Steamed ginger extract GGE03, 0.48 g/day × Reduction of pain in mild knee osteoarthritis

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 independent GGE03 question is being checked?Required	The original question concerns pain reduction after oral GGE03 in adults with mild knee osteoarthritis. The retained fields specify 0.48 g/day active extract, 1.6 g/day product and 12-week VAS versus placebo. R01 R02	The selected question, population, dose and endpoint boundaries are identifiable in the retained original.	Adults with mild knee osteoarthritis; oral GGE03; 0.48 g/day active extract and 1.6 g/day product; 12-week VAS pain versus placebo	Material needed: Adults with mild knee osteoarthritis; oral GGE03; 0.48 g/day active extract and 1.6 g/day product; 12-week VAS pain versus placebo — corresponding original reports, plans and linking documents. First verify the actual existence and acquisition of the currently unverified material. This records needed materials; no new research was executed.
2	Partly verified	Full text not readStored summary read	N02 · Evidence conditionHow are the two reports linked to unique trial families?Required	The retained study and citation summaries contain two records: the Kim 2024 direct GGE03 report and the Bartels 2015 mixed oral-ginger review. The review's 5 trials and 593 participants were not added to the number of GGE03 trials. R01 R02	Report identities are available, but the review's included trials, overlap with the direct report and unique families cannot be established from the available material.	Included-study tables and registration/trial identities for the Kim 2024 GGE03 report and Bartels 2015 mixed-formulation review	Material needed: Included-study tables and registration/trial identities for the Kim 2024 GGE03 report and Bartels 2015 mixed-formulation review — corresponding original reports, plans and linking documents. First verify the actual existence and acquisition of the currently unverified material. This records needed materials; no new research was executed.
3	Met	Full text not readStored summary read	N03 · Evidence conditionWhat was actually read in this review?Required	The whole retained summary and its report/citation summaries were read. PubMed and DOI links are retained identifiers; external abstracts, full texts, registration, protocols and SAPs were not newly opened. R01 R02	The levels of actual activity were distinguished, and summary-reading links point to retained original locations.	Separate reading histories for retained summaries and external bibliographic records/abstracts, full texts, trial registration, protocols and SAPs	Material needed: Separate reading histories for retained summaries and external bibliographic records/abstracts, full texts, trial registration, protocols and SAPs — corresponding original reports, plans and linking documents. First verify the actual existence and acquisition of the currently unverified material. This records needed materials; no new research was executed.
4	Partly verified	Full text not readStored summary read	N04 · Evidence conditionWhich adults with knee osteoarthritis does this material concern?Required	The retained population field specifies 100 adults with mild knee osteoarthritis. Detailed diagnosis, age range, eligibility criteria and baseline pain are not provided in the retained summary. R01	The selected population and total are named, but representativeness and selection remain unverified.	Diagnosis, age, severity, eligibility criteria and baseline pain in mild knee osteoarthritis	Material needed: Diagnosis, age, severity, eligibility criteria and baseline pain in mild knee osteoarthritis — corresponding original reports, plans and linking documents. First verify the actual existence and acquisition of the currently unverified material. This records needed materials; no new research was executed.
5	Partly verified	Full text not readStored summary read	N05 · Evidence conditionWhat are the GGE03 product and extract?Required	The formulation is steamed ginger extract GGE03, sourced from ginger rhizome. The retained fields say that extraction solvent and gingerol/shogaol assay were unverified in the public abstract. R01	The specific formulation's identity and unverified manufacturing/assay details are both retained.	Source, processing, extraction solvent, gingerol/shogaol assay and product documents for steamed ginger extract	Material needed: Source, processing, extraction solvent, gingerol/shogaol assay and product documents for steamed ginger extract — corresponding original reports, plans and linking documents. First verify the actual existence and acquisition of the currently unverified material. This records needed materials; no new research was executed.
6	Partly verified	Full text not readStored summary read	N06 · Evidence conditionWere active extract and total product amounts distinguished?Required	The original dose is 0.48 g/day GGE03 active extract and 1.6 g/day total product. The amounts are recorded separately; frequency, actual intake and adherence are unverified in the retained summary. R01	Nominal active and total amounts are stated, but the actual schedule and adherence are unverified.	Dosing schedule, frequency and actual intake for 0.48 g/day active extract and 1.6 g/day total product	Material needed: Dosing schedule, frequency and actual intake for 0.48 g/day active extract and 1.6 g/day total product — corresponding original reports, plans and linking documents. First verify the actual existence and acquisition of the currently unverified material. This records needed materials; no new research was executed.
7	Partly verified	Full text not readStored summary read	N07 · Evidence conditionWhat were the placebo and shared-care conditions?Required	The comparator field specifies a matching placebo, and the direct report is described as placebo controlled. Placebo ingredients, taste and shared care/concomitant treatment are not specifically verified in the current summary. R01	The placebo comparison is identifiable, but complete equivalence of the comparison background is unverified.	Actual composition of the matching placebo and concomitant/usual care in both groups	Material needed: Actual composition of the matching placebo and concomitant/usual care in both groups — corresponding original reports, plans and linking documents. First verify the actual existence and acquisition of the currently unverified material. This records needed materials; no new research was executed.
8	Partly verified	Full text not readStored summary read	N08 · Evidence conditionWhat endpoint and time point define the selected VAS pain outcome?Required	The current principal endpoint is 12-week VAS pain. The original reader answer says that the prespecified principal endpoint could not be verified in the public abstract. R01	The page's selected endpoint was distinguished from the trial's prespecified hierarchy.	The 12-week VAS scale, assessment setting, change/final-value outcome and prespecified endpoint hierarchy	Material needed: The 12-week VAS scale, assessment setting, change/final-value outcome and prespecified endpoint hierarchy — corresponding original reports, plans and linking documents. First verify the actual existence and acquisition of the currently unverified material. This records needed materials; no new research was executed.
9	Partly verified	Full text not readStored summary read	N09 · Evidence conditionHow does K-WOMAC pain relate to VAS?Required	The direct report describes between-group improvement in VAS and K-WOMAC pain. The current fields treat K-WOMAC pain as supportive, and the scope note separates function and structural change. R01	The relationship of the supportive pain result is identified, but scale definition, analysis and prespecified hierarchy remain unresolved.	K-WOMAC pain subscale, time point, analysis and reporting hierarchy in the same trial	Material needed: K-WOMAC pain subscale, time point, analysis and reporting hierarchy in the same trial — corresponding original reports, plans and linking documents. First verify the actual existence and acquisition of the currently unverified material. This records needed materials; no new research was executed.
10	Partly verified	Full text not readStored summary read	N10 · Evidence conditionWhich analysis does the reported between-group improvement describe?Required	The direct result is reported significant between-group improvement; exact differences, 95% CIs and P values are unverified. Details of change/final values, adjustment and analysis populations are absent. R01	Retain the original between-group statement without supplying an analysis definition absent from the original.	Between-group or change-score differences, adjustment and analysis populations for VAS and K-WOMAC separately	Material needed: Between-group or change-score differences, adjustment and analysis populations for VAS and K-WOMAC separately — corresponding original reports, plans and linking documents. First verify the actual existence and acquisition of the currently unverified material. This records needed materials; no new research was executed.
11	Partly verified	Full text not readStored summary read	N11 · Evidence conditionWhich denominators do 100 participants and 1:1 describe?Required	The retained participant record says 100 participants, allocated 1:1. Group-specific randomized, analyzed, completed and measured counts were not newly calculated or assigned a common denominator. R01	The total and allocation ratio are available, but relationships between endpoint-specific denominators remain unresolved.	Numbers randomized, completed, measured and analyzed by group, with endpoint-specific denominators	Material needed: Numbers randomized, completed, measured and analyzed by group, with endpoint-specific denominators — corresponding original reports, plans and linking documents. First verify the actual existence and acquisition of the currently unverified material. This records needed materials; no new research was executed.
12	Unverified	Full text not readStored summary read	N12 · Evidence conditionHow were missing data and withdrawals handled?Required	The current retained summary does not provide group-specific withdrawal reasons, missing-data handling, changes in adherence/rescue treatment or sensitivity analyses. R01	The total of 100 and generic English participant wording cannot replace actual participant-flow and missing-data records.	Group-specific withdrawal reasons, changes in adherence/rescue treatment and missing-data/analysis handling	Material needed: Group-specific withdrawal reasons, changes in adherence/rescue treatment and missing-data/analysis handling — corresponding original reports, plans and linking documents. First verify the actual existence and acquisition of the currently unverified material. This records needed materials; no new research was executed.
13	Unverified	Full text not readStored summary read	N13 · Evidence conditionAre direct GGE03 effect estimates and intervals available?Required	The direct GGE03 record retains unverified exact between-group differences, 95% CIs and P values. The review's SMD and interval were not copied as this product's values. R01 R02	No retained result table establishes the magnitude and interval of the selected direct effect.	Between-group effects, variance, 95% CIs and exact P values for 12-week VAS and K-WOMAC separately	Material needed: Between-group effects, variance, 95% CIs and exact P values for 12-week VAS and K-WOMAC separately — corresponding original reports, plans and linking documents. First verify the actual existence and acquisition of the currently unverified material. This records needed materials; no new research was executed.
14	Partly verified	Full text not readStored summary read	N14 · Evidence conditionHow are the mixed oral-ginger review's results retained?Required	The Bartels review summary gives pain SMD -0.30, 95% CI -0.50 to -0.09 and adverse-event withdrawal RR 2.33, interval 1.04 to 5.22. The original record describes mixed-formulation supportive evidence, including some combinations. R02	Synthesis estimates retain their original attribution, but included formulations/trials and correspondence to the direct product remain unresolved.	Bartels 2015 pain SMD, adverse-event withdrawal RR and included formulations	Material needed: Bartels 2015 pain SMD, adverse-event withdrawal RR and included formulations — corresponding original reports, plans and linking documents. First verify the actual existence and acquisition of the currently unverified material. This records needed materials; no new research was executed.
15	Met	Full text not readStored summary read	N15 · Evidence conditionWhich dates and verification scope apply to the original used here?Required	The original verdict date is 2026-09-08, and the 2026-09-14 correction concerns English evidence-table placeholders. The Korean text also mentions a 2020 meta-analysis, but there are two structured reports/citations. No new clinical search was performed. R01 R02	Dates, corrections and narrative scope were separated from the current conversion review.	Original verdict date, correction, Korean/English records and the current review date/search scope	Material needed: Original verdict date, correction, Korean/English records and the current review date/search scope — corresponding original reports, plans and linking documents. First verify the actual existence and acquisition of the currently unverified material. This records needed materials; no new research was executed.
16	Unverified	Full text not readStored summary read	N16 · Evidence conditionHow far were research funding and company financing verified?Supplementary; required for a claim of independent funding	The direct funding record says company involvement and product-supply details were unverified in the public abstract. The review describes mixed funding of primary trials. Specific GGE03 research funding/company financing is not established. R01 R02	Generic English funding wording and the historical I0 code do not provide original declarations of individual funding sources.	Actual funding sources and company roles in the direct GGE03 trial and the review's primary trials	Material needed: Actual funding sources and company roles in the direct GGE03 trial and the review's primary trials — corresponding original reports, plans and linking documents. First verify the actual existence and acquisition of the currently unverified material. This records needed materials; no new research was executed.
17	Unverified	Full text not readStored summary read	N17 · Evidence conditionWas product provision or support verified?Supplementary; required for a claim of independent support	The direct funding record marks product-provision details unverified. GGE03 product identity/total quantity is available, but actual supply, free support and role declarations are not retained. R01	Product name/dose and provision/support are separate matters.	GGE03 supply, free provision, support scope and company roles	Material needed: GGE03 supply, free provision, support scope and company roles — corresponding original reports, plans and linking documents. First verify the actual existence and acquisition of the currently unverified material. This records needed materials; no new research was executed.
18	Unverified	Full text not readStored summary read	N18 · Evidence conditionWere employee authors and affiliations verified?Supplementary; required for a claim of team independence	The current summary does not specify GGE03 authors' company employment, affiliations or contributions. The English funding text is a generic statement that employee authorship and other matters were assessed separately. R01	Generic assessment wording is not evidence of employee authorship, its absence or an independent team.	Author affiliations, company employment/contributions and relationships between independent research teams	Material needed: Author affiliations, company employment/contributions and relationships between independent research teams — corresponding original reports, plans and linking documents. First verify the actual existence and acquisition of the currently unverified material. This records needed materials; no new research was executed.
19	Unverified	Full text not readStored summary read	N19 · Evidence conditionHow far were declared conflicts and patents verified?Supplementary; required for a conflicts-of-interest claim	The current retained summary has no specific declared COI or patent information for the direct trial or the review's primary trials; only generic English funding wording is available. R01 R02	The original declarations were not compared, so the presence or absence of COI cannot be determined.	Declared author/institutional COI, patents and product-related interests	Material needed: Declared author/institutional COI, patents and product-related interests — corresponding original reports, plans and linking documents. First verify the actual existence and acquisition of the currently unverified material. This records needed materials; no new research was executed.
20	Partly verified	Full text not readStored summary read	N20 · Evidence conditionWhat were the actual allocation, concealment and blinding methods?Required	The direct design is described as a randomized double-blind placebo trial. Sequence generation, concealment, baseline balance and actual blinding procedures are not verified in detail in the retained summary. R01	The design label is available, but actual allocation/blinding procedures need separate material.	Sequence generation, concealment and baseline balance in the GGE03 randomized double-blind placebo trial	Material needed: Sequence generation, concealment and baseline balance in the GGE03 randomized double-blind placebo trial — corresponding original reports, plans and linking documents. First verify the actual existence and acquisition of the currently unverified material. This records needed materials; no new research was executed.
21	Unverified	Full text not readStored summary read	N21 · Evidence conditionCould concomitant care, adherence or rescue treatment mix with the GGE03 contribution?Required	Specific analgesics/rescue medication, lifestyle care, adherence and concurrent interventions in both groups are unverified in the retained summary. R01	A placebo comparison cannot replace verification of concomitant care/deviation handling.	Analgesics/rescue medication, lifestyle care, adherence and concurrent interventions in both groups	Material needed: Analgesics/rescue medication, lifestyle care, adherence and concurrent interventions in both groups — corresponding original reports, plans and linking documents. First verify the actual existence and acquisition of the currently unverified material. This records needed materials; no new research was executed.
22	Partly verified	Full text not readStored summary read	N22 · Evidence conditionWas pain measured in the same way?Required	VAS and K-WOMAC are identifiable scale names, but assessment setting, visits, assessor blinding and group-specific collection methods are not detailed. R01	Scale names and the double-blind label must be distinguished from actual measurement procedures.	VAS/K-WOMAC assessment timing, scales, assessor blinding and collection by group	Material needed: VAS/K-WOMAC assessment timing, scales, assessor blinding and collection by group — corresponding original reports, plans and linking documents. First verify the actual existence and acquisition of the currently unverified material. This records needed materials; no new research was executed.
23	Unverified	Full text not readStored summary read	N23 · Evidence conditionDo the effect of interest and analysis population correspond?Required	The original direct summary does not specify assignment/adherence effects, ITT/PP, adjustment or an analysis model. R01	Reported between-group improvement does not establish the effect of interest or analysis population.	Assignment/adherence effects, ITT/PP, adjustment and between-group estimation	Material needed: Assignment/adherence effects, ITT/PP, adjustment and between-group estimation — corresponding original reports, plans and linking documents. First verify the actual existence and acquisition of the currently unverified material. This records needed materials; no new research was executed.
24	Unverified	Full text not readStored summary read	N24 · Evidence conditionCan the interval be linked to a clinically important pain difference?Required	The current retained summary has no direct interval or justified clinical-importance threshold for the relevant VAS/K-WOMAC scale. R01	Without an original interval/threshold, the range of compatible effect sizes cannot be judged.	Direct effect interval and a justified importance threshold for the relevant scale/population	Material needed: Direct effect interval and a justified importance threshold for the relevant scale/population — corresponding original reports, plans and linking documents. First verify the actual existence and acquisition of the currently unverified material. This records needed materials; no new research was executed.
25	Unverified	Full text not readStored summary read	N25 · Evidence conditionWhich endpoints do exact P values and significance concern?Required	The direct report describes significant between-group improvement in VAS and K-WOMAC pain. Exact P values, multiple-endpoint handling and attribution by scale are unverified. R01	The summary's significance statement was not promoted to exact P values or prespecified success.	Exact P values, analyses and multiple-endpoint handling for VAS and K-WOMAC	Material needed: Exact P values, analyses and multiple-endpoint handling for VAS and K-WOMAC — corresponding original reports, plans and linking documents. First verify the actual existence and acquisition of the currently unverified material. This records needed materials; no new research was executed.
26	Unverified	Full text not readStored summary read	N26 · Evidence conditionWere registration, protocol and SAP compared with the report?Required	The direct registration field says unverified, and the prespecified principal endpoint could not be verified in the public abstract. PROSPERO CRD42011001777 is registration information for the review. R01 R02	Original trial registration/plans were distinguished from review registration; comparison of the direct prespecified hierarchy remains unresolved.	Original trial registration number, prespecified plans, outcome hierarchy and reasons for changes	Material needed: Original trial registration number, prespecified plans, outcome hierarchy and reasons for changes — corresponding original reports, plans and linking documents. First verify the actual existence and acquisition of the currently unverified material. This records needed materials; no new research was executed.
27	Unverified	Full text not readStored summary read	N27 · Evidence conditionIs there independent replication under the same GGE03 conditions?Required	The original text describes GGE03 independent replication as insufficient/unverified. VAS and K-WOMAC in the same report and 5 mixed-formulation trials were not counted as separate independent replications under the same GGE03 conditions. R01 R02	Family/team information matching formulation, population, time point and outcome is unavailable.	Independent trial families/teams matching formulation, population and 12-week VAS	Material needed: Independent trial families/teams matching formulation, population and 12-week VAS — corresponding original reports, plans and linking documents. First verify the actual existence and acquisition of the currently unverified material. This records needed materials; no new research was executed.
28	Unverified	Full text not readStored summary read	N28 · Evidence conditionDoes this answer comparisons between doses or formulations?Supplementary; required for a dose-superiority claim	The current GGE03 record contains one dose combination: 0.48 g/day active extract and 1.6 g/day total product. Direct dose/formulation superiority or an optimal dose is not retained. R01 R02	The selected dose and extension to other products/doses are different questions.	Direct dose comparisons of the same GGE03 and correspondence between product and active amounts	Material needed: Direct dose comparisons of the same GGE03 and correspondence between product and active amounts — corresponding original reports, plans and linking documents. First verify the actual existence and acquisition of the currently unverified material. This records needed materials; no new research was executed.
29	Partly verified	Full text not readStored summary read	N29 · Evidence conditionDoes the evidence cover persistence after 12 weeks or special populations?Supplementary; required for persistence or extension	Treatment and follow-up last 12 weeks. The original safety text says long-term safety and drug interactions cannot be established. Post-treatment follow-up, prespecified subgroups and follow-up in other populations are unverified in the summary. R01	The identified 12-week scope was distinguished from gaps in persistence and extension.	Post-treatment/long-term follow-up, prespecified subgroups and population-specific exposures/outcomes	Material needed: Post-treatment/long-term follow-up, prespecified subgroups and population-specific exposures/outcomes — corresponding original reports, plans and linking documents. First verify the actual existence and acquisition of the currently unverified material. This records needed materials; no new research was executed.
30	Met	Full text not readStored summary read	N30 · Evidence conditionDoes pain improvement establish function, structural change or medication replacement?Supplementary; required for an extension claim	The original scope note judges VAS pain only and separates function, structural change and EV.EXT77. The advertising interpretation says generic ginger powder regenerating cartilage or replacing NSAIDs lies beyond this scope. R01 R02	The boundary between selected pain and distinct function, structure or medication-replacement questions was stated.	Direct VAS/K-WOMAC pain, function, cartilage/structural and NSAID-replacement outcomes	Material needed: Direct VAS/K-WOMAC pain, function, cartilage/structural and NSAID-replacement outcomes — corresponding original reports, plans and linking documents. First verify the actual existence and acquisition of the currently unverified material. This records needed materials; no new research was executed.
31	Unverified	Full text not readStored summary read	N31 · Evidence conditionHow were harms collected and denominators defined in the direct GGE03 trial?Supplementary; required for a safety claim	The direct report's title includes safety, but the current summary lacks detailed GGE03 harm-collection methods, group-specific events/denominators and withdrawals. The mixed review's withdrawal RR is not direct-product incidence. R01 R02	No retained material verifies harm definitions, collection and denominators for the direct formulation.	Adverse-event definitions/collection, group-specific events/denominators, withdrawals and 12-week exposure for the direct formulation	Material needed: Adverse-event definitions/collection, group-specific events/denominators, withdrawals and 12-week exposure for the direct formulation — corresponding original reports, plans and linking documents. First verify the actual existence and acquisition of the currently unverified material. This records needed materials; no new research was executed.
32	Partly verified	Full text not readStored summary read	N32 · Evidence conditionWhat harm information does adverse-event withdrawal in the mixed review provide?Supplementary	The mixed oral-ginger review records adverse-event withdrawal RR 2.33, interval 1.04 to 5.22. The original safety text describes more withdrawals due to gastrointestinal adverse events than placebo. R02	The withdrawal comparison is retained, but definitions, denominators and formulation-specific collection remain unresolved.	Withdrawal definition, denominators and included trials for mixed-formulation review RR 2.33, interval 1.04 to 5.22	Material needed: Withdrawal definition, denominators and included trials for mixed-formulation review RR 2.33, interval 1.04 to 5.22 — corresponding original reports, plans and linking documents. First verify the actual existence and acquisition of the currently unverified material. This records needed materials; no new research was executed.
33	Unverified	Full text not readStored summary read	N33 · Evidence conditionWere harm timing, discontinuation and follow-up losses verified?Supplementary	The current summary has no individual harm timing, discontinuation/recovery, rechallenge or group-specific harm follow-up losses within 12 weeks. R01 R02	The efficacy duration does not establish temporal sequence/recovery or completeness of harm collection.	Harm occurrence, discontinuation/recovery and group-specific follow-up losses during 12-week exposure	Material needed: Harm occurrence, discontinuation/recovery and group-specific follow-up losses during 12-week exposure — corresponding original reports, plans and linking documents. First verify the actual existence and acquisition of the currently unverified material. This records needed materials; no new research was executed.
34	Unverified	Full text not readStored summary read	N34 · Evidence conditionWere drug-interaction and vulnerable-population safety verified?Supplementary; required for the relevant safety claim	The original safety text says 12 weeks cannot establish long-term safety or drug interactions. Direct material on concomitant medication, special populations and baseline risks is absent from the current summary. R01 R02	The caution's scope was distinguished from actual verification of concomitant-treatment or vulnerable-population harms.	Concomitant medication, baseline risks, interactions and harm material in other populations	Material needed: Concomitant medication, baseline risks, interactions and harm material in other populations — corresponding original reports, plans and linking documents. First verify the actual existence and acquisition of the currently unverified material. This records needed materials; no new research was executed.
35	Unverified	Full text not readStored summary read	N35 · Evidence conditionWere missing harm reports distinguished from absence of events?Supplementary	The retained summary has no complete direct-harm collection, omissions or event-specific tables; only the mixed review's withdrawal summary is available. External full texts were not read in this work. R01 R02	The absence is limited to the retained summary rather than extended to the entire original paper.	Collection, omissions and completeness of harm reporting in the direct trial and mixed review	Material needed: Collection, omissions and completeness of harm reporting in the direct trial and mixed review — corresponding original reports, plans and linking documents. First verify the actual existence and acquisition of the currently unverified material. This records needed materials; no new research was executed.
36	Met	Full text not readStored summary read	N36 · Evidence conditionWhat does the current material say about efficacy and harms?Required boundary	Reported formulation-specific significant between-group improvement and the mixed review's small pain/adverse-event withdrawal comparisons were retained separately. Original C46, Caution, axis codes and historical cross-check statements remain in the source original. R01 R02	The current table explains reports, gaps and applicability boundaries without creating a new efficacy/safety grade or dosing instruction.	Reported formulation-specific significant improvement, mixed-review withdrawals and unverified boundaries	Material needed: Reported formulation-specific significant improvement, mixed-review withdrawals and unverified boundaries — corresponding original reports, plans and linking documents. First verify the actual existence and acquisition of the currently unverified material. This records needed materials; no new research was executed.

No items match your search or filter.

36 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 conditions/application records. Full papers, supplements, registrations, plans and original data were not read.
What the dates mean: The material-review record dated 2026-10-06 concerns the retained summary. The separate condition 1.1 reapplication that day is not external full-text reading. The original verdict date 2026-09-08 and correction date 2026-09-14 are not changed into new-search or full-text-reading dates.
Population: 100 adults with mild knee osteoarthritis. Detailed diagnosis, age, eligibility criteria and baseline characteristics are unverified.
Ingredient, formulation and route: Oral steamed ginger extract GGE03 from ginger rhizome. Extraction solvent and gingerol/shogaol assay are unverified in the retained summary.
Dose: Distinguish 0.48 g/day GGE03 active extract from 1.6 g/day total product. Actual dosing frequency, adherence and quantities equivalent across products are unverified.
Comparator: Matching placebo. Actual ingredients, taste, concomitant analgesics, rescue medication and shared care are unverified.
Measured outcome: The selected question is 12-week VAS pain. K-WOMAC pain is a supportive endpoint in the same report; the trial's prespecified primary (1st) hierarchy is unverified.
Duration: 12 weeks of treatment and follow-up. Post-treatment persistence, long-term safety, drug interactions and extension to special populations remain separately unverified.
Questions outside this scope: K-WOMAC pain is a supportive scale in the same GGE03 report. It is not added to VAS as an independent trial or converted into verification of a prespecified primary (1st) hierarchy.; Pain is not extended into functional recovery, cartilage regeneration, structural change or NSAID replacement.; The ginger-galangal combination EV.EXT77, generic powder and other extracts remain distinct from GGE03. A mixed-formulation average is not transferred to the direct product's effect.; The mixed oral-ginger adverse-event withdrawal comparison does not establish GGE03 individual-event incidence or overall safety.; Other doses, independent replication of the same formulation, persistence after treatment and other populations are separate questions requiring direct material. No new equivalent quantities or optimal dose are created.

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.

R01 · Kim et al. (2024): Effectiveness and safety of steamed ginger extract on mild osteoarthritis: a randomized, double-blind, placebo-controlled clinical trial

PubMed

Material type: Randomized double-blind placebo-controlled trial
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 significant between-group improvement; exact between-group difference, 95% CI and P value unverified
Record level: These are reports and limitations in the retained summary, not results of new external-original reading or calculation.
Study overlap and independent replication: The 2024 direct GGE03 report's 100 participants and 1:1 allocation are not added to the 2015 mixed-formulation review's 5 trials and 593 participants. Included trials, overlap, independent-team relationships for the same formulation and unique participant counts are unverified.

Public availability, access and reading status by material
Material	Public availability	Access status	Actually read	Notes
Retained research/bibliographic summary	Retained existing summary acquired	Current retained local input acquired	True	The full retained record was read and this report's summary/bibliography was identified at exact locations. Kim K et al. Food Funct. 2024;15:9065-9074. PMID: 39212491. DOI: 10.1039/D4FO01651J. The direct GGE03 trial's exact effect, interval, P value, prespecified endpoint, funding, support and independent replication remain unverified. Product names and historical independence codes do not verify original declarations. The material-review record dated 2026-10-06 concerns the retained summary. The separate condition 1.1 reapplication that day is not external full-text reading. The original verdict date 2026-09-08 and correction date 2026-09-14 are not changed into new-search or full-text-reading dates.
External article abstract	External material; existence/public availability/acquisition separately unverified	Access not attempted; unread	False	The stored URL exists; actual external bibliography/abstract readings in this work: 0. The direct GGE03 trial's exact effect, interval, P value, prespecified endpoint, funding, support and independent replication remain unverified. Product names and historical independence codes do not verify original declarations. The material-review record dated 2026-10-06 concerns the retained summary. The separate condition 1.1 reapplication that day is not external full-text reading. The original verdict date 2026-09-08 and correction date 2026-09-14 are not changed into new-search or full-text-reading dates.
External article full text	External material; existence/public availability/acquisition separately unverified	Full text not acquired; unread	False	A DOI, where present, serves only as a retained identifier/link and does not establish full-text reading. The direct GGE03 trial's exact effect, interval, P value, prespecified endpoint, funding, support and independent replication remain unverified. Product names and historical independence codes do not verify original declarations. The material-review record dated 2026-10-06 concerns the retained summary. The separate condition 1.1 reapplication that day is not external full-text reading. The original verdict date 2026-09-08 and correction date 2026-09-14 are not changed into new-search or full-text-reading dates.
Direct-trial registration original	External material; existence/public availability/acquisition separately unverified	Original registration unread	False	Review PROSPERO identity is separated from unverified original-trial registration; neither nonregistration nor prespecified endpoints are established. The direct GGE03 trial's exact effect, interval, P value, prespecified endpoint, funding, support and independent replication remain unverified. Product names and historical independence codes do not verify original declarations. The material-review record dated 2026-10-06 concerns the retained summary. The separate condition 1.1 reapplication that day is not external full-text reading. The original verdict date 2026-09-08 and correction date 2026-09-14 are not changed into new-search or full-text-reading dates.
Protocol material needed (existence unverified)	External material; existence/public availability/acquisition separately unverified	Existence/public availability/acquisition unverified; unread	False	The absence of a current link/original does not establish no protocol or selective reporting. The direct GGE03 trial's exact effect, interval, P value, prespecified endpoint, funding, support and independent replication remain unverified. Product names and historical independence codes do not verify original declarations. The material-review record dated 2026-10-06 concerns the retained summary. The separate condition 1.1 reapplication that day is not external full-text reading. The original verdict date 2026-09-08 and correction date 2026-09-14 are not changed into new-search or full-text-reading dates.
Statistical-analysis-plan material needed (existence unverified)	External material; existence/public availability/acquisition separately unverified	Existence/public availability/acquisition unverified; unread	False	No current analysis-plan comparison was performed; ITT/PP/prespecified hierarchy are not inferred. The direct GGE03 trial's exact effect, interval, P value, prespecified endpoint, funding, support and independent replication remain unverified. Product names and historical independence codes do not verify original declarations. The material-review record dated 2026-10-06 concerns the retained summary. The separate condition 1.1 reapplication that day is not external full-text reading. The original verdict date 2026-09-08 and correction date 2026-09-14 are not changed into new-search or full-text-reading dates.
Product specification/supply/support material needed	External material; existence/public availability/acquisition separately unverified	Existence/public availability/acquisition unverified; unread	False	Product identity/dose remain at the original-record level; separate original documents are needed for quantification/company supply. The direct GGE03 trial's exact effect, interval, P value, prespecified endpoint, funding, support and independent replication remain unverified. Product names and historical independence codes do not verify original declarations. The material-review record dated 2026-10-06 concerns the retained summary. The separate condition 1.1 reapplication that day is not external full-text reading. The original verdict date 2026-09-08 and correction date 2026-09-14 are not changed into new-search or full-text-reading dates.
Funding/employee-authorship/conflict material needed	External material; existence/public availability/acquisition separately unverified	Existence/public availability/acquisition unverified; unread	False	Funding, support, employee authorship and declared conflicts are separately unverified; generic English wording/historical axes do not upgrade them. The direct GGE03 trial's exact effect, interval, P value, prespecified endpoint, funding, support and independent replication remain unverified. Product names and historical independence codes do not verify original declarations. The material-review record dated 2026-10-06 concerns the retained summary. The separate condition 1.1 reapplication that day is not external full-text reading. The original verdict date 2026-09-08 and correction date 2026-09-14 are not changed into new-search or full-text-reading dates.

R02 · Bartels et al. (2015): Efficacy and safety of ginger in osteoarthritis patients: a meta-analysis of randomized placebo-controlled trials

PubMed

Material type: Meta-analysis of randomized placebo-controlled trials
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: Pain SMD -0.30, 95% CI -0.50 to -0.09; adverse-event withdrawal RR 2.33, interval 1.04 to 5.22
Record level: These are mixed-formulation synthesis estimates in the retained summary, not direct GGE03 effects, incidence or new calculations.
Study overlap and independent replication: The 2024 direct GGE03 report's 100 participants and 1:1 allocation are not added to the 2015 mixed-formulation review's 5 trials and 593 participants. Included trials, overlap, independent-team relationships for the same formulation and unique participant counts are unverified.

Public availability, access and reading status by material
Material	Public availability	Access status	Actually read	Notes
Retained research/bibliographic summary	Retained existing summary acquired	Current retained local input acquired	True	The full retained record was read and this report's summary/bibliography was identified at exact locations. Bartels EM et al. Osteoarthritis Cartilage. 2015;23:13-21. PMID: 25300574. DOI: 10.1016/j.joca.2014.09.024. PROSPERO CRD42011001777. CRD42011001777 is a bibliographic registration identifier for the 2015 review; it does not establish preregistration of the 2024 GGE03 original trial or current reading of registration contents. The material-review record dated 2026-10-06 concerns the retained summary. The separate condition 1.1 reapplication that day is not external full-text reading. The original verdict date 2026-09-08 and correction date 2026-09-14 are not changed into new-search or full-text-reading dates.
External article abstract	External material; existence/public availability/acquisition separately unverified	Access not attempted; unread	False	The stored URL exists; actual external bibliography/abstract readings in this work: 0. CRD42011001777 is a bibliographic registration identifier for the 2015 review; it does not establish preregistration of the 2024 GGE03 original trial or current reading of registration contents. The material-review record dated 2026-10-06 concerns the retained summary. The separate condition 1.1 reapplication that day is not external full-text reading. The original verdict date 2026-09-08 and correction date 2026-09-14 are not changed into new-search or full-text-reading dates.
External article full text	External material; existence/public availability/acquisition separately unverified	Full text not acquired; unread	False	A DOI, where present, serves only as a retained identifier/link and does not establish full-text reading. CRD42011001777 is a bibliographic registration identifier for the 2015 review; it does not establish preregistration of the 2024 GGE03 original trial or current reading of registration contents. The material-review record dated 2026-10-06 concerns the retained summary. The separate condition 1.1 reapplication that day is not external full-text reading. The original verdict date 2026-09-08 and correction date 2026-09-14 are not changed into new-search or full-text-reading dates.
Review-registration original	External material; existence/public availability/acquisition separately unverified	Original registration unread	False	Review PROSPERO identity is separated from unverified original-trial registration; neither nonregistration nor prespecified endpoints are established. CRD42011001777 is a bibliographic registration identifier for the 2015 review; it does not establish preregistration of the 2024 GGE03 original trial or current reading of registration contents. The material-review record dated 2026-10-06 concerns the retained summary. The separate condition 1.1 reapplication that day is not external full-text reading. The original verdict date 2026-09-08 and correction date 2026-09-14 are not changed into new-search or full-text-reading dates.
Protocol material needed (existence unverified)	External material; existence/public availability/acquisition separately unverified	Existence/public availability/acquisition unverified; unread	False	The absence of a current link/original does not establish no protocol or selective reporting. CRD42011001777 is a bibliographic registration identifier for the 2015 review; it does not establish preregistration of the 2024 GGE03 original trial or current reading of registration contents. The material-review record dated 2026-10-06 concerns the retained summary. The separate condition 1.1 reapplication that day is not external full-text reading. The original verdict date 2026-09-08 and correction date 2026-09-14 are not changed into new-search or full-text-reading dates.
Statistical-analysis-plan material needed (existence unverified)	External material; existence/public availability/acquisition separately unverified	Existence/public availability/acquisition unverified; unread	False	No current analysis-plan comparison was performed; ITT/PP/prespecified hierarchy are not inferred. CRD42011001777 is a bibliographic registration identifier for the 2015 review; it does not establish preregistration of the 2024 GGE03 original trial or current reading of registration contents. The material-review record dated 2026-10-06 concerns the retained summary. The separate condition 1.1 reapplication that day is not external full-text reading. The original verdict date 2026-09-08 and correction date 2026-09-14 are not changed into new-search or full-text-reading dates.

Report counts versus independent study counts

The 2024 direct GGE03 report's 100 participants and 1:1 allocation are not added to the 2015 mixed-formulation review's 5 trials and 593 participants. Included trials, overlap, independent-team relationships for the same formulation and unique participant counts are unverified.

Review criteria

Version 1.1 · 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 independent GGE03 question is being checked?

Required materials and conditions: Adults with mild knee osteoarthritis; oral GGE03; 0.48 g/day active extract and 1.6 g/day product; 12-week VAS pain versus placebo
Conditions for verification: Link the current question to the selected VAS outcome and distinguish other formulations, function and structural outcomes.
Requirement and applicability: Required
Application exceptions: K-WOMAC pain is linked as supportive; this does not establish a prespecified principal endpoint.
Why this condition is needed: Link the current question to the selected VAS outcome and distinguish other formulations, function and structural outcomes. Without this distinction, the direct product's pain question can be mixed with other formulations, endpoints and funding material.
Referenced methods: Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.

N02 · How are the two reports linked to unique trial families?

Required materials and conditions: Included-study tables and registration/trial identities for the Kim 2024 GGE03 report and Bartels 2015 mixed-formulation review
Conditions for verification: Distinguish the 2 reports from the review's 5 included trials and 593 participants; leave unique trial/participant totals and overlap unverified.
Requirement and applicability: Required
Application exceptions: Do not add a review and its primary trials, or two scales from one trial, as independent replications.
Why this condition is needed: Distinguish the 2 reports from the review's 5 included trials and 593 participants; leave unique trial/participant totals and overlap unverified. Without this distinction, the direct product's pain question can be mixed with other formulations, endpoints and funding material.
Referenced methods: Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.

N03 · What was actually read in this review?

Required materials and conditions: Separate reading histories for retained summaries and external bibliographic records/abstracts, full texts, trial registration, protocols and SAPs
Conditions for verification: Distinguish reading the whole retained summary from unread external material; a link does not establish successful reading.
Requirement and applicability: Required
Application exceptions: Do not label material inaccessible when access was not attempted.
Why this condition is needed: Distinguish reading the whole retained summary from unread external material; a link does not establish successful reading. Without this distinction, the direct product's pain question can be mixed with other formulations, endpoints and funding material.
Referenced methods: Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.

N04 · Which adults with knee osteoarthritis does this material concern?

Required materials and conditions: Diagnosis, age, severity, eligibility criteria and baseline pain in mild knee osteoarthritis
Conditions for verification: Distinguish adults with mild knee osteoarthritis in the current report from other severities, joints and populations.
Requirement and applicability: Required
Application exceptions: A total of 100 participants does not establish representativeness or eligibility criteria.
Why this condition is needed: Distinguish adults with mild knee osteoarthritis in the current report from other severities, joints and populations. Without this distinction, the direct product's pain question can be mixed with other formulations, endpoints and funding material.
Referenced methods: Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.

N05 · What are the GGE03 product and extract?

Required materials and conditions: Source, processing, extraction solvent, gingerol/shogaol assay and product documents for steamed ginger extract
Conditions for verification: Distinguish the GGE03 steamed formulation from generic powder and combinations; do not fill in an unverified solvent or assay.
Requirement and applicability: Required
Application exceptions: Do not copy the galangal component of EV.EXT77 or another ginger product's specifications into GGE03.
Why this condition is needed: Distinguish the GGE03 steamed formulation from generic powder and combinations; do not fill in an unverified solvent or assay. Without this distinction, the direct product's pain question can be mixed with other formulations, endpoints and funding material.
Referenced methods: Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.

N06 · Were active extract and total product amounts distinguished?

Required materials and conditions: Dosing schedule, frequency and actual intake for 0.48 g/day active extract and 1.6 g/day total product
Conditions for verification: Retain the two amounts separately; do not turn 1.6 g of product into active-extract or ginger-food mass.
Requirement and applicability: Required
Application exceptions: A single-dose-level record does not establish an optimal dose or equivalent quantities across products.
Why this condition is needed: Retain the two amounts separately; do not turn 1.6 g of product into active-extract or ginger-food mass. Without this distinction, the direct product's pain question can be mixed with other formulations, endpoints and funding material.
Referenced methods: Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.

N07 · What were the placebo and shared-care conditions?

Required materials and conditions: Actual composition of the matching placebo and concomitant/usual care in both groups
Conditions for verification: Separate the actual placebo comparison from shared care when stating the intervention's contribution.
Requirement and applicability: Required
Application exceptions: Matching appearance does not verify identical ingredients, taste, care and concomitant treatment.
Why this condition is needed: Separate the actual placebo comparison from shared care when stating the intervention's contribution. Without this distinction, the direct product's pain question can be mixed with other formulations, endpoints and funding material.
Referenced methods: Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.

N08 · What endpoint and time point define the selected VAS pain outcome?

Required materials and conditions: The 12-week VAS scale, assessment setting, change/final-value outcome and prespecified endpoint hierarchy
Conditions for verification: Distinguish the page's selected 12-week VAS question from verification of the trial's prespecified hierarchy.
Requirement and applicability: Required
Application exceptions: The page's principal-endpoint field does not establish a registered primary (1st) endpoint.
Why this condition is needed: Distinguish the page's selected 12-week VAS question from verification of the trial's prespecified hierarchy. Without this distinction, the direct product's pain question can be mixed with other formulations, endpoints and funding material.
Referenced methods: Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.

N09 · How does K-WOMAC pain relate to VAS?

Required materials and conditions: K-WOMAC pain subscale, time point, analysis and reporting hierarchy in the same trial
Conditions for verification: Link K-WOMAC pain as a supportive endpoint in the same report; do not merge it with the VAS effect or trial count.
Requirement and applicability: Required
Application exceptions: Do not automatically substitute K-WOMAC pain for function, total score or structural change.
Why this condition is needed: Link K-WOMAC pain as a supportive endpoint in the same report; do not merge it with the VAS effect or trial count. Without this distinction, the direct product's pain question can be mixed with other formulations, endpoints and funding material.
Referenced methods: Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.

N10 · Which analysis does the reported between-group improvement describe?

Required materials and conditions: Between-group or change-score differences, adjustment and analysis populations for VAS and K-WOMAC separately
Conditions for verification: Do not turn retained significant between-group improvement into within-group change or an exact effect estimate.
Requirement and applicability: Required
Application exceptions: Do not fill in ITT, PP or adjusted estimates when the analysis is unspecified.
Why this condition is needed: Do not turn retained significant between-group improvement into within-group change or an exact effect estimate. Without this distinction, the direct product's pain question can be mixed with other formulations, endpoints and funding material.
Referenced methods: Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.

N11 · Which denominators do 100 participants and 1:1 describe?

Required materials and conditions: Numbers randomized, completed, measured and analyzed by group, with endpoint-specific denominators
Conditions for verification: Record only the retained 100 participants and 1:1 allocation ratio; do not create group-specific, completed or analyzed denominators.
Requirement and applicability: Required
Application exceptions: Do not newly calculate and establish 50/50 from 1:1.
Why this condition is needed: Record only the retained 100 participants and 1:1 allocation ratio; do not create group-specific, completed or analyzed denominators. Without this distinction, the direct product's pain question can be mixed with other formulations, endpoints and funding material.
Referenced methods: Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.

N12 · How were missing data and withdrawals handled?

Required materials and conditions: Group-specific withdrawal reasons, changes in adherence/rescue treatment and missing-data/analysis handling
Conditions for verification: Link actual reported losses to analysis handling; absent information does not mean 0 withdrawals or no problem.
Requirement and applicability: Required
Application exceptions: Do not assume the reported total equals the analyzed or completed denominator.
Why this condition is needed: Link actual reported losses to analysis handling; absent information does not mean 0 withdrawals or no problem. Without this distinction, the direct product's pain question can be mixed with other formulations, endpoints and funding material.
Referenced methods: Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.

N13 · Are direct GGE03 effect estimates and intervals available?

Required materials and conditions: Between-group effects, variance, 95% CIs and exact P values for 12-week VAS and K-WOMAC separately
Conditions for verification: Distinguish the reported absence of verified exact differences, 95% CIs and P values in the public abstract from mixed-review estimates.
Requirement and applicability: Required
Application exceptions: Reported P-value significance alone does not establish precision, effect magnitude or equivalence.
Why this condition is needed: Distinguish the reported absence of verified exact differences, 95% CIs and P values in the public abstract from mixed-review estimates. Without this distinction, the direct product's pain question can be mixed with other formulations, endpoints and funding material.
Referenced methods: Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.

N14 · How are the mixed oral-ginger review's results retained?

Required materials and conditions: Bartels 2015 pain SMD, adverse-event withdrawal RR and included formulations
Conditions for verification: Retain the review's SMD -0.30 and interval, and RR 2.33 and interval, as mixed-formulation results.
Requirement and applicability: Required
Application exceptions: Do not turn the review average into the exact GGE03 between-group effect, independent replication or individual incidence.
Why this condition is needed: Retain the review's SMD -0.30 and interval, and RR 2.33 and interval, as mixed-formulation results. Without this distinction, the direct product's pain question can be mixed with other formulations, endpoints and funding material.
Referenced methods: Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.

N15 · Which dates and verification scope apply to the original used here?

Required materials and conditions: Original verdict date, correction, Korean/English records and the current review date/search scope
Conditions for verification: Distinguish the original verdict date of 2026-09-08 and correction of 2026-09-14 from this preservation-based conversion.
Requirement and applicability: Required
Application exceptions: No new search does not mean 0 human studies, no retractions or verification of current originals.
Why this condition is needed: Distinguish the original verdict date of 2026-09-08 and correction of 2026-09-14 from this preservation-based conversion. Without this distinction, the direct product's pain question can be mixed with other formulations, endpoints and funding material.
Referenced methods: Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.

N16 · How far were research funding and company financing verified?

Required materials and conditions: Actual funding sources and company roles in the direct GGE03 trial and the review's primary trials
Conditions for verification: Attribute the original records of unverified company details and mixed funding to the respective reports.
Requirement and applicability: Supplementary; required for a claim of independent funding
Application exceptions: Neither a company product name nor the I0 code verifies specific company financing.
Why this condition is needed: Attribute the original records of unverified company details and mixed funding to the respective reports. Without this distinction, the direct product's pain question can be mixed with other formulations, endpoints and funding material.
Referenced methods: Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.

N17 · Was product provision or support verified?

Required materials and conditions: GGE03 supply, free provision, support scope and company roles
Conditions for verification: Do not turn unverified product-provision details into confirmed absence of support or confirmed free support.
Requirement and applicability: Supplementary; required for a claim of independent support
Application exceptions: Total product mass and brand identity cannot replace a product-support statement.
Why this condition is needed: Do not turn unverified product-provision details into confirmed absence of support or confirmed free support. Without this distinction, the direct product's pain question can be mixed with other formulations, endpoints and funding material.
Referenced methods: Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.

N18 · Were employee authors and affiliations verified?

Required materials and conditions: Author affiliations, company employment/contributions and relationships between independent research teams
Conditions for verification: Do not use generic English funding wording to establish employee authorship or its absence.
Requirement and applicability: Supplementary; required for a claim of team independence
Application exceptions: A report concerning the same product does not establish replication by another independent team.
Why this condition is needed: Do not use generic English funding wording to establish employee authorship or its absence. Without this distinction, the direct product's pain question can be mixed with other formulations, endpoints and funding material.
Referenced methods: Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.

N19 · How far were declared conflicts and patents verified?

Required materials and conditions: Declared author/institutional COI, patents and product-related interests
Conditions for verification: Do not substitute no conflicts or no bias for unread original declarations.
Requirement and applicability: Supplementary; required for a conflicts-of-interest claim
Application exceptions: Do not fill in actual COI from the historical I0/grade or generic company-role wording.
Why this condition is needed: Do not substitute no conflicts or no bias for unread original declarations. Without this distinction, the direct product's pain question can be mixed with other formulations, endpoints and funding material.
Referenced methods: Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.

N20 · What were the actual allocation, concealment and blinding methods?

Required materials and conditions: Sequence generation, concealment and baseline balance in the GGE03 randomized double-blind placebo trial
Conditions for verification: Distinguish the trial's design label from verification of actual allocation/blinding methods.
Requirement and applicability: Required
Application exceptions: Do not automatically mark crossover not applicable when parallel/crossover design details are unverified.
Why this condition is needed: Distinguish the trial's design label from verification of actual allocation/blinding methods. Without this distinction, the direct product's pain question can be mixed with other formulations, endpoints and funding material.
Referenced methods: Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.

N21 · Could concomitant care, adherence or rescue treatment mix with the GGE03 contribution?

Required materials and conditions: Analgesics/rescue medication, lifestyle care, adherence and concurrent interventions in both groups
Conditions for verification: Require material recording shared/different treatments in both groups and the additional GGE03 contrast.
Requirement and applicability: Required
Application exceptions: Do not turn unspecified concomitant treatment into no concomitant treatment.
Why this condition is needed: Require material recording shared/different treatments in both groups and the additional GGE03 contrast. Without this distinction, the direct product's pain question can be mixed with other formulations, endpoints and funding material.
Referenced methods: Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.

N22 · Was pain measured in the same way?

Required materials and conditions: VAS/K-WOMAC assessment timing, scales, assessor blinding and collection by group
Conditions for verification: State how subjective pain scales were actually collected and the remaining assessment limitations.
Requirement and applicability: Required
Application exceptions: A double-blind design label does not verify outcome-assessment procedures.
Why this condition is needed: State how subjective pain scales were actually collected and the remaining assessment limitations. Without this distinction, the direct product's pain question can be mixed with other formulations, endpoints and funding material.
Referenced methods: Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.

N23 · Do the effect of interest and analysis population correspond?

Required materials and conditions: Assignment/adherence effects, ITT/PP, adjustment and between-group estimation
Conditions for verification: Do not newly assign analysis populations or models absent from the original.
Requirement and applicability: Required
Application exceptions: Do not perform a reanalysis that differs from the original formulation-effect question.
Why this condition is needed: Do not newly assign analysis populations or models absent from the original. Without this distinction, the direct product's pain question can be mixed with other formulations, endpoints and funding material.
Referenced methods: Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.

N24 · Can the interval be linked to a clinically important pain difference?

Required materials and conditions: Direct effect interval and a justified importance threshold for the relevant scale/population
Conditions for verification: Do not invent a minimum important difference or certainty without reported intervals and supporting importance evidence.
Requirement and applicability: Required
Application exceptions: Neither significance nor a sample of 100 establishes sufficiency.
Why this condition is needed: Do not invent a minimum important difference or certainty without reported intervals and supporting importance evidence. Without this distinction, the direct product's pain question can be mixed with other formulations, endpoints and funding material.
Referenced methods: Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.

N25 · Which endpoints do exact P values and significance concern?

Required materials and conditions: Exact P values, analyses and multiple-endpoint handling for VAS and K-WOMAC
Conditions for verification: Retain reported significant between-group improvement without supplying exact P values or attribution by scale.
Requirement and applicability: Required
Application exceptions: Do not automatically promote a positive supportive endpoint into prespecified VAS success.
Why this condition is needed: Retain reported significant between-group improvement without supplying exact P values or attribution by scale. Without this distinction, the direct product's pain question can be mixed with other formulations, endpoints and funding material.
Referenced methods: Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.

N26 · Were registration, protocol and SAP compared with the report?

Required materials and conditions: Original trial registration number, prespecified plans, outcome hierarchy and reasons for changes
Conditions for verification: Retain the unverified trial-registration status and prespecified principal endpoint.
Requirement and applicability: Required
Application exceptions: Do not present the review's PROSPERO registration as GGE03 trial registration.
Why this condition is needed: Retain the unverified trial-registration status and prespecified principal endpoint. Without this distinction, the direct product's pain question can be mixed with other formulations, endpoints and funding material.
Referenced methods: Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.

N27 · Is there independent replication under the same GGE03 conditions?

Required materials and conditions: Independent trial families/teams matching formulation, population and 12-week VAS
Conditions for verification: Do not erase unverified replication under matching conditions by using the mixed review's trial count.
Requirement and applicability: Required
Application exceptions: Do not count two pain scales in one report as two independent trials.
Why this condition is needed: Do not erase unverified replication under matching conditions by using the mixed review's trial count. Without this distinction, the direct product's pain question can be mixed with other formulations, endpoints and funding material.
Referenced methods: Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.

N28 · Does this answer comparisons between doses or formulations?

Required materials and conditions: Direct dose comparisons of the same GGE03 and correspondence between product and active amounts
Conditions for verification: Distinguish the current single-dose-level question from optimal-dose and generic-ginger conversion questions.
Requirement and applicability: Supplementary; required for a dose-superiority claim
Application exceptions: Do not arrange product amounts from different studies as a direct dose-response comparison.
Why this condition is needed: Distinguish the current single-dose-level question from optimal-dose and generic-ginger conversion questions. Without this distinction, the direct product's pain question can be mixed with other formulations, endpoints and funding material.
Referenced methods: Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.

N29 · Does the evidence cover persistence after 12 weeks or special populations?

Required materials and conditions: Post-treatment/long-term follow-up, prespecified subgroups and population-specific exposures/outcomes
Conditions for verification: Separate the verified 12-week scope from unverified persistence and extension to other populations.
Requirement and applicability: Supplementary; required for persistence or extension
Application exceptions: Do not require all long-term trials for the narrow VAS question.
Why this condition is needed: Separate the verified 12-week scope from unverified persistence and extension to other populations. Without this distinction, the direct product's pain question can be mixed with other formulations, endpoints and funding material.
Referenced methods: Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.

N30 · Does pain improvement establish function, structural change or medication replacement?

Required materials and conditions: Direct VAS/K-WOMAC pain, function, cartilage/structural and NSAID-replacement outcomes
Conditions for verification: Separate pain scales from distinct clinical or structural outcomes.
Requirement and applicability: Supplementary; required for an extension claim
Application exceptions: Do not automatically require cartilage-event trials for the selected VAS question.
Why this condition is needed: Separate pain scales from distinct clinical or structural outcomes. Without this distinction, the direct product's pain question can be mixed with other formulations, endpoints and funding material.
Referenced methods: Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.

N31 · How were harms collected and denominators defined in the direct GGE03 trial?

Required materials and conditions: Adverse-event definitions/collection, group-specific events/denominators, withdrawals and 12-week exposure for the direct formulation
Conditions for verification: Do not establish safety because the title includes safety or efficacy results exist.
Requirement and applicability: Supplementary; required for a safety claim
Application exceptions: Do not turn the mixed review's adverse-event withdrawal RR into individual GGE03 incidence.
Why this condition is needed: Do not establish safety because the title includes safety or efficacy results exist. Without this distinction, the direct product's pain question can be mixed with other formulations, endpoints and funding material.
Referenced methods: Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.

N32 · What harm information does adverse-event withdrawal in the mixed review provide?

Required materials and conditions: Withdrawal definition, denominators and included trials for mixed-formulation review RR 2.33, interval 1.04 to 5.22
Conditions for verification: Attribute the adverse-event withdrawal comparison to the review's scope and distinguish it from GGE03 event incidence.
Requirement and applicability: Supplementary
Application exceptions: Do not interpret withdrawal RR as the magnitude of all harms or a specific drug interaction.
Why this condition is needed: Attribute the adverse-event withdrawal comparison to the review's scope and distinguish it from GGE03 event incidence. Without this distinction, the direct product's pain question can be mixed with other formulations, endpoints and funding material.
Referenced methods: Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.

N33 · Were harm timing, discontinuation and follow-up losses verified?

Required materials and conditions: Harm occurrence, discontinuation/recovery and group-specific follow-up losses during 12-week exposure
Conditions for verification: Separate the efficacy follow-up period from actual harm collection and event timing.
Requirement and applicability: Supplementary
Application exceptions: Do not infer improvement after discontinuation, rechallenge or 0 harms.
Why this condition is needed: Separate the efficacy follow-up period from actual harm collection and event timing. Without this distinction, the direct product's pain question can be mixed with other formulations, endpoints and funding material.
Referenced methods: Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.

N34 · Were drug-interaction and vulnerable-population safety verified?

Required materials and conditions: Concomitant medication, baseline risks, interactions and harm material in other populations
Conditions for verification: Do not turn unverified long-term safety/interactions in the original into established safety or risk magnitude.
Requirement and applicability: Supplementary; required for the relevant safety claim
Application exceptions: Do not judge individual interactions from mixed oral-ginger withdrawal results alone.
Why this condition is needed: Do not turn unverified long-term safety/interactions in the original into established safety or risk magnitude. Without this distinction, the direct product's pain question can be mixed with other formulations, endpoints and funding material.
Referenced methods: Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.

N35 · Were missing harm reports distinguished from absence of events?

Required materials and conditions: Collection, omissions and completeness of harm reporting in the direct trial and mixed review
Conditions for verification: State that detailed safety tables are absent from the retained summary.
Requirement and applicability: Supplementary
Application exceptions: Do not claim non-reporting throughout an external paper whose full text was not read.
Why this condition is needed: State that detailed safety tables are absent from the retained summary. Without this distinction, the direct product's pain question can be mixed with other formulations, endpoints and funding material.
Referenced methods: Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.

N36 · What does the current material say about efficacy and harms?

Required materials and conditions: Reported formulation-specific significant improvement, mixed-review withdrawals and unverified boundaries
Conditions for verification: Explain retained reports, gaps and applicability boundaries without creating a new efficacy/safety grade or dosing instruction.
Requirement and applicability: Required boundary
Application exceptions: Do not inherit historical C46/Caution labels or cross-check statements as new clinical certification.
Why this condition is needed: Explain retained reports, gaps and applicability boundaries without creating a new efficacy/safety grade or dosing instruction. Without this distinction, the direct product's pain question can be mixed with other formulations, endpoints and funding material.
Referenced methods: Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.

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

Partly verified: Partial information from the stored summary is linked; detailed originals and content review remain incomplete.
Unverified: Required details cannot be established within the preserved scope. This does not establish absence of effects or studies, or safety.
Review incomplete: Review of existing content remains incomplete.
Met: The selected condition for material, identity or preservation was verified; this does not establish efficacy success or independent clinical validation.
Not reported: Unreported within material actually read. Unread external material is not relabeled as unreported.
Inaccessible: This means actual access failure. External access was not attempted in this work, so this state was not assigned.
Not applicable: Used only with an application exception and reason based on the question scope.
Conflicting data: This requires actual comparison of materials; no new conflict judgment was made in this work.
Insufficient evidence for the conditions: This indicates gaps in additional material for the selected conditions. Unread material as a whole is not converted into an efficacy grade.

Change history

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

The public view and materials were prepared from the existing 36 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 independent GGE03 question is being checked?

Current findings: The original question concerns pain reduction after oral GGE03 in adults with mild knee osteoarthritis. The retained fields specify 0.48 g/day active extract, 1.6 g/day product and 12-week VAS versus placebo.
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 selected question, population, dose and endpoint boundaries are identifiable in the retained original.
Reason for missing information: The magnitude and prespecification of the direct effect are separate from identifying this boundary.
Required materials and conditions: Adults with mild knee osteoarthritis; oral GGE03; 0.48 g/day active extract and 1.6 g/day product; 12-week VAS pain versus placebo
Materials to obtain first: Adults with mild knee osteoarthritis; oral GGE03; 0.48 g/day active extract and 1.6 g/day product; 12-week VAS pain versus placebo — corresponding original reports, plans and linking documents. First verify the actual existence and acquisition of the currently unverified material.
Further research: Material needed: Adults with mild knee osteoarthritis; oral GGE03; 0.48 g/day active extract and 1.6 g/day product; 12-week VAS pain versus placebo — corresponding original reports, plans and linking documents. First verify the actual existence and acquisition of the currently unverified material. This records needed materials; no new research was executed.
Remaining uncertainty: Met here means that the question is identified, not that efficacy is established.
Conditions for verification: Link the current question to the selected VAS outcome and distinguish other formulations, function and structural outcomes.
Why this condition is needed: Link the current question to the selected VAS outcome and distinguish other formulations, function and structural outcomes. Without this distinction, the direct product's pain question can be mixed with other formulations, endpoints and funding material.
Application exceptions: K-WOMAC pain is linked as supportive; this does not establish a prespecified principal endpoint.
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 R01 R02

N02 · How are the two reports linked to unique trial families?

Current findings: The retained study and citation summaries contain two records: the Kim 2024 direct GGE03 report and the Bartels 2015 mixed oral-ginger review. The review's 5 trials and 593 participants were not added to the number of GGE03 trials.
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: Report identities are available, but the review's included trials, overlap with the direct report and unique families cannot be established from the available material.
Reason for missing information: Included-study tables, trial registration and links to unique participants/trials are unverified.
Required materials and conditions: Included-study tables and registration/trial identities for the Kim 2024 GGE03 report and Bartels 2015 mixed-formulation review
Materials to obtain first: Included-study tables and registration/trial identities for the Kim 2024 GGE03 report and Bartels 2015 mixed-formulation review — corresponding original reports, plans and linking documents. First verify the actual existence and acquisition of the currently unverified material.
Further research: Material needed: Included-study tables and registration/trial identities for the Kim 2024 GGE03 report and Bartels 2015 mixed-formulation review — corresponding original reports, plans and linking documents. First verify the actual existence and acquisition of the currently unverified material. This records needed materials; no new research was executed.
Remaining uncertainty: 2 reports do not mean 2 independent studies or a total of unique participants.
Conditions for verification: Distinguish the 2 reports from the review's 5 included trials and 593 participants; leave unique trial/participant totals and overlap unverified.
Why this condition is needed: Distinguish the 2 reports from the review's 5 included trials and 593 participants; leave unique trial/participant totals and overlap unverified. Without this distinction, the direct product's pain question can be mixed with other formulations, endpoints and funding material.
Application exceptions: Do not add a review and its primary trials, or two scales from one trial, as independent 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.

Related sources R01 R02

N03 · What was actually read in this review?

Current findings: The whole retained summary and its report/citation summaries were read. PubMed and DOI links are retained identifiers; external abstracts, full texts, registration, protocols and SAPs were not newly opened.
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 levels of actual activity were distinguished, and summary-reading links point to retained original locations.
Reason for missing information: Actual availability, acquisition and full-text content of each external material are unverified.
Required materials and conditions: Separate reading histories for retained summaries and external bibliographic records/abstracts, full texts, trial registration, protocols and SAPs
Materials to obtain first: Separate reading histories for retained summaries and external bibliographic records/abstracts, full texts, trial registration, protocols and SAPs — corresponding original reports, plans and linking documents. First verify the actual existence and acquisition of the currently unverified material.
Further research: Material needed: Separate reading histories for retained summaries and external bibliographic records/abstracts, full texts, trial registration, protocols and SAPs — corresponding original reports, plans and linking documents. First verify the actual existence and acquisition of the currently unverified material. This records needed materials; no new research was executed.
Remaining uncertainty: The current record has no access-level field; the original verdict date is not used as an external reading date.
Conditions for verification: Distinguish reading the whole retained summary from unread external material; a link does not establish successful reading.
Why this condition is needed: Distinguish reading the whole retained summary from unread external material; a link does not establish successful reading. Without this distinction, the direct product's pain question can be mixed with other formulations, endpoints and funding material.
Application exceptions: Do not label material inaccessible when access was not attempted.
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 R01 R02

N04 · Which adults with knee osteoarthritis does this material concern?

Current findings: The retained population field specifies 100 adults with mild knee osteoarthritis. Detailed diagnosis, age range, eligibility criteria and baseline pain are not provided in the retained summary.
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 population and total are named, but representativeness and selection remain unverified.
Reason for missing information: Diagnostic criteria, eligibility criteria and baseline characteristics are unverified.
Required materials and conditions: Diagnosis, age, severity, eligibility criteria and baseline pain in mild knee osteoarthritis
Materials to obtain first: Diagnosis, age, severity, eligibility criteria and baseline pain in mild knee osteoarthritis — corresponding original reports, plans and linking documents. First verify the actual existence and acquisition of the currently unverified material.
Further research: Material needed: Diagnosis, age, severity, eligibility criteria and baseline pain in mild knee osteoarthritis — corresponding original reports, plans and linking documents. First verify the actual existence and acquisition of the currently unverified material. This records needed materials; no new research was executed.
Remaining uncertainty: Direct applicability to other severities, joints and populations is not established.
Conditions for verification: Distinguish adults with mild knee osteoarthritis in the current report from other severities, joints and populations.
Why this condition is needed: Distinguish adults with mild knee osteoarthritis in the current report from other severities, joints and populations. Without this distinction, the direct product's pain question can be mixed with other formulations, endpoints and funding material.
Application exceptions: A total of 100 participants does not establish representativeness or eligibility criteria.
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 R01

N05 · What are the GGE03 product and extract?

Current findings: The formulation is steamed ginger extract GGE03, sourced from ginger rhizome. The retained fields say that extraction solvent and gingerol/shogaol assay were unverified in the public abstract.
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 specific formulation's identity and unverified manufacturing/assay details are both retained.
Reason for missing information: Extraction solvent, standardization/assay and original product documents are unverified.
Required materials and conditions: Source, processing, extraction solvent, gingerol/shogaol assay and product documents for steamed ginger extract
Materials to obtain first: Source, processing, extraction solvent, gingerol/shogaol assay and product documents for steamed ginger extract — corresponding original reports, plans and linking documents. First verify the actual existence and acquisition of the currently unverified material.
Further research: Material needed: Source, processing, extraction solvent, gingerol/shogaol assay and product documents for steamed ginger extract — corresponding original reports, plans and linking documents. First verify the actual existence and acquisition of the currently unverified material. This records needed materials; no new research was executed.
Remaining uncertainty: Do not treat generic powder, another extract or the EV.EXT77 combination as equivalent products.
Conditions for verification: Distinguish the GGE03 steamed formulation from generic powder and combinations; do not fill in an unverified solvent or assay.
Why this condition is needed: Distinguish the GGE03 steamed formulation from generic powder and combinations; do not fill in an unverified solvent or assay. Without this distinction, the direct product's pain question can be mixed with other formulations, endpoints and funding material.
Application exceptions: Do not copy the galangal component of EV.EXT77 or another ginger product's specifications into GGE03.
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 R01

N06 · Were active extract and total product amounts distinguished?

Current findings: The original dose is 0.48 g/day GGE03 active extract and 1.6 g/day total product. The amounts are recorded separately; frequency, actual intake and adherence are unverified in the retained summary.
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: Nominal active and total amounts are stated, but the actual schedule and adherence are unverified.
Reason for missing information: Actual dosing frequency, intake/adherence and product correspondence are unverified.
Required materials and conditions: Dosing schedule, frequency and actual intake for 0.48 g/day active extract and 1.6 g/day total product
Materials to obtain first: Dosing schedule, frequency and actual intake for 0.48 g/day active extract and 1.6 g/day total product — corresponding original reports, plans and linking documents. First verify the actual existence and acquisition of the currently unverified material.
Further research: Material needed: Dosing schedule, frequency and actual intake for 0.48 g/day active extract and 1.6 g/day total product — corresponding original reports, plans and linking documents. First verify the actual existence and acquisition of the currently unverified material. This records needed materials; no new research was executed.
Remaining uncertainty: Do not create converted quantities, product-equivalent amounts or an optimal dose.
Conditions for verification: Retain the two amounts separately; do not turn 1.6 g of product into active-extract or ginger-food mass.
Why this condition is needed: Retain the two amounts separately; do not turn 1.6 g of product into active-extract or ginger-food mass. Without this distinction, the direct product's pain question can be mixed with other formulations, endpoints and funding material.
Application exceptions: A single-dose-level record does not establish an optimal dose or equivalent quantities across products.
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 R01

N07 · What were the placebo and shared-care conditions?

Current findings: The comparator field specifies a matching placebo, and the direct report is described as placebo controlled. Placebo ingredients, taste and shared care/concomitant treatment are not specifically verified in the current summary.
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 placebo comparison is identifiable, but complete equivalence of the comparison background is unverified.
Reason for missing information: Placebo composition, shared care and concomitant treatment are unverified.
Required materials and conditions: Actual composition of the matching placebo and concomitant/usual care in both groups
Materials to obtain first: Actual composition of the matching placebo and concomitant/usual care in both groups — corresponding original reports, plans and linking documents. First verify the actual existence and acquisition of the currently unverified material.
Further research: Material needed: Actual composition of the matching placebo and concomitant/usual care in both groups — corresponding original reports, plans and linking documents. First verify the actual existence and acquisition of the currently unverified material. This records needed materials; no new research was executed.
Remaining uncertainty: Matching appearance does not establish identical care and ingredients.
Conditions for verification: Separate the actual placebo comparison from shared care when stating the intervention's contribution.
Why this condition is needed: Separate the actual placebo comparison from shared care when stating the intervention's contribution. Without this distinction, the direct product's pain question can be mixed with other formulations, endpoints and funding material.
Application exceptions: Matching appearance does not verify identical ingredients, taste, care and concomitant 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.

Related sources R01

N08 · What endpoint and time point define the selected VAS pain outcome?

Current findings: The current principal endpoint is 12-week VAS pain. The original reader answer says that the prespecified principal endpoint could not be verified in the public abstract.
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 page's selected endpoint was distinguished from the trial's prespecified hierarchy.
Reason for missing information: VAS scale range, assessment setting, outcome type and registered hierarchy are unverified.
Required materials and conditions: The 12-week VAS scale, assessment setting, change/final-value outcome and prespecified endpoint hierarchy
Materials to obtain first: The 12-week VAS scale, assessment setting, change/final-value outcome and prespecified endpoint hierarchy — corresponding original reports, plans and linking documents. First verify the actual existence and acquisition of the currently unverified material.
Further research: Material needed: The 12-week VAS scale, assessment setting, change/final-value outcome and prespecified endpoint hierarchy — corresponding original reports, plans and linking documents. First verify the actual existence and acquisition of the currently unverified material. This records needed materials; no new research was executed.
Remaining uncertainty: The page's principal-endpoint field does not verify the primary (1st) endpoint in the original registration.
Conditions for verification: Distinguish the page's selected 12-week VAS question from verification of the trial's prespecified hierarchy.
Why this condition is needed: Distinguish the page's selected 12-week VAS question from verification of the trial's prespecified hierarchy. Without this distinction, the direct product's pain question can be mixed with other formulations, endpoints and funding material.
Application exceptions: The page's principal-endpoint field does not establish a registered primary (1st) endpoint.
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 R01

N09 · How does K-WOMAC pain relate to VAS?

Current findings: The direct report describes between-group improvement in VAS and K-WOMAC pain. The current fields treat K-WOMAC pain as supportive, and the scope note separates function and structural change.
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 relationship of the supportive pain result is identified, but scale definition, analysis and prespecified hierarchy remain unresolved.
Reason for missing information: K-WOMAC subscale, scale direction and analysis details are unverified.
Required materials and conditions: K-WOMAC pain subscale, time point, analysis and reporting hierarchy in the same trial
Materials to obtain first: K-WOMAC pain subscale, time point, analysis and reporting hierarchy in the same trial — corresponding original reports, plans and linking documents. First verify the actual existence and acquisition of the currently unverified material.
Further research: Material needed: K-WOMAC pain subscale, time point, analysis and reporting hierarchy in the same trial — corresponding original reports, plans and linking documents. First verify the actual existence and acquisition of the currently unverified material. This records needed materials; no new research was executed.
Remaining uncertainty: Do not merge supportive pain with function/total score or count it as another independent trial.
Conditions for verification: Link K-WOMAC pain as a supportive endpoint in the same report; do not merge it with the VAS effect or trial count.
Why this condition is needed: Link K-WOMAC pain as a supportive endpoint in the same report; do not merge it with the VAS effect or trial count. Without this distinction, the direct product's pain question can be mixed with other formulations, endpoints and funding material.
Application exceptions: Do not automatically substitute K-WOMAC pain for function, total score or structural change.
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 R01

N10 · Which analysis does the reported between-group improvement describe?

Current findings: The direct result is reported significant between-group improvement; exact differences, 95% CIs and P values are unverified. Details of change/final values, adjustment and analysis populations are absent.
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: Retain the original between-group statement without supplying an analysis definition absent from the original.
Reason for missing information: Scale-specific between-group estimates/change scores, adjustment and analysis populations are unverified.
Required materials and conditions: Between-group or change-score differences, adjustment and analysis populations for VAS and K-WOMAC separately
Materials to obtain first: Between-group or change-score differences, adjustment and analysis populations for VAS and K-WOMAC separately — corresponding original reports, plans and linking documents. First verify the actual existence and acquisition of the currently unverified material.
Further research: Material needed: Between-group or change-score differences, adjustment and analysis populations for VAS and K-WOMAC separately — corresponding original reports, plans and linking documents. First verify the actual existence and acquisition of the currently unverified material. This records needed materials; no new research was executed.
Remaining uncertainty: Do not substitute within-group change or a new effect estimate.
Conditions for verification: Do not turn retained significant between-group improvement into within-group change or an exact effect estimate.
Why this condition is needed: Do not turn retained significant between-group improvement into within-group change or an exact effect estimate. Without this distinction, the direct product's pain question can be mixed with other formulations, endpoints and funding material.
Application exceptions: Do not fill in ITT, PP or adjusted estimates when the analysis is unspecified.
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 R01

N11 · Which denominators do 100 participants and 1:1 describe?

Current findings: The retained participant record says 100 participants, allocated 1:1. Group-specific randomized, analyzed, completed and measured counts were not newly calculated or assigned a common denominator.
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 and allocation ratio are available, but relationships between endpoint-specific denominators remain unresolved.
Reason for missing information: Group-specific and endpoint-specific randomized, completed and analyzed denominators are unverified.
Required materials and conditions: Numbers randomized, completed, measured and analyzed by group, with endpoint-specific denominators
Materials to obtain first: Numbers randomized, completed, measured and analyzed by group, with endpoint-specific denominators — corresponding original reports, plans and linking documents. First verify the actual existence and acquisition of the currently unverified material.
Further research: Material needed: Numbers randomized, completed, measured and analyzed by group, with endpoint-specific denominators — corresponding original reports, plans and linking documents. First verify the actual existence and acquisition of the currently unverified material. This records needed materials; no new research was executed.
Remaining uncertainty: Do not establish 50/50 or complete follow-up without original verification.
Conditions for verification: Record only the retained 100 participants and 1:1 allocation ratio; do not create group-specific, completed or analyzed denominators.
Why this condition is needed: Record only the retained 100 participants and 1:1 allocation ratio; do not create group-specific, completed or analyzed denominators. Without this distinction, the direct product's pain question can be mixed with other formulations, endpoints and funding material.
Application exceptions: Do not newly calculate and establish 50/50 from 1:1.
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 R01

N12 · How were missing data and withdrawals handled?

Current findings: The current retained summary does not provide group-specific withdrawal reasons, missing-data handling, changes in adherence/rescue treatment or sensitivity analyses.
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 total of 100 and generic English participant wording cannot replace actual participant-flow and missing-data records.
Reason for missing information: These details are absent from the read summary; external full text and analysis plans remain unread.
Required materials and conditions: Group-specific withdrawal reasons, changes in adherence/rescue treatment and missing-data/analysis handling
Materials to obtain first: Group-specific withdrawal reasons, changes in adherence/rescue treatment and missing-data/analysis handling — corresponding original reports, plans and linking documents. First verify the actual existence and acquisition of the currently unverified material.
Further research: Material needed: Group-specific withdrawal reasons, changes in adherence/rescue treatment and missing-data/analysis handling — corresponding original reports, plans and linking documents. First verify the actual existence and acquisition of the currently unverified material. This records needed materials; no new research was executed.
Remaining uncertainty: Do not fill in 0 withdrawals, ITT or no problems.
Conditions for verification: Link actual reported losses to analysis handling; absent information does not mean 0 withdrawals or no problem.
Why this condition is needed: Link actual reported losses to analysis handling; absent information does not mean 0 withdrawals or no problem. Without this distinction, the direct product's pain question can be mixed with other formulations, endpoints and funding material.
Application exceptions: Do not assume the reported total equals the analyzed or completed denominator.
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 R01

N13 · Are direct GGE03 effect estimates and intervals available?

Current findings: The direct GGE03 record retains unverified exact between-group differences, 95% CIs and P values. The review's SMD and interval were not copied as this product's values.
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 retained result table establishes the magnitude and interval of the selected direct effect.
Reason for missing information: Direct result tables, variance, CIs and exact P values are unverified.
Required materials and conditions: Between-group effects, variance, 95% CIs and exact P values for 12-week VAS and K-WOMAC separately
Materials to obtain first: Between-group effects, variance, 95% CIs and exact P values for 12-week VAS and K-WOMAC separately — corresponding original reports, plans and linking documents. First verify the actual existence and acquisition of the currently unverified material.
Further research: Material needed: Between-group effects, variance, 95% CIs and exact P values for 12-week VAS and K-WOMAC separately — corresponding original reports, plans and linking documents. First verify the actual existence and acquisition of the currently unverified material. This records needed materials; no new research was executed.
Remaining uncertainty: Reported significant improvement does not verify precision or a clinically important effect.
Conditions for verification: Distinguish the reported absence of verified exact differences, 95% CIs and P values in the public abstract from mixed-review estimates.
Why this condition is needed: Distinguish the reported absence of verified exact differences, 95% CIs and P values in the public abstract from mixed-review estimates. Without this distinction, the direct product's pain question can be mixed with other formulations, endpoints and funding material.
Application exceptions: Reported P-value significance alone does not establish precision, effect magnitude or equivalence.
Referenced methods: Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.

Related sources R01 R02

N14 · How are the mixed oral-ginger review's results retained?

Current findings: The Bartels review summary gives pain SMD -0.30, 95% CI -0.50 to -0.09 and adverse-event withdrawal RR 2.33, interval 1.04 to 5.22. The original record describes mixed-formulation supportive evidence, including some combinations.
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: Synthesis estimates retain their original attribution, but included formulations/trials and correspondence to the direct product remain unresolved.
Reason for missing information: The review's included-study table, formulation-specific results and withdrawal definitions/denominators are unverified.
Required materials and conditions: Bartels 2015 pain SMD, adverse-event withdrawal RR and included formulations
Materials to obtain first: Bartels 2015 pain SMD, adverse-event withdrawal RR and included formulations — corresponding original reports, plans and linking documents. First verify the actual existence and acquisition of the currently unverified material.
Further research: Material needed: Bartels 2015 pain SMD, adverse-event withdrawal RR and included formulations — corresponding original reports, plans and linking documents. First verify the actual existence and acquisition of the currently unverified material. This records needed materials; no new research was executed.
Remaining uncertainty: Do not transfer the mixed average to the GGE03 effect, individual incidence or independent replication of the same formulation.
Conditions for verification: Retain the review's SMD -0.30 and interval, and RR 2.33 and interval, as mixed-formulation results.
Why this condition is needed: Retain the review's SMD -0.30 and interval, and RR 2.33 and interval, as mixed-formulation results. Without this distinction, the direct product's pain question can be mixed with other formulations, endpoints and funding material.
Application exceptions: Do not turn the review average into the exact GGE03 between-group effect, independent replication or individual incidence.
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 R02

N15 · Which dates and verification scope apply to the original used here?

Current findings: The original verdict date is 2026-09-08, and the 2026-09-14 correction concerns English evidence-table placeholders. The Korean text also mentions a 2020 meta-analysis, but there are two structured reports/citations. No new clinical search was performed.
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: Dates, corrections and narrative scope were separated from the current conversion review.
Reason for missing information: Additional bibliography for the 2020 narrative and current search, publication and retraction status are unverified.
Required materials and conditions: Original verdict date, correction, Korean/English records and the current review date/search scope
Materials to obtain first: Original verdict date, correction, Korean/English records and the current review date/search scope — corresponding original reports, plans and linking documents. First verify the actual existence and acquisition of the currently unverified material.
Further research: Material needed: Original verdict date, correction, Korean/English records and the current review date/search scope — corresponding original reports, plans and linking documents. First verify the actual existence and acquisition of the currently unverified material. This records needed materials; no new research was executed.
Remaining uncertainty: Generic English wording and historical cross-check statements are not actual new verification.
Conditions for verification: Distinguish the original verdict date of 2026-09-08 and correction of 2026-09-14 from this preservation-based conversion.
Why this condition is needed: Distinguish the original verdict date of 2026-09-08 and correction of 2026-09-14 from this preservation-based conversion. Without this distinction, the direct product's pain question can be mixed with other formulations, endpoints and funding material.
Application exceptions: No new search does not mean 0 human studies, no retractions or verification of current originals.
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 R01 R02

N16 · How far were research funding and company financing verified?

Current findings: The direct funding record says company involvement and product-supply details were unverified in the public abstract. The review describes mixed funding of primary trials. Specific GGE03 research funding/company financing is not established.
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: Generic English funding wording and the historical I0 code do not provide original declarations of individual funding sources.
Reason for missing information: Original funding sources and company financing/roles are unverified.
Required materials and conditions: Actual funding sources and company roles in the direct GGE03 trial and the review's primary trials
Materials to obtain first: Actual funding sources and company roles in the direct GGE03 trial and the review's primary trials — corresponding original reports, plans and linking documents. First verify the actual existence and acquisition of the currently unverified material.
Further research: Material needed: Actual funding sources and company roles in the direct GGE03 trial and the review's primary trials — corresponding original reports, plans and linking documents. First verify the actual existence and acquisition of the currently unverified material. This records needed materials; no new research was executed.
Remaining uncertainty: Do not convert unverified funding into confirmed independent or company funding.
Conditions for verification: Attribute the original records of unverified company details and mixed funding to the respective reports.
Why this condition is needed: Attribute the original records of unverified company details and mixed funding to the respective reports. Without this distinction, the direct product's pain question can be mixed with other formulations, endpoints and funding material.
Application exceptions: Neither a company product name nor the I0 code verifies specific company financing.
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 R01 R02

N17 · Was product provision or support verified?

Current findings: The direct funding record marks product-provision details unverified. GGE03 product identity/total quantity is available, but actual supply, free support and role declarations are not retained.
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: Product name/dose and provision/support are separate matters.
Reason for missing information: Original product supply, support and company-role documents are unverified.
Required materials and conditions: GGE03 supply, free provision, support scope and company roles
Materials to obtain first: GGE03 supply, free provision, support scope and company roles — corresponding original reports, plans and linking documents. First verify the actual existence and acquisition of the currently unverified material.
Further research: Material needed: GGE03 supply, free provision, support scope and company roles — corresponding original reports, plans and linking documents. First verify the actual existence and acquisition of the currently unverified material. This records needed materials; no new research was executed.
Remaining uncertainty: Do not fill in no support or confirmed free support.
Conditions for verification: Do not turn unverified product-provision details into confirmed absence of support or confirmed free support.
Why this condition is needed: Do not turn unverified product-provision details into confirmed absence of support or confirmed free support. Without this distinction, the direct product's pain question can be mixed with other formulations, endpoints and funding material.
Application exceptions: Total product mass and brand identity cannot replace a product-support statement.
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 R01

N18 · Were employee authors and affiliations verified?

Current findings: The current summary does not specify GGE03 authors' company employment, affiliations or contributions. The English funding text is a generic statement that employee authorship and other matters were assessed separately.
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: Generic assessment wording is not evidence of employee authorship, its absence or an independent team.
Reason for missing information: Author affiliations, employment and research-team relationships are unverified.
Required materials and conditions: Author affiliations, company employment/contributions and relationships between independent research teams
Materials to obtain first: Author affiliations, company employment/contributions and relationships between independent research teams — corresponding original reports, plans and linking documents. First verify the actual existence and acquisition of the currently unverified material.
Further research: Material needed: Author affiliations, company employment/contributions and relationships between independent research teams — corresponding original reports, plans and linking documents. First verify the actual existence and acquisition of the currently unverified material. This records needed materials; no new research was executed.
Remaining uncertainty: Do not claim no employees or replication by another independent team.
Conditions for verification: Do not use generic English funding wording to establish employee authorship or its absence.
Why this condition is needed: Do not use generic English funding wording to establish employee authorship or its absence. Without this distinction, the direct product's pain question can be mixed with other formulations, endpoints and funding material.
Application exceptions: A report concerning the same product does not establish replication by another independent 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.

Related sources R01

N19 · How far were declared conflicts and patents verified?

Current findings: The current retained summary has no specific declared COI or patent information for the direct trial or the review's primary trials; only generic English funding wording is available.
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 original declarations were not compared, so the presence or absence of COI cannot be determined.
Reason for missing information: Declared details are absent from the retained summary; external COI/patent material remains unread.
Required materials and conditions: Declared author/institutional COI, patents and product-related interests
Materials to obtain first: Declared author/institutional COI, patents and product-related interests — corresponding original reports, plans and linking documents. First verify the actual existence and acquisition of the currently unverified material.
Further research: Material needed: Declared author/institutional COI, patents and product-related interests — corresponding original reports, plans and linking documents. First verify the actual existence and acquisition of the currently unverified material. This records needed materials; no new research was executed.
Remaining uncertainty: Do not convert this into no COI, no bias or a new independence grade.
Conditions for verification: Do not substitute no conflicts or no bias for unread original declarations.
Why this condition is needed: Do not substitute no conflicts or no bias for unread original declarations. Without this distinction, the direct product's pain question can be mixed with other formulations, endpoints and funding material.
Application exceptions: Do not fill in actual COI from the historical I0/grade or generic company-role wording.
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 R01 R02

N20 · What were the actual allocation, concealment and blinding methods?

Current findings: The direct design is described as a randomized double-blind placebo trial. Sequence generation, concealment, baseline balance and actual blinding procedures are not verified in detail in the retained summary.
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 is available, but actual allocation/blinding procedures need separate material.
Reason for missing information: Sequence generation, concealment, baseline balance and blinding procedures are unverified.
Required materials and conditions: Sequence generation, concealment and baseline balance in the GGE03 randomized double-blind placebo trial
Materials to obtain first: Sequence generation, concealment and baseline balance in the GGE03 randomized double-blind placebo trial — corresponding original reports, plans and linking documents. First verify the actual existence and acquisition of the currently unverified material.
Further research: Material needed: Sequence generation, concealment and baseline balance in the GGE03 randomized double-blind placebo trial — corresponding original reports, plans and linking documents. First verify the actual existence and acquisition of the currently unverified material. This records needed materials; no new research was executed.
Remaining uncertainty: The label alone does not establish no bias or that crossover/cluster considerations are inapplicable.
Conditions for verification: Distinguish the trial's design label from verification of actual allocation/blinding methods.
Why this condition is needed: Distinguish the trial's design label from verification of actual allocation/blinding methods. Without this distinction, the direct product's pain question can be mixed with other formulations, endpoints and funding material.
Application exceptions: Do not automatically mark crossover not applicable when parallel/crossover design details are unverified.
Referenced methods: Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.

Related sources R01

N21 · Could concomitant care, adherence or rescue treatment mix with the GGE03 contribution?

Current findings: Specific analgesics/rescue medication, lifestyle care, adherence and concurrent interventions in both groups are unverified in the retained 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: A placebo comparison cannot replace verification of concomitant care/deviation handling.
Reason for missing information: Concomitant care, adherence, rescue treatment and analysis implications are unverified.
Required materials and conditions: Analgesics/rescue medication, lifestyle care, adherence and concurrent interventions in both groups
Materials to obtain first: Analgesics/rescue medication, lifestyle care, adherence and concurrent interventions in both groups — corresponding original reports, plans and linking documents. First verify the actual existence and acquisition of the currently unverified material.
Further research: Material needed: Analgesics/rescue medication, lifestyle care, adherence and concurrent interventions in both groups — corresponding original reports, plans and linking documents. First verify the actual existence and acquisition of the currently unverified material. This records needed materials; no new research was executed.
Remaining uncertainty: Do not infer no concomitant treatment or the magnitude attributable to GGE03 alone.
Conditions for verification: Require material recording shared/different treatments in both groups and the additional GGE03 contrast.
Why this condition is needed: Require material recording shared/different treatments in both groups and the additional GGE03 contrast. Without this distinction, the direct product's pain question can be mixed with other formulations, endpoints and funding material.
Application exceptions: Do not turn unspecified concomitant treatment into no concomitant 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.

Related sources R01

N22 · Was pain measured in the same way?

Current findings: VAS and K-WOMAC are identifiable scale names, but assessment setting, visits, assessor blinding and group-specific collection methods 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: Scale names and the double-blind label must be distinguished from actual measurement procedures.
Reason for missing information: Measurement range, visits by time point and assessor blinding are unverified.
Required materials and conditions: VAS/K-WOMAC assessment timing, scales, assessor blinding and collection by group
Materials to obtain first: VAS/K-WOMAC assessment timing, scales, assessor blinding and collection by group — corresponding original reports, plans and linking documents. First verify the actual existence and acquisition of the currently unverified material.
Further research: Material needed: VAS/K-WOMAC assessment timing, scales, assessor blinding and collection by group — corresponding original reports, plans and linking documents. First verify the actual existence and acquisition of the currently unverified material. This records needed materials; no new research was executed.
Remaining uncertainty: Do not assert objective measurement or complete equivalence between groups.
Conditions for verification: State how subjective pain scales were actually collected and the remaining assessment limitations.
Why this condition is needed: State how subjective pain scales were actually collected and the remaining assessment limitations. Without this distinction, the direct product's pain question can be mixed with other formulations, endpoints and funding material.
Application exceptions: A double-blind design label does not verify outcome-assessment procedures.
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 R01

N23 · Do the effect of interest and analysis population correspond?

Current findings: The original direct summary does not specify assignment/adherence effects, ITT/PP, adjustment or an analysis 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: Reported between-group improvement does not establish the effect of interest or analysis population.
Reason for missing information: Analysis plans, populations and models are unverified.
Required materials and conditions: Assignment/adherence effects, ITT/PP, adjustment and between-group estimation
Materials to obtain first: Assignment/adherence effects, ITT/PP, adjustment and between-group estimation — corresponding original reports, plans and linking documents. First verify the actual existence and acquisition of the currently unverified material.
Further research: Material needed: Assignment/adherence effects, ITT/PP, adjustment and between-group estimation — corresponding original reports, plans and linking documents. First verify the actual existence and acquisition of the currently unverified material. This records needed materials; no new research was executed.
Remaining uncertainty: Do not reanalyze raw data or calculate a new effect.
Conditions for verification: Do not newly assign analysis populations or models absent from the original.
Why this condition is needed: Do not newly assign analysis populations or models absent from the original. Without this distinction, the direct product's pain question can be mixed with other formulations, endpoints and funding material.
Application exceptions: Do not perform a reanalysis that differs from the original formulation-effect 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.

Related sources R01

N24 · Can the interval be linked to a clinically important pain difference?

Current findings: The current retained summary has no direct interval or justified clinical-importance threshold for the relevant VAS/K-WOMAC scale.
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 original interval/threshold, the range of compatible effect sizes cannot be judged.
Reason for missing information: Direct CIs and importance thresholds are unverified.
Required materials and conditions: Direct effect interval and a justified importance threshold for the relevant scale/population
Materials to obtain first: Direct effect interval and a justified importance threshold for the relevant scale/population — corresponding original reports, plans and linking documents. First verify the actual existence and acquisition of the currently unverified material.
Further research: Material needed: Direct effect interval and a justified importance threshold for the relevant scale/population — corresponding original reports, plans and linking documents. First verify the actual existence and acquisition of the currently unverified material. This records needed materials; no new research was executed.
Remaining uncertainty: Do not use 100 participants or significance to establish sufficiency or a new efficacy grade.
Conditions for verification: Do not invent a minimum important difference or certainty without reported intervals and supporting importance evidence.
Why this condition is needed: Do not invent a minimum important difference or certainty without reported intervals and supporting importance evidence. Without this distinction, the direct product's pain question can be mixed with other formulations, endpoints and funding material.
Application exceptions: Neither significance nor a sample of 100 establishes sufficiency.
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 R01

N25 · Which endpoints do exact P values and significance concern?

Current findings: The direct report describes significant between-group improvement in VAS and K-WOMAC pain. Exact P values, multiple-endpoint handling and attribution by scale are unverified.
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 summary's significance statement was not promoted to exact P values or prespecified success.
Reason for missing information: Endpoint-specific P values, multiplicity and analysis hierarchy are unverified.
Required materials and conditions: Exact P values, analyses and multiple-endpoint handling for VAS and K-WOMAC
Materials to obtain first: Exact P values, analyses and multiple-endpoint handling for VAS and K-WOMAC — corresponding original reports, plans and linking documents. First verify the actual existence and acquisition of the currently unverified material.
Further research: Material needed: Exact P values, analyses and multiple-endpoint handling for VAS and K-WOMAC — corresponding original reports, plans and linking documents. First verify the actual existence and acquisition of the currently unverified material. This records needed materials; no new research was executed.
Remaining uncertainty: A positive supportive result does not automatically establish prespecified VAS success.
Conditions for verification: Retain reported significant between-group improvement without supplying exact P values or attribution by scale.
Why this condition is needed: Retain reported significant between-group improvement without supplying exact P values or attribution by scale. Without this distinction, the direct product's pain question can be mixed with other formulations, endpoints and funding material.
Application exceptions: Do not automatically promote a positive supportive endpoint into prespecified VAS success.
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 R01

N26 · Were registration, protocol and SAP compared with the report?

Current findings: The direct registration field says unverified, and the prespecified principal endpoint could not be verified in the public abstract. PROSPERO CRD42011001777 is registration information for the review.
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 trial registration/plans were distinguished from review registration; comparison of the direct prespecified hierarchy remains unresolved.
Reason for missing information: Direct trial registration, protocol, SAP and reasons for hierarchy changes are unverified.
Required materials and conditions: Original trial registration number, prespecified plans, outcome hierarchy and reasons for changes
Materials to obtain first: Original trial registration number, prespecified plans, outcome hierarchy and reasons for changes — corresponding original reports, plans and linking documents. First verify the actual existence and acquisition of the currently unverified material.
Further research: Material needed: Original trial registration number, prespecified plans, outcome hierarchy and reasons for changes — corresponding original reports, plans and linking documents. First verify the actual existence and acquisition of the currently unverified material. This records needed materials; no new research was executed.
Remaining uncertainty: Unavailable registration does not establish non-registration or selective reporting.
Conditions for verification: Retain the unverified trial-registration status and prespecified principal endpoint.
Why this condition is needed: Retain the unverified trial-registration status and prespecified principal endpoint. Without this distinction, the direct product's pain question can be mixed with other formulations, endpoints and funding material.
Application exceptions: Do not present the review's PROSPERO registration as GGE03 trial registration.
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 R01 R02

N27 · Is there independent replication under the same GGE03 conditions?

Current findings: The original text describes GGE03 independent replication as insufficient/unverified. VAS and K-WOMAC in the same report and 5 mixed-formulation trials were not counted as separate independent replications under the same GGE03 conditions.
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: Family/team information matching formulation, population, time point and outcome is unavailable.
Reason for missing information: Trials under matching conditions, team independence and trial-specific distributions are unverified.
Required materials and conditions: Independent trial families/teams matching formulation, population and 12-week VAS
Materials to obtain first: Independent trial families/teams matching formulation, population and 12-week VAS — corresponding original reports, plans and linking documents. First verify the actual existence and acquisition of the currently unverified material.
Further research: Material needed: Independent trial families/teams matching formulation, population and 12-week VAS — corresponding original reports, plans and linking documents. First verify the actual existence and acquisition of the currently unverified material. This records needed materials; no new research was executed.
Remaining uncertainty: Do not turn the review's trial count or two scales into a count of independent replications.
Conditions for verification: Do not erase unverified replication under matching conditions by using the mixed review's trial count.
Why this condition is needed: Do not erase unverified replication under matching conditions by using the mixed review's trial count. Without this distinction, the direct product's pain question can be mixed with other formulations, endpoints and funding material.
Application exceptions: Do not count two pain scales in one report 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.

Related sources R01 R02

N28 · Does this answer comparisons between doses or formulations?

Current findings: The current GGE03 record contains one dose combination: 0.48 g/day active extract and 1.6 g/day total product. Direct dose/formulation superiority or an optimal dose is not retained.
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 selected dose and extension to other products/doses are different questions.
Reason for missing information: Direct dose comparisons and correspondence between product/active amounts are unverified.
Required materials and conditions: Direct dose comparisons of the same GGE03 and correspondence between product and active amounts
Materials to obtain first: Direct dose comparisons of the same GGE03 and correspondence between product and active amounts — corresponding original reports, plans and linking documents. First verify the actual existence and acquisition of the currently unverified material.
Further research: Material needed: Direct dose comparisons of the same GGE03 and correspondence between product and active amounts — corresponding original reports, plans and linking documents. First verify the actual existence and acquisition of the currently unverified material. This records needed materials; no new research was executed.
Remaining uncertainty: Do not use the mixed review or generic ginger to establish product-equivalent quantities.
Conditions for verification: Distinguish the current single-dose-level question from optimal-dose and generic-ginger conversion questions.
Why this condition is needed: Distinguish the current single-dose-level question from optimal-dose and generic-ginger conversion questions. Without this distinction, the direct product's pain question can be mixed with other formulations, endpoints and funding material.
Application exceptions: Do not arrange product amounts from different studies as a direct dose-response 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.

Related sources R01 R02

N29 · Does the evidence cover persistence after 12 weeks or special populations?

Current findings: Treatment and follow-up last 12 weeks. The original safety text says long-term safety and drug interactions cannot be established. Post-treatment follow-up, prespecified subgroups and follow-up in other populations are unverified in the summary.
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 identified 12-week scope was distinguished from gaps in persistence and extension.
Reason for missing information: Direct post-treatment, long-term, prespecified-subgroup and special-population material is unverified.
Required materials and conditions: Post-treatment/long-term follow-up, prespecified subgroups and population-specific exposures/outcomes
Materials to obtain first: Post-treatment/long-term follow-up, prespecified subgroups and population-specific exposures/outcomes — corresponding original reports, plans and linking documents. First verify the actual existence and acquisition of the currently unverified material.
Further research: Material needed: Post-treatment/long-term follow-up, prespecified subgroups and population-specific exposures/outcomes — corresponding original reports, plans and linking documents. First verify the actual existence and acquisition of the currently unverified material. This records needed materials; no new research was executed.
Remaining uncertainty: Do not require every long-term study for the narrow VAS question.
Conditions for verification: Separate the verified 12-week scope from unverified persistence and extension to other populations.
Why this condition is needed: Separate the verified 12-week scope from unverified persistence and extension to other populations. Without this distinction, the direct product's pain question can be mixed with other formulations, endpoints and funding material.
Application exceptions: Do not require all long-term trials for the narrow VAS 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.

Related sources R01

N30 · Does pain improvement establish function, structural change or medication replacement?

Current findings: The original scope note judges VAS pain only and separates function, structural change and EV.EXT77. The advertising interpretation says generic ginger powder regenerating cartilage or replacing NSAIDs lies beyond this scope.
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 pain and distinct function, structure or medication-replacement questions was stated.
Reason for missing information: Direct outcomes for extension questions are unverified within this preservation scope.
Required materials and conditions: Direct VAS/K-WOMAC pain, function, cartilage/structural and NSAID-replacement outcomes
Materials to obtain first: Direct VAS/K-WOMAC pain, function, cartilage/structural and NSAID-replacement outcomes — corresponding original reports, plans and linking documents. First verify the actual existence and acquisition of the currently unverified material.
Further research: Material needed: Direct VAS/K-WOMAC pain, function, cartilage/structural and NSAID-replacement outcomes — corresponding original reports, plans and linking documents. First verify the actual existence and acquisition of the currently unverified material. This records needed materials; no new research was executed.
Remaining uncertainty: Met here prevents overextension; it does not verify efficacy for the extended claims.
Conditions for verification: Separate pain scales from distinct clinical or structural outcomes.
Why this condition is needed: Separate pain scales from distinct clinical or structural outcomes. Without this distinction, the direct product's pain question can be mixed with other formulations, endpoints and funding material.
Application exceptions: Do not automatically require cartilage-event trials for the selected VAS 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.

Related sources R01 R02

N31 · How were harms collected and denominators defined in the direct GGE03 trial?

Current findings: The direct report's title includes safety, but the current summary lacks detailed GGE03 harm-collection methods, group-specific events/denominators and withdrawals. The mixed review's withdrawal RR is not direct-product incidence.
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 retained material verifies harm definitions, collection and denominators for the direct formulation.
Reason for missing information: Direct safety details are absent from the read summary; external full text remains unread.
Required materials and conditions: Adverse-event definitions/collection, group-specific events/denominators, withdrawals and 12-week exposure for the direct formulation
Materials to obtain first: Adverse-event definitions/collection, group-specific events/denominators, withdrawals and 12-week exposure for the direct formulation — corresponding original reports, plans and linking documents. First verify the actual existence and acquisition of the currently unverified material.
Further research: Material needed: Adverse-event definitions/collection, group-specific events/denominators, withdrawals and 12-week exposure for the direct formulation — corresponding original reports, plans and linking documents. First verify the actual existence and acquisition of the currently unverified material. This records needed materials; no new research was executed.
Remaining uncertainty: Do not claim safety, 0 harms or direct-product applicability of the mixed review's RR.
Conditions for verification: Do not establish safety because the title includes safety or efficacy results exist.
Why this condition is needed: Do not establish safety because the title includes safety or efficacy results exist. Without this distinction, the direct product's pain question can be mixed with other formulations, endpoints and funding material.
Application exceptions: Do not turn the mixed review's adverse-event withdrawal RR into individual GGE03 incidence.
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 R01 R02

N32 · What harm information does adverse-event withdrawal in the mixed review provide?

Current findings: The mixed oral-ginger review records adverse-event withdrawal RR 2.33, interval 1.04 to 5.22. The original safety text describes more withdrawals due to gastrointestinal adverse events than placebo.
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 withdrawal comparison is retained, but definitions, denominators and formulation-specific collection remain unresolved.
Reason for missing information: Review withdrawal definitions, denominators and trial-specific harm material are unverified.
Required materials and conditions: Withdrawal definition, denominators and included trials for mixed-formulation review RR 2.33, interval 1.04 to 5.22
Materials to obtain first: Withdrawal definition, denominators and included trials for mixed-formulation review RR 2.33, interval 1.04 to 5.22 — corresponding original reports, plans and linking documents. First verify the actual existence and acquisition of the currently unverified material.
Further research: Material needed: Withdrawal definition, denominators and included trials for mixed-formulation review RR 2.33, interval 1.04 to 5.22 — corresponding original reports, plans and linking documents. First verify the actual existence and acquisition of the currently unverified material. This records needed materials; no new research was executed.
Remaining uncertainty: Do not extend the withdrawal comparison to all harms or GGE03/drug-interaction incidence.
Conditions for verification: Attribute the adverse-event withdrawal comparison to the review's scope and distinguish it from GGE03 event incidence.
Why this condition is needed: Attribute the adverse-event withdrawal comparison to the review's scope and distinguish it from GGE03 event incidence. Without this distinction, the direct product's pain question can be mixed with other formulations, endpoints and funding material.
Application exceptions: Do not interpret withdrawal RR as the magnitude of all harms or a specific drug interaction.
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 R02

N33 · Were harm timing, discontinuation and follow-up losses verified?

Current findings: The current summary has no individual harm timing, discontinuation/recovery, rechallenge or group-specific harm follow-up losses within 12 weeks.
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 duration does not establish temporal sequence/recovery or completeness of harm collection.
Reason for missing information: Event timing, discontinuation causes, recovery and collection losses are unverified.
Required materials and conditions: Harm occurrence, discontinuation/recovery and group-specific follow-up losses during 12-week exposure
Materials to obtain first: Harm occurrence, discontinuation/recovery and group-specific follow-up losses during 12-week exposure — corresponding original reports, plans and linking documents. First verify the actual existence and acquisition of the currently unverified material.
Further research: Material needed: Harm occurrence, discontinuation/recovery and group-specific follow-up losses during 12-week exposure — corresponding original reports, plans and linking documents. First verify the actual existence and acquisition of the currently unverified material. This records needed materials; no new research was executed.
Remaining uncertainty: Do not infer temporal causation, improvement after discontinuation or rechallenge.
Conditions for verification: Separate the efficacy follow-up period from actual harm collection and event timing.
Why this condition is needed: Separate the efficacy follow-up period from actual harm collection and event timing. Without this distinction, the direct product's pain question can be mixed with other formulations, endpoints and funding material.
Application exceptions: Do not infer improvement after discontinuation, rechallenge or 0 harms.
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 R01 R02

N34 · Were drug-interaction and vulnerable-population safety verified?

Current findings: The original safety text says 12 weeks cannot establish long-term safety or drug interactions. Direct material on concomitant medication, special populations and baseline risks is absent from the current 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: The caution's scope was distinguished from actual verification of concomitant-treatment or vulnerable-population harms.
Reason for missing information: Interactions, concomitant medication and vulnerable-population exposure/event material are unverified.
Required materials and conditions: Concomitant medication, baseline risks, interactions and harm material in other populations
Materials to obtain first: Concomitant medication, baseline risks, interactions and harm material in other populations — corresponding original reports, plans and linking documents. First verify the actual existence and acquisition of the currently unverified material.
Further research: Material needed: Concomitant medication, baseline risks, interactions and harm material in other populations — corresponding original reports, plans and linking documents. First verify the actual existence and acquisition of the currently unverified material. This records needed materials; no new research was executed.
Remaining uncertainty: Do not use the mixed withdrawal RR to judge a specific interaction magnitude or overall safety.
Conditions for verification: Do not turn unverified long-term safety/interactions in the original into established safety or risk magnitude.
Why this condition is needed: Do not turn unverified long-term safety/interactions in the original into established safety or risk magnitude. Without this distinction, the direct product's pain question can be mixed with other formulations, endpoints and funding material.
Application exceptions: Do not judge individual interactions from mixed oral-ginger withdrawal results 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.

Related sources R01 R02

N35 · Were missing harm reports distinguished from absence of events?

Current findings: The retained summary has no complete direct-harm collection, omissions or event-specific tables; only the mixed review's withdrawal summary is available. External full texts were not read 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: The absence is limited to the retained summary rather than extended to the entire original paper.
Reason for missing information: Safety details are absent from the summary; full texts and completeness of harm reporting remain unread.
Required materials and conditions: Collection, omissions and completeness of harm reporting in the direct trial and mixed review
Materials to obtain first: Collection, omissions and completeness of harm reporting in the direct trial and mixed review — corresponding original reports, plans and linking documents. First verify the actual existence and acquisition of the currently unverified material.
Further research: Material needed: Collection, omissions and completeness of harm reporting in the direct trial and mixed review — corresponding original reports, plans and linking documents. First verify the actual existence and acquisition of the currently unverified material. This records needed materials; no new research was executed.
Remaining uncertainty: Do not conclude that no harms occurred or the study is invalid.
Conditions for verification: State that detailed safety tables are absent from the retained summary.
Why this condition is needed: State that detailed safety tables are absent from the retained summary. Without this distinction, the direct product's pain question can be mixed with other formulations, endpoints and funding material.
Application exceptions: Do not claim non-reporting throughout an external paper whose full text was not read.
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 R01 R02

N36 · What does the current material say about efficacy and harms?

Current findings: Reported formulation-specific significant between-group improvement and the mixed review's small pain/adverse-event withdrawal comparisons were retained separately. Original C46, Caution, axis codes and historical cross-check statements remain in the source original.
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 current table explains reports, gaps and applicability boundaries without creating a new efficacy/safety grade or dosing instruction.
Reason for missing information: Direct magnitude, intervals, prespecification, independence and complete safety remain unverified under the relevant conditions.
Required materials and conditions: Reported formulation-specific significant improvement, mixed-review withdrawals and unverified boundaries
Materials to obtain first: Reported formulation-specific significant improvement, mixed-review withdrawals and unverified boundaries — corresponding original reports, plans and linking documents. First verify the actual existence and acquisition of the currently unverified material.
Further research: Material needed: Reported formulation-specific significant improvement, mixed-review withdrawals and unverified boundaries — corresponding original reports, plans and linking documents. First verify the actual existence and acquisition of the currently unverified material. This records needed materials; no new research was executed.
Remaining uncertainty: Model self-review and mechanical comparison are not independent clinical certification.
Conditions for verification: Explain retained reports, gaps and applicability boundaries without creating a new efficacy/safety grade or dosing instruction.
Why this condition is needed: Explain retained reports, gaps and applicability boundaries without creating a new efficacy/safety grade or dosing instruction. Without this distinction, the direct product's pain question can be mixed with other formulations, endpoints and funding material.
Application exceptions: Do not inherit historical C46/Caution labels or cross-check statements as new clinical 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.

Related sources R01 R02