{ "schema_version": "chamgap-public-evidence-check-1.0", "public_id": "v3056-main", "verdict_number": "3056", "title": "Ginger extract 400 mg standardized to 5% active ingredient as add-on therapy × Improvement of 2-hour pain-relief response in acute migraine", "view_version": "1.0", "view_created_date": "2026-10-25", "criteria_version": "1.0", "criteria_date": "2026-10-06", "review_date": "2026-10-06", "legacy_evidence_date": "2026-09-08", "review_scope": { "materials_read": "Retained Korean/English summaries and case-specific condition/application records", "clinical_papers_directly_read": false, "new_clinical_search": false, "limitation": "Prepared from retained summaries and condition-application records. External abstracts, full texts, registration, protocols and analysis plans remain unread. Historical review records do not establish current independent clinical validation.", "date_meaning": "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." }, "claim_context": { "population": "60 adults presenting to an emergency department with episodic migraine, 1–6 attacks per month", "intervention": "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", "endpoint": "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", "excluded_extensions": [ "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." ] }, "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.", "current_reports": [ "S1" ], "existence": "Stored research/bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original manufacturing/support/harm material remain separately unverified.", "acquired_read": "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.", "observation": "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.", "condition_status": "Met", "status_reason": "Limited to identifying the question in the current retained summary. This is not verification of clinical efficacy or full-text review.", "missingness": "Limited to identifying the question in the current retained summary. This is not verification of clinical efficacy or full-text review.", "uncertainty": "Limited to identifying the question in the current retained summary. This is not verification of clinical efficacy or full-text review.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "The current original wording and new comparison specification if the question boundary changes" }, { "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.", "current_reports": [ "S1", "S2" ], "existence": "Stored research/bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original manufacturing/support/harm material remain separately unverified.", "acquired_read": "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.", "observation": "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.", "condition_status": "Partly verified", "status_reason": "The current original record was checked, but specific clinical values behind generic English wording and past independent verification were not newly certified.", "missingness": "The current original record was checked, but specific clinical values behind generic English wording and past independent verification were not newly certified.", "uncertainty": "The current original record was checked, but specific clinical values behind generic English wording and past independent verification were not newly certified.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "Historical source material establishing the specific English correspondence and correction scope" }, { "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.", "current_reports": [ "S1" ], "existence": "Stored research/bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original manufacturing/support/harm material remain separately unverified.", "acquired_read": "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.", "observation": "The retained formulation is a 400 mg capsule with 5% active ingredient; the detailed gingerol/shogaol composition is unverified.", "condition_status": "Partly verified", "status_reason": "Nominal labeling cannot establish individual active-compound contents or product equivalence.", "missingness": "Nominal labeling cannot establish individual active-compound contents or product equivalence.", "uncertainty": "Nominal labeling cannot establish individual active-compound contents or product equivalence.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "Trial-product manufacturing, batch, quantitative-assay and composition documentation" }, { "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.", "current_reports": [ "S1" ], "existence": "Stored research/bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original manufacturing/support/harm material remain separately unverified.", "acquired_read": "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.", "observation": "This is oral add-on therapy; the comparator is common IV ketoprofen 100 mg plus cellulose placebo.", "condition_status": "Met", "status_reason": "Confirms only the retained comparison specification. Add-on effect magnitude and details of concomitant-care management remain unverified in other items.", "missingness": "Confirms only the retained comparison specification. Add-on effect magnitude and details of concomitant-care management remain unverified in other items.", "uncertainty": "Confirms only the retained comparison specification. Add-on effect magnitude and details of concomitant-care management remain unverified in other items.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "Administration procedures and concomitant-treatment tables for both groups" }, { "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.", "current_reports": [ "S1" ], "existence": "Stored research/bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original manufacturing/support/harm material remain separately unverified.", "acquired_read": "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.", "observation": "The record describes 60 adults presenting to an emergency department with episodic migraine, 1–6 attacks per month.", "condition_status": "Partly verified", "status_reason": "Detailed diagnostic criteria, age distribution, eligibility/exclusions and baseline balance could not be established from the current summary.", "missingness": "Detailed diagnostic criteria, age distribution, eligibility/exclusions and baseline balance could not be established from the current summary.", "uncertainty": "Detailed diagnostic criteria, age distribution, eligibility/exclusions and baseline balance could not be established from the current summary.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "Complete eligibility/exclusion criteria and baseline-characteristics table" }, { "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.", "current_reports": [ "S1" ], "existence": "Stored research/bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original manufacturing/support/harm material remain separately unverified.", "acquired_read": "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.", "observation": "The principal endpoint is 2-hour clinical pain-relief response; the original record explicitly distinguishes it from pain freedom.", "condition_status": "Partly verified", "status_reason": "The exact response definition, scale and event counts remain unverified within the retained scope.", "missingness": "The exact response definition, scale and event counts remain unverified within the retained scope.", "uncertainty": "The exact response definition, scale and event counts remain unverified within the retained scope.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "Response-classification criteria, pain scale and result tables" }, { "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.", "current_reports": [ "S1" ], "existence": "Stored research/bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original manufacturing/support/harm material remain separately unverified.", "acquired_read": "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.", "observation": "Single administration and 2-hour follow-up are recorded, with separate P values at 1 hour, 1.5 hours and 2 hours.", "condition_status": "Met", "status_reason": "Only the current time attribution is confirmed; long-term persistence is not addressed.", "missingness": "Only the current time attribution is confirmed; long-term persistence is not addressed.", "uncertainty": "Only the current time attribution is confirmed; long-term persistence is not addressed.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "Administration/measurement schedule and subsequent follow-up" }, { "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.", "current_reports": [ "S1" ], "existence": "Stored research/bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original manufacturing/support/harm material remain separately unverified.", "acquired_read": "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.", "observation": "S1 corresponds to the direct placebo-add-on evidence summary[0] and the Martins 2019 bibliography entry.", "condition_status": "Partly verified", "status_reason": "Local linkage was checked, but external identity, registration family and total unique trials/participants remain unestablished.", "missingness": "Local linkage was checked, but external identity, registration family and total unique trials/participants remain unestablished.", "uncertainty": "Local linkage was checked, but external identity, registration family and total unique trials/participants remain unestablished.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "Original paper, related reports and registration history" }, { "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.", "current_reports": [ "S2" ], "existence": "Stored research/bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original manufacturing/support/harm material remain separately unverified.", "acquired_read": "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.", "observation": "S2 reports ginger powder versus sumatriptan, 100 people followed over 5 attacks and headache severity at two hours. Its comparison specification differs from S1.", "condition_status": "Met", "status_reason": "Confirms only attribution of this related report. S2 product dose, group analyses and repeated-measure handling have not been verified.", "missingness": "Confirms only attribution of this related report. S2 product dose, group analyses and repeated-measure handling have not been verified.", "uncertainty": "Confirms only attribution of this related report. S2 product dose, group analyses and repeated-measure handling have not been verified.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "Active-comparator full text and analyses at participant and attack levels" }, { "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.", "current_reports": [ "S1", "S2" ], "existence": "Stored research/bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original manufacturing/support/harm material remain separately unverified.", "acquired_read": "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.", "observation": "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.", "condition_status": "Met", "status_reason": "Confirms summary reading. Historical research-description wording is a past record, not full-text reading in this review.", "missingness": "Confirms summary reading. Historical research-description wording is a past record, not full-text reading in this review.", "uncertainty": "Confirms summary reading. Historical research-description wording is a past record, not full-text reading in this review.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "Actual acquisition and reading records for original papers and registration/protocols" }, { "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.", "current_reports": [ "S1" ], "existence": "Stored research/bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original manufacturing/support/harm material remain separately unverified.", "acquired_read": "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.", "observation": "NCT02568644 appears in Korean/English research descriptions and bibliography, while S1's evidence-summary registration status is unverified.", "condition_status": "Partly verified", "status_reason": "Registration identity, the actual historical version and access/planning comparisons were not checked this time. Different record levels are not arbitrarily harmonized.", "missingness": "Registration identity, the actual historical version and access/planning comparisons were not checked this time. Different record levels are not arbitrarily harmonized.", "uncertainty": "Registration identity, the actual historical version and access/planning comparisons were not checked this time. Different record levels are not arbitrarily harmonized.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "NCT02568644 initial registration, amendment history and paper correspondence" }, { "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.", "current_reports": [ "S1", "S2" ], "existence": "Stored research/bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original manufacturing/support/harm material remain separately unverified.", "acquired_read": "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.", "observation": "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.", "condition_status": "Partly verified", "status_reason": "The search cutoff and full scope of registration/publication/retraction checks were not newly verified.", "missingness": "The search cutoff and full scope of registration/publication/retraction checks were not newly verified.", "uncertainty": "The search cutoff and full scope of registration/publication/retraction checks were not newly verified.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "Historical search records and report-level access receipts" }, { "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.", "current_reports": [ "S1" ], "existence": "Stored research/bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original manufacturing/support/harm material remain separately unverified.", "acquired_read": "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.", "observation": "S1 is described as a randomized, double-blind, placebo-add-on trial.", "condition_status": "Partly verified", "status_reason": "Actual sequence-generation/concealment methods, design unit and baseline balance are absent from the summary. Nonreporting throughout the paper remains unverified.", "missingness": "Actual sequence-generation/concealment methods, design unit and baseline balance are absent from the summary. Nonreporting throughout the paper remains unverified.", "uncertainty": "Actual sequence-generation/concealment methods, design unit and baseline balance are absent from the summary. Nonreporting throughout the paper remains unverified.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "Methods section, allocation sequence/concealment and baseline table" }, { "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.", "current_reports": [ "S1" ], "existence": "Stored research/bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original manufacturing/support/harm material remain separately unverified.", "acquired_read": "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.", "observation": "The double-blind design and cellulose placebo are retained, with pain relief as the selected endpoint.", "condition_status": "Partly verified", "status_reason": "Maintenance/success of blinding, assessors and measurement-classification details remain unverified.", "missingness": "Maintenance/success of blinding, assessors and measurement-classification details remain unverified.", "uncertainty": "Maintenance/success of blinding, assessors and measurement-classification details remain unverified.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "Original capsule-matching, assessor-procedure and response-scale descriptions" }, { "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.", "current_reports": [ "S1" ], "existence": "Stored research/bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original manufacturing/support/harm material remain separately unverified.", "acquired_read": "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.", "observation": "S1's recorded sample size is 60 randomized; the population description also states 60 emergency-department adults.", "condition_status": "Partly verified", "status_reason": "Group allocation, measurement, analysis and completion counts remain unverified from the current material.", "missingness": "Group allocation, measurement, analysis and completion counts remain unverified from the current material.", "uncertainty": "Group allocation, measurement, analysis and completion counts remain unverified from the current material.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "Group participant-flow table and denominator definitions" }, { "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.", "current_reports": [ "S1" ], "existence": "Stored research/bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original manufacturing/support/harm material remain separately unverified.", "acquired_read": "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.", "observation": "Only the overall 60 randomized are available; time-specific completion/missing counts are not linked.", "condition_status": "Unverified", "status_reason": "The occurrence, reasons and handling of missing data and their effect on results cannot be judged from the retained scope.", "missingness": "The occurrence, reasons and handling of missing data and their effect on results cannot be judged from the retained scope.", "uncertainty": "The occurrence, reasons and handling of missing data and their effect on results cannot be judged from the retained scope.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "Group/time-specific analysis denominators and missing-data handling" }, { "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.", "current_reports": [ "S1" ], "existence": "Stored research/bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original manufacturing/support/harm material remain separately unverified.", "acquired_read": "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.", "observation": "The 2-hour P value is .04; the original summary explicitly identifies event counts, RR and 95% CI as unverified.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "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.", "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.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "2-hour group event counts/denominators and reported effect estimates with CI" }, { "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.", "current_reports": [ "S1" ], "existence": "Stored research/bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original manufacturing/support/harm material remain separately unverified.", "acquired_read": "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.", "observation": "The record states 1 hour P=.04, 1.5 hours P=.01 and 2 hours P=.04.", "condition_status": "Partly verified", "status_reason": "Planning material establishing the prospective hierarchy of multiple times, multiplicity handling and completeness of reporting has not been acquired.", "missingness": "Planning material establishing the prospective hierarchy of multiple times, multiplicity handling and completeness of reporting has not been acquired.", "uncertainty": "Planning material establishing the prospective hierarchy of multiple times, multiplicity handling and completeness of reporting has not been acquired.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "Time-specific plans, hypothesis hierarchy, multiplicity control and complete results" }, { "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.", "current_reports": [ "S1" ], "existence": "Stored research/bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original manufacturing/support/harm material remain separately unverified.", "acquired_read": "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.", "observation": "Korean/English reader answers describe pain relief as the prespecified principal endpoint. A registration-identifier clue exists, while the structured registration status is unverified.", "condition_status": "Partly verified", "status_reason": "Initial registration/plans/SAP were not read this time, so prospective hierarchy and reasons for amendments are not directly certified.", "missingness": "Initial registration/plans/SAP were not read this time, so prospective hierarchy and reasons for amendments are not directly certified.", "uncertainty": "Initial registration/plans/SAP were not read this time, so prospective hierarchy and reasons for amendments are not directly certified.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "Initial registration, protocol/SAP and amendment dates" }, { "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.", "current_reports": [ "S1" ], "existence": "Stored research/bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original manufacturing/support/harm material remain separately unverified.", "acquired_read": "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.", "observation": "Common IV ketoprofen 100 mg is specified, but rescue medication, adherence and concomitant-treatment changes are not linked in the summary.", "condition_status": "Partly verified", "status_reason": "Additional treatment, rescue use and their effects on outcome analysis remain unverified.", "missingness": "Additional treatment, rescue use and their effects on outcome analysis remain unverified.", "uncertainty": "Additional treatment, rescue use and their effects on outcome analysis remain unverified.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "Group concomitant treatment, rescue care, adherence, timing and analytic handling" }, { "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.", "current_reports": [ "S1" ], "existence": "Stored research/bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original manufacturing/support/harm material remain separately unverified.", "acquired_read": "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.", "observation": "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.", "condition_status": "Unverified", "status_reason": "ITT/PP and the definition of assignment/adherence effects cannot be established from the current source material.", "missingness": "ITT/PP and the definition of assignment/adherence effects cannot be established from the current source material.", "uncertainty": "ITT/PP and the definition of assignment/adherence effects cannot be established from the current source material.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "Analysis plan, analysis population, model and effect definition" }, { "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.", "current_reports": [ "S2" ], "existence": "Stored research/bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original manufacturing/support/harm material remain separately unverified.", "acquired_read": "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.", "observation": "S2 records improvement in both groups, states that between-group nonsignificance cannot establish equivalence and describes the design as not noninferiority.", "condition_status": "Met", "status_reason": "Confirms only the retained result's interpretation boundary. External checks of exact between-group estimates, CI and trial design remain incomplete.", "missingness": "Confirms only the retained result's interpretation boundary. External checks of exact between-group estimates, CI and trial design remain incomplete.", "uncertainty": "Confirms only the retained result's interpretation boundary. External checks of exact between-group estimates, CI and trial design remain incomplete.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "Active-comparator protocol, noninferiority margin/CI and analysis method" }, { "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.", "current_reports": [ "S1" ], "existence": "Stored research/bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original manufacturing/support/harm material remain separately unverified.", "acquired_read": "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.", "observation": "The retained direct question concerns only a single 400 mg dose; no optimal-dose comparison evidence is linked.", "condition_status": "Unverified", "status_reason": "This does not claim all dose studies are absent. Optimal dose/dose response could not be established within the current input scope.", "missingness": "This does not claim all dose studies are absent. Optimal dose/dose response could not be established within the current input scope.", "uncertainty": "This does not claim all dose studies are absent. Optimal dose/dose response could not be established within the current input scope.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "Direct dose groups, batch composition and estimates/CI" }, { "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.", "current_reports": [ "S1" ], "existence": "Stored research/bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original manufacturing/support/harm material remain separately unverified.", "acquired_read": "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.", "observation": "The original scope note states that only 2-hour pain relief is judged; pain freedom, recurrence and prevention are separate.", "condition_status": "Met", "status_reason": "Only the current extension boundary is confirmed. Evidence quantity and effects for each extension were not reviewed this time.", "missingness": "Only the current extension boundary is confirmed. Evidence quantity and effects for each extension were not reviewed this time.", "uncertainty": "Only the current extension boundary is confirmed. Evidence quantity and effects for each extension were not reviewed this time.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "Subsequent follow-up, recurrence definitions and separate prevention material" }, { "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.", "current_reports": [ "S1", "S2" ], "existence": "Stored research/bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original manufacturing/support/harm material remain separately unverified.", "acquired_read": "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.", "observation": "S1 direct add-on reporting is distinguished from S2 active-comparator context; the existing R1/I2 values are historical axes.", "condition_status": "Unverified", "status_reason": "The 2 retained reports alone do not establish total unique trials/participants or product-matched independent replication.", "missingness": "The 2 retained reports alone do not establish total unique trials/participants or product-matched independent replication.", "uncertainty": "The 2 retained reports alone do not establish total unique trials/participants or product-matched independent replication.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "Original trial families, related reports, product matching and trial-specific results" }, { "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.", "current_reports": [ "S1", "S2" ], "existence": "Stored research/bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original manufacturing/support/harm material remain separately unverified.", "acquired_read": "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.", "observation": "S1 describes university research with product/funding details unverified; S2 has funding/product details unverified.", "condition_status": "Partly verified", "status_reason": "Funding, manufacturer support, author employment/patents and declared COI were not checked in the original papers this time.", "missingness": "Funding, manufacturer support, author employment/patents and declared COI were not checked in the original papers this time.", "uncertainty": "Funding, manufacturer support, author employment/patents and declared COI were not checked in the original papers this time.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "Original funding, product-provision and author/COI statements for both reports" }, { "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.", "current_reports": [ "S1" ], "existence": "Stored research/bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original manufacturing/support/harm material remain separately unverified.", "acquired_read": "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.", "observation": "Retained safety information concerns cautions about NSAID contraindications, gastrointestinal/renal/bleeding risks and interactions with other migraine medicines; no event table is retained.", "condition_status": "Unverified", "status_reason": "Event names, collection/adjudication, severity and discontinuation could not be established from the current summary. Nonreporting throughout the original paper remains unverified.", "missingness": "Event names, collection/adjudication, severity and discontinuation could not be established from the current summary. Nonreporting throughout the original paper remains unverified.", "uncertainty": "Event names, collection/adjudication, severity and discontinuation could not be established from the current summary. Nonreporting throughout the original paper remains unverified.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "S1 safety-result tables and event/collection definitions" }, { "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.", "current_reports": [ "S1" ], "existence": "Stored research/bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original manufacturing/support/harm material remain separately unverified.", "acquired_read": "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.", "observation": "Single administration and 2-hour efficacy follow-up are retained, but an event-onset/recovery timeline is not linked.", "condition_status": "Unverified", "status_reason": "Harm onset/recovery, latency, discontinuation and re-exposure remain unverified.", "missingness": "Harm onset/recovery, latency, discontinuation and re-exposure remain unverified.", "uncertainty": "Harm onset/recovery, latency, discontinuation and re-exposure remain unverified.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "Harm-onset/recovery and discontinuation/re-exposure records" }, { "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.", "current_reports": [ "S1" ], "existence": "Stored research/bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original manufacturing/support/harm material remain separately unverified.", "acquired_read": "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.", "observation": "The efficacy comparison is common ketoprofen plus ginger extract versus common ketoprofen plus placebo. The summary does not provide between-group safety results.", "condition_status": "Unverified", "status_reason": "Comparative-harm estimates were not verified; this does not mean both groups were safe or the difference was 0.", "missingness": "Comparative-harm estimates were not verified; this does not mean both groups were safe or the difference was 0.", "uncertainty": "Comparative-harm estimates were not verified; this does not mean both groups were safe or the difference was 0.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "Group safety events, denominators and reported risk estimates/CI" }, { "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.", "current_reports": [ "S1" ], "existence": "Stored research/bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original manufacturing/support/harm material remain separately unverified.", "acquired_read": "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.", "observation": "Beyond the overall 60 randomized, safety-exposure/analysis denominators and event counts are not currently linked.", "condition_status": "Unverified", "status_reason": "Incidence, risk ratios and overall event totals cannot be calculated or established.", "missingness": "Incidence, risk ratios and overall event totals cannot be calculated or established.", "uncertainty": "Incidence, risk ratios and overall event totals cannot be calculated or established.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "Safety-analysis population, group event counts and exposure time" }, { "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.", "current_reports": [ "S1" ], "existence": "Stored research/bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original manufacturing/support/harm material remain separately unverified.", "acquired_read": "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.", "observation": "Common ketoprofen 100 mg and caution wording about interactions with other medicines are retained.", "condition_status": "Partly verified", "status_reason": "Actual individual concomitant use, baseline events, alternative causes and adjustment are unverified. Original caution wording is not evidence of causality for observed events.", "missingness": "Actual individual concomitant use, baseline events, alternative causes and adjustment are unverified. Original caution wording is not evidence of causality for observed events.", "uncertainty": "Actual individual concomitant use, baseline events, alternative causes and adjustment are unverified. Original caution wording is not evidence of causality for observed events.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "Concomitant medicines, baseline risk and event-specific alternative causes/adjustment" }, { "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.", "current_reports": [ "S1" ], "existence": "Stored research/bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original manufacturing/support/harm material remain separately unverified.", "acquired_read": "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.", "observation": "The current summary contains caution wording, while safety collection/follow-up and event-disclosure scope remain unverified.", "condition_status": "Unverified", "status_reason": "Collection methods, follow-up losses and detection differences in the original full text were not compared this time.", "missingness": "Collection methods, follow-up losses and detection differences in the original full text were not compared this time.", "uncertainty": "Collection methods, follow-up losses and detection differences in the original full text were not compared this time.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "Safety collection, follow-up/attrition and disclosure scope" }, { "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.", "current_reports": [ "S1", "S2" ], "existence": "Stored research/bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original manufacturing/support/harm material remain separately unverified.", "acquired_read": "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.", "observation": "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.", "condition_status": "Unverified", "status_reason": "Unique harm-event counts and repetition of the same event cannot be established from the current input.", "missingness": "Unique harm-event counts and repetition of the same event cannot be established from the current input.", "uncertainty": "Unique harm-event counts and repetition of the same event cannot be established from the current input.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "Original event data, families/related reports and exposure matching" }, { "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.", "current_reports": [ "S1" ], "existence": "Stored research/bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original manufacturing/support/harm material remain separately unverified.", "acquired_read": "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.", "observation": "Original cautions mention NSAID contraindications, gastrointestinal/renal/bleeding risks and interactions with other migraine medicines; direct efficacy concerns one dose and 2 hours.", "condition_status": "Unverified", "status_reason": "Actual denominators/frequencies in vulnerable groups and long-term/rare events, and interaction estimates, remain unverified.", "missingness": "Actual denominators/frequencies in vulnerable groups and long-term/rare events, and interaction estimates, remain unverified.", "uncertainty": "Actual denominators/frequencies in vulnerable groups and long-term/rare events, and interaction estimates, remain unverified.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "Vulnerable-group, long-term/rare-event and concomitant-treatment material" }, { "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.", "current_reports": [ "S1" ], "existence": "Stored research/bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original manufacturing/support/harm material remain separately unverified.", "acquired_read": "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.", "observation": "The existing Caution label and cautions about medical care/concomitant ketoprofen are retained; no new safety conclusion is made.", "condition_status": "Partly verified", "status_reason": "Original cautions are retained information. Observed harms, incidence, causality or safety are not currently established.", "missingness": "Original cautions are retained information. Observed harms, incidence, causality or safety are not currently established.", "uncertainty": "Original cautions are retained information. Observed harms, incidence, causality or safety are not currently established.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "Original material linking events, exposure, comparison, time and alternative explanations" } ], "reports": [ { "report_id": "S1", "title": "Martins LB et al. Cephalalgia. 2019;39:68-76. PMID: 29768938. DOI: 10.1177/0333102418776016. NCT02568644.", "url": "https://pubmed.ncbi.nlm.nih.gov/29768938/", "report_type": "Placebo-controlled report of ginger extract added to common ketoprofen", "existence": "Stored research/bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original manufacturing/support/harm material remain separately unverified.", "acquired_read": "Retained summary read; external abstract/full text, registration and plans unread", "study_family": "Martins 2019 · PMID29768938 direct add-on report clue; registration and related-report identities not cross-checked", "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.", "observed_result": "1 hour P=.04, 1.5 hours P=.01, 2 hours P=.04; event counts, RR and 95% CI unverified", "result_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.", "source_evidence_date": "2026-09-08", "materials": [ { "material_type": "Retained direct add-on summary and bibliography", "public_status": "Stored locally", "access_status": "Acquired", "acquired": true, "actually_read": "Stored existing review summary read", "as_of": "2026-10-06", "qualification": "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." }, { "material_type": "PubMed original-report entry", "public_status": "Unverified", "access_status": "Access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-10-06", "qualification": "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." }, { "material_type": "Publisher DOI entry; full text unverified", "public_status": "Unverified", "access_status": "Access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-10-06", "qualification": "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." }, { "material_type": "NCT02568644 registration entry; history not cross-checked", "public_status": "Unverified", "access_status": "Access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-10-06", "qualification": "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." }, { "material_type": "Protocol/analysis plan for the principal endpoint, multiple time points and ITT", "public_status": "Unverified", "access_status": "Access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-10-06", "qualification": "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." }, { "material_type": "Trial-extract product, batch and quantitative-assay material", "public_status": "Unverified", "access_status": "Access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-10-06", "qualification": "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." } ], "links": [ { "label": "PubMed", "url": "https://pubmed.ncbi.nlm.nih.gov/29768938/" } ] }, { "report_id": "S2", "title": "Maghbooli M et al. Phytother Res. 2014;28:412-415. PMID: 23657930. DOI: 10.1002/ptr.4996.", "url": "https://pubmed.ncbi.nlm.nih.gov/23657930/", "report_type": "Separate ginger-powder versus sumatriptan active-comparator context report", "existence": "Stored research/bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original manufacturing/support/harm material remain separately unverified.", "acquired_read": "Retained summary read; external abstract/full text and plans unread", "study_family": "Maghbooli 2014 · PMID23657930 active-comparator report clue; not replication of the direct extract add-on comparison", "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.", "observed_result": "Both groups improved; between-group nonsignificance cannot be interpreted as equivalence.", "result_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.", "source_evidence_date": "2026-09-08", "materials": [ { "material_type": "Retained active-comparator context summary and bibliography", "public_status": "Stored locally", "access_status": "Acquired", "acquired": true, "actually_read": "Stored existing review summary read", "as_of": "2026-10-06", "qualification": "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." }, { "material_type": "PubMed original-report entry", "public_status": "Unverified", "access_status": "Access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-10-06", "qualification": "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." }, { "material_type": "Publisher DOI entry; full text unverified", "public_status": "Unverified", "access_status": "Access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-10-06", "qualification": "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." }, { "material_type": "Active-comparator design and noninferiority/repeated-attack analysis material", "public_status": "Unverified", "access_status": "Access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-10-06", "qualification": "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." } ], "links": [ { "label": "PubMed", "url": "https://pubmed.ncbi.nlm.nih.gov/23657930/" } ] } ], "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." }, "study_overlap": { "state": "Unverified", "unique_trial_count": null, "unique_participant_count": null, "reason": "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." }, "history": [ { "date": "2026-10-25", "kind": "Separation of public-facing pages and materials", "view_version": "1.0", "change": "The public view and materials were prepared from the existing 35 items. No new clinical search, verification-state change or scoring was performed." } ], "language": "en", "translation_date": "2026-10-25" }