# Oral aqueous Nigella sativa seed extract as adjunctive therapy × Reduced seizure frequency in pediatric refractory epilepsy Verdict 3032 · Evidence Check Stored-material review date: Not recorded Original evidence cut-off: 2026-09-08 Review-criteria version: 1.0 Public page/material preparation date: 2026-10-24 Clinical papers were not read directly; existing review summaries were checked. No new clinical-literature search was performed. Unverified does not mean that research is absent or that there is no effect. ## Assessment scope - Population: The population is 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. - Ingredient, formulation and route: 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. - Measured outcome: 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. - Questions outside this scope: 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. ## Checklist items ### N01 · What is the selected claim? Verification status: Partly verified Reading scope: Existing Korean and English stored summaries and the S01 citation read; external articles, registration, protocols, analysis plans and support disclosures unread - Current findings: The original claim is reduced seizure frequency in pediatric refractory epilepsy. Only adjunctive oral aqueous seed extract in children continuing antiseizure medication is linked. - Why unverified: 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. - Reason for missing information: Material supporting application of adult, purified-thymoquinone or other Nigella-formulation effects to this question remains unverified. - Required materials and conditions: The exact question on aqueous seed extract, pediatric refractory epilepsy, seizure frequency, continued antiseizure medication and added placebo - Materials to obtain first: Original material specifying formulation, population, comparison and duration for this question - Further research: Material needed: Original material specifying formulation, population, comparison and duration for this question This records needed materials; no new research was executed. - Conditions for verification: 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. - Why this condition is needed: 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 exceptions: 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. - Remaining 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. - Referenced methods: 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. - Related sources: S01 ### N02 · Which materials were actually read here? Verification status: Partly verified Reading scope: Existing Korean and English stored summaries and the S01 citation read; external articles, registration, protocols, analysis plans and support disclosures unread - Current findings: 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. - Why unverified: 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. - Reason for missing information: Existence of a link does not establish full-text reading or completed content review. - Required materials and conditions: Separate reading levels for the stored JSON summary and external articles, registration and plans - Materials to obtain first: Original material and access histories supplied by the user or obtained in subsequent work - Further 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. - Conditions for verification: 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. - Why this condition is needed: 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 exceptions: 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. - Remaining 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. - Referenced methods: 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. - Related sources: S01 ### N03 · What is the identity of the report? Verification status: Partly verified Reading scope: Existing Korean and English stored summaries and the S01 citation read; external articles, registration, protocols, analysis plans and support disclosures unread - Current findings: A stored report by Akhondian J et al. in Med Sci Monit 2007, PMID 18049435, concerns pediatric intractable seizures. - Why unverified: 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. - Reason for missing information: The original article, DOI and registration identity were not reconciled here. - Required materials and conditions: Link authors, year, title and PMID to the direct report - Materials to obtain first: Full article bibliography and lists of related registrations and reports - Further research: Material needed: Full article bibliography and lists of related registrations and reports This records needed materials; no new research was executed. - Conditions for verification: 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. - Why this condition is needed: 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 exceptions: 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. - Remaining 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. - Referenced methods: 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. - Related sources: S01 ### N04 · Are crossover periods kept distinct from independent studies or people? Verification status: Partly verified Reading scope: Existing Korean and English stored summaries and the S01 citation read; external articles, registration, protocols, analysis plans and support disclosures unread - Current findings: The stored report describes a double-blind placebo crossover. Extract and placebo periods are not pooled as separate independent trials or separate participants. - Why unverified: 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. - Reason for missing information: Sequence allocation, period-specific participant matching and related report families remain unverified; a unique clinical total is not established. - Required materials and conditions: Relationships among the single trial, its sequences/periods, participants and reports - Materials to obtain first: Participant flow, sequence/period tables and related report lists - Further research: Material needed: Participant flow, sequence/period tables and related report lists This records needed materials; no new research was executed. - Conditions for verification: 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. - Why this condition is needed: 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 exceptions: 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. - Remaining 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. - Referenced methods: 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. - Related sources: S01 ### N05 · Which children does the record concern? Verification status: Partly verified Reading scope: Existing Korean and English stored summaries and the S01 citation read; external articles, registration, protocols, analysis plans and support disclosures unread - Current findings: The retained population is children with refractory epilepsy continuing antiseizure medication. - Why unverified: 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. - Reason for missing information: Detailed ages, seizure types, the definition of refractoriness, inclusion/exclusion criteria and applicability to children with epilepsy generally remain unverified. - Required materials and conditions: Refractory diagnosis, age, seizure type, baseline severity and inclusion/exclusion criteria - Materials to obtain first: Eligibility tables, baseline characteristics and seizure-type-specific material - Further research: Material needed: Eligibility tables, baseline characteristics and seizure-type-specific material This records needed materials; no new research was executed. - Conditions for verification: 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. - Why this condition is needed: 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 exceptions: 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. - Remaining 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. - Referenced methods: 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. - Related sources: S01 ### N06 · Which extract was used? Verification status: Partly verified Reading scope: Existing Korean and English stored summaries and the S01 citation read; external articles, registration, protocols, analysis plans and support disclosures unread - Current findings: The preparation is a Soxhlet-produced aqueous extract of Nigella sativa L. seeds, not purified thymoquinone. - Why unverified: 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. - Reason for missing information: Composition, yield, batch, standardization and equivalence to marketed products remain unverified. - Required materials and conditions: Identity of the seed, Soxhlet aqueous extraction, composition/batch and formulation - Materials to obtain first: Extraction, quality, constituent-amount and trial-preparation specifications - Further research: Material needed: Extraction, quality, constituent-amount and trial-preparation specifications This records needed materials; no new research was executed. - Conditions for verification: 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. - Why this condition is needed: 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 exceptions: 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. - Remaining 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. - Referenced methods: 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. - Related sources: S01 ### N07 · What record specifies the dose and frequency? Verification status: Partly verified Reading scope: Existing Korean and English stored summaries and the S01 citation read; external articles, registration, protocols, analysis plans and support disclosures unread - Current findings: The retained oral dose is 40 mg/kg every 8 hours. A daily total is not newly calculated. - Why unverified: 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. - Reason for missing information: Reference body weight, actual administered amounts, missed doses and dose adjustments remain unverified. - Required materials and conditions: Weight-based amount per 1 administration, interval, actual dosing and adherence - Materials to obtain first: Dosing schedules, adherence and adjustment records - Further research: Material needed: Dosing schedules, adherence and adjustment records This records needed materials; no new research was executed. - Conditions for verification: 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. - Why this condition is needed: 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 exceptions: 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. - Remaining 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. - Referenced methods: 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. - Related sources: S01 ### N08 · Is this an adjunctive effect above background antiseizure medication? Verification status: Partly verified Reading scope: Existing Korean and English stored summaries and the S01 citation read; external articles, registration, protocols, analysis plans and support disclosures unread - Current findings: The original text describes extract or placebo added while existing antiseizure medication was maintained. - Why unverified: 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. - Reason for missing information: Specific drugs, doses, changes during periods, rescue treatment and their balance remain unverified. - Required materials and conditions: Background drugs, maintenance, changes and attribution of concomitant treatment by group/period - Materials to obtain first: Background drug lists, changes and rescue-treatment tables - Further research: Material needed: Background drug lists, changes and rescue-treatment tables This records needed materials; no new research was executed. - Conditions for verification: 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. - Why this condition is needed: 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 exceptions: 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. - Remaining 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. - Referenced methods: 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. - Related sources: S01 ### N09 · How was placebo actually compared? Verification status: Partly verified Reading scope: Existing Korean and English stored summaries and the S01 citation read; external articles, registration, protocols, analysis plans and support disclosures unread - Current findings: The retained comparison is a crossover with placebo added to background antiseizure medication. - Why unverified: 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. - Reason for missing information: Placebo composition, appearance/taste, matched administration and actual differences in use remain unverified. - Required materials and conditions: Placebo composition, appearance, administration and adjunctive-treatment conditions - Materials to obtain first: Placebo specifications, preparation images/descriptions and administration records - Further research: Material needed: Placebo specifications, preparation images/descriptions and administration records This records needed materials; no new research was executed. - Conditions for verification: 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. - Why this condition is needed: 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 exceptions: 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. - Remaining 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. - Referenced methods: 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. - Related sources: S01 ### N10 · What was the allocation process in the crossover design? Verification status: Partly verified Reading scope: Existing Korean and English stored summaries and the S01 citation read; external articles, registration, protocols, analysis plans and support disclosures unread - Current findings: The retained design is described as a double-blind placebo crossover. - Why unverified: 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. - Reason for missing information: Random sequence generation, allocation concealment and sequence-specific baseline characteristics remain unverified in the summary. - Required materials and conditions: Sequence allocation, concealment, randomization methods and baseline balance - Materials to obtain first: Original methods, sequence-allocation tables and baseline tables - Further research: Material needed: Original methods, sequence-allocation tables and baseline tables This records needed materials; no new research was executed. - Conditions for verification: 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. - Why this condition is needed: 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 exceptions: 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. - Remaining 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. - Referenced methods: 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. - Related sources: S01 ### N11 · Was masking maintained for parents and assessors? Verification status: Partly verified Reading scope: Existing Korean and English stored summaries and the S01 citation read; external articles, registration, protocols, analysis plans and support disclosures unread - Current findings: The original design wording of double blinding is retained. - Why unverified: 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. - Reason for missing information: Who was masked, whether placebo could be distinguished and unmasking remain unverified. - Required materials and conditions: Masking of parents, participants, administrators and assessors, and unmasking - Materials to obtain first: Records of masking targets, procedures and unmasking - Further research: Material needed: Records of masking targets, procedures and unmasking This records needed materials; no new research was executed. - Conditions for verification: 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. - Why this condition is needed: 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 exceptions: 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. - Remaining 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. - Referenced methods: 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. - Related sources: S01 ### N12 · How was observation time divided? Verification status: Partly verified Reading scope: Existing Korean and English stored summaries and the S01 citation read; external articles, registration, protocols, analysis plans and support disclosures unread - Current findings: The record retains 4 weeks per intervention and a 2-week washout. These are not converted into long-term continuous exposure. - Why unverified: 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. - Reason for missing information: Baseline recording duration, each measurement schedule, seizures during washout and treatment during washout remain unverified. - Required materials and conditions: The 4-week intervention periods, 2-week washout and period-specific measurement schedules - Materials to obtain first: Schedules, period-specific diaries and washout records - Further research: Material needed: Schedules, period-specific diaries and washout records This records needed materials; no new research was executed. - Conditions for verification: 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. - Why this condition is needed: 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 exceptions: 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. - Remaining 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. - Referenced methods: 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. - Related sources: S01 ### N13 · Were carryover, period and sequence effects addressed? Verification status: Unverified Reading scope: Existing Korean and English stored summaries and the S01 citation read; external articles, registration, protocols, analysis plans and support disclosures unread - Current findings: The original text identifies adequate reporting of sequence, period and carryover as a central gap. - Why unverified: 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. - Reason for missing information: A 2-week washout alone cannot establish removal of carryover; specific analyses remain unverified. - Required materials and conditions: Prospective assumptions and analyses for carryover, period and sequence - Materials to obtain first: Crossover analysis methods, period/sequence results and sensitivity analyses - Further research: Material needed: Crossover analysis methods, period/sequence results and sensitivity analyses This records needed materials; no new research was executed. - Conditions for verification: 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. - Why this condition is needed: 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 exceptions: 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. - Remaining 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. - Referenced methods: 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. - Related sources: S01 ### N14 · How were seizures measured? Verification status: Partly verified Reading scope: Existing Korean and English stored summaries and the S01 citation read; external articles, registration, protocols, analysis plans and support disclosures unread - Current findings: The principal endpoint is parent-recorded seizures per day. - Why unverified: 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. - Reason for missing information: Seizure definitions, recording instruction, objective confirmation, handling of missing diary entries and measurement differences across groups/periods remain unverified. - Required materials and conditions: Parent recording, daily units, seizure identification and diary completeness - Materials to obtain first: Diary forms, seizure-identification rules and measurement methods - Further research: Material needed: Diary forms, seizure-identification rules and measurement methods This records needed materials; no new research was executed. - Conditions for verification: 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. - Why this condition is needed: 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 exceptions: 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. - Remaining 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. - Referenced methods: 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. - Related sources: S01 ### N15 · What was the prospective endpoint hierarchy for seizure counts? Verification status: Unverified Reading scope: Existing Korean and English stored summaries and the S01 citation read; external articles, registration, protocols, analysis plans and support disclosures unread - Current findings: The principal endpoint in the original text is seizures per day. - Why unverified: 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. - Reason for missing information: The prespecified 1st (primary) endpoint, responder definition and analysis hierarchy remain unverified because registration and plans were unread. - Required materials and conditions: Primary/secondary endpoints, time points and analyses in registration, protocol and SAP - Materials to obtain first: Registration histories, protocol and SAP - Further research: Material needed: Registration histories, protocol and SAP This records needed materials; no new research was executed. - Conditions for verification: 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. - Why this condition is needed: 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 exceptions: 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. - Remaining 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. - Referenced methods: 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. - Related sources: S01 ### N16 · What are the enrollment, completion and period-specific analysis denominators? Verification status: Partly verified Reading scope: Existing Korean and English stored summaries and the S01 citation read; external articles, registration, protocols, analysis plans and support disclosures unread - Current findings: The original denominators of 23 enrolled participants and 20 completers are retained separately. - Why unverified: 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. - Reason for missing information: Enrollment is not converted into a randomized count; period-specific measurement/analysis denominators and inclusion of all participants remain unverified. - Required materials and conditions: The 23 enrolled participants, 20 completers and analysis denominators by period/endpoint - Materials to obtain first: Participant flow and period-/endpoint-specific analysis tables - Further research: Material needed: Participant flow and period-/endpoint-specific analysis tables This records needed materials; no new research was executed. - Conditions for verification: 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. - Why this condition is needed: 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 exceptions: 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. - Remaining 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. - Referenced methods: 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. - Related sources: S01 ### N17 · How were noncompletion and missing records handled? Verification status: Unverified Reading scope: Existing Korean and English stored summaries and the S01 citation read; external articles, registration, protocols, analysis plans and support disclosures unread - Current findings: The original text records 23 enrolled participants and 20 completers. - Why unverified: 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. - Reason for missing information: Reasons for noncompletion, its period, possible seizure worsening/harms, imputation and ITT/completer analysis remain unverified. - Required materials and conditions: Reasons for discontinuation, sequence/period, missing-data handling and analysis sets - Materials to obtain first: Discontinuation reasons, missing-data/analysis-set records and sensitivity analyses - Further research: Material needed: Discontinuation reasons, missing-data/analysis-set records and sensitivity analyses This records needed materials; no new research was executed. - Conditions for verification: 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. - Why this condition is needed: 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 exceptions: 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. - Remaining 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. - Referenced methods: 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. - Related sources: S01 ### N18 · Which results do the retained mean seizure counts represent? Verification status: Partly verified Reading scope: Existing Korean and English stored summaries and the S01 citation read; external articles, registration, protocols, analysis plans and support disclosures unread - Current findings: 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. - Why unverified: 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. - Reason for missing information: The original meaning of ±, period-/sequence-specific values, paired data and endpoint denominators remain unverified. - Required materials and conditions: Baseline, extract and placebo daily seizure counts, corresponding dispersion and denominators - Materials to obtain first: Period-specific result tables, dispersion definitions and paired analyses - Further research: Material needed: Period-specific result tables, dispersion definitions and paired analyses This records needed materials; no new research was executed. - Conditions for verification: 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. - Why this condition is needed: 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 exceptions: 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. - Remaining 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. - Referenced methods: 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. - Related sources: S01 ### N19 · What question does the overall Friedman test answer? Verification status: Partly verified Reading scope: Existing Korean and English stored summaries and the S01 citation read; external articles, registration, protocols, analysis plans and support disclosures unread - Current findings: Friedman P<.001 is retained, while the original text distinguishes it from a fully reported period-specific between-treatment effect. - Why unverified: 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. - Reason for missing information: Exact prospective contrasts, period/sequence adjustment and treatment-contrast P values remain unverified. - Required materials and conditions: Distinguish the overall test from the selected between-treatment-period contrast - Materials to obtain first: Statistical methods, prospective contrasts and result tables - Further research: Material needed: Statistical methods, prospective contrasts and result tables This records needed materials; no new research was executed. - Conditions for verification: 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. - Why this condition is needed: 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 exceptions: 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. - Remaining 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. - Referenced methods: 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. - Related sources: S01 ### N20 · What does 65% versus 20% improvement mean? Verification status: Partly verified Reading scope: Existing Korean and English stored summaries and the S01 citation read; external articles, registration, protocols, analysis plans and support disclosures unread - Current findings: The original wording of 65% versus 20% improvement is retained. - Why unverified: 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. - Reason for missing information: Reduction thresholds, pairing, participant counts, responder-analysis denominators and CIs remain unverified; new event counts are not back-calculated. - Required materials and conditions: Improvement/responder criteria, participant counts, periods/sequences and denominators - Materials to obtain first: Responder definitions, period-specific participant counts/denominators and intervals - Further research: Material needed: Responder definitions, period-specific participant counts/denominators and intervals This records needed materials; no new research was executed. - Conditions for verification: 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. - Why this condition is needed: 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 exceptions: 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. - Remaining 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. - Referenced methods: 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. - Related sources: S01 ### N21 · What are the exact effect magnitude and interval? Verification status: Unverified Reading scope: Existing Korean and English stored summaries and the S01 citation read; external articles, registration, protocols, analysis plans and support disclosures unread - Current findings: The original text records that exact CIs and period-specific between-treatment effects were unverified. - Why unverified: 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. - Reason for missing information: No new mean difference, paired CI, relative reduction or minimal important difference is calculated. - Required materials and conditions: Effect size, CI and important difference for the prospective treatment contrast - Materials to obtain first: Treatment contrasts, dispersion, CIs and evidence for an important difference - Further research: Material needed: Treatment contrasts, dispersion, CIs and evidence for an important difference This records needed materials; no new research was executed. - Conditions for verification: 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. - Why this condition is needed: 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 exceptions: 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. - Remaining 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. - Referenced methods: 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. - Related sources: S01 ### N22 · How were tests across periods, seizures and responders planned? Verification status: Unverified Reading scope: Existing Korean and English stored summaries and the S01 citation read; external articles, registration, protocols, analysis plans and support disclosures unread - Current findings: The summary retains both seizure counts and improvement proportions. - Why unverified: 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. - Reason for missing information: Multiplicity handling, prospective analyses and selective reporting remain unverified because plans were unread. - Required materials and conditions: Prospective planning for seizure-count/responder, time-point and subgroup tests - Materials to obtain first: Registration, SAP and complete endpoint tables - Further research: Material needed: Registration, SAP and complete endpoint tables This records needed materials; no new research was executed. - Conditions for verification: 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. - Why this condition is needed: 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 exceptions: 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. - Remaining 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. - Referenced methods: 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. - Related sources: S01 ### N23 · Could adherence and rescue treatment affect the results? Verification status: Unverified Reading scope: Existing Korean and English stored summaries and the S01 citation read; external articles, registration, protocols, analysis plans and support disclosures unread - Current findings: The narrative of adjunctive therapy and maintained background medication is retained. - Why unverified: 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. - Reason for missing information: Actual adherence, rescue medication, emergency care and period-specific treatment changes remain unverified. - Required materials and conditions: Extract/placebo adherence, missed doses, medication changes and emergency treatment - Materials to obtain first: Administration/rescue-treatment records and prospective handling rules - Further research: Material needed: Administration/rescue-treatment records and prospective handling rules This records needed materials; no new research was executed. - Conditions for verification: 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. - Why this condition is needed: 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 exceptions: 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. - Remaining 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. - Referenced methods: 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. - Related sources: S01 ### N24 · What is known about independent repetition or other formulations? Verification status: Unverified Reading scope: Existing Korean and English stored summaries and the S01 citation read; external articles, registration, protocols, analysis plans and support disclosures unread - Current findings: The retained evidence list contains one report. The original text did not merge adult, animal or purified-thymoquinone studies. - Why unverified: 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. - Reason for missing information: The current list does not establish the study count in the latest entire literature or independent replication. - Required materials and conditions: Unique trial relationships for the same aqueous extract, pediatric population, comparison and duration - Materials to obtain first: Direct studies of the same formulation/population and related report lists - Further research: Material needed: Direct studies of the same formulation/population and related report lists This records needed materials; no new research was executed. - Conditions for verification: 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. - Why this condition is needed: 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 exceptions: 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. - Remaining 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. - Referenced methods: 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. - Related sources: S01 ### N25 · Does the short signal answer long-term seizure-control questions? Verification status: Unverified Reading scope: Existing Korean and English stored summaries and the S01 citation read; external articles, registration, protocols, analysis plans and support disclosures unread - Current findings: The record retains a short signal from 4 weeks per intervention. - Why unverified: 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. - Reason for missing information: Long-term persistence, effects after discontinuation and comparisons of other doses remain unverified. - Required materials and conditions: Long-term persistence, effects after discontinuation, follow-up and dose questions - Materials to obtain first: Long-term follow-up, post-discontinuation records and direct dose material - Further research: Material needed: Long-term follow-up, post-discontinuation records and direct dose material This records needed materials; no new research was executed. - Conditions for verification: 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. - Why this condition is needed: 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 exceptions: 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. - Remaining 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. - Referenced methods: 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. - Related sources: S01 ### N26 · Can the finding extend to outcomes beyond seizure frequency? Verification status: Unverified Reading scope: Existing Korean and English stored summaries and the S01 citation read; external articles, registration, protocols, analysis plans and support disclosures unread - Current findings: The original text records that stopping antiseizure medication or durable seizure remission was not tested. - Why unverified: 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. - Reason for missing information: Separate outcomes such as development, quality of life, hospitalization and durable remission remain unverified; seizure-frequency signals do not replace them. - Required materials and conditions: Separate evidence for durable remission, medication withdrawal, development/quality of life and severe events - Materials to obtain first: Direct measurements, durations and denominators for separate clinical outcomes - Further research: Material needed: Direct measurements, durations and denominators for separate clinical outcomes This records needed materials; no new research was executed. - Conditions for verification: 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. - Why this condition is needed: 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 exceptions: 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. - Remaining 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. - Referenced methods: 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. - Related sources: S01 ### N27 · What was reported about research funding? Verification status: Unverified Reading scope: Existing Korean and English stored summaries and the S01 citation read; external articles, registration, protocols, analysis plans and support disclosures unread - Current findings: Funding in the stored evidence summary is recorded as unconfirmed. - Why unverified: 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. - Reason for missing information: Unconfirmed funding is not converted into no funding or independent funding. - Required materials and conditions: Funding sources, support amounts and roles - Materials to obtain first: Funding sources, sponsor roles and support specifications - Further research: Material needed: Funding sources, sponsor roles and support specifications This records needed materials; no new research was executed. - Conditions for verification: 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. - Why this condition is needed: 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 exceptions: 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. - Remaining 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. - Referenced methods: 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. - Related sources: S01 ### N28 · Are product provision, employee authorship and COI distinguished? Verification status: Unverified Reading scope: Existing Korean and English stored summaries and the S01 citation read; external articles, registration, protocols, analysis plans and support disclosures unread - Current findings: The current summary provides no record confirming specific product support, employee authorship or COI. - Why unverified: 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. - Reason for missing information: The historical generic English wording assessed separately is not inherited as current reading of material or confirmation of independence. - Required materials and conditions: Separate original records of product/free support, employment, patents and COI - Materials to obtain first: Original disclosures of product provision, employment, patents and COI - Further research: Material needed: Original disclosures of product provision, employment, patents and COI This records needed materials; no new research was executed. - Conditions for verification: 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. - Why this condition is needed: 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 exceptions: 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. - Remaining 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. - Referenced methods: 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. - Related sources: S01 ### N29 · How were harms collected during the same pediatric exposure? Verification status: Unverified Reading scope: Existing Korean and English stored summaries and the S01 citation read; external articles, registration, protocols, analysis plans and support disclosures unread - Current findings: The original Caution label and wording that small trials cannot exclude rare adverse events and long-term safety concerns are retained. - Why unverified: 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. - Reason for missing information: Systematic event collection, group-/period-specific harms, discontinuation and event denominators remain unverified; seizure improvement does not establish safety. - Required materials and conditions: Adverse-event definitions, collection, discontinuation, people/events and period-specific denominators - Materials to obtain first: Period-specific adverse events, discontinuation and collection methods - Further research: Material needed: Period-specific adverse events, discontinuation and collection methods This records needed materials; no new research was executed. - Conditions for verification: 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. - Why this condition is needed: 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 exceptions: 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. - Remaining 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. - Referenced methods: 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. - Related sources: S01 ### N30 · What are the timing, concomitant-drug and attribution limits for harms? Verification status: Unverified Reading scope: Existing Korean and English stored summaries and the S01 citation read; external articles, registration, protocols, analysis plans and support disclosures unread - Current findings: The original cautionary wording concerning children, antiseizure/concomitant drugs and differences in products/extraction methods is retained. - Why unverified: 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. - Reason for missing information: Specific interactions, seizure worsening, recovery after discontinuation, re-exposure and causality remain unverified; no new harm judgment is made. - Required materials and conditions: Period-specific occurrence, discontinuation/recovery, background drugs, baseline seizures and alternative explanations - Materials to obtain first: Original concomitant-drug, timeline, discontinuation/recovery and alternative-explanation records - Further research: Material needed: Original concomitant-drug, timeline, discontinuation/recovery and alternative-explanation records This records needed materials; no new research was executed. - Conditions for verification: 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. - Why this condition is needed: 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 exceptions: 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. - Remaining 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. - Referenced methods: 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. - Related sources: S01 ### N31 · What is known about long-term/rare harms and other vulnerable groups? Verification status: Unverified Reading scope: Existing Korean and English stored summaries and the S01 citation read; external articles, registration, protocols, analysis plans and support disclosures unread - Current findings: The original cautionary wording concerning pregnancy, breastfeeding, children, liver/kidney conditions, surgery and medication is retained. - Why unverified: 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. - Reason for missing information: Small 4-week records are not extended to absence of long-term/rare harms or safety in every vulnerable population. - Required materials and conditions: Direct safety material for long-term exposure, rare events and special populations - Materials to obtain first: Long-term safety material and population-specific exposure/event records - Further research: Material needed: Long-term safety material and population-specific exposure/event records This records needed materials; no new research was executed. - Conditions for verification: 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. - Why this condition is needed: 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 exceptions: 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. - Remaining 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. - Referenced methods: 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. - Related sources: S01 ### N32 · What do the original grade, axes and historical independent cross-check mean? Verification status: Partly verified Reading scope: Existing Korean and English stored summaries and the S01 citation read; external articles, registration, protocols, analysis plans and support disclosures unread - Current findings: C54, the original axes, historical independent Codex cross-check wording, and empty subclaim/additional-rationale records are retained in the original copy. - Why unverified: 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. - Reason for missing information: These are not used as current fulfillment of conditions, completed clinical review or certification of independent trials. - Required materials and conditions: Retain the original C54, axes, inactive/empty records and verdict history - Materials to obtain first: Clear histories of the original verdict and change events - Further research: Material needed: Clear histories of the original verdict and change events This records needed materials; no new research was executed. - Conditions for verification: 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. - Why this condition is needed: 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 exceptions: 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. - Remaining 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. - Referenced methods: 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. - Related sources: S01 ### N33 · What do current English wording, corrections and dates mean? Verification status: Partly verified Reading scope: Existing Korean and English stored summaries and the S01 citation read; external articles, registration, protocols, analysis plans and support disclosures unread - Current findings: 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. - Why unverified: 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. - Reason for missing information: Generic English wording and correction details are not promoted to new clinical confirmation; current retractions, registration and new literature were not queried. - Required materials and conditions: Distinguish Korean/English text, the original evidence date, correction events and current preparation date - Materials to obtain first: Before/after correction material, subsequent original material and user comments - Further research: Material needed: Before/after correction material, subsequent original material and user comments This records needed materials; no new research was executed. - Conditions for verification: 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. - Why this condition is needed: 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 exceptions: 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. - Remaining 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. - Referenced methods: 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. - Related sources: S01 ## Evidence and sources ### S01 Akhondian et al. 2007 · Crossover report of aqueous seed extract and intractable pediatric seizures [PubMed](https://pubmed.ncbi.nlm.nih.gov/18049435/) Materials actually read: Summary read; external material unread Findings recorded in the summary: Baseline 5.78±7.20, extract 4.21±5.77, placebo 6.14±6.75; overall Friedman P<.001; 65% versus 20% improvement Record 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. Independent replication: 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. | Material | Public availability | Access status | Actually read | Notes | |---|---|---|---|---| | Stored existing review summary | Preserved copy of the complete existing review summary | Stored summary | Summary read | 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. | | External article | Original bibliographic link or needed material; external public availability/access status unverified | Unread; access not attempted | Not read | 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. | | Registration material | Original bibliographic link or needed material; external public availability/access status unverified | Unread; access not attempted | Not read | 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. | | Protocol | Original bibliographic link or needed material; external public availability/access status unverified | Unread; access not attempted | Not read | 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. | | Statistical analysis plan | Original bibliographic link or needed material; external public availability/access status unverified | Unread; access not attempted | Not read | 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. | | Funding, product-support and COI material | Original bibliographic link or needed material; external public availability/access status unverified | Unread; access not attempted | Not read | 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. | ## Review criteria and methods These are Chamgap's own application conditions, informed by the relevant sections of official methodological guidance. They do not constitute official assessment-tool certification or a new efficacy score. - M03 [Cochrane Handbook 6.5 (2024), chapter updated 2023-08](https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-03) · §3.1, §3.2.1–3.2.3, MECIR C5/C7/C13 · Clearly record the question, eligibility conditions and reasons for changes, and distinguish variations in interventions. · Existing methodological links were reused for production. External originals were not reread and methodological content was not reassessed. - M04 [Cochrane Handbook 6.5.1 (2025), chapter updated 2025-03](https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-04) · §4.5, §4.6.1–4.6.3, MECIR C42 · Distinguish studies from reports and link them; do not omit a study solely because results are unreported. · Existing methodological links were reused for production. External originals were not reread and methodological content was not reassessed. - M08 [Cochrane Handbook 6.5 (2024), chapter updated 2019-10](https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-08) · §8.1–8.2.3, Table 8.2.a · Define the outcome and effect of interest, then examine randomization, deviations, missing data, measurement and selective reporting. · Existing methodological links were reused for production. External originals were not reread and methodological content was not reassessed. - M15 [Cochrane Handbook 6.5 (2024), chapter updated 2023-08](https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-15) · §15.2.4, §15.3.1–15.3.3 · Distinguish effect estimates, intervals, importance and applicability. Sample size alone does not determine precision. · Existing methodological links were reused for production. External originals were not reread and methodological content was not reassessed. - M19 [Cochrane Handbook 6.5 (2024), chapter updated 2019-10](https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-19) · §19.1.2, §19.2.1–19.2.4 · Harm questions may require different designs, populations and follow-up from efficacy questions. Case reports do not establish incidence rates. · Existing methodological links were reused for production. External originals were not reread and methodological content was not reassessed. ## What the statuses mean - Partly verified: Partial information from the stored summary is linked; detailed originals and content review remain incomplete. - Unverified: Required details cannot be established within the preserved scope. This does not establish absence of effects or studies, or safety. - Review incomplete: Review of existing content remains incomplete. - Met: This state is used only within the relevant conditions after material verification and content review. It was not automatically assigned in this work. - Not reported: Unreported within material actually read. Unread external material is not relabeled as unreported. - Inaccessible: This means actual access failure. External access was not attempted in this work, so this state was not assigned. - Not applicable: Used only with an application exception and reason based on the question scope. - Conflicting data: This requires actual comparison of materials; no new conflict judgment was made in this work. - Insufficient evidence for the conditions: This indicates gaps in additional material for the selected conditions. Unread material as a whole is not converted into an efficacy grade. ## Change history 2026-10-24 · Public page/materials 1.0. The public view and materials were prepared from the existing 33 items. No new clinical search, verification-state change or scoring was performed.