{ "schema_version": "chamgap-public-evidence-check-1.0", "public_id": "v3062-main", "verdict_number": "3062", "title": "Single-ingredient garlic tablets 900 mg/day; powder, processing, and active-constituent specifications unverified × Reduction of HbA1c in adults with type 2 diabetes", "view_version": "1.0", "view_created_date": "2026-10-26", "criteria_version": "1.0", "criteria_date": "2026-10-06", "review_date": "2026-10-06", "legacy_evidence_date": "2026-09-08", "review_scope": { "materials_read": "Retained Korean/English summaries and case-specific condition/application records", "clinical_papers_directly_read": false, "new_clinical_search": false, "limitation": "Prepared from retained summaries and condition-application records. External abstracts, full texts, registration, protocols and analysis plans remain unread. Historical review records do not establish current independent clinical validation.", "date_meaning": "The material check date is the original date retained in the summary and condition records. The original verdict-review date does not establish a search cut-off or historical access dates for individual materials; external access was not attempted in this conversion." }, "claim_context": { "population": "Adults with established type 2 diabetes. Diagnosis, age, baseline HbA1c, inclusion/exclusion and balance between arms remain unverified.", "intervention": "Oral single-ingredient garlic tablets derived from Allium sativum L. cloves. Powder, extraction methods, manufacturing/batch and alliin/allicin specifications remain unverified.", "dose": "Nominal 900 mg/day. Per-dose amount, divided frequency, actual intake, adherence and active-constituent amounts remain unverified.", "comparator": "Placebo tablets. Metformin is a separate active arm, and common stable glucose-lowering medication is unverified. Placebo composition/appearance and actual arm schedules also remain unverified.", "endpoint": "Absolute between-group HbA1c change at 24 weeks. P<.005 was reported for each garlic arm versus placebo, but the selected absolute %p, 95%CI, completed/ITT denominators and prespecified single rank 1 primary hierarchy remain unverified.", "duration": "24-week treatment and measurements at 12 and 24 weeks. Actual schedules, completion and persistence after stopping remain unverified.", "excluded_extensions": [ "Do not fill missing absolute effects/CIs for the selected 900 mg tablet using P values or meta-analysis means mixing other formulations.", "The primary trial’s 7 arms, description of 210 participants and 30 per arm do not establish actual completed/ITT or selected-comparison analysis denominators.", "The first meta-analysis’s HbA1c 3 trials/7 effects differ from the second’s 27 RCTs/1,619 participants across all endpoints. Included-trial/participant overlap and independent replication of the selected formulation remain unverified.", "Keep fasting glucose, HOMA-IR and lipids separate from HbA1c. Do not extend results to replacing diabetes medication, preventing complications or identical effects from all garlic foods.", "Raw garlic, powder, oil, aged garlic extract, black garlic, fermented garlic and isolated SAC do not share the same tablet specifications. Optimal dose, maintenance after stopping, subgroups and long-term/rare-event/vulnerable-group safety are separate questions.", "Do not turn original caution wording into actual harm incidence, causal risks, safety certification or individual intake instructions." ] }, "requirements": [ { "item_id": "N01", "question_type": "Evidence condition", "question": "Is the selected 900 mg tablet, 24-week HbA1c comparison with placebo distinguished from other garlic claims?", "needed": "Original locations for the current claim, formulation/route, selected dose, population, endpoint, comparator and timing", "role": "Required", "role_reason": "The specific HbA1c question with evidence gaps must first be fixed.", "application_exception": "Verifying the question’s identity does not verify the absolute effect or formulation specifications.", "criterion": "Link the current article’s selected 900 mg/day, 24-week HbA1c and placebo question to excluded endpoints.", "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained reports. Detailed conditions are Chamgap’s own application.", "condition_origin": "These are Chamgap in-house application conditions for the single-ingredient garlic-tablet versus placebo HbA1c question, developed with knowledge of the retained content. They do not establish blinding, trial preregistration, official-tool certification or new independent clinical validation.", "proposed_research": "Review separate boundaries only when adding a new question. A new clinical trial is not required to identify this question.", "current_reports": [ "S01", "S02", "S03" ], "existence": "Stored research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with access not attempted.", "observation": "The comparison concerns oral single-ingredient garlic tablets 900 mg/day for 24 weeks versus placebo for HbA1c in adults with established type 2 diabetes. Other glycemic/lipid outcomes and complications are separate.", "condition_status": "Met", "status_reason": "Verification is limited to the identity of the original claim and its inclusion/exclusion boundaries; efficacy is not established.", "missingness": "Verification is limited to the identity of the original claim and its inclusion/exclusion boundaries; efficacy is not established.", "uncertainty": "Verification is limited to the identity of the original claim and its inclusion/exclusion boundaries; efficacy is not established.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "Original locations for the current claim, formulation/route, selected dose, population, endpoint, comparator and timing" }, { "item_id": "N02", "question_type": "Evidence condition", "question": "Have the 7-arm primary trial and two meta-analyses been kept from being double-counted as independent trials?", "needed": "Links among primary reports, reviews, included-trial tables, registrations and report families", "role": "Required", "role_reason": "Counting multiple arms and reviews as additional independent replications inflates the evidence.", "application_exception": "Retain null values and unverified states when original family tables and unique-participant relationships are unavailable.", "criterion": "Separate the roles of 1 primary-trial report and 2 meta-analysis reports, the same 7 arms, and unresolved included-trial overlap.", "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained reports. Detailed conditions are Chamgap’s own application.", "condition_origin": "These are Chamgap in-house application conditions for the single-ingredient garlic-tablet versus placebo HbA1c question, developed with knowledge of the retained content. They do not establish blinding, trial preregistration, official-tool certification or new independent clinical validation.", "proposed_research": "First construct a study-level results table by comparing included-trial tables with registration numbers, authors and recruitment periods.", "current_reports": [ "S01", "S02", "S03" ], "existence": "Stored research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with access not attempted.", "observation": "The 3 retained reports comprise a 7-arm primary trial and 2 meta-analyses. The 7 arms, 7 HbA1c effects and 27 RCTs are not added together to create a new independent-trial count.", "condition_status": "Met", "status_reason": "This verifies report distinctions and the prohibition on double-counting. The reviews’ included trials and overlap with the primary trial/participants remain unverified.", "missingness": "This verifies report distinctions and the prohibition on double-counting. The reviews’ included trials and overlap with the primary trial/participants remain unverified.", "uncertainty": "This verifies report distinctions and the prohibition on double-counting. The reviews’ included trials and overlap with the primary trial/participants remain unverified.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "Links among primary reports, reviews, included-trial tables, registrations and report families" }, { "item_id": "N03", "question_type": "Evidence condition", "question": "Are the summaries actually read in this conversion distinguished from reading external papers, supplements and registrations?", "needed": "Material identity, public/access status, acquisition, actual reading level, date, original location and identity", "role": "Required", "role_reason": "External links and retained summaries must not be represented as reading a paper’s full text.", "application_exception": "Access not attempted differs from inaccessible, failed access and 0 results.", "criterion": "Show actual reading of the local retained summary separately from external material unread in this conversion, and link summaries to their exact original locations.", "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained reports. Detailed conditions are Chamgap’s own application.", "condition_origin": "These are Chamgap in-house application conditions for the single-ingredient garlic-tablet versus placebo HbA1c question, developed with knowledge of the retained content. They do not establish blinding, trial preregistration, official-tool certification or new independent clinical validation.", "proposed_research": "For lawfully acquired material, record the sections/tables read and file identity in a separate event.", "current_reports": [ "S01", "S02", "S03" ], "existence": "Stored research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with access not attempted.", "observation": "The entire current 3062 retained summary was read, including Korean/English content, 3 evidence entries, 3 citations and 1 correction. Original papers, meta-analysis full texts/supplements and registrations were not accessed, acquired or read in this conversion.", "condition_status": "Met", "status_reason": "This distinguishes actual reading in this conversion from historical statements; it does not verify full-text content.", "missingness": "This distinguishes actual reading in this conversion from historical statements; it does not verify full-text content.", "uncertainty": "This distinguishes actual reading in this conversion from historical statements; it does not verify full-text content.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "Material identity, public/access status, acquisition, actual reading level, date, original location and identity" }, { "item_id": "N04", "question_type": "Evidence condition", "question": "Are adults with type 2 diabetes and the actual selection/baseline status in the selected primary trial verified?", "needed": "Diagnosis, age, baseline HbA1c, inclusion/exclusion, baseline medication/disease and balance between arms", "role": "Required", "role_reason": "Sharing the label diabetes does not make a meta-analysis’s mixed populations applicable to this population.", "application_exception": "Do not transfer figures from other populations or formulations to the selected arms.", "criterion": "Explain the match between the primary trial’s actual population and the selected question, and unverified baseline/selection details.", "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained reports. Detailed conditions are Chamgap’s own application.", "condition_origin": "These are Chamgap in-house application conditions for the single-ingredient garlic-tablet versus placebo HbA1c question, developed with knowledge of the retained content. They do not establish blinding, trial preregistration, official-tool certification or new independent clinical validation.", "proposed_research": "Retrieve the primary trial’s Methods and baseline table to review population matching, separating direct population-specific studies when needed.", "current_reports": [ "S01" ], "existence": "Stored research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with access not attempted.", "observation": "The population is recorded as adults with established type 2 diabetes. Detailed diagnostic criteria, age distribution, baseline HbA1c, inclusion/exclusion and balance between arms are not verified in the retained summary.", "condition_status": "Partly verified", "status_reason": "Only the population label is verified; detailed selection and baseline tables remain unverified.", "missingness": "Only the population label is verified; detailed selection and baseline tables remain unverified.", "uncertainty": "Only the population label is verified; detailed selection and baseline tables remain unverified.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "Diagnosis, age, baseline HbA1c, inclusion/exclusion, baseline medication/disease and balance between arms" }, { "item_id": "N05", "question_type": "Evidence condition", "question": "Are the source, specifications and active constituents of the selected single-ingredient garlic tablet verified?", "needed": "Exact product name, manufacturing/processing, powder/extraction method, batch, alliin/allicin assays and single-ingredient composition", "role": "Required", "role_reason": "Food, oil, AGE and black garlic must not be mixed with the tablet’s actual exposure.", "application_exception": "The source Allium sativum cloves alone does not establish processing or active-constituent specifications.", "criterion": "Distinguish the verified scope of an oral single-ingredient tablet from unverified specifications, and exclude other garlic formulations.", "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained reports. Detailed conditions are Chamgap’s own application.", "condition_origin": "These are Chamgap in-house application conditions for the single-ingredient garlic-tablet versus placebo HbA1c question, developed with knowledge of the retained content. They do not establish blinding, trial preregistration, official-tool certification or new independent clinical validation.", "proposed_research": "First check the primary trial’s product documents and constituent assays; design formulation-specific effect studies as separate comparisons.", "current_reports": [ "S01" ], "existence": "Stored research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with access not attempted.", "observation": "The single-ingredient garlic tablet derives from Allium sativum L. cloves. Powder, extraction method and alliin/allicin specifications remain unverified; other garlic products are not substituted.", "condition_status": "Partly verified", "status_reason": "Tablet/source labels exist, but actual manufacturing/batch and constituent-specification matching remain unverified.", "missingness": "Tablet/source labels exist, but actual manufacturing/batch and constituent-specification matching remain unverified.", "uncertainty": "Tablet/source labels exist, but actual manufacturing/batch and constituent-specification matching remain unverified.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "Exact product name, manufacturing/processing, powder/extraction method, batch, alliin/allicin assays and single-ingredient composition" }, { "item_id": "N06", "question_type": "Evidence condition", "question": "Are the per-dose amount, divided schedule and actual intake of 900 mg/day verified?", "needed": "Dosing table for the 900 mg arm, per-dose amount/frequency, actual intake, adherence and product content", "role": "Required", "role_reason": "Nominal daily dose must be distinguished from actual administered exposure to attribute the selected dose accurately.", "application_exception": "Do not import other dose arms or meta-analysis dose-response results as the selected 900 mg schedule.", "criterion": "Preserve the original 900 mg/day and record unverified divided dosing, intake and active-constituent amounts.", "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained reports. Detailed conditions are Chamgap’s own application.", "condition_origin": "These are Chamgap in-house application conditions for the single-ingredient garlic-tablet versus placebo HbA1c question, developed with knowledge of the retained content. They do not establish blinding, trial preregistration, official-tool certification or new independent clinical validation.", "proposed_research": "Retrieve the primary trial’s dosing table and adherence data. Review direct dose comparisons separately for an optimal-dose claim.", "current_reports": [ "S01" ], "existence": "Stored research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with access not attempted.", "observation": "The selected 900 mg/day is recorded, but per-dose amount, divided frequency, actual intake/adherence and active-constituent amount remain unverified.", "condition_status": "Partly verified", "status_reason": "The daily-dose label is verified, but the actual schedule and administered exposure cannot be established.", "missingness": "The daily-dose label is verified, but the actual schedule and administered exposure cannot be established.", "uncertainty": "The daily-dose label is verified, but the actual schedule and administered exposure cannot be established.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "Dosing table for the 900 mg arm, per-dose amount/frequency, actual intake, adherence and product content" }, { "item_id": "N07", "question_type": "Evidence condition", "question": "Are common glucose-lowering medication, changes and adherence in the placebo and 900 mg arms verified?", "needed": "Common glucose-lowering drugs by arm, stable-treatment period, changes/rescue treatment, adherence and analytical handling", "role": "Required", "role_reason": "Contributions from other glucose-lowering treatment must not be attributed to the selected garlic effect.", "application_exception": "Metformin is a separate active arm and is not assumed to be common maintenance medication.", "criterion": "Distinguish common treatment in both arms from a separate active arm, recording the impact of unverified concomitant treatment/changes.", "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained reports. Detailed conditions are Chamgap’s own application.", "condition_origin": "These are Chamgap in-house application conditions for the single-ingredient garlic-tablet versus placebo HbA1c question, developed with knowledge of the retained content. They do not establish blinding, trial preregistration, official-tool certification or new independent clinical validation.", "proposed_research": "First check the primary trial’s Methods, concomitant-medication table, treatment changes and SAP to clarify the effect of interest.", "current_reports": [ "S01" ], "existence": "Stored research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with access not attempted.", "observation": "Whether stable glucose-lowering medication was maintained in common is unverified. Metformin is a separate active arm, so neither garlic nor placebo arms are described as both receiving metformin.", "condition_status": "Unverified", "status_reason": "Actual data on common concomitant medication, changes by arm, rescue treatment and adherence are unavailable.", "missingness": "Actual data on common concomitant medication, changes by arm, rescue treatment and adherence are unavailable.", "uncertainty": "Actual data on common concomitant medication, changes by arm, rescue treatment and adherence are unavailable.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "Common glucose-lowering drugs by arm, stable-treatment period, changes/rescue treatment, adherence and analytical handling" }, { "item_id": "N08", "question_type": "Evidence condition", "question": "Are the actual roles of placebo tablets and the separate metformin active arm verified?", "needed": "Allocation table for the 7 arms, placebo composition/appearance, active-arm dose, common treatment and selected contrast", "role": "Required", "role_reason": "Garlic versus placebo and garlic versus an active drug are different questions.", "application_exception": "Do not substitute the separate active drug for placebo or common background treatment in both arms.", "criterion": "Fix the selected contrast as 900 mg versus placebo, explaining unverified placebo details and actual active-arm composition.", "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained reports. Detailed conditions are Chamgap’s own application.", "condition_origin": "These are Chamgap in-house application conditions for the single-ingredient garlic-tablet versus placebo HbA1c question, developed with knowledge of the retained content. They do not establish blinding, trial preregistration, official-tool certification or new independent clinical validation.", "proposed_research": "Retrieve arm-composition/allocation tables and define a separate question before adding an active-drug comparison.", "current_reports": [ "S01" ], "existence": "Stored research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with access not attempted.", "observation": "The selected comparator is placebo tablets, while metformin is a separate active arm. Details of placebo composition, matching appearance and the active-arm schedule remain unverified.", "condition_status": "Partly verified", "status_reason": "Placebo/active-arm roles are distinguished, but actual arm composition and placebo matching details remain unresolved.", "missingness": "Placebo/active-arm roles are distinguished, but actual arm composition and placebo matching details remain unresolved.", "uncertainty": "Placebo/active-arm roles are distinguished, but actual arm composition and placebo matching details remain unresolved.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "Allocation table for the 7 arms, placebo composition/appearance, active-arm dose, common treatment and selected contrast" }, { "item_id": "N09", "question_type": "Evidence condition", "question": "Are the actual schedules of 24-week treatment and measurements at 12 and 24 weeks verified?", "needed": "Treatment/testing schedules by arm, baseline/12-week/24-week measurements, completion/stopping and follow-up duration", "role": "Required", "role_reason": "A 12-week interim value must not become the selected 24-week effect or a sustained effect after treatment stops.", "application_exception": "Distinguish measurement times from actual completed follow-up and long-term maintenance duration.", "criterion": "Preserve the selected 24-week endpoint and 12-week interim measurement, leaving actual schedules/losses by arm unverified.", "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained reports. Detailed conditions are Chamgap’s own application.", "condition_origin": "These are Chamgap in-house application conditions for the single-ingredient garlic-tablet versus placebo HbA1c question, developed with knowledge of the retained content. They do not establish blinding, trial preregistration, official-tool certification or new independent clinical validation.", "proposed_research": "Retrieve original schedules and time-specific measurement/completion data; effects after stopping require separate follow-up.", "current_reports": [ "S01" ], "existence": "Stored research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with access not attempted.", "observation": "The record describes 24-week treatment and measurements at 12 and 24 weeks. The selected endpoint is 24-week HbA1c; detailed schedules, actual completion and follow-up after stopping remain unverified.", "condition_status": "Partly verified", "status_reason": "Nominal treatment/measurement times are available, but actual follow-up schedules and completion are unverified.", "missingness": "Nominal treatment/measurement times are available, but actual follow-up schedules and completion are unverified.", "uncertainty": "Nominal treatment/measurement times are available, but actual follow-up schedules and completion are unverified.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "Treatment/testing schedules by arm, baseline/12-week/24-week measurements, completion/stopping and follow-up duration" }, { "item_id": "N10", "question_type": "Evidence condition", "question": "Are the definition and units of absolute between-group HbA1c change verified?", "needed": "Units, baseline/final values/change, contrast of interest, direction and analytical definition for 24-week HbA1c", "role": "Required", "role_reason": "Significance, glucose values and pooled means must not be mixed with the selected absolute HbA1c effect.", "application_exception": "Do not interchange % and %p, within-group before/after and between-group comparisons, or final values and changes.", "criterion": "Distinguish the question of absolute between-group HbA1c change at 24 weeks from the level of actually reported results and unverified information.", "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained reports. Detailed conditions are Chamgap’s own application.", "condition_origin": "These are Chamgap in-house application conditions for the single-ingredient garlic-tablet versus placebo HbA1c question, developed with knowledge of the retained content. They do not establish blinding, trial preregistration, official-tool certification or new independent clinical validation.", "proposed_research": "Retrieve baseline/final/change values and contrast definitions from the original results table to link them to the selected effect.", "current_reports": [ "S01" ], "existence": "Stored research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with access not attempted.", "observation": "The selected question concerns absolute between-group HbA1c change at 24 weeks. Only significance is retained for the primary trial, so the exact measure and computational contrast for the selected absolute effect remain unverified.", "condition_status": "Partly verified", "status_reason": "No table is available to compare the question’s endpoint/measure with the primary trial’s quantitative result.", "missingness": "No table is available to compare the question’s endpoint/measure with the primary trial’s quantitative result.", "uncertainty": "No table is available to compare the question’s endpoint/measure with the primary trial’s quantitative result.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "Units, baseline/final values/change, contrast of interest, direction and analytical definition for 24-week HbA1c" }, { "item_id": "N11", "question_type": "Evidence condition", "question": "Are HbA1c assay methods, collection times and assessment procedures verified?", "needed": "Laboratory method/standardization, blood-collection timing, identical procedures by arm, assessor blinding and error handling", "role": "Required", "role_reason": "Actual procedures are needed to examine whether differences in measurement conditions could explain result differences.", "application_exception": "The objective-marker name HbA1c alone does not establish absence of measurement bias.", "criterion": "Explain the actual scope and unverified aspects of testing, collection, standardization and blinding.", "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained reports. Detailed conditions are Chamgap’s own application.", "condition_origin": "These are Chamgap in-house application conditions for the single-ingredient garlic-tablet versus placebo HbA1c question, developed with knowledge of the retained content. They do not establish blinding, trial preregistration, official-tool certification or new independent clinical validation.", "proposed_research": "Acquire the original Methods, laboratory procedures and measurement-quality data.", "current_reports": [ "S01" ], "existence": "Stored research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with access not attempted.", "observation": "HbA1c measurement and the 24-week endpoint are recorded, but assay methods, standardization, assessor/laboratory blinding and procedures by arm are not verified in the retained summary.", "condition_status": "Unverified", "status_reason": "The single-blind label alone does not identify who was blinded for which measurement.", "missingness": "The single-blind label alone does not identify who was blinded for which measurement.", "uncertainty": "The single-blind label alone does not identify who was blinded for which measurement.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "Laboratory method/standardization, blood-collection timing, identical procedures by arm, assessor blinding and error handling" }, { "item_id": "N12", "question_type": "Evidence condition", "question": "Can the described 210 participants and 30 per arm be distinguished from actual 900 mg/placebo analysis denominators at 24 weeks?", "needed": "Recruitment/allocation, completion by arm, 24-week measurements, ITT/PP analysis n and participant flow diagram", "role": "Required", "role_reason": "A described sample size must not be established as a completed/analysis denominator.", "application_exception": "Do not substitute 30 in each of 7 arms for an analysis of 210 in the 900 mg/placebo contrast.", "criterion": "Preserve the original description of 210 participants and 30 per arm, distinguishing recruitment/allocation/completion/analysis roles and unverified information.", "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained reports. Detailed conditions are Chamgap’s own application.", "condition_origin": "These are Chamgap in-house application conditions for the single-ingredient garlic-tablet versus placebo HbA1c question, developed with knowledge of the retained content. They do not establish blinding, trial preregistration, official-tool certification or new independent clinical validation.", "proposed_research": "Retrieve original flow diagrams and arm-by-time/analysis tables to link the actual denominators for the selected contrast.", "current_reports": [ "S01" ], "existence": "Stored research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with access not attempted.", "observation": "The record describes 210 participants and 30 per arm; completion and ITT remain unverified. The 210 are not used as the actual analysis n for the selected 900 mg versus placebo comparison.", "condition_status": "Partly verified", "status_reason": "Original sample-size wording exists, but completed/analysis denominators by stage, arm and time are unresolved.", "missingness": "Original sample-size wording exists, but completed/analysis denominators by stage, arm and time are unresolved.", "uncertainty": "Original sample-size wording exists, but completed/analysis denominators by stage, arm and time are unresolved.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "Recruitment/allocation, completion by arm, 24-week measurements, ITT/PP analysis n and participant flow diagram" }, { "item_id": "N13", "question_type": "Evidence condition", "question": "Are missingness, dropout, exclusions and analytical handling in the selected two arms verified?", "needed": "Missingness/dropout by arm, exclusion reasons, imputed values, ITT/PP and sensitivity analyses", "role": "Required", "role_reason": "Original sample size alone cannot establish that no analysis losses occurred.", "application_exception": "Do not fill losses absent from the current summary with 0 or 100% completion.", "criterion": "Verify actual losses/handling for the selected 900 mg/placebo arms or explain that they remain unverified within the current material.", "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained reports. Detailed conditions are Chamgap’s own application.", "condition_origin": "These are Chamgap in-house application conditions for the single-ingredient garlic-tablet versus placebo HbA1c question, developed with knowledge of the retained content. They do not establish blinding, trial preregistration, official-tool certification or new independent clinical validation.", "proposed_research": "Acquire participant flow diagrams, analysis plans and sensitivity-analysis material.", "current_reports": [ "S01" ], "existence": "Stored research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with access not attempted.", "observation": "Completion and ITT are recorded as unverified; counts of missingness, dropout and exclusions by arm and their handling are not verified.", "condition_status": "Unverified", "status_reason": "Analysis losses, reasons and handling cannot be read from the currently retained material.", "missingness": "Analysis losses, reasons and handling cannot be read from the currently retained material.", "uncertainty": "Analysis losses, reasons and handling cannot be read from the currently retained material.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "Missingness/dropout by arm, exclusion reasons, imputed values, ITT/PP and sensitivity analyses" }, { "item_id": "N14", "question_type": "Evidence condition", "question": "Are randomization methods, concealment and baseline balance in the 7-arm controlled trial verified?", "needed": "Original random sequence, allocation concealment, arm composition, baseline tables and recruitment process", "role": "Required", "role_reason": "Controlled-trial/review-RCT labels must not be inherited as adequate allocation in the primary trial.", "application_exception": "An unverified randomization method does not establish that the trial was nonrandomized.", "criterion": "Distinguish the 7-arm single-blind controlled-trial wording from unverified allocation/concealment/balance.", "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained reports. Detailed conditions are Chamgap’s own application.", "condition_origin": "These are Chamgap in-house application conditions for the single-ingredient garlic-tablet versus placebo HbA1c question, developed with knowledge of the retained content. They do not establish blinding, trial preregistration, official-tool certification or new independent clinical validation.", "proposed_research": "Retrieve original Methods, allocation and baseline data to examine design limitations for the selected contrast.", "current_reports": [ "S01", "S02" ], "existence": "Stored research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with access not attempted.", "observation": "The primary study is a 7-arm single-blind controlled trial with an unverified randomization method. A meta-analysis’s RCT title is not transferred as verification of the primary trial’s allocation procedures.", "condition_status": "Partly verified", "status_reason": "Arm composition and controlled/blinding labels exist, but actual allocation, concealment and balance remain unresolved.", "missingness": "Arm composition and controlled/blinding labels exist, but actual allocation, concealment and balance remain unresolved.", "uncertainty": "Arm composition and controlled/blinding labels exist, but actual allocation, concealment and balance remain unresolved.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "Original random sequence, allocation concealment, arm composition, baseline tables and recruitment process" }, { "item_id": "N15", "question_type": "Evidence condition", "question": "Are the people blinded, placebo appearance and assessment blinding verified?", "needed": "Who was blinded, placebo appearance, blinding assessment/unblinding and tester procedures", "role": "Required", "role_reason": "The single-blind label must not be read as resolving all performance/measurement bias.", "application_exception": "An objective endpoint does not erase unverified performance/concomitant-treatment differences or measurement procedures.", "criterion": "Distinguish original blinding wording from unverified people and actual procedures for each outcome.", "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained reports. Detailed conditions are Chamgap’s own application.", "condition_origin": "These are Chamgap in-house application conditions for the single-ingredient garlic-tablet versus placebo HbA1c question, developed with knowledge of the retained content. They do not establish blinding, trial preregistration, official-tool certification or new independent clinical validation.", "proposed_research": "Acquire the primary trial’s blinding Methods and placebo/measurement procedures.", "current_reports": [ "S01" ], "existence": "Stored research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with access not attempted.", "observation": "Only the single-blind label is retained; whether participants, clinicians or testers were blinded, placebo matching and unblinding remain unverified.", "condition_status": "Partly verified", "status_reason": "Material is unavailable to establish actual implementation beyond the blinding label.", "missingness": "Material is unavailable to establish actual implementation beyond the blinding label.", "uncertainty": "Material is unavailable to establish actual implementation beyond the blinding label.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "Who was blinded, placebo appearance, blinding assessment/unblinding and tester procedures" }, { "item_id": "N16", "question_type": "Evidence condition", "question": "Are ITT/PP, adjustment, between-group contrasts and analytical models for the selected result verified?", "needed": "Original SAP, ITT/PP analysis populations, baseline adjustment, between-/within-group comparisons and multi-arm contrast definitions", "role": "Required", "role_reason": "Without knowing which effect is estimated, the P value cannot be read as the selected absolute between-group effect.", "application_exception": "Do not arbitrarily fill the analysis as ITT or turn within-group improvement into an additional effect.", "criterion": "Compare the absolute between-group effect of interest at 24 weeks with actual analytical definitions and unverified aspects.", "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained reports. Detailed conditions are Chamgap’s own application.", "condition_origin": "These are Chamgap in-house application conditions for the single-ingredient garlic-tablet versus placebo HbA1c question, developed with knowledge of the retained content. They do not establish blinding, trial preregistration, official-tool certification or new independent clinical validation.", "proposed_research": "Retrieve the selected results table and analysis plan/model to link contrasts, denominators and adjustment.", "current_reports": [ "S01" ], "existence": "Stored research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with access not attempted.", "observation": "Only P<.005 for garlic arms including 900 mg versus placebo, with completion and ITT unverified, is retained. Exact analysis populations, adjustment, models and the selected contrast definition remain unverified.", "condition_status": "Unverified", "status_reason": "Significance wording alone cannot determine allocation effects, adherence effects or adjusted between-group changes.", "missingness": "Significance wording alone cannot determine allocation effects, adherence effects or adjusted between-group changes.", "uncertainty": "Significance wording alone cannot determine allocation effects, adherence effects or adjusted between-group changes.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "Original SAP, ITT/PP analysis populations, baseline adjustment, between-/within-group comparisons and multi-arm contrast definitions" }, { "item_id": "N17", "question_type": "Evidence condition", "question": "Are the attribution of P<.005 for each garlic arm versus placebo and the selected effect’s limitations distinguished?", "needed": "Original 24-week results table, contrasts by arm, tests, multiple comparisons and effect definition", "role": "Required", "role_reason": "P values and effect size/precision provide different information.", "application_exception": "Do not convert each dose arm’s P value into the selected absolute %p or CI, or pool them as identical effects.", "criterion": "Attribute P<.005 to the original statement and show alongside it that the 900 mg absolute effect and CI remain unverified.", "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained reports. Detailed conditions are Chamgap’s own application.", "condition_origin": "These are Chamgap in-house application conditions for the single-ingredient garlic-tablet versus placebo HbA1c question, developed with knowledge of the retained content. They do not establish blinding, trial preregistration, official-tool certification or new independent clinical validation.", "proposed_research": "Acquire the original results table and handling of multiple arms in testing, linking only the selected contrast separately.", "current_reports": [ "S01" ], "existence": "Stored research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with access not attempted.", "observation": "P<.005 for each garlic arm versus placebo, including 900 mg/day, is recorded. The selected absolute between-group difference and 95%CI remain unverified.", "condition_status": "Partly verified", "status_reason": "Significance wording is retained, but test/contrast, effect-size and multiple-comparison details cannot be established.", "missingness": "Significance wording is retained, but test/contrast, effect-size and multiple-comparison details cannot be established.", "uncertainty": "Significance wording is retained, but test/contrast, effect-size and multiple-comparison details cannot be established.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "Original 24-week results table, contrasts by arm, tests, multiple comparisons and effect definition" }, { "item_id": "N18", "question_type": "Evidence condition", "question": "Are the absolute 24-week HbA1c effect and 95%CI for the selected 900 mg tablet verified?", "needed": "Baseline/final/change HbA1c in the selected/placebo arms, absolute between-group %p, variance, 95%CI and evidence for an important difference", "role": "Required", "role_reason": "Primary-trial counts, significance and pooled means cannot determine the selected effect’s size or adequacy.", "application_exception": "Do not calculate and fill missing effects or CIs from P values or meta-analysis WMDs for other formulations.", "criterion": "Link the selected 900 mg absolute effect, interval and evidence for importance, or leave them precisely unverified.", "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained reports. Detailed conditions are Chamgap’s own application.", "condition_origin": "These are Chamgap in-house application conditions for the single-ingredient garlic-tablet versus placebo HbA1c question, developed with knowledge of the retained content. They do not establish blinding, trial preregistration, official-tool certification or new independent clinical validation.", "proposed_research": "Retrieve the primary trial’s selected results table, variance and denominators. If unavailable, quantitative replication research needs prespecified outcome reporting.", "current_reports": [ "S01", "S02", "S03" ], "existence": "Stored research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with access not attempted.", "observation": "The selected 900 mg absolute between-group %p, 95%CI and completed denominator remain unverified. Meta-analysis estimates of −0.50%p/−0.53%p are not established effects of the selected tablet.", "condition_status": "Unverified", "status_reason": "The selected absolute effect, CI and analytical definitions are missing, so effect size, precision and importance cannot be established.", "missingness": "The selected absolute effect, CI and analytical definitions are missing, so effect size, precision and importance cannot be established.", "uncertainty": "The selected absolute effect, CI and analytical definitions are missing, so effect size, precision and importance cannot be established.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "Baseline/final/change HbA1c in the selected/placebo arms, absolute between-group %p, variance, 95%CI and evidence for an important difference" }, { "item_id": "N19", "question_type": "Evidence condition", "question": "Can the primary trial’s prespecified 24-week HbA1c rank 1 outcome hierarchy and analysis plan be compared with actual reporting?", "needed": "Contemporaneous primary-trial registration versions, protocol, SAP, endpoints/times and multi-arm change history", "role": "Required", "role_reason": "Comparing prespecified plans with reports is needed to examine favorable selection of endpoints, times or arms.", "application_exception": "Unable to verify registration does not establish nonregistration; do not use review PROSPERO as a primary-trial NCT.", "criterion": "Explicitly state that a prespecified single rank 1 primary endpoint is unverified and registration/SAP were not compared, separating review registration.", "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained reports. Detailed conditions are Chamgap’s own application.", "condition_origin": "These are Chamgap in-house application conditions for the single-ingredient garlic-tablet versus placebo HbA1c question, developed with knowledge of the retained content. They do not establish blinding, trial preregistration, official-tool certification or new independent clinical validation.", "proposed_research": "Retrieve contemporaneous registration, protocol and SAP to compare the prespecified hierarchy for 24-week HbA1c and the selected 900 mg contrast.", "current_reports": [ "S01", "S02" ], "existence": "Stored research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with access not attempted.", "observation": "A prespecified single rank 1 primary 24-week HbA1c endpoint in the primary trial is unverified, and the registration check is recorded as unable to verify. CRD42024628780 is a meta-analysis registration label.", "condition_status": "Unverified", "status_reason": "No direct comparison of the primary trial’s prespecified hierarchy, analysis plan or changes is available.", "missingness": "No direct comparison of the primary trial’s prespecified hierarchy, analysis plan or changes is available.", "uncertainty": "No direct comparison of the primary trial’s prespecified hierarchy, analysis plan or changes is available.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "Contemporaneous primary-trial registration versions, protocol, SAP, endpoints/times and multi-arm change history" }, { "item_id": "N20", "question_type": "Evidence condition", "question": "Is material available to distinguish the pooled HbA1c value from 3 trials and 7 effects from the selected tablet’s effect?", "needed": "HbA1c included trials, formulations/doses, populations, background treatments, times and effect/shared-control tables in the first meta-analysis", "role": "Required (applying pooled evidence)", "role_reason": "Multi-arm effects from the same trial and varied formulations/concomitant treatments must not be pooled as the selected 900 mg effect.", "application_exception": "Do not substitute 7 independent trials for 3 trials and 7 effects.", "criterion": "Explain the reported WMD/CI, roles of 3 trials and 7 effects, mixed formulations/background treatments and indirectness for the selected effect.", "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained reports. Detailed conditions are Chamgap’s own application.", "condition_origin": "These are Chamgap in-house application conditions for the single-ingredient garlic-tablet versus placebo HbA1c question, developed with knowledge of the retained content. They do not establish blinding, trial preregistration, official-tool certification or new independent clinical validation.", "proposed_research": "Retrieve included-trial tables and original results to link exposure, timing and shared controls for each HbA1c effect.", "current_reports": [ "S01", "S02" ], "existence": "Stored research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with access not attempted.", "observation": "HbA1c in the first meta-analysis involves 3 trials and 7 effects, with WMD −0.50%p (95%CI −0.66~−0.33). Mixed formulations and background treatments mean this is not an established effect of the selected tablet.", "condition_status": "Partly verified", "status_reason": "Pooled reported values/scale exist, but product, population, background-treatment and shared-control matching by effect remain unresolved.", "missingness": "Pooled reported values/scale exist, but product, population, background-treatment and shared-control matching by effect remain unresolved.", "uncertainty": "Pooled reported values/scale exist, but product, population, background-treatment and shared-control matching by effect remain unresolved.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "HbA1c included trials, formulations/doses, populations, background treatments, times and effect/shared-control tables in the first meta-analysis" }, { "item_id": "N21", "question_type": "Evidence condition", "question": "Is the overall scale of 27 RCTs and 1,619 participants across all endpoints distinguished from the HbA1c analysis scale?", "needed": "Endpoint-specific trials/participants, products, populations, times, background treatments and HbA1c analysis tables in the second meta-analysis", "role": "Required (applying pooled evidence)", "role_reason": "Reading all-endpoint scale as the sample size for HbA1c or the selected 900 mg comparison overstates precision.", "application_exception": "The 27 RCTs and 1,619 participants describe all endpoints; do not transfer them as unique HbA1c analysis n.", "criterion": "Preserve overall scale and HbA1c WMD/CI separately, marking endpoint-specific denominators and directness unverified.", "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained reports. Detailed conditions are Chamgap’s own application.", "condition_origin": "These are Chamgap in-house application conditions for the single-ingredient garlic-tablet versus placebo HbA1c question, developed with knowledge of the retained content. They do not establish blinding, trial preregistration, official-tool certification or new independent clinical validation.", "proposed_research": "Retrieve endpoint-specific included-trial/effect tables, products and durations to separate the relevant HbA1c analysis.", "current_reports": [ "S03" ], "existence": "Stored research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with access not attempted.", "observation": "The second meta-analysis records 27 RCTs and 1,619 participants across all endpoints, with HbA1c WMD −0.53%p (95%CI −0.86~−0.20). Replication counts for the selected formulation and HbA1c analysis n remain unverified.", "condition_status": "Partly verified", "status_reason": "Overall scale and a reported HbA1c mean exist, but endpoint-/formulation-specific denominators and matching for the selected question remain unresolved.", "missingness": "Overall scale and a reported HbA1c mean exist, but endpoint-/formulation-specific denominators and matching for the selected question remain unresolved.", "uncertainty": "Overall scale and a reported HbA1c mean exist, but endpoint-/formulation-specific denominators and matching for the selected question remain unresolved.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "Endpoint-specific trials/participants, products, populations, times, background treatments and HbA1c analysis tables in the second meta-analysis" }, { "item_id": "N22", "question_type": "Evidence condition", "question": "Are included-trial and unique-participant overlaps between the primary trial and the two reviews verified?", "needed": "Included-trial tables for both reviews, primary/multi-arm reports, registration numbers, recruitment sites/periods and unique-participant links", "role": "Required (independent replication)", "role_reason": "Different reviews citing the same primary trial do not add independent replication evidence.", "application_exception": "Different bibliographic DOIs for reviews alone do not establish independent included trials/participants.", "criterion": "Explain the verified scope of primary-trial inclusion, overlap between reviews and unique-study/participant counts.", "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained reports. Detailed conditions are Chamgap’s own application.", "condition_origin": "These are Chamgap in-house application conditions for the single-ingredient garlic-tablet versus placebo HbA1c question, developed with knowledge of the retained content. They do not establish blinding, trial preregistration, official-tool certification or new independent clinical validation.", "proposed_research": "First construct a report-family table, comparing recruitment periods, sites and registrations to verify overlap.", "current_reports": [ "S01", "S02", "S03" ], "existence": "Stored research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with access not attempted.", "observation": "The original retained summary has no trial-family or included-trial/participant overlap table. Overlap between the primary trial and both reviews, and independent replications of the selected 900 mg, are unresolved.", "condition_status": "Unverified", "status_reason": "The existence of same/different reports is known, but material is unavailable to establish included-trial and unique-participant relationships.", "missingness": "The existence of same/different reports is known, but material is unavailable to establish included-trial and unique-participant relationships.", "uncertainty": "The existence of same/different reports is known, but material is unavailable to establish included-trial and unique-participant relationships.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "Included-trial tables for both reviews, primary/multi-arm reports, registration numbers, recruitment sites/periods and unique-participant links" }, { "item_id": "N23", "question_type": "Evidence condition", "question": "Are the scope and causes of I²96.4% and a positive publication-bias test in the first meta-analysis verified?", "needed": "HbA1c effect distributions, I²/variance, heterogeneity/bias-test methods, prespecified hypotheses and missing results", "role": "Required (interpreting pooled evidence)", "role_reason": "The positive pooled mean and extreme heterogeneity must both be retained.", "application_exception": "A positive test alone must not generate a missing-trial count or corrected effect, or invalidate all trials.", "criterion": "Link reported heterogeneity, the positive test and unverified methods/causes to limitations in applying results to the selected formulation.", "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained reports. Detailed conditions are Chamgap’s own application.", "condition_origin": "These are Chamgap in-house application conditions for the single-ingredient garlic-tablet versus placebo HbA1c question, developed with knowledge of the retained content. They do not establish blinding, trial preregistration, official-tool certification or new independent clinical validation.", "proposed_research": "Retrieve original forest plots, tests and formulation/background-treatment/time-specific results to review explanations for heterogeneity.", "current_reports": [ "S02" ], "existence": "Stored research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with access not attempted.", "observation": "The first meta-analysis records I²=96.4% and a positive publication-bias test. Test methods, effect distributions, missing results and causes remain unverified in the retained summary.", "condition_status": "Partly verified", "status_reason": "Heterogeneity and test labels exist, but causes, test scope and missing results were not directly compared.", "missingness": "Heterogeneity and test labels exist, but causes, test scope and missing results were not directly compared.", "uncertainty": "Heterogeneity and test labels exist, but causes, test scope and missing results were not directly compared.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "HbA1c effect distributions, I²/variance, heterogeneity/bias-test methods, prespecified hypotheses and missing results" }, { "item_id": "N24", "question_type": "Evidence condition", "question": "Have −0.50%p and −0.53%p been kept from being forced into the same analysis or an actual conflict?", "needed": "Results/CIs, analysis scope, products/background treatments and endpoint-specific inclusion differences between the two reviews", "role": "Required", "role_reason": "Differences between means with different analytical scopes must neither be ignored nor declared conflicts about the same question.", "application_exception": "Differences between review estimates alone do not establish conflicting data, equivalence or an effect of 0.", "criterion": "Attribute both original reported values/CIs, heterogeneity and the need for additional high-quality RCTs to their respective sources without combining them.", "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained reports. Detailed conditions are Chamgap’s own application.", "condition_origin": "These are Chamgap in-house application conditions for the single-ingredient garlic-tablet versus placebo HbA1c question, developed with knowledge of the retained content. They do not establish blinding, trial preregistration, official-tool certification or new independent clinical validation.", "proposed_research": "Compare analytical scopes/included trials before separately reviewing whether an actual conflict concerns the same question.", "current_reports": [ "S02", "S03" ], "existence": "Stored research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with access not attempted.", "observation": "Retain the first meta-analysis’s −0.50%p/CI−0.66~−0.33 and the second’s −0.53%p/CI−0.86~−0.20 separately. Retain the second’s conclusion that additional high-quality RCTs are needed.", "condition_status": "Met", "status_reason": "Verification is limited to separately retaining each reported value and limitation; it does not establish homogeneity, independence or efficacy of the reviews.", "missingness": "Verification is limited to separately retaining each reported value and limitation; it does not establish homogeneity, independence or efficacy of the reviews.", "uncertainty": "Verification is limited to separately retaining each reported value and limitation; it does not establish homogeneity, independence or efficacy of the reviews.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "Results/CIs, analysis scope, products/background treatments and endpoint-specific inclusion differences between the two reviews" }, { "item_id": "N25", "question_type": "Evidence condition", "question": "Are an optimal 900 mg dose, persistence after stopping and effects in specific subgroups verified?", "needed": "Direct dose contrasts, cessation/long-term follow-up, prespecified subgroups, interactions and separate estimates", "role": "Supplementary; required for extension claims", "role_reason": "The selected 24-week result must not be extended to an optimal dose, long-term maintenance or effects in special populations.", "application_exception": "Do not require all extension research as mandatory for the current narrow 24-week HbA1c question.", "criterion": "Distinguish the 7-arm/review dose-response labels from unverified direct extension results for 900 mg.", "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained reports. Detailed conditions are Chamgap’s own application.", "condition_origin": "These are Chamgap in-house application conditions for the single-ingredient garlic-tablet versus placebo HbA1c question, developed with knowledge of the retained content. They do not establish blinding, trial preregistration, official-tool certification or new independent clinical validation.", "proposed_research": "Claims of an optimal dose, maintenance or subgroups require product-fixed direct contrasts and prespecified subgroup/follow-up studies.", "current_reports": [ "S01", "S03" ], "existence": "Stored research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with access not attempted.", "observation": "A 7-arm primary trial and a dose-response meta-analysis title exist, but direct results for optimality of 900 mg, maintenance after stopping and prespecified subgroup interactions remain unverified.", "condition_status": "Unverified", "status_reason": "Direct results supporting extensions beyond the current selected 24-week HbA1c scope were not verified.", "missingness": "Direct results supporting extensions beyond the current selected 24-week HbA1c scope were not verified.", "uncertainty": "Direct results supporting extensions beyond the current selected 24-week HbA1c scope were not verified.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "Direct dose contrasts, cessation/long-term follow-up, prespecified subgroups, interactions and separate estimates" }, { "item_id": "N26", "question_type": "Evidence condition", "question": "Has an HbA1c difference been kept from being extended to replacing diabetes medication or preventing complications?", "needed": "Original boundaries between the HbA1c surrogate and questions about medication replacement, complications and events", "role": "Supplementary; required for clinical extensions", "role_reason": "A surrogate-marker change does not automatically answer questions about other treatments or clinical events.", "application_exception": "Do not require event trials as mandatory to verify the numerical HbA1c question.", "criterion": "Explicitly prohibit extensions to medication replacement, complications and effects from all garlic foods.", "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained reports. Detailed conditions are Chamgap’s own application.", "condition_origin": "These are Chamgap in-house application conditions for the single-ingredient garlic-tablet versus placebo HbA1c question, developed with knowledge of the retained content. They do not establish blinding, trial preregistration, official-tool certification or new independent clinical validation.", "proposed_research": "Separate claims of replacement treatment or complication prevention require direct comparisons/event data for those clinical questions.", "current_reports": [ "S01", "S02", "S03" ], "existence": "Stored research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with access not attempted.", "observation": "Fasting glucose, HOMA-IR and lipids are kept separate from the selected HbA1c endpoint; results cannot be extended to replacing diabetes medication, preventing complications or identical effects from all garlic foods.", "condition_status": "Met", "status_reason": "Verification concerns explicit interpretive boundaries; it does not judge an absence of clinical-event effects or safety of replacement treatment.", "missingness": "Verification concerns explicit interpretive boundaries; it does not judge an absence of clinical-event effects or safety of replacement treatment.", "uncertainty": "Verification concerns explicit interpretive boundaries; it does not judge an absence of clinical-event effects or safety of replacement treatment.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "Original boundaries between the HbA1c surrogate and questions about medication replacement, complications and events" }, { "item_id": "N27", "question_type": "Evidence condition", "question": "Are funding, product provision and conflicts of interest for the primary trial and both reviews actually verified?", "needed": "Funding, product provision, author employment/patents, declared COI and institutional/independent-family relationships by report", "role": "Supplementary; required for independence claims", "role_reason": "Unverified funding must not be credited as independent funding or absence of conflicts.", "application_exception": "Do not inherit an academic-research label or original I1 as independent funding or replication certification.", "criterion": "Separate unverified primary-trial funding/product provision from the reviews’ wording of academic research and mixed primary-trial funding.", "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained reports. Detailed conditions are Chamgap’s own application.", "condition_origin": "These are Chamgap in-house application conditions for the single-ingredient garlic-tablet versus placebo HbA1c question, developed with knowledge of the retained content. They do not establish blinding, trial preregistration, official-tool certification or new independent clinical validation.", "proposed_research": "Retrieve funding, provision, COI, author and institutional information separately for primary papers/reviews, recording the actual scope.", "current_reports": [ "S01", "S02", "S03" ], "existence": "Stored research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with access not attempted.", "observation": "Primary-trial funding/product provision are unverified; the two meta-analyses are recorded as academic research with mixed original-trial funding. Original I1 is historical and is not new independence certification.", "condition_status": "Unverified", "status_reason": "Specific funding, provision, author employment/patents, declared COI and independent-institution relationships are unresolved.", "missingness": "Specific funding, provision, author employment/patents, declared COI and independent-institution relationships are unresolved.", "uncertainty": "Specific funding, provision, author employment/patents, declared COI and independent-institution relationships are unresolved.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "Funding, product provision, author employment/patents, declared COI and institutional/independent-family relationships by report" }, { "item_id": "N28", "question_type": "Evidence condition", "question": "Are hypoglycemic, gastrointestinal and bleeding events and collection methods for the selected formulation verified?", "needed": "Event definitions, active/spontaneous collection, severity, events/stopping by arm and missingness/dropout", "role": "Supplementary; required for safety claims", "role_reason": "General caution wording must not become actual primary-trial adverse-event counts or absence of harm.", "application_exception": "Unverified harm data do not delete HbA1c reports; record separate states.", "criterion": "Separate caution wording from actual events/collection and the boundaries between not reported and not read.", "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained reports. Detailed conditions are Chamgap’s own application.", "condition_origin": "These are Chamgap in-house application conditions for the single-ingredient garlic-tablet versus placebo HbA1c question, developed with knowledge of the retained content. They do not establish blinding, trial preregistration, official-tool certification or new independent clinical validation.", "proposed_research": "Acquire primary-trial AE, stopping and collection tables; review safety questions separately with suitable harm designs.", "current_reports": [ "S01" ], "existence": "Stored research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with access not attempted.", "observation": "The original caution concerns monitoring hypoglycemia with glucose-lowering medication, gastrointestinal discomfort, bleeding risk and content variation. Actual primary-trial event definitions/collection, occurrence by arm, severity and stopping remain unverified.", "condition_status": "Unverified", "status_reason": "Cautions are retained, but actual collection/counting is unverified, so no events or safety cannot be asserted.", "missingness": "Cautions are retained, but actual collection/counting is unverified, so no events or safety cannot be asserted.", "uncertainty": "Cautions are retained, but actual collection/counting is unverified, so no events or safety cannot be asserted.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "Event definitions, active/spontaneous collection, severity, events/stopping by arm and missingness/dropout" }, { "item_id": "N29", "question_type": "Evidence condition", "question": "Are harm timing, denominators, follow-up and comparative risks in the selected two arms verified?", "needed": "Exposure/events, stopping/recovery times, exposed people/people with events/event counts by arm, follow-up time and comparative estimates", "role": "Supplementary; required for comparative harms/incidence", "role_reason": "The scale of 210 participants/30 per arm and the 24-week schedule must not automatically become harm incidence or causal denominators.", "application_exception": "Do not calculate harm risk from efficacy times/sample sizes or extrapolate background rates.", "criterion": "Link reporting of actual harm timing, controls, denominators/duration to currently unverified information.", "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained reports. Detailed conditions are Chamgap’s own application.", "condition_origin": "These are Chamgap in-house application conditions for the single-ingredient garlic-tablet versus placebo HbA1c question, developed with knowledge of the retained content. They do not establish blinding, trial preregistration, official-tool certification or new independent clinical validation.", "proposed_research": "Retrieve original arm-specific AE/stopping/exposure-time tables; long-term and rare harms need suitable follow-up data.", "current_reports": [ "S01" ], "existence": "Stored research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with access not attempted.", "observation": "Nominal 24 weeks, a description of 210 participants and 30 per arm exist, but harm occurrence/recovery, stopping/re-exposure, event denominators by arm, actual follow-up and comparative risks remain unverified.", "condition_status": "Unverified", "status_reason": "Efficacy scale/duration cannot establish harm frequency or comparative risk.", "missingness": "Efficacy scale/duration cannot establish harm frequency or comparative risk.", "uncertainty": "Efficacy scale/duration cannot establish harm frequency or comparative risk.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "Exposure/events, stopping/recovery times, exposed people/people with events/event counts by arm, follow-up time and comparative estimates" }, { "item_id": "N30", "question_type": "Evidence condition", "question": "Are glucose-lowering medication, baseline disease, other exposures and alternative explanations for harms reviewed?", "needed": "Concomitant medication by arm, baseline hypoglycemia/bleeding/disease, other exposures, changes and alternatives/adjustment", "role": "Supplementary; required for causal harms", "role_reason": "A concomitant-use caution alone must not attribute actual events solely to garlic.", "application_exception": "Missing alternative-explanation information does not establish that no other causes existed.", "criterion": "Distinguish the warning context from the verified scope of actual co-exposure, underlying disease and alternatives.", "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained reports. Detailed conditions are Chamgap’s own application.", "condition_origin": "These are Chamgap in-house application conditions for the single-ingredient garlic-tablet versus placebo HbA1c question, developed with knowledge of the retained content. They do not establish blinding, trial preregistration, official-tool certification or new independent clinical validation.", "proposed_research": "Link original concomitant-medication, baseline and event records to review alternative explanations for harm and temporal relationships.", "current_reports": [ "S01" ], "existence": "Stored research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with access not attempted.", "observation": "A caution to monitor hypoglycemia with glucose-lowering medication exists, but actual common medication is unverified, and baseline risks/other exposures and alternative event explanations by arm are unavailable.", "condition_status": "Unverified", "status_reason": "Without actual event/co-exposure data, caution wording cannot be extended to a causal-risk estimate.", "missingness": "Without actual event/co-exposure data, caution wording cannot be extended to a causal-risk estimate.", "uncertainty": "Without actual event/co-exposure data, caution wording cannot be extended to a causal-risk estimate.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "Concomitant medication by arm, baseline hypoglycemia/bleeding/disease, other exposures, changes and alternatives/adjustment" }, { "item_id": "N31", "question_type": "Evidence condition", "question": "Is the scope of other independent harm records, long-term/rare risks and vulnerable groups verified?", "needed": "Unique harm families, regulatory reports versus recitations, long-term/rare events, special-population exposure and interactions", "role": "Supplementary; required for replication/overall safety", "role_reason": "Short-term efficacy trials/reviews must not be promoted to independent harm replications or overall safety.", "application_exception": "Do not require every rare-harm study for the current HbA1c question or add together repeated citations of the same event.", "criterion": "Separate direct harm replications and unverified long-term/vulnerable-group information from original efficacy material.", "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained reports. Detailed conditions are Chamgap’s own application.", "condition_origin": "These are Chamgap in-house application conditions for the single-ingredient garlic-tablet versus placebo HbA1c question, developed with knowledge of the retained content. They do not establish blinding, trial preregistration, official-tool certification or new independent clinical validation.", "proposed_research": "Review separate harm questions through unique-event links and suitable long-term follow-up/registration data.", "current_reports": [ "S01", "S02", "S03" ], "existence": "Stored research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with access not attempted.", "observation": "Harm-family tables, repeated events and direct long-term/rare-event/vulnerable-group data are not verified in the current 3 reports. The original caution does not certify overall safety.", "condition_status": "Unverified", "status_reason": "Efficacy reports and pooled means alone cannot verify independent harm replications or long-term/vulnerable-group safety.", "missingness": "Efficacy reports and pooled means alone cannot verify independent harm replications or long-term/vulnerable-group safety.", "uncertainty": "Efficacy reports and pooled means alone cannot verify independent harm replications or long-term/vulnerable-group safety.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "Unique harm families, regulatory reports versus recitations, long-term/rare events, special-population exposure and interactions" }, { "item_id": "N32", "question_type": "Evidence condition", "question": "Are positive signals, the unverified selected effect and cautions explained at distinct levels?", "needed": "Boundaries between P/pooled direction, selected quantitative gaps, original cautions and incidence/causality/individual prescribing", "role": "Required (current wording scope)", "role_reason": "Positive efficacy signals must not become safety, medication replacement or an established selected quantitative effect.", "application_exception": "Do not revise uncertainty and caution into a new safety grade or individual intake instructions.", "criterion": "Retain positive statements alongside unverified selected effects/harms, explicitly explaining limits on causal/incidence extensions.", "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained reports. Detailed conditions are Chamgap’s own application.", "condition_origin": "These are Chamgap in-house application conditions for the single-ingredient garlic-tablet versus placebo HbA1c question, developed with knowledge of the retained content. They do not establish blinding, trial preregistration, official-tool certification or new independent clinical validation.", "proposed_research": "Revisit each question/row if actual quantitative or harm data are added; retain original boundaries until then.", "current_reports": [ "S01", "S02", "S03" ], "existence": "Stored research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with access not attempted.", "observation": "Positive P values/heterogeneous meta-analysis directions exist, but the selected 900 mg absolute effect, denominator and prespecified hierarchy remain unverified; safety retains the original Caution. Do not extend this to medication replacement or individual intake instructions.", "condition_status": "Met", "status_reason": "Verification concerns currently supportable wording and limits on extension; it is not new certification of efficacy, causality or safety.", "missingness": "Verification concerns currently supportable wording and limits on extension; it is not new certification of efficacy, causality or safety.", "uncertainty": "Verification concerns currently supportable wording and limits on extension; it is not new certification of efficacy, causality or safety.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "Boundaries between P/pooled direction, selected quantitative gaps, original cautions and incidence/causality/individual prescribing" }, { "item_id": "N33", "question_type": "Evidence condition", "question": "Are the original 2026-09-08 reference date, 09-14 correction history, generic English wording and current scope distinguished?", "needed": "Original verdict-review date, corrections, original Korean/English/evidence/citation fields and current reading/search/publication-status scope", "role": "Required", "role_reason": "Historical access/correction labels must not be backdated into full-text reading, a current search or specific English verification in this conversion.", "application_exception": "Preserve original generic English principles; no translation correction or historical reconstruction is performed in this conversion.", "criterion": "Link original dates, corrections/English wording and actual reading of the retained summary to the absence of searching/external reading; do not label no response as 0 studies.", "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained reports. Detailed conditions are Chamgap’s own application.", "condition_origin": "These are Chamgap in-house application conditions for the single-ingredient garlic-tablet versus placebo HbA1c question, developed with knowledge of the retained content. They do not establish blinding, trial preregistration, official-tool certification or new independent clinical validation.", "proposed_research": "If original-data correction/evidence updating is separately requested, preserve the whole original and handle original locations/version changes as an event.", "current_reports": [ "S01", "S02", "S03" ], "existence": "Stored research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with access not attempted.", "observation": "The original verdict-review date is 2026-09-08, with a 09-14 history of correcting 3 English-placeholder fields. Current generic-principle wording in English evidence/citations remains exactly as recorded; this conversion is not specific numerical verification, a new search or a correction.", "condition_status": "Met", "status_reason": "Verification concerns preservation of original dates, history, current values and work scope. Specific replacements in the English correction history were neither reconstructed nor certified; current publication/retraction status was not queried.", "missingness": "Verification concerns preservation of original dates, history, current values and work scope. Specific replacements in the English correction history were neither reconstructed nor certified; current publication/retraction status was not queried.", "uncertainty": "Verification concerns preservation of original dates, history, current values and work scope. Specific replacements in the English correction history were neither reconstructed nor certified; current publication/retraction status was not queried.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "Original verdict-review date, corrections, original Korean/English/evidence/citation fields and current reading/search/publication-status scope" }, { "item_id": "N34", "question_type": "Evidence condition", "question": "Have original C46, Caution, all axes and empty subclaims been kept from being inherited as new condition states/grades?", "needed": "Original typed grade/score/safety, bilingual synthesis/grade decisions, axes, corrections and empty subclaims", "role": "Required (historical preservation)", "role_reason": "Conversion-table states preserve information by condition and must not automatically recalculate the original efficacy verdict.", "application_exception": "Do not display original verification labels or C46 as independent clinical certification, a new efficacy score or a condition-fulfillment rate.", "criterion": "Link original values/types unchanged, explaining that no new score/grade or subclaim index is generated.", "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained reports. Detailed conditions are Chamgap’s own application.", "condition_origin": "These are Chamgap in-house application conditions for the single-ingredient garlic-tablet versus placebo HbA1c question, developed with knowledge of the retained content. They do not establish blinding, trial preregistration, official-tool certification or new independent clinical validation.", "proposed_research": "Correcting the original verdict requires a separate request and version/change event. It is not rescoring in this sheet conversion.", "current_reports": [ "S01", "S02", "S03" ], "existence": "Stored research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with access not attempted.", "observation": "Original C46, Caution, B/S/R1/I1/EX/B1/CX, booleans/empty strings, subclaims=[] and bilingual synthesis/corrections are preserved unchanged. Row states are not new efficacy grades or recalculations of the original score.", "condition_status": "Met", "status_reason": "Verification concerns preservation of original verdict history, types and boundaries; existing verification labels are not inherited as independent clinical certification in this conversion.", "missingness": "Verification concerns preservation of original verdict history, types and boundaries; existing verification labels are not inherited as independent clinical certification in this conversion.", "uncertainty": "Verification concerns preservation of original verdict history, types and boundaries; existing verification labels are not inherited as independent clinical certification in this conversion.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "Original typed grade/score/safety, bilingual synthesis/grade decisions, axes, corrections and empty subclaims" } ], "reports": [ { "report_id": "S01", "title": "Ashraf R et al. J Med Plants Res. 2011;5:2922-2928. DOI: 10.5897/JMPR.9000523.", "url": "https://academicjournals.org/journal/JMPR/article-abstract/C214F3118656", "report_type": "Retained record: a 7-arm single-blind controlled trial. Randomization methods, concealment and baseline balance remain unverified.", "existence": "Stored research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with access not attempted.", "study_family": "One report clue for the same 7-arm primary trial. Dose arms, endpoints, times and Korean/English summaries are not summed as independent trials or participants.", "independent_replication": "Multiple doses in the same 7 arms are not independent replications. Included-trial/participant overlap with the two reviews and independent replication of the selected 900 mg formulation remain unverified.", "observed_result": "P<.005 for each garlic arm versus placebo, including 900 mg/day. The selected absolute difference and CI remain unverified.", "result_level": "The prespecified single rank 1 primary status, absolute %p and 95%CI for 24-week HbA1c remain unverified. A description of 210 participants and 30 per arm does not establish completed/ITT denominators.", "source_evidence_date": "2026-09-08", "materials": [ { "material_type": "Retained verdict summary", "public_status": "Retained verdict summary read", "access_status": "Retained copy acquired; summary read", "acquired": true, "actually_read": "Stored existing review summary read", "as_of": "2026-10-06", "qualification": "Relevant content in the retained Korean/English summary, evidence and citation was read. This does not establish acquisition or reading of the original clinical paper. This citation is linked in the retained summary. External abstracts, full texts, registration, protocols and analysis plans were not read in this conversion, and independent clinical validation was not performed. The material check date is the original date retained in the summary and condition records. The original verdict-review date does not establish a search cut-off or historical access dates for individual materials; external access was not attempted in this conversion." }, { "material_type": "External bibliographic/abstract gateway", "public_status": "Bibliographic link retained; external material unread", "access_status": "External access not attempted; not acquired", "acquired": false, "actually_read": "Not read", "as_of": "2026-10-06", "qualification": "This is an external link from the retained citation. The current response, bibliographic identity, abstract content and public access were not checked. This citation is linked in the retained summary. External abstracts, full texts, registration, protocols and analysis plans were not read in this conversion, and independent clinical validation was not performed. The material check date is the original date retained in the summary and condition records. The original verdict-review date does not establish a search cut-off or historical access dates for individual materials; external access was not attempted in this conversion." }, { "material_type": "Original full-text/supplement gateway", "public_status": "DOI gateway retained; full text/supplements unread", "access_status": "External access not attempted; not acquired", "acquired": false, "actually_read": "Not read", "as_of": "2026-10-06", "qualification": "This is a full-text/supplement gateway linked by the DOI in the retained citation. Provision, access, acquisition and reading remain unverified; access was not attempted in this conversion. This citation is linked in the retained summary. External abstracts, full texts, registration, protocols and analysis plans were not read in this conversion, and independent clinical validation was not performed. The material check date is the original date retained in the summary and condition records. The original verdict-review date does not establish a search cut-off or historical access dates for individual materials; external access was not attempted in this conversion." }, { "material_type": "Primary-trial registration; location unverified", "public_status": "Registration location/version unverified; unread", "access_status": "External access not attempted; not acquired", "acquired": false, "actually_read": "Not read", "as_of": "2026-10-06", "qualification": "Primary-trial registration is retained as unable to verify. The exact location/version is unverified; nonregistration is not established. This citation is linked in the retained summary. External abstracts, full texts, registration, protocols and analysis plans were not read in this conversion, and independent clinical validation was not performed. The material check date is the original date retained in the summary and condition records. The original verdict-review date does not establish a search cut-off or historical access dates for individual materials; external access was not attempted in this conversion." } ], "links": [ { "label": "Official source", "url": "https://academicjournals.org/journal/JMPR/article-abstract/C214F3118656" } ] }, { "report_id": "S02", "title": "Ebrahimzadeh A et al. Nutr Metab Insights. 2026. PMID: 41695233. DOI: 10.1177/11786388251413660. PROSPERO CRD42024628780.", "url": "https://pubmed.ncbi.nlm.nih.gov/41695233/", "report_type": "Retained record: systematic review and meta-analysis of RCTs. This is distinguished from the primary trial and direct replication of the selected tablet.", "existence": "Stored research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with access not attempted.", "study_family": "HbA1c: 3 trials/7 effects. Included trials, shared controls and overlap with S01/S03 remain unverified.", "independent_replication": "The 7 effects are not 7 independent trials. PROSPERO CRD42024628780 labels review registration, not a primary-trial NCT. Included-trial/participant overlap remains unverified.", "observed_result": "WMD −0.50%p, 95%CI −0.66~−0.33; I²=96.4%; positive publication-bias test.", "result_level": "This pooled value mixes formulations/background treatments and is not an established effect of the selected 900 mg tablet. Matching by effect, bias-test methods/causes and missing results remain unverified.", "source_evidence_date": "2026-09-08", "materials": [ { "material_type": "Retained verdict summary", "public_status": "Retained verdict summary read", "access_status": "Retained copy acquired; summary read", "acquired": true, "actually_read": "Stored existing review summary read", "as_of": "2026-10-06", "qualification": "Relevant content in the retained Korean/English summary, evidence and citation was read. This does not establish acquisition or reading of the original clinical paper. This citation is linked in the retained summary. External abstracts, full texts, registration, protocols and analysis plans were not read in this conversion, and independent clinical validation was not performed. The material check date is the original date retained in the summary and condition records. The original verdict-review date does not establish a search cut-off or historical access dates for individual materials; external access was not attempted in this conversion." }, { "material_type": "External bibliographic/abstract gateway", "public_status": "Bibliographic link retained; external material unread", "access_status": "External access not attempted; not acquired", "acquired": false, "actually_read": "Not read", "as_of": "2026-10-06", "qualification": "This is an external link from the retained citation. The current response, bibliographic identity, abstract content and public access were not checked. This citation is linked in the retained summary. External abstracts, full texts, registration, protocols and analysis plans were not read in this conversion, and independent clinical validation was not performed. The material check date is the original date retained in the summary and condition records. The original verdict-review date does not establish a search cut-off or historical access dates for individual materials; external access was not attempted in this conversion." }, { "material_type": "Original full-text/supplement gateway", "public_status": "DOI gateway retained; full text/supplements unread", "access_status": "External access not attempted; not acquired", "acquired": false, "actually_read": "Not read", "as_of": "2026-10-06", "qualification": "This is a full-text/supplement gateway linked by the DOI in the retained citation. Provision, access, acquisition and reading remain unverified; access was not attempted in this conversion. This citation is linked in the retained summary. External abstracts, full texts, registration, protocols and analysis plans were not read in this conversion, and independent clinical validation was not performed. The material check date is the original date retained in the summary and condition records. The original verdict-review date does not establish a search cut-off or historical access dates for individual materials; external access was not attempted in this conversion." }, { "material_type": "Meta-analysis registration; PROSPERO CRD42024628780", "public_status": "Registration location/version unverified; unread", "access_status": "External access not attempted; not acquired", "acquired": false, "actually_read": "Not read", "as_of": "2026-10-06", "qualification": "This is the review-registration ID in the retained citation. Its exact URL/version is unverified in this conversion, and it is not a primary-trial NCT. This citation is linked in the retained summary. External abstracts, full texts, registration, protocols and analysis plans were not read in this conversion, and independent clinical validation was not performed. The material check date is the original date retained in the summary and condition records. The original verdict-review date does not establish a search cut-off or historical access dates for individual materials; external access was not attempted in this conversion." } ], "links": [ { "label": "PubMed", "url": "https://pubmed.ncbi.nlm.nih.gov/41695233/" } ] }, { "report_id": "S03", "title": "Alsanie SA et al. Diabetes Res Clin Pract. 2026;239:113407. PMID: 42398591. DOI: 10.1016/j.diabres.2026.113407.", "url": "https://pubmed.ncbi.nlm.nih.gov/42398591/", "report_type": "Retained record: meta-analysis of RCTs with a reported GRADE assessment. Its title is not treated as official GRADE certification in this conversion.", "existence": "Stored research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with access not attempted.", "study_family": "The 27 RCTs/1,619 participants describe all endpoints. HbA1c denominators, direct replication of the selected 900 mg and overlap with S01/S02 remain unverified.", "independent_replication": "Different review citations alone do not establish independent included trials or participants. Replication of the selected formulation and unique totals remain unverified.", "observed_result": "HbA1c WMD −0.53%p, 95%CI −0.86~−0.20.", "result_level": "Retain the original conclusion that additional high-quality RCTs are needed. All-endpoint scale is not transferred to HbA1c or selected-tablet analysis denominators.", "source_evidence_date": "2026-09-08", "materials": [ { "material_type": "Retained verdict summary", "public_status": "Retained verdict summary read", "access_status": "Retained copy acquired; summary read", "acquired": true, "actually_read": "Stored existing review summary read", "as_of": "2026-10-06", "qualification": "Relevant content in the retained Korean/English summary, evidence and citation was read. This does not establish acquisition or reading of the original clinical paper. This citation is linked in the retained summary. External abstracts, full texts, registration, protocols and analysis plans were not read in this conversion, and independent clinical validation was not performed. The material check date is the original date retained in the summary and condition records. The original verdict-review date does not establish a search cut-off or historical access dates for individual materials; external access was not attempted in this conversion." }, { "material_type": "External bibliographic/abstract gateway", "public_status": "Bibliographic link retained; external material unread", "access_status": "External access not attempted; not acquired", "acquired": false, "actually_read": "Not read", "as_of": "2026-10-06", "qualification": "This is an external link from the retained citation. The current response, bibliographic identity, abstract content and public access were not checked. This citation is linked in the retained summary. External abstracts, full texts, registration, protocols and analysis plans were not read in this conversion, and independent clinical validation was not performed. The material check date is the original date retained in the summary and condition records. The original verdict-review date does not establish a search cut-off or historical access dates for individual materials; external access was not attempted in this conversion." }, { "material_type": "Original full-text/supplement gateway", "public_status": "DOI gateway retained; full text/supplements unread", "access_status": "External access not attempted; not acquired", "acquired": false, "actually_read": "Not read", "as_of": "2026-10-06", "qualification": "This is a full-text/supplement gateway linked by the DOI in the retained citation. Provision, access, acquisition and reading remain unverified; access was not attempted in this conversion. This citation is linked in the retained summary. External abstracts, full texts, registration, protocols and analysis plans were not read in this conversion, and independent clinical validation was not performed. The material check date is the original date retained in the summary and condition records. The original verdict-review date does not establish a search cut-off or historical access dates for individual materials; external access was not attempted in this conversion." } ], "links": [ { "label": "PubMed", "url": "https://pubmed.ncbi.nlm.nih.gov/42398591/" } ] } ], "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": "Some required facts are known, but the stated conditions involving analyses, populations, formulation or denominators remain unverified.", "Unverified": "Direct information is unverified in the retained record. This does not establish an effect of 0, no studies or absence of harm.", "Review incomplete": "Reading of the material or review of a condition is incomplete. This does not establish absence of studies or efficacy.", "Not reported": "The needed information was not found in material actually read. This is distinguished from unread material.", "Inaccessible": "Access was actually attempted but the material was not acquired. This is distinguished from access not attempted.", "Insufficient evidence matching the conditions": "Evidence directly matching the defined question and conditions is insufficient. This does not establish absence of all research.", "Not applicable": "A specific condition does not apply to the question. This does not substitute for unread or unverified material.", "Conflicting data": "This covers discrepancies in material about the same question, denominator and timing. Differences between separate questions are not automatically treated as conflicts.", "Met": "The retained identity, observation or scope required by this item was checked within stated limits. This does not establish efficacy or full-text certification." }, "study_overlap": { "state": "Unverified", "unique_trial_count": null, "unique_participant_count": null, "reason": "Distinguish reports from the 7-arm primary trial and two meta-analyses. HbA1c 3 trials/7 effects are not counted as 7 independent trials; 27 RCTs/1,619 participants describe all endpoints. Primary-trial inclusion, overlap between reviews, unique-trial/participant totals and independent replication of the selected formulation remain unverified." }, "history": [ { "date": "2026-10-26", "kind": "Separation of public-facing pages and materials", "view_version": "1.0", "change": "The public view and materials were prepared from the existing 34 items. No new clinical search, verification-state change or scoring was performed." } ], "language": "en", "translation_date": "2026-10-26" }