Oral aqueous Nigella sativa seed extract as adjunctive therapy × Reduced seizure frequency in pediatric refractory epilepsy

Required evidence, verification status and materials actually read
Item	AVerification status	BReading scope	CReview item	DCurrent findings	EWhy unverified	FRequired materials and conditions	GFurther research
1	Partly verified	Full text not readStored summary read	N01 · Evidence conditionWhat is the selected claim?Required	The original claim is reduced seizure frequency in pediatric refractory epilepsy. Only adjunctive oral aqueous seed extract in children continuing antiseizure medication is linked. S01	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.	The exact question on aqueous seed extract, pediatric refractory epilepsy, seizure frequency, continued antiseizure medication and added placebo	Material needed: Original material specifying formulation, population, comparison and duration for this question This records needed materials; no new research was executed.
2	Partly verified	Full text not readStored summary read	N02 · Evidence conditionWhich materials were actually read here?Required	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. S01	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.	Separate reading levels for the stored JSON summary and external articles, registration and plans	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.
3	Partly verified	Full text not readStored summary read	N03 · Evidence conditionWhat is the identity of the report?Required	A stored report by Akhondian J et al. in Med Sci Monit 2007, PMID 18049435, concerns pediatric intractable seizures. S01	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.	Link authors, year, title and PMID to the direct report	Material needed: Full article bibliography and lists of related registrations and reports This records needed materials; no new research was executed.
4	Partly verified	Full text not readStored summary read	N04 · Evidence conditionAre crossover periods kept distinct from independent studies or people?Required	The stored report describes a double-blind placebo crossover. Extract and placebo periods are not pooled as separate independent trials or separate participants. S01	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.	Relationships among the single trial, its sequences/periods, participants and reports	Material needed: Participant flow, sequence/period tables and related report lists This records needed materials; no new research was executed.
5	Partly verified	Full text not readStored summary read	N05 · Evidence conditionWhich children does the record concern?Required	The retained population is children with refractory epilepsy continuing antiseizure medication. S01	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.	Refractory diagnosis, age, seizure type, baseline severity and inclusion/exclusion criteria	Material needed: Eligibility tables, baseline characteristics and seizure-type-specific material This records needed materials; no new research was executed.
6	Partly verified	Full text not readStored summary read	N06 · Evidence conditionWhich extract was used?Required	The preparation is a Soxhlet-produced aqueous extract of Nigella sativa L. seeds, not purified thymoquinone. S01	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.	Identity of the seed, Soxhlet aqueous extraction, composition/batch and formulation	Material needed: Extraction, quality, constituent-amount and trial-preparation specifications This records needed materials; no new research was executed.
7	Partly verified	Full text not readStored summary read	N07 · Evidence conditionWhat record specifies the dose and frequency?Required	The retained oral dose is 40 mg/kg every 8 hours. A daily total is not newly calculated. S01	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.	Weight-based amount per 1 administration, interval, actual dosing and adherence	Material needed: Dosing schedules, adherence and adjustment records This records needed materials; no new research was executed.
8	Partly verified	Full text not readStored summary read	N08 · Evidence conditionIs this an adjunctive effect above background antiseizure medication?Required	The original text describes extract or placebo added while existing antiseizure medication was maintained. S01	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.	Background drugs, maintenance, changes and attribution of concomitant treatment by group/period	Material needed: Background drug lists, changes and rescue-treatment tables This records needed materials; no new research was executed.
9	Partly verified	Full text not readStored summary read	N09 · Evidence conditionHow was placebo actually compared?Required	The retained comparison is a crossover with placebo added to background antiseizure medication. S01	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.	Placebo composition, appearance, administration and adjunctive-treatment conditions	Material needed: Placebo specifications, preparation images/descriptions and administration records This records needed materials; no new research was executed.
10	Partly verified	Full text not readStored summary read	N10 · Evidence conditionWhat was the allocation process in the crossover design?Required	The retained design is described as a double-blind placebo crossover. S01	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.	Sequence allocation, concealment, randomization methods and baseline balance	Material needed: Original methods, sequence-allocation tables and baseline tables This records needed materials; no new research was executed.
11	Partly verified	Full text not readStored summary read	N11 · Evidence conditionWas masking maintained for parents and assessors?Required	The original design wording of double blinding is retained. S01	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.	Masking of parents, participants, administrators and assessors, and unmasking	Material needed: Records of masking targets, procedures and unmasking This records needed materials; no new research was executed.
12	Partly verified	Full text not readStored summary read	N12 · Evidence conditionHow was observation time divided?Required	The record retains 4 weeks per intervention and a 2-week washout. These are not converted into long-term continuous exposure. S01	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.	The 4-week intervention periods, 2-week washout and period-specific measurement schedules	Material needed: Schedules, period-specific diaries and washout records This records needed materials; no new research was executed.
13	Unverified	Full text not readStored summary read	N13 · Evidence conditionWere carryover, period and sequence effects addressed?Required	The original text identifies adequate reporting of sequence, period and carryover as a central gap. S01	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.	Prospective assumptions and analyses for carryover, period and sequence	Material needed: Crossover analysis methods, period/sequence results and sensitivity analyses This records needed materials; no new research was executed.
14	Partly verified	Full text not readStored summary read	N14 · Evidence conditionHow were seizures measured?Required	The principal endpoint is parent-recorded seizures per day. S01	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.	Parent recording, daily units, seizure identification and diary completeness	Material needed: Diary forms, seizure-identification rules and measurement methods This records needed materials; no new research was executed.
15	Unverified	Full text not readStored summary read	N15 · Evidence conditionWhat was the prospective endpoint hierarchy for seizure counts?Required	The principal endpoint in the original text is seizures per day. S01	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.	Primary/secondary endpoints, time points and analyses in registration, protocol and SAP	Material needed: Registration histories, protocol and SAP This records needed materials; no new research was executed.
16	Partly verified	Full text not readStored summary read	N16 · Evidence conditionWhat are the enrollment, completion and period-specific analysis denominators?Required	The original denominators of 23 enrolled participants and 20 completers are retained separately. S01	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.	The 23 enrolled participants, 20 completers and analysis denominators by period/endpoint	Material needed: Participant flow and period-/endpoint-specific analysis tables This records needed materials; no new research was executed.
17	Unverified	Full text not readStored summary read	N17 · Evidence conditionHow were noncompletion and missing records handled?Required	The original text records 23 enrolled participants and 20 completers. S01	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.	Reasons for discontinuation, sequence/period, missing-data handling and analysis sets	Material needed: Discontinuation reasons, missing-data/analysis-set records and sensitivity analyses This records needed materials; no new research was executed.
18	Partly verified	Full text not readStored summary read	N18 · Evidence conditionWhich results do the retained mean seizure counts represent?Required	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. S01	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.	Baseline, extract and placebo daily seizure counts, corresponding dispersion and denominators	Material needed: Period-specific result tables, dispersion definitions and paired analyses This records needed materials; no new research was executed.
19	Partly verified	Full text not readStored summary read	N19 · Evidence conditionWhat question does the overall Friedman test answer?Required	Friedman P<.001 is retained, while the original text distinguishes it from a fully reported period-specific between-treatment effect. S01	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.	Distinguish the overall test from the selected between-treatment-period contrast	Material needed: Statistical methods, prospective contrasts and result tables This records needed materials; no new research was executed.
20	Partly verified	Full text not readStored summary read	N20 · Evidence conditionWhat does 65% versus 20% improvement mean?Required	The original wording of 65% versus 20% improvement is retained. S01	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.	Improvement/responder criteria, participant counts, periods/sequences and denominators	Material needed: Responder definitions, period-specific participant counts/denominators and intervals This records needed materials; no new research was executed.
21	Unverified	Full text not readStored summary read	N21 · Evidence conditionWhat are the exact effect magnitude and interval?Required	The original text records that exact CIs and period-specific between-treatment effects were unverified. S01	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.	Effect size, CI and important difference for the prospective treatment contrast	Material needed: Treatment contrasts, dispersion, CIs and evidence for an important difference This records needed materials; no new research was executed.
22	Unverified	Full text not readStored summary read	N22 · Evidence conditionHow were tests across periods, seizures and responders planned?Required	The summary retains both seizure counts and improvement proportions. S01	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.	Prospective planning for seizure-count/responder, time-point and subgroup tests	Material needed: Registration, SAP and complete endpoint tables This records needed materials; no new research was executed.
23	Unverified	Full text not readStored summary read	N23 · Evidence conditionCould adherence and rescue treatment affect the results?Required	The narrative of adjunctive therapy and maintained background medication is retained. S01	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.	Extract/placebo adherence, missed doses, medication changes and emergency treatment	Material needed: Administration/rescue-treatment records and prospective handling rules This records needed materials; no new research was executed.
24	Unverified	Full text not readStored summary read	N24 · Evidence conditionWhat is known about independent repetition or other formulations?Required	The retained evidence list contains one report. The original text did not merge adult, animal or purified-thymoquinone studies. S01	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.	Unique trial relationships for the same aqueous extract, pediatric population, comparison and duration	Material needed: Direct studies of the same formulation/population and related report lists This records needed materials; no new research was executed.
25	Unverified	Full text not readStored summary read	N25 · Evidence conditionDoes the short signal answer long-term seizure-control questions?Required	The record retains a short signal from 4 weeks per intervention. S01	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.	Long-term persistence, effects after discontinuation, follow-up and dose questions	Material needed: Long-term follow-up, post-discontinuation records and direct dose material This records needed materials; no new research was executed.
26	Unverified	Full text not readStored summary read	N26 · Evidence conditionCan the finding extend to outcomes beyond seizure frequency?Required	The original text records that stopping antiseizure medication or durable seizure remission was not tested. S01	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.	Separate evidence for durable remission, medication withdrawal, development/quality of life and severe events	Material needed: Direct measurements, durations and denominators for separate clinical outcomes This records needed materials; no new research was executed.
27	Unverified	Full text not readStored summary read	N27 · Evidence conditionWhat was reported about research funding?Required	Funding in the stored evidence summary is recorded as unconfirmed. S01	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.	Funding sources, support amounts and roles	Material needed: Funding sources, sponsor roles and support specifications This records needed materials; no new research was executed.
28	Unverified	Full text not readStored summary read	N28 · Evidence conditionAre product provision, employee authorship and COI distinguished?Required	The current summary provides no record confirming specific product support, employee authorship or COI. S01	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.	Separate original records of product/free support, employment, patents and COI	Material needed: Original disclosures of product provision, employment, patents and COI This records needed materials; no new research was executed.
29	Unverified	Full text not readStored summary read	N29 · Evidence conditionHow were harms collected during the same pediatric exposure?Supplementary	The original Caution label and wording that small trials cannot exclude rare adverse events and long-term safety concerns are retained. S01	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.	Adverse-event definitions, collection, discontinuation, people/events and period-specific denominators	Material needed: Period-specific adverse events, discontinuation and collection methods This records needed materials; no new research was executed.
30	Unverified	Full text not readStored summary read	N30 · Evidence conditionWhat are the timing, concomitant-drug and attribution limits for harms?Supplementary	The original cautionary wording concerning children, antiseizure/concomitant drugs and differences in products/extraction methods is retained. S01	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.	Period-specific occurrence, discontinuation/recovery, background drugs, baseline seizures and alternative explanations	Material needed: Original concomitant-drug, timeline, discontinuation/recovery and alternative-explanation records This records needed materials; no new research was executed.
31	Unverified	Full text not readStored summary read	N31 · Evidence conditionWhat is known about long-term/rare harms and other vulnerable groups?Supplementary	The original cautionary wording concerning pregnancy, breastfeeding, children, liver/kidney conditions, surgery and medication is retained. S01	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.	Direct safety material for long-term exposure, rare events and special populations	Material needed: Long-term safety material and population-specific exposure/event records This records needed materials; no new research was executed.
32	Partly verified	Full text not readStored summary read	N32 · Evidence conditionWhat do the original grade, axes and historical independent cross-check mean?Required	C54, the original axes, historical independent Codex cross-check wording, and empty subclaim/additional-rationale records are retained in the original copy. S01	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.	Retain the original C54, axes, inactive/empty records and verdict history	Material needed: Clear histories of the original verdict and change events This records needed materials; no new research was executed.
33	Partly verified	Full text not readStored summary read	N33 · Evidence conditionWhat do current English wording, corrections and dates mean?Required	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. S01	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.	Distinguish Korean/English text, the original evidence date, correction events and current preparation date	Material needed: Before/after correction material, subsequent original material and user comments This records needed materials; no new research was executed.

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33 itemsWhat the statuses mean

Assessment scope

Stored-material review date: Not recorded
Original evidence cut-off: 2026-09-08
Scope actually checked: Existing review summaries and stored records of methodological application. Full papers, supplements, registrations, plans and original data were not read.
What the dates mean: 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.
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.

Evidence and sources

The links below lead to the sources. A link alone does not mean the original source was read or its latest publication status verified.

S01 · Akhondian et al. 2007 · Crossover report of aqueous seed extract and intractable pediatric seizures

PubMed

Material type: Retained design described as a double-blind placebo crossover; detailed sequence allocation and analysis unverified
Materials actually read: Summary read; external material unread
Findings recorded in the stored 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.
Study overlap and 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.

Public availability, access and reading status by material
Material	Public availability	Access status	Actually read	Notes
Stored existing review summary	Preserved copy of the complete existing review summary	Stored summary	Summary read	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.

Report counts versus independent study counts

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.

Review criteria

Version 1.0 · Criteria record date 2026-10-06. These are Chamgap's own application conditions, informed by the referenced methods. They do not constitute official assessment-tool certification or a new efficacy score.

N01 · What is the selected claim?

Required materials and conditions: The exact question on aqueous seed extract, pediatric refractory epilepsy, seizure frequency, continued antiseizure medication and added placebo
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.
Requirement and applicability: Required
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.
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.
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.

N02 · Which materials were actually read here?

Required materials and conditions: Separate reading levels for the stored JSON summary and external articles, registration and plans
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.
Requirement and applicability: Required
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.
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.
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.

N03 · What is the identity of the report?

Required materials and conditions: Link authors, year, title and PMID to the direct report
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.
Requirement and applicability: Required
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.
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.
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.

N04 · Are crossover periods kept distinct from independent studies or people?

Required materials and conditions: Relationships among the single trial, its sequences/periods, participants and reports
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.
Requirement and applicability: Required
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.
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.
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.

N05 · Which children does the record concern?

Required materials and conditions: Refractory diagnosis, age, seizure type, baseline severity and inclusion/exclusion criteria
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.
Requirement and applicability: Required
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.
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.
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.

N06 · Which extract was used?

Required materials and conditions: Identity of the seed, Soxhlet aqueous extraction, composition/batch and formulation
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.
Requirement and applicability: Required
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.
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.
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.

N07 · What record specifies the dose and frequency?

Required materials and conditions: Weight-based amount per 1 administration, interval, actual dosing and adherence
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.
Requirement and applicability: Required
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.
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.
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.

N08 · Is this an adjunctive effect above background antiseizure medication?

Required materials and conditions: Background drugs, maintenance, changes and attribution of concomitant treatment by group/period
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.
Requirement and applicability: Required
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.
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.
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.

N09 · How was placebo actually compared?

Required materials and conditions: Placebo composition, appearance, administration and adjunctive-treatment conditions
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.
Requirement and applicability: Required
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.
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.
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.

N10 · What was the allocation process in the crossover design?

Required materials and conditions: Sequence allocation, concealment, randomization methods and baseline balance
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.
Requirement and applicability: Required
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.
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.
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.

N11 · Was masking maintained for parents and assessors?

Required materials and conditions: Masking of parents, participants, administrators and assessors, and unmasking
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.
Requirement and applicability: Required
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.
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.
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.

N12 · How was observation time divided?

Required materials and conditions: The 4-week intervention periods, 2-week washout and period-specific measurement schedules
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.
Requirement and applicability: Required
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.
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.
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.

N13 · Were carryover, period and sequence effects addressed?

Required materials and conditions: Prospective assumptions and analyses for carryover, period and sequence
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.
Requirement and applicability: Required
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.
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.
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.

N14 · How were seizures measured?

Required materials and conditions: Parent recording, daily units, seizure identification and diary completeness
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.
Requirement and applicability: Required
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.
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.
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.

N15 · What was the prospective endpoint hierarchy for seizure counts?

Required materials and conditions: Primary/secondary endpoints, time points and analyses in registration, protocol and SAP
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.
Requirement and applicability: Required
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.
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.
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.

N16 · What are the enrollment, completion and period-specific analysis denominators?

Required materials and conditions: The 23 enrolled participants, 20 completers and analysis denominators by period/endpoint
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.
Requirement and applicability: Required
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.
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.
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.

N17 · How were noncompletion and missing records handled?

Required materials and conditions: Reasons for discontinuation, sequence/period, missing-data handling and analysis sets
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.
Requirement and applicability: Required
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.
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.
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.

N18 · Which results do the retained mean seizure counts represent?

Required materials and conditions: Baseline, extract and placebo daily seizure counts, corresponding dispersion and denominators
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.
Requirement and applicability: Required
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.
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.
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.

N19 · What question does the overall Friedman test answer?

Required materials and conditions: Distinguish the overall test from the selected between-treatment-period contrast
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.
Requirement and applicability: Required
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.
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.
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.

N20 · What does 65% versus 20% improvement mean?

Required materials and conditions: Improvement/responder criteria, participant counts, periods/sequences and denominators
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.
Requirement and applicability: Required
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.
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.
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.

N21 · What are the exact effect magnitude and interval?

Required materials and conditions: Effect size, CI and important difference for the prospective treatment contrast
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.
Requirement and applicability: Required
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.
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.
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.

N22 · How were tests across periods, seizures and responders planned?

Required materials and conditions: Prospective planning for seizure-count/responder, time-point and subgroup tests
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.
Requirement and applicability: Required
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.
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.
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.

N23 · Could adherence and rescue treatment affect the results?

Required materials and conditions: Extract/placebo adherence, missed doses, medication changes and emergency treatment
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.
Requirement and applicability: Required
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.
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.
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.

N24 · What is known about independent repetition or other formulations?

Required materials and conditions: Unique trial relationships for the same aqueous extract, pediatric population, comparison and duration
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.
Requirement and applicability: Required
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.
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.
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.

N25 · Does the short signal answer long-term seizure-control questions?

Required materials and conditions: Long-term persistence, effects after discontinuation, follow-up and dose questions
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.
Requirement and applicability: Required
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.
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.
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.

N26 · Can the finding extend to outcomes beyond seizure frequency?

Required materials and conditions: Separate evidence for durable remission, medication withdrawal, development/quality of life and severe events
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.
Requirement and applicability: Required
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.
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.
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.

N27 · What was reported about research funding?

Required materials and conditions: Funding sources, support amounts and roles
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.
Requirement and applicability: Required
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.
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.
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.

N28 · Are product provision, employee authorship and COI distinguished?

Required materials and conditions: Separate original records of product/free support, employment, patents and COI
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.
Requirement and applicability: Required
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.
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.
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.

N29 · How were harms collected during the same pediatric exposure?

Required materials and conditions: Adverse-event definitions, collection, discontinuation, people/events and period-specific denominators
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.
Requirement and applicability: Supplementary
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.
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.
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.

N30 · What are the timing, concomitant-drug and attribution limits for harms?

Required materials and conditions: Period-specific occurrence, discontinuation/recovery, background drugs, baseline seizures and alternative explanations
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.
Requirement and applicability: Supplementary
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.
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.
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.

N31 · What is known about long-term/rare harms and other vulnerable groups?

Required materials and conditions: Direct safety material for long-term exposure, rare events and special populations
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.
Requirement and applicability: Supplementary
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.
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.
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.

N32 · What do the original grade, axes and historical independent cross-check mean?

Required materials and conditions: Retain the original C54, axes, inactive/empty records and verdict history
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.
Requirement and applicability: Required
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.
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.
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.

N33 · What do current English wording, corrections and dates mean?

Required materials and conditions: Distinguish Korean/English text, the original evidence date, correction events and current preparation date
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.
Requirement and applicability: Required
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.
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.
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.

Referenced methods and the sections actually reviewed

M03 · Cochrane Handbook 6.5 (2024), chapter updated 2023-08

Official methodology · §3.1, §3.2.1–3.2.3, MECIR C5/C7/C13

Referenced principle: Clearly record the question, eligibility conditions and reasons for changes, and distinguish variations in interventions.
Extent of review: Existing methodological links were reused for production. External originals were not reread and methodological content was not reassessed.

M04 · Cochrane Handbook 6.5.1 (2025), chapter updated 2025-03

Official methodology · §4.5, §4.6.1–4.6.3, MECIR C42

Referenced principle: Distinguish studies from reports and link them; do not omit a study solely because results are unreported.
Extent of review: Existing methodological links were reused for production. External originals were not reread and methodological content was not reassessed.

M08 · Cochrane Handbook 6.5 (2024), chapter updated 2019-10

Official methodology · §8.1–8.2.3, Table 8.2.a

Referenced principle: Define the outcome and effect of interest, then examine randomization, deviations, missing data, measurement and selective reporting.
Extent of review: Existing methodological links were reused for production. External originals were not reread and methodological content was not reassessed.

M15 · Cochrane Handbook 6.5 (2024), chapter updated 2023-08

Official methodology · §15.2.4, §15.3.1–15.3.3

Referenced principle: Distinguish effect estimates, intervals, importance and applicability. Sample size alone does not determine precision.
Extent of review: Existing methodological links were reused for production. External originals were not reread and methodological content was not reassessed.

M19 · Cochrane Handbook 6.5 (2024), chapter updated 2019-10

Official methodology · §19.1.2, §19.2.1–19.2.4

Referenced principle: Harm questions may require different designs, populations and follow-up from efficacy questions. Case reports do not establish incidence rates.
Extent of review: Existing methodological links were reused for production. External originals were not reread and methodological content was not reassessed.

What the statuses mean

Partly verified: Partial information from the stored summary is linked; detailed originals and content review remain incomplete.
Unverified: Required details cannot be established within the preserved scope. This does not establish absence of effects or studies, or safety.
Review incomplete: Review of existing content remains incomplete.
Met: This state is used only within the relevant conditions after material verification and content review. It was not automatically assigned in this work.
Not reported: Unreported within material actually read. Unread external material is not relabeled as unreported.
Inaccessible: This means actual access failure. External access was not attempted in this work, so this state was not assigned.
Not applicable: Used only with an application exception and reason based on the question scope.
Conflicting data: This requires actual comparison of materials; no new conflict judgment was made in this work.
Insufficient evidence for the conditions: This indicates gaps in additional material for the selected conditions. Unread material as a whole is not converted into an efficacy grade.

Change history

2026-10-24 · Public page/material version 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.

The stored-material review date (Not recorded) and original evidence cut-off (2026-09-08) were retained unchanged.

Researcher downloads

These materials provide the same evidence, scope and verification status as this page.

View all item details

N01 · What is the selected claim?

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.
Verification status: Partly verified
Materials actually read: Existing Korean and English stored summaries and the S01 citation read; external articles, registration, protocols, analysis plans and support disclosures unread
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.
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.
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.
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?

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.
Verification status: Partly verified
Materials actually read: Existing Korean and English stored summaries and the S01 citation read; external articles, registration, protocols, analysis plans and support disclosures unread
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.
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.
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.
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?

Current findings: A stored report by Akhondian J et al. in Med Sci Monit 2007, PMID 18049435, concerns pediatric intractable seizures.
Verification status: Partly verified
Materials actually read: Existing Korean and English stored summaries and the S01 citation read; external articles, registration, protocols, analysis plans and support disclosures unread
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.
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.
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.
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?

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.
Verification status: Partly verified
Materials actually read: Existing Korean and English stored summaries and the S01 citation read; external articles, registration, protocols, analysis plans and support disclosures unread
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.
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.
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.
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?

Current findings: The retained population is children with refractory epilepsy continuing antiseizure medication.
Verification status: Partly verified
Materials actually read: Existing Korean and English stored summaries and the S01 citation read; external articles, registration, protocols, analysis plans and support disclosures unread
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.
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.
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.
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?

Current findings: The preparation is a Soxhlet-produced aqueous extract of Nigella sativa L. seeds, not purified thymoquinone.
Verification status: Partly verified
Materials actually read: Existing Korean and English stored summaries and the S01 citation read; external articles, registration, protocols, analysis plans and support disclosures unread
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.
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.
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.
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?

Current findings: The retained oral dose is 40 mg/kg every 8 hours. A daily total is not newly calculated.
Verification status: Partly verified
Materials actually read: Existing Korean and English stored summaries and the S01 citation read; external articles, registration, protocols, analysis plans and support disclosures unread
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.
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.
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.
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?

Current findings: The original text describes extract or placebo added while existing antiseizure medication was maintained.
Verification status: Partly verified
Materials actually read: Existing Korean and English stored summaries and the S01 citation read; external articles, registration, protocols, analysis plans and support disclosures unread
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.
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.
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.
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?

Current findings: The retained comparison is a crossover with placebo added to background antiseizure medication.
Verification status: Partly verified
Materials actually read: Existing Korean and English stored summaries and the S01 citation read; external articles, registration, protocols, analysis plans and support disclosures unread
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.
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.
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.
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?

Current findings: The retained design is described as a double-blind placebo crossover.
Verification status: Partly verified
Materials actually read: Existing Korean and English stored summaries and the S01 citation read; external articles, registration, protocols, analysis plans and support disclosures unread
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.
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.
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.
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?

Current findings: The original design wording of double blinding is retained.
Verification status: Partly verified
Materials actually read: Existing Korean and English stored summaries and the S01 citation read; external articles, registration, protocols, analysis plans and support disclosures unread
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.
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.
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.
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?

Current findings: The record retains 4 weeks per intervention and a 2-week washout. These are not converted into long-term continuous exposure.
Verification status: Partly verified
Materials actually read: Existing Korean and English stored summaries and the S01 citation read; external articles, registration, protocols, analysis plans and support disclosures unread
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.
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.
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.
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?

Current findings: The original text identifies adequate reporting of sequence, period and carryover as a central gap.
Verification status: Unverified
Materials actually read: Existing Korean and English stored summaries and the S01 citation read; external articles, registration, protocols, analysis plans and support disclosures unread
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.
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.
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.
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?

Current findings: The principal endpoint is parent-recorded seizures per day.
Verification status: Partly verified
Materials actually read: Existing Korean and English stored summaries and the S01 citation read; external articles, registration, protocols, analysis plans and support disclosures unread
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.
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.
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.
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?

Current findings: The principal endpoint in the original text is seizures per day.
Verification status: Unverified
Materials actually read: Existing Korean and English stored summaries and the S01 citation read; external articles, registration, protocols, analysis plans and support disclosures unread
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.
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.
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.
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?

Current findings: The original denominators of 23 enrolled participants and 20 completers are retained separately.
Verification status: Partly verified
Materials actually read: Existing Korean and English stored summaries and the S01 citation read; external articles, registration, protocols, analysis plans and support disclosures unread
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.
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.
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.
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?

Current findings: The original text records 23 enrolled participants and 20 completers.
Verification status: Unverified
Materials actually read: Existing Korean and English stored summaries and the S01 citation read; external articles, registration, protocols, analysis plans and support disclosures unread
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.
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.
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.
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?

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.
Verification status: Partly verified
Materials actually read: Existing Korean and English stored summaries and the S01 citation read; external articles, registration, protocols, analysis plans and support disclosures unread
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.
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.
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.
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?

Current findings: Friedman P<.001 is retained, while the original text distinguishes it from a fully reported period-specific between-treatment effect.
Verification status: Partly verified
Materials actually read: Existing Korean and English stored summaries and the S01 citation read; external articles, registration, protocols, analysis plans and support disclosures unread
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.
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.
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.
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?

Current findings: The original wording of 65% versus 20% improvement is retained.
Verification status: Partly verified
Materials actually read: Existing Korean and English stored summaries and the S01 citation read; external articles, registration, protocols, analysis plans and support disclosures unread
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.
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.
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.
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?

Current findings: The original text records that exact CIs and period-specific between-treatment effects were unverified.
Verification status: Unverified
Materials actually read: Existing Korean and English stored summaries and the S01 citation read; external articles, registration, protocols, analysis plans and support disclosures unread
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.
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.
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.
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?

Current findings: The summary retains both seizure counts and improvement proportions.
Verification status: Unverified
Materials actually read: Existing Korean and English stored summaries and the S01 citation read; external articles, registration, protocols, analysis plans and support disclosures unread
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.
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.
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.
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?

Current findings: The narrative of adjunctive therapy and maintained background medication is retained.
Verification status: Unverified
Materials actually read: Existing Korean and English stored summaries and the S01 citation read; external articles, registration, protocols, analysis plans and support disclosures unread
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.
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.
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.
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?

Current findings: The retained evidence list contains one report. The original text did not merge adult, animal or purified-thymoquinone studies.
Verification status: Unverified
Materials actually read: Existing Korean and English stored summaries and the S01 citation read; external articles, registration, protocols, analysis plans and support disclosures unread
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.
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.
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.
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?

Current findings: The record retains a short signal from 4 weeks per intervention.
Verification status: Unverified
Materials actually read: Existing Korean and English stored summaries and the S01 citation read; external articles, registration, protocols, analysis plans and support disclosures unread
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.
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.
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.
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?

Current findings: The original text records that stopping antiseizure medication or durable seizure remission was not tested.
Verification status: Unverified
Materials actually read: Existing Korean and English stored summaries and the S01 citation read; external articles, registration, protocols, analysis plans and support disclosures unread
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.
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.
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.
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?

Current findings: Funding in the stored evidence summary is recorded as unconfirmed.
Verification status: Unverified
Materials actually read: Existing Korean and English stored summaries and the S01 citation read; external articles, registration, protocols, analysis plans and support disclosures unread
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.
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.
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.
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?

Current findings: The current summary provides no record confirming specific product support, employee authorship or COI.
Verification status: Unverified
Materials actually read: Existing Korean and English stored summaries and the S01 citation read; external articles, registration, protocols, analysis plans and support disclosures unread
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.
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.
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.
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?

Current findings: The original Caution label and wording that small trials cannot exclude rare adverse events and long-term safety concerns are retained.
Verification status: Unverified
Materials actually read: Existing Korean and English stored summaries and the S01 citation read; external articles, registration, protocols, analysis plans and support disclosures unread
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.
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.
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.
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?

Current findings: The original cautionary wording concerning children, antiseizure/concomitant drugs and differences in products/extraction methods is retained.
Verification status: Unverified
Materials actually read: Existing Korean and English stored summaries and the S01 citation read; external articles, registration, protocols, analysis plans and support disclosures unread
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.
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.
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.
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?

Current findings: The original cautionary wording concerning pregnancy, breastfeeding, children, liver/kidney conditions, surgery and medication is retained.
Verification status: Unverified
Materials actually read: Existing Korean and English stored summaries and the S01 citation read; external articles, registration, protocols, analysis plans and support disclosures unread
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.
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.
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.
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?

Current findings: C54, the original axes, historical independent Codex cross-check wording, and empty subclaim/additional-rationale records are retained in the original copy.
Verification status: Partly verified
Materials actually read: Existing Korean and English stored summaries and the S01 citation read; external articles, registration, protocols, analysis plans and support disclosures unread
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.
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.
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.
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?

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.
Verification status: Partly verified
Materials actually read: Existing Korean and English stored summaries and the S01 citation read; external articles, registration, protocols, analysis plans and support disclosures unread
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.
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.
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.
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