{ "schema_version": "chamgap-public-criteria-1.0", "title": "Test beverage containing hot-water extract of sun-dried lotus leaves × Reduction of whole-body fat percentage in adults with overweight", "language": "en", "translation_date": "2026-10-28", "criteria_version": "1.1", "criteria_date": "2026-10-05", "condition_origin": "Chamgap's own application conditions", "method_sources": [ { "id": "M03", "version": "Cochrane Handbook 6.5 (2024), chapter updated 2023-08", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-03", "section": "§3.1, §3.2.1–3.2.3, MECIR C5/C7/C13", "official_principle": "Clearly record the question, eligibility conditions and reasons for changes; distinguish intervention variants.", "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": "Link studies and reports separately; do not omit studies 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": "Fix the result and effect of interest when examining randomization, deviations, missingness, 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.", "review_level": "Retained method-application records were reused. External originals were not reread and method content was not reassessed." } ], "status_dictionary": { "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." }, "requirements": [ { "item_id": "N01", "question_type": "Evidence condition", "question": "Which lotus-leaf preparation, population and body-fat comparison are being checked?", "needed": "Plant part, extraction, beverage, population, whole-body fat percentage, 0 g comparator and time", "role": "Required (selected 12-week whole-body fat-percentage comparison)", "role_reason": "Needed to avoid combining this question with tea, other plant parts or weight outcomes.", "application_exception": "Do not split sex- and dose-specific results into 3 independent effects while their contrasts remain unverified.", "criterion": "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.", "basis": "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.", "condition_origin": "These conditions for lotus-leaf hot-water extract and whole-body fat percentage at 12 weeks were developed with knowledge of the retained content and frozen before application. This does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.", "proposed_research": "Compare subsequent material with the formulation, population, comparator, outcome and time." }, { "item_id": "N02", "question_type": "Evidence condition", "question": "Are eligibility criteria, post hoc selection and baseline characteristics of the registered and analyzed populations verified?", "needed": "Age, BMI, diagnosis, inclusion/exclusion, baseline tables and post hoc selection process", "role": "Required (selected 12-week whole-body fat-percentage comparison)", "role_reason": "Needed to avoid automatically treating the 60 analyzed participants as representative of the 95 randomized participants.", "application_exception": "Do not generalize to other ages, BMI ranges or disease populations.", "criterion": "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.", "basis": "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.", "condition_origin": "These conditions for lotus-leaf hot-water extract and whole-body fat percentage at 12 weeks were developed with knowledge of the retained content and frozen before application. This does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.", "proposed_research": "Obtain baseline tables by arm, selection rules, timing of application and reasons for exclusion." }, { "item_id": "N03", "question_type": "Evidence condition", "question": "Are the plant part, extraction, major constituents and batch-specific assays/manufacturing specifications verified?", "needed": "Plant species, part, drying, extraction, constituents, manufacturing batches and product material", "role": "Required (selected 12-week whole-body fat-percentage comparison)", "role_reason": "Needed to avoid transferring the result to ordinary lotus-leaf tea, capsules or isolated constituents.", "application_exception": "Lotus rhizome, plumule, seed and combinations are not the trial intervention.", "criterion": "Check recorded hot-water extraction of sun-dried Nelumbo nucifera leaves and major constituents against actual manufacturing-batch, assay and product-specification material.", "basis": "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.", "condition_origin": "These conditions for lotus-leaf hot-water extract and whole-body fat percentage at 12 weeks were developed with knowledge of the retained content and frozen before application. This does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.", "proposed_research": "When product specifications, batch and constituent-assay material become available, compare the plant part, processing and formulation with the actual trial intervention." }, { "item_id": "N04", "question_type": "Evidence condition", "question": "What are the route, nominal dose and volume of the test beverage?", "needed": "Oral administration,400 mL, 2 bottles of 200 mL and 0/1/2 g beverage specifications", "role": "Required (selected 12-week whole-body fat-percentage comparison)", "role_reason": "Needed to avoid turning trial specifications into personal dosing instructions.", "application_exception": "Checking a nominal dose differs from verifying measured adherence or actual exposure.", "criterion": "Link oral 400 mL/day and 0/1/2 g specifications to the corresponding result.", "basis": "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.", "condition_origin": "These conditions for lotus-leaf hot-water extract and whole-body fat percentage at 12 weeks were developed with knowledge of the retained content and frozen before application. This does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.", "proposed_research": "Separately compare actual consumption, adherence, batches and exposure by arm." }, { "item_id": "N05", "question_type": "Evidence condition", "question": "When were treatment and body-fat assessments performed?", "needed": "12-week treatment,6/12-week measurements, completion and follow-up schedule", "role": "Required (selected 12-week whole-body fat-percentage comparison)", "role_reason": "Needed to avoid combining outcomes measured at different times as the same value.", "application_exception": "Do not substitute a 12-week result for persistence after discontinuation.", "criterion": "Distinguish 12-week treatment and the selected 12-week result, and link the recorded 6-week assessment.", "basis": "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.", "condition_origin": "These conditions for lotus-leaf hot-water extract and whole-body fat percentage at 12 weeks were developed with knowledge of the retained content and frozen before application. This does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.", "proposed_research": "Obtain time-specific result tables and follow-up after treatment stops." }, { "item_id": "N06", "question_type": "Evidence condition", "question": "How well are the 0 g control beverage and other conditions matched?", "needed": "0 g beverage specifications, appearance/taste, common management and differences between arms", "role": "Required (selected 12-week whole-body fat-percentage comparison)", "role_reason": "Needed to avoid assuming that a beverage comparator establishes matching of all concurrent conditions.", "application_exception": "Do not relabel the 0 g beverage as no treatment.", "criterion": "Compare the same-format 0 g beverage with the verified scope of taste, management and concomitant conditions.", "basis": "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.", "condition_origin": "These conditions for lotus-leaf hot-water extract and whole-body fat percentage at 12 weeks were developed with knowledge of the retained content and frozen before application. This does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.", "proposed_research": "Obtain control ingredients, blinding, common management and treatment changes by arm." }, { "item_id": "N07", "question_type": "Evidence condition", "question": "Are actual allocation, concealment and baseline balance verified?", "needed": "3-arm allocation methods, sequence generation, allocation concealment and baseline characteristics by arm", "role": "Required (selected 12-week whole-body fat-percentage comparison)", "role_reason": "Needed to avoid treating the word randomized as resolution of allocation concerns.", "application_exception": "Registration timing and randomization procedures do not substitute for each other.", "criterion": "Compare the recorded 3-arm randomization with actual sequence-generation, concealment and baseline material.", "basis": "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.", "condition_origin": "These conditions for lotus-leaf hot-water extract and whole-body fat percentage at 12 weeks were developed with knowledge of the retained content and frozen before application. This does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.", "proposed_research": "Link methods/allocation material and baseline tables by arm to review the verified scope of sequence generation, concealment and baseline balance." }, { "item_id": "N08", "question_type": "Evidence condition", "question": "Can randomization, discontinuation, analysis and other exclusions be distinguished?", "needed": "95 randomized, participant flow by arm, 22 discontinuations, 60 analyzed and reasons for 13 additional exclusions", "role": "Required (selected 12-week whole-body fat-percentage comparison)", "role_reason": "Needed to avoid counting all 13 participants with unverified exclusion reasons as discontinuations.", "application_exception": "Preserve the original counts and uncertainty without calculating new percentages or dropout rates.", "criterion": "Compare 95/22/60, discontinuations 7/6/9 and analyzed counts 22/22/16 by arm, and reasons for the additional 13 exclusions.", "basis": "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.", "condition_origin": "These conditions for lotus-leaf hot-water extract and whole-body fat percentage at 12 weeks were developed with knowledge of the retained content and frozen before application. This does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.", "proposed_research": "Obtain complete CONSORT flow, randomized/measured/analyzed counts by arm, reasons for exclusion and timing." }, { "item_id": "N09", "question_type": "Evidence condition", "question": "How does post hoc BMI selection affect the allocation effect and analysis?", "needed": "Timing of post hoc selection, selection of completers, retention of randomized groups, exclusions and analysis methods", "role": "Required (selected 12-week whole-body fat-percentage comparison)", "role_reason": "Needed to avoid relabeling selected-completer results as the allocation effect in 95 participants.", "application_exception": "Do not delete observed results because of the selection limitation.", "criterion": "Compare the difference between 95 randomized participants and 60 post-selected completers, and how selection was handled.", "basis": "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.", "condition_origin": "These conditions for lotus-leaf hot-water extract and whole-body fat percentage at 12 weeks were developed with knowledge of the retained content and frozen before application. This does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.", "proposed_research": "Obtain prespecified plans, full-arm analyses, exclusion reasons and sensitivity analyses for selection." }, { "item_id": "N10", "question_type": "Evidence condition", "question": "Are the effect of interest and handling of missingness/discontinuation verified?", "needed": "ITT/PP, missingness mechanisms, imputation, measurement losses, sensitivity analyses and effect of interest", "role": "Required (selected 12-week whole-body fat-percentage comparison)", "role_reason": "Needed to avoid arbitrarily labeling completer selection as ITT.", "application_exception": "Do not calculate unrecorded imputations, SDs or full-population results.", "criterion": "Link the full allocation effect with the actual completer analysis and check missing-data handling and sensitivity.", "basis": "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.", "condition_origin": "These conditions for lotus-leaf hot-water extract and whole-body fat percentage at 12 weeks were developed with knowledge of the retained content and frozen before application. This does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.", "proposed_research": "Obtain the analysis plan, missingness by arm, full-randomized analyses and sensitivity analyses." }, { "item_id": "N11", "question_type": "Evidence condition", "question": "Are measurement, calibration and assessment procedures for whole-body fat percentage verified?", "needed": "Instrument/method, calibration, measurement environment, assessors, timing and consistency between arms", "role": "Required (selected 12-week whole-body fat-percentage comparison)", "role_reason": "Needed to avoid automatically interpreting measurement differences as actual fat changes.", "application_exception": "Do not infer measurement equipment absent from the retained summary.", "criterion": "Link measurement methods, conditions and blinding for whole-body fat percentage to the actual result.", "basis": "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.", "condition_origin": "These conditions for lotus-leaf hot-water extract and whole-body fat percentage at 12 weeks were developed with knowledge of the retained content and frozen before application. This does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.", "proposed_research": "Obtain original methods, instrument/calibration information, measurement environment and assessment procedures." }, { "item_id": "N12", "question_type": "Evidence condition", "question": "Are participant/care-provider and outcome-assessor/analyst blinding and its maintenance verified?", "needed": "Who was blinded, formulation matching, maintenance of blinding and outcome-assessment procedures", "role": "Required (selected 12-week whole-body fat-percentage comparison)", "role_reason": "Needed to avoid extending participant/care-provider blinding to assessors and analysts.", "application_exception": "Unverified blinding does not automatically establish a null effect.", "criterion": "In addition to recorded participant/care-provider blinding, check actual material on outcome-assessor/analyst blinding, maintenance and verification.", "basis": "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.", "condition_origin": "These conditions for lotus-leaf hot-water extract and whole-body fat percentage at 12 weeks were developed with knowledge of the retained content and frozen before application. This does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.", "proposed_research": "Obtain methods, formulation matching, maintenance of blinding and assessment/analysis procedures." }, { "item_id": "N13", "question_type": "Evidence condition", "question": "How are differences in lifestyle management, concurrent treatment and adherence handled?", "needed": "Diet/exercise, concomitant medicines, actual exposure, changes by arm and analytical handling", "role": "Required (selected 12-week whole-body fat-percentage comparison)", "role_reason": "Needed to avoid attributing lifestyle or treatment differences to the extract.", "application_exception": "Do not relabel nominal 1/2 g doses as adherence effects.", "criterion": "Compare lifestyle management, concomitant treatments, deviations and analytical handling of the effect of interest by arm.", "basis": "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.", "condition_origin": "These conditions for lotus-leaf hot-water extract and whole-body fat percentage at 12 weeks were developed with knowledge of the retained content and frozen before application. This does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.", "proposed_research": "Obtain common-management arrangements, medication/lifestyle changes, adherence and handling by arm." }, { "item_id": "N14", "question_type": "Evidence condition", "question": "To which time, sex, dose and unit do the original results belong?", "needed": "12 weeks, whole-body fat percentage, percentage points, sex/dose and final values/changes", "role": "Required (selected 12-week whole-body fat-percentage comparison)", "role_reason": "Needed to avoid relabeling percentage points as relative percentages or body-weight kg.", "application_exception": "Do not calculate a pooled value from the 3 original results.", "criterion": "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.", "basis": "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.", "condition_origin": "These conditions for lotus-leaf hot-water extract and whole-body fat percentage at 12 weeks were developed with knowledge of the retained content and frozen before application. This does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.", "proposed_research": "Obtain original result tables, time-specific baseline/final values, change definitions and denominators by stratum." }, { "item_id": "N15", "question_type": "Evidence condition", "question": "Which comparison do the three reported estimates represent?", "needed": "Between-group/within-group status, comparator, analysis model, adjustment and estimand for each value", "role": "Required (selected 12-week whole-body fat-percentage comparison)", "role_reason": "Needed to avoid transferring a result to a control-group effect merely because it has a P value.", "application_exception": "Do not fill in between-group contrasts, adjustments or unified main effects by inference.", "criterion": "Link each percentage-point value’s actual contrast, model and effect of interest to the original result tables.", "basis": "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.", "condition_origin": "These conditions for lotus-leaf hot-water extract and whole-body fat percentage at 12 weeks were developed with knowledge of the retained content and frozen before application. This does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.", "proposed_research": "Link arm order, contrast, model and stratum-specific denominators in each result table to distinguish between-group estimates from within-group changes." }, { "item_id": "N16", "question_type": "Evidence condition", "question": "Are intervals available to interpret uncertainty in the selected contrast?", "needed": "95% CI, variance, denominators by stratum and model for each contrast", "role": "Required (selected 12-week whole-body fat-percentage comparison)", "role_reason": "Needed to avoid judging precision or sufficiency from significance alone.", "application_exception": "Do not back-calculate CIs from P values or pool the 3 results into a new interval.", "criterion": "Link intervals for the verified contrast to variance and denominators to explain the range of compatible effects.", "basis": "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.", "condition_origin": "These conditions for lotus-leaf hot-water extract and whole-body fat percentage at 12 weeks were developed with knowledge of the retained content and frozen before application. This does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.", "proposed_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." }, { "item_id": "N17", "question_type": "Evidence condition", "question": "Are a justified importance threshold and the actual contrast/interval for body-fat change verified?", "needed": "Justified important difference in whole-body fat percentage, population-specific interpretation and intervals", "role": "Required (selected 12-week whole-body fat-percentage comparison)", "role_reason": "Needed to avoid automatically turning statistical significance into clinical importance.", "application_exception": "Do not adopt arbitrary percentage-point thresholds, minimum sample sizes or completion rates.", "criterion": "Check an importance threshold appropriate to the population and endpoint, and actual comparative estimates/intervals, to review their relationship. If unavailable, retain unverified status.", "basis": "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.", "condition_origin": "These conditions for lotus-leaf hot-water extract and whole-body fat percentage at 12 weeks were developed with knowledge of the retained content and frozen before application. This does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.", "proposed_research": "Obtain the basis for importance, patient-relevant outcomes and contrast-specific intervals." }, { "item_id": "N18", "question_type": "Evidence condition", "question": "Do registration timing and original endpoints/analysis plans match the report?", "needed": "NCT04651023, initial/amended registrations, protocol, SAP and endpoints/times", "role": "Required (selected 12-week whole-body fat-percentage comparison)", "role_reason": "Needed to avoid retroactively treating retrospective registration as a prespecified plan.", "application_exception": "Do not upgrade historical checking described in a summary to reading the full registration in this work.", "criterion": "Compare registration 11 years after completion, multiple primary outcomes, actual reporting/selection and reasons for changes with the original plan.", "basis": "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.", "condition_origin": "These conditions for lotus-leaf hot-water extract and whole-body fat percentage at 12 weeks were developed with knowledge of the retained content and frozen before application. This does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.", "proposed_research": "Obtain registration history, prospective protocol/SAP, complete results and reasons for changes." }, { "item_id": "N19", "question_type": "Evidence condition", "question": "How are sex/dose selection and multiple endpoints handled?", "needed": "Prespecified subgroups, n by stratum, interactions, multiple comparisons and complete-arm results", "role": "Required (selected 12-week whole-body fat-percentage comparison)", "role_reason": "Needed to avoid establishing sex or dose differences from positive strata alone.", "application_exception": "Do not interpret differences between stratum-specific P values as interactions.", "criterion": "Compare planning of sex/dose selection, complete results, interactions and handling of multiplicity.", "basis": "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.", "condition_origin": "These conditions for lotus-leaf hot-water extract and whole-body fat percentage at 12 weeks were developed with knowledge of the retained content and frozen before application. This does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.", "proposed_research": "Obtain prespecified analysis plans, all stratum results, interaction estimates and multiplicity handling." }, { "item_id": "N20", "question_type": "Evidence condition", "question": "Are the family relationship of the Ye report/NCT04651023 and other direct independent replications verified?", "needed": "PMID/DOI/NCT, study families, independent material and complete results", "role": "Required (selected 12-week whole-body fat-percentage comparison)", "role_reason": "Needed to avoid counting a report, registration and bibliography as multiple independent trials.", "application_exception": "Do not turn no searching in this work into 0 independent trials worldwide.", "criterion": "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.", "basis": "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.", "condition_origin": "These conditions for lotus-leaf hot-water extract and whole-body fat percentage at 12 weeks were developed with knowledge of the retained content and frozen before application. This does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.", "proposed_research": "Obtain study-family tables, registry/report links and independent material addressing the same question." }, { "item_id": "N21", "question_type": "Evidence condition", "question": "Are sponsorship, beverage supply, author employment, sponsor design/analysis roles and full COI declarations verified?", "needed": "Funding, product supply, author employment, declared interests and independent design/analysis", "role": "Required (selected 12-week whole-body fat-percentage comparison)", "role_reason": "Needed to avoid labeling industry involvement as independent research or automatically invalidating it.", "application_exception": "Do not invent a definite magnitude of bias merely because funding is shared.", "criterion": "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.", "basis": "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.", "condition_origin": "These conditions for lotus-leaf hot-water extract and whole-body fat percentage at 12 weeks were developed with knowledge of the retained content and frozen before application. This does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.", "proposed_research": "Obtain original funding/COI declarations, roles, analytical control and author-specific disclosures." }, { "item_id": "N22", "question_type": "Evidence condition", "question": "Does this question require an optimal dose or persistence after discontinuation?", "needed": "Direct dose comparisons, long-term/post-discontinuation follow-up and separate estimates", "role": "Supplementary; required for optimal-dose or persistence extensions", "role_reason": "Needed to avoid extending a narrow 12-week effect to every additional question.", "application_exception": "Do not automatically use 1/2 g strata as evidence of an optimal dose.", "criterion": "Distinguish the 12-week body-fat-percentage question from separate optimal-dose or persistence questions.", "basis": "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.", "condition_origin": "These conditions for lotus-leaf hot-water extract and whole-body fat percentage at 12 weeks were developed with knowledge of the retained content and frozen before application. This does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.", "proposed_research": "If an extension is requested, separately design dose-versus-dose comparisons and long-term/post-discontinuation follow-up." }, { "item_id": "N23", "question_type": "Evidence condition", "question": "Are body-fat-percentage results being transferred to weight, visceral fat or clinical events?", "needed": "Separate evidence for selected body-fat percentage versus weight/visceral fat and disease events", "role": "Supplementary; required for extensions to other endpoints or events", "role_reason": "Needed to avoid extending a numerical outcome to other endpoints/disease prevention.", "application_exception": "A registry list of multiple primary outcomes is not the result for each outcome.", "criterion": "Distinguish whole-body fat percentage from other endpoints and clinical events.", "basis": "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.", "condition_origin": "These conditions for lotus-leaf hot-water extract and whole-body fat percentage at 12 weeks were developed with knowledge of the retained content and frozen before application. This does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.", "proposed_research": "If an extension is requested, separately review actual endpoint-specific results and disease events for the same preparation." }, { "item_id": "N24", "question_type": "Evidence condition", "question": "Are the 60-person/12-week report and event definitions, collection and discontinuation reasons for all exposed participants verified?", "needed": "60 analyzed, 12 weeks, all exposed participants, event definitions/collection and discontinuation reasons", "role": "Supplementary; required for safety claims", "role_reason": "Needed to avoid turning unreported adverse reactions into safety or 0 events in all 95 participants.", "application_exception": "Do not merge efficacy and harm states or calculate new incidence rates.", "criterion": "Check the reported 60-person/12-week scope against actual material on all exposed denominators, event definitions, systematic collection and reasons for discontinuation/exclusion.", "basis": "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.", "condition_origin": "These conditions for lotus-leaf hot-water extract and whole-body fat percentage at 12 weeks were developed with knowledge of the retained content and frozen before application. This does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.", "proposed_research": "Obtain all exposed participants by arm, event counts, collection methods and discontinuation reasons." }, { "item_id": "N25", "question_type": "Evidence condition", "question": "Are direct data available for vulnerable populations, concomitant medicines and long-term or rare harms?", "needed": "Pregnancy/lactation, allergy, liver/kidney conditions, blood-pressure/glucose medicines and long-term/rare harms", "role": "Supplementary; required for the corresponding safety extension", "role_reason": "Needed to avoid extending a narrow short-term record to overall safety.", "application_exception": "Do not convert unverified status into a definite interaction or a personal prohibition on use.", "criterion": "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.", "basis": "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.", "condition_origin": "These conditions for lotus-leaf hot-water extract and whole-body fat percentage at 12 weeks were developed with knowledge of the retained content and frozen before application. This does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.", "proposed_research": "Obtain comparative exposure/event material for those populations and concomitant medicines, and long-term follow-up." }, { "item_id": "N26", "question_type": "Evidence condition", "question": "Are material actually read and historical verification narratives distinguished?", "needed": "Retained JSON, original review date, bibliography/access, current date and original locations/SHA", "role": "Required (selected 12-week whole-body fat-percentage comparison)", "role_reason": "Needed to avoid upgrading a historical full-text cross-checking narrative to full-text reading in this work.", "application_exception": "Do not generate missing typed access dates, locations or levels from historical prose.", "criterion": "Separately show the JSON read in this work, unread external material and historical review dates/narratives.", "basis": "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.", "condition_origin": "These conditions for lotus-leaf hot-water extract and whole-body fat percentage at 12 weeks were developed with knowledge of the retained content and frozen before application. This does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.", "proposed_research": "When material is later acquired, record identity, material type, date, access/reading, locations and byte SHA." }, { "item_id": "N27", "question_type": "Evidence condition", "question": "Are the legacy grade, axes, corrections and under-review status preserved?", "needed": "C 46, EX/CX, original/previous axes, corrections and grade-revalidation flag false", "role": "Required (selected 12-week whole-body fat-percentage comparison)", "role_reason": "Needed to avoid automatically inheriting a retained grade as the new checklist’s final efficacy assessment.", "application_exception": "Do not calculate a new grade/score from this checklist’s condition states.", "criterion": "Link the original C 46, axes, 2026-09-14 correction and legacy-grade-under-review status to the original text.", "basis": "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.", "condition_origin": "These conditions for lotus-leaf hot-water extract and whole-body fat percentage at 12 weeks were developed with knowledge of the retained content and frozen before application. This does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.", "proposed_research": "If reassessment is later requested, preserve the original, previous values, new evidence and change decision as a separate event." }, { "item_id": "N28", "question_type": "Evidence condition", "question": "Are subsequent evidence, condition changes and verdict changes linked as separate events?", "needed": "Original results, denominators/contrasts/CIs, registration/SAP, measurement/harms, condition versions and previous values", "role": "Required (selected 12-week whole-body fat-percentage comparison)", "role_reason": "Needed to avoid making new material acquisition automatically change conditions or a verdict.", "application_exception": "Do not delete unfavorable observations, uncertainty or the original text.", "criterion": "Distinguish the current material scope, affected rows for subsequent material, condition revisions and verdict changes.", "basis": "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.", "condition_origin": "These conditions for lotus-leaf hot-water extract and whole-body fat percentage at 12 weeks were developed with knowledge of the retained content and frozen before application. This does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.", "proposed_research": "Record identity, reading and locations; review affected rows, and freeze a revised condition version before application." } ] }