{
  "schema_version": "chamgap-public-criteria-1.0",
  "title": "Steamed ginger extract GGE03, 0.48 g/day × Reduction of pain in mild knee osteoarthritis",
  "language": "en",
  "translation_date": "2026-10-25",
  "criteria_version": "1.1",
  "criteria_date": "2026-10-06",
  "condition_origin": "Chamgap's own application conditions",
  "method_sources": [
    {
      "id": "M03",
      "version": "Cochrane Handbook 6.5 (2024), chapter updated 2023-08",
      "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-03",
      "section": "§3.1, §3.2.1–3.2.3, MECIR C5/C7/C13",
      "official_principle": "Clearly record the question, eligibility conditions and reasons for changes, and distinguish variations in interventions.",
      "review_level": "Retained method-application records were reused. External originals were not reread and method content was not reassessed."
    },
    {
      "id": "M04",
      "version": "Cochrane Handbook 6.5.1 (2025), chapter updated 2025-03",
      "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-04",
      "section": "§4.5, §4.6.1–4.6.3, MECIR C42",
      "official_principle": "Distinguish studies from reports and link them; do not omit a study solely because results are unreported.",
      "review_level": "Retained method-application records were reused. External originals were not reread and method content was not reassessed."
    },
    {
      "id": "M08",
      "version": "Cochrane Handbook 6.5 (2024), chapter updated 2019-10",
      "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-08",
      "section": "§8.1–8.2.3, Table 8.2.a",
      "official_principle": "Define the outcome and effect of interest, then examine randomization, deviations, missing data, measurement and selective reporting.",
      "review_level": "Retained method-application records were reused. External originals were not reread and method content was not reassessed."
    },
    {
      "id": "M15",
      "version": "Cochrane Handbook 6.5 (2024), chapter updated 2023-08",
      "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-15",
      "section": "§15.2.4, §15.3.1–15.3.3",
      "official_principle": "Distinguish effect estimates, intervals, importance and applicability. Sample size alone does not determine precision.",
      "review_level": "Retained method-application records were reused. External originals were not reread and method content was not reassessed."
    },
    {
      "id": "M19",
      "version": "Cochrane Handbook 6.5 (2024), chapter updated 2019-10",
      "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-19",
      "section": "§19.1.2, §19.2.1–19.2.4",
      "official_principle": "Harm questions may require different designs, populations and follow-up from efficacy questions. Case reports do not establish incidence rates.",
      "review_level": "Retained method-application records were reused. External originals were not reread and method content was not reassessed."
    }
  ],
  "status_dictionary": {
    "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."
  },
  "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."
    },
    {
      "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."
    },
    {
      "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."
    },
    {
      "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."
    },
    {
      "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."
    },
    {
      "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."
    },
    {
      "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."
    },
    {
      "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."
    },
    {
      "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."
    },
    {
      "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."
    },
    {
      "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."
    },
    {
      "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."
    },
    {
      "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."
    },
    {
      "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."
    },
    {
      "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."
    },
    {
      "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."
    },
    {
      "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."
    },
    {
      "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."
    },
    {
      "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."
    },
    {
      "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."
    },
    {
      "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."
    },
    {
      "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."
    },
    {
      "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."
    },
    {
      "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."
    },
    {
      "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."
    },
    {
      "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."
    },
    {
      "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."
    },
    {
      "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."
    },
    {
      "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."
    },
    {
      "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."
    },
    {
      "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."
    },
    {
      "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."
    },
    {
      "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."
    },
    {
      "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."
    },
    {
      "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."
    },
    {
      "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."
    }
  ]
}