# Test beverage containing hot-water extract of sun-dried lotus leaves × Reduction of whole-body fat percentage in adults with overweight

Verdict 3077 · Evidence Check

Stored-material review date: 2026-10-05  
Original evidence review date: 2026-09-08  
Review-criteria version: 1.1  
Public page/material preparation date: 2026-10-28

Clinical papers were not read directly; existing review summaries were checked. No new clinical-literature search was performed. Unverified does not mean that research is absent or that there is no effect.

## Assessment scope

- Population: Chinese adults aged 40–60 with overweight; 95 with BMI 23–30 were registered, while the paper analyzed 60 completers with BMI 24–28
- Ingredient, formulation and route: Test beverage 400 mL per 1 day (2 bottles of 200 mL) containing 0, 1, or 2 g extract
- Dose: Lotus leaf hot-water extract 1 or 2 g/day
- Comparator: Same-format test beverage containing 0 g extract
- Measured outcome: Change in whole-body fat percentage at weeks 6 and 12
- Duration: 12 weeks
- Questions outside this scope: The scope is whole-body fat percentage after 12 weeks of a test beverage containing 1 or 2 g/day hot-water extract of sun-dried lotus leaves. Do not extend it to lotus-leaf tea, capsules, food, other plant parts, weight, visceral fat or disease prevention.; Distinguish 95 randomized participants,22 discontinuations and 60 analyzed participants. Reasons for excluding the other 13 remain unverified; they are not all counted as discontinuations.; Whether the sex- and dose-specific values are between-group contrasts or within-group changes, and their 95% CIs, remain unverified. Do not newly calculate or establish a unified main effect, optimal dose or persistence.; Retain the original Caution label and limits of the short-term selected sample. Unverified vulnerable populations, concomitant medicines and long-term or rare harms do not establish safety or personal dosing instructions.

## Checklist items

### N01 · Which lotus-leaf preparation, population and body-fat comparison are being checked?

Verification status: Met  
Reading scope: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.

- Current findings: The question concerns whole-body fat percentage at 12 weeks in adults with overweight given a 400 mL beverage containing 1 or 2 g/day hot-water extract of sun-dried lotus leaves. The original subclaim list is empty.
- Why unverified: Checking this boundary does not confirm efficacy or revalidate the legacy grade.
- Reason for missing information: Checking this boundary does not confirm efficacy or revalidate the legacy grade.
- Required materials and conditions: Plant part, extraction, beverage, population, whole-body fat percentage, 0 g comparator and time
- Materials to obtain first: Plant part, extraction, beverage, population, whole-body fat percentage, 0 g comparator and time
- Further research: Compare subsequent material with the formulation, population, comparator, outcome and time.
- Conditions for verification: Link the single question of 12-week whole-body fat percentage for the defined test beverage versus a 0 g beverage to the original record.
- Why this condition is needed: Needed to avoid combining this question with tea, other plant parts or weight outcomes.
- Application exceptions: Do not split sex- and dose-specific results into 3 independent effects while their contrasts remain unverified.
- Remaining uncertainty: Checking this boundary does not confirm efficacy or revalidate the legacy grade.
- Referenced methods: Existing method principles distinguish population, leaf and extraction method, test beverage, comparator, assessment time, denominators, post hoc selection, missingness, measurement, contrasts, intervals, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.
- Related sources: S1

### N02 · Are eligibility criteria, post hoc selection and baseline characteristics of the registered and analyzed populations verified?

Verification status: Partly verified  
Reading scope: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.

- Current findings: The retained record describes 95 registered Chinese adults aged 40–60 with overweight and analysis of 60 completers with BMI24–28.
- Why unverified: Baseline balance, complete eligibility criteria, the basis for post hoc criteria and representativeness cannot be established from this record alone.
- Reason for missing information: Baseline balance, complete eligibility criteria, the basis for post hoc criteria and representativeness cannot be established from this record alone.
- Required materials and conditions: Age, BMI, diagnosis, inclusion/exclusion, baseline tables and post hoc selection process
- Materials to obtain first: Age, BMI, diagnosis, inclusion/exclusion, baseline tables and post hoc selection process
- Further research: Obtain baseline tables by arm, selection rules, timing of application and reasons for exclusion.
- Conditions for verification: Check differences between age 40–60, registered BMI23–30 and analyzed BMI24–28, actual eligibility criteria, the timing and reasons for post hoc selection and baseline characteristics by arm.
- Why this condition is needed: Needed to avoid automatically treating the 60 analyzed participants as representative of the 95 randomized participants.
- Application exceptions: Do not generalize to other ages, BMI ranges or disease populations.
- Remaining uncertainty: Baseline balance, complete eligibility criteria, the basis for post hoc criteria and representativeness cannot be established from this record alone.
- Referenced methods: Existing method principles distinguish population, leaf and extraction method, test beverage, comparator, assessment time, denominators, post hoc selection, missingness, measurement, contrasts, intervals, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.
- Related sources: S1

### N03 · Are the plant part, extraction, major constituents and batch-specific assays/manufacturing specifications verified?

Verification status: Partly verified  
Reading scope: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.

- Current findings: Hot-water extract of sun-dried leaves is recorded, with quercetin-3-O-glucuronide and quercetin as major constituents.
- Why unverified: Original material for actual batches, complete constituent assays and manufacturing quality has not been read in this work.
- Reason for missing information: Original material for actual batches, complete constituent assays and manufacturing quality has not been read in this work.
- Required materials and conditions: Plant species, part, drying, extraction, constituents, manufacturing batches and product material
- Materials to obtain first: Plant species, part, drying, extraction, constituents, manufacturing batches and product material
- Further research: When product specifications, batch and constituent-assay material become available, compare the plant part, processing and formulation with the actual trial intervention.
- Conditions for verification: Check recorded hot-water extraction of sun-dried Nelumbo nucifera leaves and major constituents against actual manufacturing-batch, assay and product-specification material.
- Why this condition is needed: Needed to avoid transferring the result to ordinary lotus-leaf tea, capsules or isolated constituents.
- Application exceptions: Lotus rhizome, plumule, seed and combinations are not the trial intervention.
- Remaining uncertainty: Original material for actual batches, complete constituent assays and manufacturing quality has not been read in this work.
- Referenced methods: Existing method principles distinguish population, leaf and extraction method, test beverage, comparator, assessment time, denominators, post hoc selection, missingness, measurement, contrasts, intervals, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.
- Related sources: S1

### N04 · What are the route, nominal dose and volume of the test beverage?

Verification status: Met  
Reading scope: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.

- Current findings: The record describes oral test beverages of 400 mL/day (2 bottles of 200 mL) containing 0, 1 or 2 g; the intervention doses are 1 or 2 g/day.
- Why unverified: Individual actual consumption and adherence are not inferred from these nominal specifications.
- Reason for missing information: Individual actual consumption and adherence are not inferred from these nominal specifications.
- Required materials and conditions: Oral administration,400 mL, 2 bottles of 200 mL and 0/1/2 g beverage specifications
- Materials to obtain first: Oral administration,400 mL, 2 bottles of 200 mL and 0/1/2 g beverage specifications
- Further research: Separately compare actual consumption, adherence, batches and exposure by arm.
- Conditions for verification: Link oral 400 mL/day and 0/1/2 g specifications to the corresponding result.
- Why this condition is needed: Needed to avoid turning trial specifications into personal dosing instructions.
- Application exceptions: Checking a nominal dose differs from verifying measured adherence or actual exposure.
- Remaining uncertainty: Individual actual consumption and adherence are not inferred from these nominal specifications.
- Referenced methods: Existing method principles distinguish population, leaf and extraction method, test beverage, comparator, assessment time, denominators, post hoc selection, missingness, measurement, contrasts, intervals, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.
- Related sources: S1

### N05 · When were treatment and body-fat assessments performed?

Verification status: Met  
Reading scope: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.

- Current findings: Treatment lasted 12 weeks and the original primary endpoint specifies changes in whole-body fat percentage at 6 and 12 weeks. The retained numerical results are at 12 weeks.
- Why unverified: Detailed 6-week results and persistence beyond 12 weeks are not available in this record.
- Reason for missing information: Detailed 6-week results and persistence beyond 12 weeks are not available in this record.
- Required materials and conditions: 12-week treatment,6/12-week measurements, completion and follow-up schedule
- Materials to obtain first: 12-week treatment,6/12-week measurements, completion and follow-up schedule
- Further research: Obtain time-specific result tables and follow-up after treatment stops.
- Conditions for verification: Distinguish 12-week treatment and the selected 12-week result, and link the recorded 6-week assessment.
- Why this condition is needed: Needed to avoid combining outcomes measured at different times as the same value.
- Application exceptions: Do not substitute a 12-week result for persistence after discontinuation.
- Remaining uncertainty: Detailed 6-week results and persistence beyond 12 weeks are not available in this record.
- Referenced methods: Existing method principles distinguish population, leaf and extraction method, test beverage, comparator, assessment time, denominators, post hoc selection, missingness, measurement, contrasts, intervals, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.
- Related sources: S1

### N06 · How well are the 0 g control beverage and other conditions matched?

Verification status: Partly verified  
Reading scope: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.

- Current findings: The comparator is recorded as the same-format test beverage containing 0 g extract.
- Why unverified: Detailed taste/appearance matching, shared lifestyle management, concomitant conditions and changes remain unverified.
- Reason for missing information: Detailed taste/appearance matching, shared lifestyle management, concomitant conditions and changes remain unverified.
- Required materials and conditions: 0 g beverage specifications, appearance/taste, common management and differences between arms
- Materials to obtain first: 0 g beverage specifications, appearance/taste, common management and differences between arms
- Further research: Obtain control ingredients, blinding, common management and treatment changes by arm.
- Conditions for verification: Compare the same-format 0 g beverage with the verified scope of taste, management and concomitant conditions.
- Why this condition is needed: Needed to avoid assuming that a beverage comparator establishes matching of all concurrent conditions.
- Application exceptions: Do not relabel the 0 g beverage as no treatment.
- Remaining uncertainty: Detailed taste/appearance matching, shared lifestyle management, concomitant conditions and changes remain unverified.
- Referenced methods: Existing method principles distinguish population, leaf and extraction method, test beverage, comparator, assessment time, denominators, post hoc selection, missingness, measurement, contrasts, intervals, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.
- Related sources: S1

### N07 · Are actual allocation, concealment and baseline balance verified?

Verification status: Partly verified  
Reading scope: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.

- Current findings: The record describes a randomized 3-arm trial with participant/care-provider blinding and a 0 g beverage comparator.
- Why unverified: Detailed original material on sequence generation, concealment and baseline balance cannot be checked from the retained summary alone.
- Reason for missing information: Detailed original material on sequence generation, concealment and baseline balance cannot be checked from the retained summary alone.
- Required materials and conditions: 3-arm allocation methods, sequence generation, allocation concealment and baseline characteristics by arm
- Materials to obtain first: 3-arm allocation methods, sequence generation, allocation concealment and baseline characteristics by arm
- Further research: Link methods/allocation material and baseline tables by arm to review the verified scope of sequence generation, concealment and baseline balance.
- Conditions for verification: Compare the recorded 3-arm randomization with actual sequence-generation, concealment and baseline material.
- Why this condition is needed: Needed to avoid treating the word randomized as resolution of allocation concerns.
- Application exceptions: Registration timing and randomization procedures do not substitute for each other.
- Remaining uncertainty: Detailed original material on sequence generation, concealment and baseline balance cannot be checked from the retained summary alone.
- Referenced methods: Existing method principles distinguish population, leaf and extraction method, test beverage, comparator, assessment time, denominators, post hoc selection, missingness, measurement, contrasts, intervals, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.
- Related sources: S1

### N08 · Can randomization, discontinuation, analysis and other exclusions be distinguished?

Verification status: Partly verified  
Reading scope: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.

- Current findings: The original record distinguishes 95 randomized participants, 22 discontinuations and 60 overweight completers analyzed. Discontinuations by arm were 7/6/9 and analyzed counts 22/22/16; reasons for excluding the other 13 remain unverified.
- Why unverified: Complete allocation/measurement denominators by arm and reasons for excluding 13 participants cannot currently be verified. Do not count all 13 as discontinuations.
- Reason for missing information: Complete allocation/measurement denominators by arm and reasons for excluding 13 participants cannot currently be verified. Do not count all 13 as discontinuations.
- Required materials and conditions: 95 randomized, participant flow by arm, 22 discontinuations, 60 analyzed and reasons for 13 additional exclusions
- Materials to obtain first: 95 randomized, participant flow by arm, 22 discontinuations, 60 analyzed and reasons for 13 additional exclusions
- Further research: Obtain complete CONSORT flow, randomized/measured/analyzed counts by arm, reasons for exclusion and timing.
- Conditions for verification: Compare 95/22/60, discontinuations 7/6/9 and analyzed counts 22/22/16 by arm, and reasons for the additional 13 exclusions.
- Why this condition is needed: Needed to avoid counting all 13 participants with unverified exclusion reasons as discontinuations.
- Application exceptions: Preserve the original counts and uncertainty without calculating new percentages or dropout rates.
- Remaining uncertainty: Complete allocation/measurement denominators by arm and reasons for excluding 13 participants cannot currently be verified. Do not count all 13 as discontinuations.
- Referenced methods: Existing method principles distinguish population, leaf and extraction method, test beverage, comparator, assessment time, denominators, post hoc selection, missingness, measurement, contrasts, intervals, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.
- Related sources: S1

### N09 · How does post hoc BMI selection affect the allocation effect and analysis?

Verification status: Partly verified  
Reading scope: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.

- Current findings: The record says PubMed’s n=60 is the number of completers meeting post hoc overweight criteria, rather than the randomized denominator.
- Why unverified: Analytical handling of selection and the allocation effect in all 95 participants remain unverified within this retained scope.
- Reason for missing information: Analytical handling of selection and the allocation effect in all 95 participants remain unverified within this retained scope.
- Required materials and conditions: Timing of post hoc selection, selection of completers, retention of randomized groups, exclusions and analysis methods
- Materials to obtain first: Timing of post hoc selection, selection of completers, retention of randomized groups, exclusions and analysis methods
- Further research: Obtain prespecified plans, full-arm analyses, exclusion reasons and sensitivity analyses for selection.
- Conditions for verification: Compare the difference between 95 randomized participants and 60 post-selected completers, and how selection was handled.
- Why this condition is needed: Needed to avoid relabeling selected-completer results as the allocation effect in 95 participants.
- Application exceptions: Do not delete observed results because of the selection limitation.
- Remaining uncertainty: Analytical handling of selection and the allocation effect in all 95 participants remain unverified within this retained scope.
- Referenced methods: Existing method principles distinguish population, leaf and extraction method, test beverage, comparator, assessment time, denominators, post hoc selection, missingness, measurement, contrasts, intervals, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.
- Related sources: S1

### N10 · Are the effect of interest and handling of missingness/discontinuation verified?

Verification status: Unverified  
Reading scope: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.

- Current findings: The original summary distinguishes a post hoc analysis of 60 completers from 95 randomized participants.
- Why unverified: Missing-data handling, the effect of interest, full-randomized-analysis results and sensitivity cannot be established at the locations read in this work.
- Reason for missing information: Missing-data handling, the effect of interest, full-randomized-analysis results and sensitivity cannot be established at the locations read in this work.
- Required materials and conditions: ITT/PP, missingness mechanisms, imputation, measurement losses, sensitivity analyses and effect of interest
- Materials to obtain first: ITT/PP, missingness mechanisms, imputation, measurement losses, sensitivity analyses and effect of interest
- Further research: Obtain the analysis plan, missingness by arm, full-randomized analyses and sensitivity analyses.
- Conditions for verification: Link the full allocation effect with the actual completer analysis and check missing-data handling and sensitivity.
- Why this condition is needed: Needed to avoid arbitrarily labeling completer selection as ITT.
- Application exceptions: Do not calculate unrecorded imputations, SDs or full-population results.
- Remaining uncertainty: Missing-data handling, the effect of interest, full-randomized-analysis results and sensitivity cannot be established at the locations read in this work.
- Referenced methods: Existing method principles distinguish population, leaf and extraction method, test beverage, comparator, assessment time, denominators, post hoc selection, missingness, measurement, contrasts, intervals, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.
- Related sources: S1

### N11 · Are measurement, calibration and assessment procedures for whole-body fat percentage verified?

Verification status: Unverified  
Reading scope: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.

- Current findings: The selected outcome is whole-body fat percentage at 12 weeks; the claim conditions specify changes at 6/12 weeks.
- Why unverified: Measurement equipment, calibration, environment and assessor procedures cannot be verified in the retained record.
- Reason for missing information: Measurement equipment, calibration, environment and assessor procedures cannot be verified in the retained record.
- Required materials and conditions: Instrument/method, calibration, measurement environment, assessors, timing and consistency between arms
- Materials to obtain first: Instrument/method, calibration, measurement environment, assessors, timing and consistency between arms
- Further research: Obtain original methods, instrument/calibration information, measurement environment and assessment procedures.
- Conditions for verification: Link measurement methods, conditions and blinding for whole-body fat percentage to the actual result.
- Why this condition is needed: Needed to avoid automatically interpreting measurement differences as actual fat changes.
- Application exceptions: Do not infer measurement equipment absent from the retained summary.
- Remaining uncertainty: Measurement equipment, calibration, environment and assessor procedures cannot be verified in the retained record.
- Referenced methods: Existing method principles distinguish population, leaf and extraction method, test beverage, comparator, assessment time, denominators, post hoc selection, missingness, measurement, contrasts, intervals, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.
- Related sources: S1

### N12 · Are participant/care-provider and outcome-assessor/analyst blinding and its maintenance verified?

Verification status: Partly verified  
Reading scope: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.

- Current findings: The original design field records participant/care-provider blinding.
- Why unverified: Outcome-assessor/analyst blinding and checks that blinding was maintained cannot be verified from the retained material alone.
- Reason for missing information: Outcome-assessor/analyst blinding and checks that blinding was maintained cannot be verified from the retained material alone.
- Required materials and conditions: Who was blinded, formulation matching, maintenance of blinding and outcome-assessment procedures
- Materials to obtain first: Who was blinded, formulation matching, maintenance of blinding and outcome-assessment procedures
- Further research: Obtain methods, formulation matching, maintenance of blinding and assessment/analysis procedures.
- Conditions for verification: In addition to recorded participant/care-provider blinding, check actual material on outcome-assessor/analyst blinding, maintenance and verification.
- Why this condition is needed: Needed to avoid extending participant/care-provider blinding to assessors and analysts.
- Application exceptions: Unverified blinding does not automatically establish a null effect.
- Remaining uncertainty: Outcome-assessor/analyst blinding and checks that blinding was maintained cannot be verified from the retained material alone.
- Referenced methods: Existing method principles distinguish population, leaf and extraction method, test beverage, comparator, assessment time, denominators, post hoc selection, missingness, measurement, contrasts, intervals, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.
- Related sources: S1

### N13 · How are differences in lifestyle management, concurrent treatment and adherence handled?

Verification status: Unverified  
Reading scope: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.

- Current findings: The original claim conditions retain beverage volume, nominal extract doses and duration.
- Why unverified: Diet/exercise, concomitant medicines, consumption adherence, rescue treatment and their handling by arm remain unverified.
- Reason for missing information: Diet/exercise, concomitant medicines, consumption adherence, rescue treatment and their handling by arm remain unverified.
- Required materials and conditions: Diet/exercise, concomitant medicines, actual exposure, changes by arm and analytical handling
- Materials to obtain first: Diet/exercise, concomitant medicines, actual exposure, changes by arm and analytical handling
- Further research: Obtain common-management arrangements, medication/lifestyle changes, adherence and handling by arm.
- Conditions for verification: Compare lifestyle management, concomitant treatments, deviations and analytical handling of the effect of interest by arm.
- Why this condition is needed: Needed to avoid attributing lifestyle or treatment differences to the extract.
- Application exceptions: Do not relabel nominal 1/2 g doses as adherence effects.
- Remaining uncertainty: Diet/exercise, concomitant medicines, consumption adherence, rescue treatment and their handling by arm remain unverified.
- Referenced methods: Existing method principles distinguish population, leaf and extraction method, test beverage, comparator, assessment time, denominators, post hoc selection, missingness, measurement, contrasts, intervals, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.
- Related sources: S1

### N14 · To which time, sex, dose and unit do the original results belong?

Verification status: Partly verified  
Reading scope: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.

- Current findings: Retained 12-week results are men 1 g/day,-2.6 percentage points (P=.019); women 1 g/day,-3.7 percentage points (P=.009); and women 2 g/day,-2.9 percentage points (P=.027).
- Why unverified: Stratum-specific n, calculation definitions, baseline/final values and whether contrasts are between-group or within-group remain unverified.
- Reason for missing information: Stratum-specific n, calculation definitions, baseline/final values and whether contrasts are between-group or within-group remain unverified.
- Required materials and conditions: 12 weeks, whole-body fat percentage, percentage points, sex/dose and final values/changes
- Materials to obtain first: 12 weeks, whole-body fat percentage, percentage points, sex/dose and final values/changes
- Further research: Obtain original result tables, time-specific baseline/final values, change definitions and denominators by stratum.
- Conditions for verification: Attribute the 12-week percentage-point values for men 1 g/women 1 g/women 2 g to their strata and verify the result format.
- Why this condition is needed: Needed to avoid relabeling percentage points as relative percentages or body-weight kg.
- Application exceptions: Do not calculate a pooled value from the 3 original results.
- Remaining uncertainty: Stratum-specific n, calculation definitions, baseline/final values and whether contrasts are between-group or within-group remain unverified.
- Referenced methods: Existing method principles distinguish population, leaf and extraction method, test beverage, comparator, assessment time, denominators, post hoc selection, missingness, measurement, contrasts, intervals, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.
- Related sources: S1

### N15 · Which comparison do the three reported estimates represent?

Verification status: Unverified  
Reading scope: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.

- Current findings: The original Korean/English record explicitly says whether the three values are between-group differences or within-group changes remains unverified.
- Why unverified: Without verified actual contrasts and analysis models, the three values do not establish between-group effects or a unified main effect.
- Reason for missing information: Without verified actual contrasts and analysis models, the three values do not establish between-group effects or a unified main effect.
- Required materials and conditions: Between-group/within-group status, comparator, analysis model, adjustment and estimand for each value
- Materials to obtain first: Between-group/within-group status, comparator, analysis model, adjustment and estimand for each value
- Further research: Link arm order, contrast, model and stratum-specific denominators in each result table to distinguish between-group estimates from within-group changes.
- Conditions for verification: Link each percentage-point value’s actual contrast, model and effect of interest to the original result tables.
- Why this condition is needed: Needed to avoid transferring a result to a control-group effect merely because it has a P value.
- Application exceptions: Do not fill in between-group contrasts, adjustments or unified main effects by inference.
- Remaining uncertainty: Without verified actual contrasts and analysis models, the three values do not establish between-group effects or a unified main effect.
- Referenced methods: Existing method principles distinguish population, leaf and extraction method, test beverage, comparator, assessment time, denominators, post hoc selection, missingness, measurement, contrasts, intervals, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.
- Related sources: S1

### N16 · Are intervals available to interpret uncertainty in the selected contrast?

Verification status: Unverified  
Reading scope: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.

- Current findings: The retained results include P=.019/.009/.027 and a statement that 95% CIs were not reported.
- Why unverified: Actual CIs, variance, n and contrasts for each stratum were not verified within the material read. Do not extend this to nonreporting throughout the entire paper.
- Reason for missing information: Actual CIs, variance, n and contrasts for each stratum were not verified within the material read. Do not extend this to nonreporting throughout the entire paper.
- Required materials and conditions: 95% CI, variance, denominators by stratum and model for each contrast
- Materials to obtain first: 95% CI, variance, denominators by stratum and model for each contrast
- Further research: Link original result-table contrasts, variance, stratum-specific denominators and reported CIs to assess whether intervals are interpretable. Do not perform new back-calculations.
- Conditions for verification: Link intervals for the verified contrast to variance and denominators to explain the range of compatible effects.
- Why this condition is needed: Needed to avoid judging precision or sufficiency from significance alone.
- Application exceptions: Do not back-calculate CIs from P values or pool the 3 results into a new interval.
- Remaining uncertainty: Actual CIs, variance, n and contrasts for each stratum were not verified within the material read. Do not extend this to nonreporting throughout the entire paper.
- Referenced methods: Existing method principles distinguish population, leaf and extraction method, test beverage, comparator, assessment time, denominators, post hoc selection, missingness, measurement, contrasts, intervals, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.
- Related sources: S1

### N17 · Are a justified importance threshold and the actual contrast/interval for body-fat change verified?

Verification status: Unverified  
Reading scope: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.

- Current findings: The retained record provides sex- and dose-specific body-fat percentages and P values, while a unified main effect/CIs remain unverified.
- Why unverified: An importance threshold and estimate intervals for comparison have not been verified in this work.
- Reason for missing information: An importance threshold and estimate intervals for comparison have not been verified in this work.
- Required materials and conditions: Justified important difference in whole-body fat percentage, population-specific interpretation and intervals
- Materials to obtain first: Justified important difference in whole-body fat percentage, population-specific interpretation and intervals
- Further research: Obtain the basis for importance, patient-relevant outcomes and contrast-specific intervals.
- Conditions for verification: Check an importance threshold appropriate to the population and endpoint, and actual comparative estimates/intervals, to review their relationship. If unavailable, retain unverified status.
- Why this condition is needed: Needed to avoid automatically turning statistical significance into clinical importance.
- Application exceptions: Do not adopt arbitrary percentage-point thresholds, minimum sample sizes or completion rates.
- Remaining uncertainty: An importance threshold and estimate intervals for comparison have not been verified in this work.
- Referenced methods: Existing method principles distinguish population, leaf and extraction method, test beverage, comparator, assessment time, denominators, post hoc selection, missingness, measurement, contrasts, intervals, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.
- Related sources: S1

### N18 · Do registration timing and original endpoints/analysis plans match the report?

Verification status: Partly verified  
Reading scope: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.

- Current findings: NCT04651023 is recorded as posted 11 years after study completion. Weight, body fat, visceral fat, waist and hip were listed as multiple primary outcomes.
- Why unverified: Registration, protocol and SAP bytes remain unread in this work; complete comparison of prespecified analyses/endpoints and changes remains pending.
- Reason for missing information: Registration, protocol and SAP bytes remain unread in this work; complete comparison of prespecified analyses/endpoints and changes remains pending.
- Required materials and conditions: NCT04651023, initial/amended registrations, protocol, SAP and endpoints/times
- Materials to obtain first: NCT04651023, initial/amended registrations, protocol, SAP and endpoints/times
- Further research: Obtain registration history, prospective protocol/SAP, complete results and reasons for changes.
- Conditions for verification: Compare registration 11 years after completion, multiple primary outcomes, actual reporting/selection and reasons for changes with the original plan.
- Why this condition is needed: Needed to avoid retroactively treating retrospective registration as a prespecified plan.
- Application exceptions: Do not upgrade historical checking described in a summary to reading the full registration in this work.
- Remaining uncertainty: Registration, protocol and SAP bytes remain unread in this work; complete comparison of prespecified analyses/endpoints and changes remains pending.
- Referenced methods: Existing method principles distinguish population, leaf and extraction method, test beverage, comparator, assessment time, denominators, post hoc selection, missingness, measurement, contrasts, intervals, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.
- Related sources: S1

### N19 · How are sex/dose selection and multiple endpoints handled?

Verification status: Partly verified  
Reading scope: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.

- Current findings: The paper selected sex- and dose-specific completer results; retained positive strata are men 1 g, women 1 g and women 2 g.
- Why unverified: Prespecification, interactions, multiplicity handling and complete results including men 2 g remain unverified.
- Reason for missing information: Prespecification, interactions, multiplicity handling and complete results including men 2 g remain unverified.
- Required materials and conditions: Prespecified subgroups, n by stratum, interactions, multiple comparisons and complete-arm results
- Materials to obtain first: Prespecified subgroups, n by stratum, interactions, multiple comparisons and complete-arm results
- Further research: Obtain prespecified analysis plans, all stratum results, interaction estimates and multiplicity handling.
- Conditions for verification: Compare planning of sex/dose selection, complete results, interactions and handling of multiplicity.
- Why this condition is needed: Needed to avoid establishing sex or dose differences from positive strata alone.
- Application exceptions: Do not interpret differences between stratum-specific P values as interactions.
- Remaining uncertainty: Prespecification, interactions, multiplicity handling and complete results including men 2 g remain unverified.
- Referenced methods: Existing method principles distinguish population, leaf and extraction method, test beverage, comparator, assessment time, denominators, post hoc selection, missingness, measurement, contrasts, intervals, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.
- Related sources: S1

### N20 · Are the family relationship of the Ye report/NCT04651023 and other direct independent replications verified?

Verification status: Partly verified  
Reading scope: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.

- Current findings: One evidence/citation record retains PMID34852695, DOI10.1080/14786419.2021.2010196 and NCT04651023. The manuscript says independent replication was not verified.
- Why unverified: No current certification of unique families/participant independence or new literature search was performed. Do not establish 0 independent replications.
- Reason for missing information: No current certification of unique families/participant independence or new literature search was performed. Do not establish 0 independent replications.
- Required materials and conditions: PMID/DOI/NCT, study families, independent material and complete results
- Materials to obtain first: PMID/DOI/NCT, study families, independent material and complete results
- Further research: Obtain study-family tables, registry/report links and independent material addressing the same question.
- Conditions for verification: Check the retained PMID/DOI/NCT links, whether recruitment cohorts/results belong to the same family, and identities/independence of other direct replications. Do not establish a replication count without new searching.
- Why this condition is needed: Needed to avoid counting a report, registration and bibliography as multiple independent trials.
- Application exceptions: Do not turn no searching in this work into 0 independent trials worldwide.
- Remaining uncertainty: No current certification of unique families/participant independence or new literature search was performed. Do not establish 0 independent replications.
- Referenced methods: Existing method principles distinguish population, leaf and extraction method, test beverage, comparator, assessment time, denominators, post hoc selection, missingness, measurement, contrasts, intervals, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.
- Related sources: S1

### N21 · Are sponsorship, beverage supply, author employment, sponsor design/analysis roles and full COI declarations verified?

Verification status: Partly verified  
Reading scope: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.

- Current findings: The record describes sponsorship by Shanghai Meiji Health Science and Technology, provision of test beverages and several authors employed in Meiji R&D.
- Why unverified: Sponsor control of design/analysis and complete author-specific COI details remain unverified.
- Reason for missing information: Sponsor control of design/analysis and complete author-specific COI details remain unverified.
- Required materials and conditions: Funding, product supply, author employment, declared interests and independent design/analysis
- Materials to obtain first: Funding, product supply, author employment, declared interests and independent design/analysis
- Further research: Obtain original funding/COI declarations, roles, analytical control and author-specific disclosures.
- Conditions for verification: In addition to recorded Shanghai Meiji sponsorship, beverage supply and Meiji author employment, check actual material on sponsor control of design/analysis and author-specific COI declarations.
- Why this condition is needed: Needed to avoid labeling industry involvement as independent research or automatically invalidating it.
- Application exceptions: Do not invent a definite magnitude of bias merely because funding is shared.
- Remaining uncertainty: Sponsor control of design/analysis and complete author-specific COI details remain unverified.
- Referenced methods: Existing method principles distinguish population, leaf and extraction method, test beverage, comparator, assessment time, denominators, post hoc selection, missingness, measurement, contrasts, intervals, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.
- Related sources: S1

### N22 · Does this question require an optimal dose or persistence after discontinuation?

Verification status: Not applicable  
Reading scope: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.

- Current findings: This checklist concerns 12-week body-fat percentage and does not adopt optimal-dose or maintenance claims. Sex/dose observations are retained in separate rows.
- Why unverified: Extension effects themselves remain unverified. Do not require every dose/long-term trial as essential to the current narrow question.
- Reason for missing information: Extension effects themselves remain unverified. Do not require every dose/long-term trial as essential to the current narrow question.
- Required materials and conditions: Direct dose comparisons, long-term/post-discontinuation follow-up and separate estimates
- Materials to obtain first: Direct dose comparisons, long-term/post-discontinuation follow-up and separate estimates
- Further research: If an extension is requested, separately design dose-versus-dose comparisons and long-term/post-discontinuation follow-up.
- Conditions for verification: Distinguish the 12-week body-fat-percentage question from separate optimal-dose or persistence questions.
- Why this condition is needed: Needed to avoid extending a narrow 12-week effect to every additional question.
- Application exceptions: Do not automatically use 1/2 g strata as evidence of an optimal dose.
- Remaining uncertainty: Extension effects themselves remain unverified. Do not require every dose/long-term trial as essential to the current narrow question.
- Referenced methods: Existing method principles distinguish population, leaf and extraction method, test beverage, comparator, assessment time, denominators, post hoc selection, missingness, measurement, contrasts, intervals, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.
- Related sources: S1

### N23 · Are body-fat-percentage results being transferred to weight, visceral fat or clinical events?

Verification status: Not applicable  
Reading scope: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.

- Current findings: The manuscript explicitly says the result cannot be extended to reduced weight/visceral fat or efficacy of ordinary lotus-leaf tea.
- Why unverified: Confirmation of other endpoints/events is not added as essential to the current body-fat-percentage question. This checklist does not certify those effects.
- Reason for missing information: Confirmation of other endpoints/events is not added as essential to the current body-fat-percentage question. This checklist does not certify those effects.
- Required materials and conditions: Separate evidence for selected body-fat percentage versus weight/visceral fat and disease events
- Materials to obtain first: Separate evidence for selected body-fat percentage versus weight/visceral fat and disease events
- Further research: If an extension is requested, separately review actual endpoint-specific results and disease events for the same preparation.
- Conditions for verification: Distinguish whole-body fat percentage from other endpoints and clinical events.
- Why this condition is needed: Needed to avoid extending a numerical outcome to other endpoints/disease prevention.
- Application exceptions: A registry list of multiple primary outcomes is not the result for each outcome.
- Remaining uncertainty: Confirmation of other endpoints/events is not added as essential to the current body-fat-percentage question. This checklist does not certify those effects.
- Referenced methods: Existing method principles distinguish population, leaf and extraction method, test beverage, comparator, assessment time, denominators, post hoc selection, missingness, measurement, contrasts, intervals, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.
- Related sources: S1

### N24 · Are the 60-person/12-week report and event definitions, collection and discontinuation reasons for all exposed participants verified?

Verification status: Partly verified  
Reading scope: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.

- Current findings: The original safety description records no reported test-beverage adverse reactions among the 60 analyzed participants.
- Why unverified: This does not establish 0 events among all 95 participants, systematic collection or reasons for discontinuation/exclusion. Limitations of a short-term selected sample remain.
- Reason for missing information: This does not establish 0 events among all 95 participants, systematic collection or reasons for discontinuation/exclusion. Limitations of a short-term selected sample remain.
- Required materials and conditions: 60 analyzed, 12 weeks, all exposed participants, event definitions/collection and discontinuation reasons
- Materials to obtain first: 60 analyzed, 12 weeks, all exposed participants, event definitions/collection and discontinuation reasons
- Further research: Obtain all exposed participants by arm, event counts, collection methods and discontinuation reasons.
- Conditions for verification: Check the reported 60-person/12-week scope against actual material on all exposed denominators, event definitions, systematic collection and reasons for discontinuation/exclusion.
- Why this condition is needed: Needed to avoid turning unreported adverse reactions into safety or 0 events in all 95 participants.
- Application exceptions: Do not merge efficacy and harm states or calculate new incidence rates.
- Remaining uncertainty: This does not establish 0 events among all 95 participants, systematic collection or reasons for discontinuation/exclusion. Limitations of a short-term selected sample remain.
- Referenced methods: Existing method principles distinguish population, leaf and extraction method, test beverage, comparator, assessment time, denominators, post hoc selection, missingness, measurement, contrasts, intervals, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.
- Related sources: S1

### N25 · Are direct data available for vulnerable populations, concomitant medicines and long-term or rare harms?

Verification status: Unverified  
Reading scope: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.

- Current findings: The original safety record leaves pregnancy, lactation, allergy, liver/kidney disease and interactions with blood-pressure/glucose medicines unverified.
- Why unverified: Direct comparisons for these populations/medicines and long-term/rare-harm material have not been verified in this work.
- Reason for missing information: Direct comparisons for these populations/medicines and long-term/rare-harm material have not been verified in this work.
- Required materials and conditions: Pregnancy/lactation, allergy, liver/kidney conditions, blood-pressure/glucose medicines and long-term/rare harms
- Materials to obtain first: Pregnancy/lactation, allergy, liver/kidney conditions, blood-pressure/glucose medicines and long-term/rare harms
- Further research: Obtain comparative exposure/event material for those populations and concomitant medicines, and long-term follow-up.
- Conditions for verification: Check actual exposure, event and comparative material for the relevant vulnerable populations, concomitant medicines and long-term/rare harms. Do not convert uncertainty into definite harm or safety.
- Why this condition is needed: Needed to avoid extending a narrow short-term record to overall safety.
- Application exceptions: Do not convert unverified status into a definite interaction or a personal prohibition on use.
- Remaining uncertainty: Direct comparisons for these populations/medicines and long-term/rare-harm material have not been verified in this work.
- Referenced methods: Existing method principles distinguish population, leaf and extraction method, test beverage, comparator, assessment time, denominators, post hoc selection, missingness, measurement, contrasts, intervals, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.
- Related sources: S1

### N26 · Are material actually read and historical verification narratives distinguished?

Verification status: Met  
Reading scope: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.

- Current findings: The material read in this work is the complete current retained JSON. The original review date 2026-09-08 and historical narrative of PMID/NCT/publisher cross-checking are retained.
- Why unverified: External full text, registration, publisher PDF and SAP remain unread/unacquired in this work. Typed access-level, individual access-date and location fields are absent from the original bibliography.
- Reason for missing information: External full text, registration, publisher PDF and SAP remain unread/unacquired in this work. Typed access-level, individual access-date and location fields are absent from the original bibliography.
- Required materials and conditions: Retained JSON, original review date, bibliography/access, current date and original locations/SHA
- Materials to obtain first: Retained JSON, original review date, bibliography/access, current date and original locations/SHA
- Further research: When material is later acquired, record identity, material type, date, access/reading, locations and byte SHA.
- Conditions for verification: Separately show the JSON read in this work, unread external material and historical review dates/narratives.
- Why this condition is needed: Needed to avoid upgrading a historical full-text cross-checking narrative to full-text reading in this work.
- Application exceptions: Do not generate missing typed access dates, locations or levels from historical prose.
- Remaining uncertainty: External full text, registration, publisher PDF and SAP remain unread/unacquired in this work. Typed access-level, individual access-date and location fields are absent from the original bibliography.
- Referenced methods: Existing method principles distinguish population, leaf and extraction method, test beverage, comparator, assessment time, denominators, post hoc selection, missingness, measurement, contrasts, intervals, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.
- Related sources: S1

### N27 · Are the legacy grade, axes, corrections and under-review status preserved?

Verification status: Met  
Reading scope: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.

- Current findings: The original C 46,S/R1/I0/EX/B2/CX, grade-revalidation flag false, legacy-grade-under-review status and 2026-09-14 correction are retained.
- Why unverified: The legacy grade remains under review. This conversion is not a final reassessment or calculation of values/CIs.
- Reason for missing information: The legacy grade remains under review. This conversion is not a final reassessment or calculation of values/CIs.
- Required materials and conditions: C 46, EX/CX, original/previous axes, corrections and grade-revalidation flag false
- Materials to obtain first: C 46, EX/CX, original/previous axes, corrections and grade-revalidation flag false
- Further research: If reassessment is later requested, preserve the original, previous values, new evidence and change decision as a separate event.
- Conditions for verification: Link the original C 46, axes, 2026-09-14 correction and legacy-grade-under-review status to the original text.
- Why this condition is needed: Needed to avoid automatically inheriting a retained grade as the new checklist’s final efficacy assessment.
- Application exceptions: Do not calculate a new grade/score from this checklist’s condition states.
- Remaining uncertainty: The legacy grade remains under review. This conversion is not a final reassessment or calculation of values/CIs.
- Referenced methods: Existing method principles distinguish population, leaf and extraction method, test beverage, comparator, assessment time, denominators, post hoc selection, missingness, measurement, contrasts, intervals, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.
- Related sources: S1

### N28 · Are subsequent evidence, condition changes and verdict changes linked as separate events?

Verification status: Met  
Reading scope: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.

- Current findings: Current limitations in denominator selection, individual contrasts/CIs, retrospective registration, multiple analyses, industry funding and safety, and the original correction, are retained. Subsequent checks are linked to each row.
- Why unverified: New evidence, reassessment and public deployment were not performed in the retained case record.
- Reason for missing information: New evidence, reassessment and public deployment were not performed in the retained case record.
- Required materials and conditions: Original results, denominators/contrasts/CIs, registration/SAP, measurement/harms, condition versions and previous values
- Materials to obtain first: Original results, denominators/contrasts/CIs, registration/SAP, measurement/harms, condition versions and previous values
- Further research: Record identity, reading and locations; review affected rows, and freeze a revised condition version before application.
- Conditions for verification: Distinguish the current material scope, affected rows for subsequent material, condition revisions and verdict changes.
- Why this condition is needed: Needed to avoid making new material acquisition automatically change conditions or a verdict.
- Application exceptions: Do not delete unfavorable observations, uncertainty or the original text.
- Remaining uncertainty: New evidence, reassessment and public deployment were not performed in the retained case record.
- Referenced methods: Existing method principles distinguish population, leaf and extraction method, test beverage, comparator, assessment time, denominators, post hoc selection, missingness, measurement, contrasts, intervals, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.
- Related sources: S1

## Evidence and sources

### S1

Ye report of lotus-leaf hot-water extract and whole-body fat percentage

[PubMed](https://pubmed.ncbi.nlm.nih.gov/34852695/)

Materials actually 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; access was not attempted.  
Findings recorded in the summary: Reported subgroup changes: men, 1 g/day, -2.6 percentage points (P=.019); women, 1 g/day, -3.7 (P=.009); women, 2 g/day, -2.9 (P=.027). No 95% CI reported; the contrast underlying these changes is unverified in the retained record.  
Record level: Retained sex- and dose-specific results for whole-body fat percentage at 12 weeks. Actual contrasts, stratum-specific denominators, variance, intervals and measurement method remain unverified. This is not new checking of external full text, registration or prespecified plans.  
Independent replication: The link between report S1 and the retained registration is shown. The PMID, DOI and NCT are not counted as separate independent replications. Total unique trial and participant counts and other direct independent replications remain unverified.

| Material | Public availability | Access status | Actually read | Notes |
|---|---|---|---|---|
| Retained bilingual research/bibliographic summaries and historical review record | Retained copy acquired; summary read | Retained copy acquired; summary read | Stored existing review summary read | Actual values and locations in the retained summary were read. Distinguish this from external clinical full-text bytes. Historical manuscript descriptions of paper, registry and publisher cross-checking are historical records. They do not establish current actual reading of external bibliography, abstracts, full text or registration. The original review date is 2026-09-08, the historical correction date is 2026-09-14 and the case-record review date is 2026-10-05. Historical access level and access date for individual external materials are not recorded; current access was not attempted. |
| PubMed bibliography/abstract entry point | Material type recorded; current public availability unverified | External access not attempted; not acquired | Not read | An entry-point link from the retained bibliography. Current URL response and bibliographic/abstract contents were not checked; access, acquisition and reading were not attempted. Historical manuscript descriptions of paper, registry and publisher cross-checking are historical records. They do not establish current actual reading of external bibliography, abstracts, full text or registration. The original review date is 2026-09-08, the historical correction date is 2026-09-14 and the case-record review date is 2026-10-05. Historical access level and access date for individual external materials are not recorded; current access was not attempted. |
| Full paper: direct URL and current access scope unverified | Material type recorded; current public availability unverified | External access not attempted; not acquired | Not read | Direct full-text URL and current availability scope remain unverified. Distinguish the bibliographic entry point from full text; external access, acquisition and reading were not attempted. Historical manuscript descriptions of paper, registry and publisher cross-checking are historical records. They do not establish current actual reading of external bibliography, abstracts, full text or registration. The original review date is 2026-09-08, the historical correction date is 2026-09-14 and the case-record review date is 2026-10-05. Historical access level and access date for individual external materials are not recorded; current access was not attempted. |
| Original trial-registration material NCT04651023 | Material type recorded; current public availability unverified | External access not attempted; not acquired | Not read | The official entry point for the retained registration identifier. Actual page existence/content and current access, acquisition and reading were not established; access was not attempted. Historical manuscript descriptions of paper, registry and publisher cross-checking are historical records. They do not establish current actual reading of external bibliography, abstracts, full text or registration. The original review date is 2026-09-08, the historical correction date is 2026-09-14 and the case-record review date is 2026-10-05. Historical access level and access date for individual external materials are not recorded; current access was not attempted. |

## Review criteria and methods

These are Chamgap's own application conditions, informed by the relevant sections of official methodological guidance. They do not constitute official assessment-tool certification or a new efficacy score.

- M03 [Cochrane Handbook 6.5 (2024), chapter updated 2023-08](https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-03) · §3.1, §3.2.1–3.2.3, MECIR C5/C7/C13 · Clearly record the question, eligibility conditions and reasons for changes; distinguish intervention variants. · Retained method-application records were reused. External originals were not reread and method content was not reassessed.
- M04 [Cochrane Handbook 6.5.1 (2025), chapter updated 2025-03](https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-04) · §4.5, §4.6.1–4.6.3, MECIR C42 · Link studies and reports separately; do not omit studies solely because results are unreported. · Retained method-application records were reused. External originals were not reread and method content was not reassessed.
- M08 [Cochrane Handbook 6.5 (2024), chapter updated 2019-10](https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-08) · §8.1–8.2.3, Table 8.2.a · Fix the result and effect of interest when examining randomization, deviations, missingness, measurement and selective reporting. · Retained method-application records were reused. External originals were not reread and method content was not reassessed.
- M15 [Cochrane Handbook 6.5 (2024), chapter updated 2023-08](https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-15) · §15.2.4, §15.3.1–15.3.3 · Distinguish effect estimates, intervals, importance and applicability. Sample size alone does not determine precision. · Retained method-application records were reused. External originals were not reread and method content was not reassessed.
- M19 [Cochrane Handbook 6.5 (2024), chapter updated 2019-10](https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-19) · §19.1.2, §19.2.1–19.2.4 · Harm questions may require different designs, populations and follow-up from efficacy questions. Case reports do not establish incidence. · Retained method-application records were reused. External originals were not reread and method content was not reassessed.

## What the statuses mean

- Met: The row’s narrow record, attribution, boundary or actual fact was checked. This does not certify efficacy, precision or safety.
- Partly verified: Some required information is available, but actual exposure, definitions, denominators or other necessary material remain missing.
- Unverified: The criterion cannot be established within the retained scope. This does not mean 0 effect, 0 studies or failed access.
- Not applicable: Used only with a reason that an item is outside the actual scope of the selected question. It does not replace unverified or unread status.
- Not reported: Nonreporting is limited to a specific material or section actually read. This work did not assign a reporting status to the entire full paper.
- Inaccessible: Used only for an actual access failure. Distinguish it from external access not attempted in this work.
- Review incomplete: Original-material comparison or searching was not performed within the allowed scope.
- Insufficient evidence matching the conditions: Used only after reviewing relevant studies within a defined scope and finding insufficient evidence to answer the condition. It was not applied wholesale to all items in this work.
- Conflicting data: Materials that are difficult to reconcile were compared for the same question, time and analysis. Different review figures alone do not establish this status.

## Change history

2026-10-28 · Public page/materials 1.0. The public view and materials were prepared from the existing 28 items. No new clinical search, verification-state change or scoring was performed.
