{ "schema_version": "chamgap-public-evidence-check-1.0", "public_id": "v3053-main", "verdict_number": "3053", "title": "500-mg dried ginger-powder capsules × Reduction of office systolic blood pressure in adults with metabolic syndrome", "view_version": "1.0", "view_created_date": "2026-10-25", "criteria_version": "1.0", "criteria_date": "2026-10-06", "review_date": "2026-10-06", "legacy_evidence_date": "2026-09-08", "review_scope": { "materials_read": "Retained Korean/English summaries and case-specific condition/application records", "clinical_papers_directly_read": false, "new_clinical_search": false, "limitation": "Prepared from retained summaries and condition-application records. External abstracts, full texts, registration, protocols and analysis plans remain unread. Historical review records do not establish current independent clinical validation.", "date_meaning": "The material date 2026-10-06 concerns retained-summary review. Observations were applied after the conditions were frozen; historical records of later observation-wording and external-unread display changes were retained. The original verdict date 2026-09-08 and correction date 2026-09-14 are not new-search or external-full-text-reading dates." }, "claim_context": { "population": "Adults with metabolic syndrome; mean baseline SBP about 121 mmHg; antihypertensive users excluded", "intervention": "500-mg dried ginger-powder capsules; assay units unclear", "dose": "2 g/day", "comparator": "Starch placebo plus the same lifestyle counseling", "endpoint": "Between-group difference in 12-week office SBP change", "duration": "12 weeks", "excluded_extensions": [ "Other ginger formulations or hypertension-treatment effects in antihypertensive users", "DBP, ambulatory blood pressure and endothelial function", "Optimal dose, long-term persistence and direct subgroup effects", "Cardiovascular-event prevention and antihypertensive replacement", "Turning the diabetes −1.62 background reference without bibliography into a newly verified report", "Establishing overall safety, causal harms or incidence" ] }, "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.", "current_reports": [ "S01", "S02" ], "existence": "Stored research/bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original manufacturing/support/harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific conditions/application records were read. Linked external abstracts, full texts, registration and planning material remain unread, with no access attempt.", "observation": "The original claim concerns office systolic blood-pressure reduction in adults with metabolic syndrome. Both sets of population/intervention details connect metabolic syndrome, exclusion of antihypertensive users, mean baseline SBP about 121, dried-powder 500 mg capsules at 2 g/day for 12 weeks, starch placebo plus the same lifestyle counseling, and between-group office SBP change.", "condition_status": "Met", "status_reason": "This verifies the link between the original record and the selected narrow question. It does not establish a reduction, full-text reading or new efficacy certification.", "missingness": "This verifies the link between the original record and the selected narrow question. It does not establish a reduction, full-text reading or new efficacy certification.", "uncertainty": "This verifies the link between the original record and the selected narrow question. It does not establish a reduction, full-text reading or new efficacy certification.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "If the boundary changes, an original report specifying the population, endpoint, formulation, comparison and timing" }, { "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.", "current_reports": [ "S01", "S02" ], "existence": "Stored research/bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original manufacturing/support/harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific conditions/application records were read. Linked external abstracts, full texts, registration and planning material remain unread, with no access attempt.", "observation": "The current research and citation summaries each contain 2 entries. The Rahimlou 2019 direct report and Karimi 2026 meta-analysis are distinguished. The meta-analysis reports 12 unique RCTs and 13 SBP effect sizes; inclusion of S01 and the list of original trial families are unavailable.", "condition_status": "Partly verified", "status_reason": "The bibliographic identities of both reports are retained, but the mapping and overlap of 12 original trials and 13 effects were not compared. The number of unique independent trials and total participants remain unconfirmed.", "missingness": "The bibliographic identities of both reports are retained, but the mapping and overlap of 12 original trials and 13 effects were not compared. The number of unique independent trials and total participants remain unconfirmed.", "uncertainty": "The bibliographic identities of both reports are retained, but the mapping and overlap of 12 original trials and 13 effects were not compared. The number of unique independent trials and total participants remain unconfirmed.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "The meta-analysis included-trial/effect mapping table, registration, and a list of related direct-trial reports" }, { "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.", "current_reports": [ "S01", "S02" ], "existence": "Stored research/bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original manufacturing/support/harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific conditions/application records were read. Linked external abstracts, full texts, registration and planning material remain unread, with no access attempt.", "observation": "The Korean/English counterview and counterpoint mention −1.62 mmHg from a diabetes-only 2026 analysis. The current 2 research/citation entries identify the direct trial and broader meta-analysis; a separate bibliography, denominator, CI and P value for this diabetes analysis are not linked.", "condition_status": "Met", "status_reason": "The limited identity and attribution boundary of the retained wording was verified. It is neither deleted nor invented as S03 or a new trial family; this does not mean the study is absent from all literature.", "missingness": "The limited identity and attribution boundary of the retained wording was verified. It is neither deleted nor invented as S03 or a new trial family; this does not mean the study is absent from all literature.", "uncertainty": "The limited identity and attribution boundary of the retained wording was verified. It is neither deleted nor invented as S03 or a new trial family; this does not mean the study is absent from all literature.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "The actual bibliography, included-trial table and original result location for the diabetes-only analysis" }, { "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.", "current_reports": [ "S01", "S02" ], "existence": "Stored research/bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original manufacturing/support/harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific conditions/application records were read. Linked external abstracts, full texts, registration and planning material remain unread, with no access attempt.", "observation": "Both report summaries, Korean/English evidence and bibliographies, and all original values in the retained record were actually read. Each PubMed URL and bibliographic DOI/PMCID is a retained entry point. External abstracts, full texts, PMC material, registration and supplements were not accessed, acquired or read in this work.", "condition_status": "Met", "status_reason": "Actual acquisition and reading apply only to locally retained summaries. Current external existence and successful responses remain unverified; they are not labeled as access failures or acquired full texts.", "missingness": "Actual acquisition and reading apply only to locally retained summaries. Current external existence and successful responses remain unverified; they are not labeled as access failures or acquired full texts.", "uncertainty": "Actual acquisition and reading apply only to locally retained summaries. Current external existence and successful responses remain unverified; they are not labeled as access failures or acquired full texts.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "Actual responses, acquired original bytes, versions, reading dates and exact links for each material" }, { "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.", "current_reports": [ "S01", "S02" ], "existence": "Stored research/bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original manufacturing/support/harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific conditions/application records were read. Linked external abstracts, full texts, registration and planning material remain unread, with no access attempt.", "observation": "The population details in both languages specify adults with metabolic syndrome, mean baseline SBP about 121 mmHg, and exclusion of antihypertensive users. Differences in meta-analysis populations and baseline blood pressure appear in the rationale, but details of diagnosis, age, recruitment and baseline distributions by group in the direct trial remain unverified.", "condition_status": "Partly verified", "status_reason": "The stated population characteristics were verified, but applicability to people treated for hypertension, representativeness and detailed eligibility criteria were not newly verified.", "missingness": "The stated population characteristics were verified, but applicability to people treated for hypertension, representativeness and detailed eligibility criteria were not newly verified.", "uncertainty": "The stated population characteristics were verified, but applicability to people treated for hypertension, representativeness and detailed eligibility criteria were not newly verified.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "The direct trial's eligibility/exclusion criteria and baseline table by group, and meta-analysis results by population" }, { "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.", "current_reports": [ "S01" ], "existence": "Stored research/bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original manufacturing/support/harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific conditions/application records were read. Linked external abstracts, full texts, registration and planning material remain unread, with no access attempt.", "observation": "The original material, formulation, route and dose are Zingiber officinale Roscoe rhizome; dried ginger-powder 500 mg capsules; unclear assay-table units; oral administration; and 2 g/day. Standardized extracts, essential oil and food are distinguished in the product information.", "condition_status": "Partly verified", "status_reason": "The nominal powder formulation and dose are retained, but assay units, standardization, batch information and actual adherence-adjusted intake are unverified. Capsule counts and active-constituent amounts were not calculated.", "missingness": "The nominal powder formulation and dose are retained, but assay units, standardization, batch information and actual adherence-adjusted intake are unverified. Capsule counts and active-constituent amounts were not calculated.", "uncertainty": "The nominal powder formulation and dose are retained, but assay units, standardization, batch information and actual adherence-adjusted intake are unverified. Capsule counts and active-constituent amounts were not calculated.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "Product specifications, assay-table units, batch documentation and actual administration records" }, { "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.", "current_reports": [ "S01" ], "existence": "Stored research/bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original manufacturing/support/harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific conditions/application records were read. Linked external abstracts, full texts, registration and planning material remain unread, with no access attempt.", "observation": "The recorded comparator is starch placebo plus the same lifestyle counseling, as also stated in English. The actual content of counseling, sensory matching of the placebo, and treatment or lifestyle changes by group could not be verified in the current retained summary.", "condition_status": "Partly verified", "status_reason": "The placebo/counseling comparison is verified, but this does not establish that all actual behavior and medication changes were identical.", "missingness": "The placebo/counseling comparison is verified, but this does not establish that all actual behavior and medication changes were identical.", "uncertainty": "The placebo/counseling comparison is verified, but this does not establish that all actual behavior and medication changes were identical.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "Placebo composition, counseling procedures, and records of concomitant interventions and changes by group" }, { "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.", "current_reports": [ "S01" ], "existence": "Stored research/bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original manufacturing/support/harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific conditions/application records were read. Linked external abstracts, full texts, registration and planning material remain unread, with no access attempt.", "observation": "The selected endpoint is between-group change in office SBP at 12 weeks, and the duration is 12 weeks of treatment. The scope note limits the question to office SBP; the reader answer states that matching SBP prespecification as the 1st endpoint is unclear.", "condition_status": "Partly verified", "status_reason": "Attribution to 12-week office SBP change is verified, but the actual prespecified hierarchy, measurement method and assessment schedule are unverified. DBP, ambulatory pressure and endothelial function do not replace it.", "missingness": "Attribution to 12-week office SBP change is verified, but the actual prespecified hierarchy, measurement method and assessment schedule are unverified. DBP, ambulatory pressure and endothelial function do not replace it.", "uncertainty": "Attribution to 12-week office SBP change is verified, but the actual prespecified hierarchy, measurement method and assessment schedule are unverified. DBP, ambulatory pressure and endothelial function do not replace it.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "The 12-week result table, assessment method, and SBP hierarchy in the protocol/statistical analysis plan" }, { "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.", "current_reports": [ "S01" ], "existence": "Stored research/bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original manufacturing/support/harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific conditions/application records were read. Linked external abstracts, full texts, registration and planning material remain unread, with no access attempt.", "observation": "The direct result is retained as adjusted between-group P=.165; raw change difference from rounded means −1.12 mmHg; adjusted CI unverified. The reader answer's adjusted P=.165 and the raw rounded change difference of −1.12 mmHg are each preserved.", "condition_status": "Partly verified", "status_reason": "The distinction between the P value and raw difference is retained, but the adjusted effect/CI, exact raw table/model and analysis denominators by group are unverified. They were neither substituted as adjusted values nor recalculated.", "missingness": "The distinction between the P value and raw difference is retained, but the adjusted effect/CI, exact raw table/model and analysis denominators by group are unverified. They were neither substituted as adjusted values nor recalculated.", "uncertainty": "The distinction between the P value and raw difference is retained, but the adjusted effect/CI, exact raw table/model and analysis denominators by group are unverified. They were neither substituted as adjusted values nor recalculated.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "The exact raw result table, adjusted estimate/model/covariates, CI and denominators by group" }, { "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.", "current_reports": [ "S01" ], "existence": "Stored research/bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original manufacturing/support/harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific conditions/application records were read. Linked external abstracts, full texts, registration and planning material remain unread, with no access attempt.", "observation": "The retained direct-trial denominator is 38 randomized participants and 37 completers (19/18). The 38 are described as randomized and the 37 as completers; the ginger/placebo arm mapping of 19/18 is not explicitly stated in the original record.", "condition_status": "Partly verified", "status_reason": "Do not infer that 19 means ginger and 18 means placebo. Data on randomized/analyzed/completing denominators by group, ITT/PP, reasons for dropout and their handling are unavailable, so efficacy and safety denominators cannot be confirmed.", "missingness": "Do not infer that 19 means ginger and 18 means placebo. Data on randomized/analyzed/completing denominators by group, ITT/PP, reasons for dropout and their handling are unavailable, so efficacy and safety denominators cannot be confirmed.", "uncertainty": "Do not infer that 19 means ginger and 18 means placebo. Data on randomized/analyzed/completing denominators by group, ITT/PP, reasons for dropout and their handling are unavailable, so efficacy and safety denominators cannot be confirmed.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "Participant flow by group, completion/analysis tables, missing-data handling and the statistical analysis plan" }, { "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.", "current_reports": [ "S01", "S02" ], "existence": "Stored research/bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original manufacturing/support/harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific conditions/application records were read. Linked external abstracts, full texts, registration and planning material remain unread, with no access attempt.", "observation": "The original values are retained separately: direct adjusted between-group P=.165; raw change difference from rounded means −1.12 mmHg; adjusted CI unverified; and meta-analysis WMD −5.03 mmHg, 95% CI −8.49~−1.57, P=.004, with low certainty. The reader answer states that the direct result was not established and E0 was not assigned because prespecification is unclear; the key explanation and rationale limit the pooled signal by low certainty and heterogeneity. The diabetes −1.62 reference is background without a linked identity.", "condition_status": "Met", "status_reason": "The favorable meta-analysis value did not erase the nonsignificant direct result. Numerical differences across populations or analyses were not converted into conflicting data under the same comparison, effect 0 or equivalence.", "missingness": "The favorable meta-analysis value did not erase the nonsignificant direct result. Numerical differences across populations or analyses were not converted into conflicting data under the same comparison, effect 0 or equivalence.", "uncertainty": "The favorable meta-analysis value did not erase the nonsignificant direct result. Numerical differences across populations or analyses were not converted into conflicting data under the same comparison, effect 0 or equivalence.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "Exact result tables by report, included trials and heterogeneity in the meta-analysis, and the identity of the diabetes analysis" }, { "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.", "current_reports": [ "S01", "S02" ], "existence": "Stored research/bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original manufacturing/support/harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific conditions/application records were read. Linked external abstracts, full texts, registration and planning material remain unread, with no access attempt.", "observation": "The original verdict date is 2026-09-08, and the correction record describes the 2026-09-14 English placeholder correction, C→C. The actual source, Korean/English content, generic English evidence wording, axes, empty subclaims, deliberation and URLs were retained. This work converts the retained summary; new external full-text, abstract, registration, correction and retraction queries total 0.", "condition_status": "Met", "status_reason": "The review date concerns the current reading event; the original verdict date concerns historical record review. The historical search cutoff, individual access dates and complete current literature status were not retrospectively verified.", "missingness": "The review date concerns the current reading event; the original verdict date concerns historical record review. The historical search cutoff, individual access dates and complete current literature status were not retrospectively verified.", "uncertainty": "The review date concerns the current reading event; the original verdict date concerns historical record review. The historical search cutoff, individual access dates and complete current literature status were not retrospectively verified.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "Historical search/access records and original publication, correction and retraction records" }, { "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.", "current_reports": [ "S01" ], "existence": "Stored research/bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original manufacturing/support/harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific conditions/application records were read. Linked external abstracts, full texts, registration and planning material remain unread, with no access attempt.", "observation": "The direct-trial funding field states university support, with the manufacturer's product name separate from funding. The rationale's description of university support as a strength and the I2 axis are retained as history. Product provision, author employment/patents, detailed COI and institutional relationships are not established in this retained summary.", "condition_status": "Partly verified", "status_reason": "Only the statements of university support and the distinction between the manufacturer's product name and funding were verified. Company funding, independent teams or absence of all COI are not confirmed.", "missingness": "Only the statements of university support and the distinction between the manufacturer's product name and funding were verified. Company funding, independent teams or absence of all COI are not confirmed.", "uncertainty": "Only the statements of university support and the distinction between the manufacturer's product name and funding were verified. Company funding, independent teams or absence of all COI are not confirmed.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "Original funding, acknowledgment and COI locations, product-support documentation and author relationships for the direct trial" }, { "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.", "current_reports": [ "S02" ], "existence": "Stored research/bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original manufacturing/support/harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific conditions/application records were read. Linked external abstracts, full texts, registration and planning material remain unread, with no access attempt.", "observation": "The retained meta-analysis funding field states that the authors declared no conflicts of interest. The current record provides only the meta-analysis declaration; it does not provide funding, product/author relationships or institutional families for each included trial.", "condition_status": "Partly verified", "status_reason": "The meta-analysis authors' declaration is not used to verify independence, absence of bias or absence of product support across all 12 original trials.", "missingness": "The meta-analysis authors' declaration is not used to verify independence, absence of bias or absence of product support across all 12 original trials.", "uncertainty": "The meta-analysis authors' declaration is not used to verify independence, absence of bias or absence of product support across all 12 original trials.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "Original meta-analysis COI/funding locations and a table of funding and institutions by included trial" }, { "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.", "current_reports": [ "S01" ], "existence": "Stored research/bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original manufacturing/support/harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific conditions/application records were read. Linked external abstracts, full texts, registration and planning material remain unread, with no access attempt.", "observation": "The direct design is described as randomized, double-blind and placebo-controlled in both languages. Sequence generation, concealment, who was blinded, blinding success and baseline balance by group remain unverified.", "condition_status": "Partly verified", "status_reason": "The retained design label was verified. It does not certify that randomization, confounding or measurement issues were resolved, and unverified design details are not labeled not applicable.", "missingness": "The retained design label was verified. It does not certify that randomization, confounding or measurement issues were resolved, and unverified design details are not labeled not applicable.", "uncertainty": "The retained design label was verified. It does not certify that randomization, confounding or measurement issues were resolved, and unverified design details are not labeled not applicable.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "Original methods, baseline tables by group, and randomization, concealment and blinding procedures" }, { "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.", "current_reports": [ "S01" ], "existence": "Stored research/bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original manufacturing/support/harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific conditions/application records were read. Linked external abstracts, full texts, registration and planning material remain unread, with no access attempt.", "observation": "The population/intervention details specify the same lifestyle counseling, starch placebo and exclusion of antihypertensive users. The retained summary lacks actual adherence, discontinuation, counseling implementation, concomitant medications/rescue treatment, changes by group and their handling.", "condition_status": "Unverified", "status_reason": "Original material needed to verify the influence of actual deviations and treatment changes beyond the comparison specification on SBP analysis was not read. Absence of changes is not assumed.", "missingness": "Original material needed to verify the influence of actual deviations and treatment changes beyond the comparison specification on SBP analysis was not read. Absence of changes is not assumed.", "uncertainty": "Original material needed to verify the influence of actual deviations and treatment changes beyond the comparison specification on SBP analysis was not read. Absence of changes is not assumed.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "Consumption/counseling, concomitant medication, rescue-treatment, deviation and analysis-handling records" }, { "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.", "current_reports": [ "S01" ], "existence": "Stored research/bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original manufacturing/support/harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific conditions/application records were read. Linked external abstracts, full texts, registration and planning material remain unread, with no access attempt.", "observation": "The retained endpoint and population/intervention details specify 12-week office SBP, but do not provide devices, rest, repeated measurements/averaging, assessors or measurement timing by group. The double-blind label is not a specific assessor procedure.", "condition_status": "Unverified", "status_reason": "Material establishing actual measurement conditions and differences by group for the selected office SBP remains unread. An objective endpoint does not remove measurement limitations.", "missingness": "Material establishing actual measurement conditions and differences by group for the selected office SBP remains unread. An objective endpoint does not remove measurement limitations.", "uncertainty": "Material establishing actual measurement conditions and differences by group for the selected office SBP remains unread. An objective endpoint does not remove measurement limitations.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "Original measurement procedures and assessment schedules, including error and missing-measurement records" }, { "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.", "current_reports": [ "S01" ], "existence": "Stored research/bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original manufacturing/support/harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific conditions/application records were read. Linked external abstracts, full texts, registration and planning material remain unread, with no access attempt.", "observation": "The reader answer and rationale describe a 37-completer trial, small-sample/completer-analysis limitations and adjusted P=.165. The original denominator is 38 randomized and 37 completing; the result's −1.12 is a raw change difference from rounded means.", "condition_status": "Partly verified", "status_reason": "The completer-analysis and adjusted-P descriptions are verified, but exact analysis denominators/populations, ITT/PP, estimands, covariates/models and missing-data handling are unverified. They are not filled in as ANCOVA or ITT.", "missingness": "The completer-analysis and adjusted-P descriptions are verified, but exact analysis denominators/populations, ITT/PP, estimands, covariates/models and missing-data handling are unverified. They are not filled in as ANCOVA or ITT.", "uncertainty": "The completer-analysis and adjusted-P descriptions are verified, but exact analysis denominators/populations, ITT/PP, estimands, covariates/models and missing-data handling are unverified. They are not filled in as ANCOVA or ITT.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "Exact analysis tables, statistical analysis plan, model, analysis population and missing-data handling" }, { "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.", "current_reports": [ "S01", "S02" ], "existence": "Stored research/bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original manufacturing/support/harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific conditions/application records were read. Linked external abstracts, full texts, registration and planning material remain unread, with no access attempt.", "observation": "The direct result and rationale explicitly leave the adjusted CI and clinical threshold unverified. The meta-analysis's 95% CI −8.49~−1.57 belongs to a separate pooled WMD and is not the direct trial's adjusted interval.", "condition_status": "Unverified", "status_reason": "The relationship between the direct effect's adjusted interval and a justified important SBP difference was not verified. P values, sample size and the meta-analysis CI do not establish sufficiency.", "missingness": "The relationship between the direct effect's adjusted interval and a justified important SBP difference was not verified. P values, sample size and the meta-analysis CI do not establish sufficiency.", "uncertainty": "The relationship between the direct effect's adjusted interval and a justified important SBP difference was not verified. P values, sample size and the meta-analysis CI do not establish sufficiency.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "The direct adjusted CI, estimate/variance and basis for clinical importance" }, { "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.", "current_reports": [ "S01" ], "existence": "Stored research/bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original manufacturing/support/harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific conditions/application records were read. Linked external abstracts, full texts, registration and planning material remain unread, with no access attempt.", "observation": "The direct-trial registration field is unverified, and the evidence weight describes the principal direct trial with unverified prespecification. The Korean/English reader answers state that matching SBP prespecification is unclear. Registration, the protocol/statistical analysis plan and change history were not read in this work.", "condition_status": "Unverified", "status_reason": "The selected endpoint label is distinguished from actual confirmation of the prespecified 1st endpoint/statistical analysis plan. Unverified registration does not establish nonregistration or selective reporting, and the original EX is not changed to E0.", "missingness": "The selected endpoint label is distinguished from actual confirmation of the prespecified 1st endpoint/statistical analysis plan. Unverified registration does not establish nonregistration or selective reporting, and the original EX is not changed to E0.", "uncertainty": "The selected endpoint label is distinguished from actual confirmation of the prespecified 1st endpoint/statistical analysis plan. Unverified registration does not establish nonregistration or selective reporting, and the original EX is not changed to E0.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "Actual original-trial registration, protocol/statistical analysis plan, change history and the corresponding result tables" }, { "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.", "current_reports": [ "S01", "S02" ], "existence": "Stored research/bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original manufacturing/support/harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific conditions/application records were read. Linked external abstracts, full texts, registration and planning material remain unread, with no access attempt.", "observation": "The meta-analysis reports 12 unique RCTs and 13 SBP effect sizes; WMD −5.03 mmHg, 95% CI −8.49~−1.57, P=.004, with low certainty. The rationale specifies differences in baseline pressure, disease, formulation and dose, and some 2nd blood-pressure endpoints. Included trials, mapping of the 13 effects, inclusion of S01, and detailed heterogeneity/GRADE tables remain unread.", "condition_status": "Partly verified", "status_reason": "The reported pooled result, low certainty and different conditions are retained. The 13 effects are not counted as 13 unique studies, nor as 1+12 independent trials, and GRADE was not newly performed.", "missingness": "The reported pooled result, low certainty and different conditions are retained. The 13 effects are not counted as 13 unique studies, nor as 1+12 independent trials, and GRADE was not newly performed.", "uncertainty": "The reported pooled result, low certainty and different conditions are retained. The 13 effects are not counted as 13 unique studies, nor as 1+12 independent trials, and GRADE was not newly performed.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "Meta-analysis included-trial/effect mapping tables, subgroup/heterogeneity analyses and GRADE domain tables" }, { "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.", "current_reports": [ "S01", "S02" ], "existence": "Stored research/bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original manufacturing/support/harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific conditions/application records were read. Linked external abstracts, full texts, registration and planning material remain unread, with no access attempt.", "observation": "The current direct comparison specifies 2 g/day for 12 weeks. The advertising interpretation rejects an optimal-dose conclusion for 2 g or more, and dose-response in the meta-analysis title does not provide a direct dose comparison. Long-term/post-withdrawal follow-up, prespecified subgroups and the diabetes analysis identity are also unverified.", "condition_status": "Unverified", "status_reason": "Extension material beyond the narrow question was not read. Not every extension trial is made mandatory, and direct dose, persistence or subgroup effects are not promoted to verified status.", "missingness": "Extension material beyond the narrow question was not read. Not every extension trial is made mandatory, and direct dose, persistence or subgroup effects are not promoted to verified status.", "uncertainty": "Extension material beyond the narrow question was not read. Not every extension trial is made mandatory, and direct dose, persistence or subgroup effects are not promoted to verified status.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "Direct dose-comparison trials, post-withdrawal/long-term follow-up, subgroup plans and original results" }, { "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.", "current_reports": [ "S01", "S02" ], "existence": "Stored research/bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original manufacturing/support/harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific conditions/application records were read. Linked external abstracts, full texts, registration and planning material remain unread, with no access attempt.", "observation": "The scope note limits the verdict to office SBP, and the advertising interpretation places antihypertensive replacement and cardiovascular-event prevention outside the evidence. The key explanation's roughly 5 mmHg signal is a low-certainty short-term pooled estimate, not a result limited to hypertension-treatment trials.", "condition_status": "Partly verified", "status_reason": "The boundary between the selected endpoint and clinical extensions is verified, but direct event/treatment-replacement results, denominators and follow-up are unverified within the current material. This gap does not remove the SBP report.", "missingness": "The boundary between the selected endpoint and clinical extensions is verified, but direct event/treatment-replacement results, denominators and follow-up are unverified within the current material. This gap does not remove the SBP report.", "uncertainty": "The boundary between the selected endpoint and clinical extensions is verified, but direct event/treatment-replacement results, denominators and follow-up are unverified within the current material. This gap does not remove the SBP report.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "Separate plans, denominators, follow-up and results actually comparing events or treatment replacement" }, { "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.", "current_reports": [ "S01", "S02" ], "existence": "Stored research/bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original manufacturing/support/harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific conditions/application records were read. Linked external abstracts, full texts, registration and planning material remain unread, with no access attempt.", "observation": "The original safety label is Caution. The retained safety wording is: monitor dizziness, hypotension and possible interactions when combined with blood-pressure medicines, and do not reduce prescribed treatment on one's own. Actual observed adverse events, collection methods, event/safety denominators and discontinuation results are not linked in the current summaries of both efficacy reports.", "condition_status": "Partly verified", "status_reason": "The general caution is retained, but it does not verify actual harm records for the same exposure and population. An efficacy summary is not filled in as evidence of safety.", "missingness": "The general caution is retained, but it does not verify actual harm records for the same exposure and population. An efficacy summary is not filled in as evidence of safety.", "uncertainty": "The general caution is retained, but it does not verify actual harm records for the same exposure and population. An efficacy summary is not filled in as evidence of safety.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "Adverse-event collection methods, event/exposure denominators, discontinuations and observation periods for the trial" }, { "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.", "current_reports": [ "S01", "S02" ], "existence": "Stored research/bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original manufacturing/support/harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific conditions/application records were read. Linked external abstracts, full texts, registration and planning material remain unread, with no access attempt.", "observation": "Dizziness, hypotension and interactions are listed in the current safety caution and product information. Observed values for event diagnosis, occurrence/worsening, collection, severity and discontinuation could not be verified in the retained summary.", "condition_status": "Unverified", "status_reason": "Recommendations are not converted into actual events or confirmed diagnoses, and absence of adverse-event reporting in the unread external article is not established.", "missingness": "Recommendations are not converted into actual events or confirmed diagnoses, and absence of adverse-event reporting in the unread external article is not established.", "uncertainty": "Recommendations are not converted into actual events or confirmed diagnoses, and absence of adverse-event reporting in the unread external article is not established.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "Original adverse-event definitions, collection/adjudication procedures, and event, severity and discontinuation tables" }, { "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.", "current_reports": [ "S01" ], "existence": "Stored research/bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original manufacturing/support/harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific conditions/application records were read. Linked external abstracts, full texts, registration and planning material remain unread, with no access attempt.", "observation": "Nominal administration of 2 g/day for 12 weeks is recorded. Actual harm onset, discontinuation, recovery, re-exposure and event-specific observation periods for this trial are not provided.", "condition_status": "Unverified", "status_reason": "Treatment duration is not converted into event-onset or recovery timing. Original records needed to verify temporal order and harm causality remain unread.", "missingness": "Treatment duration is not converted into event-onset or recovery timing. Original records needed to verify temporal order and harm causality remain unread.", "uncertainty": "Treatment duration is not converted into event-onset or recovery timing. Original records needed to verify temporal order and harm causality remain unread.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "Exposure/event timelines and records of discontinuation, recovery and re-exposure" }, { "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.", "current_reports": [ "S01" ], "existence": "Stored research/bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original manufacturing/support/harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific conditions/application records were read. Linked external abstracts, full texts, registration and planning material remain unread, with no access attempt.", "observation": "Starch placebo plus the same lifestyle counseling specifies the efficacy comparison. Actual adverse events by group and comparative harm estimates are unavailable in the retained summary.", "condition_status": "Unverified", "status_reason": "Verifying an efficacy comparator does not verify comparative harm results. Background incidence or increased risk is not extrapolated.", "missingness": "Verifying an efficacy comparator does not verify comparative harm results. Background incidence or increased risk is not extrapolated.", "uncertainty": "Verifying an efficacy comparator does not verify comparative harm results. Background incidence or increased risk is not extrapolated.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "Adverse-event tables by group and event-specific comparison denominators/analyses" }, { "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.", "current_reports": [ "S01", "S02" ], "existence": "Stored research/bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original manufacturing/support/harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific conditions/application records were read. Linked external abstracts, full texts, registration and planning material remain unread, with no access attempt.", "observation": "The 38 randomized participants, 37 completers (19/18), and the meta-analysis's 12 RCTs/13 effects are efficacy/reporting denominators. No linked adverse-event table supplies a safety-analysis denominator, people/event counts, exposed participants or exposure time.", "condition_status": "Unverified", "status_reason": "The denominators, time and events needed to calculate current harm incidence are unverified. Do not create 0 events/0% or reuse efficacy denominators as safety denominators.", "missingness": "The denominators, time and events needed to calculate current harm incidence are unverified. Do not create 0 events/0% or reuse efficacy denominators as safety denominators.", "uncertainty": "The denominators, time and events needed to calculate current harm incidence are unverified. Do not create 0 events/0% or reuse efficacy denominators as safety denominators.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "Safety-analysis populations, people/event counts and exposure-duration tables" }, { "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.", "current_reports": [ "S01" ], "existence": "Stored research/bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original manufacturing/support/harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific conditions/application records were read. Linked external abstracts, full texts, registration and planning material remain unread, with no access attempt.", "observation": "The direct trial's population details exclude antihypertensive users, whereas the safety wording cautions about combining ginger with blood-pressure medicines. Records of other concomitant medications, underlying diseases, lifestyle changes, actual alternative explanations for harm or their adjustment are unavailable for this trial.", "condition_status": "Unverified", "status_reason": "A general combination-use caution is not attributed as an observed interaction in a direct trial excluding antihypertensive users. Absence of other causes is not inferred.", "missingness": "A general combination-use caution is not attributed as an observed interaction in a direct trial excluding antihypertensive users. Absence of other causes is not inferred.", "uncertainty": "A general combination-use caution is not attributed as an observed interaction in a direct trial excluding antihypertensive users. Absence of other causes is not inferred.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "Concomitant medications, underlying conditions, lifestyle changes and adjustment records in harm cases/trials" }, { "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.", "current_reports": [ "S01" ], "existence": "Stored research/bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original manufacturing/support/harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific conditions/application records were read. Linked external abstracts, full texts, registration and planning material remain unread, with no access attempt.", "observation": "Direct-trial completion counts and completer-analysis limitations are retained, but original records of adverse-event collection, selection/recall/detection, missing safety follow-up and discontinuation reasons were not read in this work.", "condition_status": "Unverified", "status_reason": "Unverified information in a summary is not converted into confirmed nonreporting of harms in the original article, absence of harm or a known extent of missingness.", "missingness": "Unverified information in a summary is not converted into confirmed nonreporting of harms in the original article, absence of harm or a known extent of missingness.", "uncertainty": "Unverified information in a summary is not converted into confirmed nonreporting of harms in the original article, absence of harm or a known extent of missingness.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "Original collection procedures and the reporting scope for all adverse events, discontinuations and dropouts" }, { "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.", "current_reports": [ "S01", "S02" ], "existence": "Stored research/bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original manufacturing/support/harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific conditions/application records were read. Linked external abstracts, full texts, registration and planning material remain unread, with no access attempt.", "observation": "The current retained material contains a direct efficacy report, a meta-analysis and general safety cautions. Identities and repeat reporting/citation of separate independent harm events or materials are not linked, and no new safety search was performed.", "condition_status": "Unverified", "status_reason": "Meta-analysis, Korean/English repetition and caution wording are not counted as independent events. Unconfirmed unique harm replication or total safety-study counts do not mean 0 studies.", "missingness": "Meta-analysis, Korean/English repetition and caution wording are not counted as independent events. Unconfirmed unique harm replication or total safety-study counts do not mean 0 studies.", "uncertainty": "Meta-analysis, Korean/English repetition and caution wording are not counted as independent events. Unconfirmed unique harm replication or total safety-study counts do not mean 0 studies.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "Independent original safety reports with specified identities and exposures/events, and a repeat-citation mapping table" }, { "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.", "current_reports": [ "S01", "S02" ], "existence": "Stored research/bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original manufacturing/support/harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific conditions/application records were read. Linked external abstracts, full texts, registration and planning material remain unread, with no access attempt.", "observation": "The current direct comparison concerns adults with metabolic syndrome not using antihypertensives over 12 weeks. Direct safety material on long-term or rare events, combined medication use, pregnancy and other vulnerable populations is outside the current verified scope.", "condition_status": "Unverified", "status_reason": "A limited efficacy population/period is not extended into overall safety. The narrow SBP question does not require every long-term or rare-harm trial.", "missingness": "A limited efficacy population/period is not extended into overall safety. The narrow SBP question does not require every long-term or rare-harm trial.", "uncertainty": "A limited efficacy population/period is not extended into overall safety. The narrow SBP question does not require every long-term or rare-harm trial.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "Safety observation, comparison and registration material suited to the target vulnerable population and duration" }, { "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.", "current_reports": [ "S01", "S02" ], "existence": "Stored research/bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original manufacturing/support/harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific conditions/application records were read. Linked external abstracts, full texts, registration and planning material remain unread, with no access attempt.", "observation": "The current caution and wording about monitoring combined use with blood-pressure medicines and avoiding self-directed dose reduction are retained. They do not verify event counts, comparative risk, causality or a safety grade in this trial; harm design, denominators, timing and alternatives remain unverified.", "condition_status": "Met", "status_reason": "This verifies the interpretation boundary and retained uncertainty of a cautionary statement. It does not create a new judgment that harm occurred or safety was established, or provide personal dosing instructions.", "missingness": "This verifies the interpretation boundary and retained uncertainty of a cautionary statement. It does not create a new judgment that harm occurred or safety was established, or provide personal dosing instructions.", "uncertainty": "This verifies the interpretation boundary and retained uncertainty of a cautionary statement. It does not create a new judgment that harm occurred or safety was established, or provide personal dosing instructions.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "Actual original harm material linking design, comparison, denominators, timing and alternative explanations" } ], "reports": [ { "report_id": "S01", "title": "Rahimlou M et al. Diabetol Metab Syndr. 2019. PMID: 31275882. PMCID: PMC6582048. DOI: 10.1007/s40200-019-00397-z.", "url": "https://pubmed.ncbi.nlm.nih.gov/31275882/", "report_type": "Stored summary of a direct dried-ginger-powder trial in metabolic syndrome", "existence": "Stored research/bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original manufacturing/support/harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific conditions/application records were read. Linked external abstracts, full texts, registration and planning material remain unread, with no access attempt.", "study_family": "The Rahimlou 2019 direct report distinguishes 38 randomized participants from 37 completers (19/18). Arm mapping, exact analysis denominators, SBP prespecification and inclusion in the meta-analysis remain unverified.", "independent_replication": "The Rahimlou 2019 direct report distinguishes 38 randomized participants from 37 completers (19/18). Arm mapping, exact analysis denominators, SBP prespecification and inclusion in the meta-analysis remain unverified.", "observed_result": "Adjusted between-group P=.165; raw change difference from rounded means −1.12 mmHg; adjusted CI unverified", "result_level": "These are retained reported values and limitations, not current full-text verification or recalculation.", "source_evidence_date": "2026-09-08", "materials": [ { "material_type": "Stored existing review summary", "public_status": "Locally retained; stored summary read", "access_status": "Acquired", "acquired": true, "actually_read": "Stored existing review summary read", "as_of": "2026-10-06", "qualification": "The linked summary, Korean/English evidence and bibliography were read in the retained record. This does not verify original article bytes or full text. The roles of 38 randomized participants and 37 completers (19/18) are preserved. Arm mapping, adjusted effect/CI, actual SBP prespecification, registration and observed harm records remain unverified. The material date 2026-10-06 concerns retained-summary review. Observations were applied after the conditions were frozen; historical records of later observation-wording and external-unread display changes were retained. The original verdict date 2026-09-08 and correction date 2026-09-14 are not new-search or external-full-text-reading dates." }, { "material_type": "External bibliography and abstract", "public_status": "Existence, availability and acquisition unverified; not read", "access_status": "Access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-10-06", "qualification": "This is a retained PubMed entry point. Current response and abstract reading were not verified. The roles of 38 randomized participants and 37 completers (19/18) are preserved. Arm mapping, adjusted effect/CI, actual SBP prespecification, registration and observed harm records remain unverified. The material date 2026-10-06 concerns retained-summary review. Observations were applied after the conditions were frozen; historical records of later observation-wording and external-unread display changes were retained. The original verdict date 2026-09-08 and correction date 2026-09-14 are not new-search or external-full-text-reading dates." }, { "material_type": "Original full text and DOI entry point", "public_status": "Existence, availability and acquisition unverified; not read", "access_status": "Access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-10-06", "qualification": "This full-text entry point was constructed from the DOI in the retained bibliography. Full-text existence, access, downloading and reading are unverified. The roles of 38 randomized participants and 37 completers (19/18) are preserved. Arm mapping, adjusted effect/CI, actual SBP prespecification, registration and observed harm records remain unverified. The material date 2026-10-06 concerns retained-summary review. Observations were applied after the conditions were frozen; historical records of later observation-wording and external-unread display changes were retained. The original verdict date 2026-09-08 and correction date 2026-09-14 are not new-search or external-full-text-reading dates." }, { "material_type": "PMC full-text entry point", "public_status": "Existence, availability and acquisition unverified; not read", "access_status": "Access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-10-06", "qualification": "This full-text entry point was constructed from the retained PMCID. Current response, full text and accessibility are unverified; it is another entry point for the same report, not a separate trial. The roles of 38 randomized participants and 37 completers (19/18) are preserved. Arm mapping, adjusted effect/CI, actual SBP prespecification, registration and observed harm records remain unverified. The material date 2026-10-06 concerns retained-summary review. Observations were applied after the conditions were frozen; historical records of later observation-wording and external-unread display changes were retained. The original verdict date 2026-09-08 and correction date 2026-09-14 are not new-search or external-full-text-reading dates." }, { "material_type": "Trial registration", "public_status": "Existence, availability and acquisition unverified; not read", "access_status": "Access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-10-06", "qualification": "Unverified registration does not establish that registration was absent. Meta-analysis registration and included-trial registration are distinguished; no registration ID or location was created. The roles of 38 randomized participants and 37 completers (19/18) are preserved. Arm mapping, adjusted effect/CI, actual SBP prespecification, registration and observed harm records remain unverified. The material date 2026-10-06 concerns retained-summary review. Observations were applied after the conditions were frozen; historical records of later observation-wording and external-unread display changes were retained. The original verdict date 2026-09-08 and correction date 2026-09-14 are not new-search or external-full-text-reading dates." }, { "material_type": "Original supplementary material", "public_status": "Existence, availability and acquisition unverified; not read", "access_status": "Access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-10-06", "qualification": "Supplement existence, exact location and original bytes are unverified. This does not establish supplement absence or actual access failure. The roles of 38 randomized participants and 37 completers (19/18) are preserved. Arm mapping, adjusted effect/CI, actual SBP prespecification, registration and observed harm records remain unverified. The material date 2026-10-06 concerns retained-summary review. Observations were applied after the conditions were frozen; historical records of later observation-wording and external-unread display changes were retained. The original verdict date 2026-09-08 and correction date 2026-09-14 are not new-search or external-full-text-reading dates." } ], "links": [ { "label": "PubMed", "url": "https://pubmed.ncbi.nlm.nih.gov/31275882/" } ] }, { "report_id": "S02", "title": "Karimi M et al. J Hum Nutr Diet. 2026;39:e70329. PMID: 42566667. PMCID: PMC13450692. DOI: 10.1111/jhn.70329.", "url": "https://pubmed.ncbi.nlm.nih.gov/42566667/", "report_type": "Stored summary of a GRADE dose-response meta-analysis", "existence": "Stored research/bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original manufacturing/support/harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific conditions/application records were read. Linked external abstracts, full texts, registration and planning material remain unread, with no access attempt.", "study_family": "The Karimi 2026 synthesis distinguishes 12 unique RCTs from 13 SBP effects. They are not converted into independent replications of the current direct question or a confirmed participant total.", "independent_replication": "The Karimi 2026 synthesis distinguishes 12 unique RCTs from 13 SBP effects. They are not converted into independent replications of the current direct question or a confirmed participant total.", "observed_result": "WMD −5.03 mmHg, 95% CI −8.49~−1.57, P=.004; low certainty of evidence", "result_level": "These are retained reported values and limitations, not current full-text verification or recalculation.", "source_evidence_date": "2026-09-08", "materials": [ { "material_type": "Stored existing review summary", "public_status": "Locally retained; stored summary read", "access_status": "Acquired", "acquired": true, "actually_read": "Stored existing review summary read", "as_of": "2026-10-06", "qualification": "The linked summary, Korean/English evidence and bibliography were read in the retained record. This does not verify original article bytes or full text. The 12 unique RCTs and 13 SBP effects are wording from the retained report. Included trials, overlap, analysis-specific denominators, heterogeneity and detailed GRADE domains remain unverified. The material date 2026-10-06 concerns retained-summary review. Observations were applied after the conditions were frozen; historical records of later observation-wording and external-unread display changes were retained. The original verdict date 2026-09-08 and correction date 2026-09-14 are not new-search or external-full-text-reading dates." }, { "material_type": "External bibliography and abstract", "public_status": "Existence, availability and acquisition unverified; not read", "access_status": "Access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-10-06", "qualification": "This is a retained PubMed entry point. Current response and abstract reading were not verified. The 12 unique RCTs and 13 SBP effects are wording from the retained report. Included trials, overlap, analysis-specific denominators, heterogeneity and detailed GRADE domains remain unverified. The material date 2026-10-06 concerns retained-summary review. Observations were applied after the conditions were frozen; historical records of later observation-wording and external-unread display changes were retained. The original verdict date 2026-09-08 and correction date 2026-09-14 are not new-search or external-full-text-reading dates." }, { "material_type": "Original full text and DOI entry point", "public_status": "Existence, availability and acquisition unverified; not read", "access_status": "Access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-10-06", "qualification": "This full-text entry point was constructed from the DOI in the retained bibliography. Full-text existence, access, downloading and reading are unverified. The 12 unique RCTs and 13 SBP effects are wording from the retained report. Included trials, overlap, analysis-specific denominators, heterogeneity and detailed GRADE domains remain unverified. The material date 2026-10-06 concerns retained-summary review. Observations were applied after the conditions were frozen; historical records of later observation-wording and external-unread display changes were retained. The original verdict date 2026-09-08 and correction date 2026-09-14 are not new-search or external-full-text-reading dates." }, { "material_type": "PMC full-text entry point", "public_status": "Existence, availability and acquisition unverified; not read", "access_status": "Access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-10-06", "qualification": "This full-text entry point was constructed from the retained PMCID. Current response, full text and accessibility are unverified; it is another entry point for the same report, not a separate trial. The 12 unique RCTs and 13 SBP effects are wording from the retained report. Included trials, overlap, analysis-specific denominators, heterogeneity and detailed GRADE domains remain unverified. The material date 2026-10-06 concerns retained-summary review. Observations were applied after the conditions were frozen; historical records of later observation-wording and external-unread display changes were retained. The original verdict date 2026-09-08 and correction date 2026-09-14 are not new-search or external-full-text-reading dates." }, { "material_type": "Meta-analysis registration and list of included trials", "public_status": "Existence, availability and acquisition unverified; not read", "access_status": "Access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-10-06", "qualification": "Unverified registration does not establish that registration was absent. Meta-analysis registration and included-trial registration are distinguished; no registration ID or location was created. The 12 unique RCTs and 13 SBP effects are wording from the retained report. Included trials, overlap, analysis-specific denominators, heterogeneity and detailed GRADE domains remain unverified. The material date 2026-10-06 concerns retained-summary review. Observations were applied after the conditions were frozen; historical records of later observation-wording and external-unread display changes were retained. The original verdict date 2026-09-08 and correction date 2026-09-14 are not new-search or external-full-text-reading dates." }, { "material_type": "Original supplementary material", "public_status": "Existence, availability and acquisition unverified; not read", "access_status": "Access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-10-06", "qualification": "Supplement existence, exact location and original bytes are unverified. This does not establish supplement absence or actual access failure. The 12 unique RCTs and 13 SBP effects are wording from the retained report. Included trials, overlap, analysis-specific denominators, heterogeneity and detailed GRADE domains remain unverified. The material date 2026-10-06 concerns retained-summary review. Observations were applied after the conditions were frozen; historical records of later observation-wording and external-unread display changes were retained. The original verdict date 2026-09-08 and correction date 2026-09-14 are not new-search or external-full-text-reading dates." } ], "links": [ { "label": "PubMed", "url": "https://pubmed.ncbi.nlm.nih.gov/42566667/" } ] } ], "method_sources": [ { "id": "M03", "version": "Cochrane Handbook 6.5 (2024), chapter updated 2023-08", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-03", "section": "§3.1, §3.2.1–3.2.3, MECIR C5/C7/C13", "official_principle": "Clearly record the question, eligibility conditions and reasons for changes, and distinguish variations in interventions.", "review_level": "Retained method-application records were reused. External originals were not reread and method content was not reassessed." }, { "id": "M04", "version": "Cochrane Handbook 6.5.1 (2025), chapter updated 2025-03", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-04", "section": "§4.5, §4.6.1–4.6.3, MECIR C42", "official_principle": "Distinguish studies from reports and link them; do not omit a study solely because results are unreported.", "review_level": "Retained method-application records were reused. External originals were not reread and method content was not reassessed." }, { "id": "M08", "version": "Cochrane Handbook 6.5 (2024), chapter updated 2019-10", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-08", "section": "§8.1–8.2.3, Table 8.2.a", "official_principle": "Define the outcome and effect of interest, then examine randomization, deviations, missing data, measurement and selective reporting.", "review_level": "Retained method-application records were reused. External originals were not reread and method content was not reassessed." }, { "id": "M15", "version": "Cochrane Handbook 6.5 (2024), chapter updated 2023-08", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-15", "section": "§15.2.4, §15.3.1–15.3.3", "official_principle": "Distinguish effect estimates, intervals, importance and applicability. Sample size alone does not determine precision.", "review_level": "Retained method-application records were reused. External originals were not reread and method content was not reassessed." }, { "id": "M19", "version": "Cochrane Handbook 6.5 (2024), chapter updated 2019-10", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-19", "section": "§19.1.2, §19.2.1–19.2.4", "official_principle": "Harm questions may require different designs, populations and follow-up from efficacy questions. Case reports do not establish incidence rates.", "review_level": "Retained method-application records were reused. External originals were not reread and method content was not reassessed." } ], "status_dictionary": { "Partly verified": "Partial information from the stored summary is linked; detailed originals and content review remain incomplete.", "Unverified": "Required details cannot be established within the preserved scope. This does not establish absence of effects or studies, or safety.", "Review incomplete": "Review of existing content remains incomplete.", "Met": "The selected condition for material, identity or preservation was verified; this does not establish efficacy success or independent clinical validation.", "Not reported": "Unreported within material actually read. Unread external material is not relabeled as unreported.", "Inaccessible": "This means actual access failure. External access was not attempted in this work, so this state was not assigned.", "Not applicable": "Used only with an application exception and reason based on the question scope.", "Conflicting data": "This requires actual comparison of materials; no new conflict judgment was made in this work.", "Insufficient evidence for the conditions": "This indicates gaps in additional material for the selected conditions. Unread material as a whole is not converted into an efficacy grade." }, "study_overlap": { "state": "Unverified", "unique_trial_count": null, "unique_participant_count": null, "reason": "The direct report and meta-analysis are not added as independent replications of the same question. The 12 unique RCTs and 13 SBP effects are wording from the retained meta-analysis; inclusion of the direct trial, overlap with other meta-analyses, unique trials and total participants remain unverified. The diabetes background reference is not added as a separate report." }, "history": [ { "date": "2026-10-25", "kind": "Separation of public-facing pages and materials", "view_version": "1.0", "change": "The public view and materials were prepared from the existing 33 items. No new clinical search, verification-state change or scoring was performed." } ], "language": "en", "translation_date": "2026-10-25" }