{ "schema_version": "chamgap-public-criteria-1.0", "title": "Ginger-rhizome powder capsules × Reduction of PBAC-assessed menstrual blood loss in heavy menstrual bleeding", "language": "en", "translation_date": "2026-10-25", "criteria_version": "1.0", "criteria_date": "2026-10-06", "condition_origin": "Chamgap's own application conditions", "method_sources": [ { "id": "M03", "version": "Cochrane Handbook 6.5 (2024), chapter updated 2023-08", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-03", "section": "§3.1, §3.2.1–3.2.3, MECIR C5/C7/C13", "official_principle": "Clearly record the question, eligibility conditions and reasons for changes, and distinguish variations in interventions.", "review_level": "Retained method-application records were reused. External originals were not reread and method content was not reassessed." }, { "id": "M04", "version": "Cochrane Handbook 6.5.1 (2025), chapter updated 2025-03", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-04", "section": "§4.5, §4.6.1–4.6.3, MECIR C42", "official_principle": "Distinguish studies from reports and link them; do not omit a study solely because results are unreported.", "review_level": "Retained method-application records were reused. External originals were not reread and method content was not reassessed." }, { "id": "M08", "version": "Cochrane Handbook 6.5 (2024), chapter updated 2019-10", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-08", "section": "§8.1–8.2.3, Table 8.2.a", "official_principle": "Define the outcome and effect of interest, then examine randomization, deviations, missing data, measurement and selective reporting.", "review_level": "Retained method-application records were reused. External originals were not reread and method content was not reassessed." }, { "id": "M15", "version": "Cochrane Handbook 6.5 (2024), chapter updated 2023-08", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-15", "section": "§15.2.4, §15.3.1–15.3.3", "official_principle": "Distinguish effect estimates, intervals, importance and applicability. Sample size alone does not determine precision.", "review_level": "Retained method-application records were reused. External originals were not reread and method content was not reassessed." }, { "id": "M19", "version": "Cochrane Handbook 6.5 (2024), chapter updated 2019-10", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-19", "section": "§19.1.2, §19.2.1–19.2.4", "official_principle": "Harm questions may require different designs, populations and follow-up from efficacy questions. Case reports do not establish incidence rates.", "review_level": "Retained method-application records were reused. External originals were not reread and method content was not reassessed." } ], "status_dictionary": { "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." }, "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." } ] }