{ "schema_version": "chamgap-public-evidence-check-1.0", "public_id": "v3052-main", "verdict_number": "3052", "title": "500-mg dried ginger-powder capsules × Reduction of LDL cholesterol in adults", "view_version": "1.0", "view_created_date": "2026-10-25", "criteria_version": "1.1", "criteria_date": "2026-10-06", "review_date": "2026-10-06", "legacy_evidence_date": "2026-09-08", "review_scope": { "materials_read": "Retained Korean/English summaries and case-specific conditions/application records", "clinical_papers_directly_read": false, "new_clinical_search": false, "limitation": "Prepared from retained summaries and condition-application records. External abstracts, full texts, registration, protocols and analysis plans remain unread. Historical review records do not establish current independent clinical validation.", "date_meaning": "The material record dated 2026-10-06 concerns retained-summary review. Condition 1.1 refinement before observation application and later preservation/reading-disclosure status changes were separately retained. The original verdict date 2026-09-08 and correction date 2026-09-14 are not new-search or full-text-reading dates." }, "claim_context": { "population": "Adults with type 2 diabetes maintaining existing oral glucose-lowering medication. A statin add-on population cannot be established; detailed eligibility and baseline characteristics are also unverified.", "intervention": "Oral 500 mg capsules of dried ginger rhizome powder. Gingerol/shogaol assay, manufacturing and quality are unverified.", "dose": "1 g per dose, 2 times daily, 2 g/day total. Nominal powder quantity remains distinct from active-constituent assay or equivalent amounts for other products.", "comparator": "Wheat-flour placebo plus usual care. Lipid-medication control is recorded as inadequate; details of arm-specific medication, changes, diet, activity and rescue care remain unverified.", "endpoint": "The selected question is the between-group LDL-C difference at 10 weeks. The retained report gives final arm values and describes a registered secondary (2nd) endpoint. Exact change differences, adjusted CIs and comparison of actual registration/planning originals remain unverified.", "duration": "10 weeks of treatment. Actual adherence, post-treatment follow-up, long-term results and extension to special populations remain separately unverified.", "excluded_extensions": [ "This addresses LDL-C alone; TG, HDL, total cholesterol and HbA1c are separate questions.", "Final LDL-C 100±42.1 versus 107±34.3 mg/dL, P=.57, is not calculated into a change difference or new confidence interval. Whether ± denotes SD or SE remains unverified.", "Retain pooled MD -5.36 mg/dL, 95% CI -12.37 to 1.65, I²=90.93%. An interval including 0 does not prove effect 0 or equivalence.", "The approximately 5.14 mg/dL reduction across 26 trials in 2022 is a historical narrative in the original record. Separate exact bibliography/original tables were not acquired and no new report was added in this work.", "Statin replacement, cardiovascular-event prevention, other doses, products, populations, long-term persistence and rare harms require separate direct material." ] }, "requirements": [ { "item_id": "N01", "question_type": "Evidence condition", "question": "Which type 2 diabetes population and 10-week endpoint comparison are being checked?", "needed": "Current LDL-C claim, Korean/English intervention/population details, oral powder 2 g/day, 10 weeks, comparator and independent boundary", "role": "Required", "role_reason": "Needed to read the original claim with the actual T2D and concomitant-medication contract", "application_exception": "Read the broad adult wording of the Korean claim alongside the T2D/concomitant-treatment scope. Retain only the main question without automatically generating independent claims for other endpoints or formulations.", "criterion": "Keep the LDL-C question distinct from other endpoints, formulations and populations and link it to the original location.", "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.", "condition_origin": "These existing in-house conditions concern dried ginger powder and a 10-week LDL-C comparison in adults with type 2 diabetes. They do not establish preregistration, official-tool certification or new independent clinical validation.", "proposed_research": "Material needed: Current LDL-C claim, Korean/English intervention/population details, oral powder 2 g/day, 10 weeks, comparator and independent boundary. This records needed materials; no new research was executed.", "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 LDL-C reduction in adults. The selected details connect LDL-C with dried ginger-powder 500 mg capsules, 2 g/day for 10 weeks, versus wheat-flour placebo plus usual care with inadequately controlled lipid medication in adults with type 2 diabetes maintaining oral glucose-lowering medication; a statin add-on population cannot be established.", "condition_status": "Met", "status_reason": "The question, population, intervention, comparator, timing and main boundary were identified within retained material. This is not a status of demonstrated efficacy.", "missingness": "External eligibility and original-trial details are outside this boundary-identification status.", "uncertainty": "The table organizes retained evidence for the selected endpoint and does not certify efficacy in all adults or products.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "Current LDL-C claim, Korean/English intervention/population details, oral powder 2 g/day, 10 weeks, comparator and independent boundary" }, { "item_id": "N02", "question_type": "Evidence condition", "question": "Is the same direct trial counted again in another endpoint table?", "needed": "Direct-trial PMID/PMC/DOI, bibliographic NCT, report title and LDL/HbA1c correspondence", "role": "Required", "role_reason": "Needed to avoid adding the same sample as a new independent trial in different endpoint tables", "application_exception": "Retain endpoint-specific results even when the endpoints use the same trial report. Table/report counts are not unique-trial counts.", "criterion": "Link matching report identifiers across the endpoints while retaining endpoint-specific estimates and avoiding certification of unique trials or participants.", "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.", "condition_origin": "These existing in-house conditions concern dried ginger powder and a 10-week LDL-C comparison in adults with type 2 diabetes. They do not establish preregistration, official-tool certification or new independent clinical validation.", "proposed_research": "Material needed: Direct-trial PMID/PMC/DOI, bibliographic NCT, report title and LDL/HbA1c correspondence. This records needed materials; no new research was executed.", "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 report is The Effects of Ginger on Fasting Blood Sugar, Hemoglobin A1c, and Lipid Profiles in Patients with Type 2 Diabetes; PMID29344037, PMC5750786, DOI10.5812/ijem.57927, bibliographic NCT02666807. Table 3051 also uses this report and its 50 randomized/45 analyzed participants (23/22). LDL/HbA1c are different outcomes and are not added into 100/90.", "condition_status": "Partly verified", "status_reason": "The historical record describes full reading of both retained records and agreement of report identity/denominator literals; external trial/participant details were not compared.", "missingness": "Unique-trial/participant certification and endpoint-specific duplication details are unverified.", "uncertainty": "Different endpoints under the same bibliography are not independent replication; unique counts remain null.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "Direct-trial PMID/PMC/DOI, bibliographic NCT, report title and LDL/HbA1c correspondence" }, { "item_id": "N03", "question_type": "Evidence condition", "question": "How are matching review identifiers, different titles and included trials linked?", "needed": "Review PMID/PMC/DOI, record-specific bibliographic/title literals, included-trial table and endpoint contribution/overlap", "role": "Required", "role_reason": "Needed to avoid converting the same review into independent replication or exact bibliographic certification", "application_exception": "Do not harmonize record-specific study-title literals merely because bibliographic identifiers match. A missing included-trial table does not establish no overlap.", "criterion": "Retain the verification level for matching identifiers and different titles, distinguishing paper counts from unique-trial counts.", "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.", "condition_origin": "These existing in-house conditions concern dried ginger powder and a 10-week LDL-C comparison in adults with type 2 diabetes. They do not establish preregistration, official-tool certification or new independent clinical validation.", "proposed_research": "Material needed: Review PMID/PMC/DOI, record-specific bibliographic/title literals, included-trial table and endpoint contribution/overlap. This records needed materials; no new research was executed.", "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 review title is Meta-analysis of the effects of ginger supplementation on glycemic control, blood pressure and lipid profile in patients with type 2 diabetes. Bibliographic PMID42337792, PMC13495174 and DOI10.1186/s13643-026-03251-5 match the other endpoint record, while the study title/bibliographic author display differ. The sample wording is 13 papers overall, with an LDL-contributing subset.", "condition_status": "Partly verified", "status_reason": "Matching retained identifiers and different titles were linked as recorded. Without an included-trial table, endpoint contribution and overlap with the direct trial could not be compared.", "missingness": "Exact review-title/author identity, included trials, endpoint subsets and unique participants are unverified.", "uncertainty": "13 papers do not mean 13 unique trials or replication of the same formulation. Separate bibliographic corrections: 0.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "Review PMID/PMC/DOI, record-specific bibliographic/title literals, included-trial table and endpoint contribution/overlap" }, { "item_id": "N04", "question_type": "Evidence condition", "question": "Which retained summaries and external originals were actually read?", "needed": "Retained summaries, bibliography/abstracts, full texts, access attempts and acquisition/reading records by material type", "role": "Required", "role_reason": "Needed to avoid upgrading original links into full-text reading records", "application_exception": "Acknowledge reading of retained summaries without labeling it full-text or registration reading. Unattempted external access is not inaccessibility.", "criterion": "Display actual reading of retained local summaries separately from unread external full texts/abstracts/registration and unattempted access.", "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.", "condition_origin": "These existing in-house conditions concern dried ginger powder and a 10-week LDL-C comparison in adults with type 2 diabetes. They do not establish preregistration, official-tool certification or new independent clinical validation.", "proposed_research": "Material needed: Retained summaries, bibliography/abstracts, full texts, access attempts and acquisition/reading records by material type. This records needed materials; no new research was executed.", "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": "Actual reading in this work covers the complete retained original and its research/bibliographic summaries. External PubMed/abstracts, PMC/publisher full texts and registration for its reports were neither read nor accessed. Original links are not reading records.", "condition_status": "Met", "status_reason": "This condition concerns disclosure of reading level. Actual reading of the full retained summary and unattempted/unread linked external materials were separately disclosed by material, meeting that disclosure scope. External-original and clinical-content verification remain unverified.", "missingness": "External full-text/abstract/registration/protocol/SAP files were not acquired or read; this is not inaccessibility.", "uncertainty": "Historical verification/date and review wording are not backdated into successful external access in this work.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "Retained summaries, bibliography/abstracts, full texts, access attempts and acquisition/reading records by material type" }, { "item_id": "N05", "question_type": "Evidence condition", "question": "Were registration, protocol and SAP actually acquired and compared?", "needed": "Bibliographic NCT string, original registration field, registration version/time and protocol/SAP originals", "role": "Required", "role_reason": "Needed to avoid treating a registration identifier as verification of a prespecified plan", "application_exception": "An NCT string does not establish completed acquisition/comparison of registration, protocol or SAP. Unacquired material is not described as nonregistration.", "criterion": "Distinguish historical registration narratives from the current level of retained bibliographic strings, leaving external comparison unverified.", "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.", "condition_origin": "These existing in-house conditions concern dried ginger powder and a 10-week LDL-C comparison in adults with type 2 diabetes. They do not establish preregistration, official-tool certification or new independent clinical validation.", "proposed_research": "Material needed: Bibliographic NCT string, original registration field, registration version/time and protocol/SAP originals. This records needed materials; no new research was executed.", "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 bibliography includes NCT02666807, while its original registration field says unverified. Protocol/SAP originals and registration version, time and page positions are not specified in the retained record and were not accessed in this work.", "condition_status": "Unverified", "status_reason": "A bibliographic string alone cannot meet registration/planning-content comparison or actual-acquisition requirements.", "missingness": "External registration/protocol/SAP, versions, times and original locations remain unverified.", "uncertainty": "Unacquired material does not establish nonregistration, no plan or confirmed selective reporting.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "Bibliographic NCT string, original registration field, registration version/time and protocol/SAP originals" }, { "item_id": "N06", "question_type": "Evidence condition", "question": "Who is the selected T2D population, including exclusions and baseline characteristics?", "needed": "Age/diagnosis, insulin/lipid medication, baseline LDL-C, eligibility and arm-specific characteristics of adults with type 2 diabetes maintaining oral glucose-lowering medication; a statin add-on population cannot be established", "role": "Required", "role_reason": "Needed to avoid extrapolating differences in study populations into efficacy for all adults", "application_exception": "Retain record-specific insulin/statin wording differences. Matching T2D labels do not authorize importing baseline/exclusion criteria from another record.", "criterion": "Link only the stated population, preserving record-specific nonuse-of-insulin/statin limitations.", "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.", "condition_origin": "These existing in-house conditions concern dried ginger powder and a 10-week LDL-C comparison in adults with type 2 diabetes. They do not establish preregistration, official-tool certification or new independent clinical validation.", "proposed_research": "Material needed: Age/diagnosis, insulin/lipid medication, baseline LDL-C, eligibility and arm-specific characteristics of adults with type 2 diabetes maintaining oral glucose-lowering medication; a statin add-on population cannot be established. This records needed materials; no new research was executed.", "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 is adults with type 2 diabetes maintaining oral glucose-lowering medication; a statin add-on population cannot be established. That limitation is retained as written. Nonuse-of-insulin wording from the other HbA1c record is not inserted into this LDL population field.", "condition_status": "Partly verified", "status_reason": "The selected T2D/concomitant-treatment scope is retained, but original recruitment and arm-specific baseline characteristics are unavailable.", "missingness": "Age, diagnostic criteria, arm-specific baseline measures/exclusions and selection flow remain unverified.", "uncertainty": "A population summary is not extended into efficacy for all adults or other medication groups.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "Age/diagnosis, insulin/lipid medication, baseline LDL-C, eligibility and arm-specific characteristics of adults with type 2 diabetes maintaining oral glucose-lowering medication; a statin add-on population cannot be established" }, { "item_id": "N07", "question_type": "Evidence condition", "question": "What are the dried powder's composition, capsules and actual administered amount?", "needed": "Rhizome, 500 mg capsules, 2 g/day, dosing frequency, gingerol/shogaol assay and manufacturing/quality", "role": "Required", "role_reason": "Needed to avoid applying a formulation or dose directly to other products", "application_exception": "Nominal capsule powder quantity differs from gingerol/shogaol active-constituent assay. Unverified assay does not establish 0 active constituent or a defective product.", "criterion": "Distinguish nominal powder amount from active-constituent assay/actual adherence without treating foods or extracts as automatically equivalent.", "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.", "condition_origin": "These existing in-house conditions concern dried ginger powder and a 10-week LDL-C comparison in adults with type 2 diabetes. They do not establish preregistration, official-tool certification or new independent clinical validation.", "proposed_research": "Material needed: Rhizome, 500 mg capsules, 2 g/day, dosing frequency, gingerol/shogaol assay and manufacturing/quality. This records needed materials; no new research was executed.", "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 formulation is dried ginger-powder 500 mg capsules; gingerol/shogaol assay is unverified. Zingiber officinale Roscoe rhizome was taken orally at 1 g, 2 times daily, 2 g/day total. Nominal powder quantity remains distinct from gingerol/shogaol assay.", "condition_status": "Partly verified", "status_reason": "Nominal formulation/dose appear in the current record, but active constituents, manufacturing/quality and actual adherence are unverified.", "missingness": "Gingerol/shogaol assay, manufacturing/consistency and actual intake remain unverified.", "uncertainty": "There is no automatic equivalence with standardized extracts, foods, essential oils or combinations.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "Rhizome, 500 mg capsules, 2 g/day, dosing frequency, gingerol/shogaol assay and manufacturing/quality" }, { "item_id": "N08", "question_type": "Evidence condition", "question": "What actually differed between placebo and existing treatment in the arms?", "needed": "Wheat-flour placebo, continued oral glucose-lowering medication, lipid-medication control and arm-specific concomitant treatment/changes", "role": "Required", "role_reason": "Needed to avoid attributing concomitant-treatment differences to powder alone", "application_exception": "Shared continuation of existing medication differs from control of arm-specific changes. Inadequate lipid-medication control does not determine success/failure of statin add-on or statin replacement.", "criterion": "Separate shared existing care from added ginger and do not convert the comparison into statin-add-on or medication-replacement efficacy.", "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.", "condition_origin": "These existing in-house conditions concern dried ginger powder and a 10-week LDL-C comparison in adults with type 2 diabetes. They do not establish preregistration, official-tool certification or new independent clinical validation.", "proposed_research": "Material needed: Wheat-flour placebo, continued oral glucose-lowering medication, lipid-medication control and arm-specific concomitant treatment/changes. This records needed materials; no new research was executed.", "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 comparator is wheat-flour placebo plus usual care with inadequate lipid-medication control; the population is adults with type 2 diabetes maintaining oral glucose-lowering medication, without an established statin add-on population. Inadequate lipid-medication control and the unverified statin add-on scope are retained separately.", "condition_status": "Partly verified", "status_reason": "Nominal shared treatment/wheat-flour placebo are present, but arm-specific medication types, changes and other-treatment differences are unavailable.", "missingness": "Arm-specific glucose/lipid medication types, doses, changes and placebo details remain unverified.", "uncertainty": "The original comparison is not converted into statin-add-on efficacy or glucose-lowering-medication replacement evidence.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "Wheat-flour placebo, continued oral glucose-lowering medication, lipid-medication control and arm-specific concomitant treatment/changes" }, { "item_id": "N09", "question_type": "Evidence condition", "question": "What is known about 10-week exposure, dosing schedule and post-treatment observation?", "needed": "10-week treatment, visits, exposure/adherence, post-treatment follow-up and time-specific results", "role": "Required", "role_reason": "Needed to avoid extending short treatment data into sustained long-term effects", "application_exception": "A 10-week treatment statement does not establish complete visits, actual adherence or post-treatment follow-up. Unverified long-term results do not erase the 10-week endpoint value.", "criterion": "Record the selected 10-week result separately from existence or uncertainty of withdrawal/long-term follow-up.", "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.", "condition_origin": "These existing in-house conditions concern dried ginger powder and a 10-week LDL-C comparison in adults with type 2 diabetes. They do not establish preregistration, official-tool certification or new independent clinical validation.", "proposed_research": "Material needed: 10-week treatment, visits, exposure/adherence, post-treatment follow-up and time-specific results. This records needed materials; no new research was executed.", "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 exposure contract is 10-week treatment, 1 g at each of 2 daily doses, 2 g/day total; the selected endpoint is the between-group LDL-C difference at 10 weeks. Visit-specific intake/adherence and post-treatment follow-up cannot be established from this summary.", "condition_status": "Partly verified", "status_reason": "The nominal 10-week exposure/endpoint contract is linked, but actual exposure and the complete timeline are unverified.", "missingness": "Visits, adherence, exposure loss and post-treatment follow-up remain unverified.", "uncertainty": "The 10-week endpoint change is not extended into post-treatment or long-term effects.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "10-week treatment, visits, exposure/adherence, post-treatment follow-up and time-specific results" }, { "item_id": "N10", "question_type": "Evidence condition", "question": "Are the direct-trial LDL-C values final values, within-arm changes or between-arm differences?", "needed": "LDL-C result units, arm values/changes, adjusted between-arm estimate, comparison time and direction", "role": "Required", "role_reason": "Needed to avoid transferring numerically different analysis formats as the same effect", "application_exception": "Arm-specific final values or changes differ from adjusted between-arm effects. Do not subtract the values or derive exact change differences/CIs from the P value.", "criterion": "Preserve the original LDL-C result format without newly calculating unreported differences or adjusted effects.", "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.", "condition_origin": "These existing in-house conditions concern dried ginger powder and a 10-week LDL-C comparison in adults with type 2 diabetes. They do not establish preregistration, official-tool certification or new independent clinical validation.", "proposed_research": "Material needed: LDL-C result units, arm values/changes, adjusted between-arm estimate, comparison time and direction. This records needed materials; no new research was executed.", "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 reports final LDL-C 100±42.1 versus 107±34.3 mg/dL, P=.57; the exact change-difference CI is unverified. Final arm values remain distinct from changes/adjusted between-arm effects, and 100−107 was not calculated into a new estimate.", "condition_status": "Partly verified", "status_reason": "The reported value format, units and timing are linked, but exact between-arm changes/adjusted estimates and CIs remain unverified.", "missingness": "Original tables for exact change differences/adjusted between-arm effects, denominators and CIs remain unverified.", "uncertainty": "Significance or differences between arm values are not transferred into another effect without verifying the reported estimation contract.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "LDL-C result units, arm values/changes, adjusted between-arm estimate, comparison time and direction" }, { "item_id": "N11", "question_type": "Evidence condition", "question": "What does the review's pooled LDL-C estimate, CI and I² refer to?", "needed": "Endpoint-specific MD, units, CI, I², contributing trials/populations/formulations and analysis model", "role": "Required", "role_reason": "Needed to avoid extending a review average into guaranteed effects for an identical product", "application_exception": "The review's overall paper count is not its endpoint-specific contributing-trial count or same-product trial count. Do not turn a pooled estimate into direct-trial arm values or guaranteed personal effects.", "criterion": "Attribute pooled values to their endpoint/question without using them as expected effects for a particular product or person.", "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.", "condition_origin": "These existing in-house conditions concern dried ginger powder and a 10-week LDL-C comparison in adults with type 2 diabetes. They do not establish preregistration, official-tool certification or new independent clinical validation.", "proposed_research": "Material needed: Endpoint-specific MD, units, CI, I², contributing trials/populations/formulations and analysis model. This records needed materials; no new research was executed.", "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 synthesis reports MD -5.36 mg/dL, 95% CI -12.37 to 1.65; I²=90.93%; 13 papers overall, with an LDL-contributing subset. Retain the LDL interval including 0 and high heterogeneity.", "condition_status": "Partly verified", "status_reason": "Endpoint-specific pooled values/reported intervals are retained, but details of contributing trials, formulation, medication and model directness remain unverified.", "missingness": "Contributing subsets, trial-specific conditions/estimates, exact denominators, models and overlap tables remain unverified.", "uncertainty": "The review average does not replace the between-arm effect of the original 10-week, 2 g capsule product.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "Endpoint-specific MD, units, CI, I², contributing trials/populations/formulations and analysis model" }, { "item_id": "N12", "question_type": "Evidence condition", "question": "Is the table's selected endpoint the same as the registered primary (1st)/secondary (2nd) hierarchy?", "needed": "The selected-endpoint field's role, the direct trial's registered endpoints, NF-κB and article/plan comparison", "role": "Required", "role_reason": "Needed to avoid deriving original-trial primary (1st) success/failure from a field name alone", "application_exception": "The selected-endpoint field is the table's selection key. Do not relabel registered secondary (2nd) status as co-primary (1st) or as an invalid primary (1st) trial.", "criterion": "Do not promote the selected measure into the registered primary (1st) endpoint; retain the reported secondary (2nd) status and unperformed comparison.", "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.", "condition_origin": "These existing in-house conditions concern dried ginger powder and a 10-week LDL-C comparison in adults with type 2 diabetes. They do not establish preregistration, official-tool certification or new independent clinical validation.", "proposed_research": "Material needed: The selected-endpoint field's role, the direct trial's registered endpoints, NF-κB and article/plan comparison. This records needed materials; no new research was executed.", "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 page endpoint is the between-group LDL-C difference at 10 weeks. The direct report's hierarchy is registered LDL-C secondary (2nd); the original reader answer explicitly describes registered LDL secondary (2nd) status.", "condition_status": "Partly verified", "status_reason": "The selected endpoint and historical registration hierarchy were distinguished, but actual planning originals were not compared.", "missingness": "External comparison of original registration/protocol, article hierarchy and reasons for changes remains unverified.", "uncertainty": "The selected-endpoint field name does not certify the registered primary (1st) endpoint.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "The selected-endpoint field's role, the direct trial's registered endpoints, NF-κB and article/plan comparison" }, { "item_id": "N13", "question_type": "Evidence condition", "question": "What are the randomized, analyzed and completed denominators and the arm mapping of 23/22?", "needed": "50 randomized, 45 analyzed, arm/endpoint denominators, arm mapping and completion/flow diagram", "role": "Required", "role_reason": "Needed to avoid duplication or misattribution of denominator roles and shared participants", "application_exception": "Distinguish 50 randomized from 45 analyzed. Do not infer the ginger/placebo order of 23/22 or the completion denominator when unstated.", "criterion": "Distinguish each reported denominator without inferring ginger/placebo mapping or completion from 23/22.", "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.", "condition_origin": "These existing in-house conditions concern dried ginger powder and a 10-week LDL-C comparison in adults with type 2 diabetes. They do not establish preregistration, official-tool certification or new independent clinical validation.", "proposed_research": "Material needed: 50 randomized, 45 analyzed, arm/endpoint denominators, arm mapping and completion/flow diagram. This records needed materials; no new research was executed.", "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 denominators are 50 randomized and 45 analyzed (23/22). Randomized 50/analyzed 45 remain distinct; the summary does not state ginger/placebo mapping of 23/22 or completion. Matching values in another endpoint table are not summed.", "condition_status": "Partly verified", "status_reason": "Randomized/analyzed literals are verified, but arm/endpoint denominator roles remain incomplete.", "missingness": "Arm mapping, endpoint-specific analysis/completion and shared-participant details remain unverified.", "uncertainty": "Do not create new denominators from rounding, generic English sample wording or counts of mentions.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "50 randomized, 45 analyzed, arm/endpoint denominators, arm mapping and completion/flow diagram" }, { "item_id": "N14", "question_type": "Evidence condition", "question": "Were missingness, dropout reasons and ITT/PP handling verified?", "needed": "Participant flow, arm-specific missingness/dropout, analysis exclusion and ITT/PP/imputation", "role": "Required", "role_reason": "Needed to avoid treating analyzed participant counts as proof of no missingness", "application_exception": "Do not calculate the randomized/analyzed difference as a dropout/discontinuation count. Missing handling information does not establish ITT, PP or no missingness.", "criterion": "Report the distinction between randomized and analyzed participants without calculating dropout/completion or naming the analysis method.", "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.", "condition_origin": "These existing in-house conditions concern dried ginger powder and a 10-week LDL-C comparison in adults with type 2 diabetes. They do not establish preregistration, official-tool certification or new independent clinical validation.", "proposed_research": "Material needed: Participant flow, arm-specific missingness/dropout, analysis exclusion and ITT/PP/imputation. This records needed materials; no new research was executed.", "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 summary gives 50 randomized and 45 analyzed (23/22), without specific missingness/dropout reasons, analysis exclusion/imputation or ITT/PP. No new dropout/completion count was calculated by subtracting analyzed from randomized participants.", "condition_status": "Unverified", "status_reason": "Denominator summaries cannot establish missing-data handling or the estimand, and external flow diagrams were not read.", "missingness": "Arm-specific missingness, dropout/discontinuation, exclusion/imputation and ITT/PP remain unverified.", "uncertainty": "Unverified information does not establish no missingness or definite analysis bias.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "Participant flow, arm-specific missingness/dropout, analysis exclusion and ITT/PP/imputation" }, { "item_id": "N15", "question_type": "Evidence condition", "question": "Are the direct trial's SD, SE, CI and exact between-arm estimates distinguished?", "needed": "LDL-C original tables, variance definitions, exact change differences/adjusted effects, CIs and arm denominators", "role": "Required", "role_reason": "Needed to avoid establishing effect precision from P values or sample sizes alone", "application_exception": "Retain the original ± notation if SD/SE definitions are unavailable. Missing CIs do not justify an arbitrary precision score or effect 0.", "criterion": "Separate reported values from unverified precision without calculating missing CIs or variance definitions.", "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.", "condition_origin": "These existing in-house conditions concern dried ginger powder and a 10-week LDL-C comparison in adults with type 2 diabetes. They do not establish preregistration, official-tool certification or new independent clinical validation.", "proposed_research": "Material needed: LDL-C original tables, variance definitions, exact change differences/adjusted effects, CIs and arm denominators. This records needed materials; no new research was executed.", "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 LDL result's ±42.1/±34.3 notation is retained, while this summary does not fully specify its definition or the exact change-difference CI. No CI was calculated from P=.57.", "condition_status": "Unverified", "status_reason": "Some original values exist, but the requested exact between-arm estimates and precision contract remain unverified.", "missingness": "SD/SE definitions, original variance/denominators and exact change/adjusted-effect CIs remain unverified.", "uncertainty": "Do not infer absent variance/CIs or convert them into a new score.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "LDL-C original tables, variance definitions, exact change differences/adjusted effects, CIs and arm denominators" }, { "item_id": "N16", "question_type": "Evidence condition", "question": "Were favorable, null and contrary endpoint results kept within their original questions?", "needed": "Direct/pooled endpoint results, original counterarguments and other-endpoint scope", "role": "Required", "role_reason": "Needed to avoid erasing material gaps by selecting favorable results", "application_exception": "Preserve counterarguments from other endpoints/analyses as relevant context. Their values do not erase uncertainty in the selected endpoint.", "criterion": "Retain related positive, nonsignificant and differing results without substituting other endpoints for the selected endpoint's efficacy.", "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.", "condition_origin": "These existing in-house conditions concern dried ginger powder and a 10-week LDL-C comparison in adults with type 2 diabetes. They do not establish preregistration, official-tool certification or new independent clinical validation.", "proposed_research": "Material needed: Direct/pooled endpoint results, original counterarguments and other-endpoint scope. This records needed materials; no new research was executed.", "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": "Retain direct LDL P=.57 and the pooled LDL interval including 0. Also retain the original narrative of an approximately 5.14 mg/dL reduction across 26 trials in 2022, while its separate original tables remain unverified. Positive TG/total-cholesterol results are not transferred to LDL.", "condition_status": "Partly verified", "status_reason": "Favorable/counterargument narratives and result formats are linked, but the full distribution of contrary/null trial results is unavailable.", "missingness": "Trial-level result distributions, older review/direct original tables and endpoint comparisons remain unverified.", "uncertainty": "Do not select only favorable narratives or use positives on other endpoints to erase heterogeneity/precision gaps.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "Direct/pooled endpoint results, original counterarguments and other-endpoint scope" }, { "item_id": "N17", "question_type": "Evidence condition", "question": "How are nonsignificance, heterogeneity and decimal differences interpreted?", "needed": "Reported P values, inclusion of 0, CIs, rounded I² and different analysis conditions", "role": "Required", "role_reason": "Needed to avoid conflating different limitations with the same failure or conflict", "application_exception": "Nonsignificance does not prove equivalence/effect 0. Rounded I² and different review estimates require comparison of endpoint/analysis contracts before judging conflict.", "criterion": "Do not convert nonsignificance into effect 0/equivalence or automatically label rounding/different-analysis values as data conflicts.", "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.", "condition_origin": "These existing in-house conditions concern dried ginger powder and a 10-week LDL-C comparison in adults with type 2 diabetes. They do not establish preregistration, official-tool certification or new independent clinical validation.", "proposed_research": "Material needed: Reported P values, inclusion of 0, CIs, rounded I² and different analysis conditions. This records needed materials; no new research was executed.", "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": "Retain LDL P=.57 and the MD -5.36 CI -12.37 to 1.65 with I²90.93% exactly. Nonsignificance is not established as effect 0/equivalence; positive results and condition differences in other reviews remain distinct.", "condition_status": "Partly verified", "status_reason": "Statistical/rounding literals are retained, but original-material assessment of imprecision and between-study differences was not performed.", "missingness": "Causes of high heterogeneity, original decimals/models, equivalence plans and trial estimates remain unverified.", "uncertainty": "High I² does not itself mean effect 0 or failure of the registered plan.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "Reported P values, inclusion of 0, CIs, rounded I² and different analysis conditions" }, { "item_id": "N18", "question_type": "Evidence condition", "question": "What are the limits of historical search/review narratives and currently acquired reports?", "needed": "Current research/bibliographic summaries 2, historical year/trial-count narratives, search sources/strategies, selection and included-study tables", "role": "Required", "role_reason": "Needed to avoid conflating absence of literature with work not performed", "application_exception": "Historical claims of reviewing studies do not record new original acquisition beyond the current 2 reports. An unperformed search does not mean 0 human studies.", "criterion": "Retain historical search/review narratives while separating missing current source locations from the absence of a new search.", "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.", "condition_origin": "These existing in-house conditions concern dried ginger powder and a 10-week LDL-C comparison in adults with type 2 diabetes. They do not establish preregistration, official-tool certification or new independent clinical validation.", "proposed_research": "Material needed: Current research/bibliographic summaries 2, historical year/trial-count narratives, search sources/strategies, selection and included-study tables. This records needed materials; no new research was executed.", "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 record describes comparisons of 2018, 2022 and 2023 meta-analyses and an approximately 5.14 mg/dL reduction across 26 trials in 2022. The actual 2 research/bibliographic summaries concern the 2017 direct trial and 2026 review; exact bibliography, original tables and included-study details for the older reviews are absent here.", "condition_status": "Partly verified", "status_reason": "Historical narratives were separated from current retained-material reading. Without original-material details, neither a current exhaustive search nor absence of articles can be certified.", "missingness": "Historical search records, review bibliography and selection/included-trial details remain unverified.", "uncertainty": "An unperformed search is not described as 0 studies or absence of all human studies.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "Current research/bibliographic summaries 2, historical year/trial-count narratives, search sources/strategies, selection and included-study tables" }, { "item_id": "N19", "question_type": "Evidence condition", "question": "How are the original verdict date, correction date and actual current reading date distinguished?", "needed": "Original verification date, correction date, current conversion-review date, input hashes and revision links", "role": "Required", "role_reason": "Needed to avoid presenting historical verification as a new current-literature review", "application_exception": "Original verification/correction dates are historical values. The current date is retained-material conversion review, without issuing a new evidence cutoff/external-reading date.", "criterion": "Do not reuse historical dates as current external full-text reading dates; state the scope of retained-material review.", "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.", "condition_origin": "These existing in-house conditions concern dried ginger powder and a 10-week LDL-C comparison in adults with type 2 diabetes. They do not establish preregistration, official-tool certification or new independent clinical validation.", "proposed_research": "Material needed: Original verification date, correction date, current conversion-review date, input hashes and revision links. This records needed materials; no new research was executed.", "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; the correction is the English correction record of 2026-09-14. The current date concerns retained-summary conversion review, not external full-text verification or a new evidence cutoff.", "condition_status": "Met", "status_reason": "Historical record dates and the current work date were retained with separate roles, without converting dates into successful new clinical searches.", "missingness": "The original evidence-cutoff field and historical search date/external access level, location and date are unverified in this input.", "uncertainty": "Do not automatically fill an unverified cutoff with the original verdict date.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "Original verification date, correction date, current conversion-review date, input hashes and revision links" }, { "item_id": "N20", "question_type": "Evidence condition", "question": "What does university support and capsule purchasing establish about direct-trial independence?", "needed": "TUMS28653 support, product purchasing/provision, employee authors, patents, declared COI and institutions/teams", "role": "Supplementary; required for an independence claim", "role_reason": "Needed to avoid establishing overall independence from a single funding item", "application_exception": "University funding and capsule purchasing differ from product provision, employment, patents and COI. Do not inherit the historical independence axis as certification of independent replication.", "criterion": "Retain reported funding without using unverified product/authorship/conflict details as proof of independent replication or no bias.", "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.", "condition_origin": "These existing in-house conditions concern dried ginger powder and a 10-week LDL-C comparison in adults with type 2 diabetes. They do not establish preregistration, official-tool certification or new independent clinical validation.", "proposed_research": "Material needed: TUMS28653 support, product purchasing/provision, employee authors, patents, declared COI and institutions/teams. This records needed materials; no new research was executed.", "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 funding is reported as TUMS 28653 university support and capsule purchasing. These are retained; product provision, employee authors, patents, declared COI and unique-team independence were not compared against external originals.", "condition_status": "Partly verified", "status_reason": "Original funding is reported, but other components of independence remain unverified.", "missingness": "Product support, author employment, patents, COI originals and institution/team links remain unverified.", "uncertainty": "The original independent-funding strength/I2 axis does not certify new independent clinical validation.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "TUMS28653 support, product purchasing/provision, employee authors, patents, declared COI and institutions/teams" }, { "item_id": "N21", "question_type": "Evidence condition", "question": "How do review funding and author COI differ from included-trial independence?", "needed": "Review funding/COI, funding of each included trial, research teams/products and overlap", "role": "Supplementary; required for an independence claim", "role_reason": "Needed to avoid transferring review support into independence of all contributing trials", "application_exception": "Review COI/funding and included-trial funding are considered separately. A no-conflict declaration alone does not establish absence of product/included-trial bias.", "criterion": "Separate review declarations from mixed original-trial funding without certifying papers as unique independent teams.", "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.", "condition_origin": "These existing in-house conditions concern dried ginger powder and a 10-week LDL-C comparison in adults with type 2 diabetes. They do not establish preregistration, official-tool certification or new independent clinical validation.", "proposed_research": "Material needed: Review funding/COI, funding of each included trial, research teams/products and overlap. This records needed materials; no new research was executed.", "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": "Review funding is recorded as public/university support, with mixed funding among original trials. Review declarations/funding remain distinct from contributing trials' mixed funding, products and institutions.", "condition_status": "Partly verified", "status_reason": "Limited declarations in the review record are retained, but contributing-trial funding/independence were not compared.", "missingness": "Original review funding/COI declarations, included-trial funding/products, institutions/teams and overlap remain unverified.", "uncertainty": "No-conflict/public-university-support summaries are not transferred into absence of bias across included trials.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "Review funding/COI, funding of each included trial, research teams/products and overlap" }, { "item_id": "N22", "question_type": "Evidence condition", "question": "Were allocation, concealment and baseline balance verified beyond the randomized/double-blind label?", "needed": "Parallel/crossover/cluster design, random sequence, concealment, baseline tables and blinding", "role": "Required", "role_reason": "Needed to avoid treating a design label as resolution of allocation and confounding problems", "application_exception": "The randomized/double-blind label does not verify sequence, concealment or baseline balance. Unverified design does not automatically make crossover/cluster considerations not applicable.", "criterion": "Separate the RCT label from unverified details; do not arbitrarily mark crossover/cluster considerations not applicable when the design is unverified.", "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.", "condition_origin": "These existing in-house conditions concern dried ginger powder and a 10-week LDL-C comparison in adults with type 2 diabetes. They do not establish preregistration, official-tool certification or new independent clinical validation.", "proposed_research": "Material needed: Parallel/crossover/cluster design, random sequence, concealment, baseline tables and blinding. This records needed materials; no new research was executed.", "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 design label is a randomized double-blind placebo trial. This summary does not establish sequence generation, allocation concealment, baseline balance or detailed parallel/crossover/cluster structure.", "condition_status": "Partly verified", "status_reason": "Original RCT/blinding labels exist, but actual methodological information was not compared.", "missingness": "Original allocation/concealment, baseline tables, design details and blinding methods remain unverified.", "uncertainty": "The blinding label does not establish no problems or a completed formal RoB2 assessment.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "Parallel/crossover/cluster design, random sequence, concealment, baseline tables and blinding" }, { "item_id": "N23", "question_type": "Evidence condition", "question": "Could concomitant medication, adherence, rescue care and arm-specific changes affect the estimate?", "needed": "Glucose/lipid medication types, arm changes, diet/activity, adherence, rescue care and estimand", "role": "Required", "role_reason": "Needed to avoid attributing changes in other treatments to added ginger", "application_exception": "Continuation of existing oral medication does not establish identical arm changes, adherence, diet or rescue care. Do not require that all changes must be identical.", "criterion": "Distinguish a continuation-of-medication statement from unverified arm-specific changes and adherence.", "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.", "condition_origin": "These existing in-house conditions concern dried ginger powder and a 10-week LDL-C comparison in adults with type 2 diabetes. They do not establish preregistration, official-tool certification or new independent clinical validation.", "proposed_research": "Material needed: Glucose/lipid medication types, arm changes, diet/activity, adherence, rescue care and estimand. This records needed materials; no new research was executed.", "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 comparison with maintained oral glucose-lowering medication concerns adults with type 2 diabetes on continued oral treatment, without an established statin add-on population, versus wheat-flour placebo plus usual care with inadequate lipid-medication control. Details of arm-specific medication changes, adherence, diet/activity, rescue care and analysis handling are not recorded.", "condition_status": "Unverified", "status_reason": "The nominal shared-treatment scope exists, but actual changes/deviations/estimand comparison for E02 lacks material.", "missingness": "Medication types/doses/changes, actual adherence, diet/activity and rescue-treatment handling remain unverified.", "uncertainty": "Unverified changes do not establish fully controlled identical care or an isolated ginger effect.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "Glucose/lipid medication types, arm changes, diet/activity, adherence, rescue care and estimand" }, { "item_id": "N24", "question_type": "Evidence condition", "question": "How, when and under what blinding was LDL-C measured?", "needed": "LDL-C assay/units, sampling conditions, baseline/10-week visits, measurement error and assessor blinding", "role": "Required", "role_reason": "Needed to avoid conflating measurement differences with actual outcome differences", "application_exception": "An endpoint name and units do not verify the assay, sampling/visit times or assessor blinding. Even an objective assay requires separate assessment of measurement limitations.", "criterion": "Separate the nominal endpoint/units from unverified assay details.", "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.", "condition_origin": "These existing in-house conditions concern dried ginger powder and a 10-week LDL-C comparison in adults with type 2 diabetes. They do not establish preregistration, official-tool certification or new independent clinical validation.", "proposed_research": "Material needed: LDL-C assay/units, sampling conditions, baseline/10-week visits, measurement error and assessor blinding. This records needed materials; no new research was executed.", "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 measure is the between-group LDL-C difference at 10 weeks; the reported values are final LDL-C arm values in mg/dL. Assay, sampling/visit times, baseline values and assessor-blinding details are absent from the current summary.", "condition_status": "Unverified", "status_reason": "The endpoint name/nominal time exist, but the measurement method and arm-specific error procedures remain unverified.", "missingness": "Assay/sampling/baseline, 10-week visits, measurement error and assessor blinding remain unverified.", "uncertainty": "Do not fill measurement details from another endpoint's trial or generic legacy English wording.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "LDL-C assay/units, sampling conditions, baseline/10-week visits, measurement error and assessor blinding" }, { "item_id": "N25", "question_type": "Evidence condition", "question": "What is the direct trial's estimand and analysis model?", "needed": "Assignment/adherence effects, covariates, ITT/PP, within/between-arm analysis, change/final values and model", "role": "Required", "role_reason": "Needed to distinguish arm-specific values from the actual analysis estimand", "application_exception": "Classify only the reported final/change format. If the estimand is unverified, do not assign assignment/adherence effects or ITT/PP.", "criterion": "Explain only the reported result format; absent analysis methods are not filled with adjusted estimates or ITT.", "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.", "condition_origin": "These existing in-house conditions concern dried ginger powder and a 10-week LDL-C comparison in adults with type 2 diabetes. They do not establish preregistration, official-tool certification or new independent clinical validation.", "proposed_research": "Material needed: Assignment/adherence effects, covariates, ITT/PP, within/between-arm analysis, change/final values and model. This records needed materials; no new research was executed.", "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 contract is the between-group LDL difference at 10 weeks, but the current direct summary reports final arm values and P. Exact change differences/adjusted CIs remain unverified, and analysis populations/models or ITT/PP are not newly assigned.", "condition_status": "Unverified", "status_reason": "Knowing the result format does not complete the effect definition without comparison of the estimand and original model.", "missingness": "Assignment/adherence effects, analysis populations, covariates and original models remain unverified.", "uncertainty": "Do not infer adjusted estimates or assignment effects without material.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "Assignment/adherence effects, covariates, ITT/PP, within/between-arm analysis, change/final values and model" }, { "item_id": "N26", "question_type": "Evidence condition", "question": "Can the CI be interpreted alongside a justified important difference?", "needed": "Direct/pooled CIs, endpoint-specific variance, justified clinically important difference and interpretation contract", "role": "Required", "role_reason": "Needed to avoid upgrading statistical signals into clinical importance or a new grade", "application_exception": "P values, sample sizes or review paper counts alone do not establish sufficient precision or clinical importance. Do not adopt arbitrary minimum participant, duration or difference thresholds.", "criterion": "Retain the scope of reported intervals and unverified importance criteria; do not judge sufficiency using arbitrary minimum samples, duration or differences.", "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.", "condition_origin": "These existing in-house conditions concern dried ginger powder and a 10-week LDL-C comparison in adults with type 2 diabetes. They do not establish preregistration, official-tool certification or new independent clinical validation.", "proposed_research": "Material needed: Direct/pooled CIs, endpoint-specific variance, justified clinically important difference and interpretation contract. This records needed materials; no new research was executed.", "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 synthesis provides an interval: MD -5.36 mg/dL, 95% CI -12.37 to 1.65; I²=90.93%, but the direct trial's exact CI is unverified. The record supplies no justified important-difference threshold for the selected population/endpoint.", "condition_status": "Partly verified", "status_reason": "The scope of reported intervals was read, but direct precision and clinical-importance comparison remain unverified.", "missingness": "Direct CIs, justified important differences and interpretive material remain unverified.", "uncertainty": "Do not create arbitrary minimum N, durations, important differences, fulfillment rates or new efficacy grades.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "Direct/pooled CIs, endpoint-specific variance, justified clinically important difference and interpretation contract" }, { "item_id": "N27", "question_type": "Evidence condition", "question": "Was the prespecified endpoint, timing and analysis compared with actual reporting?", "needed": "Original registration versions, protocol, SAP, article tables/change reasons and endpoint-specific plans", "role": "Required", "role_reason": "Needed to expose missing material for assessing selection of favorable analyses", "application_exception": "Separate historical registration-endpoint narratives from actual planning comparison in this work. Unacquired plans do not establish confirmed selective reporting.", "criterion": "Retain reported secondary (2nd) status and unperformed comparison without converting unavailable plans into confirmed nonregistration/selective reporting.", "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.", "condition_origin": "These existing in-house conditions concern dried ginger powder and a 10-week LDL-C comparison in adults with type 2 diabetes. They do not establish preregistration, official-tool certification or new independent clinical validation.", "proposed_research": "Material needed: Original registration versions, protocol, SAP, article tables/change reasons and endpoint-specific plans. This records needed materials; no new research was executed.", "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 record describes registered LDL-C secondary (2nd) status in the direct trial; external registration/SAP/protocol were not compared with actual endpoint, timing or analysis changes in this work.", "condition_status": "Unverified", "status_reason": "Historical registration hierarchy alone cannot certify agreement between prespecified plans and reporting.", "missingness": "Registration versions/endpoints, analyses/timing, change reasons and SAP remain uncompared.", "uncertainty": "Unperformed comparison establishes neither nonregistration/confirmed selective reporting nor absence of planning problems.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "Original registration versions, protocol, SAP, article tables/change reasons and endpoint-specific plans" }, { "item_id": "N28", "question_type": "Evidence condition", "question": "Was the result replicated in independent families with the same formulation, dose and population?", "needed": "Trial/family-specific formulation, dose, duration, population, concomitant medication, result distributions and overlap", "role": "Required", "role_reason": "Needed to avoid converting review paper counts/averages into same-product replication", "application_exception": "Do not assume that the representative direct trial is included in the review and add it as new independent replication. A mixed-formulation/population review does not certify replication of the same 500 mg capsules at 2 g/day.", "criterion": "Do not label the representative trial and mixed review as independent replication of an identical formulation; retain condition differences and unverified direct replication.", "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.", "condition_origin": "These existing in-house conditions concern dried ginger powder and a 10-week LDL-C comparison in adults with type 2 diabetes. They do not establish preregistration, official-tool certification or new independent clinical validation.", "proposed_research": "Material needed: Trial/family-specific formulation, dose, duration, population, concomitant medication, result distributions and overlap. This records needed materials; no new research was executed.", "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 record notes formulation/dose/existing-medication differences, high heterogeneity and limited same-formulation replication. Included-trial/family-specific conditions and results for the representative 500 mg powder, 2 g/day, 10-week direct trial and mixed review were not acquired.", "condition_status": "Unverified", "status_reason": "A review count does not establish unique independent same-formulation replication for the selected contract.", "missingness": "Included trials/overlap, family-specific formulations/medication, populations/doses/duration and result distributions remain unverified.", "uncertainty": "Do not add the representative report and review into 14 independent trials or same-product reproducibility.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "Trial/family-specific formulation, dose, duration, population, concomitant medication, result distributions and overlap" }, { "item_id": "N29", "question_type": "Evidence condition", "question": "Can direct comparisons of doses/products identify an optimal amount?", "needed": "Direct dose/product comparison, active-constituent assay, dose response/interactions and independent estimates", "role": "Supplementary; required for a dose/product extension", "role_reason": "Needed to avoid extending a trial dose into an individual's optimal intake", "application_exception": "A trial's 2 g/day does not establish optimal dosage or equivalent-product efficacy. Unverified direct dose comparisons do not automatically suspend the narrow question.", "criterion": "Do not call the selected 2 g/day optimal or equivalent to other products. Missing direct comparison does not erase the narrow 10-week result.", "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.", "condition_origin": "These existing in-house conditions concern dried ginger powder and a 10-week LDL-C comparison in adults with type 2 diabetes. They do not establish preregistration, official-tool certification or new independent clinical validation.", "proposed_research": "Material needed: Direct dose/product comparison, active-constituent assay, dose response/interactions and independent estimates. This records needed materials; no new research was executed.", "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 trial's nominal powder amount is 2 g/day; the retained summary has no direct superiority/optimal-dose comparison with other doses/products. Gingerol/shogaol assay is also unverified.", "condition_status": "Unverified", "status_reason": "A placebo comparison at a single dose and a mixed review do not answer direct dose/product comparisons.", "missingness": "Direct dose-response/product comparisons, active-constituent assay and interaction estimates remain unverified.", "uncertainty": "2 g/day does not establish personal dosing instructions, an optimal dose or equivalent efficacy of other products.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "Direct dose/product comparison, active-constituent assay, dose response/interactions and independent estimates" }, { "item_id": "N30", "question_type": "Evidence condition", "question": "Were persistence after withdrawal and results beyond 10 weeks verified?", "needed": "Follow-up beyond 10 weeks/after withdrawal, repeated measurements, time-specific results and separate comparisons", "role": "Supplementary; required for a long-term extension", "role_reason": "Needed to avoid extending short-term values into long-term maintenance or suppressed progression", "application_exception": "Short-term endpoints and post-treatment persistence/long-term results are separate questions. Unverified long-term material does not establish no long-term effect.", "criterion": "Separate 10-week material from long-term persistence questions and retain unverified long-term evidence.", "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.", "condition_origin": "These existing in-house conditions concern dried ginger powder and a 10-week LDL-C comparison in adults with type 2 diabetes. They do not establish preregistration, official-tool certification or new independent clinical validation.", "proposed_research": "Material needed: Follow-up beyond 10 weeks/after withdrawal, repeated measurements, time-specific results and separate comparisons. This records needed materials; no new research was executed.", "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 selected duration is 10 weeks of treatment. Separate reports and denominators for post-treatment persistence or long-term results beyond 10 weeks are unverified in the retained summary.", "condition_status": "Unverified", "status_reason": "10-week material alone does not answer post-treatment or long-term-follow-up questions.", "missingness": "Post-treatment/long-term visits, time-specific between-arm estimates and denominators remain unverified.", "uncertainty": "Unverified long-term material means neither no long-term effect nor a reason to erase original 10-week values.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "Follow-up beyond 10 weeks/after withdrawal, repeated measurements, time-specific results and separate comparisons" }, { "item_id": "N31", "question_type": "Evidence condition", "question": "Were baseline, medication and special-population subgroup effects separately verified?", "needed": "Prespecified subgroups, interactions, baseline measures/medication/insulin, and separate denominators/estimates in older adults or kidney disease", "role": "Supplementary; required for a subgroup extension", "role_reason": "Needed to avoid extending a selected-population main effect into special-population efficacy", "application_exception": "Subgroup estimates require prespecification, interaction assessment and arm-specific denominators. Do not infer insulin, older-adult, kidney-disease or complex-medication information from a small-sample main effect.", "criterion": "Do not apply nominal T2D results to all populations; preserve the original population wording and unverified subgroup questions.", "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.", "condition_origin": "These existing in-house conditions concern dried ginger powder and a 10-week LDL-C comparison in adults with type 2 diabetes. They do not establish preregistration, official-tool certification or new independent clinical validation.", "proposed_research": "Material needed: Prespecified subgroups, interactions, baseline measures/medication/insulin, and separate denominators/estimates in older adults or kidney disease. This records needed materials; no new research was executed.", "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 selected population is adults with type 2 diabetes maintaining oral glucose-lowering medication, without an established statin add-on population. Prespecified baseline/medication subgroups, interactions and separate denominators/estimates for insulin, older adults, kidney disease or complex concomitant treatment are absent from the retained summary.", "condition_status": "Unverified", "status_reason": "A population name alone cannot establish special-population or individual differences in response.", "missingness": "Prespecified subgroups, interactions, denominators/estimates and concomitant-treatment material remain unverified.", "uncertainty": "Separate unverified subgroups from the overall selected T2D question without creating unsupported efficacy.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "Prespecified subgroups, interactions, baseline measures/medication/insulin, and separate denominators/estimates in older adults or kidney disease" }, { "item_id": "N32", "question_type": "Evidence condition", "question": "Does LDL-C change answer clinical-event or medication-replacement questions?", "needed": "Distinguish endpoint changes from cardiovascular events, diabetes complications/remission, quality of life and medication reduction", "role": "Supplementary; required for a clinical-event extension", "role_reason": "Needed to avoid combining surrogate measures and patient clinical outcomes into the same claim", "application_exception": "Retain the numerical-endpoint comparison itself. Do not automatically substitute endpoint values for events/complications/remission or medication discontinuation, or require event trials as a prerequisite for endpoint values.", "criterion": "Do not transfer a narrow endpoint result into event prevention, remission or medication replacement. Do not make event trials mandatory for the endpoint result.", "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.", "condition_origin": "These existing in-house conditions concern dried ginger powder and a 10-week LDL-C comparison in adults with type 2 diabetes. They do not establish preregistration, official-tool certification or new independent clinical validation.", "proposed_research": "Material needed: Distinguish endpoint changes from cardiovascular events, diabetes complications/remission, quality of life and medication reduction. This records needed materials; no new research was executed.", "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 advertising boundary does not support statin replacement, cardiovascular prevention or marketing TG improvement as an LDL effect. Retain the scope of LDL-C alone, with TG, HDL and total cholesterol separate. Direct event/complication, remission, quality-of-life and medication-reduction material was not verified in this summary.", "condition_status": "Partly verified", "status_reason": "The boundary between the selected endpoint and clinical/medication questions is stated, but separate direct clinical outcomes remain unverified.", "missingness": "Separate direct results for cardiovascular events, complications, remission and medication reduction remain unverified.", "uncertainty": "Endpoint signals do not support medication replacement/stopping treatment, and event evidence is not forced as a prerequisite for endpoint values.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "Distinguish endpoint changes from cardiovascular events, diabetes complications/remission, quality of life and medication reduction" }, { "item_id": "N33", "question_type": "Evidence condition", "question": "What is known about actual adverse events, withdrawal and denominators for the same exposure?", "needed": "Arm-specific harms, definitions/collection, denominators/duration, withdrawal and separation from efficacy denominators", "role": "Supplementary; required for a safety claim", "role_reason": "Needed to avoid treating available efficacy material as verified safety", "application_exception": "Caution wording differs from actual adverse-event collection. Do not reuse efficacy denominators for harm incidence or fill missing event/withdrawal counts with 0.", "criterion": "Separate existing caution wording from actual harm counts; unverified information is not safety or absence of events.", "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.", "condition_origin": "These existing in-house conditions concern dried ginger powder and a 10-week LDL-C comparison in adults with type 2 diabetes. They do not establish preregistration, official-tool certification or new independent clinical validation.", "proposed_research": "Material needed: Arm-specific harms, definitions/collection, denominators/duration, withdrawal and separation from efficacy denominators. This records needed materials; no new research was executed.", "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. Its detailed guidance says not to arbitrarily stop lipid-lowering medication and to consider gastrointestinal discomfort and possible drug interactions, including anticoagulants and antiplatelets. Actual arm-specific harm counts/denominators, collection methods/duration and withdrawals in both reports remain unverified in the summary.", "condition_status": "Unverified", "status_reason": "General caution wording exists, but actual adverse-event collection for the selected exposure is not established.", "missingness": "Harm definitions, arm-specific events, denominators/duration, withdrawal, collection and missingness remain unverified.", "uncertainty": "Do not substitute efficacy 50/45 as harm denominators or display no events/safety.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "Arm-specific harms, definitions/collection, denominators/duration, withdrawal and separation from efficacy denominators" }, { "item_id": "N34", "question_type": "Evidence condition", "question": "What is known about medication interactions, rare/long-term harms and special populations?", "needed": "Original hypoglycemia/gastrointestinal, anticoagulant/antiplatelet, concomitant-treatment, long-term/vulnerable-population harm material", "role": "Supplementary; required for a harm extension", "role_reason": "Needed to separate general cautions from actually observed harms", "application_exception": "Do not display possible-interaction cautions as observed causal interactions. Do not extend 10-week efficacy material into certification of rare/long-term harms or vulnerable-population safety.", "criterion": "Retain only the original caution level without certifying causal interactions, incidence or long-term safety.", "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.", "condition_origin": "These existing in-house conditions concern dried ginger powder and a 10-week LDL-C comparison in adults with type 2 diabetes. They do not establish preregistration, official-tool certification or new independent clinical validation.", "proposed_research": "Material needed: Original hypoglycemia/gastrointestinal, anticoagulant/antiplatelet, concomitant-treatment, long-term/vulnerable-population harm material. This records needed materials; no new research was executed.", "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": "Retain the existing guidance against stopping lipid-lowering medication, and about gastrointestinal discomfort and possible anticoagulant/antiplatelet interactions. Causality and frequency of actually observed interactions, and long-term/vulnerable-population harms, remain separately unverified.", "condition_status": "Unverified", "status_reason": "Possibility-based guidance differs from established arm-specific events or interaction risks.", "missingness": "Drug-specific, long-term/rare/vulnerable-population harms, onset/recovery and independent event material remain unverified.", "uncertainty": "Do not inherit the caution label as a new safety assessment, causal conclusion or personal medication-change instruction.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "Original hypoglycemia/gastrointestinal, anticoagulant/antiplatelet, concomitant-treatment, long-term/vulnerable-population harm material" }, { "item_id": "N35", "question_type": "Evidence condition", "question": "How are actual generic English wording and historical English corrections preserved?", "needed": "Specific Korean results, generic English fields, full correction originals, currently selected original and authority for translation changes", "role": "Required", "role_reason": "Needed to avoid conflating a reported correction with actual current content", "application_exception": "A correction record does not prove current specific English exists. Retain specific Korean values and generic English wording separately; translation/criteria correction requires a separate authorized event.", "criterion": "Retain both current English literals and historical correction reports without inferring specific English exists or performing a correction of the original translation in this work.", "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.", "condition_origin": "These existing in-house conditions concern dried ginger powder and a 10-week LDL-C comparison in adults with type 2 diabetes. They do not establish preregistration, official-tool certification or new independent clinical validation.", "proposed_research": "Material needed: Specific Korean results, generic English fields, full correction originals, currently selected original and authority for translation changes. This records needed materials; no new research was executed.", "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 2026-09-14 correction says that 2 generic English evidence-table fields were replaced with specific English. However, both reports' English sample, funding, endpoint, result and weighting fields still contain generic sentences in the current original. Both originals were preserved.", "condition_status": "Met", "status_reason": "This condition concerns preservation of current English literals and historical correction reports. Residual generic English and the full 2026-09-14 correction are preserved without inferring specific English or a new translation, meeting that preservation scope. Historical corrected versions, field correspondence and omission details remain unverified.", "missingness": "The actual historical English correction version, field correspondence and a separate translation-correction event remain unverified.", "uncertainty": "Generic English does not independently validate specific Korean numbers; no new English numbers are written into the original.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "Specific Korean results, generic English fields, full correction originals, currently selected original and authority for translation changes" }, { "item_id": "N36", "question_type": "Evidence condition", "question": "How is the bibliographic NCT string distinguished from the unverified original registration field?", "needed": "Direct bibliographic NCT, original registration value, external registration identity/version and comparison history", "role": "Required", "role_reason": "Needed to preserve different states for exact bibliographic links and planning comparison", "application_exception": "An unverified original registration field and a bibliographic NCT string are different verification levels. Do not replace them with a convenient single value or add a completed-registration-reading badge.", "criterion": "Separate string existence from registration-content verification without arbitrarily harmonizing the original registration field.", "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.", "condition_origin": "These existing in-house conditions concern dried ginger powder and a 10-week LDL-C comparison in adults with type 2 diabetes. They do not establish preregistration, official-tool certification or new independent clinical validation.", "proposed_research": "Material needed: Direct bibliographic NCT, original registration value, external registration identity/version and comparison history. This records needed materials; no new research was executed.", "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": "Direct bibliographic NCT02666807, unverified direct-trial registration and unverified review registration are each retained. A registration entrance built from a bibliographic string is not a link whose current response/original identity was verified.", "condition_status": "Partly verified", "status_reason": "Different verification levels of original fields are retained, but registration-content comparison/field correction was not performed.", "missingness": "External comparison of registration identity/contents, versions, endpoints and times remains unverified.", "uncertainty": "Do not replace the registration field with the bibliographic ID or describe unverified information as nonregistration.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "Direct bibliographic NCT, original registration value, external registration identity/version and comparison history" }, { "item_id": "N37", "question_type": "Evidence condition", "question": "Were the existing C50, all axes, original dates/URLs and historical review labels retained?", "needed": "Grade/score/safety, boolean/empty axis values, Korean/English historical values, corrections, URL and original verification date", "role": "Required", "role_reason": "Needed to distinguish preservation of the original verdict from current gap-map statuses", "application_exception": "Retain the existing grade/score, false/blank axis values, original URLs and dates. Do not display historical Codex independent cross-checks as current independent clinical validation.", "criterion": "Preserve the whole original exactly without inheriting historical scores, axes or verification wording as current condition status, new conclusions or clinical certification.", "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.", "condition_origin": "These existing in-house conditions concern dried ginger powder and a 10-week LDL-C comparison in adults with type 2 diabetes. They do not establish preregistration, official-tool certification or new independent clinical validation.", "proposed_research": "Material needed: Grade/score/safety, boolean/empty axis values, Korean/English historical values, corrections, URL and original verification date. This records needed materials; no new research was executed.", "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 original C50, Caution, all axes, final Korean/English values, dates/corrections, URLs, empty subclaims and blank deliberation were retained exactly in the preserved original. Its Codex independent-cross-check wording is a historical label, not current clinical validation.", "condition_status": "Met", "status_reason": "Original-byte preservation and the distinction between historical values and current condition status were directly checked. C50 did not automatically upgrade condition statuses.", "missingness": "No original-text/score change in this work. External independent clinical review or formal-assessment certification was not performed.", "uncertainty": "Source-hash checks do not establish clinical truth or independent expert validation.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "Grade/score/safety, boolean/empty axis values, Korean/English historical values, corrections, URL and original verification date" } ], "reports": [ { "report_id": "S01", "title": "The Effects of Ginger on Fasting Blood Sugar, Hemoglobin A1c, and Lipid Profiles in Patients with Type 2 Diabetes", "url": "https://pubmed.ncbi.nlm.nih.gov/29344037/", "report_type": "Randomized double-blind placebo-controlled trial", "existence": "Stored research/bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original manufacturing/support/harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific conditions/application records were read. Linked external abstracts, full texts, registration and planning material remain unread, with no access attempt.", "study_family": "Direct 10-week dried-powder trial. LDL and HbA1c reports from the same participants are not added as independent replication.", "independent_replication": "Independent replication matching formulation, population, duration and endpoint, and unique study/participant counts, remain unverified.", "observed_result": "Final LDL-C 100±42.1 versus 107±34.3 mg/dL, P=.57; exact change-difference CI unverified", "result_level": "The original record describes LDL-C as a registered secondary (2nd) endpoint. Final arm values are not converted into between-group change differences or adjusted estimates; actual registration/planning originals remain unread.", "source_evidence_date": "2026-09-08", "materials": [ { "material_type": "Retained research/bibliographic summary", "public_status": "Existence verified in retained input", "access_status": "Local input read", "acquired": true, "actually_read": "Retained existing review summary read", "as_of": "2026-10-06T09:37:06.123572+09:00", "qualification": "The retained research/bibliographic summary was actually read; this is not full-text reading. Bibliographic NCT02666807 and the original unverified-registration field are each preserved. Exact change differences/CIs, SD/SE meaning of ±, arm mapping of 23/22 and harm counts remain unverified. The material record dated 2026-10-06 concerns retained-summary review. Condition 1.1 refinement before observation application and later preservation/reading-disclosure status changes were separately retained. The original verdict date 2026-09-08 and correction date 2026-09-14 are not new-search or full-text-reading dates." }, { "material_type": "Bibliography/abstract", "public_status": "Bibliographic identifier/entrance retained; actual availability/response unverified", "access_status": "External access not attempted; not acquired", "acquired": false, "actually_read": false, "as_of": "2026-10-06T09:37:06.123572+09:00", "qualification": "Only URLs/identifiers were retained. Current external responses, files, identity and contents are unverified. Bibliographic NCT02666807 and the original unverified-registration field are each preserved. Exact change differences/CIs, SD/SE meaning of ±, arm mapping of 23/22 and harm counts remain unverified. The material record dated 2026-10-06 concerns retained-summary review. Condition 1.1 refinement before observation application and later preservation/reading-disclosure status changes were separately retained. The original verdict date 2026-09-08 and correction date 2026-09-14 are not new-search or full-text-reading dates." }, { "material_type": "Article full text", "public_status": "Bibliographic identifier/entrance retained; actual availability/response unverified", "access_status": "External access not attempted; not acquired", "acquired": false, "actually_read": false, "as_of": "2026-10-06T09:37:06.123572+09:00", "qualification": "Only URLs/identifiers were retained. Current external responses, files, identity and contents are unverified. Bibliographic NCT02666807 and the original unverified-registration field are each preserved. Exact change differences/CIs, SD/SE meaning of ±, arm mapping of 23/22 and harm counts remain unverified. The material record dated 2026-10-06 concerns retained-summary review. Condition 1.1 refinement before observation application and later preservation/reading-disclosure status changes were separately retained. The original verdict date 2026-09-08 and correction date 2026-09-14 are not new-search or full-text-reading dates." }, { "material_type": "Publisher-original entrance", "public_status": "Bibliographic identifier/entrance retained; actual availability/response unverified", "access_status": "External access not attempted; not acquired", "acquired": false, "actually_read": false, "as_of": "2026-10-06T09:37:06.123572+09:00", "qualification": "Only URLs/identifiers were retained. Current external responses, files, identity and contents are unverified. Bibliographic NCT02666807 and the original unverified-registration field are each preserved. Exact change differences/CIs, SD/SE meaning of ±, arm mapping of 23/22 and harm counts remain unverified. The material record dated 2026-10-06 concerns retained-summary review. Condition 1.1 refinement before observation application and later preservation/reading-disclosure status changes were separately retained. The original verdict date 2026-09-08 and correction date 2026-09-14 are not new-search or full-text-reading dates." }, { "material_type": "Trial registration", "public_status": "Bibliographic identifier/entrance retained; actual availability/response unverified", "access_status": "External access not attempted; not acquired", "acquired": false, "actually_read": false, "as_of": "2026-10-06T09:37:06.123572+09:00", "qualification": "Only URLs/identifiers were retained. Current external responses, files, identity and contents are unverified. Bibliographic NCT02666807 and the original unverified-registration field are each preserved. Exact change differences/CIs, SD/SE meaning of ±, arm mapping of 23/22 and harm counts remain unverified. The material record dated 2026-10-06 concerns retained-summary review. Condition 1.1 refinement before observation application and later preservation/reading-disclosure status changes were separately retained. The original verdict date 2026-09-08 and correction date 2026-09-14 are not new-search or full-text-reading dates." }, { "material_type": "Protocol", "public_status": "Actual existence/availability unverified; required original-material type", "access_status": "External access not attempted; not acquired", "acquired": false, "actually_read": false, "as_of": "2026-10-06T09:37:06.123572+09:00", "qualification": "This is a required material type. Existence, URL and public availability were not verified; the material read is the retained summary. Bibliographic NCT02666807 and the original unverified-registration field are each preserved. Exact change differences/CIs, SD/SE meaning of ±, arm mapping of 23/22 and harm counts remain unverified. The material record dated 2026-10-06 concerns retained-summary review. Condition 1.1 refinement before observation application and later preservation/reading-disclosure status changes were separately retained. The original verdict date 2026-09-08 and correction date 2026-09-14 are not new-search or full-text-reading dates." }, { "material_type": "Statistical analysis plan", "public_status": "Actual existence/availability unverified; required original-material type", "access_status": "External access not attempted; not acquired", "acquired": false, "actually_read": false, "as_of": "2026-10-06T09:37:06.123572+09:00", "qualification": "This is a required material type. Existence, URL and public availability were not verified; the material read is the retained summary. Bibliographic NCT02666807 and the original unverified-registration field are each preserved. Exact change differences/CIs, SD/SE meaning of ±, arm mapping of 23/22 and harm counts remain unverified. The material record dated 2026-10-06 concerns retained-summary review. Condition 1.1 refinement before observation application and later preservation/reading-disclosure status changes were separately retained. The original verdict date 2026-09-08 and correction date 2026-09-14 are not new-search or full-text-reading dates." }, { "material_type": "Original result tables/participant flow", "public_status": "Actual existence/availability unverified; required original-material type", "access_status": "External access not attempted; not acquired", "acquired": false, "actually_read": false, "as_of": "2026-10-06T09:37:06.123572+09:00", "qualification": "This is a required material type. Existence, URL and public availability were not verified; the material read is the retained summary. Bibliographic NCT02666807 and the original unverified-registration field are each preserved. Exact change differences/CIs, SD/SE meaning of ±, arm mapping of 23/22 and harm counts remain unverified. The material record dated 2026-10-06 concerns retained-summary review. Condition 1.1 refinement before observation application and later preservation/reading-disclosure status changes were separately retained. The original verdict date 2026-09-08 and correction date 2026-09-14 are not new-search or full-text-reading dates." } ], "links": [ { "label": "PubMed", "url": "https://pubmed.ncbi.nlm.nih.gov/29344037/" } ] }, { "report_id": "S02", "title": "Meta-analysis of the effects of ginger supplementation on glycemic control, blood pressure and lipid profile in patients with type 2 diabetes", "url": "https://pubmed.ncbi.nlm.nih.gov/42337792/", "report_type": "Systematic review and meta-analysis of randomized controlled trials", "existence": "Stored research/bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original manufacturing/support/harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific conditions/application records were read. Linked external abstracts, full texts, registration and planning material remain unread, with no access attempt.", "study_family": "Ginger synthesis in type 2 diabetes. The overall 13 papers remain distinct from the LDL-C-contributing subset, products, background medication and overlap.", "independent_replication": "Independent replication matching formulation, population, duration and endpoint, and unique study/participant counts, remain unverified.", "observed_result": "MD −5.36 mg/dL, 95% CI −12.37~1.65; I²=90.93%", "result_level": "These are retained pooled LDL-C estimates; the contributing subset, variance, denominators, models and application to the direct product remain unverified.", "source_evidence_date": "2026-09-08", "materials": [ { "material_type": "Retained research/bibliographic summary", "public_status": "Existence verified in retained input", "access_status": "Local input read", "acquired": true, "actually_read": "Retained existing review summary read", "as_of": "2026-10-06T09:37:06.123638+09:00", "qualification": "The retained research/bibliographic summary was actually read; this is not full-text reading. Different titles/author displays under the same bibliographic identifiers were preserved. Included trials, contributing subsets, variance, denominators and models remain unverified. The material record dated 2026-10-06 concerns retained-summary review. Condition 1.1 refinement before observation application and later preservation/reading-disclosure status changes were separately retained. The original verdict date 2026-09-08 and correction date 2026-09-14 are not new-search or full-text-reading dates." }, { "material_type": "Bibliography/abstract", "public_status": "Bibliographic identifier/entrance retained; actual availability/response unverified", "access_status": "External access not attempted; not acquired", "acquired": false, "actually_read": false, "as_of": "2026-10-06T09:37:06.123638+09:00", "qualification": "Only URLs/identifiers were retained. Current external responses, files, identity and contents are unverified. Different titles/author displays under the same bibliographic identifiers were preserved. Included trials, contributing subsets, variance, denominators and models remain unverified. The material record dated 2026-10-06 concerns retained-summary review. Condition 1.1 refinement before observation application and later preservation/reading-disclosure status changes were separately retained. The original verdict date 2026-09-08 and correction date 2026-09-14 are not new-search or full-text-reading dates." }, { "material_type": "Article full text", "public_status": "Bibliographic identifier/entrance retained; actual availability/response unverified", "access_status": "External access not attempted; not acquired", "acquired": false, "actually_read": false, "as_of": "2026-10-06T09:37:06.123638+09:00", "qualification": "Only URLs/identifiers were retained. Current external responses, files, identity and contents are unverified. Different titles/author displays under the same bibliographic identifiers were preserved. Included trials, contributing subsets, variance, denominators and models remain unverified. The material record dated 2026-10-06 concerns retained-summary review. Condition 1.1 refinement before observation application and later preservation/reading-disclosure status changes were separately retained. The original verdict date 2026-09-08 and correction date 2026-09-14 are not new-search or full-text-reading dates." }, { "material_type": "Publisher-original entrance", "public_status": "Bibliographic identifier/entrance retained; actual availability/response unverified", "access_status": "External access not attempted; not acquired", "acquired": false, "actually_read": false, "as_of": "2026-10-06T09:37:06.123638+09:00", "qualification": "Only URLs/identifiers were retained. Current external responses, files, identity and contents are unverified. Different titles/author displays under the same bibliographic identifiers were preserved. Included trials, contributing subsets, variance, denominators and models remain unverified. The material record dated 2026-10-06 concerns retained-summary review. Condition 1.1 refinement before observation application and later preservation/reading-disclosure status changes were separately retained. The original verdict date 2026-09-08 and correction date 2026-09-14 are not new-search or full-text-reading dates." }, { "material_type": "Included-trial table", "public_status": "Actual existence/availability unverified; required original-material type", "access_status": "External access not attempted; not acquired", "acquired": false, "actually_read": false, "as_of": "2026-10-06T09:37:06.123638+09:00", "qualification": "This is a required material type. Existence, URL and public availability were not verified; the material read is the retained summary. Different titles/author displays under the same bibliographic identifiers were preserved. Included trials, contributing subsets, variance, denominators and models remain unverified. The material record dated 2026-10-06 concerns retained-summary review. Condition 1.1 refinement before observation application and later preservation/reading-disclosure status changes were separately retained. The original verdict date 2026-09-08 and correction date 2026-09-14 are not new-search or full-text-reading dates." }, { "material_type": "Synthesis appendix", "public_status": "Actual existence/availability unverified; required original-material type", "access_status": "External access not attempted; not acquired", "acquired": false, "actually_read": false, "as_of": "2026-10-06T09:37:06.123638+09:00", "qualification": "This is a required material type. Existence, URL and public availability were not verified; the material read is the retained summary. Different titles/author displays under the same bibliographic identifiers were preserved. Included trials, contributing subsets, variance, denominators and models remain unverified. The material record dated 2026-10-06 concerns retained-summary review. Condition 1.1 refinement before observation application and later preservation/reading-disclosure status changes were separately retained. The original verdict date 2026-09-08 and correction date 2026-09-14 are not new-search or full-text-reading dates." } ], "links": [ { "label": "PubMed", "url": "https://pubmed.ncbi.nlm.nih.gov/42337792/" } ] } ], "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's 50 randomized and 45 analyzed participants (23/22) are shared with the HbA1c endpoint in record 3051 and are not added together. The 13 papers remain distinct from the LDL-contributing subset; included trials, overlap and unique participant counts are unverified." }, "history": [ { "date": "2026-10-25", "kind": "Separation of public-facing pages and materials", "view_version": "1.0", "change": "The public view and materials were prepared from the existing 37 items. No new clinical search, verification-state change or scoring was performed." } ], "language": "en", "translation_date": "2026-10-25" }