{ "schema_version": "chamgap-public-criteria-1.0", "title": "500-mg dried ginger-powder capsules × Reduction of office systolic blood pressure in adults with metabolic syndrome", "language": "en", "translation_date": "2026-10-25", "criteria_version": "1.0", "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 question does this table check?", "needed": "The comparison of between-group office SBP change in adults with metabolic syndrome not using antihypertensives: dried-powder 500 mg capsules at 2 g/day for 12 weeks versus starch placebo plus the same lifestyle counseling", "role": "Required", "role_reason": "Needed to avoid combining ginger in general, other formulations, populations and endpoints into a single efficacy status", "application_exception": "Meta-analysis averages, DBP, ambulatory blood pressure and endothelial function do not replace this selected question", "criterion": "Link the original Korean claim and both languages' population/intervention details to a single population, formulation, dose, 12-week period and placebo comparison, and record excluded extensions", "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 12-week office SBP comparison in adults with metabolic syndrome who were not using antihypertensives. They do not establish preregistration, official-tool certification or new independent clinical validation.", "proposed_research": "Material needed: If the boundary changes, an original report specifying the population, endpoint, formulation, comparison and timing. This records needed materials; no new research was executed." }, { "item_id": "N02", "question_type": "Evidence condition", "question": "Have direct and meta-analysis reports been kept from being double-counted as independent replications?", "needed": "The identities of the Rahimlou 2019 direct report and Karimi 2026 synthesis, the included-trial table, and whether the direct trial was included", "role": "Required", "role_reason": "Needed to avoid converting 2 reports and the meta-analysis's 12 RCTs and 13 effects into a count of unique replications", "application_exception": "When included-trial tables and registration are unavailable, retain provisional report identities and unverified overlap", "criterion": "Link the 2 retained reports and their bibliographies, distinguish 12 RCTs from 13 effects, and leave unique study and participant counts unconfirmed", "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 12-week office SBP comparison in adults with metabolic syndrome who were not using antihypertensives. They do not establish preregistration, official-tool certification or new independent clinical validation.", "proposed_research": "Material needed: The meta-analysis included-trial/effect mapping table, registration, and a list of related direct-trial reports. This records needed materials; no new research was executed." }, { "item_id": "N03", "question_type": "Evidence condition", "question": "What is the scope of the diabetes-only −1.62 mmHg reference without a bibliography?", "needed": "Check the value in the Korean/English counterview and counterpoint, and whether a separate bibliography, design, population, denominator and CI are linked", "role": "Required", "role_reason": "Needed to avoid inventing an unidentified background reference as a newly verified report or direct replication", "application_exception": "Retain the current wording without creating S03 for an unidentified meta-analysis", "criterion": "Retain −1.62 as background and record the limited fact that the current research/citation summaries contain only 2 reports without a separate identity for the diabetes analysis", "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 12-week office SBP comparison in adults with metabolic syndrome who were not using antihypertensives. They do not establish preregistration, official-tool certification or new independent clinical validation.", "proposed_research": "Material needed: The actual bibliography, included-trial table and original result location for the diabetes-only analysis. This records needed materials; no new research was executed." }, { "item_id": "N04", "question_type": "Evidence condition", "question": "Which materials were actually read, and which remain unread?", "needed": "The existence, access, acquisition, reading levels and links for the current retained summary and external index, DOI, PMC, registration and supplements", "role": "Required", "role_reason": "Needed to avoid treating the existence of a URL or PMCID as reading the original full text", "application_exception": "Access not attempted is not inaccessibility; do not create registration or supplement links without an exact location", "criterion": "Link both local report summaries to the locations read and separately record unverified external material, unread status and access not attempted", "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 12-week office SBP comparison in adults with metabolic syndrome who were not using antihypertensives. They do not establish preregistration, official-tool certification or new independent clinical validation.", "proposed_research": "Material needed: Actual responses, acquired original bytes, versions, reading dates and exact links for each material. This records needed materials; no new research was executed." }, { "item_id": "N05", "question_type": "Evidence condition", "question": "Which adults with metabolic syndrome were studied, and how far does applicability extend?", "needed": "Diagnosis, eligibility and exclusion criteria, age, setting, baseline SBP, medication use and characteristics by group", "role": "Required", "role_reason": "Needed to avoid converting a population not using antihypertensives with baseline SBP about 121 into a population receiving hypertension treatment", "application_exception": "Effects in mixed meta-analysis populations are not treated as effects in the same population as the direct trial", "criterion": "Record metabolic syndrome, exclusion of antihypertensive users and mean baseline about 121 together with unverified eligibility 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 12-week office SBP comparison in adults with metabolic syndrome who were not using antihypertensives. They do not establish preregistration, official-tool certification or new independent clinical validation.", "proposed_research": "Material needed: The direct trial's eligibility/exclusion criteria and baseline table by group, and meta-analysis results by population. This records needed materials; no new research was executed." }, { "item_id": "N06", "question_type": "Evidence condition", "question": "Which ginger formulation, route and dose were administered?", "needed": "Dried rhizome-powder 500 mg capsules, oral 2 g/day, assay-table units and batch information, and actual consumption", "role": "Required", "role_reason": "Needed to avoid interchanging powder with standardized extracts, essential oil or food", "application_exception": "Retain 2 g/day and 500 mg without calculating capsule counts or active-constituent amounts", "criterion": "Link the formulation, route and dose in both languages to the original values and retain unclear assay units and unverified standardization/batch information", "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 12-week office SBP comparison in adults with metabolic syndrome who were not using antihypertensives. They do not establish preregistration, official-tool certification or new independent clinical validation.", "proposed_research": "Material needed: Product specifications, assay-table units, batch documentation and actual administration records. This records needed materials; no new research was executed." }, { "item_id": "N07", "question_type": "Evidence condition", "question": "What did the placebo and lifestyle counseling actually compare?", "needed": "The starch placebo, the content of identical lifestyle counseling, sensory matching, and actual treatment changes by group", "role": "Required", "role_reason": "Needed to avoid attributing differences in lifestyle intervention to ginger's own SBP effect", "application_exception": "Do not extend the statement of the same counseling to identical actual behavior, medication use or adherence", "criterion": "Retain starch placebo and the same lifestyle counseling as the verified comparison, leaving detailed content and changes by group 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 12-week office SBP comparison in adults with metabolic syndrome who were not using antihypertensives. They do not establish preregistration, official-tool certification or new independent clinical validation.", "proposed_research": "Material needed: Placebo composition, counseling procedures, and records of concomitant interventions and changes by group. This records needed materials; no new research was executed." }, { "item_id": "N08", "question_type": "Evidence condition", "question": "Which outcome, unit, change and time point does 12-week SBP represent?", "needed": "Between-group change from baseline in 12-week office systolic blood pressure, mmHg, prespecified hierarchy and measurement conditions", "role": "Required", "role_reason": "Needed to avoid combining final values, within-group change, DBP, ambulatory pressure and endothelial function as the same result", "application_exception": "The selected endpoint label does not establish actual prespecification as the 1st endpoint", "criterion": "Link selected 12-week office SBP change and the exclusion of other endpoints to the original locations, retaining unverified prespecification and measurement 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 12-week office SBP comparison in adults with metabolic syndrome who were not using antihypertensives. They do not establish preregistration, official-tool certification or new independent clinical validation.", "proposed_research": "Material needed: The 12-week result table, assessment method, and SBP hierarchy in the protocol/statistical analysis plan. This records needed materials; no new research was executed." }, { "item_id": "N09", "question_type": "Evidence condition", "question": "Are the adjusted P value and raw change difference from rounded means the same estimate?", "needed": "The separate analyses, directions and CIs for adjusted between-group P=.165 and the raw −1.12 mmHg from rounded means", "role": "Required", "role_reason": "Needed to avoid converting a raw difference from rounded means into an adjusted effect or meta-analysis WMD", "application_exception": "Do not recalculate raw −1.12 in this work or back-calculate an adjusted CI", "criterion": "Retain adjusted P=.165, raw −1.12 and the unverified adjusted CI as separate attributions", "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 12-week office SBP comparison in adults with metabolic syndrome who were not using antihypertensives. They do not establish preregistration, official-tool certification or new independent clinical validation.", "proposed_research": "Material needed: The exact raw result table, adjusted estimate/model/covariates, CI and denominators by group. This records needed materials; no new research was executed." }, { "item_id": "N10", "question_type": "Evidence condition", "question": "Which denominators are represented by 38 randomized participants and 37 completers (19/18)?", "needed": "The total 38 randomized, 37 completers, arm mapping of 19/18, denominators randomized/analyzed/completing by group, and handling of missingness", "role": "Required", "role_reason": "Needed to avoid converting completer counts into randomized denominators by group or an ITT denominator", "application_exception": "Do not infer 19=ginger or 18=placebo, or derive dropout reasons from the 38 randomized participants", "criterion": "Retain the original 38/37/19/18 and leave arm mapping, analysis denominators, ITT/PP and dropout reasons 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 12-week office SBP comparison in adults with metabolic syndrome who were not using antihypertensives. They do not establish preregistration, official-tool certification or new independent clinical validation.", "proposed_research": "Material needed: Participant flow by group, completion/analysis tables, missing-data handling and the statistical analysis plan. This records needed materials; no new research was executed." }, { "item_id": "N11", "question_type": "Evidence condition", "question": "Are the nonsignificant direct result and positive supportive meta-analysis signal both retained?", "needed": "Direct P=.165 and raw −1.12, and meta-analysis WMD −5.03/95% CI −8.49~−1.57/P=.004, low certainty and the diabetes background value −1.62", "role": "Required", "role_reason": "Needed to avoid erasing the direct result with a favorable pooled estimate", "application_exception": "Numerical differences across populations, formulations or analyses are not automatically labeled conflicting data, effect 0 or equivalence", "criterion": "Attribute each value to its report/analysis and retain the unestablished direct result, low-certainty supportive signal and background reference without an identity together", "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 12-week office SBP comparison in adults with metabolic syndrome who were not using antihypertensives. They do not establish preregistration, official-tool certification or new independent clinical validation.", "proposed_research": "Material needed: Exact result tables by report, included trials and heterogeneity in the meta-analysis, and the identity of the diabetes analysis. This records needed materials; no new research was executed." }, { "item_id": "N12", "question_type": "Evidence condition", "question": "Which dates and preservation, search and correction scope support these statements?", "needed": "The original verdict date 2026-09-08, correction date 2026-09-14, actual current review date, retained record and unread external scope", "role": "Required", "role_reason": "Needed to avoid inheriting past cross-checks, corrections or generic English wording as a current comprehensive literature check", "application_exception": "The verdict date is not a search cutoff or individual access date; an unperformed search does not mean 0 studies", "criterion": "Retain the complete current original record, all Korean/English content, axes and corrections, and disclose 0 new readings of full texts, abstracts or registration", "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 12-week office SBP comparison in adults with metabolic syndrome who were not using antihypertensives. They do not establish preregistration, official-tool certification or new independent clinical validation.", "proposed_research": "Material needed: Historical search/access records and original publication, correction and retraction records. This records needed materials; no new research was executed." }, { "item_id": "N13", "question_type": "Evidence condition", "question": "What do university support and the manufacturer's product name establish about funding and independence?", "needed": "The direct trial's funding, product provision, authors/institutions, employment, patents and COI details", "role": "Supplementary; required for independence claims", "role_reason": "Needed to avoid combining university support and a manufacturer's product name as certification of independent funding or an independent team", "application_exception": "A product name alone does not establish company funding, and university support does not establish absence of all COI", "criterion": "Retain the original statement that university support and the product name are separate funding matters, and leave detailed support, author and institutional relationships 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 12-week office SBP comparison in adults with metabolic syndrome who were not using antihypertensives. They do not establish preregistration, official-tool certification or new independent clinical validation.", "proposed_research": "Material needed: Original funding, acknowledgment and COI locations, product-support documentation and author relationships for the direct trial. This records needed materials; no new research was executed." }, { "item_id": "N14", "question_type": "Evidence condition", "question": "What level of verification is represented by the meta-analysis authors' declaration of no conflicts?", "needed": "Declared COI, funding and institutions of the meta-analysis, and funding/author relationships in the original trials", "role": "Supplementary; required for independence claims", "role_reason": "Needed to avoid converting review authors' declarations into independence of the 12 original trials", "application_exception": "The authors' declaration alone is not extended to absence of bias, independent replication or absence of product support", "criterion": "Retain the authors' declaration of no conflicts at its reported level, distinguishing it from detailed COI across original trials and verification of actually 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 12-week office SBP comparison in adults with metabolic syndrome who were not using antihypertensives. They do not establish preregistration, official-tool certification or new independent clinical validation.", "proposed_research": "Material needed: Original meta-analysis COI/funding locations and a table of funding and institutions by included trial. This records needed materials; no new research was executed." }, { "item_id": "N15", "question_type": "Evidence condition", "question": "How were randomization, concealment and blinding actually performed in the direct trial?", "needed": "The randomized, double-blind placebo-controlled design label, sequence generation, concealment and baseline balance", "role": "Required", "role_reason": "Needed to avoid verifying resolution of randomization issues from randomized and double-blind design labels alone", "application_exception": "Do not assign crossover or cluster exceptions as not applicable when design details are unverified", "criterion": "Retain the original randomized/double-blind/placebo design, leaving actual randomization, concealment, blinding targets and baseline balance 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 12-week office SBP comparison in adults with metabolic syndrome who were not using antihypertensives. They do not establish preregistration, official-tool certification or new independent clinical validation.", "proposed_research": "Material needed: Original methods, baseline tables by group, and randomization, concealment and blinding procedures. This records needed materials; no new research was executed." }, { "item_id": "N16", "question_type": "Evidence condition", "question": "Could adherence, concomitant treatment or changes in counseling be mixed with the effect?", "needed": "Actual consumption, discontinuation, lifestyle counseling, medications/rescue treatment, deviations and their handling by group", "role": "Required", "role_reason": "Needed to avoid attributing differences in adherence and lifestyle changes to ginger", "application_exception": "Exclusion of antihypertensive users does not mean all treatment or behavior changes were absent during the trial", "criterion": "Record unverified adherence, changes by group and handling of deviations beyond the current comparator information", "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 12-week office SBP comparison in adults with metabolic syndrome who were not using antihypertensives. They do not establish preregistration, official-tool certification or new independent clinical validation.", "proposed_research": "Material needed: Consumption/counseling, concomitant medication, rescue-treatment, deviation and analysis-handling records. This records needed materials; no new research was executed." }, { "item_id": "N17", "question_type": "Evidence condition", "question": "Under which conditions and procedures was office SBP measured?", "needed": "Devices, rest, repeated measurements/averaging, assessors, blinding and assessment timing by group", "role": "Required", "role_reason": "Needed to distinguish measurement-procedure differences from actual between-group SBP differences", "application_exception": "A double-blind design alone does not establish all assessors and measurement methods", "criterion": "Retain the 12-week office SBP label, leaving devices, assessment procedures, assessors and differences by group 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 12-week office SBP comparison in adults with metabolic syndrome who were not using antihypertensives. They do not establish preregistration, official-tool certification or new independent clinical validation.", "proposed_research": "Material needed: Original measurement procedures and assessment schedules, including error and missing-measurement records. This records needed materials; no new research was executed." }, { "item_id": "N18", "question_type": "Evidence condition", "question": "Which population and intervention effect does the adjusted analysis estimate?", "needed": "Completer analysis, ITT/PP, adjustment covariates/model, estimand and analysis denominator", "role": "Required", "role_reason": "Needed to avoid combining a completer analysis and raw difference from rounded means as an adjusted assignment effect", "application_exception": "Do not fill in an unspecified analysis as ITT, PP or ANCOVA", "criterion": "Retain the descriptions of 37 completers and an adjusted P value, leaving the exact analysis population, denominators by group, adjustment covariates and model 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 12-week office SBP comparison in adults with metabolic syndrome who were not using antihypertensives. They do not establish preregistration, official-tool certification or new independent clinical validation.", "proposed_research": "Material needed: Exact analysis tables, statistical analysis plan, model, analysis population and missing-data handling. This records needed materials; no new research was executed." }, { "item_id": "N19", "question_type": "Evidence condition", "question": "Can the adjusted interval and clinical importance of the direct effect be assessed?", "needed": "The direct trial's adjusted effect/95% CI, variance/denominators by group and a justified important SBP difference", "role": "Required", "role_reason": "Needed to avoid judging direct-effect precision or importance sufficient from a P value, 38 participants or the meta-analysis CI alone", "application_exception": "Do not arbitrarily set a common minimum sample size, trial count, duration or clinical threshold", "criterion": "Retain the unverified direct adjusted CI and clinical threshold, and do not use the meta-analysis's 95% CI as the direct trial's interval", "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 12-week office SBP comparison in adults with metabolic syndrome who were not using antihypertensives. They do not establish preregistration, official-tool certification or new independent clinical validation.", "proposed_research": "Material needed: The direct adjusted CI, estimate/variance and basis for clinical importance. This records needed materials; no new research was executed." }, { "item_id": "N20", "question_type": "Evidence condition", "question": "Were prespecified SBP endpoints, analyses and registration compared with actual reporting?", "needed": "Original trial registration, protocol/statistical analysis plan, the hierarchy of 12-week SBP and analysis/multiplicity plans", "role": "Required", "role_reason": "Needed to avoid mistaking the selected endpoint label for a prespecified 1st endpoint designation", "application_exception": "Unverified registration does not establish nonregistration or selective reporting", "criterion": "Retain unverified prespecification and the unverified registration field, and disclose 0 current comparisons with registration/plans", "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 12-week office SBP comparison in adults with metabolic syndrome who were not using antihypertensives. They do not establish preregistration, official-tool certification or new independent clinical validation.", "proposed_research": "Material needed: Actual original-trial registration, protocol/statistical analysis plan, change history and the corresponding result tables. This records needed materials; no new research was executed." }, { "item_id": "N21", "question_type": "Evidence condition", "question": "How different are the supportive meta-analysis's unique trials, effects and conditions?", "needed": "The mapping of 12 unique RCTs and 13 SBP effects, populations/baseline pressure/formulations/doses/endpoint hierarchy, heterogeneity and detailed GRADE domains", "role": "Required", "role_reason": "Needed to avoid presenting a positive pooled-average signal as independent replication of a single comparison", "application_exception": "Do not turn 13 effect sizes into 13 unique studies or add the direct trial as 1+12", "criterion": "Retain the original 12 RCTs/13 effects, different conditions, some 2nd blood-pressure endpoints and low certainty; leave trial-specific distributions and inclusion of the direct trial 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 12-week office SBP comparison in adults with metabolic syndrome who were not using antihypertensives. They do not establish preregistration, official-tool certification or new independent clinical validation.", "proposed_research": "Material needed: Meta-analysis included-trial/effect mapping tables, subgroup/heterogeneity analyses and GRADE domain tables. This records needed materials; no new research was executed." }, { "item_id": "N22", "question_type": "Evidence condition", "question": "Does the material answer questions about optimal dose, long-term persistence or subgroups?", "needed": "Direct dose comparisons, withdrawal/long-term follow-up, prespecified subgroups/interactions and the identity of the diabetes analysis", "role": "Supplementary; required for extension claims", "role_reason": "Needed to avoid extending 2 g/day, 12 weeks and a meta-analysis title into optimal dose, persistence or diabetes effects", "application_exception": "Do not require every extension trial for the narrow 12-week SBP question", "criterion": "Treat the current 2 g/day and 12 weeks only as the trial specification, separating unverified direct evidence for optimal dose, persistence and subgroups", "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 12-week office SBP comparison in adults with metabolic syndrome who were not using antihypertensives. They do not establish preregistration, official-tool certification or new independent clinical validation.", "proposed_research": "Material needed: Direct dose-comparison trials, post-withdrawal/long-term follow-up, subgroup plans and original results. This records needed materials; no new research was executed." }, { "item_id": "N23", "question_type": "Evidence condition", "question": "Does an SBP change also answer questions about event prevention or medication replacement?", "needed": "Separate questions and direct evidence for the selected SBP outcome versus cardiovascular events, quality of life, mortality and antihypertensive replacement", "role": "Supplementary; required for clinical extension claims", "role_reason": "Needed to avoid converting a blood-pressure signal into cardiovascular-event prevention or treatment replacement", "application_exception": "Because SBP itself is the question, absence of event trials does not remove direct SBP reporting", "criterion": "Keep the office-SBP boundary and do not present event prevention or replacement as currently verified 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 dried ginger powder and a 12-week office SBP comparison in adults with metabolic syndrome who were not using antihypertensives. They do not establish preregistration, official-tool certification or new independent clinical validation.", "proposed_research": "Material needed: Separate plans, denominators, follow-up and results actually comparing events or treatment replacement. This records needed materials; no new research was executed." }, { "item_id": "N24", "question_type": "Evidence condition", "question": "What level of harm verification is represented by the caution in the efficacy summary?", "needed": "Actual adverse events, collection methods, denominators, discontinuations and the original caution for the same population, powder and period", "role": "Supplementary; required for safety claims", "role_reason": "Needed to avoid converting the existence of an efficacy/meta-analysis summary into verified safety", "application_exception": "Unverified harm information does not remove the original SBP report or justify filling in safety", "criterion": "Retain dizziness, hypotension and interaction cautions as the original narrative, separately showing unverified observed events, frequencies and discontinuations", "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 12-week office SBP comparison in adults with metabolic syndrome who were not using antihypertensives. They do not establish preregistration, official-tool certification or new independent clinical validation.", "proposed_research": "Material needed: Adverse-event collection methods, event/exposure denominators, discontinuations and observation periods for the trial. This records needed materials; no new research was executed." }, { "item_id": "N25", "question_type": "Evidence condition", "question": "Are dizziness and hypotension actual observed events or cautionary statements?", "needed": "Trial event definitions/adjudication, systematic or spontaneous collection, severity and discontinuation records", "role": "Supplementary; required for harm questions", "role_reason": "Needed to avoid converting recommendations into actual events or confirmed diagnoses", "application_exception": "Retain the original caution list without inventing observed events", "criterion": "Separate the original caution wording from unverified current information on adverse events and their collection", "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 12-week office SBP comparison in adults with metabolic syndrome who were not using antihypertensives. They do not establish preregistration, official-tool certification or new independent clinical validation.", "proposed_research": "Material needed: Original adverse-event definitions, collection/adjudication procedures, and event, severity and discontinuation tables. This records needed materials; no new research was executed." }, { "item_id": "N26", "question_type": "Evidence condition", "question": "Is the temporal relationship between exposure and actual harm verified?", "needed": "Starting 2 g/day, the 12-week period, event onset/recovery, discontinuation/re-exposure and observation periods", "role": "Supplementary; required for harm questions", "role_reason": "Needed to avoid inferring harm-onset or recovery timing from treatment duration alone", "application_exception": "Do not fill in temporal order or causality without discontinuation/re-exposure records", "criterion": "Distinguish the 12-week treatment specification from unverified timing of actual events, discontinuation and re-exposure", "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 12-week office SBP comparison in adults with metabolic syndrome who were not using antihypertensives. They do not establish preregistration, official-tool certification or new independent clinical validation.", "proposed_research": "Material needed: Exposure/event timelines and records of discontinuation, recovery and re-exposure. This records needed materials; no new research was executed." }, { "item_id": "N27", "question_type": "Evidence condition", "question": "Against which comparator were harms actually compared?", "needed": "Actual adverse events and comparative estimates involving placebo, background conditions and concomitant medications", "role": "Supplementary; required for comparative harm claims", "role_reason": "Needed to avoid converting an efficacy comparison with starch placebo into observed comparative harm results", "application_exception": "When an efficacy comparator exists but harm-event tables do not, leave comparative harms unverified", "criterion": "Record the starch-placebo/same-counseling comparison separately from unverified comparative harms by group", "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 12-week office SBP comparison in adults with metabolic syndrome who were not using antihypertensives. They do not establish preregistration, official-tool certification or new independent clinical validation.", "proposed_research": "Material needed: Adverse-event tables by group and event-specific comparison denominators/analyses. This records needed materials; no new research was executed." }, { "item_id": "N28", "question_type": "Evidence condition", "question": "Are denominators and exposure time available for harm frequency?", "needed": "Numbers exposed or in the safety analysis, people with events versus event counts, and exposure/follow-up time", "role": "Supplementary; required for incidence claims", "role_reason": "Needed to avoid converting 38 randomized participants, 37 completers or the meta-analysis's 12 trials into an adverse-event incidence denominator", "application_exception": "Do not calculate 0 events, 0% or a denominator from a current summary without events", "criterion": "Do not reuse randomized/completer efficacy denominators as safety denominators; retain unverified event, exposure and follow-up 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 dried ginger powder and a 12-week office SBP comparison in adults with metabolic syndrome who were not using antihypertensives. They do not establish preregistration, official-tool certification or new independent clinical validation.", "proposed_research": "Material needed: Safety-analysis populations, people/event counts and exposure-duration tables. This records needed materials; no new research was executed." }, { "item_id": "N29", "question_type": "Evidence condition", "question": "What alternative explanations involve concomitant medications, baseline conditions or lifestyle changes?", "needed": "Exclusion of antihypertensive users, other medications/diseases, lifestyle counseling, dose and their relationship to actual harms", "role": "Supplementary; required for causal harm claims", "role_reason": "Needed to avoid converting an interaction caution into direct verification of harm from combined use in this trial", "application_exception": "Do not describe an undocumented concomitant exposure as absent", "criterion": "Distinguish medication-user exclusion in the direct trial from the general antihypertensive-combination caution, retaining unverified other concomitant exposures and alternatives", "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 12-week office SBP comparison in adults with metabolic syndrome who were not using antihypertensives. They do not establish preregistration, official-tool certification or new independent clinical validation.", "proposed_research": "Material needed: Concomitant medications, underlying conditions, lifestyle changes and adjustment records in harm cases/trials. This records needed materials; no new research was executed." }, { "item_id": "N30", "question_type": "Evidence condition", "question": "What is known about harm collection, reporting and loss to follow-up?", "needed": "Collection of all adverse events, selection/recall/detection, missing safety follow-up and reasons for discontinuation/dropout", "role": "Supplementary; required for harm questions", "role_reason": "Needed to avoid converting omissions in a summary or a completer analysis into absence of harms", "application_exception": "Because the external full text was not read, nonreporting of adverse events in the original article is not established", "criterion": "State that the current retained summary cannot establish collection, selection or missingness, without estimating the extent of actual missing harms", "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 12-week office SBP comparison in adults with metabolic syndrome who were not using antihypertensives. They do not establish preregistration, official-tool certification or new independent clinical validation.", "proposed_research": "Material needed: Original collection procedures and the reporting scope for all adverse events, discontinuations and dropouts. This records needed materials; no new research was executed." }, { "item_id": "N31", "question_type": "Evidence condition", "question": "Are the same harm events linked in other independent material?", "needed": "Identities of unique events/study families, reports and repeat citations, matched exposure/events and regulatory material", "role": "Supplementary; required for repeated harm claims", "role_reason": "Needed to avoid counting meta-analysis, caution wording and Korean/English repeat citations as independent repetitions of events", "application_exception": "Do not search for new safety material here or convert unverified status into 0 harm studies", "criterion": "Retain the limited fact that independent harm cases/families are unverified in both stored efficacy reports, without inventing replication 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 12-week office SBP comparison in adults with metabolic syndrome who were not using antihypertensives. They do not establish preregistration, official-tool certification or new independent clinical validation.", "proposed_research": "Material needed: Independent original safety reports with specified identities and exposures/events, and a repeat-citation mapping table. This records needed materials; no new research was executed." }, { "item_id": "N32", "question_type": "Evidence condition", "question": "Does the material address long-term or rare harms and other vulnerable populations?", "needed": "Exposure beyond 12 weeks and separate direct material on rare events, medication users, pregnancy/baseline risk and interactions", "role": "Supplementary; required for overall safety claims", "role_reason": "Needed to avoid extending short-term material in a limited population not using antihypertensives into safety for everyone", "application_exception": "Do not require every long-term or rare-harm trial for the narrow SBP question", "criterion": "Separate the current population/12-week period from unverified long-term, combined-medication and special-population 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 12-week office SBP comparison in adults with metabolic syndrome who were not using antihypertensives. They do not establish preregistration, official-tool certification or new independent clinical validation.", "proposed_research": "Material needed: Safety observation, comparison and registration material suited to the target vulnerable population and duration. This records needed materials; no new research was executed." }, { "item_id": "N33", "question_type": "Evidence condition", "question": "Does the current caution wording describe a signal, incidence or causality?", "needed": "The reporting level of the original caution, actual design/events/denominators/timing/alternatives and possible interpretation", "role": "Supplementary; required for causal harm or safety claims", "role_reason": "Needed to avoid promoting a general caution into harm causality, incidence or a new safety grade", "application_exception": "Do not create personal dosing instructions or a new efficacy/safety judgment", "criterion": "Retain the original caution as a limited statement, without presenting actual causal effects, frequencies or safety certification as verified in the current trial", "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 12-week office SBP comparison in adults with metabolic syndrome who were not using antihypertensives. They do not establish preregistration, official-tool certification or new independent clinical validation.", "proposed_research": "Material needed: Actual original harm material linking design, comparison, denominators, timing and alternative explanations. This records needed materials; no new research was executed." } ] }