the pediatric population to formulation, dose, background treatment, placebo, seizure recording, crossover periods and sequences, denominators, intervals or harms.", "application_exception": "The records of 23 enrolled participants and 20 completers are not converted into randomized, period-specific analysis or safety denominators, and no new dropout count is calculated. Crossover periods are not pooled as independent trials or new participants, and an overall test is not converted into an effect between treatment periods.", "criterion": "Original records on Sequence allocation, concealment, randomization methods and baseline balance must link to the relevant report, crossover design, concomitant medication, measurement, timing and denominator, distinguishing recorded information from what remains unverified.", "basis": "Existing principles distinguish formulation, population, background antiseizure medication, placebo, seizure recording, crossover periods and sequences, denominators, effect intervals, support and harms for adjunctive aqueous seed extract in children.", "condition_origin": "These existing conditions are linked to the crossover comparison of aqueous seed extract and placebo in children continuing antiseizure medication. They explain stored summaries and material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Original methods, sequence-allocation tables and baseline tables This records needed materials; no new research was executed.", "current_reports": [ "S01" ], "existence": "The information is recorded in a stored pediatric crossover report, citation and existing Korean and English summaries. Actual reading of external articles, registration, plans and support disclosures remains separately unverified.", "acquired_read": "Existing Korean and English stored summaries and the S01 citation read; external articles, registration, protocols, analysis plans and support disclosures unread", "observation": "The retained design is described as a double-blind placebo crossover.", "condition_status": "Partly verified", "status_reason": "Information retained in stored summaries 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": "Random sequence generation, allocation concealment and sequence-specific baseline characteristics remain unverified in the summary.", "uncertainty": "Gaps in extract specifications, background drugs, adherence, allocation, masking, parent diaries, crossover periods and sequences, carryover, missing data, effect intervals, support roles and harms remain. A short seizure-frequency signal is not converted into medication withdrawal, durable remission, efficacy of other formulations or long-term safety.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original methods, sequence-allocation tables and baseline tables" }, { "item_id": "N11", "question_type": "Evidence condition", "question": "Was masking maintained for parents and assessors?", "needed": "Masking of parents, participants, administrators and assessors, and unmasking", "role": "Required", "role_reason": "Material on Masking of parents, participants, administrators and assessors, and unmasking is needed to connect the pediatric population to formulation, dose, background treatment, placebo, seizure recording, crossover periods and sequences, denominators, intervals or harms.", "application_exception": "The records of 23 enrolled participants and 20 completers are not converted into randomized, period-specific analysis or safety denominators, and no new dropout count is calculated. Crossover periods are not pooled as independent trials or new participants, and an overall test is not converted into an effect between treatment periods.", "criterion": "Original records on Masking of parents, participants, administrators and assessors, and unmasking must link to the relevant report, crossover design, concomitant medication, measurement, timing and denominator, distinguishing recorded information from what remains unverified.", "basis": "Existing principles distinguish formulation, population, background antiseizure medication, placebo, seizure recording, crossover periods and sequences, denominators, effect intervals, support and harms for adjunctive aqueous seed extract in children.", "condition_origin": "These existing conditions are linked to the crossover comparison of aqueous seed extract and placebo in children continuing antiseizure medication. They explain stored summaries and material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Records of masking targets, procedures and unmasking This records needed materials; no new research was executed.", "current_reports": [ "S01" ], "existence": "The information is recorded in a stored pediatric crossover report, citation and existing Korean and English summaries. Actual reading of external articles, registration, plans and support disclosures remains separately unverified.", "acquired_read": "Existing Korean and English stored summaries and the S01 citation read; external articles, registration, protocols, analysis plans and support disclosures unread", "observation": "The original design wording of double blinding is retained.", "condition_status": "Partly verified", "status_reason": "Information retained in stored summaries 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": "Who was masked, whether placebo could be distinguished and unmasking remain unverified.", "uncertainty": "Gaps in extract specifications, background drugs, adherence, allocation, masking, parent diaries, crossover periods and sequences, carryover, missing data, effect intervals, support roles and harms remain. A short seizure-frequency signal is not converted into medication withdrawal, durable remission, efficacy of other formulations or long-term safety.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Records of masking targets, procedures and unmasking" }, { "item_id": "N12", "question_type": "Evidence condition", "question": "How was observation time divided?", "needed": "The 4-week intervention periods, 2-week washout and period-specific measurement schedules", "role": "Required", "role_reason": "Material on The 4-week intervention periods, 2-week washout and period-specific measurement schedules is needed to connect the pediatric population to formulation, dose, background treatment, placebo, seizure recording, crossover periods and sequences, denominators, intervals or harms.", "application_exception": "The records of 23 enrolled participants and 20 completers are not converted into randomized, period-specific analysis or safety denominators, and no new dropout count is calculated. Crossover periods are not pooled as independent trials or new participants, and an overall test is not converted into an effect between treatment periods.", "criterion": "Original records on The 4-week intervention periods, 2-week washout and period-specific measurement schedules must link to the relevant report, crossover design, concomitant medication, measurement, timing and denominator, distinguishing recorded information from what remains unverified.", "basis": "Existing principles distinguish formulation, population, background antiseizure medication, placebo, seizure recording, crossover periods and sequences, denominators, effect intervals, support and harms for adjunctive aqueous seed extract in children.", "condition_origin": "These existing conditions are linked to the crossover comparison of aqueous seed extract and placebo in children continuing antiseizure medication. They explain stored summaries and material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Schedules, period-specific diaries and washout records This records needed materials; no new research was executed.", "current_reports": [ "S01" ], "existence": "The information is recorded in a stored pediatric crossover report, citation and existing Korean and English summaries. Actual reading of external articles, registration, plans and support disclosures remains separately unverified.", "acquired_read": "Existing Korean and English stored summaries and the S01 citation read; external articles, registration, protocols, analysis plans and support disclosures unread", "observation": "The record retains 4 weeks per intervention and a 2-week washout. These are not converted into long-term continuous exposure.", "condition_status": "Partly verified", "status_reason": "Information retained in stored summaries 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": "Baseline recording duration, each measurement schedule, seizures during washout and treatment during washout remain unverified.", "uncertainty": "Gaps in extract specifications, background drugs, adherence, allocation, masking, parent diaries, crossover periods and sequences, carryover, missing data, effect intervals, support roles and harms remain. A short seizure-frequency signal is not converted into medication withdrawal, durable remission, efficacy of other formulations or long-term safety.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Schedules, period-specific diaries and washout records" }, { "item_id": "N13", "question_type": "Evidence condition", "question": "Were carryover, period and sequence effects addressed?", "needed": "Prospective assumptions and analyses for carryover, period and sequence", "role": "Required", "role_reason": "Material on Prospective assumptions and analyses for carryover, period and sequence is needed to connect the pediatric population to formulation, dose, background treatment, placebo, seizure recording, crossover periods and sequences, denominators, intervals or harms.", "application_exception": "The records of 23 enrolled participants and 20 completers are not converted into randomized, period-specific analysis or safety denominators, and no new dropout count is calculated. Crossover periods are not pooled as independent trials or new participants, and an overall test is not converted into an effect between treatment periods.", "criterion": "Original records on Prospective assumptions and analyses for carryover, period and sequence must link to the relevant report, crossover design, concomitant medication, measurement, timing and denominator, distinguishing recorded information from what remains unverified.", "basis": "Existing principles distinguish formulation, population, background antiseizure medication, placebo, seizure recording, crossover periods and sequences, denominators, effect intervals, support and harms for adjunctive aqueous seed extract in children.", "condition_origin": "These existing conditions are linked to the crossover comparison of aqueous seed extract and placebo in children continuing antiseizure medication. They explain stored summaries and material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Crossover analysis methods, period/sequence results and sensitivity analyses This records needed materials; no new research was executed.", "current_reports": [ "S01" ], "existence": "The information is recorded in a stored pediatric crossover report, citation and existing Korean and English summaries. Actual reading of external articles, registration, plans and support disclosures remains separately unverified.", "acquired_read": "Existing Korean and English stored summaries and the S01 citation read; external articles, registration, protocols, analysis plans and support disclosures unread", "observation": "The original text identifies adequate reporting of sequence, period and carryover as a central gap.", "condition_status": "Unverified", "status_reason": "Information retained in stored summaries 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": "A 2-week washout alone cannot establish removal of carryover; specific analyses remain unverified.", "uncertainty": "Gaps in extract specifications, background drugs, adherence, allocation, masking, parent diaries, crossover periods and sequences, carryover, missing data, effect intervals, support roles and harms remain. A short seizure-frequency signal is not converted into medication withdrawal, durable remission, efficacy of other formulations or long-term safety.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Crossover analysis methods, period/sequence results and sensitivity analyses" }, { "item_id": "N14", "question_type": "Evidence condition", "question": "How were seizures measured?", "needed": "Parent recording, daily units, seizure identification and diary completeness", "role": "Required", "role_reason": "Material on Parent recording, daily units, seizure identification and diary completeness is needed to connect the pediatric population to formulation, dose, background treatment, placebo, seizure recording, crossover periods and sequences, denominators, intervals or harms.", "application_exception": "The records of 23 enrolled participants and 20 completers are not converted into randomized, period-specific analysis or safety denominators, and no new dropout count is calculated. Crossover periods are not pooled as independent trials or new participants, and an overall test is not converted into an effect between treatment periods.", "criterion": "Original records on Parent recording, daily units, seizure identification and diary completeness must link to the relevant report, crossover design, concomitant medication, measurement, timing and denominator, distinguishing recorded information from what remains unverified.", "basis": "Existing principles distinguish formulation, population, background antiseizure medication, placebo, seizure recording, crossover periods and sequences, denominators, effect intervals, support and harms for adjunctive aqueous seed extract in children.", "condition_origin": "These existing conditions are linked to the crossover comparison of aqueous seed extract and placebo in children continuing antiseizure medication. They explain stored summaries and material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Diary forms, seizure-identification rules and measurement methods This records needed materials; no new research was executed.", "current_reports": [ "S01" ], "existence": "The information is recorded in a stored pediatric crossover report, citation and existing Korean and English summaries. Actual reading of external articles, registration, plans and support disclosures remains separately unverified.", "acquired_read": "Existing Korean and English stored summaries and the S01 citation read; external articles, registration, protocols, analysis plans and support disclosures unread", "observation": "The principal endpoint is parent-recorded seizures per day.", "condition_status": "Partly verified", "status_reason": "Information retained in stored summaries 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": "Seizure definitions, recording instruction, objective confirmation, handling of missing diary entries and measurement differences across groups/periods remain unverified.", "uncertainty": "Gaps in extract specifications, background drugs, adherence, allocation, masking, parent diaries, crossover periods and sequences, carryover, missing data, effect intervals, support roles and harms remain. A short seizure-frequency signal is not converted into medication withdrawal, durable remission, efficacy of other formulations or long-term safety.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Diary forms, seizure-identification rules and measurement methods" }, { "item_id": "N15", "question_type": "Evidence condition", "question": "What was the prospective endpoint hierarchy for seizure counts?", "needed": "Primary/secondary endpoints, time points and analyses in registration, protocol and SAP", "role": "Required", "role_reason": "Material on Primary/secondary endpoints, time points and analyses in registration, protocol and SAP is needed to connect the pediatric population to formulation, dose, background treatment, placebo, seizure recording, crossover periods and sequences, denominators, intervals or harms.", "application_exception": "The records of 23 enrolled participants and 20 completers are not converted into randomized, period-specific analysis or safety denominators, and no new dropout count is calculated. Crossover periods are not pooled as independent trials or new participants, and an overall test is not converted into an effect between treatment periods.", "criterion": "Original records on Primary/secondary endpoints, time points and analyses in registration, protocol and SAP must link to the relevant report, crossover design, concomitant medication, measurement, timing and denominator, distinguishing recorded information from what remains unverified.", "basis": "Existing principles distinguish formulation, population, background antiseizure medication, placebo, seizure recording, crossover periods and sequences, denominators, effect intervals, support and harms for adjunctive aqueous seed extract in children.", "condition_origin": "These existing conditions are linked to the crossover comparison of aqueous seed extract and placebo in children continuing antiseizure medication. They explain stored summaries and material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Registration histories, protocol and SAP This records needed materials; no new research was executed.", "current_reports": [ "S01" ], "existence": "The information is recorded in a stored pediatric crossover report, citation and existing Korean and English summaries. Actual reading of external articles, registration, plans and support disclosures remains separately unverified.", "acquired_read": "Existing Korean and English stored summaries and the S01 citation read; external articles, registration, protocols, analysis plans and support disclosures unread", "observation": "The principal endpoint in the original text is seizures per day.", "condition_status": "Unverified", "status_reason": "Information retained in stored summaries 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": "The prespecified 1st (primary) endpoint, responder definition and analysis hierarchy remain unverified because registration and plans were unread.", "uncertainty": "Gaps in extract specifications, background drugs, adherence, allocation, masking, parent diaries, crossover periods and sequences, carryover, missing data, effect intervals, support roles and harms remain. A short seizure-frequency signal is not converted into medication withdrawal, durable remission, efficacy of other formulations or long-term safety.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Registration histories, protocol and SAP" }, { "item_id": "N16", "question_type": "Evidence condition", "question": "What are the enrollment, completion and period-specific analysis denominators?", "needed": "The 23 enrolled participants, 20 completers and analysis denominators by period/endpoint", "role": "Required", "role_reason": "Material on The 23 enrolled participants, 20 completers and analysis denominators by period/endpoint is needed to connect the pediatric population to formulation, dose, background treatment, placebo, seizure recording, crossover periods and sequences, denominators, intervals or harms.", "application_exception": "The records of 23 enrolled participants and 20 completers are not converted into randomized, period-specific analysis or safety denominators, and no new dropout count is calculated. Crossover periods are not pooled as independent trials or new participants, and an overall test is not converted into an effect between treatment periods.", "criterion": "Original records on The 23 enrolled participants, 20 completers and analysis denominators by period/endpoint must link to the relevant report, crossover design, concomitant medication, measurement, timing and denominator, distinguishing recorded information from what remains unverified.", "basis": "Existing principles distinguish formulation, population, background antiseizure medication, placebo, seizure recording, crossover periods and sequences, denominators, effect intervals, support and harms for adjunctive aqueous seed extract in children.", "condition_origin": "These existing conditions are linked to the crossover comparison of aqueous seed extract and placebo in children continuing antiseizure medication. They explain stored summaries and material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Participant flow and period-/endpoint-specific analysis tables This records needed materials; no new research was executed.", "current_reports": [ "S01" ], "existence": "The information is recorded in a stored pediatric crossover report, citation and existing Korean and English summaries. Actual reading of external articles, registration, plans and support disclosures remains separately unverified.", "acquired_read": "Existing Korean and English stored summaries and the S01 citation read; external articles, registration, protocols, analysis plans and support disclosures unread", "observation": "The original denominators of 23 enrolled participants and 20 completers are retained separately.", "condition_status": "Partly verified", "status_reason": "Information retained in stored summaries 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": "Enrollment is not converted into a randomized count; period-specific measurement/analysis denominators and inclusion of all participants remain unverified.", "uncertainty": "Gaps in extract specifications, background drugs, adherence, allocation, masking, parent diaries, crossover periods and sequences, carryover, missing data, effect intervals, support roles and harms remain. A short seizure-frequency signal is not converted into medication withdrawal, durable remission, efficacy of other formulations or long-term safety.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Participant flow and period-/endpoint-specific analysis tables" }, { "item_id": "N17", "question_type": "Evidence condition", "question": "How were noncompletion and missing records handled?", "needed": "Reasons for discontinuation, sequence/period, missing-data handling and analysis sets", "role": "Required", "role_reason": "Material on Reasons for discontinuation, sequence/period, missing-data handling and analysis sets is needed to connect the pediatric population to formulation, dose, background treatment, placebo, seizure recording, crossover periods and sequences, denominators, intervals or harms.", "application_exception": "The records of 23 enrolled participants and 20 completers are not converted into randomized, period-specific analysis or safety denominators, and no new dropout count is calculated. Crossover periods are not pooled as independent trials or new participants, and an overall test is not converted into an effect between treatment periods.", "criterion": "Original records on Reasons for discontinuation, sequence/period, missing-data handling and analysis sets must link to the relevant report, crossover design, concomitant medication, measurement, timing and denominator, distinguishing recorded information from what remains unverified.", "basis": "Existing principles distinguish formulation, population, background antiseizure medication, placebo, seizure recording, crossover periods and sequences, denominators, effect intervals, support and harms for adjunctive aqueous seed extract in children.", "condition_origin": "These existing conditions are linked to the crossover comparison of aqueous seed extract and placebo in children continuing antiseizure medication. They explain stored summaries and material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Discontinuation reasons, missing-data/analysis-set records and sensitivity analyses This records needed materials; no new research was executed.", "current_reports": [ "S01" ], "existence": "The information is recorded in a stored pediatric crossover report, citation and existing Korean and English summaries. Actual reading of external articles, registration, plans and support disclosures remains separately unverified.", "acquired_read": "Existing Korean and English stored summaries and the S01 citation read; external articles, registration, protocols, analysis plans and support disclosures unread", "observation": "The original text records 23 enrolled participants and 20 completers.", "condition_status": "Unverified", "status_reason": "Information retained in stored summaries 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": "Reasons for noncompletion, its period, possible seizure worsening/harms, imputation and ITT/completer analysis remain unverified.", "uncertainty": "Gaps in extract specifications, background drugs, adherence, allocation, masking, parent diaries, crossover periods and sequences, carryover, missing data, effect intervals, support roles and harms remain. A short seizure-frequency signal is not converted into medication withdrawal, durable remission, efficacy of other formulations or long-term safety.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Discontinuation reasons, missing-data/analysis-set records and sensitivity analyses" }, { "item_id": "N18", "question_type": "Evidence condition", "question": "Which results do the retained mean seizure counts represent?", "needed": "Baseline, extract and placebo daily seizure counts, corresponding dispersion and denominators", "role": "Required", "role_reason": "Material on Baseline, extract and placebo daily seizure counts, corresponding dispersion and denominators is needed to connect the pediatric population to formulation, dose, background treatment, placebo, seizure recording, crossover periods and sequences, denominators, intervals or harms.", "application_exception": "The records of 23 enrolled participants and 20 completers are not converted into randomized, period-specific analysis or safety denominators, and no new dropout count is calculated. Crossover periods are not pooled as independent trials or new participants, and an overall test is not converted into an effect between treatment periods.", "criterion": "Original records on Baseline, extract and placebo daily seizure counts, corresponding dispersion and denominators must link to the relevant report, crossover design, concomitant medication, measurement, timing and denominator, distinguishing recorded information from what remains unverified.", "basis": "Existing principles distinguish formulation, population, background antiseizure medication, placebo, seizure recording, crossover periods and sequences, denominators, effect intervals, support and harms for adjunctive aqueous seed extract in children.", "condition_origin": "These existing conditions are linked to the crossover comparison of aqueous seed extract and placebo in children continuing antiseizure medication. They explain stored summaries and material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Period-specific result tables, dispersion definitions and paired analyses This records needed materials; no new research was executed.", "current_reports": [ "S01" ], "existence": "The information is recorded in a stored pediatric crossover report, citation and existing Korean and English summaries. Actual reading of external articles, registration, plans and support disclosures remains separately unverified.", "acquired_read": "Existing Korean and English stored summaries and the S01 citation read; external articles, registration, protocols, analysis plans and support disclosures unread", "observation": "Baseline 5.78±7.20, extract 4.21±5.77 and placebo 6.14±6.75 are retained. They are not recalculated as new changes, treatment effects or total seizure-event counts.", "condition_status": "Partly verified", "status_reason": "Information retained in stored summaries 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": "The original meaning of ±, period-/sequence-specific values, paired data and endpoint denominators remain unverified.", "uncertainty": "Gaps in extract specifications, background drugs, adherence, allocation, masking, parent diaries, crossover periods and sequences, carryover, missing data, effect intervals, support roles and harms remain. A short seizure-frequency signal is not converted into medication withdrawal, durable remission, efficacy of other formulations or long-term safety.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Period-specific result tables, dispersion definitions and paired analyses" }, { "item_id": "N19", "question_type": "Evidence condition", "question": "What question does the overall Friedman test answer?", "needed": "Distinguish the overall test from the selected between-treatment-period contrast", "role": "Required", "role_reason": "Material on Distinguish the overall test from the selected between-treatment-period contrast is needed to connect the pediatric population to formulation, dose, background treatment, placebo, seizure recording, crossover periods and sequences, denominators, intervals or harms.", "application_exception": "The records of 23 enrolled participants and 20 completers are not converted into randomized, period-specific analysis or safety denominators, and no new dropout count is calculated. Crossover periods are not pooled as independent trials or new participants, and an overall test is not converted into an effect between treatment periods.", "criterion": "Original records on Distinguish the overall test from the selected between-treatment-period contrast must link to the relevant report, crossover design, concomitant medication, measurement, timing and denominator, distinguishing recorded information from what remains unverified.", "basis": "Existing principles distinguish formulation, population, background antiseizure medication, placebo, seizure recording, crossover periods and sequences, denominators, effect intervals, support and harms for adjunctive aqueous seed extract in children.", "condition_origin": "These existing conditions are linked to the crossover comparison of aqueous seed extract and placebo in children continuing antiseizure medication. They explain stored summaries and material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Statistical methods, prospective contrasts and result tables This records needed materials; no new research was executed.", "current_reports": [ "S01" ], "existence": "The information is recorded in a stored pediatric crossover report, citation and existing Korean and English summaries. Actual reading of external articles, registration, plans and support disclosures remains separately unverified.", "acquired_read": "Existing Korean and English stored summaries and the S01 citation read; external articles, registration, protocols, analysis plans and support disclosures unread", "observation": "Friedman P<.001 is retained, while the original text distinguishes it from a fully reported period-specific between-treatment effect.", "condition_status": "Partly verified", "status_reason": "Information retained in stored summaries 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": "Exact prospective contrasts, period/sequence adjustment and treatment-contrast P values remain unverified.", "uncertainty": "Gaps in extract specifications, background drugs, adherence, allocation, masking, parent diaries, crossover periods and sequences, carryover, missing data, effect intervals, support roles and harms remain. A short seizure-frequency signal is not converted into medication withdrawal, durable remission, efficacy of other formulations or long-term safety.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Statistical methods, prospective contrasts and result tables" }, { "item_id": "N20", "question_type": "Evidence condition", "question": "What does 65% versus 20% improvement mean?", "needed": "Improvement/responder criteria, participant counts, periods/sequences and denominators", "role": "Required", "role_reason": "Material on Improvement/responder criteria, participant counts, periods/sequences and denominators is needed to connect the pediatric population to formulation, dose, background treatment, placebo, seizure recording, crossover periods and sequences, denominators, intervals or harms.", "application_exception": "The records of 23 enrolled participants and 20 completers are not converted into randomized, period-specific analysis or safety denominators, and no new dropout count is calculated. Crossover periods are not pooled as independent trials or new participants, and an overall test is not converted into an effect between treatment periods.", "criterion": "Original records on Improvement/responder criteria, participant counts, periods/sequences and denominators must link to the relevant report, crossover design, concomitant medication, measurement, timing and denominator, distinguishing recorded information from what remains unverified.", "basis": "Existing principles distinguish formulation, population, background antiseizure medication, placebo, seizure recording, crossover periods and sequences, denominators, effect intervals, support and harms for adjunctive aqueous seed extract in children.", "condition_origin": "These existing conditions are linked to the crossover comparison of aqueous seed extract and placebo in children continuing antiseizure medication. They explain stored summaries and material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Responder definitions, period-specific participant counts/denominators and intervals This records needed materials; no new research was executed.", "current_reports": [ "S01" ], "existence": "The information is recorded in a stored pediatric crossover report, citation and existing Korean and English summaries. Actual reading of external articles, registration, plans and support disclosures remains separately unverified.", "acquired_read": "Existing Korean and English stored summaries and the S01 citation read; external articles, registration, protocols, analysis plans and support disclosures unread", "observation": "The original wording of 65% versus 20% improvement is retained.", "condition_status": "Partly verified", "status_reason": "Information retained in stored summaries 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": "Reduction thresholds, pairing, participant counts, responder-analysis denominators and CIs remain unverified; new event counts are not back-calculated.", "uncertainty": "Gaps in extract specifications, background drugs, adherence, allocation, masking, parent diaries, crossover periods and sequences, carryover, missing data, effect intervals, support roles and harms remain. A short seizure-frequency signal is not converted into medication withdrawal, durable remission, efficacy of other formulations or long-term safety.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Responder definitions, period-specific participant counts/denominators and intervals" }, { "item_id": "N21", "question_type": "Evidence condition", "question": "What are the exact effect magnitude and interval?", "needed": "Effect size, CI and important difference for the prospective treatment contrast", "role": "Required", "role_reason": "Material on Effect size, CI and important difference for the prospective treatment contrast is needed to connect the pediatric population to formulation, dose, background treatment, placebo, seizure recording, crossover periods and sequences, denominators, intervals or harms.", "application_exception": "The records of 23 enrolled participants and 20 completers are not converted into randomized, period-specific analysis or safety denominators, and no new dropout count is calculated. Crossover periods are not pooled as independent trials or new participants, and an overall test is not converted into an effect between treatment periods.", "criterion": "Original records on Effect size, CI and important difference for the prospective treatment contrast must link to the relevant report, crossover design, concomitant medication, measurement, timing and denominator, distinguishing recorded information from what remains unverified.", "basis": "Existing principles distinguish formulation, population, background antiseizure medication, placebo, seizure recording, crossover periods and sequences, denominators, effect intervals, support and harms for adjunctive aqueous seed extract in children.", "condition_origin": "These existing conditions are linked to the crossover comparison of aqueous seed extract and placebo in children continuing antiseizure medication. They explain stored summaries and material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Treatment contrasts, dispersion, CIs and evidence for an important difference This records needed materials; no new research was executed.", "current_reports": [ "S01" ], "existence": "The information is recorded in a stored pediatric crossover report, citation and existing Korean and English summaries. Actual reading of external articles, registration, plans and support disclosures remains separately unverified.", "acquired_read": "Existing Korean and English stored summaries and the S01 citation read; external articles, registration, protocols, analysis plans and support disclosures unread", "observation": "The original text records that exact CIs and period-specific between-treatment effects were unverified.", "condition_status": "Unverified", "status_reason": "Information retained in stored summaries 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": "No new mean difference, paired CI, relative reduction or minimal important difference is calculated.", "uncertainty": "Gaps in extract specifications, background drugs, adherence, allocation, masking, parent diaries, crossover periods and sequences, carryover, missing data, effect intervals, support roles and harms remain. A short seizure-frequency signal is not converted into medication withdrawal, durable remission, efficacy of other formulations or long-term safety.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Treatment contrasts, dispersion, CIs and evidence for an important difference" }, { "item_id": "N22", "question_type": "Evidence condition", "question": "How were tests across periods, seizures and responders planned?", "needed": "Prospective planning for seizure-count/responder, time-point and subgroup tests", "role": "Required", "role_reason": "Material on Prospective planning for seizure-count/responder, time-point and subgroup tests is needed to connect the pediatric population to formulation, dose, background treatment, placebo, seizure recording, crossover periods and sequences, denominators, intervals or harms.", "application_exception": "The records of 23 enrolled participants and 20 completers are not converted into randomized, period-specific analysis or safety denominators, and no new dropout count is calculated. Crossover periods are not pooled as independent trials or new participants, and an overall test is not converted into an effect between treatment periods.", "criterion": "Original records on Prospective planning for seizure-count/responder, time-point and subgroup tests must link to the relevant report, crossover design, concomitant medication, measurement, timing and denominator, distinguishing recorded information from what remains unverified.", "basis": "Existing principles distinguish formulation, population, background antiseizure medication, placebo, seizure recording, crossover periods and sequences, denominators, effect intervals, support and harms for adjunctive aqueous seed extract in children.", "condition_origin": "These existing conditions are linked to the crossover comparison of aqueous seed extract and placebo in children continuing antiseizure medication. They explain stored summaries and material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Registration, SAP and complete endpoint tables This records needed materials; no new research was executed.", "current_reports": [ "S01" ], "existence": "The information is recorded in a stored pediatric crossover report, citation and existing Korean and English summaries. Actual reading of external articles, registration, plans and support disclosures remains separately unverified.", "acquired_read": "Existing Korean and English stored summaries and the S01 citation read; external articles, registration, protocols, analysis plans and support disclosures unread", "observation": "The summary retains both seizure counts and improvement proportions.", "condition_status": "Unverified", "status_reason": "Information retained in stored summaries 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": "Multiplicity handling, prospective analyses and selective reporting remain unverified because plans were unread.", "uncertainty": "Gaps in extract specifications, background drugs, adherence, allocation, masking, parent diaries, crossover periods and sequences, carryover, missing data, effect intervals, support roles and harms remain. A short seizure-frequency signal is not converted into medication withdrawal, durable remission, efficacy of other formulations or long-term safety.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Registration, SAP and complete endpoint tables" }, { "item_id": "N23", "question_type": "Evidence condition", "question": "Could adherence and rescue treatment affect the results?", "needed": "Extract/placebo adherence, missed doses, medication changes and emergency treatment", "role": "Required", "role_reason": "Material on Extract/placebo adherence, missed doses, medication changes and emergency treatment is needed to connect the pediatric population to formulation, dose, background treatment, placebo, seizure recording, crossover periods and sequences, denominators, intervals or harms.", "application_exception": "The records of 23 enrolled participants and 20 completers are not converted into randomized, period-specific analysis or safety denominators, and no new dropout count is calculated. Crossover periods are not pooled as independent trials or new participants, and an overall test is not converted into an effect between treatment periods.", "criterion": "Original records on Extract/placebo adherence, missed doses, medication changes and emergency treatment must link to the relevant report, crossover design, concomitant medication, measurement, timing and denominator, distinguishing recorded information from what remains unverified.", "basis": "Existing principles distinguish formulation, population, background antiseizure medication, placebo, seizure recording, crossover periods and sequences, denominators, effect intervals, support and harms for adjunctive aqueous seed extract in children.", "condition_origin": "These existing conditions are linked to the crossover comparison of aqueous seed extract and placebo in children continuing antiseizure medication. They explain stored summaries and material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Administration/rescue-treatment records and prospective handling rules This records needed materials; no new research was executed.", "current_reports": [ "S01" ], "existence": "The information is recorded in a stored pediatric crossover report, citation and existing Korean and English summaries. Actual reading of external articles, registration, plans and support disclosures remains separately unverified.", "acquired_read": "Existing Korean and English stored summaries and the S01 citation read; external articles, registration, protocols, analysis plans and support disclosures unread", "observation": "The narrative of adjunctive therapy and maintained background medication is retained.", "condition_status": "Unverified", "status_reason": "Information retained in stored summaries 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, rescue medication, emergency care and period-specific treatment changes remain unverified.", "uncertainty": "Gaps in extract specifications, background drugs, adherence, allocation, masking, parent diaries, crossover periods and sequences, carryover, missing data, effect intervals, support roles and harms remain. A short seizure-frequency signal is not converted into medication withdrawal, durable remission, efficacy of other formulations or long-term safety.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Administration/rescue-treatment records and prospective handling rules" }, { "item_id": "N24", "question_type": "Evidence condition", "question": "What is known about independent repetition or other formulations?", "needed": "Unique trial relationships for the same aqueous extract, pediatric population, comparison and duration", "role": "Required", "role_reason": "Material on Unique trial relationships for the same aqueous extract, pediatric population, comparison and duration is needed to connect the pediatric population to formulation, dose, background treatment, placebo, seizure recording, crossover periods and sequences, denominators, intervals or harms.", "application_exception": "The records of 23 enrolled participants and 20 completers are not converted into randomized, period-specific analysis or safety denominators, and no new dropout count is calculated. Crossover periods are not pooled as independent trials or new participants, and an overall test is not converted into an effect between treatment periods.", "criterion": "Original records on Unique trial relationships for the same aqueous extract, pediatric population, comparison and duration must link to the relevant report, crossover design, concomitant medication, measurement, timing and denominator, distinguishing recorded information from what remains unverified.", "basis": "Existing principles distinguish formulation, population, background antiseizure medication, placebo, seizure recording, crossover periods and sequences, denominators, effect intervals, support and harms for adjunctive aqueous seed extract in children.", "condition_origin": "These existing conditions are linked to the crossover comparison of aqueous seed extract and placebo in children continuing antiseizure medication. They explain stored summaries and material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Direct studies of the same formulation/population and related report lists This records needed materials; no new research was executed.", "current_reports": [ "S01" ], "existence": "The information is recorded in a stored pediatric crossover report, citation and existing Korean and English summaries. Actual reading of external articles, registration, plans and support disclosures remains separately unverified.", "acquired_read": "Existing Korean and English stored summaries and the S01 citation read; external articles, registration, protocols, analysis plans and support disclosures unread", "observation": "The retained evidence list contains one report. The original text did not merge adult, animal or purified-thymoquinone studies.", "condition_status": "Unverified", "status_reason": "Information retained in stored summaries 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": "The current list does not establish the study count in the latest entire literature or independent replication.", "uncertainty": "Gaps in extract specifications, background drugs, adherence, allocation, masking, parent diaries, crossover periods and sequences, carryover, missing data, effect intervals, support roles and harms remain. A short seizure-frequency signal is not converted into medication withdrawal, durable remission, efficacy of other formulations or long-term safety.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Direct studies of the same formulation/population and related report lists" }, { "item_id": "N25", "question_type": "Evidence condition", "question": "Does the short signal answer long-term seizure-control questions?", "needed": "Long-term persistence, effects after discontinuation, follow-up and dose questions", "role": "Required", "role_reason": "Material on Long-term persistence, effects after discontinuation, follow-up and dose questions is needed to connect the pediatric population to formulation, dose, background treatment, placebo, seizure recording, crossover periods and sequences, denominators, intervals or harms.", "application_exception": "The records of 23 enrolled participants and 20 completers are not converted into randomized, period-specific analysis or safety denominators, and no new dropout count is calculated. Crossover periods are not pooled as independent trials or new participants, and an overall test is not converted into an effect between treatment periods.", "criterion": "Original records on Long-term persistence, effects after discontinuation, follow-up and dose questions must link to the relevant report, crossover design, concomitant medication, measurement, timing and denominator, distinguishing recorded information from what remains unverified.", "basis": "Existing principles distinguish formulation, population, background antiseizure medication, placebo, seizure recording, crossover periods and sequences, denominators, effect intervals, support and harms for adjunctive aqueous seed extract in children.", "condition_origin": "These existing conditions are linked to the crossover comparison of aqueous seed extract and placebo in children continuing antiseizure medication. They explain stored summaries and material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Long-term follow-up, post-discontinuation records and direct dose material This records needed materials; no new research was executed.", "current_reports": [ "S01" ], "existence": "The information is recorded in a stored pediatric crossover report, citation and existing Korean and English summaries. Actual reading of external articles, registration, plans and support disclosures remains separately unverified.", "acquired_read": "Existing Korean and English stored summaries and the S01 citation read; external articles, registration, protocols, analysis plans and support disclosures unread", "observation": "The record retains a short signal from 4 weeks per intervention.", "condition_status": "Unverified", "status_reason": "Information retained in stored summaries 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": "Long-term persistence, effects after discontinuation and comparisons of other doses remain unverified.", "uncertainty": "Gaps in extract specifications, background drugs, adherence, allocation, masking, parent diaries, crossover periods and sequences, carryover, missing data, effect intervals, support roles and harms remain. A short seizure-frequency signal is not converted into medication withdrawal, durable remission, efficacy of other formulations or long-term safety.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Long-term follow-up, post-discontinuation records and direct dose material" }, { "item_id": "N26", "question_type": "Evidence condition", "question": "Can the finding extend to outcomes beyond seizure frequency?", "needed": "Separate evidence for durable remission, medication withdrawal, development/quality of life and severe events", "role": "Required", "role_reason": "Material on Separate evidence for durable remission, medication withdrawal, development/quality of life and severe events is needed to connect the pediatric population to formulation, dose, background treatment, placebo, seizure recording, crossover periods and sequences, denominators, intervals or harms.", "application_exception": "The records of 23 enrolled participants and 20 completers are not converted into randomized, period-specific analysis or safety denominators, and no new dropout count is calculated. Crossover periods are not pooled as independent trials or new participants, and an overall test is not converted into an effect between treatment periods.", "criterion": "Original records on Separate evidence for durable remission, medication withdrawal, development/quality of life and severe events must link to the relevant report, crossover design, concomitant medication, measurement, timing and denominator, distinguishing recorded information from what remains unverified.", "basis": "Existing principles distinguish formulation, population, background antiseizure medication, placebo, seizure recording, crossover periods and sequences, denominators, effect intervals, support and harms for adjunctive aqueous seed extract in children.", "condition_origin": "These existing conditions are linked to the crossover comparison of aqueous seed extract and placebo in children continuing antiseizure medication. They explain stored summaries and material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Direct measurements, durations and denominators for separate clinical outcomes This records needed materials; no new research was executed.", "current_reports": [ "S01" ], "existence": "The information is recorded in a stored pediatric crossover report, citation and existing Korean and English summaries. Actual reading of external articles, registration, plans and support disclosures remains separately unverified.", "acquired_read": "Existing Korean and English stored summaries and the S01 citation read; external articles, registration, protocols, analysis plans and support disclosures unread", "observation": "The original text records that stopping antiseizure medication or durable seizure remission was not tested.", "condition_status": "Unverified", "status_reason": "Information retained in stored summaries 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": "Separate outcomes such as development, quality of life, hospitalization and durable remission remain unverified; seizure-frequency signals do not replace them.", "uncertainty": "Gaps in extract specifications, background drugs, adherence, allocation, masking, parent diaries, crossover periods and sequences, carryover, missing data, effect intervals, support roles and harms remain. A short seizure-frequency signal is not converted into medication withdrawal, durable remission, efficacy of other formulations or long-term safety.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Direct measurements, durations and denominators for separate clinical outcomes" }, { "item_id": "N27", "question_type": "Evidence condition", "question": "What was reported about research funding?", "needed": "Funding sources, support amounts and roles", "role": "Required", "role_reason": "Material on Funding sources, support amounts and roles is needed to connect the pediatric population to formulation, dose, background treatment, placebo, seizure recording, crossover periods and sequences, denominators, intervals or harms.", "application_exception": "The records of 23 enrolled participants and 20 completers are not converted into randomized, period-specific analysis or safety denominators, and no new dropout count is calculated. Crossover periods are not pooled as independent trials or new participants, and an overall test is not converted into an effect between treatment periods.", "criterion": "Original records on Funding sources, support amounts and roles must link to the relevant report, crossover design, concomitant medication, measurement, timing and denominator, distinguishing recorded information from what remains unverified.", "basis": "Existing principles distinguish formulation, population, background antiseizure medication, placebo, seizure recording, crossover periods and sequences, denominators, effect intervals, support and harms for adjunctive aqueous seed extract in children.", "condition_origin": "These existing conditions are linked to the crossover comparison of aqueous seed extract and placebo in children continuing antiseizure medication. They explain stored summaries and material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Funding sources, sponsor roles and support specifications This records needed materials; no new research was executed.", "current_reports": [ "S01" ], "existence": "The information is recorded in a stored pediatric crossover report, citation and existing Korean and English summaries. Actual reading of external articles, registration, plans and support disclosures remains separately unverified.", "acquired_read": "Existing Korean and English stored summaries and the S01 citation read; external articles, registration, protocols, analysis plans and support disclosures unread", "observation": "Funding in the stored evidence summary is recorded as unconfirmed.", "condition_status": "Unverified", "status_reason": "Information retained in stored summaries 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": "Unconfirmed funding is not converted into no funding or independent funding.", "uncertainty": "Gaps in extract specifications, background drugs, adherence, allocation, masking, parent diaries, crossover periods and sequences, carryover, missing data, effect intervals, support roles and harms remain. A short seizure-frequency signal is not converted into medication withdrawal, durable remission, efficacy of other formulations or long-term safety.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Funding sources, sponsor roles and support specifications" }, { "item_id": "N28", "question_type": "Evidence condition", "question": "Are product provision, employee authorship and COI distinguished?", "needed": "Separate original records of product/free support, employment, patents and COI", "role": "Required", "role_reason": "Material on Separate original records of product/free support, employment, patents and COI is needed to connect the pediatric population to formulation, dose, background treatment, placebo, seizure recording, crossover periods and sequences, denominators, intervals or harms.", "application_exception": "The records of 23 enrolled participants and 20 completers are not converted into randomized, period-specific analysis or safety denominators, and no new dropout count is calculated. Crossover periods are not pooled as independent trials or new participants, and an overall test is not converted into an effect between treatment periods.", "criterion": "Original records on Separate original records of product/free support, employment, patents and COI must link to the relevant report, crossover design, concomitant medication, measurement, timing and denominator, distinguishing recorded information from what remains unverified.", "basis": "Existing principles distinguish formulation, population, background antiseizure medication, placebo, seizure recording, crossover periods and sequences, denominators, effect intervals, support and harms for adjunctive aqueous seed extract in children.", "condition_origin": "These existing conditions are linked to the crossover comparison of aqueous seed extract and placebo in children continuing antiseizure medication. They explain stored summaries and material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Original disclosures of product provision, employment, patents and COI This records needed materials; no new research was executed.", "current_reports": [ "S01" ], "existence": "The information is recorded in a stored pediatric crossover report, citation and existing Korean and English summaries. Actual reading of external articles, registration, plans and support disclosures remains separately unverified.", "acquired_read": "Existing Korean and English stored summaries and the S01 citation read; external articles, registration, protocols, analysis plans and support disclosures unread", "observation": "The current summary provides no record confirming specific product support, employee authorship or COI.", "condition_status": "Unverified", "status_reason": "Information retained in stored summaries 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": "The historical generic English wording assessed separately is not inherited as current reading of material or confirmation of independence.", "uncertainty": "Gaps in extract specifications, background drugs, adherence, allocation, masking, parent diaries, crossover periods and sequences, carryover, missing data, effect intervals, support roles and harms remain. A short seizure-frequency signal is not converted into medication withdrawal, durable remission, efficacy of other formulations or long-term safety.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original disclosures of product provision, employment, patents and COI" }, { "item_id": "N29", "question_type": "Evidence condition", "question": "How were harms collected during the same pediatric exposure?", "needed": "Adverse-event definitions, collection, discontinuation, people/events and period-specific denominators", "role": "Supplementary", "role_reason": "Material on Adverse-event definitions, collection, discontinuation, people/events and period-specific denominators is needed to connect the pediatric population to formulation, dose, background treatment, placebo, seizure recording, crossover periods and sequences, denominators, intervals or harms.", "application_exception": "The records of 23 enrolled participants and 20 completers are not converted into randomized, period-specific analysis or safety denominators, and no new dropout count is calculated. Crossover periods are not pooled as independent trials or new participants, and an overall test is not converted into an effect between treatment periods.", "criterion": "Original records on Adverse-event definitions, collection, discontinuation, people/events and period-specific denominators must link to the relevant report, crossover design, concomitant medication, measurement, timing and denominator, distinguishing recorded information from what remains unverified.", "basis": "Existing principles distinguish formulation, population, background antiseizure medication, placebo, seizure recording, crossover periods and sequences, denominators, effect intervals, support and harms for adjunctive aqueous seed extract in children.", "condition_origin": "These existing conditions are linked to the crossover comparison of aqueous seed extract and placebo in children continuing antiseizure medication. They explain stored summaries and material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Period-specific adverse events, discontinuation and collection methods This records needed materials; no new research was executed.", "current_reports": [ "S01" ], "existence": "The information is recorded in a stored pediatric crossover report, citation and existing Korean and English summaries. Actual reading of external articles, registration, plans and support disclosures remains separately unverified.", "acquired_read": "Existing Korean and English stored summaries and the S01 citation read; external articles, registration, protocols, analysis plans and support disclosures unread", "observation": "The original Caution label and wording that small trials cannot exclude rare adverse events and long-term safety concerns are retained.", "condition_status": "Unverified", "status_reason": "Information retained in stored summaries 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": "Systematic event collection, group-/period-specific harms, discontinuation and event denominators remain unverified; seizure improvement does not establish safety.", "uncertainty": "Gaps in extract specifications, background drugs, adherence, allocation, masking, parent diaries, crossover periods and sequences, carryover, missing data, effect intervals, support roles and harms remain. A short seizure-frequency signal is not converted into medication withdrawal, durable remission, efficacy of other formulations or long-term safety.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Period-specific adverse events, discontinuation and collection methods" }, { "item_id": "N30", "question_type": "Evidence condition", "question": "What are the timing, concomitant-drug and attribution limits for harms?", "needed": "Period-specific occurrence, discontinuation/recovery, background drugs, baseline seizures and alternative explanations", "role": "Supplementary", "role_reason": "Material on Period-specific occurrence, discontinuation/recovery, background drugs, baseline seizures and alternative explanations is needed to connect the pediatric population to formulation, dose, background treatment, placebo, seizure recording, crossover periods and sequences, denominators, intervals or harms.", "application_exception": "The records of 23 enrolled participants and 20 completers are not converted into randomized, period-specific analysis or safety denominators, and no new dropout count is calculated. Crossover periods are not pooled as independent trials or new participants, and an overall test is not converted into an effect between treatment periods.", "criterion": "Original records on Period-specific occurrence, discontinuation/recovery, background drugs, baseline seizures and alternative explanations must link to the relevant report, crossover design, concomitant medication, measurement, timing and denominator, distinguishing recorded information from what remains unverified.", "basis": "Existing principles distinguish formulation, population, background antiseizure medication, placebo, seizure recording, crossover periods and sequences, denominators, effect intervals, support and harms for adjunctive aqueous seed extract in children.", "condition_origin": "These existing conditions are linked to the crossover comparison of aqueous seed extract and placebo in children continuing antiseizure medication. They explain stored summaries and material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Original concomitant-drug, timeline, discontinuation/recovery and alternative-explanation records This records needed materials; no new research was executed.", "current_reports": [ "S01" ], "existence": "The information is recorded in a stored pediatric crossover report, citation and existing Korean and English summaries. Actual reading of external articles, registration, plans and support disclosures remains separately unverified.", "acquired_read": "Existing Korean and English stored summaries and the S01 citation read; external articles, registration, protocols, analysis plans and support disclosures unread", "observation": "The original cautionary wording concerning children, antiseizure/concomitant drugs and differences in products/extraction methods is retained.", "condition_status": "Unverified", "status_reason": "Information retained in stored summaries 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 interactions, seizure worsening, recovery after discontinuation, re-exposure and causality remain unverified; no new harm judgment is made.", "uncertainty": "Gaps in extract specifications, background drugs, adherence, allocation, masking, parent diaries, crossover periods and sequences, carryover, missing data, effect intervals, support roles and harms remain. A short seizure-frequency signal is not converted into medication withdrawal, durable remission, efficacy of other formulations or long-term safety.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original concomitant-drug, timeline, discontinuation/recovery and alternative-explanation records" }, { "item_id": "N31", "question_type": "Evidence condition", "question": "What is known about long-term/rare harms and other vulnerable groups?", "needed": "Direct safety material for long-term exposure, rare events and special populations", "role": "Supplementary", "role_reason": "Material on Direct safety material for long-term exposure, rare events and special populations is needed to connect the pediatric population to formulation, dose, background treatment, placebo, seizure recording, crossover periods and sequences, denominators, intervals or harms.", "application_exception": "The records of 23 enrolled participants and 20 completers are not converted into randomized, period-specific analysis or safety denominators, and no new dropout count is calculated. Crossover periods are not pooled as independent trials or new participants, and an overall test is not converted into an effect between treatment periods.", "criterion": "Original records on Direct safety material for long-term exposure, rare events and special populations must link to the relevant report, crossover design, concomitant medication, measurement, timing and denominator, distinguishing recorded information from what remains unverified.", "basis": "Existing principles distinguish formulation, population, background antiseizure medication, placebo, seizure recording, crossover periods and sequences, denominators, effect intervals, support and harms for adjunctive aqueous seed extract in children.", "condition_origin": "These existing conditions are linked to the crossover comparison of aqueous seed extract and placebo in children continuing antiseizure medication. They explain stored summaries and material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Long-term safety material and population-specific exposure/event records This records needed materials; no new research was executed.", "current_reports": [ "S01" ], "existence": "The information is recorded in a stored pediatric crossover report, citation and existing Korean and English summaries. Actual reading of external articles, registration, plans and support disclosures remains separately unverified.", "acquired_read": "Existing Korean and English stored summaries and the S01 citation read; external articles, registration, protocols, analysis plans and support disclosures unread", "observation": "The original cautionary wording concerning pregnancy, breastfeeding, children, liver/kidney conditions, surgery and medication is retained.", "condition_status": "Unverified", "status_reason": "Information retained in stored summaries 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": "Small 4-week records are not extended to absence of long-term/rare harms or safety in every vulnerable population.", "uncertainty": "Gaps in extract specifications, background drugs, adherence, allocation, masking, parent diaries, crossover periods and sequences, carryover, missing data, effect intervals, support roles and harms remain. A short seizure-frequency signal is not converted into medication withdrawal, durable remission, efficacy of other formulations or long-term safety.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Long-term safety material and population-specific exposure/event records" }, { "item_id": "N32", "question_type": "Evidence condition", "question": "What do the original grade, axes and historical independent cross-check mean?", "needed": "Retain the original C54, axes, inactive/empty records and verdict history", "role": "Required", "role_reason": "Material on Retain the original C54, axes, inactive/empty records and verdict history is needed to connect the pediatric population to formulation, dose, background treatment, placebo, seizure recording, crossover periods and sequences, denominators, intervals or harms.", "application_exception": "The records of 23 enrolled participants and 20 completers are not converted into randomized, period-specific analysis or safety denominators, and no new dropout count is calculated. Crossover periods are not pooled as independent trials or new participants, and an overall test is not converted into an effect between treatment periods.", "criterion": "Original records on Retain the original C54, axes, inactive/empty records and verdict history must link to the relevant report, crossover design, concomitant medication, measurement, timing and denominator, distinguishing recorded information from what remains unverified.", "basis": "Existing principles distinguish formulation, population, background antiseizure medication, placebo, seizure recording, crossover periods and sequences, denominators, effect intervals, support and harms for adjunctive aqueous seed extract in children.", "condition_origin": "These existing conditions are linked to the crossover comparison of aqueous seed extract and placebo in children continuing antiseizure medication. They explain stored summaries and material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Clear histories of the original verdict and change events This records needed materials; no new research was executed.", "current_reports": [ "S01" ], "existence": "The information is recorded in a stored pediatric crossover report, citation and existing Korean and English summaries. Actual reading of external articles, registration, plans and support disclosures remains separately unverified.", "acquired_read": "Existing Korean and English stored summaries and the S01 citation read; external articles, registration, protocols, analysis plans and support disclosures unread", "observation": "C54, the original axes, historical independent Codex cross-check wording, and empty subclaim/additional-rationale records are retained in the original copy.", "condition_status": "Partly verified", "status_reason": "Information retained in stored summaries 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": "These are not used as current fulfillment of conditions, completed clinical review or certification of independent trials.", "uncertainty": "Gaps in extract specifications, background drugs, adherence, allocation, masking, parent diaries, crossover periods and sequences, carryover, missing data, effect intervals, support roles and harms remain. A short seizure-frequency signal is not converted into medication withdrawal, durable remission, efficacy of other formulations or long-term safety.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Clear histories of the original verdict and change events" }, { "item_id": "N33", "question_type": "Evidence condition", "question": "What do current English wording, corrections and dates mean?", "needed": "Distinguish Korean/English text, the original evidence date, correction events and current preparation date", "role": "Required", "role_reason": "Material on Distinguish Korean/English text, the original evidence date, correction events and current preparation date is needed to connect the pediatric population to formulation, dose, background treatment, placebo, seizure recording, crossover periods and sequences, denominators, intervals or harms.", "application_exception": "The records of 23 enrolled participants and 20 completers are not converted into randomized, period-specific analysis or safety denominators, and no new dropout count is calculated. Crossover periods are not pooled as independent trials or new participants, and an overall test is not converted into an effect between treatment periods.", "criterion": "Original records on Distinguish Korean/English text, the original evidence date, correction events and current preparation date must link to the relevant report, crossover design, concomitant medication, measurement, timing and denominator, distinguishing recorded information from what remains unverified.", "basis": "Existing principles distinguish formulation, population, background antiseizure medication, placebo, seizure recording, crossover periods and sequences, denominators, effect intervals, support and harms for adjunctive aqueous seed extract in children.", "condition_origin": "These existing conditions are linked to the crossover comparison of aqueous seed extract and placebo in children continuing antiseizure medication. They explain stored summaries and material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Before/after correction material, subsequent original material and user comments This records needed materials; no new research was executed.", "current_reports": [ "S01" ], "existence": "The information is recorded in a stored pediatric crossover report, citation and existing Korean and English summaries. Actual reading of external articles, registration, plans and support disclosures remains separately unverified.", "acquired_read": "Existing Korean and English stored summaries and the S01 citation read; external articles, registration, protocols, analysis plans and support disclosures unread", "observation": "The original verdict date 2026-09-08, correction of 1 English evidence-table field on 2026-09-14 with the grade unchanged, and existing specific/generic English wording are retained in the original copy. This is a production record with user review pending.", "condition_status": "Partly verified", "status_reason": "Information retained in stored summaries 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": "Generic English wording and correction details are not promoted to new clinical confirmation; current retractions, registration and new literature were not queried.", "uncertainty": "Gaps in extract specifications, background drugs, adherence, allocation, masking, parent diaries, crossover periods and sequences, carryover, missing data, effect intervals, support roles and harms remain. A short seizure-frequency signal is not converted into medication withdrawal, durable remission, efficacy of other formulations or long-term safety.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Before/after correction material, subsequent original material and user comments" } ], "reports": [ { "report_id": "S01", "title": "Akhondian et al. 2007 · Crossover report of aqueous seed extract and intractable pediatric seizures", "url": "https://pubmed.ncbi.nlm.nih.gov/18049435/", "report_type": "Retained design described as a double-blind placebo crossover; detailed sequence allocation and analysis unverified", "existence": "The information is recorded in a stored pediatric crossover report, citation and existing Korean and English summaries. Actual reading of external articles, registration, plans and support disclosures remains separately unverified.", "acquired_read": "Summary read; external material unread", "study_family": "TF3032-01", "independent_replication": null, "observed_result": "Baseline 5.78±7.20, extract 4.21±5.77, placebo 6.14±6.75; overall Friedman P<.001; 65% versus 20% improvement", "result_level": "The original record reports 23 enrolled participants and 20 completers. Paired period- and sequence-specific data, analysis sets, the definition of ±, response criteria, exact treatment contrasts and CIs remain unverified. The overall test is not used as an effect between treatment periods.", "source_evidence_date": "2026-09-08", "materials": [ { "material_type": "Stored existing review summary", "public_status": "Preserved copy of the complete existing review summary", "access_status": "Stored summary", "acquired": true, "actually_read": "Summary read", "as_of": "2026-09-08", "qualification": "PMID18049435 is retained bibliography. DOI, PMCID and registration identifiers are unrecorded, and the original registration identity is unconfirmed. External articles, registration, protocols, analysis plans and support disclosures are unread; identifiers or NULL values alone do not establish full-text acquisition, actual reading or absence of material. The date 2026-09-08 retained in every material item is the original evidence date, not a date of external reading. The date 2026-10-06 is the original production date, not a completed-content-review date. Pending-review wording is not a verification date." }, { "material_type": "External article", "public_status": "Original bibliographic link or needed material; external public availability/access status unverified", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-09-08", "qualification": "PMID18049435 is retained bibliography. DOI, PMCID and registration identifiers are unrecorded, and the original registration identity is unconfirmed. External articles, registration, protocols, analysis plans and support disclosures are unread; identifiers or NULL values alone do not establish full-text acquisition, actual reading or absence of material. The date 2026-09-08 retained in every material item is the original evidence date, not a date of external reading. The date 2026-10-06 is the original production date, not a completed-content-review date. Pending-review wording is not a verification date." }, { "material_type": "Registration material", "public_status": "Original bibliographic link or needed material; external public availability/access status unverified", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-09-08", "qualification": "PMID18049435 is retained bibliography. DOI, PMCID and registration identifiers are unrecorded, and the original registration identity is unconfirmed. External articles, registration, protocols, analysis plans and support disclosures are unread; identifiers or NULL values alone do not establish full-text acquisition, actual reading or absence of material. The date 2026-09-08 retained in every material item is the original evidence date, not a date of external reading. The date 2026-10-06 is the original production date, not a completed-content-review date. Pending-review wording is not a verification date." }, { "material_type": "Protocol", "public_status": "Original bibliographic link or needed material; external public availability/access status unverified", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-09-08", "qualification": "PMID18049435 is retained bibliography. DOI, PMCID and registration identifiers are unrecorded, and the original registration identity is unconfirmed. External articles, registration, protocols, analysis plans and support disclosures are unread; identifiers or NULL values alone do not establish full-text acquisition, actual reading or absence of material. The date 2026-09-08 retained in every material item is the original evidence date, not a date of external reading. The date 2026-10-06 is the original production date, not a completed-content-review date. Pending-review wording is not a verification date." }, { "material_type": "Statistical analysis plan", "public_status": "Original bibliographic link or needed material; external public availability/access status unverified", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-09-08", "qualification": "PMID18049435 is retained bibliography. DOI, PMCID and registration identifiers are unrecorded, and the original registration identity is unconfirmed. External articles, registration, protocols, analysis plans and support disclosures are unread; identifiers or NULL values alone do not establish full-text acquisition, actual reading or absence of material. The date 2026-09-08 retained in every material item is the original evidence date, not a date of external reading. The date 2026-10-06 is the original production date, not a completed-content-review date. Pending-review wording is not a verification date." }, { "material_type": "Funding, product-support and COI material", "public_status": "Original bibliographic link or needed material; external public availability/access status unverified", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-09-08", "qualification": "PMID18049435 is retained bibliography. DOI, PMCID and registration identifiers are unrecorded, and the original registration identity is unconfirmed. External articles, registration, protocols, analysis plans and support disclosures are unread; identifiers or NULL values alone do not establish full-text acquisition, actual reading or absence of material. The date 2026-09-08 retained in every material item is the original evidence date, not a date of external reading. The date 2026-10-06 is the original production date, not a completed-content-review date. Pending-review wording is not a verification date." } ], "links": [ { "label": "PubMed", "url": "https://pubmed.ncbi.nlm.nih.gov/18049435/" } ] } ], "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 Akhondian crossover report remains distinct from possible related reports. Extract and placebo periods in the same children are not converted into new unique trials or participant totals. An established independent-replication count and period-specific participant matching remain unverified." }, "history": [ { "date": "2026-10-24", "kind": "Separation of public-facing pages and materials", "view_version": "1.0", "change": "The public view and materials were prepared from the existing 33 items. No new clinical search, verification-state change or scoring was performed." } ], "language": "en", "translation_date": "2026-10-24" }