{ "schema_version": "chamgap-public-evidence-check-1.0", "public_id": "v3054-main", "verdict_number": "3054", "title": "Ginger-rhizome powder capsules × Reduction of PBAC-assessed menstrual blood loss in heavy menstrual bleeding", "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 retained-summary review date; no external-material reading date is recorded. 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. Application after condition freezing is distinguished from historical self-review and display-change records." }, "claim_context": { "population": "Adolescents aged 15–18 with normal BMI, regular menstrual cycles and PBAC-assessed heavy menstrual bleeding", "intervention": "Dried rhizome powder of Zingiber officinale Roscoe · 250 mg powder capsules · oral", "dose": "250 mg 3 times daily; 4 days from the day before menstruation through day 3, with a reported total of 750 mg/day", "comparator": "Lactose placebo matched in appearance", "endpoint": "PBAC-based menstrual-blood-loss score per cycle; not directly measured mL", "duration": "3 baseline cycles followed by 3 treatment cycles", "excluded_extensions": [ "Separate effects on dysmenorrhea, duration, hemoglobin, anemia or quality of life", "Converting PBAC scores into directly measured blood volume", "Extending to general adults, abnormal BMI, irregular cycles or other causes of bleeding", "Substituting other foods, extracts, essential oils, topical or combination products, or doses", "Establishing an optimal dose, persistence after stopping or long-term effects", "Establishing overall safety, causal harms, incidence, self-treatment or replacement of medical care" ] }, "requirements": [ { "item_id": "N01", "question_type": "Evidence condition", "question": "Which ginger and PBAC question is linked to the original claim?", "needed": "Original Korean/English effect, population/intervention details, scope note and final boundary document", "role": "Required", "role_reason": "Needed to avoid merging ginger as a whole or dysmenorrhea questions with this adolescent PBAC bleeding-measure question.", "application_exception": "Pain, duration, hemoglobin and other formulations/populations are not added as separate efficacy claims within this table.", "criterion": "Link the original effect, both language versions of the population/intervention details and final boundaries to identify the powder/oral/cycle-specific dosing/narrow adolescent/placebo/PBAC 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 adolescent heavy menstrual bleeding assessed by PBAC, ginger powder and lactose placebo. They do not establish blinding, clinical-trial preregistration, official-tool certification or new independent clinical validation.", "proposed_research": "Material needed: Original Korean/English effect, population/intervention details, scope note and final boundary document. 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 selected comparison is lactose placebo versus oral dried rhizome powder, 250 mg 3 times daily, from the day before menstruation through day 3 for 4 days per cycle over 3 intervention cycles, in adolescents aged 15–18 with normal BMI, regular cycles and PBAC-assessed heavy bleeding. The original effect is reduction in the PBAC menstrual-blood-loss score.", "condition_status": "Met", "status_reason": "The original effect, both language versions of the population/intervention details, and the summary's single PBAC question are linked. This verifies question identity, not approval of treatment efficacy.", "missingness": "Other formulations, causes of bleeding, populations, pain, duration and Hb are not treated as outcomes of this question.", "uncertainty": "Other formulations, causes of bleeding, populations, pain, duration and Hb are not treated as outcomes of this question.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "Original Korean/English effect, population/intervention details, scope note and final boundary document" }, { "item_id": "N02", "question_type": "Evidence condition", "question": "How are the sole report, bibliography entry and trial family related?", "needed": "Report/bibliographic identity and a linkage table for registration and related reports", "role": "Required", "role_reason": "Needed to avoid counting one evidence entry and one bibliography entry as two independent trials.", "application_exception": "Verify the bibliographic link without inferring unique trial or participant totals from unread registration or related reports.", "criterion": "Link the retained Kashefi2015 report to its PMID/DOI bibliography, distinguishing a provisional family from unconfirmed unique totals.", "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 adolescent heavy menstrual bleeding assessed by PBAC, ginger powder and lactose placebo. They do not establish blinding, clinical-trial preregistration, official-tool certification or new independent clinical validation.", "proposed_research": "Material needed: Report/bibliographic identity and a linkage table for registration and related reports. 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 1 retained evidence entry and 1 bibliography entry are linked to the same direct report, Kashefi F et al. 2015, PMID25298352/DOI10.1002/ptr.5235. The record describes a sole direct trial and a single research team.", "condition_status": "Partly verified", "status_reason": "The report/bibliographic link is verified and S1 is grouped into one provisional trial family. External registration and the full set of related reports remain unread, so official unique trial and participant totals remain unverified.", "missingness": "Registration, related reports, detailed cohort identifiers and participant overlap remain unverified. A report and bibliography entry are not 2 independent replications.", "uncertainty": "Registration, related reports, detailed cohort identifiers and participant overlap remain unverified. A report and bibliography entry are not 2 independent replications.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "Report/bibliographic identity and a linkage table for registration and related reports" }, { "item_id": "N03", "question_type": "Evidence condition", "question": "What summary, abstract and full-text material was actually read?", "needed": "Material-specific actual access/acquisition/reading records and source provenance", "role": "Required", "role_reason": "Needed to avoid retrospectively turning historical wording about accessible-full-text comparison into full-text reading in this work.", "application_exception": "Do not relabel unattempted external access as inaccessible, or an existing link as full-text reading.", "criterion": "Link the current retained summary and its provenance while separately showing unread external PubMed/DOI 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 adolescent heavy menstrual bleeding assessed by PBAC, ginger powder and lactose placebo. They do not establish blinding, clinical-trial preregistration, official-tool certification or new independent clinical validation.", "proposed_research": "Material needed: Material-specific actual access/acquisition/reading records and source provenance. 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": "What was read in this work was the whole retained verdict and its linked report/bibliographic summary. The original research description records historical comparison with an abstract and accessible full text, but there were 0 external PubMed/DOI requests or abstract/full-text readings in this work.", "condition_status": "Met", "status_reason": "Retained-summary reading and unread external material are separated according to actual actions. The summary link identifies provenance in the retained record; historical wording is not reused as a full-text-reading badge.", "missingness": "Current external responses, public availability, original article bytes, full text, supplements and registration access were not verified. No inaccessible status is assigned.", "uncertainty": "Current external responses, public availability, original article bytes, full text, supplements and registration access were not verified. No inaccessible status is assigned.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "Material-specific actual access/acquisition/reading records and source provenance" }, { "item_id": "N04", "question_type": "Evidence condition", "question": "Which adolescents and bleeding conditions produced these data?", "needed": "Eligibility/exclusion table, PBAC criterion, assessment of bleeding causes and arm-level baseline table", "role": "Required", "role_reason": "Needed to avoid extending the 15–18 age range, normal BMI and regular-cycle conditions to all patients with heavy bleeding.", "application_exception": "Do not substitute this result for effects in other causes of bleeding, anemia, pregnancy, abnormal BMI or irregular cycles.", "criterion": "Distinguish the retained population record from verified or missing eligibility/exclusion, diagnostic and baseline PBAC details.", "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 adolescent heavy menstrual bleeding assessed by PBAC, ginger powder and lactose placebo. They do not establish blinding, clinical-trial preregistration, official-tool certification or new independent clinical validation.", "proposed_research": "Material needed: Eligibility/exclusion table, PBAC criterion, assessment of bleeding causes and arm-level 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": "The retained population is adolescents aged 15–18 with normal BMI, regular cycles and PBAC-assessed heavy bleeding. The original advertising-interpretation section limits application to general adults, anemia, pregnancy-related bleeding or other diseases.", "condition_status": "Partly verified", "status_reason": "The narrow population is verified, but the PBAC eligibility threshold, detailed exclusions/diagnostic testing and arm-level baseline condition are not specified in the current summary.", "missingness": "Details of bleeding-cause assessment, recruitment, PBAC criteria, arm-level baseline characteristics and representativeness remain unverified.", "uncertainty": "Details of bleeding-cause assessment, recruitment, PBAC criteria, arm-level baseline characteristics and representativeness remain unverified.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "Eligibility/exclusion table, PBAC criterion, assessment of bleeding causes and arm-level baseline table" }, { "item_id": "N05", "question_type": "Evidence condition", "question": "Which powder, route and nominal dose were administered?", "needed": "Product specification, batch/content verification and arm-level actual medication/adherence records", "role": "Required", "role_reason": "Needed to avoid treating the dried-rhizome-powder 250 mg capsule as interchangeable with food, standardized extract or essential oil.", "application_exception": "Do not calculate or substitute active-constituent amount or actual intake for the nominal 750 mg/day.", "criterion": "Distinguish the retained plant part, formulation, oral route and 250 mg 3 times daily from unverified product, batch and constituent details.", "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 adolescent heavy menstrual bleeding assessed by PBAC, ginger powder and lactose placebo. They do not establish blinding, clinical-trial preregistration, official-tool certification or new independent clinical validation.", "proposed_research": "Material needed: Product specification, batch/content verification and arm-level actual medication/adherence 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": "The formulation is dried rhizome powder of Zingiber officinale Roscoe in 250 mg capsules, taken orally. The original nominal dose is 250 mg 3 times daily, a reported total of 750 mg/day; it is not interchangeable with foods, extracts, essential oils or combination products.", "condition_status": "Partly verified", "status_reason": "Formulation, route and nominal dose are verified as retained values. Product batch/content and measured medication use are unverified, so full formulation identity is not upgraded to Met.", "missingness": "Manufacturer/batch, active constituents, contamination testing, capsule-content verification and actual intake/adherence remain unverified.", "uncertainty": "Manufacturer/batch, active constituents, contamination testing, capsule-content verification and actual intake/adherence remain unverified.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "Product specification, batch/content verification and arm-level actual medication/adherence records" }, { "item_id": "N06", "question_type": "Evidence condition", "question": "What was the placebo, and which difference was compared?", "needed": "Placebo composition/specification, sensory matching and distribution/concomitant-treatment records", "role": "Required", "role_reason": "Needed to avoid turning an appearance-matched lactose-placebo comparison into an uncontrolled before/after or treatment-replacement comparison.", "application_exception": "Appearance matching alone does not establish complete taste/smell matching or assessor blinding.", "criterion": "Distinguish the dried-powder versus appearance-matched lactose-placebo comparison from unverified sensory/capsule and concomitant-treatment details.", "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 adolescent heavy menstrual bleeding assessed by PBAC, ginger powder and lactose placebo. They do not establish blinding, clinical-trial preregistration, official-tool certification or new independent clinical validation.", "proposed_research": "Material needed: Placebo composition/specification, sensory matching and distribution/concomitant-treatment 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": "The selected comparator is lactose placebo matched in appearance. It is linked to the retained randomized, double-blind, placebo-controlled design, rather than an uncontrolled question based only on the ginger arm's before/after values.", "condition_status": "Partly verified", "status_reason": "Lactose placebo, appearance matching and comparison direction are verified. Smell/taste, capsule specification, actual blinding and arm-level concomitant differences remain separate gaps.", "missingness": "Placebo amount/specification, sensory matching, distribution/concurrent treatment and successful blinding details remain unverified.", "uncertainty": "Placebo amount/specification, sensory matching, distribution/concurrent treatment and successful blinding details remain unverified.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "Placebo composition/specification, sensory matching and distribution/concomitant-treatment records" }, { "item_id": "N07", "question_type": "Evidence condition", "question": "Is the PBAC score directly measured mL?", "needed": "PBAC instrument/score range, scoring education, diary validation and missing-data rules", "role": "Required", "role_reason": "Needed to avoid turning the original article's blood-loss wording into measured volumetric blood loss.", "application_exception": "Do not newly apply a PBAC-to-volume conversion formula or another bleeding scale.", "criterion": "Preserve the original distinction between pictorial PBAC and directly measured mL, while identifying gaps in the scale/scoring, validation and error details.", "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 adolescent heavy menstrual bleeding assessed by PBAC, ginger powder and lactose placebo. They do not establish blinding, clinical-trial preregistration, official-tool certification or new independent clinical validation.", "proposed_research": "Material needed: PBAC instrument/score range, scoring education, diary validation and missing-data rules. 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 central explanation states that the paper's mL wording refers to a pictorial PBAC diary score rather than direct measurement. The reported means 113.73→60.67 and 113.43→110.97 are not presented as directly measured blood volume in mL.", "condition_status": "Partly verified", "status_reason": "The distinction between PBAC scores and directly measured mL is verified. Scoring instruments, education, diary validation and collection-error details cannot be established from the current summary.", "missingness": "PBAC range/scoring, instrument validation, participant education, error/missing-data handling and consistency of measurement between arms remain unverified.", "uncertainty": "PBAC range/scoring, instrument validation, participant education, error/missing-data handling and consistency of measurement between arms remain unverified.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "PBAC instrument/score range, scoring education, diary validation and missing-data rules" }, { "item_id": "N08", "question_type": "Evidence condition", "question": "How do 4 dosing days per cycle differ from 3 intervention cycles?", "needed": "Cycle-specific medication/diary schedule, actual cycle lengths and assessment windows", "role": "Required", "role_reason": "Needed to avoid turning the 4-day dosing window into the full follow-up period or continuous 3-month use.", "application_exception": "Do not calculate cycle lengths, calendar dates or medication-free intervals while they remain unverified.", "criterion": "Link day-before-menstruation through day 3, 4 days per cycle, 3 baseline→3 intervention cycles, and the outcome-assessment window 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 adolescent heavy menstrual bleeding assessed by PBAC, ginger powder and lactose placebo. They do not establish blinding, clinical-trial preregistration, official-tool certification or new independent clinical validation.", "proposed_research": "Material needed: Cycle-specific medication/diary schedule, actual cycle lengths and assessment windows. 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 dosing window is the day before menstruation through day 3, for 4 days per cycle, with 3 baseline cycles followed by 3 intervention cycles observed. The 4 days are a within-cycle medication window, not the full follow-up or continuous-use period.", "condition_status": "Partly verified", "status_reason": "Both language versions of the retained population/intervention details verify the distinction between 4 days per cycle and 3-cycle baseline/intervention periods. Actual cycle dates and assessment/aggregation windows remain unverified.", "missingness": "Actual cycle lengths/medication dates, missed cycles and details of the final assessment window/intervention completion remain unverified.", "uncertainty": "Actual cycle lengths/medication dates, missed cycles and details of the final assessment window/intervention completion remain unverified.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "Cycle-specific medication/diary schedule, actual cycle lengths and assessment windows" }, { "item_id": "N09", "question_type": "Evidence condition", "question": "Which denominators are represented by 92 randomized participants and 71 completers?", "needed": "Arm-level CONSORT flow and PBAC analysis/completion-denominator table", "role": "Required", "role_reason": "Needed to avoid converting total randomized/completed counts into arm-level denominators or analysis counts.", "application_exception": "Do not infer 46/46 allocation, a 71-person ITT population, event rates or attrition rates.", "criterion": "Distinguish the original 92 randomized and 71 completed, leaving arm-level randomized, measured, completed and analyzed counts unverified.", "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 adolescent heavy menstrual bleeding assessed by PBAC, ginger powder and lactose placebo. They do not establish blinding, clinical-trial preregistration, official-tool certification or new independent clinical validation.", "proposed_research": "Material needed: Arm-level CONSORT flow and PBAC analysis/completion-denominator 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 original participant record gives 92 randomized and 71 completed. The retained reader answer and explanation describe 71 completers and largely completer-based results. Arm-level randomized, measured, completed and analyzed counts are not specified.", "condition_status": "Partly verified", "status_reason": "The total 92 randomized and total 71 completed are preserved as different denominators. The 71 are not used as an ITT analysis count or an arm-level denominator, and 46/46 allocation is not inferred.", "missingness": "Arm-level randomized/measured/completed/analyzed/withdrawal denominators and ITT/PP definitions remain unverified. No new attrition or event rate is calculated.", "uncertainty": "Arm-level randomized/measured/completed/analyzed/withdrawal denominators and ITT/PP definitions remain unverified. No new attrition or event rate is calculated.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "Arm-level CONSORT flow and PBAC analysis/completion-denominator table" }, { "item_id": "N10", "question_type": "Evidence condition", "question": "What attrition, missing diaries and handling methods were recorded?", "needed": "Arm-level attrition/missing-diary table and missing-data/sensitivity analyses", "role": "Required", "role_reason": "Needed because a total of 71 completers does not explain the direction of missing-data bias or adequacy of its handling.", "application_exception": "Do not convert the retained substantial-attrition/completer-based description into verified missing-data handling or bias magnitude.", "criterion": "Distinguish the verified scope of arm-level attrition timing/reasons, missing PBAC data, imputation/sensitivity methods and analysis populations.", "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 adolescent heavy menstrual bleeding assessed by PBAC, ginger powder and lactose placebo. They do not establish blinding, clinical-trial preregistration, official-tool certification or new independent clinical validation.", "proposed_research": "Material needed: Arm-level attrition/missing-diary table and missing-data/sensitivity analyses. 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 limitations of 92 randomized/71 completed, substantial attrition and largely completer-based results are preserved. However, the current summary does not identify who left in which cycle and why, or diary missingness, imputation or sensitivity methods.", "condition_status": "Unverified", "status_reason": "Total randomized/completed information cannot determine arm-level missing-data handling or its effect on results. The retained substantial-attrition wording is not quantified as a new bias magnitude or direction.", "missingness": "Arm-level reasons/timing of attrition, missing diaries, imputation/completer selection and sensitivity analyses remain unverified. This does not establish nonreporting throughout the original article.", "uncertainty": "Arm-level reasons/timing of attrition, missing diaries, imputation/completer selection and sensitivity analyses remain unverified. This does not establish nonreporting throughout the original article.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "Arm-level attrition/missing-diary table and missing-data/sensitivity analyses" }, { "item_id": "N11", "question_type": "Evidence condition", "question": "Were the original results and boundaries with dysmenorrhea or other outcomes preserved?", "needed": "Whole current report/bibliography, outcome-specific results and opposing context in the record", "role": "Required", "role_reason": "Needed to avoid keeping only favorable PBAC wording or combining dysmenorrhea evidence as blood-loss replication.", "application_exception": "Do not turn nonselection of another outcome into a null result or an opposing PBAC trial.", "criterion": "Preserve the original PBAC values/P, single-trial limitations and wording separating pain, duration and Hb.", "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 adolescent heavy menstrual bleeding assessed by PBAC, ginger powder and lactose placebo. They do not establish blinding, clinical-trial preregistration, official-tool certification or new independent clinical validation.", "proposed_research": "Material needed: Whole current report/bibliography, outcome-specific results and opposing context in the record. 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 means/P<.001 are preserved alongside the sole-direct-trial, substantial-attrition, exact-CI and independent-replication limitations. The original wording that dysmenorrhea pain evidence does not replicate PBAC, and that duration and Hb are separate, is also retained.", "condition_status": "Met", "status_reason": "Favorable values, limitations and opposing context from the whole record actually read are retained regardless of direction. Other outcomes were not made into new opposing trials or reports.", "missingness": "Results across the wider literature were not searched in this work. Distinguishing the current outcome scope does not verify absence of recent opposing literature or a 0-effect result.", "uncertainty": "Results across the wider literature were not searched in this work. Distinguishing the current outcome scope does not verify absence of recent opposing literature or a 0-effect result.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "Whole current report/bibliography, outcome-specific results and opposing context in the record" }, { "item_id": "N12", "question_type": "Evidence condition", "question": "Which dates and retained scope frame these gaps?", "needed": "Original verdict/correction identity and actual authorized search, registration and access records", "role": "Required", "role_reason": "Needed to avoid overstating the original verdict date or historical verification wording as a current comprehensive search or reading.", "application_exception": "Do not present an unperformed new search as verification of 0 studies, absent registration or no retractions.", "criterion": "Distinguish the original verdict date 2026-09-08, correction 2026-09-14, current actual review date, input scope and unread external 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 adolescent heavy menstrual bleeding assessed by PBAC, ginger powder and lactose placebo. They do not establish blinding, clinical-trial preregistration, official-tool certification or new independent clinical validation.", "proposed_research": "Material needed: Original verdict/correction identity and actual authorized search, registration and access 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": "The original verdict date is 2026-09-08, and the correction is the 2026-09-14 English evidence-table placeholder correction. This work converts the retained record as reviewed on 2026-10-06; the verdict date is not substituted for a search cutoff or current external-reading date.", "condition_status": "Met", "status_reason": "The original verdict date, correction/retained scope and current review date are distinguished. The correction's before/after grade C and original values remain historical records.", "missingness": "An evidence-search-cutoff field and actual report-specific access dates are absent from the original record. Current registration, publication, retraction and the full extent of unpublished material remain unverified in this work.", "uncertainty": "An evidence-search-cutoff field and actual report-specific access dates are absent from the original record. Current registration, publication, retraction and the full extent of unpublished material remain unverified in this work.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "Original verdict/correction identity and actual authorized search, registration and access records" }, { "item_id": "N13", "question_type": "Evidence condition", "question": "What funding and declared conflicts were retained?", "needed": "Original funding/COI statements, funding/contracts and product-support material", "role": "Supplementary; required for independence claims", "role_reason": "Needed to distinguish a university-support description from actual verification of independent funding.", "application_exception": "A declaration of no conflicts does not guarantee absence of bias or product support, or replication by a separate team.", "criterion": "Limit the original Bojnoord University grant89-162/no-conflicts record and historical grade reasoning to the currently verified level.", "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 adolescent heavy menstrual bleeding assessed by PBAC, ginger powder and lactose placebo. They do not establish blinding, clinical-trial preregistration, official-tool certification or new independent clinical validation.", "proposed_research": "Material needed: Original funding/COI statements, funding/contracts and product-support 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 funding entry records Bojnoord University of Medical Sciences grant89-162 and no conflicts of interest. The original grade explanation describes independent university support as a strength.", "condition_status": "Partly verified", "status_reason": "The retained funding and declaration wording are verified, but there were 0 readings of the original article's statements or contracts in this work. The original independent-support wording is preserved without becoming new independence certification.", "missingness": "Independent-verification details for the original support/COI statements, contracts, product support and researcher relationships remain unverified.", "uncertainty": "Independent-verification details for the original support/COI statements, contracts, product support and researcher relationships remain unverified.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "Original funding/COI statements, funding/contracts and product-support material" }, { "item_id": "N14", "question_type": "Evidence condition", "question": "Were product support, author employment/patents and independent teams verified?", "needed": "Product provision, author affiliation/employment, patents/COI and related-team material", "role": "Supplementary; required for independence claims", "role_reason": "Needed to avoid inheriting the original I2 as complete verification of product/employment/patent relationships and independent replication.", "application_exception": "Do not turn missing material into absence of industry links, or one research team into independent replication.", "criterion": "Identify unverified product provision, author employment/patents and related institution/team families beyond the retained funding 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 adolescent heavy menstrual bleeding assessed by PBAC, ginger powder and lactose placebo. They do not establish blinding, clinical-trial preregistration, official-tool certification or new independent clinical validation.", "proposed_research": "Material needed: Product provision, author affiliation/employment, patents/COI and related-team 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 I2 independence axis and university-support wording remain historical records. The original evidence entry's generic English funding statement says that detailed items were assessed, but supplies no current product-provision or author-employment/patent material.", "condition_status": "Unverified", "status_reason": "Verification of reported funding cannot be extended to all product/author/patent and independent-team replication questions. Current uncertainty does not establish either absence of industry links or confirmed bias.", "missingness": "Original material on product provision, author employment/patents, individual COI, related teams/institutions and contract details remains unverified.", "uncertainty": "Original material on product provision, author employment/patents, individual COI, related teams/institutions and contract details remains unverified.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "Product provision, author affiliation/employment, patents/COI and related-team material" }, { "item_id": "N15", "question_type": "Evidence condition", "question": "Can randomization, concealment and baseline balance be verified?", "needed": "Sequence generation/concealment methods, actual design and arm-level baseline table", "role": "Required (causal efficacy)", "role_reason": "Needed to avoid treating an RCT label and PBAC baseline means as resolution of all allocation risks.", "application_exception": "Do not fill parallel/crossover/cluster details from the design label alone or relabel uncertainty as not applicable.", "criterion": "Distinguish the retained randomized, double-blind, placebo-trial description from gaps in sequence generation, concealment and baseline-characteristic tables.", "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 adolescent heavy menstrual bleeding assessed by PBAC, ginger powder and lactose placebo. They do not establish blinding, clinical-trial preregistration, official-tool certification or new independent clinical validation.", "proposed_research": "Material needed: Sequence generation/concealment methods, actual design and arm-level 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": "The retained design is a randomized, double-blind, placebo-controlled trial. Reported baseline PBAC means are ginger113.73/placebo113.43, but sequence generation/concealment, other baseline tables and detailed actual design are not provided.", "condition_status": "Partly verified", "status_reason": "The design label and original baseline values are verified. The RCT label or similar means alone do not establish adequacy of the whole randomization process or baseline balance.", "missingness": "Sequence generation/concealment, arm allocation, detailed design and baseline/recruitment tables remain unverified. Crossover or cluster designs are not inferred.", "uncertainty": "Sequence generation/concealment, arm allocation, detailed design and baseline/recruitment tables remain unverified. Crossover or cluster designs are not inferred.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "Sequence generation/concealment methods, actual design and arm-level baseline table" }, { "item_id": "N16", "question_type": "Evidence condition", "question": "Could concomitant treatment, adherence or rescue therapy mix with the result difference?", "needed": "Arm-level adherence, concomitant/rescue medication and stopping/change records", "role": "Required", "role_reason": "Needed to distinguish planned medication from actual intake and differences in accompanying treatment.", "application_exception": "Do not infer nonuse of hormones, iron or analgesics from their omission.", "criterion": "Specify gaps in arm-level medication/rescue treatment, concurrent interventions, stopping/changes and their analysis 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 adolescent heavy menstrual bleeding assessed by PBAC, ginger powder and lactose placebo. They do not establish blinding, clinical-trial preregistration, official-tool certification or new independent clinical validation.", "proposed_research": "Material needed: Arm-level adherence, concomitant/rescue medication and stopping/change 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": "The nominal dosing plan and placebo are recorded, but the retained summary does not verify arm-level actual intake/adherence, rescue treatment, hormone/iron/analgesic use, or stopping/changes.", "condition_status": "Unverified", "status_reason": "No material links planned medication to deviations/concurrent treatment for the actual effect of interest. Absence of concomitant use or high adherence is not inferred.", "missingness": "Arm-level adherence/missed doses, concomitant medication, rescue treatment, stopping/changes and their analysis handling remain unverified.", "uncertainty": "Arm-level adherence/missed doses, concomitant medication, rescue treatment, stopping/changes and their analysis handling remain unverified.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "Arm-level adherence, concomitant/rescue medication and stopping/change records" }, { "item_id": "N17", "question_type": "Evidence condition", "question": "How were double blinding and PBAC diary collection carried out?", "needed": "Blinding targets/success, PBAC education/collection and arm-level detection/scoring records", "role": "Required", "role_reason": "Needed because a double-blind trial label does not guarantee actual blinding or consistent collection for participant diaries/scorers.", "application_exception": "A subjective diary alone does not justify automatic failure or confirmed measurement bias.", "criterion": "Distinguish the original design/appearance-matching record from gaps in participant/assessor scoring, diary return and correction 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 adolescent heavy menstrual bleeding assessed by PBAC, ginger powder and lactose placebo. They do not establish blinding, clinical-trial preregistration, official-tool certification or new independent clinical validation.", "proposed_research": "Material needed: Blinding targets/success, PBAC education/collection and arm-level detection/scoring 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": "The retained design is double-blind and the placebo is lactose matched in appearance. PBAC is diary-based, but participant/assessor/scorer blinding, diary return/consistent collection, education and validation procedures are not detailed.", "condition_status": "Partly verified", "status_reason": "Double-blinding/placebo-matching descriptions are preserved without becoming resolution of actual PBAC measurement differences. A subjective diary is not automatically labeled unmet either.", "missingness": "Blinding targets/success, diary education/return, scoring/error correction and arm-level measurement/detection differences remain unverified.", "uncertainty": "Blinding targets/success, diary education/return, scoring/error correction and arm-level measurement/detection differences remain unverified.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "Blinding targets/success, PBAC education/collection and arm-level detection/scoring records" }, { "item_id": "N18", "question_type": "Evidence condition", "question": "Which analysis do the reported means and between-group P represent?", "needed": "Original between-group analysis table, estimates/CI, model/covariates and analysis-population definitions", "role": "Required", "role_reason": "Needed to avoid creating a new adjusted between-group difference or CI from ginger/placebo baseline→treatment means.", "application_exception": "Do not replace the original P<.001 with an ITT assignment effect, exact between-group estimate or newly subtracted value.", "criterion": "Attribute 113.73→60.67 versus113.43→110.97/P<.001 to its original reporting level, retaining unverified model, adjustment and analysis population.", "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 adolescent heavy menstrual bleeding assessed by PBAC, ginger powder and lactose placebo. They do not establish blinding, clinical-trial preregistration, official-tool certification or new independent clinical validation.", "proposed_research": "Material needed: Original between-group analysis table, estimates/CI, model/covariates and analysis-population 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": "The original result is reported means113.73→60.67 versus113.43→110.97, with between-group P<.001. The original English preserves the same values, but the exact adjusted CI is unverified and the actual model, adjustment, ITT/PP and analysis population are unspecified.", "condition_status": "Partly verified", "status_reason": "Each arm's baseline→treatment means and the original between-group P are linked at their reported level. No new subtraction, between-group CI or ITT assignment effect was created, so analysis gaps remain.", "missingness": "The exact effect of interest, original between-group estimate/variance/CI, model/covariates, ITT/PP and actual denominators remain unverified.", "uncertainty": "The exact effect of interest, original between-group estimate/variance/CI, model/covariates, ITT/PP and actual denominators remain unverified.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "Original between-group analysis table, estimates/CI, model/covariates and analysis-population definitions" }, { "item_id": "N19", "question_type": "Evidence condition", "question": "What are the averaging and aggregation units for the 3 baseline and 3 intervention cycles?", "needed": "Cycle-specific PBAC source table, participant aggregation/weighting and repeated-measures model", "role": "Required", "role_reason": "Needed to avoid inflating sample size or precision by mixing participant and cycle units.", "application_exception": "Do not calculate a participant count 3 times larger from 3 cycles or assume independence of repeated measurements.", "criterion": "Preserve the original means and the 3-intervention-cycle record, identifying gaps in participant/cycle averaging, final-cycle values and repeated-measures 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 adolescent heavy menstrual bleeding assessed by PBAC, ginger powder and lactose placebo. They do not establish blinding, clinical-trial preregistration, official-tool certification or new independent clinical validation.", "proposed_research": "Material needed: Cycle-specific PBAC source table, participant aggregation/weighting and repeated-measures model. 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 record retains baseline3→intervention3-cycle PBAC reported means and records for 3 intervention cycles. The current summary does not specify whether these are participant-level 3-cycle averages, cycle-level averages or final-cycle values, or the weighting/repeated-measures model.", "condition_status": "Unverified", "status_reason": "Cycle counts and dosing windows are verified, but no table establishes the aggregation/analysis-unit contract of the original means. Cycles are not multiplied into participant counts or treated as independent observations.", "missingness": "Participant/cycle aggregation, missing-cycle handling, weighting, assessment windows and repeated-measure correlation/model remain unverified.", "uncertainty": "Participant/cycle aggregation, missing-cycle handling, weighting, assessment windows and repeated-measure correlation/model remain unverified.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "Cycle-specific PBAC source table, participant aggregation/weighting and repeated-measures model" }, { "item_id": "N20", "question_type": "Evidence condition", "question": "Were exact between-group estimates, intervals and variance verified?", "needed": "Exact between-group effect/CI, variance, arm-level analysis counts and adjusted model", "role": "Required", "role_reason": "Needed to avoid declaring sufficient precision from significance, total sample size or the historical CX alone.", "application_exception": "Do not newly calculate variance, CI, standardized effects or probabilities from the original means/P.", "criterion": "Retain the original statement that the exact adjusted CI is unverified, linking gaps in arm-level variance, denominators and the original between-group estimate.", "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 adolescent heavy menstrual bleeding assessed by PBAC, ginger powder and lactose placebo. They do not establish blinding, clinical-trial preregistration, official-tool certification or new independent clinical validation.", "proposed_research": "Material needed: Exact between-group effect/CI, variance, arm-level analysis counts and adjusted model. 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 report specifies means/P<.001 and an unverified exact adjusted CI. The original CX/C54 are historical precision/grade records, not interval verification in this work.", "condition_status": "Unverified", "status_reason": "Without an exact between-group estimate, variance/CI and arm-level analysis counts, the range of compatible differences cannot be verified. P is not used to calculate adequacy or a new CI.", "missingness": "The original between-group effect/CI, variance, exact denominators and model/adjusted values remain unverified.", "uncertainty": "The original between-group effect/CI, variance, exact denominators and model/adjusted values remain unverified.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "Exact between-group effect/CI, variance, arm-level analysis counts and adjusted model" }, { "item_id": "N21", "question_type": "Evidence condition", "question": "Is there a patient-important PBAC difference or interpretation criterion?", "needed": "Evidence supporting adolescent PBAC important differences, responder criteria and validation", "role": "Supplementary; required for clinical-importance claims", "role_reason": "Needed to avoid automatically upgrading statistical P or score changes to patient-important improvement in bleeding.", "application_exception": "Do not arbitrarily adopt a common minimum sample/period, an unverified MID or a PBAC→mL conversion.", "criterion": "Show whether an important difference and response definition justified for this population, scale and cycle were verified or remain unverified.", "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 adolescent heavy menstrual bleeding assessed by PBAC, ginger powder and lactose placebo. They do not establish blinding, clinical-trial preregistration, official-tool certification or new independent clinical validation.", "proposed_research": "Material needed: Evidence supporting adolescent PBAC important differences, responder criteria and validation. 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 PBAC-score reductions and P are retained, but adolescent PBAC patient-important differences/MID, responder criteria or interpretation criteria for the relevant interval are not specified in the retained record.", "condition_status": "Unverified", "status_reason": "Statistical significance or the original C54 cannot establish a patient-important difference or a change in volumetric blood loss. An unverified threshold is not newly adopted.", "missingness": "Population/scale/cycle-appropriate MID, response definitions, validation and effect intervals remain unverified.", "uncertainty": "Population/scale/cycle-appropriate MID, response definitions, validation and effect intervals remain unverified.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "Evidence supporting adolescent PBAC important differences, responder criteria and validation" }, { "item_id": "N22", "question_type": "Evidence condition", "question": "Were prespecified outcomes/analyses compared against registration, protocol and SAP?", "needed": "Trial registration, dates/change history, protocol/SAP and a results-comparison table", "role": "Required", "role_reason": "Needed to avoid turning an unverified NCT into confirmed absence of registration or verified prespecification of a primary outcome.", "application_exception": "Failure to acquire registration does not establish selective reporting or not-applicable status.", "criterion": "Distinguish the retained unverified registration status from unread registration/protocol/SAP, leaving prespecified PBAC, time points, analyses and changes unverified.", "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 adolescent heavy menstrual bleeding assessed by PBAC, ginger powder and lactose placebo. They do not establish blinding, clinical-trial preregistration, official-tool certification or new independent clinical validation.", "proposed_research": "Material needed: Trial registration, dates/change history, protocol/SAP and a results-comparison 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 original registration status is unverified. There were 0 external readings of registration/protocol/SAP in this work, and planned PBAC, 3-cycle timing, analyses and change dates were not compared.", "condition_status": "Unverified", "status_reason": "Unverified registration identity and the lack of plan comparison are retained. Neither absent registration nor selective reporting is newly established.", "missingness": "Preregistration ID/date, protocol/SAP, outcome hierarchy, analysis changes and multiplicity handling remain unverified.", "uncertainty": "Preregistration ID/date, protocol/SAP, outcome hierarchy, analysis changes and multiplicity handling remain unverified.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "Trial registration, dates/change history, protocol/SAP and a results-comparison table" }, { "item_id": "N23", "question_type": "Evidence condition", "question": "Are acceptance of a paper-level primary outcome and preregistered hierarchy the same?", "needed": "Article outcome descriptions, prospective protocol/SAP and multiplicity handling", "role": "Required", "role_reason": "Needed to avoid inheriting historical paper-level primary/P-axis information as verification of prospectively registered hierarchy in this work.", "application_exception": "Do not erase the original paper-level acceptance or turn it into a new hierarchy/efficacy assessment.", "criterion": "Preserve paper-level primary acceptance and the historical P axis, separating them from prespecification, multiplicity and registered hierarchy.", "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 adolescent heavy menstrual bleeding assessed by PBAC, ginger powder and lactose placebo. They do not establish blinding, clinical-trial preregistration, official-tool certification or new independent clinical validation.", "proposed_research": "Material needed: Article outcome descriptions, prospective protocol/SAP and multiplicity 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": "The original reader answer says the paper-level primary hierarchy was accepted; the historical endpoint P axis and primary-positive grade explanation are retained. Registration hierarchy is distinguished as incomplete.", "condition_status": "Partly verified", "status_reason": "The historical acceptance of a paper-level primary outcome is verified. This is not a current comparison with preregistration/SAP hierarchy; the history is neither erased nor turned into a new efficacy assessment.", "missingness": "Prespecification, registered hierarchy, adjustment for multiple outcomes/cycle analyses and change history remain unverified.", "uncertainty": "Prespecification, registered hierarchy, adjustment for multiple outcomes/cycle analyses and change history remain unverified.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "Article outcome descriptions, prospective protocol/SAP and multiplicity handling" }, { "item_id": "N24", "question_type": "Evidence condition", "question": "Was this PBAC result replicated in other independent trials or conditions?", "needed": "Independent-team/unique-trial family table, direct PBAC results and condition-specific comparisons", "role": "Supplementary; required for replication or generalization claims", "role_reason": "Needed to avoid marking a sole direct report from one team and age range as completed independent replication.", "application_exception": "Do not add dysmenorrhea reports, or Korean/English text and bibliography from the same record, as separate replications.", "criterion": "Describe the retained single direct report's family and population/formulation/outcome match, leaving the full independent total unconfirmed.", "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 adolescent heavy menstrual bleeding assessed by PBAC, ginger powder and lactose placebo. They do not establish blinding, clinical-trial preregistration, official-tool certification or new independent clinical validation.", "proposed_research": "Material needed: Independent-team/unique-trial family table, direct PBAC results and condition-specific comparisons. 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 record describes one research team, one age range, a sole direct trial and limitations of independent replication. It explicitly states that dysmenorrhea pain evidence does not replicate this blood-loss claim.", "condition_status": "Partly verified", "status_reason": "The current direct report's limitations and separation of other outcomes are verified. Without a new comprehensive search or reading of trial families, worldwide independent trial and participant totals are not established.", "missingness": "Independent-team results for the same formulation/adolescent/PBAC question, family-specific comparisons and heterogeneity material remain unverified within this work's scope.", "uncertainty": "Independent-team results for the same formulation/adolescent/PBAC question, family-specific comparisons and heterogeneity material remain unverified within this work's scope.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "Independent-team/unique-trial family table, direct PBAC results and condition-specific comparisons" }, { "item_id": "N25", "question_type": "Evidence condition", "question": "Does the material establish optimal dose, persistence after stopping or long-term application?", "needed": "Direct dose comparisons, post-discontinuation/long-term follow-up and prespecified subgroups/interactions", "role": "Supplementary; required for the relevant extension claims", "role_reason": "Needed to avoid extending one nominal dose/3 intervention cycles to optimal dose or long-term persistence.", "application_exception": "Do not make every dose/long-term trial mandatory for this narrow PBAC result.", "criterion": "Distinguish the selected dose/dosing window/3-cycle scope from unverified direct dose comparisons, post-discontinuation/long-term follow-up and subgroups.", "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 adolescent heavy menstrual bleeding assessed by PBAC, ginger powder and lactose placebo. They do not establish blinding, clinical-trial preregistration, official-tool certification or new independent clinical validation.", "proposed_research": "Material needed: Direct dose comparisons, post-discontinuation/long-term follow-up and prespecified subgroups/interactions. 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 question concerns a nominal 750 mg/day, 4 days per cycle and 3 intervention cycles. Direct dose comparisons, persistence after stopping, long-term follow-up and prespecified subgroup-interaction results are not verified in the retained material.", "condition_status": "Partly verified", "status_reason": "The selected scope is verified without extending it to optimal dose, long-term persistence or specific subgroup claims. Unverified extension material is not a criterion for deleting the narrow PBAC result.", "missingness": "Direct dose comparisons, post-discontinuation/long-term follow-up and subgroup prespecification/interactions remain unverified.", "uncertainty": "Direct dose comparisons, post-discontinuation/long-term follow-up and subgroup prespecification/interactions remain unverified.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "Direct dose comparisons, post-discontinuation/long-term follow-up and prespecified subgroups/interactions" }, { "item_id": "N26", "question_type": "Evidence condition", "question": "Does a PBAC change also answer pain, duration, Hb, anemia or clinical-event questions?", "needed": "Direct results for separate outcomes/clinical events and evidence on patient importance/relevance", "role": "Supplementary; required for clinical extension claims", "role_reason": "Needed to avoid extending a bleeding-diary score result to improved hemoglobin/anemia, quality of life or replacement of medical care.", "application_exception": "Do not make all clinical-event trials mandatory for the PBAC question itself.", "criterion": "Preserve the original scope note and advertising limitations, distinguishing PBAC, pain/duration/Hb and clinical events 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 adolescent heavy menstrual bleeding assessed by PBAC, ginger powder and lactose placebo. They do not establish blinding, clinical-trial preregistration, official-tool certification or new independent clinical validation.", "proposed_research": "Material needed: Direct results for separate outcomes/clinical events and evidence on patient importance/relevance. 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 PBAC menstrual blood loss is judged, with pain, duration and hemoglobin separate. The original advertising-interpretation section limits self-treatment without diagnosis of the cause and application to iron deficiency, anemia or pregnancy-related bleeding.", "condition_status": "Met", "status_reason": "The boundary between selected PBAC and other symptom/clinical questions is faithfully preserved. This status verifies a boundary, not improvement in anemia/clinical events or effects replacing medical care.", "missingness": "Direct comparative results and patient importance for pain/duration/Hb, anemia, quality of life and clinical events are not established by the retained material for this question.", "uncertainty": "Direct comparative results and patient importance for pain/duration/Hb, anemia, quality of life and clinical events are not established by the retained material for this question.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "Direct results for separate outcomes/clinical events and evidence on patient importance/relevance" }, { "item_id": "N27", "question_type": "Evidence condition", "question": "What actual harm events were recorded, and how were they collected?", "needed": "Trial AE collection methods, definitions, event/discontinuation tables and severity", "role": "Supplementary; required for safety or harm claims", "role_reason": "Needed to avoid turning general cautions into actual observed events in this PBAC trial or 0 adverse events.", "application_exception": "Do not label missing AE information in an efficacy summary as nonreporting throughout the original article or as safety.", "criterion": "Separate original cautions from gaps in actual AE definitions, collection/severity and discontinuation/event records.", "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 adolescent heavy menstrual bleeding assessed by PBAC, ginger powder and lactose placebo. They do not establish blinding, clinical-trial preregistration, official-tool certification or new independent clinical validation.", "proposed_research": "Material needed: Trial AE collection methods, definitions, event/discontinuation tables and severity. 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 safety label is Caution, with repeated wording about assessment of heavy bleeding, anticoagulant/antiplatelet use, pregnancy possibility and worsening bleeding. Trial-specific AE definitions, actual events/collection methods, severity and discontinuations are not specified in the summary.", "condition_status": "Unverified", "status_reason": "General cautions are preserved without becoming actual trial AE observations, 0 events or nonreporting throughout the original article. Original efficacy values and harm-verification status are separate.", "missingness": "AE definitions, planned/actual collection, actual events/severity, discontinuations and arm-level reporting scope remain unverified.", "uncertainty": "AE definitions, planned/actual collection, actual events/severity, discontinuations and arm-level reporting scope remain unverified.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "Trial AE collection methods, definitions, event/discontinuation tables and severity" }, { "item_id": "N28", "question_type": "Evidence condition", "question": "What is the timing of intake, events, discontinuation and recovery?", "needed": "Individual AE timelines, medication/stopping/recovery and harm-follow-up records", "role": "Supplementary; required for harm-timing claims", "role_reason": "Needed to avoid substituting the efficacy dosing window for AE observation time or evidence of causality.", "application_exception": "Do not infer improvement after stopping, rechallenge or event timing without records.", "criterion": "Distinguish the 4-day-per-cycle/3-intervention-cycle exposure record from unverified event/recovery, stopping and rechallenge observations.", "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 adolescent heavy menstrual bleeding assessed by PBAC, ginger powder and lactose placebo. They do not establish blinding, clinical-trial preregistration, official-tool certification or new independent clinical validation.", "proposed_research": "Material needed: Individual AE timelines, medication/stopping/recovery and harm-follow-up 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": "Medication timing is retained as 4 days per cycle/3 intervention cycles. Event onset, stopping/recovery, latency, rechallenge timing and a separate harm-follow-up window are not specified in the current material.", "condition_status": "Unverified", "status_reason": "The efficacy dosing window alone cannot verify actual AE temporal order or that exposure was causal. Rechallenge or improvement after stopping is not inferred.", "missingness": "Individual-event onset/recovery, stopping/rechallenge, end of observation and harm-follow-up time remain unverified.", "uncertainty": "Individual-event onset/recovery, stopping/rechallenge, end of observation and harm-follow-up time remain unverified.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "Individual AE timelines, medication/stopping/recovery and harm-follow-up records" }, { "item_id": "N29", "question_type": "Evidence condition", "question": "Were actual harms compared with the lactose-placebo arm?", "needed": "Consistent AE collection in both arms, arm-level events/exposure and comparative-estimate table", "role": "Supplementary; required for comparative harm claims", "role_reason": "Needed because a placebo-controlled efficacy design does not establish that comparative-harm results were acquired.", "application_exception": "Do not extrapolate background incidence or general cautions to create a risk difference or RR.", "criterion": "Separate the efficacy placebo's existence from the presence or uncertainty of arm-level harm collection/comparative results.", "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 adolescent heavy menstrual bleeding assessed by PBAC, ginger powder and lactose placebo. They do not establish blinding, clinical-trial preregistration, official-tool certification or new independent clinical validation.", "proposed_research": "Material needed: Consistent AE collection in both arms, arm-level events/exposure and comparative-estimate 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 lactose-placebo comparison is verified as the PBAC efficacy design. Consistent AE collection, actual events/exposure and comparative-risk results in both arms are not verified from the retained material.", "condition_status": "Unverified", "status_reason": "An efficacy comparator is not upgraded to an acquired harm comparison. General cautions or background incidence are not used to create risk differences or RR.", "missingness": "Consistent AE definitions/collection windows, arm-level events/exposure denominators and comparative-harm estimates remain unverified.", "uncertainty": "Consistent AE definitions/collection windows, arm-level events/exposure denominators and comparative-harm estimates remain unverified.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "Consistent AE collection in both arms, arm-level events/exposure and comparative-estimate table" }, { "item_id": "N30", "question_type": "Evidence condition", "question": "Are event counts, exposure denominators and time available for harm frequency?", "needed": "Arm-level exposure denominators, people with events/event counts and follow-up/discontinuation tables", "role": "Supplementary; required for incidence claims", "role_reason": "Needed to avoid automatically using the 92 randomized/71 completed as harm-exposed participants or event denominators.", "application_exception": "Do not calculate frequency or safety from event names/caution wording and efficacy denominators alone.", "criterion": "Identify gaps in people with AEs/event counts, exposed participants, time, attrition and recurrent-event aggregation.", "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 adolescent heavy menstrual bleeding assessed by PBAC, ginger powder and lactose placebo. They do not establish blinding, clinical-trial preregistration, official-tool certification or new independent clinical validation.", "proposed_research": "Material needed: Arm-level exposure denominators, people with events/event counts and follow-up/discontinuation 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 total 92 randomized/71 completed describe participant flow in the efficacy trial. Numbers exposed for harm assessment, people with events/event counts, exposure time and discontinuation/recurrent-event aggregation are not specified in the original material.", "condition_status": "Unverified", "status_reason": "Efficacy denominators cannot automatically become AE denominators, and warnings alone cannot establish frequency or safety.", "missingness": "Arm-level harm-exposure/follow-up denominators, people with events/event counts, observation time and recurrent-event/discontinuation tables remain unverified. There are 0 new frequency calculations.", "uncertainty": "Arm-level harm-exposure/follow-up denominators, people with events/event counts, observation time and recurrent-event/discontinuation tables remain unverified. There are 0 new frequency calculations.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "Arm-level exposure denominators, people with events/event counts and follow-up/discontinuation tables" }, { "item_id": "N31", "question_type": "Evidence condition", "question": "Were concurrent medication, bleeding causes and alternative harm explanations verified?", "needed": "Arm-level medication/disease, bleeding causes, baseline events and alternative/adjustment material", "role": "Supplementary; required for causal or comparative harm claims", "role_reason": "Needed to avoid attributing all effects of existing disease or medication to ginger exposure.", "application_exception": "Anticoagulant/antiplatelet and pregnancy warnings are not evidence of concomitant use or pregnancy cases among actual trial participants.", "criterion": "Distinguish the narrow population/original cautions from gaps in actual concomitant medication, disease/bleeding causes and alternatives/adjustment.", "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 adolescent heavy menstrual bleeding assessed by PBAC, ginger powder and lactose placebo. They do not establish blinding, clinical-trial preregistration, official-tool certification or new independent clinical validation.", "proposed_research": "Material needed: Arm-level medication/disease, bleeding causes, baseline events and alternative/adjustment 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 retained population is a narrow adolescent group, while original cautions mention anticoagulants/antiplatelets, pregnancy possibility, worsening bleeding and assessment of causes. Actual trial concomitant exposures, baseline diseases, alternative causes and adjustments are not specified.", "condition_status": "Partly verified", "status_reason": "The population/concurrent-exposure boundaries of general cautions are verified. They are not mistaken for actual participants' medication, pregnancy or harm events; causal/confounding material remains unverified.", "missingness": "Arm-level concomitant medication/baseline disease, bleeding causes, pregnancy/other exposures and alternative explanations/adjustment remain unverified.", "uncertainty": "Arm-level concomitant medication/baseline disease, bleeding causes, pregnancy/other exposures and alternative explanations/adjustment remain unverified.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "Arm-level medication/disease, bleeding causes, baseline events and alternative/adjustment material" }, { "item_id": "N32", "question_type": "Evidence condition", "question": "Were harms among noncompleters and selection/detection differences verified?", "needed": "Harm follow-up for withdrawals, stopping reasons, AE aggregation/collection and arm-level disclosure scope", "role": "Supplementary; required for harm reporting or missingness claims", "role_reason": "Needed to avoid treating harms outside the 71 efficacy completers as absent events.", "application_exception": "Do not establish AE-related discontinuation or the direction/magnitude of reporting bias from total attrition alone.", "criterion": "Identify gaps in participants covered by AE collection, withdrawal/stopping reasons, unobserved events and arm-level detection/reporting differences.", "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 adolescent heavy menstrual bleeding assessed by PBAC, ginger powder and lactose placebo. They do not establish blinding, clinical-trial preregistration, official-tool certification or new independent clinical validation.", "proposed_research": "Material needed: Harm follow-up for withdrawals, stopping reasons, AE aggregation/collection and arm-level 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": "Harm follow-up/reporting and reasons for stopping outside the total 71 completers, and arm-level detection or spontaneous/systematic collection differences, are not specified in the current material. The original substantial-attrition limitation is preserved.", "condition_status": "Unverified", "status_reason": "Efficacy attrition alone cannot establish AE-related discontinuation or reporting bias. Absence of events among noncompleters is not assumed.", "missingness": "The actual scope of harm follow-up among withdrawals, arm-level stopping reasons, event disclosure/collection systems and detection differences remains unverified.", "uncertainty": "The actual scope of harm follow-up among withdrawals, arm-level stopping reasons, event disclosure/collection systems and detection differences remains unverified.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "Harm follow-up for withdrawals, stopping reasons, AE aggregation/collection and arm-level disclosure scope" }, { "item_id": "N33", "question_type": "Evidence condition", "question": "Were independent harm sources for the same formulation/population linked?", "needed": "Original identities of formulation/population/event-specific harm reports and unique-case/family linkage table", "role": "Supplementary; required for repeated-signal claims", "role_reason": "Needed to avoid counting repeated safety-guidance/product-description wording in one record as multiple independent harm reports.", "application_exception": "Do not turn general cautions or an efficacy bibliography into newly added harm cases/reports.", "criterion": "Distinguish duplicated locations of original cautions from unverified individual events or unique families.", "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 adolescent heavy menstrual bleeding assessed by PBAC, ginger powder and lactose placebo. They do not establish blinding, clinical-trial preregistration, official-tool certification or new independent clinical validation.", "proposed_research": "Material needed: Original identities of formulation/population/event-specific harm reports and unique-case/family linkage 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": "Caution wording in safety guidance, product descriptions and the synthesis repeats within the same verdict. The current efficacy report/bibliography does not provide identities for separate independent harm cases or repeated signals.", "condition_status": "Unverified", "status_reason": "Repeated locations of the same warning are preserved without being added as independent harm reports or generating a new S2 report. Individual-event/family identities remain unverified.", "missingness": "Unique harm cases, contrary records and report/regulatory recitation families for the same formulation/population remain unverified.", "uncertainty": "Unique harm cases, contrary records and report/regulatory recitation families for the same formulation/population remain unverified.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "Original identities of formulation/population/event-specific harm reports and unique-case/family linkage table" }, { "item_id": "N34", "question_type": "Evidence condition", "question": "Were other populations, long-term/rare harms and interactions verified?", "needed": "Direct material from suitable long-term/rare-harm designs, vulnerable populations and medication interactions", "role": "Supplementary; required for the relevant safety scope", "role_reason": "Needed to avoid extending normal-BMI adolescent 3-cycle data to pregnancy, anticoagulant use or overall long-term safety.", "application_exception": "Do not make every rare-harm study mandatory for the current narrow efficacy question or turn unread material into not applicable.", "criterion": "Identify original caution boundaries for populations/interactions and unverified direct long-term, rare-harm or vulnerable-population data.", "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 adolescent heavy menstrual bleeding assessed by PBAC, ginger powder and lactose placebo. They do not establish blinding, clinical-trial preregistration, official-tool certification or new independent clinical validation.", "proposed_research": "Material needed: Direct material from suitable long-term/rare-harm designs, vulnerable populations and medication interactions. 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 concern assessment of causes, anticoagulant/antiplatelet use and pregnancy possibility. Direct long-term, rare-harm, vulnerable-population or interaction data beyond the selected trial's adolescent/3-intervention-cycle scope were not verified.", "condition_status": "Unverified", "status_reason": "Original cautions are preserved without extending narrow efficacy material to overall safety. Unread material in other populations is not substituted with not applicable or safe.", "missingness": "Direct material on long-term/rare harms, pregnancy/other baseline disease/medication interactions, exposure and follow-up remains unverified.", "uncertainty": "Direct material on long-term/rare harms, pregnancy/other baseline disease/medication interactions, exposure and follow-up remains unverified.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "Direct material from suitable long-term/rare-harm designs, vulnerable populations and medication interactions" }, { "item_id": "N35", "question_type": "Evidence condition", "question": "Do caution warnings establish incidence, causality or safety certification?", "needed": "Original caution/advertising boundaries, harm design/comparison/denominators/time and alternative-source material", "role": "Supplementary; required for safety-interpretation boundaries", "role_reason": "Needed to avoid upgrading historical cautions/C54 and general consultation wording to new dosing instructions, clinical causality or safety certification.", "application_exception": "Do not delete uncertain material or turn this table into self-treatment or replacement-of-care instructions.", "criterion": "Distinguish original cautions/advertising limitations from unverified actual events, comparative risk and causality, retaining the historical grade only as a quotation.", "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 adolescent heavy menstrual bleeding assessed by PBAC, ginger powder and lactose placebo. They do not establish blinding, clinical-trial preregistration, official-tool certification or new independent clinical validation.", "proposed_research": "Material needed: Original caution/advertising boundaries, harm design/comparison/denominators/time and alternative-source 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 C54/Caution, all axes, and consultation/advertising limitations are retained as historical wording. Actual harm events, comparative risk/incidence and causal material were not verified in this work; no self-treatment/replacement-of-care approval or new safety grade was created.", "condition_status": "Met", "status_reason": "The interpretation boundary distinguishing preservation of cautions/grade from established safety matches the original record. This status verifies a wording boundary rather than fulfillment of safety.", "missingness": "Actual harm events, comparisons/denominators/time, alternatives, causality and overall safety remain unverified.", "uncertainty": "Actual harm events, comparisons/denominators/time, alternatives, causality and overall safety remain unverified.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "Original caution/advertising boundaries, harm design/comparison/denominators/time and alternative-source material" } ], "reports": [ { "report_id": "S1", "title": "Effect of ginger (Zingiber officinale) on heavy menstrual bleeding: a placebo-controlled, randomized clinical trial", "url": "https://pubmed.ncbi.nlm.nih.gov/25298352/", "report_type": "Stored summary of a randomized placebo trial of adolescent heavy menstrual bleeding assessed by PBAC", "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.", "study_family": "The retained Kashefi 2015 direct report is linked to a provisional trial family. The 92 randomized participants are distinguished from 71 completers; arm-level denominators, ITT, registration, related reports and the full extent of independent replication remain unverified.", "independent_replication": "The retained Kashefi 2015 direct report is linked to a provisional trial family. The 92 randomized participants are distinguished from 71 completers; arm-level denominators, ITT, registration, related reports and the full extent of independent replication remain unverified.", "observed_result": "Reported means 113.73→60.67 versus 113.43→110.97, P<.001; exact adjusted CI unverified", "result_level": "These are retained arm-level means and a reported between-group result, not current full-text verification or recalculation. The exact adjusted effect, interval, aggregation and analysis population remain unverified.", "source_evidence_date": "2026-09-08", "materials": [ { "material_type": "Stored existing review summary", "public_status": "Locally retained; stored summary read", "access_status": "Acquired", "acquired": true, "actually_read": "Stored existing review summary read", "as_of": "2026-10-06", "qualification": "The retained Korean/English summaries and linked report and bibliography were read. Original article bytes, abstract and full text were not newly verified. PBAC is a pictorial-diary score, not directly measured blood volume. The 92 randomized participants, 71 completers, arm-level baseline→treatment values and between-group P are preserved at their respective levels. Arm-level analysis denominators, exact effect/CI, cycle aggregation, preregistered hierarchy and actual harm material remain unverified. 2026-10-06 is the retained-summary review date; no external-material reading date is recorded. 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. Application after condition freezing is distinguished from historical self-review and display-change records." }, { "material_type": "External bibliography and abstract", "public_status": "Existence, availability and acquisition unverified; not read", "access_status": "Not attempted", "acquired": false, "actually_read": "Not read", "as_of": null, "qualification": "This is a retained PubMed link. Current response, public availability, abstract/full-text access and reading were not verified. PBAC is a pictorial-diary score, not directly measured blood volume. The 92 randomized participants, 71 completers, arm-level baseline→treatment values and between-group P are preserved at their respective levels. Arm-level analysis denominators, exact effect/CI, cycle aggregation, preregistered hierarchy and actual harm material remain unverified. 2026-10-06 is the retained-summary review date; no external-material reading date is recorded. 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. Application after condition freezing is distinguished from historical self-review and display-change records." }, { "material_type": "Original full text and DOI entry point", "public_status": "Existence, availability and acquisition unverified; not read", "access_status": "Not attempted", "acquired": false, "actually_read": "Not read", "as_of": null, "qualification": "This original-article entry point is linked from the retained DOI bibliography. Current public or subscription availability, response, downloading, and full-text and supplement reading are unverified. PBAC is a pictorial-diary score, not directly measured blood volume. The 92 randomized participants, 71 completers, arm-level baseline→treatment values and between-group P are preserved at their respective levels. Arm-level analysis denominators, exact effect/CI, cycle aggregation, preregistered hierarchy and actual harm material remain unverified. 2026-10-06 is the retained-summary review date; no external-material reading date is recorded. 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. Application after condition freezing is distinguished from historical self-review and display-change records." } ], "links": [ { "label": "PubMed", "url": "https://pubmed.ncbi.nlm.nih.gov/25298352/" } ] } ], "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": { "Met": "The specified material, question or interpretation boundary was verified; this is not approval of clinical efficacy, safety or full-text reading.", "Partly verified": "Some retained information was verified; axes or material required by the criterion remain unverified.", "Unverified": "The value cannot be established within the retained scope; this does not mean 0 studies, 0 effect or harmlessness.", "Not reported": "Unreported only within the specific material or section actually read; this is not extended to the whole external article.", "Inaccessible": "Limited to an actual failed access attempt; it is not assigned to external material in this work.", "Not applicable": "Limited to a specific application exception; not a substitute for unread material.", "Review incomplete": "Remaining actual comparisons and their reasons are specified.", "Conflicting data": "Limited to actual incompatibility identified by comparing the same question, time point and analysis." }, "study_overlap": { "state": "Unverified", "unique_trial_count": null, "unique_participant_count": null, "reason": "The 1 retained direct report and 1 bibliography entry are linked to the same report. Korean/English text, bibliography and caution wording within that record, and separate dysmenorrhea evidence, are not added as independent PBAC replications. Trial families and unique trial and participant totals 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" }