{ "schema_version": "chamgap-public-evidence-check-1.0", "public_id": "v3050-main", "verdict_number": "3050", "title": "Steamed ginger extract GGE03, 0.48 g/day × Reduction of pain in mild knee osteoarthritis", "view_version": "1.0", "view_created_date": "2026-10-25", "criteria_version": "1.1", "criteria_date": "2026-10-06", "review_date": "2026-10-06", "legacy_evidence_date": "2026-09-08", "review_scope": { "materials_read": "Retained Korean/English summaries and case-specific conditions/application records", "clinical_papers_directly_read": false, "new_clinical_search": false, "limitation": "Prepared from retained summaries and condition-application records. External abstracts, full texts, registration, protocols and analysis plans remain unread. Historical review records do not establish current independent clinical validation.", "date_meaning": "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." }, "claim_context": { "population": "100 adults with mild knee osteoarthritis. Detailed diagnosis, age, eligibility criteria and baseline characteristics are unverified.", "intervention": "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.", "endpoint": "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.", "excluded_extensions": [ "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." ] }, "requirements": [ { "item_id": "N01", "question_type": "Evidence condition", "question": "Which independent GGE03 question is being checked?", "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", "role": "Required", "role_reason": "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_exception": "K-WOMAC pain is linked as supportive; this does not establish a prespecified principal endpoint.", "criterion": "Link the current question to the selected VAS outcome and distinguish other formulations, function and structural outcomes.", "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.", "condition_origin": "These existing in-house conditions concern GGE03 steamed ginger extract and VAS pain in mild knee osteoarthritis. They do not establish preregistration, official-tool certification or new independent clinical validation.", "proposed_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.", "current_reports": [ "R01", "R02" ], "existence": "Stored research/bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original manufacturing/support/harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific conditions/application records were read. Linked external abstracts, full texts, registration and planning material remain unread, with no access attempt.", "observation": "The original 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.", "condition_status": "Met", "status_reason": "The selected question, population, dose and endpoint boundaries are identifiable in the retained original.", "missingness": "The magnitude and prespecification of the direct effect are separate from identifying this boundary.", "uncertainty": "Met here means that the question is identified, not that efficacy is established.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "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." }, { "item_id": "N02", "question_type": "Evidence condition", "question": "How are the two reports linked to unique trial families?", "needed": "Included-study tables and registration/trial identities for the Kim 2024 GGE03 report and Bartels 2015 mixed-formulation review", "role": "Required", "role_reason": "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_exception": "Do not add a review and its primary trials, or two scales from one trial, as independent replications.", "criterion": "Distinguish the 2 reports from the review's 5 included trials and 593 participants; leave unique trial/participant totals and overlap unverified.", "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.", "condition_origin": "These existing in-house conditions concern GGE03 steamed ginger extract and VAS pain in mild knee osteoarthritis. They do not establish preregistration, official-tool certification or new independent clinical validation.", "proposed_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.", "current_reports": [ "R01", "R02" ], "existence": "Stored research/bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original manufacturing/support/harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific conditions/application records were read. Linked external abstracts, full texts, registration and planning material remain unread, with no access attempt.", "observation": "The retained 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.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Included-study tables, trial registration and links to unique participants/trials are unverified.", "uncertainty": "2 reports do not mean 2 independent studies or a total of unique participants.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "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." }, { "item_id": "N03", "question_type": "Evidence condition", "question": "What was actually read in this review?", "needed": "Separate reading histories for retained summaries and external bibliographic records/abstracts, full texts, trial registration, protocols and SAPs", "role": "Required", "role_reason": "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_exception": "Do not label material inaccessible when access was not attempted.", "criterion": "Distinguish reading the whole retained summary from unread external material; a link does not establish successful reading.", "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.", "condition_origin": "These existing in-house conditions concern GGE03 steamed ginger extract and VAS pain in mild knee osteoarthritis. They do not establish preregistration, official-tool certification or new independent clinical validation.", "proposed_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.", "current_reports": [ "R01", "R02" ], "existence": "Stored research/bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original manufacturing/support/harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific conditions/application records were read. Linked external abstracts, full texts, registration and planning material remain unread, with no access attempt.", "observation": "The 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.", "condition_status": "Met", "status_reason": "The levels of actual activity were distinguished, and summary-reading links point to retained original locations.", "missingness": "Actual availability, acquisition and full-text content of each external material are unverified.", "uncertainty": "The current record has no access-level field; the original verdict date is not used as an external reading date.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "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." }, { "item_id": "N04", "question_type": "Evidence condition", "question": "Which adults with knee osteoarthritis does this material concern?", "needed": "Diagnosis, age, severity, eligibility criteria and baseline pain in mild knee osteoarthritis", "role": "Required", "role_reason": "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_exception": "A total of 100 participants does not establish representativeness or eligibility criteria.", "criterion": "Distinguish adults with mild knee osteoarthritis in the current report from other severities, joints and populations.", "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.", "condition_origin": "These existing in-house conditions concern GGE03 steamed ginger extract and VAS pain in mild knee osteoarthritis. They do not establish preregistration, official-tool certification or new independent clinical validation.", "proposed_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.", "current_reports": [ "R01" ], "existence": "Stored research/bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original manufacturing/support/harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific conditions/application records were read. Linked external abstracts, full texts, registration and planning material remain unread, with no access attempt.", "observation": "The retained population field specifies 100 adults with mild knee osteoarthritis. Detailed diagnosis, age range, eligibility criteria and baseline pain are not provided in the retained summary.", "condition_status": "Partly verified", "status_reason": "The selected population and total are named, but representativeness and selection remain unverified.", "missingness": "Diagnostic criteria, eligibility criteria and baseline characteristics are unverified.", "uncertainty": "Direct applicability to other severities, joints and populations is not established.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "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." }, { "item_id": "N05", "question_type": "Evidence condition", "question": "What are the GGE03 product and extract?", "needed": "Source, processing, extraction solvent, gingerol/shogaol assay and product documents for steamed ginger extract", "role": "Required", "role_reason": "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_exception": "Do not copy the galangal component of EV.EXT77 or another ginger product's specifications into GGE03.", "criterion": "Distinguish the GGE03 steamed formulation from generic powder and combinations; do not fill in an unverified solvent or assay.", "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.", "condition_origin": "These existing in-house conditions concern GGE03 steamed ginger extract and VAS pain in mild knee osteoarthritis. They do not establish preregistration, official-tool certification or new independent clinical validation.", "proposed_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.", "current_reports": [ "R01" ], "existence": "Stored research/bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original manufacturing/support/harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific conditions/application records were read. Linked external abstracts, full texts, registration and planning material remain unread, with no access attempt.", "observation": "The formulation is 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.", "condition_status": "Partly verified", "status_reason": "The specific formulation's identity and unverified manufacturing/assay details are both retained.", "missingness": "Extraction solvent, standardization/assay and original product documents are unverified.", "uncertainty": "Do not treat generic powder, another extract or the EV.EXT77 combination as equivalent products.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "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." }, { "item_id": "N06", "question_type": "Evidence condition", "question": "Were active extract and total product amounts distinguished?", "needed": "Dosing schedule, frequency and actual intake for 0.48 g/day active extract and 1.6 g/day total product", "role": "Required", "role_reason": "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_exception": "A single-dose-level record does not establish an optimal dose or equivalent quantities across products.", "criterion": "Retain the two amounts separately; do not turn 1.6 g of product into active-extract or ginger-food mass.", "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.", "condition_origin": "These existing in-house conditions concern GGE03 steamed ginger extract and VAS pain in mild knee osteoarthritis. They do not establish preregistration, official-tool certification or new independent clinical validation.", "proposed_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.", "current_reports": [ "R01" ], "existence": "Stored research/bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original manufacturing/support/harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific conditions/application records were read. Linked external abstracts, full texts, registration and planning material remain unread, with no access attempt.", "observation": "The original 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.", "condition_status": "Partly verified", "status_reason": "Nominal active and total amounts are stated, but the actual schedule and adherence are unverified.", "missingness": "Actual dosing frequency, intake/adherence and product correspondence are unverified.", "uncertainty": "Do not create converted quantities, product-equivalent amounts or an optimal dose.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "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." }, { "item_id": "N07", "question_type": "Evidence condition", "question": "What were the placebo and shared-care conditions?", "needed": "Actual composition of the matching placebo and concomitant/usual care in both groups", "role": "Required", "role_reason": "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_exception": "Matching appearance does not verify identical ingredients, taste, care and concomitant treatment.", "criterion": "Separate the actual placebo comparison from shared care when stating the intervention's contribution.", "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.", "condition_origin": "These existing in-house conditions concern GGE03 steamed ginger extract and VAS pain in mild knee osteoarthritis. They do not establish preregistration, official-tool certification or new independent clinical validation.", "proposed_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.", "current_reports": [ "R01" ], "existence": "Stored research/bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original manufacturing/support/harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific conditions/application records were read. Linked external abstracts, full texts, registration and planning material remain unread, with no access attempt.", "observation": "The 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.", "condition_status": "Partly verified", "status_reason": "The placebo comparison is identifiable, but complete equivalence of the comparison background is unverified.", "missingness": "Placebo composition, shared care and concomitant treatment are unverified.", "uncertainty": "Matching appearance does not establish identical care and ingredients.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "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." }, { "item_id": "N08", "question_type": "Evidence condition", "question": "What endpoint and time point define the selected VAS pain outcome?", "needed": "The 12-week VAS scale, assessment setting, change/final-value outcome and prespecified endpoint hierarchy", "role": "Required", "role_reason": "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_exception": "The page's principal-endpoint field does not establish a registered primary (1st) endpoint.", "criterion": "Distinguish the page's selected 12-week VAS question from verification of the trial's prespecified hierarchy.", "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.", "condition_origin": "These existing in-house conditions concern GGE03 steamed ginger extract and VAS pain in mild knee osteoarthritis. They do not establish preregistration, official-tool certification or new independent clinical validation.", "proposed_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.", "current_reports": [ "R01" ], "existence": "Stored research/bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original manufacturing/support/harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific conditions/application records were read. Linked external abstracts, full texts, registration and planning material remain unread, with no access attempt.", "observation": "The current 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.", "condition_status": "Partly verified", "status_reason": "The page's selected endpoint was distinguished from the trial's prespecified hierarchy.", "missingness": "VAS scale range, assessment setting, outcome type and registered hierarchy are unverified.", "uncertainty": "The page's principal-endpoint field does not verify the primary (1st) endpoint in the original registration.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "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." }, { "item_id": "N09", "question_type": "Evidence condition", "question": "How does K-WOMAC pain relate to VAS?", "needed": "K-WOMAC pain subscale, time point, analysis and reporting hierarchy in the same trial", "role": "Required", "role_reason": "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_exception": "Do not automatically substitute K-WOMAC pain for function, total score or structural change.", "criterion": "Link K-WOMAC pain as a supportive endpoint in the same report; do not merge it with the VAS effect or trial count.", "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.", "condition_origin": "These existing in-house conditions concern GGE03 steamed ginger extract and VAS pain in mild knee osteoarthritis. They do not establish preregistration, official-tool certification or new independent clinical validation.", "proposed_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.", "current_reports": [ "R01" ], "existence": "Stored research/bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original manufacturing/support/harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific conditions/application records were read. Linked external abstracts, full texts, registration and planning material remain unread, with no access attempt.", "observation": "The 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.", "condition_status": "Partly verified", "status_reason": "The relationship of the supportive pain result is identified, but scale definition, analysis and prespecified hierarchy remain unresolved.", "missingness": "K-WOMAC subscale, scale direction and analysis details are unverified.", "uncertainty": "Do not merge supportive pain with function/total score or count it as another independent trial.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "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." }, { "item_id": "N10", "question_type": "Evidence condition", "question": "Which analysis does the reported between-group improvement describe?", "needed": "Between-group or change-score differences, adjustment and analysis populations for VAS and K-WOMAC separately", "role": "Required", "role_reason": "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_exception": "Do not fill in ITT, PP or adjusted estimates when the analysis is unspecified.", "criterion": "Do not turn retained significant between-group improvement into within-group change or an exact effect estimate.", "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.", "condition_origin": "These existing in-house conditions concern GGE03 steamed ginger extract and VAS pain in mild knee osteoarthritis. They do not establish preregistration, official-tool certification or new independent clinical validation.", "proposed_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.", "current_reports": [ "R01" ], "existence": "Stored research/bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original manufacturing/support/harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific conditions/application records were read. Linked external abstracts, full texts, registration and planning material remain unread, with no access attempt.", "observation": "The 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.", "condition_status": "Partly verified", "status_reason": "Retain the original between-group statement without supplying an analysis definition absent from the original.", "missingness": "Scale-specific between-group estimates/change scores, adjustment and analysis populations are unverified.", "uncertainty": "Do not substitute within-group change or a new effect estimate.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "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." }, { "item_id": "N11", "question_type": "Evidence condition", "question": "Which denominators do 100 participants and 1:1 describe?", "needed": "Numbers randomized, completed, measured and analyzed by group, with endpoint-specific denominators", "role": "Required", "role_reason": "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_exception": "Do not newly calculate and establish 50/50 from 1:1.", "criterion": "Record only the retained 100 participants and 1:1 allocation ratio; do not create group-specific, completed or analyzed denominators.", "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.", "condition_origin": "These existing in-house conditions concern GGE03 steamed ginger extract and VAS pain in mild knee osteoarthritis. They do not establish preregistration, official-tool certification or new independent clinical validation.", "proposed_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.", "current_reports": [ "R01" ], "existence": "Stored research/bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original manufacturing/support/harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific conditions/application records were read. Linked external abstracts, full texts, registration and planning material remain unread, with no access attempt.", "observation": "The retained 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.", "condition_status": "Partly verified", "status_reason": "The total and allocation ratio are available, but relationships between endpoint-specific denominators remain unresolved.", "missingness": "Group-specific and endpoint-specific randomized, completed and analyzed denominators are unverified.", "uncertainty": "Do not establish 50/50 or complete follow-up without original verification.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "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." }, { "item_id": "N12", "question_type": "Evidence condition", "question": "How were missing data and withdrawals handled?", "needed": "Group-specific withdrawal reasons, changes in adherence/rescue treatment and missing-data/analysis handling", "role": "Required", "role_reason": "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_exception": "Do not assume the reported total equals the analyzed or completed denominator.", "criterion": "Link actual reported losses to analysis handling; absent information does not mean 0 withdrawals or no problem.", "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.", "condition_origin": "These existing in-house conditions concern GGE03 steamed ginger extract and VAS pain in mild knee osteoarthritis. They do not establish preregistration, official-tool certification or new independent clinical validation.", "proposed_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.", "current_reports": [ "R01" ], "existence": "Stored research/bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original manufacturing/support/harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific conditions/application records were read. Linked external abstracts, full texts, registration and planning material remain unread, with no access attempt.", "observation": "The current retained summary does not provide group-specific withdrawal reasons, missing-data handling, changes in adherence/rescue treatment or sensitivity analyses.", "condition_status": "Unverified", "status_reason": "The total of 100 and generic English participant wording cannot replace actual participant-flow and missing-data records.", "missingness": "These details are absent from the read summary; external full text and analysis plans remain unread.", "uncertainty": "Do not fill in 0 withdrawals, ITT or no problems.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "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." }, { "item_id": "N13", "question_type": "Evidence condition", "question": "Are direct GGE03 effect estimates and intervals available?", "needed": "Between-group effects, variance, 95% CIs and exact P values for 12-week VAS and K-WOMAC separately", "role": "Required", "role_reason": "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_exception": "Reported P-value significance alone does not establish precision, effect magnitude or equivalence.", "criterion": "Distinguish the reported absence of verified exact differences, 95% CIs and P values in the public abstract from mixed-review estimates.", "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.", "condition_origin": "These existing in-house conditions concern GGE03 steamed ginger extract and VAS pain in mild knee osteoarthritis. They do not establish preregistration, official-tool certification or new independent clinical validation.", "proposed_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.", "current_reports": [ "R01", "R02" ], "existence": "Stored research/bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original manufacturing/support/harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific conditions/application records were read. Linked external abstracts, full texts, registration and planning material remain unread, with no access attempt.", "observation": "The 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.", "condition_status": "Unverified", "status_reason": "No retained result table establishes the magnitude and interval of the selected direct effect.", "missingness": "Direct result tables, variance, CIs and exact P values are unverified.", "uncertainty": "Reported significant improvement does not verify precision or a clinically important effect.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "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." }, { "item_id": "N14", "question_type": "Evidence condition", "question": "How are the mixed oral-ginger review's results retained?", "needed": "Bartels 2015 pain SMD, adverse-event withdrawal RR and included formulations", "role": "Required", "role_reason": "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_exception": "Do not turn the review average into the exact GGE03 between-group effect, independent replication or individual incidence.", "criterion": "Retain the review's SMD -0.30 and interval, and RR 2.33 and interval, as mixed-formulation results.", "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.", "condition_origin": "These existing in-house conditions concern GGE03 steamed ginger extract and VAS pain in mild knee osteoarthritis. They do not establish preregistration, official-tool certification or new independent clinical validation.", "proposed_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.", "current_reports": [ "R02" ], "existence": "Stored research/bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original manufacturing/support/harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific conditions/application records were read. Linked external abstracts, full texts, registration and planning material remain unread, with no access attempt.", "observation": "The 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.", "condition_status": "Partly verified", "status_reason": "Synthesis estimates retain their original attribution, but included formulations/trials and correspondence to the direct product remain unresolved.", "missingness": "The review's included-study table, formulation-specific results and withdrawal definitions/denominators are unverified.", "uncertainty": "Do not transfer the mixed average to the GGE03 effect, individual incidence or independent replication of the same formulation.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "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." }, { "item_id": "N15", "question_type": "Evidence condition", "question": "Which dates and verification scope apply to the original used here?", "needed": "Original verdict date, correction, Korean/English records and the current review date/search scope", "role": "Required", "role_reason": "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_exception": "No new search does not mean 0 human studies, no retractions or verification of current originals.", "criterion": "Distinguish the original verdict date of 2026-09-08 and correction of 2026-09-14 from this preservation-based conversion.", "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.", "condition_origin": "These existing in-house conditions concern GGE03 steamed ginger extract and VAS pain in mild knee osteoarthritis. They do not establish preregistration, official-tool certification or new independent clinical validation.", "proposed_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.", "current_reports": [ "R01", "R02" ], "existence": "Stored research/bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original manufacturing/support/harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific conditions/application records were read. Linked external abstracts, full texts, registration and planning material remain unread, with no access attempt.", "observation": "The original verdict date is 2026-09-08, and the 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.", "condition_status": "Met", "status_reason": "Dates, corrections and narrative scope were separated from the current conversion review.", "missingness": "Additional bibliography for the 2020 narrative and current search, publication and retraction status are unverified.", "uncertainty": "Generic English wording and historical cross-check statements are not actual new verification.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "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." }, { "item_id": "N16", "question_type": "Evidence condition", "question": "How far were research funding and company financing verified?", "needed": "Actual funding sources and company roles in the direct GGE03 trial and the review's primary trials", "role": "Supplementary; required for a claim of independent funding", "role_reason": "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_exception": "Neither a company product name nor the I0 code verifies specific company financing.", "criterion": "Attribute the original records of unverified company details and mixed funding to the respective reports.", "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.", "condition_origin": "These existing in-house conditions concern GGE03 steamed ginger extract and VAS pain in mild knee osteoarthritis. They do not establish preregistration, official-tool certification or new independent clinical validation.", "proposed_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.", "current_reports": [ "R01", "R02" ], "existence": "Stored research/bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original manufacturing/support/harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific conditions/application records were read. Linked external abstracts, full texts, registration and planning material remain unread, with no access attempt.", "observation": "The 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.", "condition_status": "Unverified", "status_reason": "Generic English funding wording and the historical I0 code do not provide original declarations of individual funding sources.", "missingness": "Original funding sources and company financing/roles are unverified.", "uncertainty": "Do not convert unverified funding into confirmed independent or company funding.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "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." }, { "item_id": "N17", "question_type": "Evidence condition", "question": "Was product provision or support verified?", "needed": "GGE03 supply, free provision, support scope and company roles", "role": "Supplementary; required for a claim of independent support", "role_reason": "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_exception": "Total product mass and brand identity cannot replace a product-support statement.", "criterion": "Do not turn unverified product-provision details into confirmed absence of support or confirmed free support.", "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.", "condition_origin": "These existing in-house conditions concern GGE03 steamed ginger extract and VAS pain in mild knee osteoarthritis. They do not establish preregistration, official-tool certification or new independent clinical validation.", "proposed_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.", "current_reports": [ "R01" ], "existence": "Stored research/bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original manufacturing/support/harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific conditions/application records were read. Linked external abstracts, full texts, registration and planning material remain unread, with no access attempt.", "observation": "The 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.", "condition_status": "Unverified", "status_reason": "Product name/dose and provision/support are separate matters.", "missingness": "Original product supply, support and company-role documents are unverified.", "uncertainty": "Do not fill in no support or confirmed free support.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "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." }, { "item_id": "N18", "question_type": "Evidence condition", "question": "Were employee authors and affiliations verified?", "needed": "Author affiliations, company employment/contributions and relationships between independent research teams", "role": "Supplementary; required for a claim of team independence", "role_reason": "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_exception": "A report concerning the same product does not establish replication by another independent team.", "criterion": "Do not use generic English funding wording to establish employee authorship or its absence.", "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.", "condition_origin": "These existing in-house conditions concern GGE03 steamed ginger extract and VAS pain in mild knee osteoarthritis. They do not establish preregistration, official-tool certification or new independent clinical validation.", "proposed_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.", "current_reports": [ "R01" ], "existence": "Stored research/bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original manufacturing/support/harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific conditions/application records were read. Linked external abstracts, full texts, registration and planning material remain unread, with no access attempt.", "observation": "The current summary 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.", "condition_status": "Unverified", "status_reason": "Generic assessment wording is not evidence of employee authorship, its absence or an independent team.", "missingness": "Author affiliations, employment and research-team relationships are unverified.", "uncertainty": "Do not claim no employees or replication by another independent team.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "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." }, { "item_id": "N19", "question_type": "Evidence condition", "question": "How far were declared conflicts and patents verified?", "needed": "Declared author/institutional COI, patents and product-related interests", "role": "Supplementary; required for a conflicts-of-interest claim", "role_reason": "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_exception": "Do not fill in actual COI from the historical I0/grade or generic company-role wording.", "criterion": "Do not substitute no conflicts or no bias for unread original declarations.", "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.", "condition_origin": "These existing in-house conditions concern GGE03 steamed ginger extract and VAS pain in mild knee osteoarthritis. They do not establish preregistration, official-tool certification or new independent clinical validation.", "proposed_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.", "current_reports": [ "R01", "R02" ], "existence": "Stored research/bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original manufacturing/support/harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific conditions/application records were read. Linked external abstracts, full texts, registration and planning material remain unread, with no access attempt.", "observation": "The current 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.", "condition_status": "Unverified", "status_reason": "The original declarations were not compared, so the presence or absence of COI cannot be determined.", "missingness": "Declared details are absent from the retained summary; external COI/patent material remains unread.", "uncertainty": "Do not convert this into no COI, no bias or a new independence grade.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "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." }, { "item_id": "N20", "question_type": "Evidence condition", "question": "What were the actual allocation, concealment and blinding methods?", "needed": "Sequence generation, concealment and baseline balance in the GGE03 randomized double-blind placebo trial", "role": "Required", "role_reason": "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_exception": "Do not automatically mark crossover not applicable when parallel/crossover design details are unverified.", "criterion": "Distinguish the trial's design label from verification of actual allocation/blinding methods.", "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.", "condition_origin": "These existing in-house conditions concern GGE03 steamed ginger extract and VAS pain in mild knee osteoarthritis. They do not establish preregistration, official-tool certification or new independent clinical validation.", "proposed_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.", "current_reports": [ "R01" ], "existence": "Stored research/bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original manufacturing/support/harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific conditions/application records were read. Linked external abstracts, full texts, registration and planning material remain unread, with no access attempt.", "observation": "The 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.", "condition_status": "Partly verified", "status_reason": "The design label is available, but actual allocation/blinding procedures need separate material.", "missingness": "Sequence generation, concealment, baseline balance and blinding procedures are unverified.", "uncertainty": "The label alone does not establish no bias or that crossover/cluster considerations are inapplicable.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "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." }, { "item_id": "N21", "question_type": "Evidence condition", "question": "Could concomitant care, adherence or rescue treatment mix with the GGE03 contribution?", "needed": "Analgesics/rescue medication, lifestyle care, adherence and concurrent interventions in both groups", "role": "Required", "role_reason": "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_exception": "Do not turn unspecified concomitant treatment into no concomitant treatment.", "criterion": "Require material recording shared/different treatments in both groups and the additional GGE03 contrast.", "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.", "condition_origin": "These existing in-house conditions concern GGE03 steamed ginger extract and VAS pain in mild knee osteoarthritis. They do not establish preregistration, official-tool certification or new independent clinical validation.", "proposed_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.", "current_reports": [ "R01" ], "existence": "Stored research/bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original manufacturing/support/harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific conditions/application records were read. Linked external abstracts, full texts, registration and planning material remain unread, with no access attempt.", "observation": "Specific analgesics/rescue medication, lifestyle care, adherence and concurrent interventions in both groups are unverified in the retained summary.", "condition_status": "Unverified", "status_reason": "A placebo comparison cannot replace verification of concomitant care/deviation handling.", "missingness": "Concomitant care, adherence, rescue treatment and analysis implications are unverified.", "uncertainty": "Do not infer no concomitant treatment or the magnitude attributable to GGE03 alone.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "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." }, { "item_id": "N22", "question_type": "Evidence condition", "question": "Was pain measured in the same way?", "needed": "VAS/K-WOMAC assessment timing, scales, assessor blinding and collection by group", "role": "Required", "role_reason": "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_exception": "A double-blind design label does not verify outcome-assessment procedures.", "criterion": "State how subjective pain scales were actually collected and the remaining assessment limitations.", "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.", "condition_origin": "These existing in-house conditions concern GGE03 steamed ginger extract and VAS pain in mild knee osteoarthritis. They do not establish preregistration, official-tool certification or new independent clinical validation.", "proposed_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.", "current_reports": [ "R01" ], "existence": "Stored research/bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original manufacturing/support/harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific conditions/application records were read. Linked external abstracts, full texts, registration and planning material remain unread, with no access attempt.", "observation": "VAS and K-WOMAC are identifiable scale names, but assessment setting, visits, assessor blinding and group-specific collection methods are not detailed.", "condition_status": "Partly verified", "status_reason": "Scale names and the double-blind label must be distinguished from actual measurement procedures.", "missingness": "Measurement range, visits by time point and assessor blinding are unverified.", "uncertainty": "Do not assert objective measurement or complete equivalence between groups.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "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." }, { "item_id": "N23", "question_type": "Evidence condition", "question": "Do the effect of interest and analysis population correspond?", "needed": "Assignment/adherence effects, ITT/PP, adjustment and between-group estimation", "role": "Required", "role_reason": "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_exception": "Do not perform a reanalysis that differs from the original formulation-effect question.", "criterion": "Do not newly assign analysis populations or models absent from the original.", "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.", "condition_origin": "These existing in-house conditions concern GGE03 steamed ginger extract and VAS pain in mild knee osteoarthritis. They do not establish preregistration, official-tool certification or new independent clinical validation.", "proposed_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.", "current_reports": [ "R01" ], "existence": "Stored research/bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original manufacturing/support/harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific conditions/application records were read. Linked external abstracts, full texts, registration and planning material remain unread, with no access attempt.", "observation": "The original direct summary does not specify assignment/adherence effects, ITT/PP, adjustment or an analysis model.", "condition_status": "Unverified", "status_reason": "Reported between-group improvement does not establish the effect of interest or analysis population.", "missingness": "Analysis plans, populations and models are unverified.", "uncertainty": "Do not reanalyze raw data or calculate a new effect.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "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." }, { "item_id": "N24", "question_type": "Evidence condition", "question": "Can the interval be linked to a clinically important pain difference?", "needed": "Direct effect interval and a justified importance threshold for the relevant scale/population", "role": "Required", "role_reason": "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_exception": "Neither significance nor a sample of 100 establishes sufficiency.", "criterion": "Do not invent a minimum important difference or certainty without reported intervals and supporting importance evidence.", "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.", "condition_origin": "These existing in-house conditions concern GGE03 steamed ginger extract and VAS pain in mild knee osteoarthritis. They do not establish preregistration, official-tool certification or new independent clinical validation.", "proposed_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.", "current_reports": [ "R01" ], "existence": "Stored research/bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original manufacturing/support/harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific conditions/application records were read. Linked external abstracts, full texts, registration and planning material remain unread, with no access attempt.", "observation": "The current retained summary has no direct interval or justified clinical-importance threshold for the relevant VAS/K-WOMAC scale.", "condition_status": "Unverified", "status_reason": "Without an original interval/threshold, the range of compatible effect sizes cannot be judged.", "missingness": "Direct CIs and importance thresholds are unverified.", "uncertainty": "Do not use 100 participants or significance to establish sufficiency or a new efficacy grade.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "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." }, { "item_id": "N25", "question_type": "Evidence condition", "question": "Which endpoints do exact P values and significance concern?", "needed": "Exact P values, analyses and multiple-endpoint handling for VAS and K-WOMAC", "role": "Required", "role_reason": "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_exception": "Do not automatically promote a positive supportive endpoint into prespecified VAS success.", "criterion": "Retain reported significant between-group improvement without supplying exact P values or attribution by scale.", "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.", "condition_origin": "These existing in-house conditions concern GGE03 steamed ginger extract and VAS pain in mild knee osteoarthritis. They do not establish preregistration, official-tool certification or new independent clinical validation.", "proposed_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.", "current_reports": [ "R01" ], "existence": "Stored research/bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original manufacturing/support/harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific conditions/application records were read. Linked external abstracts, full texts, registration and planning material remain unread, with no access attempt.", "observation": "The 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.", "condition_status": "Unverified", "status_reason": "The summary's significance statement was not promoted to exact P values or prespecified success.", "missingness": "Endpoint-specific P values, multiplicity and analysis hierarchy are unverified.", "uncertainty": "A positive supportive result does not automatically establish prespecified VAS success.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "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." }, { "item_id": "N26", "question_type": "Evidence condition", "question": "Were registration, protocol and SAP compared with the report?", "needed": "Original trial registration number, prespecified plans, outcome hierarchy and reasons for changes", "role": "Required", "role_reason": "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_exception": "Do not present the review's PROSPERO registration as GGE03 trial registration.", "criterion": "Retain the unverified trial-registration status and prespecified principal endpoint.", "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.", "condition_origin": "These existing in-house conditions concern GGE03 steamed ginger extract and VAS pain in mild knee osteoarthritis. They do not establish preregistration, official-tool certification or new independent clinical validation.", "proposed_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.", "current_reports": [ "R01", "R02" ], "existence": "Stored research/bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original manufacturing/support/harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific conditions/application records were read. Linked external abstracts, full texts, registration and planning material remain unread, with no access attempt.", "observation": "The 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.", "condition_status": "Unverified", "status_reason": "Original trial registration/plans were distinguished from review registration; comparison of the direct prespecified hierarchy remains unresolved.", "missingness": "Direct trial registration, protocol, SAP and reasons for hierarchy changes are unverified.", "uncertainty": "Unavailable registration does not establish non-registration or selective reporting.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "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." }, { "item_id": "N27", "question_type": "Evidence condition", "question": "Is there independent replication under the same GGE03 conditions?", "needed": "Independent trial families/teams matching formulation, population and 12-week VAS", "role": "Required", "role_reason": "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_exception": "Do not count two pain scales in one report as two independent trials.", "criterion": "Do not erase unverified replication under matching conditions by using the mixed review's trial count.", "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.", "condition_origin": "These existing in-house conditions concern GGE03 steamed ginger extract and VAS pain in mild knee osteoarthritis. They do not establish preregistration, official-tool certification or new independent clinical validation.", "proposed_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.", "current_reports": [ "R01", "R02" ], "existence": "Stored research/bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original manufacturing/support/harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific conditions/application records were read. Linked external abstracts, full texts, registration and planning material remain unread, with no access attempt.", "observation": "The original 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.", "condition_status": "Unverified", "status_reason": "Family/team information matching formulation, population, time point and outcome is unavailable.", "missingness": "Trials under matching conditions, team independence and trial-specific distributions are unverified.", "uncertainty": "Do not turn the review's trial count or two scales into a count of independent replications.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "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." }, { "item_id": "N28", "question_type": "Evidence condition", "question": "Does this answer comparisons between doses or formulations?", "needed": "Direct dose comparisons of the same GGE03 and correspondence between product and active amounts", "role": "Supplementary; required for a dose-superiority claim", "role_reason": "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_exception": "Do not arrange product amounts from different studies as a direct dose-response comparison.", "criterion": "Distinguish the current single-dose-level question from optimal-dose and generic-ginger conversion questions.", "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.", "condition_origin": "These existing in-house conditions concern GGE03 steamed ginger extract and VAS pain in mild knee osteoarthritis. They do not establish preregistration, official-tool certification or new independent clinical validation.", "proposed_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.", "current_reports": [ "R01", "R02" ], "existence": "Stored research/bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original manufacturing/support/harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific conditions/application records were read. Linked external abstracts, full texts, registration and planning material remain unread, with no access attempt.", "observation": "The current 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.", "condition_status": "Unverified", "status_reason": "The selected dose and extension to other products/doses are different questions.", "missingness": "Direct dose comparisons and correspondence between product/active amounts are unverified.", "uncertainty": "Do not use the mixed review or generic ginger to establish product-equivalent quantities.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "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." }, { "item_id": "N29", "question_type": "Evidence condition", "question": "Does the evidence cover persistence after 12 weeks or special populations?", "needed": "Post-treatment/long-term follow-up, prespecified subgroups and population-specific exposures/outcomes", "role": "Supplementary; required for persistence or extension", "role_reason": "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_exception": "Do not require all long-term trials for the narrow VAS question.", "criterion": "Separate the verified 12-week scope from unverified persistence and extension to other populations.", "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.", "condition_origin": "These existing in-house conditions concern GGE03 steamed ginger extract and VAS pain in mild knee osteoarthritis. They do not establish preregistration, official-tool certification or new independent clinical validation.", "proposed_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.", "current_reports": [ "R01" ], "existence": "Stored research/bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original manufacturing/support/harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific conditions/application records were read. Linked external abstracts, full texts, registration and planning material remain unread, with no access attempt.", "observation": "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.", "condition_status": "Partly verified", "status_reason": "The identified 12-week scope was distinguished from gaps in persistence and extension.", "missingness": "Direct post-treatment, long-term, prespecified-subgroup and special-population material is unverified.", "uncertainty": "Do not require every long-term study for the narrow VAS question.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "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." }, { "item_id": "N30", "question_type": "Evidence condition", "question": "Does pain improvement establish function, structural change or medication replacement?", "needed": "Direct VAS/K-WOMAC pain, function, cartilage/structural and NSAID-replacement outcomes", "role": "Supplementary; required for an extension claim", "role_reason": "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_exception": "Do not automatically require cartilage-event trials for the selected VAS question.", "criterion": "Separate pain scales from distinct clinical or structural outcomes.", "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.", "condition_origin": "These existing in-house conditions concern GGE03 steamed ginger extract and VAS pain in mild knee osteoarthritis. They do not establish preregistration, official-tool certification or new independent clinical validation.", "proposed_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.", "current_reports": [ "R01", "R02" ], "existence": "Stored research/bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original manufacturing/support/harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific conditions/application records were read. Linked external abstracts, full texts, registration and planning material remain unread, with no access attempt.", "observation": "The original scope note 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.", "condition_status": "Met", "status_reason": "The boundary between selected pain and distinct function, structure or medication-replacement questions was stated.", "missingness": "Direct outcomes for extension questions are unverified within this preservation scope.", "uncertainty": "Met here prevents overextension; it does not verify efficacy for the extended claims.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "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." }, { "item_id": "N31", "question_type": "Evidence condition", "question": "How were harms collected and denominators defined in the direct GGE03 trial?", "needed": "Adverse-event definitions/collection, group-specific events/denominators, withdrawals and 12-week exposure for the direct formulation", "role": "Supplementary; required for a safety claim", "role_reason": "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_exception": "Do not turn the mixed review's adverse-event withdrawal RR into individual GGE03 incidence.", "criterion": "Do not establish safety because the title includes safety or efficacy results exist.", "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.", "condition_origin": "These existing in-house conditions concern GGE03 steamed ginger extract and VAS pain in mild knee osteoarthritis. They do not establish preregistration, official-tool certification or new independent clinical validation.", "proposed_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.", "current_reports": [ "R01", "R02" ], "existence": "Stored research/bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original manufacturing/support/harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific conditions/application records were read. Linked external abstracts, full texts, registration and planning material remain unread, with no access attempt.", "observation": "The 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.", "condition_status": "Unverified", "status_reason": "No retained material verifies harm definitions, collection and denominators for the direct formulation.", "missingness": "Direct safety details are absent from the read summary; external full text remains unread.", "uncertainty": "Do not claim safety, 0 harms or direct-product applicability of the mixed review's RR.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "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." }, { "item_id": "N32", "question_type": "Evidence condition", "question": "What harm information does adverse-event withdrawal in the mixed review provide?", "needed": "Withdrawal definition, denominators and included trials for mixed-formulation review RR 2.33, interval 1.04 to 5.22", "role": "Supplementary", "role_reason": "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_exception": "Do not interpret withdrawal RR as the magnitude of all harms or a specific drug interaction.", "criterion": "Attribute the adverse-event withdrawal comparison to the review's scope and distinguish it from GGE03 event incidence.", "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.", "condition_origin": "These existing in-house conditions concern GGE03 steamed ginger extract and VAS pain in mild knee osteoarthritis. They do not establish preregistration, official-tool certification or new independent clinical validation.", "proposed_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.", "current_reports": [ "R02" ], "existence": "Stored research/bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original manufacturing/support/harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific conditions/application records were read. Linked external abstracts, full texts, registration and planning material remain unread, with no access attempt.", "observation": "The 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.", "condition_status": "Partly verified", "status_reason": "The withdrawal comparison is retained, but definitions, denominators and formulation-specific collection remain unresolved.", "missingness": "Review withdrawal definitions, denominators and trial-specific harm material are unverified.", "uncertainty": "Do not extend the withdrawal comparison to all harms or GGE03/drug-interaction incidence.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "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." }, { "item_id": "N33", "question_type": "Evidence condition", "question": "Were harm timing, discontinuation and follow-up losses verified?", "needed": "Harm occurrence, discontinuation/recovery and group-specific follow-up losses during 12-week exposure", "role": "Supplementary", "role_reason": "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_exception": "Do not infer improvement after discontinuation, rechallenge or 0 harms.", "criterion": "Separate the efficacy follow-up period from actual harm collection and event timing.", "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.", "condition_origin": "These existing in-house conditions concern GGE03 steamed ginger extract and VAS pain in mild knee osteoarthritis. They do not establish preregistration, official-tool certification or new independent clinical validation.", "proposed_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.", "current_reports": [ "R01", "R02" ], "existence": "Stored research/bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original manufacturing/support/harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific conditions/application records were read. Linked external abstracts, full texts, registration and planning material remain unread, with no access attempt.", "observation": "The current summary has no individual harm timing, discontinuation/recovery, rechallenge or group-specific harm follow-up losses within 12 weeks.", "condition_status": "Unverified", "status_reason": "The efficacy duration does not establish temporal sequence/recovery or completeness of harm collection.", "missingness": "Event timing, discontinuation causes, recovery and collection losses are unverified.", "uncertainty": "Do not infer temporal causation, improvement after discontinuation or rechallenge.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "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." }, { "item_id": "N34", "question_type": "Evidence condition", "question": "Were drug-interaction and vulnerable-population safety verified?", "needed": "Concomitant medication, baseline risks, interactions and harm material in other populations", "role": "Supplementary; required for the relevant safety claim", "role_reason": "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_exception": "Do not judge individual interactions from mixed oral-ginger withdrawal results alone.", "criterion": "Do not turn unverified long-term safety/interactions in the original into established safety or risk magnitude.", "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.", "condition_origin": "These existing in-house conditions concern GGE03 steamed ginger extract and VAS pain in mild knee osteoarthritis. They do not establish preregistration, official-tool certification or new independent clinical validation.", "proposed_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.", "current_reports": [ "R01", "R02" ], "existence": "Stored research/bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original manufacturing/support/harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific conditions/application records were read. Linked external abstracts, full texts, registration and planning material remain unread, with no access attempt.", "observation": "The original safety 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.", "condition_status": "Unverified", "status_reason": "The caution's scope was distinguished from actual verification of concomitant-treatment or vulnerable-population harms.", "missingness": "Interactions, concomitant medication and vulnerable-population exposure/event material are unverified.", "uncertainty": "Do not use the mixed withdrawal RR to judge a specific interaction magnitude or overall safety.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "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." }, { "item_id": "N35", "question_type": "Evidence condition", "question": "Were missing harm reports distinguished from absence of events?", "needed": "Collection, omissions and completeness of harm reporting in the direct trial and mixed review", "role": "Supplementary", "role_reason": "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_exception": "Do not claim non-reporting throughout an external paper whose full text was not read.", "criterion": "State that detailed safety tables are absent from the retained summary.", "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.", "condition_origin": "These existing in-house conditions concern GGE03 steamed ginger extract and VAS pain in mild knee osteoarthritis. They do not establish preregistration, official-tool certification or new independent clinical validation.", "proposed_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.", "current_reports": [ "R01", "R02" ], "existence": "Stored research/bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original manufacturing/support/harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific conditions/application records were read. Linked external abstracts, full texts, registration and planning material remain unread, with no access attempt.", "observation": "The retained 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.", "condition_status": "Unverified", "status_reason": "The absence is limited to the retained summary rather than extended to the entire original paper.", "missingness": "Safety details are absent from the summary; full texts and completeness of harm reporting remain unread.", "uncertainty": "Do not conclude that no harms occurred or the study is invalid.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "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." }, { "item_id": "N36", "question_type": "Evidence condition", "question": "What does the current material say about efficacy and harms?", "needed": "Reported formulation-specific significant improvement, mixed-review withdrawals and unverified boundaries", "role": "Required boundary", "role_reason": "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_exception": "Do not inherit historical C46/Caution labels or cross-check statements as new clinical certification.", "criterion": "Explain retained reports, gaps and applicability boundaries without creating a new efficacy/safety grade or dosing instruction.", "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.", "condition_origin": "These existing in-house conditions concern GGE03 steamed ginger extract and VAS pain in mild knee osteoarthritis. They do not establish preregistration, official-tool certification or new independent clinical validation.", "proposed_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.", "current_reports": [ "R01", "R02" ], "existence": "Stored research/bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original manufacturing/support/harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific conditions/application records were read. Linked external abstracts, full texts, registration and planning material remain unread, with no access attempt.", "observation": "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.", "condition_status": "Met", "status_reason": "The current table explains reports, gaps and applicability boundaries without creating a new efficacy/safety grade or dosing instruction.", "missingness": "Direct magnitude, intervals, prespecification, independence and complete safety remain unverified under the relevant conditions.", "uncertainty": "Model self-review and mechanical comparison are not independent clinical certification.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "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." } ], "reports": [ { "report_id": "R01", "title": "Kim et al. (2024): Effectiveness and safety of steamed ginger extract on mild osteoarthritis: a randomized, double-blind, placebo-controlled clinical trial", "url": "https://pubmed.ncbi.nlm.nih.gov/39212491/", "report_type": "Randomized double-blind placebo-controlled trial", "existence": "Stored research/bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original manufacturing/support/harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific conditions/application records were read. Linked external abstracts, full texts, registration and planning material remain unread, with no access attempt.", "study_family": "Direct GGE03 report. VAS and K-WOMAC are pain scales in the same trial, not separate independent replications.", "independent_replication": "Independent replication matching formulation, population, time point and endpoint, and unique study/participant counts, are unverified.", "observed_result": "Reported significant between-group improvement; exact between-group difference, 95% CI and P value unverified", "result_level": "These are reports and limitations in the retained summary, not results of new external-original reading or calculation.", "source_evidence_date": "2026-09-08", "materials": [ { "material_type": "Retained research/bibliographic summary", "public_status": "Retained existing summary acquired", "access_status": "Current retained local input acquired", "acquired": true, "actually_read": true, "as_of": "2026-10-06T09:34:52.631481+09:00", "qualification": "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." }, { "material_type": "External article abstract", "public_status": "External material; existence/public availability/acquisition separately unverified", "access_status": "Access not attempted; unread", "acquired": false, "actually_read": false, "as_of": "2026-10-06T09:34:52.631481+09:00", "qualification": "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." }, { "material_type": "External article full text", "public_status": "External material; existence/public availability/acquisition separately unverified", "access_status": "Full text not acquired; unread", "acquired": false, "actually_read": false, "as_of": "2026-10-06T09:34:52.631481+09:00", "qualification": "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." }, { "material_type": "Direct-trial registration original", "public_status": "External material; existence/public availability/acquisition separately unverified", "access_status": "Original registration unread", "acquired": false, "actually_read": false, "as_of": "2026-10-06T09:34:52.631481+09:00", "qualification": "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." }, { "material_type": "Protocol material needed (existence unverified)", "public_status": "External material; existence/public availability/acquisition separately unverified", "access_status": "Existence/public availability/acquisition unverified; unread", "acquired": false, "actually_read": false, "as_of": "2026-10-06T09:34:52.631481+09:00", "qualification": "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." }, { "material_type": "Statistical-analysis-plan material needed (existence unverified)", "public_status": "External material; existence/public availability/acquisition separately unverified", "access_status": "Existence/public availability/acquisition unverified; unread", "acquired": false, "actually_read": false, "as_of": "2026-10-06T09:34:52.631481+09:00", "qualification": "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." }, { "material_type": "Product specification/supply/support material needed", "public_status": "External material; existence/public availability/acquisition separately unverified", "access_status": "Existence/public availability/acquisition unverified; unread", "acquired": false, "actually_read": false, "as_of": "2026-10-06T09:34:52.631481+09:00", "qualification": "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." }, { "material_type": "Funding/employee-authorship/conflict material needed", "public_status": "External material; existence/public availability/acquisition separately unverified", "access_status": "Existence/public availability/acquisition unverified; unread", "acquired": false, "actually_read": false, "as_of": "2026-10-06T09:34:52.631481+09:00", "qualification": "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." } ], "links": [ { "label": "PubMed", "url": "https://pubmed.ncbi.nlm.nih.gov/39212491/" } ] }, { "report_id": "R02", "title": "Bartels et al. (2015): Efficacy and safety of ginger in osteoarthritis patients: a meta-analysis of randomized placebo-controlled trials", "url": "https://pubmed.ncbi.nlm.nih.gov/25300574/", "report_type": "Meta-analysis of randomized placebo-controlled trials", "existence": "Stored research/bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original manufacturing/support/harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific conditions/application records were read. Linked external abstracts, full texts, registration and planning material remain unread, with no access attempt.", "study_family": "Review of mixed oral-ginger formulations. Its 5 trials and 593 participants describe the included scope, not GGE03 independent replication or a unique-participant total.", "independent_replication": "The review's trial count is not converted into replication of the same GGE03 formulation. Overlap, study families and independent-team relationships are unverified.", "observed_result": "Pain SMD -0.30, 95% CI -0.50 to -0.09; adverse-event withdrawal RR 2.33, interval 1.04 to 5.22", "result_level": "These are mixed-formulation synthesis estimates in the retained summary, not direct GGE03 effects, incidence or new calculations.", "source_evidence_date": "2026-09-08", "materials": [ { "material_type": "Retained research/bibliographic summary", "public_status": "Retained existing summary acquired", "access_status": "Current retained local input acquired", "acquired": true, "actually_read": true, "as_of": "2026-10-06T09:34:52.631523+09:00", "qualification": "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." }, { "material_type": "External article abstract", "public_status": "External material; existence/public availability/acquisition separately unverified", "access_status": "Access not attempted; unread", "acquired": false, "actually_read": false, "as_of": "2026-10-06T09:34:52.631523+09:00", "qualification": "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." }, { "material_type": "External article full text", "public_status": "External material; existence/public availability/acquisition separately unverified", "access_status": "Full text not acquired; unread", "acquired": false, "actually_read": false, "as_of": "2026-10-06T09:34:52.631523+09:00", "qualification": "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." }, { "material_type": "Review-registration original", "public_status": "External material; existence/public availability/acquisition separately unverified", "access_status": "Original registration unread", "acquired": false, "actually_read": false, "as_of": "2026-10-06T09:34:52.631523+09:00", "qualification": "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." }, { "material_type": "Protocol material needed (existence unverified)", "public_status": "External material; existence/public availability/acquisition separately unverified", "access_status": "Existence/public availability/acquisition unverified; unread", "acquired": false, "actually_read": false, "as_of": "2026-10-06T09:34:52.631523+09:00", "qualification": "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." }, { "material_type": "Statistical-analysis-plan material needed (existence unverified)", "public_status": "External material; existence/public availability/acquisition separately unverified", "access_status": "Existence/public availability/acquisition unverified; unread", "acquired": false, "actually_read": false, "as_of": "2026-10-06T09:34:52.631523+09:00", "qualification": "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." } ], "links": [ { "label": "PubMed", "url": "https://pubmed.ncbi.nlm.nih.gov/25300574/" } ] } ], "method_sources": [ { "id": "M03", "version": "Cochrane Handbook 6.5 (2024), chapter updated 2023-08", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-03", "section": "§3.1, §3.2.1–3.2.3, MECIR C5/C7/C13", "official_principle": "Clearly record the question, eligibility conditions and reasons for changes, and distinguish variations in interventions.", "review_level": "Retained method-application records were reused. External originals were not reread and method content was not reassessed." }, { "id": "M04", "version": "Cochrane Handbook 6.5.1 (2025), chapter updated 2025-03", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-04", "section": "§4.5, §4.6.1–4.6.3, MECIR C42", "official_principle": "Distinguish studies from reports and link them; do not omit a study solely because results are unreported.", "review_level": "Retained method-application records were reused. External originals were not reread and method content was not reassessed." }, { "id": "M08", "version": "Cochrane Handbook 6.5 (2024), chapter updated 2019-10", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-08", "section": "§8.1–8.2.3, Table 8.2.a", "official_principle": "Define the outcome and effect of interest, then examine randomization, deviations, missing data, measurement and selective reporting.", "review_level": "Retained method-application records were reused. External originals were not reread and method content was not reassessed." }, { "id": "M15", "version": "Cochrane Handbook 6.5 (2024), chapter updated 2023-08", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-15", "section": "§15.2.4, §15.3.1–15.3.3", "official_principle": "Distinguish effect estimates, intervals, importance and applicability. Sample size alone does not determine precision.", "review_level": "Retained method-application records were reused. External originals were not reread and method content was not reassessed." }, { "id": "M19", "version": "Cochrane Handbook 6.5 (2024), chapter updated 2019-10", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-19", "section": "§19.1.2, §19.2.1–19.2.4", "official_principle": "Harm questions may require different designs, populations and follow-up from efficacy questions. Case reports do not establish incidence rates.", "review_level": "Retained method-application records were reused. External originals were not reread and method content was not reassessed." } ], "status_dictionary": { "Partly verified": "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." }, "study_overlap": { "state": "Unverified", "unique_trial_count": null, "unique_participant_count": null, "reason": "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." }, "history": [ { "date": "2026-10-25", "kind": "Separation of public-facing pages and materials", "view_version": "1.0", "change": "The public view and materials were prepared from the existing 36 items. No new clinical search, verification-state change or scoring was performed." } ], "language": "en", "translation_date": "2026-10-25" }