# Ginger extract 400 mg standardized to 5% active ingredient as add-on therapy × Improvement of 2-hour pain-relief response in acute migraine Verdict 3056 · Evidence Check Stored-material review date: 2026-10-06 Original evidence cut-off: 2026-09-08 Review-criteria version: 1.0 Public page/material preparation date: 2026-10-25 Clinical papers were not read directly; existing review summaries were checked. No new clinical-literature search was performed. Unverified does not mean that research is absent or that there is no effect. ## Assessment scope - Population: 60 adults presenting to an emergency department with episodic migraine, 1–6 attacks per month - Ingredient, formulation and route: Zingiber officinale rhizome extract, 400 mg capsule, nominally 5% active ingredient, as oral add-on therapy; detailed gingerol/shogaol composition and batch unverified - Dose: A single 400 mg dose during an acute attack - Comparator: Ginger extract versus cellulose placebo added to the same IV ketoprofen 100 mg in both groups - Measured outcome: 2-hour pain-relief clinical response; distinct from complete pain freedom, with response criteria, group event counts, RR and 95% CI unverified - Duration: Single dose and 2-hour follow-up; results at 1 hour, 1.5 hours and 2 hours are separate observation times - Questions outside this scope: Pain relief is not extended to complete pain freedom at 2 hours, 24-hour persistence, reduced recurrence or migraine prevention under ID3009.; This is not converted to ginger monotherapy, intravenous ginger, ketoprofen replacement or triptan replacement.; The total 60 is not assumed to mean 30/30 per group or completion by everyone. The other comparison report’s 100 people and 5 attacks are not counted as 500 unique participants.; P values alone are not used to calculate events, effect magnitude, RR, CI or NNT, and nominal 5% is not used to calculate mg of individual active compounds.; A registration identifier clue, historical verdict or nonsignificance is not converted to verified prospective planning, new independent validation, equivalence or safety. ## Checklist items ### N01 · What is this sheet's independent question? Verification status: Met Reading scope: The retained Korean/English summaries and case-specific conditions/application records were read. Linked external abstracts, full texts, registration and planning material remain unread, with no access attempt. - Current findings: The original claim concerns improved 2-hour pain-relief response in acute migraine, comparing ginger extract 400 mg added to common IV ketoprofen 100 mg. - Why unverified: Limited to identifying the question in the current retained summary. This is not verification of clinical efficacy or full-text review. - Reason for missing information: Limited to identifying the question in the current retained summary. This is not verification of clinical efficacy or full-text review. - Required materials and conditions: Emergency-department episodic migraine; a single oral ginger-extract add-on; common ketoprofen; 2-hour pain relief - Materials to obtain first: The current original wording and new comparison specification if the question boundary changes - Further 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. - Conditions for verification: Connect the original Korean claim to formulation, population, comparison and time, and state exclusions. - Why this condition is needed: Distinguish the add-on question from monotherapy, prevention and pain freedom. - Application exceptions: Do not merge the same ginger name or a different comparison into this question. - Remaining uncertainty: Limited to identifying the question in the current retained summary. This is not verification of clinical efficacy or full-text review. - Referenced methods: 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. - Related sources: S1 ### N02 · How are the original verdict, both languages and correction records retained? Verification status: Partly verified Reading scope: The retained Korean/English summaries and case-specific conditions/application records were read. Linked external abstracts, full texts, registration and planning material remain unread, with no access attempt. - Current findings: C50, Caution and B/P/R1/I2/EX/B2/CX are retained as historical records. Some English evidence fields contain generic wording; the 1 correction and Korean/English cross-check statements are historical reports. - Why unverified: The current original record was checked, but specific clinical values behind generic English wording and past independent verification were not newly certified. - Reason for missing information: The current original record was checked, but specific clinical values behind generic English wording and past independent verification were not newly certified. - Required materials and conditions: Original C50, Caution, all axes, Korean/English text, the correction and the actual verification scope - Materials to obtain first: Historical source material establishing the specific English correspondence and correction scope - Further research: Material needed: Historical source material establishing the specific English correspondence and correction scope. This records needed materials; no new research was executed. - Conditions for verification: Retain the typed original and distinguish generic English text and historical cross-check wording from current certification. - Why this condition is needed: Do not inherit historical verdicts or translation wording as current row statuses or independent clinical certification. - Application exceptions: Do not arbitrarily retranslate or replace generic English fields and specific Korean content in the original correction record. - Remaining uncertainty: The current original record was checked, but specific clinical values behind generic English wording and past independent verification were not newly certified. - Referenced methods: 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. - Related sources: S1, S2 ### N03 · What product do 400 mg and 5% active ingredient describe? Verification status: Partly verified Reading scope: The retained Korean/English summaries and case-specific conditions/application records were read. Linked external abstracts, full texts, registration and planning material remain unread, with no access attempt. - Current findings: The retained formulation is a 400 mg capsule with 5% active ingredient; the detailed gingerol/shogaol composition is unverified. - Why unverified: Nominal labeling cannot establish individual active-compound contents or product equivalence. - Reason for missing information: Nominal labeling cannot establish individual active-compound contents or product equivalence. - Required materials and conditions: Rhizome-extract capsules, composition, trial product/batch and assay method - Materials to obtain first: Trial-product manufacturing, batch, quantitative-assay and composition documentation - Further research: Material needed: Trial-product manufacturing, batch, quantitative-assay and composition documentation. This records needed materials; no new research was executed. - Conditions for verification: Record the nominal formulation/dose alongside unverified actual composition and batch. - Why this condition is needed: Do not interchange ginger food, powder or essential oil with the trial extract. - Application exceptions: Do not newly calculate gingerol/shogaol mg or batch equivalence from nominal 5%. - Remaining uncertainty: Nominal labeling cannot establish individual active-compound contents or product equivalence. - Referenced methods: 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. - Related sources: S1 ### N04 · What actually differs between the add-on groups? Verification status: Met Reading scope: The retained Korean/English summaries and case-specific conditions/application records were read. Linked external abstracts, full texts, registration and planning material remain unread, with no access attempt. - Current findings: This is oral add-on therapy; the comparator is common IV ketoprofen 100 mg plus cellulose placebo. - Why unverified: Confirms only the retained comparison specification. Add-on effect magnitude and details of concomitant-care management remain unverified in other items. - Reason for missing information: Confirms only the retained comparison specification. Add-on effect magnitude and details of concomitant-care management remain unverified in other items. - Required materials and conditions: Common IV ketoprofen 100 mg; oral extract 400 mg versus cellulose placebo - Materials to obtain first: Administration procedures and concomitant-treatment tables for both groups - Further research: Material needed: Administration procedures and concomitant-treatment tables for both groups. This records needed materials; no new research was executed. - Conditions for verification: Distinguish common treatment from the add-on difference at the current source location. - Why this condition is needed: Separate the contribution of common treatment from the added-ingredient comparison. - Application exceptions: Do not attribute this to ginger monotherapy, ketoprofen replacement or triptan replacement. - Remaining uncertainty: Confirms only the retained comparison specification. Add-on effect magnitude and details of concomitant-care management remain unverified in other items. - Referenced methods: 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. - Related sources: S1 ### N05 · Who was included in the trial? Verification status: Partly verified Reading scope: The retained Korean/English summaries and case-specific conditions/application records were read. Linked external abstracts, full texts, registration and planning material remain unread, with no access attempt. - Current findings: The record describes 60 adults presenting to an emergency department with episodic migraine, 1–6 attacks per month. - Why unverified: Detailed diagnostic criteria, age distribution, eligibility/exclusions and baseline balance could not be established from the current summary. - Reason for missing information: Detailed diagnostic criteria, age distribution, eligibility/exclusions and baseline balance could not be established from the current summary. - Required materials and conditions: Emergency care for adults with episodic migraine, 1–6 attacks per month; eligibility/exclusions and baseline characteristics - Materials to obtain first: Complete eligibility/exclusion criteria and baseline-characteristics table - Further research: Material needed: Complete eligibility/exclusion criteria and baseline-characteristics table. This records needed materials; no new research was executed. - Conditions for verification: Distinguish the retained population from unverified diagnostic, baseline and eligibility information. - Why this condition is needed: Do not extend this to general headache, chronic migraine or self-medication. - Application exceptions: Do not equate the overall 60 with the actual eligible or completing population. - Remaining uncertainty: Detailed diagnostic criteria, age distribution, eligibility/exclusions and baseline balance could not be established from the current summary. - Referenced methods: 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. - Related sources: S1 ### N06 · Are pain-relief response and pain freedom distinguished? Verification status: Partly verified Reading scope: The retained Korean/English summaries and case-specific conditions/application records were read. Linked external abstracts, full texts, registration and planning material remain unread, with no access attempt. - Current findings: The principal endpoint is 2-hour clinical pain-relief response; the original record explicitly distinguishes it from pain freedom. - Why unverified: The exact response definition, scale and event counts remain unverified within the retained scope. - Reason for missing information: The exact response definition, scale and event counts remain unverified within the retained scope. - Required materials and conditions: Definition, scale and response threshold for 2-hour pain-relief clinical response - Materials to obtain first: Response-classification criteria, pain scale and result tables - Further research: Material needed: Response-classification criteria, pain scale and result tables. This records needed materials; no new research was executed. - Conditions for verification: Separate the retained response endpoint from other endpoints and retain uncertainty about its measurement definition. - Why this condition is needed: Do not turn a pain-relief signal into complete pain freedom. - Application exceptions: Pain intensity, pain freedom and recurrence are different endpoints. - Remaining uncertainty: The exact response definition, scale and event counts remain unverified within the retained scope. - Referenced methods: 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. - Related sources: S1 ### N07 · What are the limits of the single dose and 2-hour observation? Verification status: Met Reading scope: The retained Korean/English summaries and case-specific conditions/application records were read. Linked external abstracts, full texts, registration and planning material remain unread, with no access attempt. - Current findings: Single administration and 2-hour follow-up are recorded, with separate P values at 1 hour, 1.5 hours and 2 hours. - Why unverified: Only the current time attribution is confirmed; long-term persistence is not addressed. - Reason for missing information: Only the current time attribution is confirmed; long-term persistence is not addressed. - Required materials and conditions: A single acute-attack dose of 400 mg; measurements at 1/1.5/2 hours - Materials to obtain first: Administration/measurement schedule and subsequent follow-up - Further research: Material needed: Administration/measurement schedule and subsequent follow-up. This records needed materials; no new research was executed. - Conditions for verification: Attribute administration and each reported time separately. - Why this condition is needed: Do not combine observations at different times into one sustained effect. - Application exceptions: Do not extend a single-dose 2-hour result to repeated dosing or prevention. - Remaining uncertainty: Only the current time attribution is confirmed; long-term persistence is not addressed. - Referenced methods: 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. - Related sources: S1 ### N08 · How well is the direct add-on report identified? Verification status: Partly verified Reading scope: The retained Korean/English summaries and case-specific conditions/application records were read. Linked external abstracts, full texts, registration and planning material remain unread, with no access attempt. - Current findings: S1 corresponds to the direct placebo-add-on evidence summary[0] and the Martins 2019 bibliography entry. - Why unverified: Local linkage was checked, but external identity, registration family and total unique trials/participants remain unestablished. - Reason for missing information: Local linkage was checked, but external identity, registration family and total unique trials/participants remain unestablished. - Required materials and conditions: Martins 2019, PMID29768938, DOI and evidence/bibliography correspondence - Materials to obtain first: Original paper, related reports and registration history - Further research: Material needed: Original paper, related reports and registration history. This records needed materials; no new research was executed. - Conditions for verification: Connect source locations for the same direct-report clues without inferring total unique participants. - Why this condition is needed: Do not count summaries, bibliography and Korean/English recitation as independent replications. - Application exceptions: Identifiers alone do not complete registration or original-paper identity checks. - Remaining uncertainty: Local linkage was checked, but external identity, registration family and total unique trials/participants remain unestablished. - Referenced methods: 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. - Related sources: S1 ### N09 · Why is the sumatriptan comparison separate context? Verification status: Met Reading scope: The retained Korean/English summaries and case-specific conditions/application records were read. Linked external abstracts, full texts, registration and planning material remain unread, with no access attempt. - Current findings: S2 reports ginger powder versus sumatriptan, 100 people followed over 5 attacks and headache severity at two hours. Its comparison specification differs from S1. - Why unverified: Confirms only attribution of this related report. S2 product dose, group analyses and repeated-measure handling have not been verified. - Reason for missing information: Confirms only attribution of this related report. S2 product dose, group analyses and repeated-measure handling have not been verified. - Required materials and conditions: Powder versus sumatriptan; 100 people; 5 attacks; headache severity at two hours - Materials to obtain first: Active-comparator full text and analyses at participant and attack levels - Further research: Material needed: Active-comparator full text and analyses at participant and attack levels. This records needed materials; no new research was executed. - Conditions for verification: Separate S2 results and denominator/repeated-measure boundaries from S1. - Why this condition is needed: Do not count within-group improvement in an active comparison as replication of the same extract add-on effect. - Application exceptions: Do not multiply 100 people by 5 attacks to count 500 people; retain formulation and comparison differences. - Remaining uncertainty: Confirms only attribution of this related report. S2 product dose, group analyses and repeated-measure handling have not been verified. - Referenced methods: 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. - Related sources: S2 ### N10 · Which material was actually read for this review? Verification status: Met Reading scope: The retained Korean/English summaries and case-specific conditions/application records were read. Linked external abstracts, full texts, registration and planning material remain unread, with no access attempt. - Current findings: The entire current summary, both languages, 2 evidence records and 2 bibliography entries were read. External abstract/full-text/registration access was 0; retained URLs are entry points. - Why unverified: Confirms summary reading. Historical research-description wording is a past record, not full-text reading in this review. - Reason for missing information: Confirms summary reading. Historical research-description wording is a past record, not full-text reading in this review. - Required materials and conditions: Current retained summary and bibliography versus access history for external abstracts, full texts and registration - Materials to obtain first: Actual acquisition and reading records for original papers and registration/protocols - Further research: Material needed: Actual acquisition and reading records for original papers and registration/protocols. This records needed materials; no new research was executed. - Conditions for verification: Link the retained summary actually read to its location and hash; leave external material unread. - Why this condition is needed: Do not equate an available reading link with full-text reading. - Application exceptions: Do not label unattempted access as inaccessibility or nonreporting in the paper. - Remaining uncertainty: Confirms summary reading. Historical research-description wording is a past record, not full-text reading in this review. - Referenced methods: 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. - Related sources: S1, S2 ### N11 · How does the registration-number clue relate to the structured registration status? Verification status: Partly verified Reading scope: The retained Korean/English summaries and case-specific conditions/application records were read. Linked external abstracts, full texts, registration and planning material remain unread, with no access attempt. - Current findings: NCT02568644 appears in Korean/English research descriptions and bibliography, while S1's evidence-summary registration status is unverified. - Why unverified: Registration identity, the actual historical version and access/planning comparisons were not checked this time. Different record levels are not arbitrarily harmonized. - Reason for missing information: Registration identity, the actual historical version and access/planning comparisons were not checked this time. Different record levels are not arbitrarily harmonized. - Required materials and conditions: NCT02568644 in bibliography/both-language wording versus registration status marked unverified - Materials to obtain first: NCT02568644 initial registration, amendment history and paper correspondence - Further research: Material needed: NCT02568644 initial registration, amendment history and paper correspondence. This records needed materials; no new research was executed. - Conditions for verification: Retain both clues and state the scope of original-registration identity/version comparison. - Why this condition is needed: Do not establish registration identity or prospective hierarchy from a bibliographic identifier. - Application exceptions: Do not delete either retained value or convert it to failed registration. - Remaining uncertainty: Registration identity, the actual historical version and access/planning comparisons were not checked this time. Different record levels are not arbitrarily harmonized. - Referenced methods: 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. - Related sources: S1 ### N12 · What do the evidence date and current review date mean? Verification status: Partly verified Reading scope: The retained Korean/English summaries and case-specific conditions/application records were read. Linked external abstracts, full texts, registration and planning material remain unread, with no access attempt. - Current findings: The original verdict date is 2026-09-08 and the correction date is 2026-09-14; this review converts retained material. The original search cutoff and report-level access records are absent. - Why unverified: The search cutoff and full scope of registration/publication/retraction checks were not newly verified. - Reason for missing information: The search cutoff and full scope of registration/publication/retraction checks were not newly verified. - Required materials and conditions: Original verdict date, search cutoff, report-level access dates and correction date - Materials to obtain first: Historical search records and report-level access receipts - Further research: Material needed: Historical search records and report-level access receipts. This records needed materials; no new research was executed. - Conditions for verification: Distinguish the role of the evidence date from the current retained scope. - Why this condition is needed: Do not reuse the original review date 2026-09-08 as a current search or external-access date. - Application exceptions: An unperformed new search does not mean 0 studies. - Remaining uncertainty: The search cutoff and full scope of registration/publication/retraction checks were not newly verified. - Referenced methods: 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. - Related sources: S1, S2 ### N13 · What is known about randomization and allocation concealment? Verification status: Partly verified Reading scope: The retained Korean/English summaries and case-specific conditions/application records were read. Linked external abstracts, full texts, registration and planning material remain unread, with no access attempt. - Current findings: S1 is described as a randomized, double-blind, placebo-add-on trial. - Why unverified: Actual sequence-generation/concealment methods, design unit and baseline balance are absent from the summary. Nonreporting throughout the paper remains unverified. - Reason for missing information: Actual sequence-generation/concealment methods, design unit and baseline balance are absent from the summary. Nonreporting throughout the paper remains unverified. - Required materials and conditions: Randomized, double-blind placebo add-on; sequence/concealment and baseline balance - Materials to obtain first: Methods section, allocation sequence/concealment and baseline table - Further research: Material needed: Methods section, allocation sequence/concealment and baseline table. This records needed materials; no new research was executed. - Conditions for verification: Separate the retained design description from unverified procedures. - Why this condition is needed: An RCT label alone does not establish that allocation bias was resolved. - Application exceptions: Do not convert unverified parallel/cluster/crossover details to nonapplicability. - Remaining uncertainty: Actual sequence-generation/concealment methods, design unit and baseline balance are absent from the summary. Nonreporting throughout the paper remains unverified. - Referenced methods: 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. - Related sources: S1 ### N14 · How were blinding and subjective pain measurement conducted? Verification status: Partly verified Reading scope: The retained Korean/English summaries and case-specific conditions/application records were read. Linked external abstracts, full texts, registration and planning material remain unread, with no access attempt. - Current findings: The double-blind design and cellulose placebo are retained, with pain relief as the selected endpoint. - Why unverified: Maintenance/success of blinding, assessors and measurement-classification details remain unverified. - Reason for missing information: Maintenance/success of blinding, assessors and measurement-classification details remain unverified. - Required materials and conditions: Participant/assessor blinding, capsule matching and measurement procedures - Materials to obtain first: Original capsule-matching, assessor-procedure and response-scale descriptions - Further research: Material needed: Original capsule-matching, assessor-procedure and response-scale descriptions. This records needed materials; no new research was executed. - Conditions for verification: State limitations according to the measurement procedure and actual verification scope. - Why this condition is needed: Distinguish the double-blind label from actual response assessment. - Application exceptions: A subjective endpoint or blinding limitation alone is not an automatic failure. - Remaining uncertainty: Maintenance/success of blinding, assessors and measurement-classification details remain unverified. - Referenced methods: 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. - Related sources: S1 ### N15 · Which denominator does 60 represent? Verification status: Partly verified Reading scope: The retained Korean/English summaries and case-specific conditions/application records were read. Linked external abstracts, full texts, registration and planning material remain unread, with no access attempt. - Current findings: S1's recorded sample size is 60 randomized; the population description also states 60 emergency-department adults. - Why unverified: Group allocation, measurement, analysis and completion counts remain unverified from the current material. - Reason for missing information: Group allocation, measurement, analysis and completion counts remain unverified from the current material. - Required materials and conditions: Overall 60 randomized versus group allocation, measurement, completion and analysis - Materials to obtain first: Group participant-flow table and denominator definitions - Further research: Material needed: Group participant-flow table and denominator definitions. This records needed materials; no new research was executed. - Conditions for verification: Distinguish the retained overall randomized count from other unavailable denominators. - Why this condition is needed: Do not infer 30/30 per group or an outcome-analysis denominator from total N. - Application exceptions: Do not equate the summary's 60 with actual analyzed or completing counts. - Remaining uncertainty: Group allocation, measurement, analysis and completion counts remain unverified from the current material. - Referenced methods: 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. - Related sources: S1 ### N16 · How were withdrawals and missing data handled? Verification status: Unverified Reading scope: The retained Korean/English summaries and case-specific conditions/application records were read. Linked external abstracts, full texts, registration and planning material remain unread, with no access attempt. - Current findings: Only the overall 60 randomized are available; time-specific completion/missing counts are not linked. - Why unverified: The occurrence, reasons and handling of missing data and their effect on results cannot be judged from the retained scope. - Reason for missing information: The occurrence, reasons and handling of missing data and their effect on results cannot be judged from the retained scope. - Required materials and conditions: Time-specific missing data, withdrawal reasons and analysis inclusion/handling - Materials to obtain first: Group/time-specific analysis denominators and missing-data handling - Further research: Material needed: Group/time-specific analysis denominators and missing-data handling. This records needed materials; no new research was executed. - Conditions for verification: Distinguish reported randomization counts from unverified missingness and handling. - Why this condition is needed: Do not convert missing denominators to 0 withdrawals or completion by everyone. - Application exceptions: Generic English sample-size wording is not an actual time-specific denominator. - Remaining uncertainty: The occurrence, reasons and handling of missing data and their effect on results cannot be judged from the retained scope. - Referenced methods: 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. - Related sources: S1 ### N17 · What are the magnitude and precision of the 2-hour effect? Verification status: Partly verified Reading scope: The retained Korean/English summaries and case-specific conditions/application records were read. Linked external abstracts, full texts, registration and planning material remain unread, with no access attempt. - Current findings: The 2-hour P value is .04; the original summary explicitly identifies event counts, RR and 95% CI as unverified. - Why unverified: Exact effect magnitude, absolute response difference, interval and clinical-importance threshold are unverified. The historical statement that these were absent from the public abstract does not mean the abstract was reread this time. - Reason for missing information: Exact effect magnitude, absolute response difference, interval and clinical-importance threshold are unverified. The historical statement that these were absent from the public abstract does not mean the abstract was reread this time. - Required materials and conditions: Group response-event counts, RR/absolute difference, 95% CI and denominators - Materials to obtain first: 2-hour group event counts/denominators and reported effect estimates with CI - Further research: Material needed: 2-hour group event counts/denominators and reported effect estimates with CI. This records needed materials; no new research was executed. - Conditions for verification: Show the reported P value separately from unverified estimates and intervals. - Why this condition is needed: Do not read P=.04 as effect magnitude, an individual's response probability or sufficiency. - Application exceptions: Do not infer event counts/CI or fill gaps with new calculations. - Remaining uncertainty: Exact effect magnitude, absolute response difference, interval and clinical-importance threshold are unverified. The historical statement that these were absent from the public abstract does not mean the abstract was reread this time. - Referenced methods: 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. - Related sources: S1 ### N18 · How are the P values at 1, 1.5 and 2 hours attributed? Verification status: Partly verified Reading scope: The retained Korean/English summaries and case-specific conditions/application records were read. Linked external abstracts, full texts, registration and planning material remain unread, with no access attempt. - Current findings: The record states 1 hour P=.04, 1.5 hours P=.01 and 2 hours P=.04. - Why unverified: Planning material establishing the prospective hierarchy of multiple times, multiplicity handling and completeness of reporting has not been acquired. - Reason for missing information: Planning material establishing the prospective hierarchy of multiple times, multiplicity handling and completeness of reporting has not been acquired. - Required materials and conditions: 1h P=.04, 1.5h P=.01, 2h P=.04 and the multiple-testing plan - Materials to obtain first: Time-specific plans, hypothesis hierarchy, multiplicity control and complete results - Further research: Material needed: Time-specific plans, hypothesis hierarchy, multiplicity control and complete results. This records needed materials; no new research was executed. - Conditions for verification: Link each time-specific value to the original record and retain unverified multiplicity control. - Why this condition is needed: Do not substitute the most favorable time-specific P value for the principal 2-hour effect. - Application exceptions: Do not count the three values as independent trials or participants. - Remaining uncertainty: Planning material establishing the prospective hierarchy of multiple times, multiplicity handling and completeness of reporting has not been acquired. - Referenced methods: 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. - Related sources: S1 ### N19 · How far was the claim of a prespecified principal endpoint checked? Verification status: Partly verified Reading scope: The retained Korean/English summaries and case-specific conditions/application records were read. Linked external abstracts, full texts, registration and planning material remain unread, with no access attempt. - Current findings: Korean/English reader answers describe pain relief as the prespecified principal endpoint. A registration-identifier clue exists, while the structured registration status is unverified. - Why unverified: Initial registration/plans/SAP were not read this time, so prospective hierarchy and reasons for amendments are not directly certified. - Reason for missing information: Initial registration/plans/SAP were not read this time, so prospective hierarchy and reasons for amendments are not directly certified. - Required materials and conditions: Designation of 2-hour pain relief, registration/protocol/SAP and amendment history - Materials to obtain first: Initial registration, protocol/SAP and amendment dates - Further research: Material needed: Initial registration, protocol/SAP and amendment dates. This records needed materials; no new research was executed. - Conditions for verification: Retain the historical wording while identifying unperformed comparisons with historical plans and amendments. - Why this condition is needed: Separate the manuscript's prespecification statement from original-plan comparison in this review. - Application exceptions: Unacquired planning material does not establish nonregistration or selective reporting. - Remaining uncertainty: Initial registration/plans/SAP were not read this time, so prospective hierarchy and reasons for amendments are not directly certified. - Referenced methods: 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. - Related sources: S1 ### N20 · Were rescue medication, adherence and concomitant-treatment changes controlled? Verification status: Partly verified Reading scope: The retained Korean/English summaries and case-specific conditions/application records were read. Linked external abstracts, full texts, registration and planning material remain unread, with no access attempt. - Current findings: Common IV ketoprofen 100 mg is specified, but rescue medication, adherence and concomitant-treatment changes are not linked in the summary. - Why unverified: Additional treatment, rescue use and their effects on outcome analysis remain unverified. - Reason for missing information: Additional treatment, rescue use and their effects on outcome analysis remain unverified. - Required materials and conditions: Common ketoprofen administration and additional concomitant/rescue medication, with administration timing - Materials to obtain first: Group concomitant treatment, rescue care, adherence, timing and analytic handling - Further research: Material needed: Group concomitant treatment, rescue care, adherence, timing and analytic handling. This records needed materials; no new research was executed. - Conditions for verification: Record specified common treatment separately from unverified changes and handling. - Why this condition is needed: Do not attribute differences in other treatments to the ginger add-on contribution. - Application exceptions: Specification of a common medicine does not establish identical concomitant care and adherence throughout. - Remaining uncertainty: Additional treatment, rescue use and their effects on outcome analysis remain unverified. - Referenced methods: 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. - Related sources: S1 ### N21 · Is the analysis estimating assignment or adherence effects? Verification status: Unverified Reading scope: The retained Korean/English summaries and case-specific conditions/application records were read. Linked external abstracts, full texts, registration and planning material remain unread, with no access attempt. - Current findings: The original reader answer states that 2-hour clinical response was better than placebo add-on, but analysis population, adjustment and model are absent from the retained evidence table. - Why unverified: ITT/PP and the definition of assignment/adherence effects cannot be established from the current source material. - Reason for missing information: ITT/PP and the definition of assignment/adherence effects cannot be established from the current source material. - Required materials and conditions: ITT/PP, analysis population, adjustment/model and time-specific between-group comparisons - Materials to obtain first: Analysis plan, analysis population, model and effect definition - Further research: Material needed: Analysis plan, analysis population, model and effect definition. This records needed materials; no new research was executed. - Conditions for verification: Distinguish the add-on effect of interest from the unverified actual estimand. - Why this condition is needed: Do not fill in ITT solely because allocation was randomized. - Application exceptions: Do not equate unspecified within-group change with a between-group effect. - Remaining uncertainty: ITT/PP and the definition of assignment/adherence effects cannot be established from the current source material. - Referenced methods: 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. - Related sources: S1 ### N22 · Does active-comparator nonsignificance prove equivalence? Verification status: Met Reading scope: The retained Korean/English summaries and case-specific conditions/application records were read. Linked external abstracts, full texts, registration and planning material remain unread, with no access attempt. - Current findings: S2 records improvement in both groups, states that between-group nonsignificance cannot establish equivalence and describes the design as not noninferiority. - Why unverified: Confirms only the retained result's interpretation boundary. External checks of exact between-group estimates, CI and trial design remain incomplete. - Reason for missing information: Confirms only the retained result's interpretation boundary. External checks of exact between-group estimates, CI and trial design remain incomplete. - Required materials and conditions: S2 noninferiority design/margin, between-group estimate, CI and repeated-attack handling - Materials to obtain first: Active-comparator protocol, noninferiority margin/CI and analysis method - Further research: Material needed: Active-comparator protocol, noninferiority margin/CI and analysis method. This records needed materials; no new research was executed. - Conditions for verification: Retain contrary/no-difference reporting and state the different comparison and its limitations. - Why this condition is needed: Do not turn within-group improvement or between-group nonsignificance into triptan replacement efficacy. - Application exceptions: Do not make equivalence/noninferiority conclusions without a prospective margin and CI. - Remaining uncertainty: Confirms only the retained result's interpretation boundary. External checks of exact between-group estimates, CI and trial design remain incomplete. - Referenced methods: 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. - Related sources: S2 ### N23 · Is 400 mg known to be the optimal dose? Verification status: Unverified Reading scope: The retained Korean/English summaries and case-specific conditions/application records were read. Linked external abstracts, full texts, registration and planning material remain unread, with no access attempt. - Current findings: The retained direct question concerns only a single 400 mg dose; no optimal-dose comparison evidence is linked. - Why unverified: This does not claim all dose studies are absent. Optimal dose/dose response could not be established within the current input scope. - Reason for missing information: This does not claim all dose studies are absent. Optimal dose/dose response could not be established within the current input scope. - Required materials and conditions: Direct dose comparisons for the same extract, composition and adherence - Materials to obtain first: Direct dose groups, batch composition and estimates/CI - Further research: Material needed: Direct dose groups, batch composition and estimates/CI. This records needed materials; no new research was executed. - Conditions for verification: Separate the current 400 mg dose from the gap for a distinct dose question. - Why this condition is needed: Do not extend one single dose to an optimal-dose claim. - Application exceptions: Do not make dose-optimization research a completion requirement for this narrow add-on question. - Remaining uncertainty: This does not claim all dose studies are absent. Optimal dose/dose response could not be established within the current input scope. - Referenced methods: 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. - Related sources: S1 ### N24 · Does this answer recurrence, persistence or prevention questions? Verification status: Met Reading scope: The retained Korean/English summaries and case-specific conditions/application records were read. Linked external abstracts, full texts, registration and planning material remain unread, with no access attempt. - Current findings: The original scope note states that only 2-hour pain relief is judged; pain freedom, recurrence and prevention are separate. - Why unverified: Only the current extension boundary is confirmed. Evidence quantity and effects for each extension were not reviewed this time. - Reason for missing information: Only the current extension boundary is confirmed. Evidence quantity and effects for each extension were not reviewed this time. - Required materials and conditions: Pain/rescue medication after 2 hours, recurrence and prevention questions - Materials to obtain first: Subsequent follow-up, recurrence definitions and separate prevention material - Further research: Material needed: Subsequent follow-up, recurrence definitions and separate prevention material. This records needed materials; no new research was executed. - Conditions for verification: Distinguish the original 2-hour result from later-outcome and prevention questions. - Why this condition is needed: Do not extend single-dose pain-relief results to long-term prevention or reduced recurrence. - Application exceptions: Prevention ID3009 is not read/converted in this sheet or imposed as a requirement for the narrow question. - Remaining uncertainty: Only the current extension boundary is confirmed. Evidence quantity and effects for each extension were not reviewed this time. - Referenced methods: 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. - Related sources: S1 ### N25 · What independent replications match the same formulation and add-on comparison? Verification status: Unverified Reading scope: The retained Korean/English summaries and case-specific conditions/application records were read. Linked external abstracts, full texts, registration and planning material remain unread, with no access attempt. - Current findings: S1 direct add-on reporting is distinguished from S2 active-comparator context; the existing R1/I2 values are historical axes. - Why unverified: The 2 retained reports alone do not establish total unique trials/participants or product-matched independent replication. - Reason for missing information: The 2 retained reports alone do not establish total unique trials/participants or product-matched independent replication. - Required materials and conditions: Unique report/trial families and matching product, common treatment, endpoint and time - Materials to obtain first: Original trial families, related reports, product matching and trial-specific results - Further research: Material needed: Original trial families, related reports, product matching and trial-specific results. This records needed materials; no new research was executed. - Conditions for verification: Distinguish currently linked reports from unestablished total independent families and unique participants. - Why this condition is needed: Do not count S2's different comparison, Korean/English text or bibliography as independent confirmation. - Application exceptions: Do not add the current 2 reports as 2 trials of the same comparison or a total of 160 unique participants. - Remaining uncertainty: The 2 retained reports alone do not establish total unique trials/participants or product-matched independent replication. - Referenced methods: 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. - Related sources: S1, S2 ### N26 · What is known about funding, product provision and author interests? Verification status: Partly verified Reading scope: The retained Korean/English summaries and case-specific conditions/application records were read. Linked external abstracts, full texts, registration and planning material remain unread, with no access attempt. - Current findings: S1 describes university research with product/funding details unverified; S2 has funding/product details unverified. - Why unverified: Funding, manufacturer support, author employment/patents and declared COI were not checked in the original papers this time. - Reason for missing information: Funding, manufacturer support, author employment/patents and declared COI were not checked in the original papers this time. - Required materials and conditions: University research, funding, product support, author employment/patents and declared COI - Materials to obtain first: Original funding, product-provision and author/COI statements for both reports - Further research: Material needed: Original funding, product-provision and author/COI statements for both reports. This records needed materials; no new research was executed. - Conditions for verification: Link each report's specified support and each unverified aspect separately. - Why this condition is needed: Do not read a university label or historical I2 as independent funding or absence of bias. - Application exceptions: Generic English funding wording is not specific COI-verification material. - Remaining uncertainty: Funding, manufacturer support, author employment/patents and declared COI were not checked in the original papers this time. - Referenced methods: 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. - Related sources: S1, S2 ### N27 · Which adverse events were collected, and how? Verification status: Unverified Reading scope: The retained Korean/English summaries and case-specific conditions/application records were read. Linked external abstracts, full texts, registration and planning material remain unread, with no access attempt. - Current findings: Retained safety information concerns cautions about NSAID contraindications, gastrointestinal/renal/bleeding risks and interactions with other migraine medicines; no event table is retained. - Why unverified: Event names, collection/adjudication, severity and discontinuation could not be established from the current summary. Nonreporting throughout the original paper remains unverified. - Reason for missing information: Event names, collection/adjudication, severity and discontinuation could not be established from the current summary. Nonreporting throughout the original paper remains unverified. - Required materials and conditions: Event definitions, collection methods, severity, discontinuation and group results - Materials to obtain first: S1 safety-result tables and event/collection definitions - Further research: Material needed: S1 safety-result tables and event/collection definitions. This records needed materials; no new research was executed. - Conditions for verification: Show the verification scope for actual events separately from historical caution wording. - Why this condition is needed: Do not turn caution wording into adverse events observed in the trial. - Application exceptions: Distinguish NSAID-related cautions from observed events in the ginger add-on comparison. - Remaining uncertainty: Event names, collection/adjudication, severity and discontinuation could not be established from the current summary. Nonreporting throughout the original paper remains unverified. - Referenced methods: 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. - Related sources: S1 ### N28 · What is the timeline of events and recovery after exposure? Verification status: Unverified Reading scope: The retained Korean/English summaries and case-specific conditions/application records were read. Linked external abstracts, full texts, registration and planning material remain unread, with no access attempt. - Current findings: Single administration and 2-hour efficacy follow-up are retained, but an event-onset/recovery timeline is not linked. - Why unverified: Harm onset/recovery, latency, discontinuation and re-exposure remain unverified. - Reason for missing information: Harm onset/recovery, latency, discontinuation and re-exposure remain unverified. - Required materials and conditions: Administration, event onset, recovery and discontinuation/re-exposure times - Materials to obtain first: Harm-onset/recovery and discontinuation/re-exposure records - Further research: Material needed: Harm-onset/recovery and discontinuation/re-exposure records. This records needed materials; no new research was executed. - Conditions for verification: Separate known administration/follow-up from the unverified event timeline. - Why this condition is needed: Do not turn single-dose 2-hour efficacy follow-up into sufficient harm observation. - Application exceptions: Do not infer improvement after discontinuation or re-exposure information when unavailable. - Remaining uncertainty: Harm onset/recovery, latency, discontinuation and re-exposure remain unverified. - Referenced methods: 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. - Related sources: S1 ### N29 · What is the actual comparison for harms? Verification status: Unverified Reading scope: The retained Korean/English summaries and case-specific conditions/application records were read. Linked external abstracts, full texts, registration and planning material remain unread, with no access attempt. - Current findings: The efficacy comparison is common ketoprofen plus ginger extract versus common ketoprofen plus placebo. The summary does not provide between-group safety results. - Why unverified: Comparative-harm estimates were not verified; this does not mean both groups were safe or the difference was 0. - Reason for missing information: Comparative-harm estimates were not verified; this does not mean both groups were safe or the difference was 0. - Required materials and conditions: Between-group safety estimates for extract versus placebo on common ketoprofen - Materials to obtain first: Group safety events, denominators and reported risk estimates/CI - Further research: Material needed: Group safety events, denominators and reported risk estimates/CI. This records needed materials; no new research was executed. - Conditions for verification: Show common/additional exposure and unverified comparative-harm material. - Why this condition is needed: An efficacy comparator does not establish a verified difference in harms. - Application exceptions: Do not extrapolate background risk rates or convert this to a no-treatment comparison. - Remaining uncertainty: Comparative-harm estimates were not verified; this does not mean both groups were safe or the difference was 0. - Referenced methods: 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. - Related sources: S1 ### N30 · Are denominators available for harm frequency? Verification status: Unverified Reading scope: The retained Korean/English summaries and case-specific conditions/application records were read. Linked external abstracts, full texts, registration and planning material remain unread, with no access attempt. - Current findings: Beyond the overall 60 randomized, safety-exposure/analysis denominators and event counts are not currently linked. - Why unverified: Incidence, risk ratios and overall event totals cannot be calculated or established. - Reason for missing information: Incidence, risk ratios and overall event totals cannot be calculated or established. - Required materials and conditions: Safety-exposed population, people with events/event counts, period and collection scope - Materials to obtain first: Safety-analysis population, group event counts and exposure time - Further research: Material needed: Safety-analysis population, group event counts and exposure time. This records needed materials; no new research was executed. - Conditions for verification: Show frequencies only for original reported values linking exposure, events and time. - Why this condition is needed: Do not reuse the total 60 as a safety denominator or a denominator for 0 events. - Application exceptions: Do not calculate incidence from P values, caution wording or original C50. - Remaining uncertainty: Incidence, risk ratios and overall event totals cannot be calculated or established. - Referenced methods: 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. - Related sources: S1 ### N31 · Can concomitant exposures and alternative causes be distinguished? Verification status: Partly verified Reading scope: The retained Korean/English summaries and case-specific conditions/application records were read. Linked external abstracts, full texts, registration and planning material remain unread, with no access attempt. - Current findings: Common ketoprofen 100 mg and caution wording about interactions with other medicines are retained. - Why unverified: Actual individual concomitant use, baseline events, alternative causes and adjustment are unverified. Original caution wording is not evidence of causality for observed events. - Reason for missing information: Actual individual concomitant use, baseline events, alternative causes and adjustment are unverified. Original caution wording is not evidence of causality for observed events. - Required materials and conditions: IV ketoprofen, other migraine medicines, baseline/concomitant exposures and adjustment - Materials to obtain first: Concomitant medicines, baseline risk and event-specific alternative causes/adjustment - Further research: Material needed: Concomitant medicines, baseline risk and event-specific alternative causes/adjustment. This records needed materials; no new research was executed. - Conditions for verification: Distinguish specified common medicine from unverified concomitant/baseline information and alternative explanations. - Why this condition is needed: Do not attribute potential harm causally to ginger alone. - Application exceptions: Unavailable information about other causes does not mean other causes are absent. - Remaining uncertainty: Actual individual concomitant use, baseline events, alternative causes and adjustment are unverified. Original caution wording is not evidence of causality for observed events. - Referenced methods: 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. - Related sources: S1 ### N32 · What is missing from harm reporting and follow-up? Verification status: Unverified Reading scope: The retained Korean/English summaries and case-specific conditions/application records were read. Linked external abstracts, full texts, registration and planning material remain unread, with no access attempt. - Current findings: The current summary contains caution wording, while safety collection/follow-up and event-disclosure scope remain unverified. - Why unverified: Collection methods, follow-up losses and detection differences in the original full text were not compared this time. - Reason for missing information: Collection methods, follow-up losses and detection differences in the original full text were not compared this time. - Required materials and conditions: Systematic/spontaneous collection, detection, attrition and complete event disclosure - Materials to obtain first: Safety collection, follow-up/attrition and disclosure scope - Further research: Material needed: Safety collection, follow-up/attrition and disclosure scope. This records needed materials; no new research was executed. - Conditions for verification: Connect the summary actually read to unverified collection and missingness. - Why this condition is needed: An unavailable event table does not mean events did not occur. - Application exceptions: Possible bias is not an established bias magnitude or proof that the trial is invalid. - Remaining uncertainty: Collection methods, follow-up losses and detection differences in the original full text were not compared this time. - Referenced methods: 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. - Related sources: S1 ### N33 · Can independent repetitions of the same harm be counted? Verification status: Unverified Reading scope: The retained Korean/English summaries and case-specific conditions/application records were read. Linked external abstracts, full texts, registration and planning material remain unread, with no access attempt. - Current findings: Korean/English safety guidance and product-fact cautions belong to the same original record; unique harm events are not established in the 2 efficacy reports. - Why unverified: Unique harm-event counts and repetition of the same event cannot be established from the current input. - Reason for missing information: Unique harm-event counts and repetition of the same event cannot be established from the current input. - Required materials and conditions: Unique event/trial families, exposure/event matching and repeated citation - Materials to obtain first: Original event data, families/related reports and exposure matching - Further research: Material needed: Original event data, families/related reports and exposure matching. This records needed materials; no new research was executed. - Conditions for verification: Explain material types, family/exposure relationships and unestablished repetition counts. - Why this condition is needed: Do not count the same caution wording and Korean/English recitation as independent events. - Application exceptions: Do not automatically link a different S2 formulation or administrative data as recurrence of the same event. - Remaining uncertainty: Unique harm-event counts and repetition of the same event cannot be established from the current input. - Referenced methods: 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. - Related sources: S1, S2 ### N34 · What harms or vulnerable groups lie beyond the short follow-up? Verification status: Unverified Reading scope: The retained Korean/English summaries and case-specific conditions/application records were read. Linked external abstracts, full texts, registration and planning material remain unread, with no access attempt. - Current findings: Original cautions mention NSAID contraindications, gastrointestinal/renal/bleeding risks and interactions with other migraine medicines; direct efficacy concerns one dose and 2 hours. - Why unverified: Actual denominators/frequencies in vulnerable groups and long-term/rare events, and interaction estimates, remain unverified. - Reason for missing information: Actual denominators/frequencies in vulnerable groups and long-term/rare events, and interaction estimates, remain unverified. - Required materials and conditions: Long-term/rare events, baseline risk, interactions and exposure duration - Materials to obtain first: Vulnerable-group, long-term/rare-event and concomitant-treatment material - Further research: Material needed: Vulnerable-group, long-term/rare-event and concomitant-treatment material. This records needed materials; no new research was executed. - Conditions for verification: Distinguish direct exposure scope from gaps in separate vulnerable-group/long-term questions. - Why this condition is needed: Do not extend an emergency-department single-dose 2-hour result to overall safety. - Application exceptions: Do not require all rare-harm trials as completion conditions for the narrow efficacy sheet. - Remaining uncertainty: Actual denominators/frequencies in vulnerable groups and long-term/rare events, and interaction estimates, remain unverified. - Referenced methods: 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. - Related sources: S1 ### N35 · What can this material say about safety? Verification status: Partly verified Reading scope: The retained Korean/English summaries and case-specific conditions/application records were read. Linked external abstracts, full texts, registration and planning material remain unread, with no access attempt. - Current findings: The existing Caution label and cautions about medical care/concomitant ketoprofen are retained; no new safety conclusion is made. - Why unverified: Original cautions are retained information. Observed harms, incidence, causality or safety are not currently established. - Reason for missing information: Original cautions are retained information. Observed harms, incidence, causality or safety are not currently established. - Required materials and conditions: Observed events, comparison, denominators, time, alternatives and original cautions - Materials to obtain first: Original material linking events, exposure, comparison, time and alternative explanations - Further research: Material needed: Original material linking events, exposure, comparison, time and alternative explanations. This records needed materials; no new research was executed. - Conditions for verification: Distinguish retained cautions from unverified events, comparisons, denominators and causality. - Why this condition is needed: Do not turn a Caution label into established harm causality, absence of harm or personal dosing advice. - Application exceptions: Do not run new efficacy/safety scoring or causal-assessment tools. - Remaining uncertainty: Original cautions are retained information. Observed harms, incidence, causality or safety are not currently established. - Referenced methods: 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. - Related sources: S1 ## Evidence and sources ### S1 Martins LB et al. Cephalalgia. 2019;39:68-76. PMID: 29768938. DOI: 10.1177/0333102418776016. NCT02568644. [PubMed](https://pubmed.ncbi.nlm.nih.gov/29768938/) Materials actually read: Retained summary read; external abstract/full text, registration and plans unread Findings recorded in the summary: 1 hour P=.04, 1.5 hours P=.01, 2 hours P=.04; event counts, RR and 95% CI unverified Record level: The overall 60 randomized and time-specific P values are retained. Group allocation, analysis, completion and event denominators, effect magnitude, CI, ITT and multiplicity handling remain unverified. Independent replication: The retained S1 direct extract add-on report and S2 powder-versus-sumatriptan active-comparator report address different comparisons. Korean/English text, bibliography, three observation times and repeated attacks are not independent trials. Product-matched independent replication and total unique trials and participants remain unverified. | Material | Public availability | Access status | Actually read | Notes | |---|---|---|---|---| | Retained direct add-on summary and bibliography | Stored locally | Acquired | Stored existing review summary read | The current retained summary was read. An original clinical-paper file was not acquired. These are links from the retained summary. Original papers, registration and plans were not newly read; unread does not mean no research, no effect or safety. 2026-10-06 is the date retained summaries and material status were checked, not an actual external-material reading date. The original verdict date 2026-09-08 and English-wording correction date 2026-09-14 are not new-search or external-full-text-reading dates. | | PubMed original-report entry | Unverified | Access not attempted | Not read | Entry linked from the retained bibliographic URL/PMID; response, identity and abstract were not checked this time. These are links from the retained summary. Original papers, registration and plans were not newly read; unread does not mean no research, no effect or safety. 2026-10-06 is the date retained summaries and material status were checked, not an actual external-material reading date. The original verdict date 2026-09-08 and English-wording correction date 2026-09-14 are not new-search or external-full-text-reading dates. | | Publisher DOI entry; full text unverified | Unverified | Access not attempted | Not read | Entry constructed from the retained DOI. Actual full-text existence, public availability, acquisition and reading remain unverified. These are links from the retained summary. Original papers, registration and plans were not newly read; unread does not mean no research, no effect or safety. 2026-10-06 is the date retained summaries and material status were checked, not an actual external-material reading date. The original verdict date 2026-09-08 and English-wording correction date 2026-09-14 are not new-search or external-full-text-reading dates. | | NCT02568644 registration entry; history not cross-checked | Unverified | Access not attempted | Not read | The bibliographic NCT02568644 clue is retained. Structured registration status is unverified; initial registration, amendment history and correspondence with the paper were not cross-checked. These are links from the retained summary. Original papers, registration and plans were not newly read; unread does not mean no research, no effect or safety. 2026-10-06 is the date retained summaries and material status were checked, not an actual external-material reading date. The original verdict date 2026-09-08 and English-wording correction date 2026-09-14 are not new-search or external-full-text-reading dates. | | Protocol/analysis plan for the principal endpoint, multiple time points and ITT | Unverified | Access not attempted | Not read | Plan existence, public availability and location, prospective endpoint hierarchy, multiplicity, ITT and amendments remain unverified. These are links from the retained summary. Original papers, registration and plans were not newly read; unread does not mean no research, no effect or safety. 2026-10-06 is the date retained summaries and material status were checked, not an actual external-material reading date. The original verdict date 2026-09-08 and English-wording correction date 2026-09-14 are not new-search or external-full-text-reading dates. | | Trial-extract product, batch and quantitative-assay material | Unverified | Access not attempted | Not read | Material linking nominal 400 mg and 5% to actual composition and batch has not been acquired. These are links from the retained summary. Original papers, registration and plans were not newly read; unread does not mean no research, no effect or safety. 2026-10-06 is the date retained summaries and material status were checked, not an actual external-material reading date. The original verdict date 2026-09-08 and English-wording correction date 2026-09-14 are not new-search or external-full-text-reading dates. | ### S2 Maghbooli M et al. Phytother Res. 2014;28:412-415. PMID: 23657930. DOI: 10.1002/ptr.4996. [PubMed](https://pubmed.ncbi.nlm.nih.gov/23657930/) Materials actually read: Retained summary read; external abstract/full text and plans unread Findings recorded in the summary: Both groups improved; between-group nonsignificance cannot be interpreted as equivalence. Record level: A separate comparison of 100 people, 5 attacks followed and headache severity at two hours. Group analyses, repeated-measure handling, exact between-group estimates/CI and product dose are unverified. Independent replication: The retained S1 direct extract add-on report and S2 powder-versus-sumatriptan active-comparator report address different comparisons. Korean/English text, bibliography, three observation times and repeated attacks are not independent trials. Product-matched independent replication and total unique trials and participants remain unverified. | Material | Public availability | Access status | Actually read | Notes | |---|---|---|---|---| | Retained active-comparator context summary and bibliography | Stored locally | Acquired | Stored existing review summary read | The current retained summary was read. An original clinical-paper file was not acquired. These are links from the retained summary. Original papers, registration and plans were not newly read; unread does not mean no research, no effect or safety. 2026-10-06 is the date retained summaries and material status were checked, not an actual external-material reading date. The original verdict date 2026-09-08 and English-wording correction date 2026-09-14 are not new-search or external-full-text-reading dates. | | PubMed original-report entry | Unverified | Access not attempted | Not read | Entry linked from the retained bibliographic URL/PMID; response, identity and abstract were not checked this time. These are links from the retained summary. Original papers, registration and plans were not newly read; unread does not mean no research, no effect or safety. 2026-10-06 is the date retained summaries and material status were checked, not an actual external-material reading date. The original verdict date 2026-09-08 and English-wording correction date 2026-09-14 are not new-search or external-full-text-reading dates. | | Publisher DOI entry; full text unverified | Unverified | Access not attempted | Not read | Entry constructed from the retained DOI. Actual full-text existence, public availability, acquisition and reading remain unverified. These are links from the retained summary. Original papers, registration and plans were not newly read; unread does not mean no research, no effect or safety. 2026-10-06 is the date retained summaries and material status were checked, not an actual external-material reading date. The original verdict date 2026-09-08 and English-wording correction date 2026-09-14 are not new-search or external-full-text-reading dates. | | Active-comparator design and noninferiority/repeated-attack analysis material | Unverified | Access not attempted | Not read | Locations of prospective margin, CI, repeated-measure and group-analysis material for this separate comparison remain unverified. These are links from the retained summary. Original papers, registration and plans were not newly read; unread does not mean no research, no effect or safety. 2026-10-06 is the date retained summaries and material status were checked, not an actual external-material reading date. The original verdict date 2026-09-08 and English-wording correction date 2026-09-14 are not new-search or external-full-text-reading dates. | ## Review criteria and methods These are Chamgap's own application conditions, informed by the relevant sections of official methodological guidance. They do not constitute official assessment-tool certification or a new efficacy score. - M03 [Cochrane Handbook 6.5 (2024), chapter updated 2023-08](https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-03) · §3.1, §3.2.1–3.2.3, MECIR C5/C7/C13 · Clearly record the question, eligibility conditions and reasons for changes, and distinguish variations in interventions. · Retained method-application records were reused. External originals were not reread and method content was not reassessed. - M04 [Cochrane Handbook 6.5.1 (2025), chapter updated 2025-03](https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-04) · §4.5, §4.6.1–4.6.3, MECIR C42 · Distinguish studies from reports and link them; do not omit a study solely because results are unreported. · Retained method-application records were reused. External originals were not reread and method content was not reassessed. - M08 [Cochrane Handbook 6.5 (2024), chapter updated 2019-10](https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-08) · §8.1–8.2.3, Table 8.2.a · Define the outcome and effect of interest, then examine randomization, deviations, missing data, measurement and selective reporting. · Retained method-application records were reused. External originals were not reread and method content was not reassessed. - M15 [Cochrane Handbook 6.5 (2024), chapter updated 2023-08](https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-15) · §15.2.4, §15.3.1–15.3.3 · Distinguish effect estimates, intervals, importance and applicability. Sample size alone does not determine precision. · Retained method-application records were reused. External originals were not reread and method content was not reassessed. - M19 [Cochrane Handbook 6.5 (2024), chapter updated 2019-10](https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-19) · §19.1.2, §19.2.1–19.2.4 · Harm questions may require different designs, populations and follow-up from efficacy questions. Case reports do not establish incidence rates. · Retained method-application records were reused. External originals were not reread and method content was not reassessed. ## What the statuses mean - 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. ## Change history 2026-10-25 · Public page/materials 1.0. The public view and materials were prepared from the existing 35 items. No new clinical search, verification-state change or scoring was performed.