{
  "schema_version": "chamgap-public-criteria-1.0",
  "title": "500-mg dried ginger-powder capsules × Reduction of LDL cholesterol in adults",
  "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 type 2 diabetes population and 10-week endpoint comparison are being checked?",
      "needed": "Current LDL-C claim, Korean/English intervention/population details, oral powder 2 g/day, 10 weeks, comparator and independent boundary",
      "role": "Required",
      "role_reason": "Needed to read the original claim with the actual T2D and concomitant-medication contract",
      "application_exception": "Read the broad adult wording of the Korean claim alongside the T2D/concomitant-treatment scope. Retain only the main question without automatically generating independent claims for other endpoints or formulations.",
      "criterion": "Keep the LDL-C question distinct from other endpoints, formulations and populations and link it to the original location.",
      "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 dried ginger powder and a 10-week LDL-C comparison in adults with type 2 diabetes. They do not establish preregistration, official-tool certification or new independent clinical validation.",
      "proposed_research": "Material needed: Current LDL-C claim, Korean/English intervention/population details, oral powder 2 g/day, 10 weeks, comparator and independent boundary. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N02",
      "question_type": "Evidence condition",
      "question": "Is the same direct trial counted again in another endpoint table?",
      "needed": "Direct-trial PMID/PMC/DOI, bibliographic NCT, report title and LDL/HbA1c correspondence",
      "role": "Required",
      "role_reason": "Needed to avoid adding the same sample as a new independent trial in different endpoint tables",
      "application_exception": "Retain endpoint-specific results even when the endpoints use the same trial report. Table/report counts are not unique-trial counts.",
      "criterion": "Link matching report identifiers across the endpoints while retaining endpoint-specific estimates and avoiding certification of unique trials or participants.",
      "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 dried ginger powder and a 10-week LDL-C comparison in adults with type 2 diabetes. They do not establish preregistration, official-tool certification or new independent clinical validation.",
      "proposed_research": "Material needed: Direct-trial PMID/PMC/DOI, bibliographic NCT, report title and LDL/HbA1c correspondence. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N03",
      "question_type": "Evidence condition",
      "question": "How are matching review identifiers, different titles and included trials linked?",
      "needed": "Review PMID/PMC/DOI, record-specific bibliographic/title literals, included-trial table and endpoint contribution/overlap",
      "role": "Required",
      "role_reason": "Needed to avoid converting the same review into independent replication or exact bibliographic certification",
      "application_exception": "Do not harmonize record-specific study-title literals merely because bibliographic identifiers match. A missing included-trial table does not establish no overlap.",
      "criterion": "Retain the verification level for matching identifiers and different titles, distinguishing paper counts from unique-trial counts.",
      "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 dried ginger powder and a 10-week LDL-C comparison in adults with type 2 diabetes. They do not establish preregistration, official-tool certification or new independent clinical validation.",
      "proposed_research": "Material needed: Review PMID/PMC/DOI, record-specific bibliographic/title literals, included-trial table and endpoint contribution/overlap. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N04",
      "question_type": "Evidence condition",
      "question": "Which retained summaries and external originals were actually read?",
      "needed": "Retained summaries, bibliography/abstracts, full texts, access attempts and acquisition/reading records by material type",
      "role": "Required",
      "role_reason": "Needed to avoid upgrading original links into full-text reading records",
      "application_exception": "Acknowledge reading of retained summaries without labeling it full-text or registration reading. Unattempted external access is not inaccessibility.",
      "criterion": "Display actual reading of retained local summaries separately from unread external full texts/abstracts/registration and unattempted access.",
      "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 dried ginger powder and a 10-week LDL-C comparison in adults with type 2 diabetes. They do not establish preregistration, official-tool certification or new independent clinical validation.",
      "proposed_research": "Material needed: Retained summaries, bibliography/abstracts, full texts, access attempts and acquisition/reading records by material type. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N05",
      "question_type": "Evidence condition",
      "question": "Were registration, protocol and SAP actually acquired and compared?",
      "needed": "Bibliographic NCT string, original registration field, registration version/time and protocol/SAP originals",
      "role": "Required",
      "role_reason": "Needed to avoid treating a registration identifier as verification of a prespecified plan",
      "application_exception": "An NCT string does not establish completed acquisition/comparison of registration, protocol or SAP. Unacquired material is not described as nonregistration.",
      "criterion": "Distinguish historical registration narratives from the current level of retained bibliographic strings, leaving external comparison 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 dried ginger powder and a 10-week LDL-C comparison in adults with type 2 diabetes. They do not establish preregistration, official-tool certification or new independent clinical validation.",
      "proposed_research": "Material needed: Bibliographic NCT string, original registration field, registration version/time and protocol/SAP originals. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N06",
      "question_type": "Evidence condition",
      "question": "Who is the selected T2D population, including exclusions and baseline characteristics?",
      "needed": "Age/diagnosis, insulin/lipid medication, baseline LDL-C, eligibility and arm-specific characteristics of adults with type 2 diabetes maintaining oral glucose-lowering medication; a statin add-on population cannot be established",
      "role": "Required",
      "role_reason": "Needed to avoid extrapolating differences in study populations into efficacy for all adults",
      "application_exception": "Retain record-specific insulin/statin wording differences. Matching T2D labels do not authorize importing baseline/exclusion criteria from another record.",
      "criterion": "Link only the stated population, preserving record-specific nonuse-of-insulin/statin 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 dried ginger powder and a 10-week LDL-C comparison in adults with type 2 diabetes. They do not establish preregistration, official-tool certification or new independent clinical validation.",
      "proposed_research": "Material needed: Age/diagnosis, insulin/lipid medication, baseline LDL-C, eligibility and arm-specific characteristics of adults with type 2 diabetes maintaining oral glucose-lowering medication; a statin add-on population cannot be established. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N07",
      "question_type": "Evidence condition",
      "question": "What are the dried powder's composition, capsules and actual administered amount?",
      "needed": "Rhizome, 500 mg capsules, 2 g/day, dosing frequency, gingerol/shogaol assay and manufacturing/quality",
      "role": "Required",
      "role_reason": "Needed to avoid applying a formulation or dose directly to other products",
      "application_exception": "Nominal capsule powder quantity differs from gingerol/shogaol active-constituent assay. Unverified assay does not establish 0 active constituent or a defective product.",
      "criterion": "Distinguish nominal powder amount from active-constituent assay/actual adherence without treating foods or extracts as automatically equivalent.",
      "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 dried ginger powder and a 10-week LDL-C comparison in adults with type 2 diabetes. They do not establish preregistration, official-tool certification or new independent clinical validation.",
      "proposed_research": "Material needed: Rhizome, 500 mg capsules, 2 g/day, dosing frequency, gingerol/shogaol assay and manufacturing/quality. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N08",
      "question_type": "Evidence condition",
      "question": "What actually differed between placebo and existing treatment in the arms?",
      "needed": "Wheat-flour placebo, continued oral glucose-lowering medication, lipid-medication control and arm-specific concomitant treatment/changes",
      "role": "Required",
      "role_reason": "Needed to avoid attributing concomitant-treatment differences to powder alone",
      "application_exception": "Shared continuation of existing medication differs from control of arm-specific changes. Inadequate lipid-medication control does not determine success/failure of statin add-on or statin replacement.",
      "criterion": "Separate shared existing care from added ginger and do not convert the comparison into statin-add-on or medication-replacement efficacy.",
      "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 dried ginger powder and a 10-week LDL-C comparison in adults with type 2 diabetes. They do not establish preregistration, official-tool certification or new independent clinical validation.",
      "proposed_research": "Material needed: Wheat-flour placebo, continued oral glucose-lowering medication, lipid-medication control and arm-specific concomitant treatment/changes. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N09",
      "question_type": "Evidence condition",
      "question": "What is known about 10-week exposure, dosing schedule and post-treatment observation?",
      "needed": "10-week treatment, visits, exposure/adherence, post-treatment follow-up and time-specific results",
      "role": "Required",
      "role_reason": "Needed to avoid extending short treatment data into sustained long-term effects",
      "application_exception": "A 10-week treatment statement does not establish complete visits, actual adherence or post-treatment follow-up. Unverified long-term results do not erase the 10-week endpoint value.",
      "criterion": "Record the selected 10-week result separately from existence or uncertainty of withdrawal/long-term follow-up.",
      "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 dried ginger powder and a 10-week LDL-C comparison in adults with type 2 diabetes. They do not establish preregistration, official-tool certification or new independent clinical validation.",
      "proposed_research": "Material needed: 10-week treatment, visits, exposure/adherence, post-treatment follow-up and time-specific results. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N10",
      "question_type": "Evidence condition",
      "question": "Are the direct-trial LDL-C values final values, within-arm changes or between-arm differences?",
      "needed": "LDL-C result units, arm values/changes, adjusted between-arm estimate, comparison time and direction",
      "role": "Required",
      "role_reason": "Needed to avoid transferring numerically different analysis formats as the same effect",
      "application_exception": "Arm-specific final values or changes differ from adjusted between-arm effects. Do not subtract the values or derive exact change differences/CIs from the P value.",
      "criterion": "Preserve the original LDL-C result format without newly calculating unreported differences or adjusted effects.",
      "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 dried ginger powder and a 10-week LDL-C comparison in adults with type 2 diabetes. They do not establish preregistration, official-tool certification or new independent clinical validation.",
      "proposed_research": "Material needed: LDL-C result units, arm values/changes, adjusted between-arm estimate, comparison time and direction. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N11",
      "question_type": "Evidence condition",
      "question": "What does the review's pooled LDL-C estimate, CI and I² refer to?",
      "needed": "Endpoint-specific MD, units, CI, I², contributing trials/populations/formulations and analysis model",
      "role": "Required",
      "role_reason": "Needed to avoid extending a review average into guaranteed effects for an identical product",
      "application_exception": "The review's overall paper count is not its endpoint-specific contributing-trial count or same-product trial count. Do not turn a pooled estimate into direct-trial arm values or guaranteed personal effects.",
      "criterion": "Attribute pooled values to their endpoint/question without using them as expected effects for a particular product or person.",
      "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 dried ginger powder and a 10-week LDL-C comparison in adults with type 2 diabetes. They do not establish preregistration, official-tool certification or new independent clinical validation.",
      "proposed_research": "Material needed: Endpoint-specific MD, units, CI, I², contributing trials/populations/formulations and analysis model. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N12",
      "question_type": "Evidence condition",
      "question": "Is the table's selected endpoint the same as the registered primary (1st)/secondary (2nd) hierarchy?",
      "needed": "The selected-endpoint field's role, the direct trial's registered endpoints, NF-κB and article/plan comparison",
      "role": "Required",
      "role_reason": "Needed to avoid deriving original-trial primary (1st) success/failure from a field name alone",
      "application_exception": "The selected-endpoint field is the table's selection key. Do not relabel registered secondary (2nd) status as co-primary (1st) or as an invalid primary (1st) trial.",
      "criterion": "Do not promote the selected measure into the registered primary (1st) endpoint; retain the reported secondary (2nd) status and unperformed comparison.",
      "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 dried ginger powder and a 10-week LDL-C comparison in adults with type 2 diabetes. They do not establish preregistration, official-tool certification or new independent clinical validation.",
      "proposed_research": "Material needed: The selected-endpoint field's role, the direct trial's registered endpoints, NF-κB and article/plan comparison. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N13",
      "question_type": "Evidence condition",
      "question": "What are the randomized, analyzed and completed denominators and the arm mapping of 23/22?",
      "needed": "50 randomized, 45 analyzed, arm/endpoint denominators, arm mapping and completion/flow diagram",
      "role": "Required",
      "role_reason": "Needed to avoid duplication or misattribution of denominator roles and shared participants",
      "application_exception": "Distinguish 50 randomized from 45 analyzed. Do not infer the ginger/placebo order of 23/22 or the completion denominator when unstated.",
      "criterion": "Distinguish each reported denominator without inferring ginger/placebo mapping or completion from 23/22.",
      "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 dried ginger powder and a 10-week LDL-C comparison in adults with type 2 diabetes. They do not establish preregistration, official-tool certification or new independent clinical validation.",
      "proposed_research": "Material needed: 50 randomized, 45 analyzed, arm/endpoint denominators, arm mapping and completion/flow diagram. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N14",
      "question_type": "Evidence condition",
      "question": "Were missingness, dropout reasons and ITT/PP handling verified?",
      "needed": "Participant flow, arm-specific missingness/dropout, analysis exclusion and ITT/PP/imputation",
      "role": "Required",
      "role_reason": "Needed to avoid treating analyzed participant counts as proof of no missingness",
      "application_exception": "Do not calculate the randomized/analyzed difference as a dropout/discontinuation count. Missing handling information does not establish ITT, PP or no missingness.",
      "criterion": "Report the distinction between randomized and analyzed participants without calculating dropout/completion or naming the analysis method.",
      "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 dried ginger powder and a 10-week LDL-C comparison in adults with type 2 diabetes. They do not establish preregistration, official-tool certification or new independent clinical validation.",
      "proposed_research": "Material needed: Participant flow, arm-specific missingness/dropout, analysis exclusion and ITT/PP/imputation. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N15",
      "question_type": "Evidence condition",
      "question": "Are the direct trial's SD, SE, CI and exact between-arm estimates distinguished?",
      "needed": "LDL-C original tables, variance definitions, exact change differences/adjusted effects, CIs and arm denominators",
      "role": "Required",
      "role_reason": "Needed to avoid establishing effect precision from P values or sample sizes alone",
      "application_exception": "Retain the original ± notation if SD/SE definitions are unavailable. Missing CIs do not justify an arbitrary precision score or effect 0.",
      "criterion": "Separate reported values from unverified precision without calculating missing CIs or variance definitions.",
      "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 dried ginger powder and a 10-week LDL-C comparison in adults with type 2 diabetes. They do not establish preregistration, official-tool certification or new independent clinical validation.",
      "proposed_research": "Material needed: LDL-C original tables, variance definitions, exact change differences/adjusted effects, CIs and arm denominators. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N16",
      "question_type": "Evidence condition",
      "question": "Were favorable, null and contrary endpoint results kept within their original questions?",
      "needed": "Direct/pooled endpoint results, original counterarguments and other-endpoint scope",
      "role": "Required",
      "role_reason": "Needed to avoid erasing material gaps by selecting favorable results",
      "application_exception": "Preserve counterarguments from other endpoints/analyses as relevant context. Their values do not erase uncertainty in the selected endpoint.",
      "criterion": "Retain related positive, nonsignificant and differing results without substituting other endpoints for the selected endpoint's efficacy.",
      "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 dried ginger powder and a 10-week LDL-C comparison in adults with type 2 diabetes. They do not establish preregistration, official-tool certification or new independent clinical validation.",
      "proposed_research": "Material needed: Direct/pooled endpoint results, original counterarguments and other-endpoint scope. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N17",
      "question_type": "Evidence condition",
      "question": "How are nonsignificance, heterogeneity and decimal differences interpreted?",
      "needed": "Reported P values, inclusion of 0, CIs, rounded I² and different analysis conditions",
      "role": "Required",
      "role_reason": "Needed to avoid conflating different limitations with the same failure or conflict",
      "application_exception": "Nonsignificance does not prove equivalence/effect 0. Rounded I² and different review estimates require comparison of endpoint/analysis contracts before judging conflict.",
      "criterion": "Do not convert nonsignificance into effect 0/equivalence or automatically label rounding/different-analysis values as data conflicts.",
      "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 dried ginger powder and a 10-week LDL-C comparison in adults with type 2 diabetes. They do not establish preregistration, official-tool certification or new independent clinical validation.",
      "proposed_research": "Material needed: Reported P values, inclusion of 0, CIs, rounded I² and different analysis conditions. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N18",
      "question_type": "Evidence condition",
      "question": "What are the limits of historical search/review narratives and currently acquired reports?",
      "needed": "Current research/bibliographic summaries 2, historical year/trial-count narratives, search sources/strategies, selection and included-study tables",
      "role": "Required",
      "role_reason": "Needed to avoid conflating absence of literature with work not performed",
      "application_exception": "Historical claims of reviewing studies do not record new original acquisition beyond the current 2 reports. An unperformed search does not mean 0 human studies.",
      "criterion": "Retain historical search/review narratives while separating missing current source locations from the absence of a new search.",
      "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 dried ginger powder and a 10-week LDL-C comparison in adults with type 2 diabetes. They do not establish preregistration, official-tool certification or new independent clinical validation.",
      "proposed_research": "Material needed: Current research/bibliographic summaries 2, historical year/trial-count narratives, search sources/strategies, selection and included-study tables. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N19",
      "question_type": "Evidence condition",
      "question": "How are the original verdict date, correction date and actual current reading date distinguished?",
      "needed": "Original verification date, correction date, current conversion-review date, input hashes and revision links",
      "role": "Required",
      "role_reason": "Needed to avoid presenting historical verification as a new current-literature review",
      "application_exception": "Original verification/correction dates are historical values. The current date is retained-material conversion review, without issuing a new evidence cutoff/external-reading date.",
      "criterion": "Do not reuse historical dates as current external full-text reading dates; state the scope of retained-material review.",
      "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 dried ginger powder and a 10-week LDL-C comparison in adults with type 2 diabetes. They do not establish preregistration, official-tool certification or new independent clinical validation.",
      "proposed_research": "Material needed: Original verification date, correction date, current conversion-review date, input hashes and revision links. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N20",
      "question_type": "Evidence condition",
      "question": "What does university support and capsule purchasing establish about direct-trial independence?",
      "needed": "TUMS28653 support, product purchasing/provision, employee authors, patents, declared COI and institutions/teams",
      "role": "Supplementary; required for an independence claim",
      "role_reason": "Needed to avoid establishing overall independence from a single funding item",
      "application_exception": "University funding and capsule purchasing differ from product provision, employment, patents and COI. Do not inherit the historical independence axis as certification of independent replication.",
      "criterion": "Retain reported funding without using unverified product/authorship/conflict details as proof of independent replication or no bias.",
      "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 dried ginger powder and a 10-week LDL-C comparison in adults with type 2 diabetes. They do not establish preregistration, official-tool certification or new independent clinical validation.",
      "proposed_research": "Material needed: TUMS28653 support, product purchasing/provision, employee authors, patents, declared COI and institutions/teams. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N21",
      "question_type": "Evidence condition",
      "question": "How do review funding and author COI differ from included-trial independence?",
      "needed": "Review funding/COI, funding of each included trial, research teams/products and overlap",
      "role": "Supplementary; required for an independence claim",
      "role_reason": "Needed to avoid transferring review support into independence of all contributing trials",
      "application_exception": "Review COI/funding and included-trial funding are considered separately. A no-conflict declaration alone does not establish absence of product/included-trial bias.",
      "criterion": "Separate review declarations from mixed original-trial funding without certifying papers as unique independent teams.",
      "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 dried ginger powder and a 10-week LDL-C comparison in adults with type 2 diabetes. They do not establish preregistration, official-tool certification or new independent clinical validation.",
      "proposed_research": "Material needed: Review funding/COI, funding of each included trial, research teams/products and overlap. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N22",
      "question_type": "Evidence condition",
      "question": "Were allocation, concealment and baseline balance verified beyond the randomized/double-blind label?",
      "needed": "Parallel/crossover/cluster design, random sequence, concealment, baseline tables and blinding",
      "role": "Required",
      "role_reason": "Needed to avoid treating a design label as resolution of allocation and confounding problems",
      "application_exception": "The randomized/double-blind label does not verify sequence, concealment or baseline balance. Unverified design does not automatically make crossover/cluster considerations not applicable.",
      "criterion": "Separate the RCT label from unverified details; do not arbitrarily mark crossover/cluster considerations not applicable when the design is 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 dried ginger powder and a 10-week LDL-C comparison in adults with type 2 diabetes. They do not establish preregistration, official-tool certification or new independent clinical validation.",
      "proposed_research": "Material needed: Parallel/crossover/cluster design, random sequence, concealment, baseline tables and blinding. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N23",
      "question_type": "Evidence condition",
      "question": "Could concomitant medication, adherence, rescue care and arm-specific changes affect the estimate?",
      "needed": "Glucose/lipid medication types, arm changes, diet/activity, adherence, rescue care and estimand",
      "role": "Required",
      "role_reason": "Needed to avoid attributing changes in other treatments to added ginger",
      "application_exception": "Continuation of existing oral medication does not establish identical arm changes, adherence, diet or rescue care. Do not require that all changes must be identical.",
      "criterion": "Distinguish a continuation-of-medication statement from unverified arm-specific changes and adherence.",
      "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 dried ginger powder and a 10-week LDL-C comparison in adults with type 2 diabetes. They do not establish preregistration, official-tool certification or new independent clinical validation.",
      "proposed_research": "Material needed: Glucose/lipid medication types, arm changes, diet/activity, adherence, rescue care and estimand. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N24",
      "question_type": "Evidence condition",
      "question": "How, when and under what blinding was LDL-C measured?",
      "needed": "LDL-C assay/units, sampling conditions, baseline/10-week visits, measurement error and assessor blinding",
      "role": "Required",
      "role_reason": "Needed to avoid conflating measurement differences with actual outcome differences",
      "application_exception": "An endpoint name and units do not verify the assay, sampling/visit times or assessor blinding. Even an objective assay requires separate assessment of measurement limitations.",
      "criterion": "Separate the nominal endpoint/units from unverified assay details.",
      "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.",
      "condition_origin": "These existing in-house conditions concern dried ginger powder and a 10-week LDL-C comparison in adults with type 2 diabetes. They do not establish preregistration, official-tool certification or new independent clinical validation.",
      "proposed_research": "Material needed: LDL-C assay/units, sampling conditions, baseline/10-week visits, measurement error and assessor blinding. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N25",
      "question_type": "Evidence condition",
      "question": "What is the direct trial's estimand and analysis model?",
      "needed": "Assignment/adherence effects, covariates, ITT/PP, within/between-arm analysis, change/final values and model",
      "role": "Required",
      "role_reason": "Needed to distinguish arm-specific values from the actual analysis estimand",
      "application_exception": "Classify only the reported final/change format. If the estimand is unverified, do not assign assignment/adherence effects or ITT/PP.",
      "criterion": "Explain only the reported result format; absent analysis methods are not filled with adjusted estimates or ITT.",
      "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 dried ginger powder and a 10-week LDL-C comparison in adults with type 2 diabetes. They do not establish preregistration, official-tool certification or new independent clinical validation.",
      "proposed_research": "Material needed: Assignment/adherence effects, covariates, ITT/PP, within/between-arm analysis, change/final values and model. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N26",
      "question_type": "Evidence condition",
      "question": "Can the CI be interpreted alongside a justified important difference?",
      "needed": "Direct/pooled CIs, endpoint-specific variance, justified clinically important difference and interpretation contract",
      "role": "Required",
      "role_reason": "Needed to avoid upgrading statistical signals into clinical importance or a new grade",
      "application_exception": "P values, sample sizes or review paper counts alone do not establish sufficient precision or clinical importance. Do not adopt arbitrary minimum participant, duration or difference thresholds.",
      "criterion": "Retain the scope of reported intervals and unverified importance criteria; do not judge sufficiency using arbitrary minimum samples, duration or differences.",
      "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.",
      "condition_origin": "These existing in-house conditions concern dried ginger powder and a 10-week LDL-C comparison in adults with type 2 diabetes. They do not establish preregistration, official-tool certification or new independent clinical validation.",
      "proposed_research": "Material needed: Direct/pooled CIs, endpoint-specific variance, justified clinically important difference and interpretation contract. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N27",
      "question_type": "Evidence condition",
      "question": "Was the prespecified endpoint, timing and analysis compared with actual reporting?",
      "needed": "Original registration versions, protocol, SAP, article tables/change reasons and endpoint-specific plans",
      "role": "Required",
      "role_reason": "Needed to expose missing material for assessing selection of favorable analyses",
      "application_exception": "Separate historical registration-endpoint narratives from actual planning comparison in this work. Unacquired plans do not establish confirmed selective reporting.",
      "criterion": "Retain reported secondary (2nd) status and unperformed comparison without converting unavailable plans into confirmed nonregistration/selective reporting.",
      "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 dried ginger powder and a 10-week LDL-C comparison in adults with type 2 diabetes. They do not establish preregistration, official-tool certification or new independent clinical validation.",
      "proposed_research": "Material needed: Original registration versions, protocol, SAP, article tables/change reasons and endpoint-specific plans. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N28",
      "question_type": "Evidence condition",
      "question": "Was the result replicated in independent families with the same formulation, dose and population?",
      "needed": "Trial/family-specific formulation, dose, duration, population, concomitant medication, result distributions and overlap",
      "role": "Required",
      "role_reason": "Needed to avoid converting review paper counts/averages into same-product replication",
      "application_exception": "Do not assume that the representative direct trial is included in the review and add it as new independent replication. A mixed-formulation/population review does not certify replication of the same 500 mg capsules at 2 g/day.",
      "criterion": "Do not label the representative trial and mixed review as independent replication of an identical formulation; retain condition differences and unverified direct replication.",
      "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 dried ginger powder and a 10-week LDL-C comparison in adults with type 2 diabetes. They do not establish preregistration, official-tool certification or new independent clinical validation.",
      "proposed_research": "Material needed: Trial/family-specific formulation, dose, duration, population, concomitant medication, result distributions and overlap. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N29",
      "question_type": "Evidence condition",
      "question": "Can direct comparisons of doses/products identify an optimal amount?",
      "needed": "Direct dose/product comparison, active-constituent assay, dose response/interactions and independent estimates",
      "role": "Supplementary; required for a dose/product extension",
      "role_reason": "Needed to avoid extending a trial dose into an individual's optimal intake",
      "application_exception": "A trial's 2 g/day does not establish optimal dosage or equivalent-product efficacy. Unverified direct dose comparisons do not automatically suspend the narrow question.",
      "criterion": "Do not call the selected 2 g/day optimal or equivalent to other products. Missing direct comparison does not erase the narrow 10-week result.",
      "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 dried ginger powder and a 10-week LDL-C comparison in adults with type 2 diabetes. They do not establish preregistration, official-tool certification or new independent clinical validation.",
      "proposed_research": "Material needed: Direct dose/product comparison, active-constituent assay, dose response/interactions and independent estimates. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N30",
      "question_type": "Evidence condition",
      "question": "Were persistence after withdrawal and results beyond 10 weeks verified?",
      "needed": "Follow-up beyond 10 weeks/after withdrawal, repeated measurements, time-specific results and separate comparisons",
      "role": "Supplementary; required for a long-term extension",
      "role_reason": "Needed to avoid extending short-term values into long-term maintenance or suppressed progression",
      "application_exception": "Short-term endpoints and post-treatment persistence/long-term results are separate questions. Unverified long-term material does not establish no long-term effect.",
      "criterion": "Separate 10-week material from long-term persistence questions and retain unverified long-term 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 dried ginger powder and a 10-week LDL-C comparison in adults with type 2 diabetes. They do not establish preregistration, official-tool certification or new independent clinical validation.",
      "proposed_research": "Material needed: Follow-up beyond 10 weeks/after withdrawal, repeated measurements, time-specific results and separate comparisons. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N31",
      "question_type": "Evidence condition",
      "question": "Were baseline, medication and special-population subgroup effects separately verified?",
      "needed": "Prespecified subgroups, interactions, baseline measures/medication/insulin, and separate denominators/estimates in older adults or kidney disease",
      "role": "Supplementary; required for a subgroup extension",
      "role_reason": "Needed to avoid extending a selected-population main effect into special-population efficacy",
      "application_exception": "Subgroup estimates require prespecification, interaction assessment and arm-specific denominators. Do not infer insulin, older-adult, kidney-disease or complex-medication information from a small-sample main effect.",
      "criterion": "Do not apply nominal T2D results to all populations; preserve the original population wording and unverified subgroup 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 dried ginger powder and a 10-week LDL-C comparison in adults with type 2 diabetes. They do not establish preregistration, official-tool certification or new independent clinical validation.",
      "proposed_research": "Material needed: Prespecified subgroups, interactions, baseline measures/medication/insulin, and separate denominators/estimates in older adults or kidney disease. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N32",
      "question_type": "Evidence condition",
      "question": "Does LDL-C change answer clinical-event or medication-replacement questions?",
      "needed": "Distinguish endpoint changes from cardiovascular events, diabetes complications/remission, quality of life and medication reduction",
      "role": "Supplementary; required for a clinical-event extension",
      "role_reason": "Needed to avoid combining surrogate measures and patient clinical outcomes into the same claim",
      "application_exception": "Retain the numerical-endpoint comparison itself. Do not automatically substitute endpoint values for events/complications/remission or medication discontinuation, or require event trials as a prerequisite for endpoint values.",
      "criterion": "Do not transfer a narrow endpoint result into event prevention, remission or medication replacement. Do not make event trials mandatory for the endpoint result.",
      "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 dried ginger powder and a 10-week LDL-C comparison in adults with type 2 diabetes. They do not establish preregistration, official-tool certification or new independent clinical validation.",
      "proposed_research": "Material needed: Distinguish endpoint changes from cardiovascular events, diabetes complications/remission, quality of life and medication reduction. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N33",
      "question_type": "Evidence condition",
      "question": "What is known about actual adverse events, withdrawal and denominators for the same exposure?",
      "needed": "Arm-specific harms, definitions/collection, denominators/duration, withdrawal and separation from efficacy denominators",
      "role": "Supplementary; required for a safety claim",
      "role_reason": "Needed to avoid treating available efficacy material as verified safety",
      "application_exception": "Caution wording differs from actual adverse-event collection. Do not reuse efficacy denominators for harm incidence or fill missing event/withdrawal counts with 0.",
      "criterion": "Separate existing caution wording from actual harm counts; unverified information is not safety or absence of events.",
      "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 dried ginger powder and a 10-week LDL-C comparison in adults with type 2 diabetes. They do not establish preregistration, official-tool certification or new independent clinical validation.",
      "proposed_research": "Material needed: Arm-specific harms, definitions/collection, denominators/duration, withdrawal and separation from efficacy denominators. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N34",
      "question_type": "Evidence condition",
      "question": "What is known about medication interactions, rare/long-term harms and special populations?",
      "needed": "Original hypoglycemia/gastrointestinal, anticoagulant/antiplatelet, concomitant-treatment, long-term/vulnerable-population harm material",
      "role": "Supplementary; required for a harm extension",
      "role_reason": "Needed to separate general cautions from actually observed harms",
      "application_exception": "Do not display possible-interaction cautions as observed causal interactions. Do not extend 10-week efficacy material into certification of rare/long-term harms or vulnerable-population safety.",
      "criterion": "Retain only the original caution level without certifying causal interactions, incidence or long-term safety.",
      "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 dried ginger powder and a 10-week LDL-C comparison in adults with type 2 diabetes. They do not establish preregistration, official-tool certification or new independent clinical validation.",
      "proposed_research": "Material needed: Original hypoglycemia/gastrointestinal, anticoagulant/antiplatelet, concomitant-treatment, long-term/vulnerable-population harm material. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N35",
      "question_type": "Evidence condition",
      "question": "How are actual generic English wording and historical English corrections preserved?",
      "needed": "Specific Korean results, generic English fields, full correction originals, currently selected original and authority for translation changes",
      "role": "Required",
      "role_reason": "Needed to avoid conflating a reported correction with actual current content",
      "application_exception": "A correction record does not prove current specific English exists. Retain specific Korean values and generic English wording separately; translation/criteria correction requires a separate authorized event.",
      "criterion": "Retain both current English literals and historical correction reports without inferring specific English exists or performing a correction of the original translation in this work.",
      "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 dried ginger powder and a 10-week LDL-C comparison in adults with type 2 diabetes. They do not establish preregistration, official-tool certification or new independent clinical validation.",
      "proposed_research": "Material needed: Specific Korean results, generic English fields, full correction originals, currently selected original and authority for translation changes. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N36",
      "question_type": "Evidence condition",
      "question": "How is the bibliographic NCT string distinguished from the unverified original registration field?",
      "needed": "Direct bibliographic NCT, original registration value, external registration identity/version and comparison history",
      "role": "Required",
      "role_reason": "Needed to preserve different states for exact bibliographic links and planning comparison",
      "application_exception": "An unverified original registration field and a bibliographic NCT string are different verification levels. Do not replace them with a convenient single value or add a completed-registration-reading badge.",
      "criterion": "Separate string existence from registration-content verification without arbitrarily harmonizing the original registration field.",
      "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 dried ginger powder and a 10-week LDL-C comparison in adults with type 2 diabetes. They do not establish preregistration, official-tool certification or new independent clinical validation.",
      "proposed_research": "Material needed: Direct bibliographic NCT, original registration value, external registration identity/version and comparison history. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N37",
      "question_type": "Evidence condition",
      "question": "Were the existing C50, all axes, original dates/URLs and historical review labels retained?",
      "needed": "Grade/score/safety, boolean/empty axis values, Korean/English historical values, corrections, URL and original verification date",
      "role": "Required",
      "role_reason": "Needed to distinguish preservation of the original verdict from current gap-map statuses",
      "application_exception": "Retain the existing grade/score, false/blank axis values, original URLs and dates. Do not display historical Codex independent cross-checks as current independent clinical validation.",
      "criterion": "Preserve the whole original exactly without inheriting historical scores, axes or verification wording as current condition status, new conclusions or clinical certification.",
      "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 dried ginger powder and a 10-week LDL-C comparison in adults with type 2 diabetes. They do not establish preregistration, official-tool certification or new independent clinical validation.",
      "proposed_research": "Material needed: Grade/score/safety, boolean/empty axis values, Korean/English historical values, corrections, URL and original verification date. This records needed materials; no new research was executed."
    }
  ]
}