Ginger-rhizome powder capsules × Reduction of PBAC-assessed menstrual blood loss in heavy menstrual bleeding

Required evidence, verification status and materials actually read
Item	AVerification status	BReading scope	CReview item	DCurrent findings	EWhy unverified	FRequired materials and conditions	GFurther research
1	Met	Full text not readStored summary read	N01 · Evidence conditionWhich ginger and PBAC question is linked to the original claim?Required	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. S1	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.	Original Korean/English effect, population/intervention details, scope note and final boundary document	Material needed: Original Korean/English effect, population/intervention details, scope note and final boundary document. This records needed materials; no new research was executed.
2	Partly verified	Full text not readStored summary read	N02 · Evidence conditionHow are the sole report, bibliography entry and trial family related?Required	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. S1	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.	Report/bibliographic identity and a linkage table for registration and related reports	Material needed: Report/bibliographic identity and a linkage table for registration and related reports. This records needed materials; no new research was executed.
3	Met	Full text not readStored summary read	N03 · Evidence conditionWhat summary, abstract and full-text material was actually read?Required	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. S1	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.	Material-specific actual access/acquisition/reading records and source provenance	Material needed: Material-specific actual access/acquisition/reading records and source provenance. This records needed materials; no new research was executed.
4	Partly verified	Full text not readStored summary read	N04 · Evidence conditionWhich adolescents and bleeding conditions produced these data?Required	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. S1	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.	Eligibility/exclusion table, PBAC criterion, assessment of bleeding causes and arm-level baseline table	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.
5	Partly verified	Full text not readStored summary read	N05 · Evidence conditionWhich powder, route and nominal dose were administered?Required	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. S1	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.	Product specification, batch/content verification and arm-level actual medication/adherence records	Material needed: Product specification, batch/content verification and arm-level actual medication/adherence records. This records needed materials; no new research was executed.
6	Partly verified	Full text not readStored summary read	N06 · Evidence conditionWhat was the placebo, and which difference was compared?Required	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. S1	Lactose placebo, appearance matching and comparison direction are verified. Smell/taste, capsule specification, actual blinding and arm-level concomitant differences remain separate gaps.	Placebo composition/specification, sensory matching and distribution/concomitant-treatment records	Material needed: Placebo composition/specification, sensory matching and distribution/concomitant-treatment records. This records needed materials; no new research was executed.
7	Partly verified	Full text not readStored summary read	N07 · Evidence conditionIs the PBAC score directly measured mL?Required	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. S1	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.	PBAC instrument/score range, scoring education, diary validation and missing-data rules	Material needed: PBAC instrument/score range, scoring education, diary validation and missing-data rules. This records needed materials; no new research was executed.
8	Partly verified	Full text not readStored summary read	N08 · Evidence conditionHow do 4 dosing days per cycle differ from 3 intervention cycles?Required	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. S1	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.	Cycle-specific medication/diary schedule, actual cycle lengths and assessment windows	Material needed: Cycle-specific medication/diary schedule, actual cycle lengths and assessment windows. This records needed materials; no new research was executed.
9	Partly verified	Full text not readStored summary read	N09 · Evidence conditionWhich denominators are represented by 92 randomized participants and 71 completers?Required	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. S1	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.	Arm-level CONSORT flow and PBAC analysis/completion-denominator table	Material needed: Arm-level CONSORT flow and PBAC analysis/completion-denominator table. This records needed materials; no new research was executed.
10	Unverified	Full text not readStored summary read	N10 · Evidence conditionWhat attrition, missing diaries and handling methods were recorded?Required	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. S1	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.	Arm-level attrition/missing-diary table and missing-data/sensitivity analyses	Material needed: Arm-level attrition/missing-diary table and missing-data/sensitivity analyses. This records needed materials; no new research was executed.
11	Met	Full text not readStored summary read	N11 · Evidence conditionWere the original results and boundaries with dysmenorrhea or other outcomes preserved?Required	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. S1	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.	Whole current report/bibliography, outcome-specific results and opposing context in the record	Material needed: Whole current report/bibliography, outcome-specific results and opposing context in the record. This records needed materials; no new research was executed.
12	Met	Full text not readStored summary read	N12 · Evidence conditionWhich dates and retained scope frame these gaps?Required	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. S1	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.	Original verdict/correction identity and actual authorized search, registration and access records	Material needed: Original verdict/correction identity and actual authorized search, registration and access records. This records needed materials; no new research was executed.
13	Partly verified	Full text not readStored summary read	N13 · Evidence conditionWhat funding and declared conflicts were retained?Supplementary; required for independence claims	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. S1	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.	Original funding/COI statements, funding/contracts and product-support material	Material needed: Original funding/COI statements, funding/contracts and product-support material. This records needed materials; no new research was executed.
14	Unverified	Full text not readStored summary read	N14 · Evidence conditionWere product support, author employment/patents and independent teams verified?Supplementary; required for independence claims	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. S1	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.	Product provision, author affiliation/employment, patents/COI and related-team material	Material needed: Product provision, author affiliation/employment, patents/COI and related-team material. This records needed materials; no new research was executed.
15	Partly verified	Full text not readStored summary read	N15 · Evidence conditionCan randomization, concealment and baseline balance be verified?Required (causal efficacy)	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. S1	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.	Sequence generation/concealment methods, actual design and arm-level baseline table	Material needed: Sequence generation/concealment methods, actual design and arm-level baseline table. This records needed materials; no new research was executed.
16	Unverified	Full text not readStored summary read	N16 · Evidence conditionCould concomitant treatment, adherence or rescue therapy mix with the result difference?Required	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. S1	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.	Arm-level adherence, concomitant/rescue medication and stopping/change records	Material needed: Arm-level adherence, concomitant/rescue medication and stopping/change records. This records needed materials; no new research was executed.
17	Partly verified	Full text not readStored summary read	N17 · Evidence conditionHow were double blinding and PBAC diary collection carried out?Required	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. S1	Double-blinding/placebo-matching descriptions are preserved without becoming resolution of actual PBAC measurement differences. A subjective diary is not automatically labeled unmet either.	Blinding targets/success, PBAC education/collection and arm-level detection/scoring records	Material needed: Blinding targets/success, PBAC education/collection and arm-level detection/scoring records. This records needed materials; no new research was executed.
18	Partly verified	Full text not readStored summary read	N18 · Evidence conditionWhich analysis do the reported means and between-group P represent?Required	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. S1	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.	Original between-group analysis table, estimates/CI, model/covariates and analysis-population definitions	Material needed: Original between-group analysis table, estimates/CI, model/covariates and analysis-population definitions. This records needed materials; no new research was executed.
19	Unverified	Full text not readStored summary read	N19 · Evidence conditionWhat are the averaging and aggregation units for the 3 baseline and 3 intervention cycles?Required	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. S1	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.	Cycle-specific PBAC source table, participant aggregation/weighting and repeated-measures model	Material needed: Cycle-specific PBAC source table, participant aggregation/weighting and repeated-measures model. This records needed materials; no new research was executed.
20	Unverified	Full text not readStored summary read	N20 · Evidence conditionWere exact between-group estimates, intervals and variance verified?Required	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. S1	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.	Exact between-group effect/CI, variance, arm-level analysis counts and adjusted model	Material needed: Exact between-group effect/CI, variance, arm-level analysis counts and adjusted model. This records needed materials; no new research was executed.
21	Unverified	Full text not readStored summary read	N21 · Evidence conditionIs there a patient-important PBAC difference or interpretation criterion?Supplementary; required for clinical-importance claims	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. S1	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.	Evidence supporting adolescent PBAC important differences, responder criteria and validation	Material needed: Evidence supporting adolescent PBAC important differences, responder criteria and validation. This records needed materials; no new research was executed.
22	Unverified	Full text not readStored summary read	N22 · Evidence conditionWere prespecified outcomes/analyses compared against registration, protocol and SAP?Required	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. S1	Unverified registration identity and the lack of plan comparison are retained. Neither absent registration nor selective reporting is newly established.	Trial registration, dates/change history, protocol/SAP and a results-comparison table	Material needed: Trial registration, dates/change history, protocol/SAP and a results-comparison table. This records needed materials; no new research was executed.
23	Partly verified	Full text not readStored summary read	N23 · Evidence conditionAre acceptance of a paper-level primary outcome and preregistered hierarchy the same?Required	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. S1	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.	Article outcome descriptions, prospective protocol/SAP and multiplicity handling	Material needed: Article outcome descriptions, prospective protocol/SAP and multiplicity handling. This records needed materials; no new research was executed.
24	Partly verified	Full text not readStored summary read	N24 · Evidence conditionWas this PBAC result replicated in other independent trials or conditions?Supplementary; required for replication or generalization claims	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. S1	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.	Independent-team/unique-trial family table, direct PBAC results and condition-specific comparisons	Material needed: Independent-team/unique-trial family table, direct PBAC results and condition-specific comparisons. This records needed materials; no new research was executed.
25	Partly verified	Full text not readStored summary read	N25 · Evidence conditionDoes the material establish optimal dose, persistence after stopping or long-term application?Supplementary; required for the relevant extension claims	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. S1	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.	Direct dose comparisons, post-discontinuation/long-term follow-up and prespecified subgroups/interactions	Material needed: Direct dose comparisons, post-discontinuation/long-term follow-up and prespecified subgroups/interactions. This records needed materials; no new research was executed.
26	Met	Full text not readStored summary read	N26 · Evidence conditionDoes a PBAC change also answer pain, duration, Hb, anemia or clinical-event questions?Supplementary; required for clinical extension claims	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. S1	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.	Direct results for separate outcomes/clinical events and evidence on patient importance/relevance	Material needed: Direct results for separate outcomes/clinical events and evidence on patient importance/relevance. This records needed materials; no new research was executed.
27	Unverified	Full text not readStored summary read	N27 · Evidence conditionWhat actual harm events were recorded, and how were they collected?Supplementary; required for safety or harm claims	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. S1	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.	Trial AE collection methods, definitions, event/discontinuation tables and severity	Material needed: Trial AE collection methods, definitions, event/discontinuation tables and severity. This records needed materials; no new research was executed.
28	Unverified	Full text not readStored summary read	N28 · Evidence conditionWhat is the timing of intake, events, discontinuation and recovery?Supplementary; required for harm-timing claims	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. S1	The efficacy dosing window alone cannot verify actual AE temporal order or that exposure was causal. Rechallenge or improvement after stopping is not inferred.	Individual AE timelines, medication/stopping/recovery and harm-follow-up records	Material needed: Individual AE timelines, medication/stopping/recovery and harm-follow-up records. This records needed materials; no new research was executed.
29	Unverified	Full text not readStored summary read	N29 · Evidence conditionWere actual harms compared with the lactose-placebo arm?Supplementary; required for comparative harm claims	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. S1	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.	Consistent AE collection in both arms, arm-level events/exposure and comparative-estimate table	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.
30	Unverified	Full text not readStored summary read	N30 · Evidence conditionAre event counts, exposure denominators and time available for harm frequency?Supplementary; required for incidence claims	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. S1	Efficacy denominators cannot automatically become AE denominators, and warnings alone cannot establish frequency or safety.	Arm-level exposure denominators, people with events/event counts and follow-up/discontinuation tables	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.
31	Partly verified	Full text not readStored summary read	N31 · Evidence conditionWere concurrent medication, bleeding causes and alternative harm explanations verified?Supplementary; required for causal or comparative harm claims	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. S1	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.	Arm-level medication/disease, bleeding causes, baseline events and alternative/adjustment material	Material needed: Arm-level medication/disease, bleeding causes, baseline events and alternative/adjustment material. This records needed materials; no new research was executed.
32	Unverified	Full text not readStored summary read	N32 · Evidence conditionWere harms among noncompleters and selection/detection differences verified?Supplementary; required for harm reporting or missingness claims	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. S1	Efficacy attrition alone cannot establish AE-related discontinuation or reporting bias. Absence of events among noncompleters is not assumed.	Harm follow-up for withdrawals, stopping reasons, AE aggregation/collection and arm-level disclosure scope	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.
33	Unverified	Full text not readStored summary read	N33 · Evidence conditionWere independent harm sources for the same formulation/population linked?Supplementary; required for repeated-signal claims	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. S1	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.	Original identities of formulation/population/event-specific harm reports and unique-case/family linkage table	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.
34	Unverified	Full text not readStored summary read	N34 · Evidence conditionWere other populations, long-term/rare harms and interactions verified?Supplementary; required for the relevant safety scope	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. S1	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.	Direct material from suitable long-term/rare-harm designs, vulnerable populations and medication interactions	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.
35	Met	Full text not readStored summary read	N35 · Evidence conditionDo caution warnings establish incidence, causality or safety certification?Supplementary; required for safety-interpretation boundaries	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. S1	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.	Original caution/advertising boundaries, harm design/comparison/denominators/time and alternative-source material	Material needed: Original caution/advertising boundaries, harm design/comparison/denominators/time and alternative-source material. This records needed materials; no new research was executed.

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35 itemsWhat the statuses mean

Assessment scope

Stored-material review date: 2026-10-06
Original evidence cut-off: 2026-09-08
Scope actually checked: Retained Korean/English summaries and case-specific condition/application records. Full papers, supplements, registrations, plans and original data were not read.
What the dates mean: 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.
Population: Adolescents aged 15–18 with normal BMI, regular menstrual cycles and PBAC-assessed heavy menstrual bleeding
Ingredient, formulation and route: 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
Measured outcome: PBAC-based menstrual-blood-loss score per cycle; not directly measured mL
Duration: 3 baseline cycles followed by 3 treatment cycles
Questions outside this scope: 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

Evidence and sources

The links below lead to the sources. A link alone does not mean the original source was read or its latest publication status verified.

S1 · Effect of ginger (Zingiber officinale) on heavy menstrual bleeding: a placebo-controlled, randomized clinical trial

PubMed

Material type: Stored summary of a randomized placebo trial of adolescent heavy menstrual bleeding assessed by PBAC
Materials actually 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.
Findings recorded in the stored summary: Reported means 113.73→60.67 versus 113.43→110.97, P<.001; exact adjusted CI unverified
Record 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.
Study overlap and independent replication: 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.

Public availability, access and reading status by material
Material	Public availability	Access status	Actually read	Notes
Stored existing review summary	Locally retained; stored summary read	Acquired	Stored existing review summary read	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.
External bibliography and abstract	Existence, availability and acquisition unverified; not read	Not attempted	Not read	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.
Original full text and DOI entry point	Existence, availability and acquisition unverified; not read	Not attempted	Not read	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.

Report counts versus independent study counts

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.

Review criteria

Version 1.0 · Criteria record date 2026-10-06. These are Chamgap's own application conditions, informed by the referenced methods. They do not constitute official assessment-tool certification or a new efficacy score.

N01 · Which ginger and PBAC question is linked to the original claim?

Required materials and conditions: Original Korean/English effect, population/intervention details, scope note and final boundary document
Conditions for verification: 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.
Requirement and applicability: Required
Application exceptions: Pain, duration, hemoglobin and other formulations/populations are not added as separate efficacy claims within this table.
Why this condition is needed: Needed to avoid merging ginger as a whole or dysmenorrhea questions with this adolescent PBAC bleeding-measure question.
Referenced methods: Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.

N02 · How are the sole report, bibliography entry and trial family related?

Required materials and conditions: Report/bibliographic identity and a linkage table for registration and related reports
Conditions for verification: Link the retained Kashefi2015 report to its PMID/DOI bibliography, distinguishing a provisional family from unconfirmed unique totals.
Requirement and applicability: Required
Application exceptions: Verify the bibliographic link without inferring unique trial or participant totals from unread registration or related reports.
Why this condition is needed: Needed to avoid counting one evidence entry and one bibliography entry as two independent trials.
Referenced methods: Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.

N03 · What summary, abstract and full-text material was actually read?

Required materials and conditions: Material-specific actual access/acquisition/reading records and source provenance
Conditions for verification: Link the current retained summary and its provenance while separately showing unread external PubMed/DOI material.
Requirement and applicability: Required
Application exceptions: Do not relabel unattempted external access as inaccessible, or an existing link as full-text reading.
Why this condition is needed: Needed to avoid retrospectively turning historical wording about accessible-full-text comparison into full-text reading in this work.
Referenced methods: Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.

N04 · Which adolescents and bleeding conditions produced these data?

Required materials and conditions: Eligibility/exclusion table, PBAC criterion, assessment of bleeding causes and arm-level baseline table
Conditions for verification: Distinguish the retained population record from verified or missing eligibility/exclusion, diagnostic and baseline PBAC details.
Requirement and applicability: Required
Application exceptions: Do not substitute this result for effects in other causes of bleeding, anemia, pregnancy, abnormal BMI or irregular cycles.
Why this condition is needed: Needed to avoid extending the 15–18 age range, normal BMI and regular-cycle conditions to all patients with heavy bleeding.
Referenced methods: Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.

N05 · Which powder, route and nominal dose were administered?

Required materials and conditions: Product specification, batch/content verification and arm-level actual medication/adherence records
Conditions for verification: Distinguish the retained plant part, formulation, oral route and 250 mg 3 times daily from unverified product, batch and constituent details.
Requirement and applicability: Required
Application exceptions: Do not calculate or substitute active-constituent amount or actual intake for the nominal 750 mg/day.
Why this condition is needed: Needed to avoid treating the dried-rhizome-powder 250 mg capsule as interchangeable with food, standardized extract or essential oil.
Referenced methods: Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.

N06 · What was the placebo, and which difference was compared?

Required materials and conditions: Placebo composition/specification, sensory matching and distribution/concomitant-treatment records
Conditions for verification: Distinguish the dried-powder versus appearance-matched lactose-placebo comparison from unverified sensory/capsule and concomitant-treatment details.
Requirement and applicability: Required
Application exceptions: Appearance matching alone does not establish complete taste/smell matching or assessor blinding.
Why this condition is needed: Needed to avoid turning an appearance-matched lactose-placebo comparison into an uncontrolled before/after or treatment-replacement comparison.
Referenced methods: Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.

N07 · Is the PBAC score directly measured mL?

Required materials and conditions: PBAC instrument/score range, scoring education, diary validation and missing-data rules
Conditions for verification: Preserve the original distinction between pictorial PBAC and directly measured mL, while identifying gaps in the scale/scoring, validation and error details.
Requirement and applicability: Required
Application exceptions: Do not newly apply a PBAC-to-volume conversion formula or another bleeding scale.
Why this condition is needed: Needed to avoid turning the original article's blood-loss wording into measured volumetric blood loss.
Referenced methods: Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.

N08 · How do 4 dosing days per cycle differ from 3 intervention cycles?

Required materials and conditions: Cycle-specific medication/diary schedule, actual cycle lengths and assessment windows
Conditions for verification: Link day-before-menstruation through day 3, 4 days per cycle, 3 baseline→3 intervention cycles, and the outcome-assessment window separately.
Requirement and applicability: Required
Application exceptions: Do not calculate cycle lengths, calendar dates or medication-free intervals while they remain unverified.
Why this condition is needed: Needed to avoid turning the 4-day dosing window into the full follow-up period or continuous 3-month use.
Referenced methods: Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.

N09 · Which denominators are represented by 92 randomized participants and 71 completers?

Required materials and conditions: Arm-level CONSORT flow and PBAC analysis/completion-denominator table
Conditions for verification: Distinguish the original 92 randomized and 71 completed, leaving arm-level randomized, measured, completed and analyzed counts unverified.
Requirement and applicability: Required
Application exceptions: Do not infer 46/46 allocation, a 71-person ITT population, event rates or attrition rates.
Why this condition is needed: Needed to avoid converting total randomized/completed counts into arm-level denominators or analysis counts.
Referenced methods: Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.

N10 · What attrition, missing diaries and handling methods were recorded?

Required materials and conditions: Arm-level attrition/missing-diary table and missing-data/sensitivity analyses
Conditions for verification: Distinguish the verified scope of arm-level attrition timing/reasons, missing PBAC data, imputation/sensitivity methods and analysis populations.
Requirement and applicability: Required
Application exceptions: Do not convert the retained substantial-attrition/completer-based description into verified missing-data handling or bias magnitude.
Why this condition is needed: Needed because a total of 71 completers does not explain the direction of missing-data bias or adequacy of its handling.
Referenced methods: Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.

N11 · Were the original results and boundaries with dysmenorrhea or other outcomes preserved?

Required materials and conditions: Whole current report/bibliography, outcome-specific results and opposing context in the record
Conditions for verification: Preserve the original PBAC values/P, single-trial limitations and wording separating pain, duration and Hb.
Requirement and applicability: Required
Application exceptions: Do not turn nonselection of another outcome into a null result or an opposing PBAC trial.
Why this condition is needed: Needed to avoid keeping only favorable PBAC wording or combining dysmenorrhea evidence as blood-loss replication.
Referenced methods: Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.

N12 · Which dates and retained scope frame these gaps?

Required materials and conditions: Original verdict/correction identity and actual authorized search, registration and access records
Conditions for verification: Distinguish the original verdict date 2026-09-08, correction 2026-09-14, current actual review date, input scope and unread external material.
Requirement and applicability: Required
Application exceptions: Do not present an unperformed new search as verification of 0 studies, absent registration or no retractions.
Why this condition is needed: Needed to avoid overstating the original verdict date or historical verification wording as a current comprehensive search or reading.
Referenced methods: Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.

N13 · What funding and declared conflicts were retained?

Required materials and conditions: Original funding/COI statements, funding/contracts and product-support material
Conditions for verification: Limit the original Bojnoord University grant89-162/no-conflicts record and historical grade reasoning to the currently verified level.
Requirement and applicability: Supplementary; required for independence claims
Application exceptions: A declaration of no conflicts does not guarantee absence of bias or product support, or replication by a separate team.
Why this condition is needed: Needed to distinguish a university-support description from actual verification of independent funding.
Referenced methods: Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.

N14 · Were product support, author employment/patents and independent teams verified?

Required materials and conditions: Product provision, author affiliation/employment, patents/COI and related-team material
Conditions for verification: Identify unverified product provision, author employment/patents and related institution/team families beyond the retained funding information.
Requirement and applicability: Supplementary; required for independence claims
Application exceptions: Do not turn missing material into absence of industry links, or one research team into independent replication.
Why this condition is needed: Needed to avoid inheriting the original I2 as complete verification of product/employment/patent relationships and independent replication.
Referenced methods: Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.

N15 · Can randomization, concealment and baseline balance be verified?

Required materials and conditions: Sequence generation/concealment methods, actual design and arm-level baseline table
Conditions for verification: Distinguish the retained randomized, double-blind, placebo-trial description from gaps in sequence generation, concealment and baseline-characteristic tables.
Requirement and applicability: Required (causal efficacy)
Application exceptions: Do not fill parallel/crossover/cluster details from the design label alone or relabel uncertainty as not applicable.
Why this condition is needed: Needed to avoid treating an RCT label and PBAC baseline means as resolution of all allocation risks.
Referenced methods: Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.

N16 · Could concomitant treatment, adherence or rescue therapy mix with the result difference?

Required materials and conditions: Arm-level adherence, concomitant/rescue medication and stopping/change records
Conditions for verification: Specify gaps in arm-level medication/rescue treatment, concurrent interventions, stopping/changes and their analysis handling.
Requirement and applicability: Required
Application exceptions: Do not infer nonuse of hormones, iron or analgesics from their omission.
Why this condition is needed: Needed to distinguish planned medication from actual intake and differences in accompanying treatment.
Referenced methods: Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.

N17 · How were double blinding and PBAC diary collection carried out?

Required materials and conditions: Blinding targets/success, PBAC education/collection and arm-level detection/scoring records
Conditions for verification: Distinguish the original design/appearance-matching record from gaps in participant/assessor scoring, diary return and correction procedures.
Requirement and applicability: Required
Application exceptions: A subjective diary alone does not justify automatic failure or confirmed measurement bias.
Why this condition is needed: Needed because a double-blind trial label does not guarantee actual blinding or consistent collection for participant diaries/scorers.
Referenced methods: Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.

N18 · Which analysis do the reported means and between-group P represent?

Required materials and conditions: Original between-group analysis table, estimates/CI, model/covariates and analysis-population definitions
Conditions for verification: Attribute 113.73→60.67 versus113.43→110.97/P<.001 to its original reporting level, retaining unverified model, adjustment and analysis population.
Requirement and applicability: Required
Application exceptions: Do not replace the original P<.001 with an ITT assignment effect, exact between-group estimate or newly subtracted value.
Why this condition is needed: Needed to avoid creating a new adjusted between-group difference or CI from ginger/placebo baseline→treatment means.
Referenced methods: Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.

N19 · What are the averaging and aggregation units for the 3 baseline and 3 intervention cycles?

Required materials and conditions: Cycle-specific PBAC source table, participant aggregation/weighting and repeated-measures model
Conditions for verification: Preserve the original means and the 3-intervention-cycle record, identifying gaps in participant/cycle averaging, final-cycle values and repeated-measures handling.
Requirement and applicability: Required
Application exceptions: Do not calculate a participant count 3 times larger from 3 cycles or assume independence of repeated measurements.
Why this condition is needed: Needed to avoid inflating sample size or precision by mixing participant and cycle units.
Referenced methods: Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.

N20 · Were exact between-group estimates, intervals and variance verified?

Required materials and conditions: Exact between-group effect/CI, variance, arm-level analysis counts and adjusted model
Conditions for verification: Retain the original statement that the exact adjusted CI is unverified, linking gaps in arm-level variance, denominators and the original between-group estimate.
Requirement and applicability: Required
Application exceptions: Do not newly calculate variance, CI, standardized effects or probabilities from the original means/P.
Why this condition is needed: Needed to avoid declaring sufficient precision from significance, total sample size or the historical CX alone.
Referenced methods: Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.

N21 · Is there a patient-important PBAC difference or interpretation criterion?

Required materials and conditions: Evidence supporting adolescent PBAC important differences, responder criteria and validation
Conditions for verification: Show whether an important difference and response definition justified for this population, scale and cycle were verified or remain unverified.
Requirement and applicability: Supplementary; required for clinical-importance claims
Application exceptions: Do not arbitrarily adopt a common minimum sample/period, an unverified MID or a PBAC→mL conversion.
Why this condition is needed: Needed to avoid automatically upgrading statistical P or score changes to patient-important improvement in bleeding.
Referenced methods: Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.

N22 · Were prespecified outcomes/analyses compared against registration, protocol and SAP?

Required materials and conditions: Trial registration, dates/change history, protocol/SAP and a results-comparison table
Conditions for verification: Distinguish the retained unverified registration status from unread registration/protocol/SAP, leaving prespecified PBAC, time points, analyses and changes unverified.
Requirement and applicability: Required
Application exceptions: Failure to acquire registration does not establish selective reporting or not-applicable status.
Why this condition is needed: Needed to avoid turning an unverified NCT into confirmed absence of registration or verified prespecification of a primary outcome.
Referenced methods: Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.

N23 · Are acceptance of a paper-level primary outcome and preregistered hierarchy the same?

Required materials and conditions: Article outcome descriptions, prospective protocol/SAP and multiplicity handling
Conditions for verification: Preserve paper-level primary acceptance and the historical P axis, separating them from prespecification, multiplicity and registered hierarchy.
Requirement and applicability: Required
Application exceptions: Do not erase the original paper-level acceptance or turn it into a new hierarchy/efficacy assessment.
Why this condition is needed: Needed to avoid inheriting historical paper-level primary/P-axis information as verification of prospectively registered hierarchy in this work.
Referenced methods: Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.

N24 · Was this PBAC result replicated in other independent trials or conditions?

Required materials and conditions: Independent-team/unique-trial family table, direct PBAC results and condition-specific comparisons
Conditions for verification: Describe the retained single direct report's family and population/formulation/outcome match, leaving the full independent total unconfirmed.
Requirement and applicability: Supplementary; required for replication or generalization claims
Application exceptions: Do not add dysmenorrhea reports, or Korean/English text and bibliography from the same record, as separate replications.
Why this condition is needed: Needed to avoid marking a sole direct report from one team and age range as completed independent replication.
Referenced methods: Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.

N25 · Does the material establish optimal dose, persistence after stopping or long-term application?

Required materials and conditions: Direct dose comparisons, post-discontinuation/long-term follow-up and prespecified subgroups/interactions
Conditions for verification: Distinguish the selected dose/dosing window/3-cycle scope from unverified direct dose comparisons, post-discontinuation/long-term follow-up and subgroups.
Requirement and applicability: Supplementary; required for the relevant extension claims
Application exceptions: Do not make every dose/long-term trial mandatory for this narrow PBAC result.
Why this condition is needed: Needed to avoid extending one nominal dose/3 intervention cycles to optimal dose or long-term persistence.
Referenced methods: Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.

N26 · Does a PBAC change also answer pain, duration, Hb, anemia or clinical-event questions?

Required materials and conditions: Direct results for separate outcomes/clinical events and evidence on patient importance/relevance
Conditions for verification: Preserve the original scope note and advertising limitations, distinguishing PBAC, pain/duration/Hb and clinical events separately.
Requirement and applicability: Supplementary; required for clinical extension claims
Application exceptions: Do not make all clinical-event trials mandatory for the PBAC question itself.
Why this condition is needed: Needed to avoid extending a bleeding-diary score result to improved hemoglobin/anemia, quality of life or replacement of medical care.
Referenced methods: Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.

N27 · What actual harm events were recorded, and how were they collected?

Required materials and conditions: Trial AE collection methods, definitions, event/discontinuation tables and severity
Conditions for verification: Separate original cautions from gaps in actual AE definitions, collection/severity and discontinuation/event records.
Requirement and applicability: Supplementary; required for safety or harm claims
Application exceptions: Do not label missing AE information in an efficacy summary as nonreporting throughout the original article or as safety.
Why this condition is needed: Needed to avoid turning general cautions into actual observed events in this PBAC trial or 0 adverse events.
Referenced methods: Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.

N28 · What is the timing of intake, events, discontinuation and recovery?

Required materials and conditions: Individual AE timelines, medication/stopping/recovery and harm-follow-up records
Conditions for verification: Distinguish the 4-day-per-cycle/3-intervention-cycle exposure record from unverified event/recovery, stopping and rechallenge observations.
Requirement and applicability: Supplementary; required for harm-timing claims
Application exceptions: Do not infer improvement after stopping, rechallenge or event timing without records.
Why this condition is needed: Needed to avoid substituting the efficacy dosing window for AE observation time or evidence of causality.
Referenced methods: Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.

N29 · Were actual harms compared with the lactose-placebo arm?

Required materials and conditions: Consistent AE collection in both arms, arm-level events/exposure and comparative-estimate table
Conditions for verification: Separate the efficacy placebo's existence from the presence or uncertainty of arm-level harm collection/comparative results.
Requirement and applicability: Supplementary; required for comparative harm claims
Application exceptions: Do not extrapolate background incidence or general cautions to create a risk difference or RR.
Why this condition is needed: Needed because a placebo-controlled efficacy design does not establish that comparative-harm results were acquired.
Referenced methods: Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.

N30 · Are event counts, exposure denominators and time available for harm frequency?

Required materials and conditions: Arm-level exposure denominators, people with events/event counts and follow-up/discontinuation tables
Conditions for verification: Identify gaps in people with AEs/event counts, exposed participants, time, attrition and recurrent-event aggregation.
Requirement and applicability: Supplementary; required for incidence claims
Application exceptions: Do not calculate frequency or safety from event names/caution wording and efficacy denominators alone.
Why this condition is needed: Needed to avoid automatically using the 92 randomized/71 completed as harm-exposed participants or event denominators.
Referenced methods: Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.

N31 · Were concurrent medication, bleeding causes and alternative harm explanations verified?

Required materials and conditions: Arm-level medication/disease, bleeding causes, baseline events and alternative/adjustment material
Conditions for verification: Distinguish the narrow population/original cautions from gaps in actual concomitant medication, disease/bleeding causes and alternatives/adjustment.
Requirement and applicability: Supplementary; required for causal or comparative harm claims
Application exceptions: Anticoagulant/antiplatelet and pregnancy warnings are not evidence of concomitant use or pregnancy cases among actual trial participants.
Why this condition is needed: Needed to avoid attributing all effects of existing disease or medication to ginger exposure.
Referenced methods: Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.

N32 · Were harms among noncompleters and selection/detection differences verified?

Required materials and conditions: Harm follow-up for withdrawals, stopping reasons, AE aggregation/collection and arm-level disclosure scope
Conditions for verification: Identify gaps in participants covered by AE collection, withdrawal/stopping reasons, unobserved events and arm-level detection/reporting differences.
Requirement and applicability: Supplementary; required for harm reporting or missingness claims
Application exceptions: Do not establish AE-related discontinuation or the direction/magnitude of reporting bias from total attrition alone.
Why this condition is needed: Needed to avoid treating harms outside the 71 efficacy completers as absent events.
Referenced methods: Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.

N33 · Were independent harm sources for the same formulation/population linked?

Required materials and conditions: Original identities of formulation/population/event-specific harm reports and unique-case/family linkage table
Conditions for verification: Distinguish duplicated locations of original cautions from unverified individual events or unique families.
Requirement and applicability: Supplementary; required for repeated-signal claims
Application exceptions: Do not turn general cautions or an efficacy bibliography into newly added harm cases/reports.
Why this condition is needed: Needed to avoid counting repeated safety-guidance/product-description wording in one record as multiple independent harm reports.
Referenced methods: Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.

N34 · Were other populations, long-term/rare harms and interactions verified?

Required materials and conditions: Direct material from suitable long-term/rare-harm designs, vulnerable populations and medication interactions
Conditions for verification: Identify original caution boundaries for populations/interactions and unverified direct long-term, rare-harm or vulnerable-population data.
Requirement and applicability: Supplementary; required for the relevant safety scope
Application exceptions: Do not make every rare-harm study mandatory for the current narrow efficacy question or turn unread material into not applicable.
Why this condition is needed: Needed to avoid extending normal-BMI adolescent 3-cycle data to pregnancy, anticoagulant use or overall long-term safety.
Referenced methods: Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.

N35 · Do caution warnings establish incidence, causality or safety certification?

Required materials and conditions: Original caution/advertising boundaries, harm design/comparison/denominators/time and alternative-source material
Conditions for verification: Distinguish original cautions/advertising limitations from unverified actual events, comparative risk and causality, retaining the historical grade only as a quotation.
Requirement and applicability: Supplementary; required for safety-interpretation boundaries
Application exceptions: Do not delete uncertain material or turn this table into self-treatment or replacement-of-care instructions.
Why this condition is needed: Needed to avoid upgrading historical cautions/C54 and general consultation wording to new dosing instructions, clinical causality or safety certification.
Referenced methods: Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.

Referenced methods and the sections actually reviewed

M03 · Cochrane Handbook 6.5 (2024), chapter updated 2023-08

Official methodology · §3.1, §3.2.1–3.2.3, MECIR C5/C7/C13

Referenced principle: Clearly record the question, eligibility conditions and reasons for changes, and distinguish variations in interventions.
Extent of review: Retained method-application records were reused. External originals were not reread and method content was not reassessed.

M04 · Cochrane Handbook 6.5.1 (2025), chapter updated 2025-03

Official methodology · §4.5, §4.6.1–4.6.3, MECIR C42

Referenced principle: Distinguish studies from reports and link them; do not omit a study solely because results are unreported.
Extent of review: Retained method-application records were reused. External originals were not reread and method content was not reassessed.

M08 · Cochrane Handbook 6.5 (2024), chapter updated 2019-10

Official methodology · §8.1–8.2.3, Table 8.2.a

Referenced principle: Define the outcome and effect of interest, then examine randomization, deviations, missing data, measurement and selective reporting.
Extent of review: Retained method-application records were reused. External originals were not reread and method content was not reassessed.

M15 · Cochrane Handbook 6.5 (2024), chapter updated 2023-08

Official methodology · §15.2.4, §15.3.1–15.3.3

Referenced principle: Distinguish effect estimates, intervals, importance and applicability. Sample size alone does not determine precision.
Extent of review: Retained method-application records were reused. External originals were not reread and method content was not reassessed.

M19 · Cochrane Handbook 6.5 (2024), chapter updated 2019-10

Official methodology · §19.1.2, §19.2.1–19.2.4

Referenced principle: Harm questions may require different designs, populations and follow-up from efficacy questions. Case reports do not establish incidence rates.
Extent of review: Retained method-application records were reused. External originals were not reread and method content was not reassessed.

What the statuses mean

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.

Change history

2026-10-25 · Public page/material version 1.0

The public view and materials were prepared from the existing 35 items. No new clinical search, verification-state change or scoring was performed.

The stored-material review date (2026-10-06) and original evidence cut-off (2026-09-08) were retained unchanged.

Researcher downloads

These materials provide the same evidence, scope and verification status as this page.

View all item details

N01 · Which ginger and PBAC question is linked to the original claim?

Current findings: 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.
Verification status: Met
Materials actually 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.
Why unverified: 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.
Reason for missing information: Other formulations, causes of bleeding, populations, pain, duration and Hb are not treated as outcomes of this question.
Required materials and conditions: Original Korean/English effect, population/intervention details, scope note and final boundary document
Materials to obtain first: Original Korean/English effect, population/intervention details, scope note and final boundary document
Further 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.
Remaining uncertainty: Other formulations, causes of bleeding, populations, pain, duration and Hb are not treated as outcomes of this question.
Conditions for verification: 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.
Why this condition is needed: Needed to avoid merging ginger as a whole or dysmenorrhea questions with this adolescent PBAC bleeding-measure question.
Application exceptions: Pain, duration, hemoglobin and other formulations/populations are not added as separate efficacy claims within this table.
Referenced methods: Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.

Related sources S1

N02 · How are the sole report, bibliography entry and trial family related?

Current findings: 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.
Verification status: Partly verified
Materials actually 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.
Why unverified: 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.
Reason for missing information: Registration, related reports, detailed cohort identifiers and participant overlap remain unverified. A report and bibliography entry are not 2 independent replications.
Required materials and conditions: Report/bibliographic identity and a linkage table for registration and related reports
Materials to obtain first: Report/bibliographic identity and a linkage table for registration and related reports
Further research: Material needed: Report/bibliographic identity and a linkage table for registration and related reports. This records needed materials; no new research was executed.
Remaining uncertainty: Registration, related reports, detailed cohort identifiers and participant overlap remain unverified. A report and bibliography entry are not 2 independent replications.
Conditions for verification: Link the retained Kashefi2015 report to its PMID/DOI bibliography, distinguishing a provisional family from unconfirmed unique totals.
Why this condition is needed: Needed to avoid counting one evidence entry and one bibliography entry as two independent trials.
Application exceptions: Verify the bibliographic link without inferring unique trial or participant totals from unread registration or related reports.
Referenced methods: Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.

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N03 · What summary, abstract and full-text material was actually read?

Current findings: 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.
Verification status: Met
Materials actually 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.
Why unverified: 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.
Reason for missing information: Current external responses, public availability, original article bytes, full text, supplements and registration access were not verified. No inaccessible status is assigned.
Required materials and conditions: Material-specific actual access/acquisition/reading records and source provenance
Materials to obtain first: Material-specific actual access/acquisition/reading records and source provenance
Further research: Material needed: Material-specific actual access/acquisition/reading records and source provenance. This records needed materials; no new research was executed.
Remaining uncertainty: Current external responses, public availability, original article bytes, full text, supplements and registration access were not verified. No inaccessible status is assigned.
Conditions for verification: Link the current retained summary and its provenance while separately showing unread external PubMed/DOI material.
Why this condition is needed: Needed to avoid retrospectively turning historical wording about accessible-full-text comparison into full-text reading in this work.
Application exceptions: Do not relabel unattempted external access as inaccessible, or an existing link as full-text reading.
Referenced methods: Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.

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N04 · Which adolescents and bleeding conditions produced these data?

Current findings: 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.
Verification status: Partly verified
Materials actually 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.
Why unverified: 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.
Reason for missing information: Details of bleeding-cause assessment, recruitment, PBAC criteria, arm-level baseline characteristics and representativeness remain unverified.
Required materials and conditions: Eligibility/exclusion table, PBAC criterion, assessment of bleeding causes and arm-level baseline table
Materials to obtain first: Eligibility/exclusion table, PBAC criterion, assessment of bleeding causes and arm-level baseline table
Further 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.
Remaining uncertainty: Details of bleeding-cause assessment, recruitment, PBAC criteria, arm-level baseline characteristics and representativeness remain unverified.
Conditions for verification: Distinguish the retained population record from verified or missing eligibility/exclusion, diagnostic and baseline PBAC details.
Why this condition is needed: Needed to avoid extending the 15–18 age range, normal BMI and regular-cycle conditions to all patients with heavy bleeding.
Application exceptions: Do not substitute this result for effects in other causes of bleeding, anemia, pregnancy, abnormal BMI or irregular cycles.
Referenced methods: Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.

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N05 · Which powder, route and nominal dose were administered?

Current findings: 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.
Verification status: Partly verified
Materials actually 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.
Why unverified: 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.
Reason for missing information: Manufacturer/batch, active constituents, contamination testing, capsule-content verification and actual intake/adherence remain unverified.
Required materials and conditions: Product specification, batch/content verification and arm-level actual medication/adherence records
Materials to obtain first: Product specification, batch/content verification and arm-level actual medication/adherence records
Further research: Material needed: Product specification, batch/content verification and arm-level actual medication/adherence records. This records needed materials; no new research was executed.
Remaining uncertainty: Manufacturer/batch, active constituents, contamination testing, capsule-content verification and actual intake/adherence remain unverified.
Conditions for verification: Distinguish the retained plant part, formulation, oral route and 250 mg 3 times daily from unverified product, batch and constituent details.
Why this condition is needed: Needed to avoid treating the dried-rhizome-powder 250 mg capsule as interchangeable with food, standardized extract or essential oil.
Application exceptions: Do not calculate or substitute active-constituent amount or actual intake for the nominal 750 mg/day.
Referenced methods: Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.

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N06 · What was the placebo, and which difference was compared?

Current findings: 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.
Verification status: Partly verified
Materials actually 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.
Why unverified: Lactose placebo, appearance matching and comparison direction are verified. Smell/taste, capsule specification, actual blinding and arm-level concomitant differences remain separate gaps.
Reason for missing information: Placebo amount/specification, sensory matching, distribution/concurrent treatment and successful blinding details remain unverified.
Required materials and conditions: Placebo composition/specification, sensory matching and distribution/concomitant-treatment records
Materials to obtain first: Placebo composition/specification, sensory matching and distribution/concomitant-treatment records
Further research: Material needed: Placebo composition/specification, sensory matching and distribution/concomitant-treatment records. This records needed materials; no new research was executed.
Remaining uncertainty: Placebo amount/specification, sensory matching, distribution/concurrent treatment and successful blinding details remain unverified.
Conditions for verification: Distinguish the dried-powder versus appearance-matched lactose-placebo comparison from unverified sensory/capsule and concomitant-treatment details.
Why this condition is needed: Needed to avoid turning an appearance-matched lactose-placebo comparison into an uncontrolled before/after or treatment-replacement comparison.
Application exceptions: Appearance matching alone does not establish complete taste/smell matching or assessor blinding.
Referenced methods: Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.

Related sources S1

N07 · Is the PBAC score directly measured mL?

Current findings: 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.
Verification status: Partly verified
Materials actually 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.
Why unverified: 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.
Reason for missing information: PBAC range/scoring, instrument validation, participant education, error/missing-data handling and consistency of measurement between arms remain unverified.
Required materials and conditions: PBAC instrument/score range, scoring education, diary validation and missing-data rules
Materials to obtain first: PBAC instrument/score range, scoring education, diary validation and missing-data rules
Further research: Material needed: PBAC instrument/score range, scoring education, diary validation and missing-data rules. This records needed materials; no new research was executed.
Remaining uncertainty: PBAC range/scoring, instrument validation, participant education, error/missing-data handling and consistency of measurement between arms remain unverified.
Conditions for verification: Preserve the original distinction between pictorial PBAC and directly measured mL, while identifying gaps in the scale/scoring, validation and error details.
Why this condition is needed: Needed to avoid turning the original article's blood-loss wording into measured volumetric blood loss.
Application exceptions: Do not newly apply a PBAC-to-volume conversion formula or another bleeding scale.
Referenced methods: Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.

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N08 · How do 4 dosing days per cycle differ from 3 intervention cycles?

Current findings: 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.
Verification status: Partly verified
Materials actually 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.
Why unverified: 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.
Reason for missing information: Actual cycle lengths/medication dates, missed cycles and details of the final assessment window/intervention completion remain unverified.
Required materials and conditions: Cycle-specific medication/diary schedule, actual cycle lengths and assessment windows
Materials to obtain first: Cycle-specific medication/diary schedule, actual cycle lengths and assessment windows
Further research: Material needed: Cycle-specific medication/diary schedule, actual cycle lengths and assessment windows. This records needed materials; no new research was executed.
Remaining uncertainty: Actual cycle lengths/medication dates, missed cycles and details of the final assessment window/intervention completion remain unverified.
Conditions for verification: Link day-before-menstruation through day 3, 4 days per cycle, 3 baseline→3 intervention cycles, and the outcome-assessment window separately.
Why this condition is needed: Needed to avoid turning the 4-day dosing window into the full follow-up period or continuous 3-month use.
Application exceptions: Do not calculate cycle lengths, calendar dates or medication-free intervals while they remain unverified.
Referenced methods: Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.

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N09 · Which denominators are represented by 92 randomized participants and 71 completers?

Current findings: 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.
Verification status: Partly verified
Materials actually 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.
Why unverified: 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.
Reason for missing information: Arm-level randomized/measured/completed/analyzed/withdrawal denominators and ITT/PP definitions remain unverified. No new attrition or event rate is calculated.
Required materials and conditions: Arm-level CONSORT flow and PBAC analysis/completion-denominator table
Materials to obtain first: Arm-level CONSORT flow and PBAC analysis/completion-denominator table
Further research: Material needed: Arm-level CONSORT flow and PBAC analysis/completion-denominator table. This records needed materials; no new research was executed.
Remaining uncertainty: Arm-level randomized/measured/completed/analyzed/withdrawal denominators and ITT/PP definitions remain unverified. No new attrition or event rate is calculated.
Conditions for verification: Distinguish the original 92 randomized and 71 completed, leaving arm-level randomized, measured, completed and analyzed counts unverified.
Why this condition is needed: Needed to avoid converting total randomized/completed counts into arm-level denominators or analysis counts.
Application exceptions: Do not infer 46/46 allocation, a 71-person ITT population, event rates or attrition rates.
Referenced methods: Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.

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N10 · What attrition, missing diaries and handling methods were recorded?

Current findings: 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.
Verification status: Unverified
Materials actually 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.
Why unverified: 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.
Reason for missing information: 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.
Required materials and conditions: Arm-level attrition/missing-diary table and missing-data/sensitivity analyses
Materials to obtain first: Arm-level attrition/missing-diary table and missing-data/sensitivity analyses
Further research: Material needed: Arm-level attrition/missing-diary table and missing-data/sensitivity analyses. This records needed materials; no new research was executed.
Remaining 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.
Conditions for verification: Distinguish the verified scope of arm-level attrition timing/reasons, missing PBAC data, imputation/sensitivity methods and analysis populations.
Why this condition is needed: Needed because a total of 71 completers does not explain the direction of missing-data bias or adequacy of its handling.
Application exceptions: Do not convert the retained substantial-attrition/completer-based description into verified missing-data handling or bias magnitude.
Referenced methods: Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.

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N11 · Were the original results and boundaries with dysmenorrhea or other outcomes preserved?

Current findings: 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.
Verification status: Met
Materials actually 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.
Why unverified: 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.
Reason for missing information: 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.
Required materials and conditions: Whole current report/bibliography, outcome-specific results and opposing context in the record
Materials to obtain first: Whole current report/bibliography, outcome-specific results and opposing context in the record
Further 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.
Remaining 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.
Conditions for verification: Preserve the original PBAC values/P, single-trial limitations and wording separating pain, duration and Hb.
Why this condition is needed: Needed to avoid keeping only favorable PBAC wording or combining dysmenorrhea evidence as blood-loss replication.
Application exceptions: Do not turn nonselection of another outcome into a null result or an opposing PBAC trial.
Referenced methods: Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.

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N12 · Which dates and retained scope frame these gaps?

Current findings: 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.
Verification status: Met
Materials actually 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.
Why unverified: 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.
Reason for missing information: 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.
Required materials and conditions: Original verdict/correction identity and actual authorized search, registration and access records
Materials to obtain first: Original verdict/correction identity and actual authorized search, registration and access records
Further research: Material needed: Original verdict/correction identity and actual authorized search, registration and access records. This records needed materials; no new research was executed.
Remaining 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.
Conditions for verification: Distinguish the original verdict date 2026-09-08, correction 2026-09-14, current actual review date, input scope and unread external material.
Why this condition is needed: Needed to avoid overstating the original verdict date or historical verification wording as a current comprehensive search or reading.
Application exceptions: Do not present an unperformed new search as verification of 0 studies, absent registration or no retractions.
Referenced methods: Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.

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N13 · What funding and declared conflicts were retained?

Current findings: 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.
Verification status: Partly verified
Materials actually 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.
Why unverified: 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.
Reason for missing information: Independent-verification details for the original support/COI statements, contracts, product support and researcher relationships remain unverified.
Required materials and conditions: Original funding/COI statements, funding/contracts and product-support material
Materials to obtain first: Original funding/COI statements, funding/contracts and product-support material
Further research: Material needed: Original funding/COI statements, funding/contracts and product-support material. This records needed materials; no new research was executed.
Remaining uncertainty: Independent-verification details for the original support/COI statements, contracts, product support and researcher relationships remain unverified.
Conditions for verification: Limit the original Bojnoord University grant89-162/no-conflicts record and historical grade reasoning to the currently verified level.
Why this condition is needed: Needed to distinguish a university-support description from actual verification of independent funding.
Application exceptions: A declaration of no conflicts does not guarantee absence of bias or product support, or replication by a separate team.
Referenced methods: Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.

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N14 · Were product support, author employment/patents and independent teams verified?

Current findings: 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.
Verification status: Unverified
Materials actually 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.
Why unverified: 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.
Reason for missing information: Original material on product provision, author employment/patents, individual COI, related teams/institutions and contract details remains unverified.
Required materials and conditions: Product provision, author affiliation/employment, patents/COI and related-team material
Materials to obtain first: Product provision, author affiliation/employment, patents/COI and related-team material
Further research: Material needed: Product provision, author affiliation/employment, patents/COI and related-team material. This records needed materials; no new research was executed.
Remaining uncertainty: Original material on product provision, author employment/patents, individual COI, related teams/institutions and contract details remains unverified.
Conditions for verification: Identify unverified product provision, author employment/patents and related institution/team families beyond the retained funding information.
Why this condition is needed: Needed to avoid inheriting the original I2 as complete verification of product/employment/patent relationships and independent replication.
Application exceptions: Do not turn missing material into absence of industry links, or one research team into independent replication.
Referenced methods: Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.

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N15 · Can randomization, concealment and baseline balance be verified?

Current findings: 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.
Verification status: Partly verified
Materials actually 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.
Why unverified: 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.
Reason for missing information: Sequence generation/concealment, arm allocation, detailed design and baseline/recruitment tables remain unverified. Crossover or cluster designs are not inferred.
Required materials and conditions: Sequence generation/concealment methods, actual design and arm-level baseline table
Materials to obtain first: Sequence generation/concealment methods, actual design and arm-level baseline table
Further research: Material needed: Sequence generation/concealment methods, actual design and arm-level baseline table. This records needed materials; no new research was executed.
Remaining uncertainty: Sequence generation/concealment, arm allocation, detailed design and baseline/recruitment tables remain unverified. Crossover or cluster designs are not inferred.
Conditions for verification: Distinguish the retained randomized, double-blind, placebo-trial description from gaps in sequence generation, concealment and baseline-characteristic tables.
Why this condition is needed: Needed to avoid treating an RCT label and PBAC baseline means as resolution of all allocation risks.
Application exceptions: Do not fill parallel/crossover/cluster details from the design label alone or relabel uncertainty as not applicable.
Referenced methods: Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.

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N16 · Could concomitant treatment, adherence or rescue therapy mix with the result difference?

Current findings: 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.
Verification status: Unverified
Materials actually 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.
Why unverified: 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.
Reason for missing information: Arm-level adherence/missed doses, concomitant medication, rescue treatment, stopping/changes and their analysis handling remain unverified.
Required materials and conditions: Arm-level adherence, concomitant/rescue medication and stopping/change records
Materials to obtain first: Arm-level adherence, concomitant/rescue medication and stopping/change records
Further research: Material needed: Arm-level adherence, concomitant/rescue medication and stopping/change records. This records needed materials; no new research was executed.
Remaining uncertainty: Arm-level adherence/missed doses, concomitant medication, rescue treatment, stopping/changes and their analysis handling remain unverified.
Conditions for verification: Specify gaps in arm-level medication/rescue treatment, concurrent interventions, stopping/changes and their analysis handling.
Why this condition is needed: Needed to distinguish planned medication from actual intake and differences in accompanying treatment.
Application exceptions: Do not infer nonuse of hormones, iron or analgesics from their omission.
Referenced methods: Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.

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N17 · How were double blinding and PBAC diary collection carried out?

Current findings: 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.
Verification status: Partly verified
Materials actually 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.
Why unverified: Double-blinding/placebo-matching descriptions are preserved without becoming resolution of actual PBAC measurement differences. A subjective diary is not automatically labeled unmet either.
Reason for missing information: Blinding targets/success, diary education/return, scoring/error correction and arm-level measurement/detection differences remain unverified.
Required materials and conditions: Blinding targets/success, PBAC education/collection and arm-level detection/scoring records
Materials to obtain first: Blinding targets/success, PBAC education/collection and arm-level detection/scoring records
Further research: Material needed: Blinding targets/success, PBAC education/collection and arm-level detection/scoring records. This records needed materials; no new research was executed.
Remaining uncertainty: Blinding targets/success, diary education/return, scoring/error correction and arm-level measurement/detection differences remain unverified.
Conditions for verification: Distinguish the original design/appearance-matching record from gaps in participant/assessor scoring, diary return and correction procedures.
Why this condition is needed: Needed because a double-blind trial label does not guarantee actual blinding or consistent collection for participant diaries/scorers.
Application exceptions: A subjective diary alone does not justify automatic failure or confirmed measurement bias.
Referenced methods: Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.

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N18 · Which analysis do the reported means and between-group P represent?

Current findings: 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.
Verification status: Partly verified
Materials actually 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.
Why unverified: 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.
Reason for missing information: The exact effect of interest, original between-group estimate/variance/CI, model/covariates, ITT/PP and actual denominators remain unverified.
Required materials and conditions: Original between-group analysis table, estimates/CI, model/covariates and analysis-population definitions
Materials to obtain first: Original between-group analysis table, estimates/CI, model/covariates and analysis-population definitions
Further 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.
Remaining uncertainty: The exact effect of interest, original between-group estimate/variance/CI, model/covariates, ITT/PP and actual denominators remain unverified.
Conditions for verification: Attribute 113.73→60.67 versus113.43→110.97/P<.001 to its original reporting level, retaining unverified model, adjustment and analysis population.
Why this condition is needed: Needed to avoid creating a new adjusted between-group difference or CI from ginger/placebo baseline→treatment means.
Application exceptions: Do not replace the original P<.001 with an ITT assignment effect, exact between-group estimate or newly subtracted value.
Referenced methods: Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.

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N19 · What are the averaging and aggregation units for the 3 baseline and 3 intervention cycles?

Current findings: 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.
Verification status: Unverified
Materials actually 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.
Why unverified: 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.
Reason for missing information: Participant/cycle aggregation, missing-cycle handling, weighting, assessment windows and repeated-measure correlation/model remain unverified.
Required materials and conditions: Cycle-specific PBAC source table, participant aggregation/weighting and repeated-measures model
Materials to obtain first: Cycle-specific PBAC source table, participant aggregation/weighting and repeated-measures model
Further research: Material needed: Cycle-specific PBAC source table, participant aggregation/weighting and repeated-measures model. This records needed materials; no new research was executed.
Remaining uncertainty: Participant/cycle aggregation, missing-cycle handling, weighting, assessment windows and repeated-measure correlation/model remain unverified.
Conditions for verification: Preserve the original means and the 3-intervention-cycle record, identifying gaps in participant/cycle averaging, final-cycle values and repeated-measures handling.
Why this condition is needed: Needed to avoid inflating sample size or precision by mixing participant and cycle units.
Application exceptions: Do not calculate a participant count 3 times larger from 3 cycles or assume independence of repeated measurements.
Referenced methods: Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.

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N20 · Were exact between-group estimates, intervals and variance verified?

Current findings: 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.
Verification status: Unverified
Materials actually 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.
Why unverified: 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.
Reason for missing information: The original between-group effect/CI, variance, exact denominators and model/adjusted values remain unverified.
Required materials and conditions: Exact between-group effect/CI, variance, arm-level analysis counts and adjusted model
Materials to obtain first: Exact between-group effect/CI, variance, arm-level analysis counts and adjusted model
Further 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.
Remaining uncertainty: The original between-group effect/CI, variance, exact denominators and model/adjusted values remain unverified.
Conditions for verification: Retain the original statement that the exact adjusted CI is unverified, linking gaps in arm-level variance, denominators and the original between-group estimate.
Why this condition is needed: Needed to avoid declaring sufficient precision from significance, total sample size or the historical CX alone.
Application exceptions: Do not newly calculate variance, CI, standardized effects or probabilities from the original means/P.
Referenced methods: Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.

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N21 · Is there a patient-important PBAC difference or interpretation criterion?

Current findings: 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.
Verification status: Unverified
Materials actually 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.
Why unverified: 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.
Reason for missing information: Population/scale/cycle-appropriate MID, response definitions, validation and effect intervals remain unverified.
Required materials and conditions: Evidence supporting adolescent PBAC important differences, responder criteria and validation
Materials to obtain first: Evidence supporting adolescent PBAC important differences, responder criteria and validation
Further research: Material needed: Evidence supporting adolescent PBAC important differences, responder criteria and validation. This records needed materials; no new research was executed.
Remaining uncertainty: Population/scale/cycle-appropriate MID, response definitions, validation and effect intervals remain unverified.
Conditions for verification: Show whether an important difference and response definition justified for this population, scale and cycle were verified or remain unverified.
Why this condition is needed: Needed to avoid automatically upgrading statistical P or score changes to patient-important improvement in bleeding.
Application exceptions: Do not arbitrarily adopt a common minimum sample/period, an unverified MID or a PBAC→mL conversion.
Referenced methods: Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.

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N22 · Were prespecified outcomes/analyses compared against registration, protocol and SAP?

Current findings: 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.
Verification status: Unverified
Materials actually 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.
Why unverified: Unverified registration identity and the lack of plan comparison are retained. Neither absent registration nor selective reporting is newly established.
Reason for missing information: Preregistration ID/date, protocol/SAP, outcome hierarchy, analysis changes and multiplicity handling remain unverified.
Required materials and conditions: Trial registration, dates/change history, protocol/SAP and a results-comparison table
Materials to obtain first: Trial registration, dates/change history, protocol/SAP and a results-comparison table
Further research: Material needed: Trial registration, dates/change history, protocol/SAP and a results-comparison table. This records needed materials; no new research was executed.
Remaining uncertainty: Preregistration ID/date, protocol/SAP, outcome hierarchy, analysis changes and multiplicity handling remain unverified.
Conditions for verification: Distinguish the retained unverified registration status from unread registration/protocol/SAP, leaving prespecified PBAC, time points, analyses and changes unverified.
Why this condition is needed: Needed to avoid turning an unverified NCT into confirmed absence of registration or verified prespecification of a primary outcome.
Application exceptions: Failure to acquire registration does not establish selective reporting or not-applicable status.
Referenced methods: Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.

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N23 · Are acceptance of a paper-level primary outcome and preregistered hierarchy the same?

Current findings: 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.
Verification status: Partly verified
Materials actually 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.
Why unverified: 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.
Reason for missing information: Prespecification, registered hierarchy, adjustment for multiple outcomes/cycle analyses and change history remain unverified.
Required materials and conditions: Article outcome descriptions, prospective protocol/SAP and multiplicity handling
Materials to obtain first: Article outcome descriptions, prospective protocol/SAP and multiplicity handling
Further research: Material needed: Article outcome descriptions, prospective protocol/SAP and multiplicity handling. This records needed materials; no new research was executed.
Remaining uncertainty: Prespecification, registered hierarchy, adjustment for multiple outcomes/cycle analyses and change history remain unverified.
Conditions for verification: Preserve paper-level primary acceptance and the historical P axis, separating them from prespecification, multiplicity and registered hierarchy.
Why this condition is needed: Needed to avoid inheriting historical paper-level primary/P-axis information as verification of prospectively registered hierarchy in this work.
Application exceptions: Do not erase the original paper-level acceptance or turn it into a new hierarchy/efficacy assessment.
Referenced methods: Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.

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N24 · Was this PBAC result replicated in other independent trials or conditions?

Current findings: 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.
Verification status: Partly verified
Materials actually 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.
Why unverified: 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.
Reason for missing information: Independent-team results for the same formulation/adolescent/PBAC question, family-specific comparisons and heterogeneity material remain unverified within this work's scope.
Required materials and conditions: Independent-team/unique-trial family table, direct PBAC results and condition-specific comparisons
Materials to obtain first: Independent-team/unique-trial family table, direct PBAC results and condition-specific comparisons
Further 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.
Remaining uncertainty: Independent-team results for the same formulation/adolescent/PBAC question, family-specific comparisons and heterogeneity material remain unverified within this work's scope.
Conditions for verification: Describe the retained single direct report's family and population/formulation/outcome match, leaving the full independent total unconfirmed.
Why this condition is needed: Needed to avoid marking a sole direct report from one team and age range as completed independent replication.
Application exceptions: Do not add dysmenorrhea reports, or Korean/English text and bibliography from the same record, as separate replications.
Referenced methods: Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.

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N25 · Does the material establish optimal dose, persistence after stopping or long-term application?

Current findings: 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.
Verification status: Partly verified
Materials actually 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.
Why unverified: 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.
Reason for missing information: Direct dose comparisons, post-discontinuation/long-term follow-up and subgroup prespecification/interactions remain unverified.
Required materials and conditions: Direct dose comparisons, post-discontinuation/long-term follow-up and prespecified subgroups/interactions
Materials to obtain first: Direct dose comparisons, post-discontinuation/long-term follow-up and prespecified subgroups/interactions
Further 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.
Remaining uncertainty: Direct dose comparisons, post-discontinuation/long-term follow-up and subgroup prespecification/interactions remain unverified.
Conditions for verification: Distinguish the selected dose/dosing window/3-cycle scope from unverified direct dose comparisons, post-discontinuation/long-term follow-up and subgroups.
Why this condition is needed: Needed to avoid extending one nominal dose/3 intervention cycles to optimal dose or long-term persistence.
Application exceptions: Do not make every dose/long-term trial mandatory for this narrow PBAC result.
Referenced methods: Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.

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N26 · Does a PBAC change also answer pain, duration, Hb, anemia or clinical-event questions?

Current findings: 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.
Verification status: Met
Materials actually 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.
Why unverified: 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.
Reason for missing information: 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.
Required materials and conditions: Direct results for separate outcomes/clinical events and evidence on patient importance/relevance
Materials to obtain first: Direct results for separate outcomes/clinical events and evidence on patient importance/relevance
Further 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.
Remaining 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.
Conditions for verification: Preserve the original scope note and advertising limitations, distinguishing PBAC, pain/duration/Hb and clinical events separately.
Why this condition is needed: Needed to avoid extending a bleeding-diary score result to improved hemoglobin/anemia, quality of life or replacement of medical care.
Application exceptions: Do not make all clinical-event trials mandatory for the PBAC question itself.
Referenced methods: Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.

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N27 · What actual harm events were recorded, and how were they collected?

Current findings: 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.
Verification status: Unverified
Materials actually 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.
Why unverified: 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.
Reason for missing information: AE definitions, planned/actual collection, actual events/severity, discontinuations and arm-level reporting scope remain unverified.
Required materials and conditions: Trial AE collection methods, definitions, event/discontinuation tables and severity
Materials to obtain first: Trial AE collection methods, definitions, event/discontinuation tables and severity
Further research: Material needed: Trial AE collection methods, definitions, event/discontinuation tables and severity. This records needed materials; no new research was executed.
Remaining uncertainty: AE definitions, planned/actual collection, actual events/severity, discontinuations and arm-level reporting scope remain unverified.
Conditions for verification: Separate original cautions from gaps in actual AE definitions, collection/severity and discontinuation/event records.
Why this condition is needed: Needed to avoid turning general cautions into actual observed events in this PBAC trial or 0 adverse events.
Application exceptions: Do not label missing AE information in an efficacy summary as nonreporting throughout the original article or as safety.
Referenced methods: Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.

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N28 · What is the timing of intake, events, discontinuation and recovery?

Current findings: 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.
Verification status: Unverified
Materials actually 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.
Why unverified: The efficacy dosing window alone cannot verify actual AE temporal order or that exposure was causal. Rechallenge or improvement after stopping is not inferred.
Reason for missing information: Individual-event onset/recovery, stopping/rechallenge, end of observation and harm-follow-up time remain unverified.
Required materials and conditions: Individual AE timelines, medication/stopping/recovery and harm-follow-up records
Materials to obtain first: Individual AE timelines, medication/stopping/recovery and harm-follow-up records
Further research: Material needed: Individual AE timelines, medication/stopping/recovery and harm-follow-up records. This records needed materials; no new research was executed.
Remaining uncertainty: Individual-event onset/recovery, stopping/rechallenge, end of observation and harm-follow-up time remain unverified.
Conditions for verification: Distinguish the 4-day-per-cycle/3-intervention-cycle exposure record from unverified event/recovery, stopping and rechallenge observations.
Why this condition is needed: Needed to avoid substituting the efficacy dosing window for AE observation time or evidence of causality.
Application exceptions: Do not infer improvement after stopping, rechallenge or event timing without records.
Referenced methods: Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.

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N29 · Were actual harms compared with the lactose-placebo arm?

Current findings: 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.
Verification status: Unverified
Materials actually 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.
Why unverified: 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.
Reason for missing information: Consistent AE definitions/collection windows, arm-level events/exposure denominators and comparative-harm estimates remain unverified.
Required materials and conditions: Consistent AE collection in both arms, arm-level events/exposure and comparative-estimate table
Materials to obtain first: Consistent AE collection in both arms, arm-level events/exposure and comparative-estimate table
Further 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.
Remaining uncertainty: Consistent AE definitions/collection windows, arm-level events/exposure denominators and comparative-harm estimates remain unverified.
Conditions for verification: Separate the efficacy placebo's existence from the presence or uncertainty of arm-level harm collection/comparative results.
Why this condition is needed: Needed because a placebo-controlled efficacy design does not establish that comparative-harm results were acquired.
Application exceptions: Do not extrapolate background incidence or general cautions to create a risk difference or RR.
Referenced methods: Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.

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N30 · Are event counts, exposure denominators and time available for harm frequency?

Current findings: 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.
Verification status: Unverified
Materials actually 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.
Why unverified: Efficacy denominators cannot automatically become AE denominators, and warnings alone cannot establish frequency or safety.
Reason for missing information: 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.
Required materials and conditions: Arm-level exposure denominators, people with events/event counts and follow-up/discontinuation tables
Materials to obtain first: Arm-level exposure denominators, people with events/event counts and follow-up/discontinuation tables
Further 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.
Remaining 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.
Conditions for verification: Identify gaps in people with AEs/event counts, exposed participants, time, attrition and recurrent-event aggregation.
Why this condition is needed: Needed to avoid automatically using the 92 randomized/71 completed as harm-exposed participants or event denominators.
Application exceptions: Do not calculate frequency or safety from event names/caution wording and efficacy denominators alone.
Referenced methods: Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.

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N31 · Were concurrent medication, bleeding causes and alternative harm explanations verified?

Current findings: 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.
Verification status: Partly verified
Materials actually 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.
Why unverified: 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.
Reason for missing information: Arm-level concomitant medication/baseline disease, bleeding causes, pregnancy/other exposures and alternative explanations/adjustment remain unverified.
Required materials and conditions: Arm-level medication/disease, bleeding causes, baseline events and alternative/adjustment material
Materials to obtain first: Arm-level medication/disease, bleeding causes, baseline events and alternative/adjustment material
Further research: Material needed: Arm-level medication/disease, bleeding causes, baseline events and alternative/adjustment material. This records needed materials; no new research was executed.
Remaining uncertainty: Arm-level concomitant medication/baseline disease, bleeding causes, pregnancy/other exposures and alternative explanations/adjustment remain unverified.
Conditions for verification: Distinguish the narrow population/original cautions from gaps in actual concomitant medication, disease/bleeding causes and alternatives/adjustment.
Why this condition is needed: Needed to avoid attributing all effects of existing disease or medication to ginger exposure.
Application exceptions: Anticoagulant/antiplatelet and pregnancy warnings are not evidence of concomitant use or pregnancy cases among actual trial participants.
Referenced methods: Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.

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N32 · Were harms among noncompleters and selection/detection differences verified?

Current findings: 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.
Verification status: Unverified
Materials actually 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.
Why unverified: Efficacy attrition alone cannot establish AE-related discontinuation or reporting bias. Absence of events among noncompleters is not assumed.
Reason for missing information: The actual scope of harm follow-up among withdrawals, arm-level stopping reasons, event disclosure/collection systems and detection differences remains unverified.
Required materials and conditions: Harm follow-up for withdrawals, stopping reasons, AE aggregation/collection and arm-level disclosure scope
Materials to obtain first: Harm follow-up for withdrawals, stopping reasons, AE aggregation/collection and arm-level disclosure scope
Further 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.
Remaining uncertainty: The actual scope of harm follow-up among withdrawals, arm-level stopping reasons, event disclosure/collection systems and detection differences remains unverified.
Conditions for verification: Identify gaps in participants covered by AE collection, withdrawal/stopping reasons, unobserved events and arm-level detection/reporting differences.
Why this condition is needed: Needed to avoid treating harms outside the 71 efficacy completers as absent events.
Application exceptions: Do not establish AE-related discontinuation or the direction/magnitude of reporting bias from total attrition alone.
Referenced methods: Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.

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N33 · Were independent harm sources for the same formulation/population linked?

Current findings: 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.
Verification status: Unverified
Materials actually 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.
Why unverified: 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.
Reason for missing information: Unique harm cases, contrary records and report/regulatory recitation families for the same formulation/population remain unverified.
Required materials and conditions: Original identities of formulation/population/event-specific harm reports and unique-case/family linkage table
Materials to obtain first: Original identities of formulation/population/event-specific harm reports and unique-case/family linkage table
Further 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.
Remaining uncertainty: Unique harm cases, contrary records and report/regulatory recitation families for the same formulation/population remain unverified.
Conditions for verification: Distinguish duplicated locations of original cautions from unverified individual events or unique families.
Why this condition is needed: Needed to avoid counting repeated safety-guidance/product-description wording in one record as multiple independent harm reports.
Application exceptions: Do not turn general cautions or an efficacy bibliography into newly added harm cases/reports.
Referenced methods: Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.

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N34 · Were other populations, long-term/rare harms and interactions verified?

Current findings: 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.
Verification status: Unverified
Materials actually 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.
Why unverified: 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.
Reason for missing information: Direct material on long-term/rare harms, pregnancy/other baseline disease/medication interactions, exposure and follow-up remains unverified.
Required materials and conditions: Direct material from suitable long-term/rare-harm designs, vulnerable populations and medication interactions
Materials to obtain first: Direct material from suitable long-term/rare-harm designs, vulnerable populations and medication interactions
Further 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.
Remaining uncertainty: Direct material on long-term/rare harms, pregnancy/other baseline disease/medication interactions, exposure and follow-up remains unverified.
Conditions for verification: Identify original caution boundaries for populations/interactions and unverified direct long-term, rare-harm or vulnerable-population data.
Why this condition is needed: Needed to avoid extending normal-BMI adolescent 3-cycle data to pregnancy, anticoagulant use or overall long-term safety.
Application exceptions: Do not make every rare-harm study mandatory for the current narrow efficacy question or turn unread material into not applicable.
Referenced methods: Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.

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N35 · Do caution warnings establish incidence, causality or safety certification?

Current findings: 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.
Verification status: Met
Materials actually 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.
Why unverified: 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.
Reason for missing information: Actual harm events, comparisons/denominators/time, alternatives, causality and overall safety remain unverified.
Required materials and conditions: Original caution/advertising boundaries, harm design/comparison/denominators/time and alternative-source material
Materials to obtain first: Original caution/advertising boundaries, harm design/comparison/denominators/time and alternative-source material
Further 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.
Remaining uncertainty: Actual harm events, comparisons/denominators/time, alternatives, causality and overall safety remain unverified.
Conditions for verification: Distinguish original cautions/advertising limitations from unverified actual events, comparative risk and causality, retaining the historical grade only as a quotation.
Why this condition is needed: Needed to avoid upgrading historical cautions/C54 and general consultation wording to new dosing instructions, clinical causality or safety certification.
Application exceptions: Do not delete uncertain material or turn this table into self-treatment or replacement-of-care instructions.
Referenced methods: Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.

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