{ "schema_version": "chamgap-public-criteria-1.0", "title": "Ginger extract 400 mg standardized to 5% active ingredient as add-on therapy × Improvement of 2-hour pain-relief response in acute migraine", "language": "en", "translation_date": "2026-10-25", "criteria_version": "1.0", "criteria_date": "2026-10-06", "condition_origin": "Chamgap's own application conditions", "method_sources": [ { "id": "M03", "version": "Cochrane Handbook 6.5 (2024), chapter updated 2023-08", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-03", "section": "§3.1, §3.2.1–3.2.3, MECIR C5/C7/C13", "official_principle": "Clearly record the question, eligibility conditions and reasons for changes, and distinguish variations in interventions.", "review_level": "Retained method-application records were reused. External originals were not reread and method content was not reassessed." }, { "id": "M04", "version": "Cochrane Handbook 6.5.1 (2025), chapter updated 2025-03", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-04", "section": "§4.5, §4.6.1–4.6.3, MECIR C42", "official_principle": "Distinguish studies from reports and link them; do not omit a study solely because results are unreported.", "review_level": "Retained method-application records were reused. External originals were not reread and method content was not reassessed." }, { "id": "M08", "version": "Cochrane Handbook 6.5 (2024), chapter updated 2019-10", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-08", "section": "§8.1–8.2.3, Table 8.2.a", "official_principle": "Define the outcome and effect of interest, then examine randomization, deviations, missing data, measurement and selective reporting.", "review_level": "Retained method-application records were reused. External originals were not reread and method content was not reassessed." }, { "id": "M15", "version": "Cochrane Handbook 6.5 (2024), chapter updated 2023-08", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-15", "section": "§15.2.4, §15.3.1–15.3.3", "official_principle": "Distinguish effect estimates, intervals, importance and applicability. Sample size alone does not determine precision.", "review_level": "Retained method-application records were reused. External originals were not reread and method content was not reassessed." }, { "id": "M19", "version": "Cochrane Handbook 6.5 (2024), chapter updated 2019-10", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-19", "section": "§19.1.2, §19.2.1–19.2.4", "official_principle": "Harm questions may require different designs, populations and follow-up from efficacy questions. Case reports do not establish incidence rates.", "review_level": "Retained method-application records were reused. External originals were not reread and method content was not reassessed." } ], "status_dictionary": { "Partly verified": "Some retained information is available, while material needed for this criterion remains unverified.", "Unverified": "This criterion could not be established from the retained scope; this does not mean 0 studies, 0 effect or no harm.", "Review incomplete": "Source comparison or searching within the permitted scope was not performed.", "Not reported": "Limited to a specified read source or section that did not report the item.", "Inaccessible": "Used only where access was actually attempted and failed; not assigned to clinical material here.", "Insufficient evidence for the conditions": "Used only after reviewing relevant studies in the defined scope and finding evidence insufficient to answer the condition; not applied universally here.", "Not applicable": "A specific exception based on applicability conditions; not a substitute for unread material.", "Conflicting data": "Incompatible material was compared for the same question, time and analysis; different review estimates alone do not justify this status.", "Met": "Confirms the stated retained information and reading, attribution or interpretation boundary; not certification of clinical efficacy, full-text reading or reassessment." }, "requirements": [ { "item_id": "N01", "question_type": "Evidence condition", "question": "What is this sheet's independent question?", "needed": "Emergency-department episodic migraine; a single oral ginger-extract add-on; common ketoprofen; 2-hour pain relief", "role": "Required", "role_reason": "Distinguish the add-on question from monotherapy, prevention and pain freedom.", "application_exception": "Do not merge the same ginger name or a different comparison into this question.", "criterion": "Connect the original Korean claim to formulation, population, comparison and time, and state exclusions.", "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.", "condition_origin": "These are Chamgap in-house conditions developed with knowledge of the retained record for acute migraine, ginger extract added to common ketoprofen and 2-hour pain relief. They do not establish blinding, clinical-trial preregistration, official-tool certification or new independent clinical validation.", "proposed_research": "Material needed: The current original wording and new comparison specification if the question boundary changes. This records needed materials; no new research was executed." }, { "item_id": "N02", "question_type": "Evidence condition", "question": "How are the original verdict, both languages and correction records retained?", "needed": "Original C50, Caution, all axes, Korean/English text, the correction and the actual verification scope", "role": "Required", "role_reason": "Do not inherit historical verdicts or translation wording as current row statuses or independent clinical certification.", "application_exception": "Do not arbitrarily retranslate or replace generic English fields and specific Korean content in the original correction record.", "criterion": "Retain the typed original and distinguish generic English text and historical cross-check wording from current certification.", "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.", "condition_origin": "These are Chamgap in-house conditions developed with knowledge of the retained record for acute migraine, ginger extract added to common ketoprofen and 2-hour pain relief. They do not establish blinding, clinical-trial preregistration, official-tool certification or new independent clinical validation.", "proposed_research": "Material needed: Historical source material establishing the specific English correspondence and correction scope. This records needed materials; no new research was executed." }, { "item_id": "N03", "question_type": "Evidence condition", "question": "What product do 400 mg and 5% active ingredient describe?", "needed": "Rhizome-extract capsules, composition, trial product/batch and assay method", "role": "Required", "role_reason": "Do not interchange ginger food, powder or essential oil with the trial extract.", "application_exception": "Do not newly calculate gingerol/shogaol mg or batch equivalence from nominal 5%.", "criterion": "Record the nominal formulation/dose alongside unverified actual composition and batch.", "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.", "condition_origin": "These are Chamgap in-house conditions developed with knowledge of the retained record for acute migraine, ginger extract added to common ketoprofen and 2-hour pain relief. They do not establish blinding, clinical-trial preregistration, official-tool certification or new independent clinical validation.", "proposed_research": "Material needed: Trial-product manufacturing, batch, quantitative-assay and composition documentation. This records needed materials; no new research was executed." }, { "item_id": "N04", "question_type": "Evidence condition", "question": "What actually differs between the add-on groups?", "needed": "Common IV ketoprofen 100 mg; oral extract 400 mg versus cellulose placebo", "role": "Required", "role_reason": "Separate the contribution of common treatment from the added-ingredient comparison.", "application_exception": "Do not attribute this to ginger monotherapy, ketoprofen replacement or triptan replacement.", "criterion": "Distinguish common treatment from the add-on difference at the current source location.", "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.", "condition_origin": "These are Chamgap in-house conditions developed with knowledge of the retained record for acute migraine, ginger extract added to common ketoprofen and 2-hour pain relief. They do not establish blinding, clinical-trial preregistration, official-tool certification or new independent clinical validation.", "proposed_research": "Material needed: Administration procedures and concomitant-treatment tables for both groups. This records needed materials; no new research was executed." }, { "item_id": "N05", "question_type": "Evidence condition", "question": "Who was included in the trial?", "needed": "Emergency care for adults with episodic migraine, 1–6 attacks per month; eligibility/exclusions and baseline characteristics", "role": "Required", "role_reason": "Do not extend this to general headache, chronic migraine or self-medication.", "application_exception": "Do not equate the overall 60 with the actual eligible or completing population.", "criterion": "Distinguish the retained population from unverified diagnostic, baseline and eligibility information.", "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.", "condition_origin": "These are Chamgap in-house conditions developed with knowledge of the retained record for acute migraine, ginger extract added to common ketoprofen and 2-hour pain relief. They do not establish blinding, clinical-trial preregistration, official-tool certification or new independent clinical validation.", "proposed_research": "Material needed: Complete eligibility/exclusion criteria and baseline-characteristics table. This records needed materials; no new research was executed." }, { "item_id": "N06", "question_type": "Evidence condition", "question": "Are pain-relief response and pain freedom distinguished?", "needed": "Definition, scale and response threshold for 2-hour pain-relief clinical response", "role": "Required", "role_reason": "Do not turn a pain-relief signal into complete pain freedom.", "application_exception": "Pain intensity, pain freedom and recurrence are different endpoints.", "criterion": "Separate the retained response endpoint from other endpoints and retain uncertainty about its measurement definition.", "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.", "condition_origin": "These are Chamgap in-house conditions developed with knowledge of the retained record for acute migraine, ginger extract added to common ketoprofen and 2-hour pain relief. They do not establish blinding, clinical-trial preregistration, official-tool certification or new independent clinical validation.", "proposed_research": "Material needed: Response-classification criteria, pain scale and result tables. This records needed materials; no new research was executed." }, { "item_id": "N07", "question_type": "Evidence condition", "question": "What are the limits of the single dose and 2-hour observation?", "needed": "A single acute-attack dose of 400 mg; measurements at 1/1.5/2 hours", "role": "Required", "role_reason": "Do not combine observations at different times into one sustained effect.", "application_exception": "Do not extend a single-dose 2-hour result to repeated dosing or prevention.", "criterion": "Attribute administration and each reported time separately.", "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.", "condition_origin": "These are Chamgap in-house conditions developed with knowledge of the retained record for acute migraine, ginger extract added to common ketoprofen and 2-hour pain relief. They do not establish blinding, clinical-trial preregistration, official-tool certification or new independent clinical validation.", "proposed_research": "Material needed: Administration/measurement schedule and subsequent follow-up. This records needed materials; no new research was executed." }, { "item_id": "N08", "question_type": "Evidence condition", "question": "How well is the direct add-on report identified?", "needed": "Martins 2019, PMID29768938, DOI and evidence/bibliography correspondence", "role": "Required", "role_reason": "Do not count summaries, bibliography and Korean/English recitation as independent replications.", "application_exception": "Identifiers alone do not complete registration or original-paper identity checks.", "criterion": "Connect source locations for the same direct-report clues without inferring total unique participants.", "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.", "condition_origin": "These are Chamgap in-house conditions developed with knowledge of the retained record for acute migraine, ginger extract added to common ketoprofen and 2-hour pain relief. They do not establish blinding, clinical-trial preregistration, official-tool certification or new independent clinical validation.", "proposed_research": "Material needed: Original paper, related reports and registration history. This records needed materials; no new research was executed." }, { "item_id": "N09", "question_type": "Evidence condition", "question": "Why is the sumatriptan comparison separate context?", "needed": "Powder versus sumatriptan; 100 people; 5 attacks; headache severity at two hours", "role": "Required", "role_reason": "Do not count within-group improvement in an active comparison as replication of the same extract add-on effect.", "application_exception": "Do not multiply 100 people by 5 attacks to count 500 people; retain formulation and comparison differences.", "criterion": "Separate S2 results and denominator/repeated-measure boundaries from S1.", "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.", "condition_origin": "These are Chamgap in-house conditions developed with knowledge of the retained record for acute migraine, ginger extract added to common ketoprofen and 2-hour pain relief. They do not establish blinding, clinical-trial preregistration, official-tool certification or new independent clinical validation.", "proposed_research": "Material needed: Active-comparator full text and analyses at participant and attack levels. This records needed materials; no new research was executed." }, { "item_id": "N10", "question_type": "Evidence condition", "question": "Which material was actually read for this review?", "needed": "Current retained summary and bibliography versus access history for external abstracts, full texts and registration", "role": "Required", "role_reason": "Do not equate an available reading link with full-text reading.", "application_exception": "Do not label unattempted access as inaccessibility or nonreporting in the paper.", "criterion": "Link the retained summary actually read to its location and hash; leave external material unread.", "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.", "condition_origin": "These are Chamgap in-house conditions developed with knowledge of the retained record for acute migraine, ginger extract added to common ketoprofen and 2-hour pain relief. They do not establish blinding, clinical-trial preregistration, official-tool certification or new independent clinical validation.", "proposed_research": "Material needed: Actual acquisition and reading records for original papers and registration/protocols. This records needed materials; no new research was executed." }, { "item_id": "N11", "question_type": "Evidence condition", "question": "How does the registration-number clue relate to the structured registration status?", "needed": "NCT02568644 in bibliography/both-language wording versus registration status marked unverified", "role": "Required", "role_reason": "Do not establish registration identity or prospective hierarchy from a bibliographic identifier.", "application_exception": "Do not delete either retained value or convert it to failed registration.", "criterion": "Retain both clues and state the scope of original-registration identity/version comparison.", "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.", "condition_origin": "These are Chamgap in-house conditions developed with knowledge of the retained record for acute migraine, ginger extract added to common ketoprofen and 2-hour pain relief. They do not establish blinding, clinical-trial preregistration, official-tool certification or new independent clinical validation.", "proposed_research": "Material needed: NCT02568644 initial registration, amendment history and paper correspondence. This records needed materials; no new research was executed." }, { "item_id": "N12", "question_type": "Evidence condition", "question": "What do the evidence date and current review date mean?", "needed": "Original verdict date, search cutoff, report-level access dates and correction date", "role": "Required", "role_reason": "Do not reuse the original review date 2026-09-08 as a current search or external-access date.", "application_exception": "An unperformed new search does not mean 0 studies.", "criterion": "Distinguish the role of the evidence date from the current retained scope.", "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.", "condition_origin": "These are Chamgap in-house conditions developed with knowledge of the retained record for acute migraine, ginger extract added to common ketoprofen and 2-hour pain relief. They do not establish blinding, clinical-trial preregistration, official-tool certification or new independent clinical validation.", "proposed_research": "Material needed: Historical search records and report-level access receipts. This records needed materials; no new research was executed." }, { "item_id": "N13", "question_type": "Evidence condition", "question": "What is known about randomization and allocation concealment?", "needed": "Randomized, double-blind placebo add-on; sequence/concealment and baseline balance", "role": "Required", "role_reason": "An RCT label alone does not establish that allocation bias was resolved.", "application_exception": "Do not convert unverified parallel/cluster/crossover details to nonapplicability.", "criterion": "Separate the retained design description from unverified procedures.", "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.", "condition_origin": "These are Chamgap in-house conditions developed with knowledge of the retained record for acute migraine, ginger extract added to common ketoprofen and 2-hour pain relief. They do not establish blinding, clinical-trial preregistration, official-tool certification or new independent clinical validation.", "proposed_research": "Material needed: Methods section, allocation sequence/concealment and baseline table. This records needed materials; no new research was executed." }, { "item_id": "N14", "question_type": "Evidence condition", "question": "How were blinding and subjective pain measurement conducted?", "needed": "Participant/assessor blinding, capsule matching and measurement procedures", "role": "Required", "role_reason": "Distinguish the double-blind label from actual response assessment.", "application_exception": "A subjective endpoint or blinding limitation alone is not an automatic failure.", "criterion": "State limitations according to the measurement procedure and actual verification scope.", "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.", "condition_origin": "These are Chamgap in-house conditions developed with knowledge of the retained record for acute migraine, ginger extract added to common ketoprofen and 2-hour pain relief. They do not establish blinding, clinical-trial preregistration, official-tool certification or new independent clinical validation.", "proposed_research": "Material needed: Original capsule-matching, assessor-procedure and response-scale descriptions. This records needed materials; no new research was executed." }, { "item_id": "N15", "question_type": "Evidence condition", "question": "Which denominator does 60 represent?", "needed": "Overall 60 randomized versus group allocation, measurement, completion and analysis", "role": "Required", "role_reason": "Do not infer 30/30 per group or an outcome-analysis denominator from total N.", "application_exception": "Do not equate the summary's 60 with actual analyzed or completing counts.", "criterion": "Distinguish the retained overall randomized count from other unavailable denominators.", "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.", "condition_origin": "These are Chamgap in-house conditions developed with knowledge of the retained record for acute migraine, ginger extract added to common ketoprofen and 2-hour pain relief. They do not establish blinding, clinical-trial preregistration, official-tool certification or new independent clinical validation.", "proposed_research": "Material needed: Group participant-flow table and denominator definitions. This records needed materials; no new research was executed." }, { "item_id": "N16", "question_type": "Evidence condition", "question": "How were withdrawals and missing data handled?", "needed": "Time-specific missing data, withdrawal reasons and analysis inclusion/handling", "role": "Required", "role_reason": "Do not convert missing denominators to 0 withdrawals or completion by everyone.", "application_exception": "Generic English sample-size wording is not an actual time-specific denominator.", "criterion": "Distinguish reported randomization counts from unverified missingness and handling.", "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.", "condition_origin": "These are Chamgap in-house conditions developed with knowledge of the retained record for acute migraine, ginger extract added to common ketoprofen and 2-hour pain relief. They do not establish blinding, clinical-trial preregistration, official-tool certification or new independent clinical validation.", "proposed_research": "Material needed: Group/time-specific analysis denominators and missing-data handling. This records needed materials; no new research was executed." }, { "item_id": "N17", "question_type": "Evidence condition", "question": "What are the magnitude and precision of the 2-hour effect?", "needed": "Group response-event counts, RR/absolute difference, 95% CI and denominators", "role": "Required", "role_reason": "Do not read P=.04 as effect magnitude, an individual's response probability or sufficiency.", "application_exception": "Do not infer event counts/CI or fill gaps with new calculations.", "criterion": "Show the reported P value separately from unverified estimates and intervals.", "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.", "condition_origin": "These are Chamgap in-house conditions developed with knowledge of the retained record for acute migraine, ginger extract added to common ketoprofen and 2-hour pain relief. They do not establish blinding, clinical-trial preregistration, official-tool certification or new independent clinical validation.", "proposed_research": "Material needed: 2-hour group event counts/denominators and reported effect estimates with CI. This records needed materials; no new research was executed." }, { "item_id": "N18", "question_type": "Evidence condition", "question": "How are the P values at 1, 1.5 and 2 hours attributed?", "needed": "1h P=.04, 1.5h P=.01, 2h P=.04 and the multiple-testing plan", "role": "Required", "role_reason": "Do not substitute the most favorable time-specific P value for the principal 2-hour effect.", "application_exception": "Do not count the three values as independent trials or participants.", "criterion": "Link each time-specific value to the original record and retain unverified multiplicity control.", "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.", "condition_origin": "These are Chamgap in-house conditions developed with knowledge of the retained record for acute migraine, ginger extract added to common ketoprofen and 2-hour pain relief. They do not establish blinding, clinical-trial preregistration, official-tool certification or new independent clinical validation.", "proposed_research": "Material needed: Time-specific plans, hypothesis hierarchy, multiplicity control and complete results. This records needed materials; no new research was executed." }, { "item_id": "N19", "question_type": "Evidence condition", "question": "How far was the claim of a prespecified principal endpoint checked?", "needed": "Designation of 2-hour pain relief, registration/protocol/SAP and amendment history", "role": "Required", "role_reason": "Separate the manuscript's prespecification statement from original-plan comparison in this review.", "application_exception": "Unacquired planning material does not establish nonregistration or selective reporting.", "criterion": "Retain the historical wording while identifying unperformed comparisons with historical plans and amendments.", "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.", "condition_origin": "These are Chamgap in-house conditions developed with knowledge of the retained record for acute migraine, ginger extract added to common ketoprofen and 2-hour pain relief. They do not establish blinding, clinical-trial preregistration, official-tool certification or new independent clinical validation.", "proposed_research": "Material needed: Initial registration, protocol/SAP and amendment dates. This records needed materials; no new research was executed." }, { "item_id": "N20", "question_type": "Evidence condition", "question": "Were rescue medication, adherence and concomitant-treatment changes controlled?", "needed": "Common ketoprofen administration and additional concomitant/rescue medication, with administration timing", "role": "Required", "role_reason": "Do not attribute differences in other treatments to the ginger add-on contribution.", "application_exception": "Specification of a common medicine does not establish identical concomitant care and adherence throughout.", "criterion": "Record specified common treatment separately from unverified changes and handling.", "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.", "condition_origin": "These are Chamgap in-house conditions developed with knowledge of the retained record for acute migraine, ginger extract added to common ketoprofen and 2-hour pain relief. They do not establish blinding, clinical-trial preregistration, official-tool certification or new independent clinical validation.", "proposed_research": "Material needed: Group concomitant treatment, rescue care, adherence, timing and analytic handling. This records needed materials; no new research was executed." }, { "item_id": "N21", "question_type": "Evidence condition", "question": "Is the analysis estimating assignment or adherence effects?", "needed": "ITT/PP, analysis population, adjustment/model and time-specific between-group comparisons", "role": "Required", "role_reason": "Do not fill in ITT solely because allocation was randomized.", "application_exception": "Do not equate unspecified within-group change with a between-group effect.", "criterion": "Distinguish the add-on effect of interest from the unverified actual estimand.", "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.", "condition_origin": "These are Chamgap in-house conditions developed with knowledge of the retained record for acute migraine, ginger extract added to common ketoprofen and 2-hour pain relief. They do not establish blinding, clinical-trial preregistration, official-tool certification or new independent clinical validation.", "proposed_research": "Material needed: Analysis plan, analysis population, model and effect definition. This records needed materials; no new research was executed." }, { "item_id": "N22", "question_type": "Evidence condition", "question": "Does active-comparator nonsignificance prove equivalence?", "needed": "S2 noninferiority design/margin, between-group estimate, CI and repeated-attack handling", "role": "Required", "role_reason": "Do not turn within-group improvement or between-group nonsignificance into triptan replacement efficacy.", "application_exception": "Do not make equivalence/noninferiority conclusions without a prospective margin and CI.", "criterion": "Retain contrary/no-difference reporting and state the different comparison and its limitations.", "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.", "condition_origin": "These are Chamgap in-house conditions developed with knowledge of the retained record for acute migraine, ginger extract added to common ketoprofen and 2-hour pain relief. They do not establish blinding, clinical-trial preregistration, official-tool certification or new independent clinical validation.", "proposed_research": "Material needed: Active-comparator protocol, noninferiority margin/CI and analysis method. This records needed materials; no new research was executed." }, { "item_id": "N23", "question_type": "Evidence condition", "question": "Is 400 mg known to be the optimal dose?", "needed": "Direct dose comparisons for the same extract, composition and adherence", "role": "Supplementary; required for an optimal-dose extension", "role_reason": "Do not extend one single dose to an optimal-dose claim.", "application_exception": "Do not make dose-optimization research a completion requirement for this narrow add-on question.", "criterion": "Separate the current 400 mg dose from the gap for a distinct dose question.", "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.", "condition_origin": "These are Chamgap in-house conditions developed with knowledge of the retained record for acute migraine, ginger extract added to common ketoprofen and 2-hour pain relief. They do not establish blinding, clinical-trial preregistration, official-tool certification or new independent clinical validation.", "proposed_research": "Material needed: Direct dose groups, batch composition and estimates/CI. This records needed materials; no new research was executed." }, { "item_id": "N24", "question_type": "Evidence condition", "question": "Does this answer recurrence, persistence or prevention questions?", "needed": "Pain/rescue medication after 2 hours, recurrence and prevention questions", "role": "Supplementary; required for a persistence/prevention extension", "role_reason": "Do not extend single-dose pain-relief results to long-term prevention or reduced recurrence.", "application_exception": "Prevention ID3009 is not read/converted in this sheet or imposed as a requirement for the narrow question.", "criterion": "Distinguish the original 2-hour result from later-outcome and prevention questions.", "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.", "condition_origin": "These are Chamgap in-house conditions developed with knowledge of the retained record for acute migraine, ginger extract added to common ketoprofen and 2-hour pain relief. They do not establish blinding, clinical-trial preregistration, official-tool certification or new independent clinical validation.", "proposed_research": "Material needed: Subsequent follow-up, recurrence definitions and separate prevention material. This records needed materials; no new research was executed." }, { "item_id": "N25", "question_type": "Evidence condition", "question": "What independent replications match the same formulation and add-on comparison?", "needed": "Unique report/trial families and matching product, common treatment, endpoint and time", "role": "Required", "role_reason": "Do not count S2's different comparison, Korean/English text or bibliography as independent confirmation.", "application_exception": "Do not add the current 2 reports as 2 trials of the same comparison or a total of 160 unique participants.", "criterion": "Distinguish currently linked reports from unestablished total independent families and unique participants.", "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.", "condition_origin": "These are Chamgap in-house conditions developed with knowledge of the retained record for acute migraine, ginger extract added to common ketoprofen and 2-hour pain relief. They do not establish blinding, clinical-trial preregistration, official-tool certification or new independent clinical validation.", "proposed_research": "Material needed: Original trial families, related reports, product matching and trial-specific results. This records needed materials; no new research was executed." }, { "item_id": "N26", "question_type": "Evidence condition", "question": "What is known about funding, product provision and author interests?", "needed": "University research, funding, product support, author employment/patents and declared COI", "role": "Supplementary; required for an independence claim", "role_reason": "Do not read a university label or historical I2 as independent funding or absence of bias.", "application_exception": "Generic English funding wording is not specific COI-verification material.", "criterion": "Link each report's specified support and each unverified aspect separately.", "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.", "condition_origin": "These are Chamgap in-house conditions developed with knowledge of the retained record for acute migraine, ginger extract added to common ketoprofen and 2-hour pain relief. They do not establish blinding, clinical-trial preregistration, official-tool certification or new independent clinical validation.", "proposed_research": "Material needed: Original funding, product-provision and author/COI statements for both reports. This records needed materials; no new research was executed." }, { "item_id": "N27", "question_type": "Evidence condition", "question": "Which adverse events were collected, and how?", "needed": "Event definitions, collection methods, severity, discontinuation and group results", "role": "Required", "role_reason": "Do not turn caution wording into adverse events observed in the trial.", "application_exception": "Distinguish NSAID-related cautions from observed events in the ginger add-on comparison.", "criterion": "Show the verification scope for actual events separately from historical caution wording.", "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.", "condition_origin": "These are Chamgap in-house conditions developed with knowledge of the retained record for acute migraine, ginger extract added to common ketoprofen and 2-hour pain relief. They do not establish blinding, clinical-trial preregistration, official-tool certification or new independent clinical validation.", "proposed_research": "Material needed: S1 safety-result tables and event/collection definitions. This records needed materials; no new research was executed." }, { "item_id": "N28", "question_type": "Evidence condition", "question": "What is the timeline of events and recovery after exposure?", "needed": "Administration, event onset, recovery and discontinuation/re-exposure times", "role": "Required", "role_reason": "Do not turn single-dose 2-hour efficacy follow-up into sufficient harm observation.", "application_exception": "Do not infer improvement after discontinuation or re-exposure information when unavailable.", "criterion": "Separate known administration/follow-up from the unverified event timeline.", "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.", "condition_origin": "These are Chamgap in-house conditions developed with knowledge of the retained record for acute migraine, ginger extract added to common ketoprofen and 2-hour pain relief. They do not establish blinding, clinical-trial preregistration, official-tool certification or new independent clinical validation.", "proposed_research": "Material needed: Harm-onset/recovery and discontinuation/re-exposure records. This records needed materials; no new research was executed." }, { "item_id": "N29", "question_type": "Evidence condition", "question": "What is the actual comparison for harms?", "needed": "Between-group safety estimates for extract versus placebo on common ketoprofen", "role": "Required", "role_reason": "An efficacy comparator does not establish a verified difference in harms.", "application_exception": "Do not extrapolate background risk rates or convert this to a no-treatment comparison.", "criterion": "Show common/additional exposure and unverified comparative-harm material.", "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.", "condition_origin": "These are Chamgap in-house conditions developed with knowledge of the retained record for acute migraine, ginger extract added to common ketoprofen and 2-hour pain relief. They do not establish blinding, clinical-trial preregistration, official-tool certification or new independent clinical validation.", "proposed_research": "Material needed: Group safety events, denominators and reported risk estimates/CI. This records needed materials; no new research was executed." }, { "item_id": "N30", "question_type": "Evidence condition", "question": "Are denominators available for harm frequency?", "needed": "Safety-exposed population, people with events/event counts, period and collection scope", "role": "Required", "role_reason": "Do not reuse the total 60 as a safety denominator or a denominator for 0 events.", "application_exception": "Do not calculate incidence from P values, caution wording or original C50.", "criterion": "Show frequencies only for original reported values linking exposure, events and time.", "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.", "condition_origin": "These are Chamgap in-house conditions developed with knowledge of the retained record for acute migraine, ginger extract added to common ketoprofen and 2-hour pain relief. They do not establish blinding, clinical-trial preregistration, official-tool certification or new independent clinical validation.", "proposed_research": "Material needed: Safety-analysis population, group event counts and exposure time. This records needed materials; no new research was executed." }, { "item_id": "N31", "question_type": "Evidence condition", "question": "Can concomitant exposures and alternative causes be distinguished?", "needed": "IV ketoprofen, other migraine medicines, baseline/concomitant exposures and adjustment", "role": "Required", "role_reason": "Do not attribute potential harm causally to ginger alone.", "application_exception": "Unavailable information about other causes does not mean other causes are absent.", "criterion": "Distinguish specified common medicine from unverified concomitant/baseline information and alternative explanations.", "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.", "condition_origin": "These are Chamgap in-house conditions developed with knowledge of the retained record for acute migraine, ginger extract added to common ketoprofen and 2-hour pain relief. They do not establish blinding, clinical-trial preregistration, official-tool certification or new independent clinical validation.", "proposed_research": "Material needed: Concomitant medicines, baseline risk and event-specific alternative causes/adjustment. This records needed materials; no new research was executed." }, { "item_id": "N32", "question_type": "Evidence condition", "question": "What is missing from harm reporting and follow-up?", "needed": "Systematic/spontaneous collection, detection, attrition and complete event disclosure", "role": "Required", "role_reason": "An unavailable event table does not mean events did not occur.", "application_exception": "Possible bias is not an established bias magnitude or proof that the trial is invalid.", "criterion": "Connect the summary actually read to unverified collection and missingness.", "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.", "condition_origin": "These are Chamgap in-house conditions developed with knowledge of the retained record for acute migraine, ginger extract added to common ketoprofen and 2-hour pain relief. They do not establish blinding, clinical-trial preregistration, official-tool certification or new independent clinical validation.", "proposed_research": "Material needed: Safety collection, follow-up/attrition and disclosure scope. This records needed materials; no new research was executed." }, { "item_id": "N33", "question_type": "Evidence condition", "question": "Can independent repetitions of the same harm be counted?", "needed": "Unique event/trial families, exposure/event matching and repeated citation", "role": "Supplementary; required for repeated-harm-signal claims", "role_reason": "Do not count the same caution wording and Korean/English recitation as independent events.", "application_exception": "Do not automatically link a different S2 formulation or administrative data as recurrence of the same event.", "criterion": "Explain material types, family/exposure relationships and unestablished repetition counts.", "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.", "condition_origin": "These are Chamgap in-house conditions developed with knowledge of the retained record for acute migraine, ginger extract added to common ketoprofen and 2-hour pain relief. They do not establish blinding, clinical-trial preregistration, official-tool certification or new independent clinical validation.", "proposed_research": "Material needed: Original event data, families/related reports and exposure matching. This records needed materials; no new research was executed." }, { "item_id": "N34", "question_type": "Evidence condition", "question": "What harms or vulnerable groups lie beyond the short follow-up?", "needed": "Long-term/rare events, baseline risk, interactions and exposure duration", "role": "Supplementary; required for long-term/vulnerable-group safety extensions", "role_reason": "Do not extend an emergency-department single-dose 2-hour result to overall safety.", "application_exception": "Do not require all rare-harm trials as completion conditions for the narrow efficacy sheet.", "criterion": "Distinguish direct exposure scope from gaps in separate vulnerable-group/long-term questions.", "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.", "condition_origin": "These are Chamgap in-house conditions developed with knowledge of the retained record for acute migraine, ginger extract added to common ketoprofen and 2-hour pain relief. They do not establish blinding, clinical-trial preregistration, official-tool certification or new independent clinical validation.", "proposed_research": "Material needed: Vulnerable-group, long-term/rare-event and concomitant-treatment material. This records needed materials; no new research was executed." }, { "item_id": "N35", "question_type": "Evidence condition", "question": "What can this material say about safety?", "needed": "Observed events, comparison, denominators, time, alternatives and original cautions", "role": "Required", "role_reason": "Do not turn a Caution label into established harm causality, absence of harm or personal dosing advice.", "application_exception": "Do not run new efficacy/safety scoring or causal-assessment tools.", "criterion": "Distinguish retained cautions from unverified events, comparisons, denominators and causality.", "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.", "condition_origin": "These are Chamgap in-house conditions developed with knowledge of the retained record for acute migraine, ginger extract added to common ketoprofen and 2-hour pain relief. They do not establish blinding, clinical-trial preregistration, official-tool certification or new independent clinical validation.", "proposed_research": "Material needed: Original material linking events, exposure, comparison, time and alternative explanations. This records needed materials; no new research was executed." } ] }