{ "schema_version": "chamgap-public-evidence-check-1.0", "public_id": "v3078-main", "verdict_number": "3078", "title": "Lotus leaf tea or defined lotus leaf infusion × Reduction of systolic blood pressure in adults with hypertension", "view_version": "1.0", "view_created_date": "2026-10-28", "criteria_version": "1.0", "criteria_date": "2026-10-05", "review_date": "2026-10-05", "legacy_evidence_date": "2026-09-08", "review_scope": { "materials_read": "Retained Korean/English summaries and case-specific condition/application records", "clinical_papers_directly_read": false, "new_clinical_search": false, "limitation": "Prepared from retained summaries and condition-application records. External abstracts, full texts, registration, protocols and analysis plans remain unread. Historical review records do not establish current independent clinical validation.", "date_meaning": "The 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." }, "claim_context": { "population": "Adults with hypertension", "intervention": "Oral consumption of single Nelumbo nucifera lotus leaf tea or a defined lotus leaf hot-water infusion; an actually eligible trial formulation is unverified", "dose": "Actual dose in a directly eligible blood-pressure trial is unverified", "comparator": "Actual concurrent comparator in a directly eligible blood-pressure trial is unverified", "endpoint": "The intended endpoint is office or 24-hour systolic blood pressure; measurement and results in an actual direct trial are unverified", "duration": "Actual exposure duration and assessment times in a directly eligible blood-pressure trial are unverified", "excluded_extensions": [ "The human body-fat trial and in vitro ACE material are retained as related context; they do not replace a direct blood-pressure comparison. Directly eligible unique study/participant counts are unrecorded; this does not mean 0 studies or an effect of 0.", "Allocation of 95 and analysis of 60 overweight completers, and the 1–2 g extract/400 mL beverage, belong to the body-fat report. Do not transfer them as hypertension blood-pressure trial counts/dose or equivalence with ordinary tea.", "Do not extend to other plant parts, alkaloids, capsules, combination products, intravenous animal results, cardiovascular-event prevention, medication replacement, optimal dose or persistence after discontinuation.", "Retain the original Caution label. Unverified pregnancy, lactation, liver/kidney disease, concomitant medicines, long-term or rare harms do not establish safety or personal dosing instructions." ] }, "requirements": [ { "item_id": "N01", "question_type": "Evidence condition", "question": "Which original claim and boundaries does this table convert?", "needed": "Canonical claim, plant part, route, population, endpoint, exclusions and original record locations", "role": "Required", "role_reason": "Needed to avoid combining body-fat, mechanistic or other plant-part effects solely because the plant name is the same.", "application_exception": "Korean and English describe the same claim. The original subclaim list is empty; do not create absent subclaims.", "criterion": "Connect the systolic-blood-pressure claim to a comparative question about single lotus leaf tea or a defined hot-water infusion in adults with hypertension; exclude other endpoints and plant parts.", "basis": "Existing method principles distinguish population, plant part, manufacture, drinking exposure, comparator, timing, denominators, missingness, measurement, between-group effects, intervals, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.", "condition_origin": "These conditions for lotus leaf tea/hot-water infusion and systolic blood pressure in adults with hypertension 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 the manuscript boundary changes, preserve the whole previous manuscript and compare the independent question again.", "current_reports": [ "S01", "S02" ], "existence": "Retained bilingual research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material have not been separately established.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.", "observation": "The original claim is reduced systolic blood pressure in adults with hypertension. It is limited to oral consumption of a single lotus leaf tea or defined hot-water infusion; body-fat, in vitro ACE, seed, alkaloid and intravenous animal results are excluded.", "condition_status": "Met", "status_reason": "The original claim and table inclusion/exclusion boundaries are connected to the retained manuscript. This does not mean a direct blood-pressure effect was verified.", "missingness": "None within this narrow record scope.", "uncertainty": "None within this narrow record scope. No new effect, interval, denominator, incidence or grade was calculated or reassessed.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "Canonical claim, plant part, route, population, endpoint, exclusions and original record locations" }, { "item_id": "N02", "question_type": "Evidence condition", "question": "Can an actual controlled human blood-pressure trial matching this boundary be identified?", "needed": "Trial report and identity matching the exact plant part, formulation, population, blood-pressure endpoint and comparator", "role": "Required", "role_reason": "Needed to avoid treating the existence of a related human body-fat trial as the existence of a direct blood-pressure comparison.", "application_exception": "Do not fill facts unverified in the retained material with evidence about other lotus parts, formulations, populations or endpoints. Unverified material does not prove an effect of 0 or the worldwide absence of research.", "criterion": "Verify the identity and design of a report in which adults with hypertension actually drank single lotus leaf tea or infusion and systolic blood pressure was compared with a concurrent control.", "basis": "Existing method principles distinguish population, plant part, manufacture, drinking exposure, comparator, timing, denominators, missingness, measurement, between-group effects, intervals, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.", "condition_origin": "These conditions for lotus leaf tea/hot-water infusion and systolic blood pressure in adults with hypertension 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": "In subsequent material selection, compare each report with this eligibility boundary and retain exclusion reasons.", "current_reports": [ "S01", "S02" ], "existence": "Retained bilingual research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material have not been separately established.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.", "observation": "The retained reader answer and evidence table record that no directly eligible controlled human blood-pressure trial was identified. The Ye body-fat trial and in vitro ACE material are excluded for different reasons.", "condition_status": "Unverified", "status_reason": "A directly eligible comparison is unverified in this retained input. No new search was conducted; this does not establish the absence of all human studies.", "missingness": "A directly eligible comparison is unverified in this retained input. No new search was conducted; this does not establish the absence of all human studies.", "uncertainty": "A directly eligible comparison is unverified in this retained input. No new search was conducted; this does not establish the absence of all human studies. No new effect, interval, denominator, incidence or grade was calculated or reassessed.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "Trial report and identity matching the exact plant part, formulation, population, blood-pressure endpoint and comparator" }, { "item_id": "N03", "question_type": "Evidence condition", "question": "Can the botanical identity and leaf history of the actual blood-pressure trial product be verified?", "needed": "Botanical identification, plant part, batch, cultivar, origin and harvest records for the direct-trial product", "role": "Required", "role_reason": "Needed to avoid exchanging lotus plumules, seeds, roots or different leaf conditions for the same exposure.", "application_exception": "Do not fill facts unverified in the retained material with evidence about other lotus parts, formulations, populations or endpoints. Unverified material does not prove an effect of 0 or the worldwide absence of research.", "criterion": "Verify Nelumbo nucifera leaf identification, cultivar, origin and harvest timing, or equivalent product traceability, for the actual trial.", "basis": "Existing method principles distinguish population, plant part, manufacture, drinking exposure, comparator, timing, denominators, missingness, measurement, between-group effects, intervals, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.", "condition_origin": "These conditions for lotus leaf tea/hot-water infusion and systolic blood pressure in adults with hypertension 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 product specifications with the trial report and distinguish leaf identity from unverified history.", "current_reports": [ "S01", "S02" ], "existence": "Retained bilingual research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material have not been separately established.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.", "observation": "The original claim conditions specify Nelumbo nucifera leaves, but exact cultivar, origin and harvest timing are unverified. Product identification material for a direct blood-pressure trial is also not retained.", "condition_status": "Unverified", "status_reason": "The question concerns the actual direct-trial product. Naming the intended leaf does not establish its history.", "missingness": "The question concerns the actual direct-trial product. Naming the intended leaf does not establish its history.", "uncertainty": "The question concerns the actual direct-trial product. Naming the intended leaf does not establish its history. No new effect, interval, denominator, incidence or grade was calculated or reassessed.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "Botanical identification, plant part, batch, cultivar, origin and harvest records for the direct-trial product" }, { "item_id": "N04", "question_type": "Evidence condition", "question": "What formulation and manufacturing conditions were actually consumed in the blood-pressure trial?", "needed": "Manufacturing specifications, infusion conditions, batch testing and full ingredient list for the direct blood-pressure trial", "role": "Required", "role_reason": "Needed to avoid treating similarly named teas, capsules and extract test beverages as the same exposure.", "application_exception": "Do not fill facts unverified in the retained material with evidence about other lotus parts, formulations, populations or endpoints. Unverified material does not prove an effect of 0 or the worldwide absence of research.", "criterion": "Verify raw-material quantity, extraction/infusion procedure, composition or batch standardization, and mixed ingredients for the actual single tea or hot-water infusion.", "basis": "Existing method principles distinguish population, plant part, manufacture, drinking exposure, comparator, timing, denominators, missingness, measurement, between-group effects, intervals, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.", "condition_origin": "These conditions for lotus leaf tea/hot-water infusion and systolic blood pressure in adults with hypertension 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 the trial formulation with the drinking boundary and record differences from ordinary tea, capsules and combination products.", "current_reports": [ "S01", "S02" ], "existence": "Retained bilingual research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material have not been separately established.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.", "observation": "The original formulation is tea or a defined hot-water infusion; the eligible trial formulation is unverified. The manuscript excludes importing hot-water-extract capsules, body-fat beverages or mixed teas.", "condition_status": "Unverified", "status_reason": "No material verifies actual manufacture, batch or mixed ingredients in a direct blood-pressure trial.", "missingness": "No material verifies actual manufacture, batch or mixed ingredients in a direct blood-pressure trial.", "uncertainty": "No material verifies actual manufacture, batch or mixed ingredients in a direct blood-pressure trial. No new effect, interval, denominator, incidence or grade was calculated or reassessed.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "Manufacturing specifications, infusion conditions, batch testing and full ingredient list for the direct blood-pressure trial" }, { "item_id": "N05", "question_type": "Evidence condition", "question": "Are dose and drinking schedule in a direct blood-pressure trial verified?", "needed": "Raw-material/extract quantity, beverage volume, frequency and consumption records for the direct trial", "role": "Required", "role_reason": "Needed to avoid inheriting the body-fat trial’s 1–2 g and 400 mL as a hypertension treatment dose.", "application_exception": "Do not fill facts unverified in the retained material with evidence about other lotus parts, formulations, populations or endpoints. Unverified material does not prove an effect of 0 or the worldwide absence of research.", "criterion": "Connect raw-material/extract mass, beverage volume/frequency and actual daily amount to the blood-pressure trial; distinguish amounts provided from amounts consumed.", "basis": "Existing method principles distinguish population, plant part, manufacture, drinking exposure, comparator, timing, denominators, missingness, measurement, between-group effects, intervals, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.", "condition_origin": "These conditions for lotus leaf tea/hot-water infusion and systolic blood pressure in adults with hypertension 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": "Verify trial-specific units and manufacturing yield, then distinguish nominal quantity from actual consumption.", "current_reports": [ "S01", "S02" ], "existence": "Retained bilingual research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material have not been separately established.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.", "observation": "The dose in a directly eligible controlled trial is unverified. The 1–2 g lotus-leaf hot-water extract and 400 mL in the original key explanation describe only the body-fat trial beverage.", "condition_status": "Unverified", "status_reason": "Direct blood-pressure dose data are absent. The body-fat trial figures do not verify this dose.", "missingness": "Direct blood-pressure dose data are absent. The body-fat trial figures do not verify this dose.", "uncertainty": "Direct blood-pressure dose data are absent. The body-fat trial figures do not verify this dose. No new effect, interval, denominator, incidence or grade was calculated or reassessed.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "Raw-material/extract quantity, beverage volume, frequency and consumption records for the direct trial" }, { "item_id": "N06", "question_type": "Evidence condition", "question": "Are exposure duration and assessment times in a direct blood-pressure trial verified?", "needed": "Exposure schedule, blood-pressure visits and observations after discontinuation for the direct trial", "role": "Required", "role_reason": "Needed to avoid filling blood-pressure observation duration with another endpoint’s trial duration or traditional-use duration.", "application_exception": "Do not fill facts unverified in the retained material with evidence about other lotus parts, formulations, populations or endpoints. Unverified material does not prove an effect of 0 or the worldwide absence of research.", "criterion": "Connect start/end dates, blood-pressure assessment visits and actual exposure duration to the comparison.", "basis": "Existing method principles distinguish population, plant part, manufacture, drinking exposure, comparator, timing, denominators, missingness, measurement, between-group effects, intervals, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.", "condition_origin": "These conditions for lotus leaf tea/hot-water infusion and systolic blood pressure in adults with hypertension 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 visits with drinking records and separate effects during treatment from persistence after stopping.", "current_reports": [ "S01", "S02" ], "existence": "Retained bilingual research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material have not been separately established.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.", "observation": "Direct-trial duration is unverified in the claim conditions. The two current evidence records do not provide visits or exposure duration for a direct blood-pressure comparison.", "condition_status": "Unverified", "status_reason": "Actual duration and assessment times for a direct comparison cannot be established. No arbitrary minimum duration is imposed on every trial.", "missingness": "Actual duration and assessment times for a direct comparison cannot be established. No arbitrary minimum duration is imposed on every trial.", "uncertainty": "Actual duration and assessment times for a direct comparison cannot be established. No arbitrary minimum duration is imposed on every trial. No new effect, interval, denominator, incidence or grade was calculated or reassessed.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "Exposure schedule, blood-pressure visits and observations after discontinuation for the direct trial" }, { "item_id": "N07", "question_type": "Evidence condition", "question": "Can actual hypertension participants’ selection and baseline status be verified?", "needed": "Diagnostic criteria, baseline characteristics, selection/exclusion table and group-specific blood pressure for the direct trial", "role": "Required", "role_reason": "Needed to avoid relabeling overweight completers as hypertension patients or extending results unchanged to general adults.", "application_exception": "Do not fill facts unverified in the retained material with evidence about other lotus parts, formulations, populations or endpoints. Unverified material does not prove an effect of 0 or the worldwide absence of research.", "criterion": "Connect diagnostic criteria, baseline blood pressure, age, severity, inclusion/exclusion, baseline treatment and distributions by group to the direct trial.", "basis": "Existing method principles distinguish population, plant part, manufacture, drinking exposure, comparator, timing, denominators, missingness, measurement, between-group effects, intervals, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.", "condition_origin": "These conditions for lotus leaf tea/hot-water infusion and systolic blood pressure in adults with hypertension 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 recruitment and baseline tables to distinguish the hypertension population in the question from other populations.", "current_reports": [ "S01", "S02" ], "existence": "Retained bilingual research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material have not been separately established.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.", "observation": "The population boundary is adults with hypertension, but diagnosis and baseline status in an actually eligible trial are unverified. The Ye material analyzes body fat in overweight completers.", "condition_status": "Unverified", "status_reason": "The intended population is specified, but actual hypertension recruitment and baseline tables are not retained.", "missingness": "The intended population is specified, but actual hypertension recruitment and baseline tables are not retained.", "uncertainty": "The intended population is specified, but actual hypertension recruitment and baseline tables are not retained. No new effect, interval, denominator, incidence or grade was calculated or reassessed.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "Diagnostic criteria, baseline characteristics, selection/exclusion table and group-specific blood pressure for the direct trial" }, { "item_id": "N08", "question_type": "Evidence condition", "question": "Can oral consumption and actual adherence in a direct trial be verified?", "needed": "Route, consumption, returned-product, adherence and other lotus-product use records for the direct trial", "role": "Required", "role_reason": "Needed to distinguish in vitro or intravenous animal results from oral drinking and avoid automatically equating supplied beverage with actual intake.", "application_exception": "Do not fill facts unverified in the retained material with evidence about other lotus parts, formulations, populations or endpoints. Unverified material does not prove an effect of 0 or the worldwide absence of research.", "criterion": "Verify actual route, frequency, adherence, contamination or crossover consumption of the trial product.", "basis": "Existing method principles distinguish population, plant part, manufacture, drinking exposure, comparator, timing, denominators, missingness, measurement, between-group effects, intervals, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.", "condition_origin": "These conditions for lotus leaf tea/hot-water infusion and systolic blood pressure in adults with hypertension 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 exposure records with result timing and separately retain gaps in adherence information.", "current_reports": [ "S01", "S02" ], "existence": "Retained bilingual research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material have not been separately established.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.", "observation": "The original route is oral drinking. Actual consumption/adherence in a direct human blood-pressure trial are unverified; the manuscript excludes intravenous animal, cell and enzyme experiments.", "condition_status": "Unverified", "status_reason": "The intended route alone cannot verify actual trial exposure and adherence.", "missingness": "The intended route alone cannot verify actual trial exposure and adherence.", "uncertainty": "The intended route alone cannot verify actual trial exposure and adherence. No new effect, interval, denominator, incidence or grade was calculated or reassessed.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "Route, consumption, returned-product, adherence and other lotus-product use records for the direct trial" }, { "item_id": "N09", "question_type": "Evidence condition", "question": "Is the actual comparator in a direct blood-pressure comparison verified?", "needed": "Control beverage, ingredients, intake schedule and common-treatment specifications for the direct trial", "role": "Required", "role_reason": "Needed to avoid converting uncontrolled or mechanistic material into a between-group comparison or recording an intended placebo as an actual placebo.", "application_exception": "Do not fill facts unverified in the retained material with evidence about other lotus parts, formulations, populations or endpoints. Unverified material does not prove an effect of 0 or the worldwide absence of research.", "criterion": "Verify the actual control beverage, placebo or usual-care group’s ingredients, intake, common management and differences between groups.", "basis": "Existing method principles distinguish population, plant part, manufacture, drinking exposure, comparator, timing, denominators, missingness, measurement, between-group effects, intervals, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.", "condition_origin": "These conditions for lotus leaf tea/hot-water infusion and systolic blood pressure in adults with hypertension 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": "Separate actual differences in the comparison and examine what can be attributed to single lotus-leaf consumption.", "current_reports": [ "S01", "S02" ], "existence": "Retained bilingual research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material have not been separately established.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.", "observation": "The original comparator is unverified because no eligible controlled trial was identified. Do not import a direct blood-pressure comparator from the body-fat trial or in vitro material.", "condition_status": "Unverified", "status_reason": "The contents, intake and treatment of an actual blood-pressure comparison group are not retained.", "missingness": "The contents, intake and treatment of an actual blood-pressure comparison group are not retained.", "uncertainty": "The contents, intake and treatment of an actual blood-pressure comparison group are not retained. No new effect, interval, denominator, incidence or grade was calculated or reassessed.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "Control beverage, ingredients, intake schedule and common-treatment specifications for the direct trial" }, { "item_id": "N10", "question_type": "Evidence condition", "question": "Are the comparative design and allocation procedures of a direct blood-pressure trial verified?", "needed": "Original design, allocation, concealment and baseline-comparison material for the direct trial", "role": "Required", "role_reason": "A related report’s use of the word trial does not establish the design for the direct question.", "application_exception": "Do not fill facts unverified in the retained material with evidence about other lotus parts, formulations, populations or endpoints. Unverified material does not prove an effect of 0 or the worldwide absence of research.", "criterion": "Verify parallel/crossover design, randomized/nonrandomized allocation, concealment and baseline comparison for the actual result.", "basis": "Existing method principles distinguish population, plant part, manufacture, drinking exposure, comparator, timing, denominators, missingness, measurement, between-group effects, intervals, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.", "condition_origin": "These conditions for lotus leaf tea/hot-water infusion and systolic blood pressure in adults with hypertension 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 design/allocation information for each result and retain unverified designs as unverified.", "current_reports": [ "S01", "S02" ], "existence": "Retained bilingual research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material have not been separately established.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.", "observation": "The design and allocation procedures of a direct human blood-pressure trial are unverified in the retained material. The trial in the related evidence entry addresses a different body-fat endpoint.", "condition_status": "Unverified", "status_reason": "Direct comparative design is unverified; do not replace examination of crossover, clustering or allocation with Not applicable.", "missingness": "Direct comparative design is unverified; do not replace examination of crossover, clustering or allocation with Not applicable.", "uncertainty": "Direct comparative design is unverified; do not replace examination of crossover, clustering or allocation with Not applicable. No new effect, interval, denominator, incidence or grade was calculated or reassessed.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "Original design, allocation, concealment and baseline-comparison material for the direct trial" }, { "item_id": "N11", "question_type": "Evidence condition", "question": "Can antihypertensive treatment, lifestyle and rescue-treatment changes be separated from the drinking contribution?", "needed": "Group-specific concomitant medication, adjustments, lifestyle, rescue treatment, adherence and analytical handling", "role": "Required", "role_reason": "Needed to avoid attributing differences in concurrent management affecting blood pressure to lotus leaf tea.", "application_exception": "Do not require every change to be identical between groups. Match the actual effect of interest and analysis; distinguish interaction-data gaps from absent efficacy.", "criterion": "Verify baseline antihypertensives, medication adjustments, rescue treatment, diet/exercise changes and actual analytical handling by group.", "basis": "Existing method principles distinguish population, plant part, manufacture, drinking exposure, comparator, timing, denominators, missingness, measurement, between-group effects, intervals, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.", "condition_origin": "These conditions for lotus leaf tea/hot-water infusion and systolic blood pressure in adults with hypertension 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 concomitant treatment over time with the effect of interest to distinguish common management from drinking differences.", "current_reports": [ "S01", "S02" ], "existence": "Retained bilingual research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material have not been separately established.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.", "observation": "Concomitant/rescue treatment and lifestyle data for a directly eligible trial are unverified. The original safety explanation retains gaps in checking interactions with antihypertensive and glucose-lowering medicines.", "condition_status": "Unverified", "status_reason": "There is no basis for verifying that other treatment was absent or the same between groups.", "missingness": "There is no basis for verifying that other treatment was absent or the same between groups.", "uncertainty": "There is no basis for verifying that other treatment was absent or the same between groups. No new effect, interval, denominator, incidence or grade was calculated or reassessed.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "Group-specific concomitant medication, adjustments, lifestyle, rescue treatment, adherence and analytical handling" }, { "item_id": "N12", "question_type": "Evidence condition", "question": "Can systolic-blood-pressure measurement conditions in a direct trial be verified?", "needed": "Direct blood-pressure measurement manual, devices, visits, repetitions and blinding material", "role": "Required", "role_reason": "Needed to avoid converting body-fat percentage or enzyme inhibition into blood-pressure values and to distinguish measurement differences from actual change.", "application_exception": "Do not fill facts unverified in the retained material with evidence about other lotus parts, formulations, populations or endpoints. Unverified material does not prove an effect of 0 or the worldwide absence of research.", "criterion": "Verify office or 24-hour measurement, device, posture, repetitions/averaging, time of day, assessor and the same procedure between groups.", "basis": "Existing method principles distinguish population, plant part, manufacture, drinking exposure, comparator, timing, denominators, missingness, measurement, between-group effects, intervals, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.", "condition_origin": "These conditions for lotus leaf tea/hot-water infusion and systolic blood pressure in adults with hypertension 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 measurement procedures with result tables and attribute office and 24-hour results separately.", "current_reports": [ "S01", "S02" ], "existence": "Retained bilingual research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material have not been separately established.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.", "observation": "The intended endpoint is office or 24-hour systolic blood pressure, but measurement in an eligible trial is unverified. Body-fat percentage and in vitro enzyme inhibition in the evidence records are different measurements.", "condition_status": "Unverified", "status_reason": "Direct blood-pressure devices, procedures, assessor blinding and measurement conditions by group cannot be verified.", "missingness": "Direct blood-pressure devices, procedures, assessor blinding and measurement conditions by group cannot be verified.", "uncertainty": "Direct blood-pressure devices, procedures, assessor blinding and measurement conditions by group cannot be verified. No new effect, interval, denominator, incidence or grade was calculated or reassessed.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "Direct blood-pressure measurement manual, devices, visits, repetitions and blinding material" }, { "item_id": "N13", "question_type": "Evidence condition", "question": "Are blood-pressure units, final values or changes, and assessment visits verified?", "needed": "Direct blood-pressure result table, units, baseline/end values, visits and change definitions", "role": "Required", "role_reason": "Needed to avoid turning the presence of an endpoint name into reported actual blood-pressure figures.", "application_exception": "Do not fill facts unverified in the retained material with evidence about other lotus parts, formulations, populations or endpoints. Unverified material does not prove an effect of 0 or the worldwide absence of research.", "criterion": "Connect systolic-blood-pressure units, final value/change, visit and analytical direction for direct results to the original table.", "basis": "Existing method principles distinguish population, plant part, manufacture, drinking exposure, comparator, timing, denominators, missingness, measurement, between-group effects, intervals, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.", "condition_origin": "These conditions for lotus leaf tea/hot-water infusion and systolic blood pressure in adults with hypertension 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": "Connect original-table result definitions with comparator and time; do not mix figures from other endpoints.", "current_reports": [ "S01", "S02" ], "existence": "Retained bilingual research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material have not been separately established.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.", "observation": "The retained evidence entries record no blood-pressure efficacy result and no human blood-pressure result, respectively. Direct mmHg final values, changes and visits are unverified.", "condition_status": "Unverified", "status_reason": "No direct table establishes actual blood-pressure units, timing or change definitions. Do not extend this to nonreporting throughout an unread paper.", "missingness": "No direct table establishes actual blood-pressure units, timing or change definitions. Do not extend this to nonreporting throughout an unread paper.", "uncertainty": "No direct table establishes actual blood-pressure units, timing or change definitions. Do not extend this to nonreporting throughout an unread paper. No new effect, interval, denominator, incidence or grade was calculated or reassessed.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "Direct blood-pressure result table, units, baseline/end values, visits and change definitions" }, { "item_id": "N14", "question_type": "Evidence condition", "question": "Are allocation, measurement and analysis denominators in a direct blood-pressure trial verified?", "needed": "Group-specific flowchart and blood-pressure measurement/analysis denominators for the direct trial", "role": "Required", "role_reason": "Needed to avoid inheriting 95 and 60 from another endpoint as direct blood-pressure analysis counts.", "application_exception": "Do not fill facts unverified in the retained material with evidence about other lotus parts, formulations, populations or endpoints. Unverified material does not prove an effect of 0 or the worldwide absence of research.", "criterion": "Distinguish allocation, exposure, blood-pressure measurement and analysis counts by group; connect each denominator with its actual result.", "basis": "Existing method principles distinguish population, plant part, manufacture, drinking exposure, comparator, timing, denominators, missingness, measurement, between-group effects, intervals, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.", "condition_origin": "These conditions for lotus leaf tea/hot-water infusion and systolic blood pressure in adults with hypertension 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 the flow from allocation to blood-pressure analysis and distinguish the role of each denominator.", "current_reports": [ "S01", "S02" ], "existence": "Retained bilingual research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material have not been separately established.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.", "observation": "The direct blood-pressure denominator is unverified. Allocation of 95 participants and analysis of 60 overweight completers belong only to the Ye body-fat trial.", "condition_status": "Unverified", "status_reason": "The direct blood-pressure analysis denominator is absent. Do not reuse 95/60 or calculate new unique participant counts.", "missingness": "The direct blood-pressure analysis denominator is absent. Do not reuse 95/60 or calculate new unique participant counts.", "uncertainty": "The direct blood-pressure analysis denominator is absent. Do not reuse 95/60 or calculate new unique participant counts. No new effect, interval, denominator, incidence or grade was calculated or reassessed.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "Group-specific flowchart and blood-pressure measurement/analysis denominators for the direct trial" }, { "item_id": "N15", "question_type": "Evidence condition", "question": "Can missingness, withdrawals and their handling in a direct blood-pressure analysis be verified?", "needed": "Direct blood-pressure trial flowchart, withdrawal reasons, missing-data handling and sensitivity analyses", "role": "Required", "role_reason": "Needed to avoid judging follow-up completeness or missing-data bias in a direct trial solely from the word completers.", "application_exception": "Do not fill facts unverified in the retained material with evidence about other lotus parts, formulations, populations or endpoints. Unverified material does not prove an effect of 0 or the worldwide absence of research.", "criterion": "Verify missing blood-pressure observations, discontinuation/withdrawal reasons, group differences and analysis inclusion, imputation and sensitivity handling.", "basis": "Existing method principles distinguish population, plant part, manufacture, drinking exposure, comparator, timing, denominators, missingness, measurement, between-group effects, intervals, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.", "condition_origin": "These conditions for lotus leaf tea/hot-water infusion and systolic blood pressure in adults with hypertension 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 reasons for missing blood-pressure observations with analysis inclusion; do not estimate an unknown magnitude of bias.", "current_reports": [ "S01", "S02" ], "existence": "Retained bilingual research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material have not been separately established.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.", "observation": "No direct blood-pressure follow-up or missingness material is retained. The related description of 60 body-fat completers informs that analysis, not blood-pressure missing-data handling.", "condition_status": "Unverified", "status_reason": "Missingness, loss to follow-up and handling by group in a direct trial cannot be verified. Do not calculate a new withdrawal rate from the difference between 95 and 60.", "missingness": "Missingness, loss to follow-up and handling by group in a direct trial cannot be verified. Do not calculate a new withdrawal rate from the difference between 95 and 60.", "uncertainty": "Missingness, loss to follow-up and handling by group in a direct trial cannot be verified. Do not calculate a new withdrawal rate from the difference between 95 and 60. No new effect, interval, denominator, incidence or grade was calculated or reassessed.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "Direct blood-pressure trial flowchart, withdrawal reasons, missing-data handling and sensitivity analyses" }, { "item_id": "N16", "question_type": "Evidence condition", "question": "Is the between-group effect estimated by a direct blood-pressure analysis verified?", "needed": "Analysis population, model, effect of interest and between-group result table for the direct trial", "role": "Required", "role_reason": "Needed to avoid importing uncontrolled changes or another endpoint’s analysis as a between-group blood-pressure effect of lotus leaf tea.", "application_exception": "A valid unadjusted between-group analysis may suit the design and effect of interest. Verifying a formal effect does not always require covariate adjustment.", "criterion": "Verify assignment/adherence effects, ITT/PP or other analysis populations, between-/within-group distinctions and a valid analytical model.", "basis": "Existing method principles distinguish population, plant part, manufacture, drinking exposure, comparator, timing, denominators, missingness, measurement, between-group effects, intervals, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.", "condition_origin": "These conditions for lotus leaf tea/hot-water infusion and systolic blood pressure in adults with hypertension 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 the analysis plan with original results to identify an estimator appropriate for the effect of interest.", "current_reports": [ "S01", "S02" ], "existence": "Retained bilingual research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material have not been separately established.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.", "observation": "The analysis population, model and between-group estimate for a direct blood-pressure comparison are not retained. Current material contains only the body-fat trial and in vitro results.", "condition_status": "Unverified", "status_reason": "An actual analysis corresponding to the blood-pressure effect of interest cannot be verified. Do not assign ITT or adjusted analysis arbitrarily.", "missingness": "An actual analysis corresponding to the blood-pressure effect of interest cannot be verified. Do not assign ITT or adjusted analysis arbitrarily.", "uncertainty": "An actual analysis corresponding to the blood-pressure effect of interest cannot be verified. Do not assign ITT or adjusted analysis arbitrarily. No new effect, interval, denominator, incidence or grade was calculated or reassessed.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "Analysis population, model, effect of interest and between-group result table for the direct trial" }, { "item_id": "N17", "question_type": "Evidence condition", "question": "Can a direct between-group blood-pressure estimate and uncertainty interval be verified?", "needed": "Direct between-group blood-pressure estimate, interval, variance definition, denominator and assessment time", "role": "Required", "role_reason": "Needed to avoid turning a failure to identify evidence into an effect of 0 or a sufficiently precise null difference.", "application_exception": "Do not fill facts unverified in the retained material with evidence about other lotus parts, formulations, populations or endpoints. Unverified material does not prove an effect of 0 or the worldwide absence of research.", "criterion": "Connect a reported between-group blood-pressure estimate, CI/SE/SD type, result denominator and assessment time to the original table.", "basis": "Existing method principles distinguish population, plant part, manufacture, drinking exposure, comparator, timing, denominators, missingness, measurement, between-group effects, intervals, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.", "condition_origin": "These conditions for lotus leaf tea/hot-water infusion and systolic blood pressure in adults with hypertension 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 reported intervals and estimands with the original model; do not calculate absent values to fill gaps.", "current_reports": [ "S01", "S02" ], "existence": "Retained bilingual research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material have not been separately established.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.", "observation": "Direct blood-pressure effect estimates, CI, SE and SD are unverified in the retained material. The original applicability-limit discussion explicitly states that unverified material does not prove an effect of 0.", "condition_status": "Unverified", "status_reason": "No original values establish between-group effect magnitude or interval. Do not create an interval from P values, mechanisms or related body-fat figures.", "missingness": "No original values establish between-group effect magnitude or interval. Do not create an interval from P values, mechanisms or related body-fat figures.", "uncertainty": "No original values establish between-group effect magnitude or interval. Do not create an interval from P values, mechanisms or related body-fat figures. No new effect, interval, denominator, incidence or grade was calculated or reassessed.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "Direct between-group blood-pressure estimate, interval, variance definition, denominator and assessment time" }, { "item_id": "N18", "question_type": "Evidence condition", "question": "Are the evidence and criteria for judging the importance of a blood-pressure change verified?", "needed": "Direct blood-pressure effect/interval and a clearly sourced important difference or application criterion", "role": "Required", "role_reason": "Needed to avoid declaring clinical sufficiency solely from significance or trial counts.", "application_exception": "Do not fill facts unverified in the retained material with evidence about other lotus parts, formulations, populations or endpoints. Unverified material does not prove an effect of 0 or the worldwide absence of research.", "criterion": "Verify material allowing the actually reported interval to be compared with a justified important difference and application context for the question.", "basis": "Existing method principles distinguish population, plant part, manufacture, drinking exposure, comparator, timing, denominators, missingness, measurement, between-group effects, intervals, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.", "condition_origin": "These conditions for lotus leaf tea/hot-water infusion and systolic blood pressure in adults with hypertension 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 effect intervals with importance evidence without arbitrarily setting new thresholds or grades.", "current_reports": [ "S01", "S02" ], "existence": "Retained bilingual research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material have not been separately established.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.", "observation": "A direct blood-pressure effect, interval and important-difference criterion for this question are not retained. The original ? and unrecorded values are retained.", "condition_status": "Unverified", "status_reason": "Importance cannot be judged without a direct estimate and criterion. Do not adopt arbitrary minimum n, duration or mmHg thresholds.", "missingness": "Importance cannot be judged without a direct estimate and criterion. Do not adopt arbitrary minimum n, duration or mmHg thresholds.", "uncertainty": "Importance cannot be judged without a direct estimate and criterion. Do not adopt arbitrary minimum n, duration or mmHg thresholds. No new effect, interval, denominator, incidence or grade was calculated or reassessed.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "Direct blood-pressure effect/interval and a clearly sourced important difference or application criterion" }, { "item_id": "N19", "question_type": "Evidence condition", "question": "Can the prespecified plan and actual report of a direct blood-pressure trial be compared?", "needed": "Registration, protocol, analysis plan, complete results and amendment reasons for the direct blood-pressure trial", "role": "Required", "role_reason": "Needed to avoid inheriting a related body-fat registration as a direct blood-pressure plan or declaring selective reporting without evidence.", "application_exception": "Do not fill facts unverified in the retained material with evidence about other lotus parts, formulations, populations or endpoints. Unverified material does not prove an effect of 0 or the worldwide absence of research.", "criterion": "Compare registration/protocol, analysis plan and reports for direct blood-pressure endpoints, times and analyses; verify reasons for changes.", "basis": "Existing method principles distinguish population, plant part, manufacture, drinking exposure, comparator, timing, denominators, missingness, measurement, between-group effects, intervals, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.", "condition_origin": "These conditions for lotus leaf tea/hot-water infusion and systolic blood pressure in adults with hypertension 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 planned and reported endpoints/times; preserve unfavorable and null results as well.", "current_reports": [ "S01", "S02" ], "existence": "Retained bilingual research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material have not been separately established.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.", "observation": "The current NCT04651023 is linked to the excluded Ye body-fat trial. Plans, reports and amendments for a direct blood-pressure trial are unverified.", "condition_status": "Unverified", "status_reason": "Material for comparing a direct prespecified plan is absent. Do not declare nonregistration, selective reporting or worldwide absence of registration.", "missingness": "Material for comparing a direct prespecified plan is absent. Do not declare nonregistration, selective reporting or worldwide absence of registration.", "uncertainty": "Material for comparing a direct prespecified plan is absent. Do not declare nonregistration, selective reporting or worldwide absence of registration. No new effect, interval, denominator, incidence or grade was calculated or reassessed.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "Registration, protocol, analysis plan, complete results and amendment reasons for the direct blood-pressure trial" }, { "item_id": "N20", "question_type": "Evidence condition", "question": "Is the same direct blood-pressure comparison verified in other independent study families?", "needed": "Direct blood-pressure trial family identities, registration, institutions, populations and result-link table", "role": "Required", "role_reason": "Needed to avoid turning report counts or mechanistic studies into independent replications of direct efficacy.", "application_exception": "Do not fill facts unverified in the retained material with evidence about other lotus parts, formulations, populations or endpoints. Unverified material does not prove an effect of 0 or the worldwide absence of research.", "criterion": "Verify eligible-family populations, drinking exposures, blood-pressure outcomes, comparators, times and report links to distinguish replication from recitation.", "basis": "Existing method principles distinguish population, plant part, manufacture, drinking exposure, comparator, timing, denominators, missingness, measurement, between-group effects, intervals, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.", "condition_origin": "These conditions for lotus leaf tea/hot-water infusion and systolic blood pressure in adults with hypertension 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 eligibility by family; do not count reports/registration from the same trial more than once.", "current_reports": [ "S01", "S02" ], "existence": "Retained bilingual research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material have not been separately established.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.", "observation": "The retained bibliography contains 2 reports in different contexts: a body-fat report and an in vitro report. Replication information for directly eligible blood-pressure families is unverified.", "condition_status": "Unverified", "status_reason": "No material establishes direct families or replication. Do not count the 2 reports as 2 blood-pressure trials or sum them into unique participant counts.", "missingness": "No material establishes direct families or replication. Do not count the 2 reports as 2 blood-pressure trials or sum them into unique participant counts.", "uncertainty": "No material establishes direct families or replication. Do not count the 2 reports as 2 blood-pressure trials or sum them into unique participant counts. No new effect, interval, denominator, incidence or grade was calculated or reassessed.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "Direct blood-pressure trial family identities, registration, institutions, populations and result-link table" }, { "item_id": "N21", "question_type": "Evidence condition", "question": "Was the Ye body-fat report retained separately from direct blood-pressure efficacy?", "needed": "Ye report title, population, body-fat endpoint, formulation, exclusion reason and original locations", "role": "Required", "role_reason": "Needed to retain related human material without upgrading effects outside the question into direct evidence.", "application_exception": "Successful record separation does not satisfy the direct-comparison requirement. Direct blood-pressure material remains unverified in N02 and the other actual-data questions.", "criterion": "Preserve both the related formulation and the exclusion reason based on mismatched population, effect and endpoint.", "basis": "Existing method principles distinguish population, plant part, manufacture, drinking exposure, comparator, timing, denominators, missingness, measurement, between-group effects, intervals, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.", "condition_origin": "These conditions for lotus leaf tea/hot-water infusion and systolic blood pressure in adults with hypertension 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 related reports are added, compare matching and mismatched aspects of the question separately.", "current_reports": [ "S01" ], "existence": "Retained bilingual research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material have not been separately established.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.", "observation": "The Ye report concerns body fat after a lotus-leaf hot-water-extract beverage. The original record contains no blood-pressure efficacy result; it retains the similar-formulation context and exclusion for population, effect and endpoint mismatch.", "condition_status": "Met", "status_reason": "This item asks about retaining the related report’s role and exclusion reason. It does not assess verification of body-fat or direct blood-pressure effects.", "missingness": "None within this narrow record scope.", "uncertainty": "None within this narrow record scope. No new effect, interval, denominator, incidence or grade was calculated or reassessed.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "Ye report title, population, body-fat endpoint, formulation, exclusion reason and original locations" }, { "item_id": "N22", "question_type": "Evidence condition", "question": "Were Ye’s 95 and 60 retained in their original denominator roles?", "needed": "Ye’s original denominator description and population/endpoint locations", "role": "Required", "role_reason": "Needed to avoid converting allocation counts into analysis counts or denominators for other results.", "application_exception": "Do not newly calculate withdrawal counts, rates or causes from the difference between 95 and 60. Do not infer absent flowcharts or hypertension subgroups.", "criterion": "Retain allocation of 95 and analysis of 60 overweight completers as distinct body-fat report denominators; do not use them as direct blood-pressure analysis n.", "basis": "Existing method principles distinguish population, plant part, manufacture, drinking exposure, comparator, timing, denominators, missingness, measurement, between-group effects, intervals, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.", "condition_origin": "These conditions for lotus leaf tea/hot-water infusion and systolic blood pressure in adults with hypertension 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 further flowchart and analysis material is obtained, compare each denominator’s role without synthesizing a new withdrawal rate.", "current_reports": [ "S01" ], "existence": "Retained bilingual research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material have not been separately established.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.", "observation": "The original description is 95 allocated participants and 60 overweight completers analyzed. Both figures belong to the body-fat report and were not used as direct hypertension/systolic-blood-pressure denominators.", "condition_status": "Met", "status_reason": "The original denominator roles are retained separately. This does not establish the validity of Ye’s whole analysis or verify direct blood-pressure n.", "missingness": "None within this narrow record scope.", "uncertainty": "None within this narrow record scope. No new effect, interval, denominator, incidence or grade was calculated or reassessed.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "Ye’s original denominator description and population/endpoint locations" }, { "item_id": "N23", "question_type": "Evidence condition", "question": "Is equivalence between the body-fat test beverage and hypertension-targeted lotus leaf tea verified?", "needed": "Manufacture, composition, raw-material/extract quantity and intake for both formulations, plus direct blood-pressure population data", "role": "Required", "role_reason": "A similar-formulation description does not prove the same product or exposure.", "application_exception": "Do not fill facts unverified in the retained material with evidence about other lotus parts, formulations, populations or endpoints. Unverified material does not prove an effect of 0 or the worldwide absence of research.", "criterion": "Verify manufacture, composition, exposure and application to a direct population for the 1–2 g hot-water extract/400 mL test beverage and the selected tea/infusion.", "basis": "Existing method principles distinguish population, plant part, manufacture, drinking exposure, comparator, timing, denominators, missingness, measurement, between-group effects, intervals, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.", "condition_origin": "These conditions for lotus leaf tea/hot-water infusion and systolic blood pressure in adults with hypertension 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 formulation and exposure equivalence using material; retain unverified application to ordinary tea.", "current_reports": [ "S01" ], "existence": "Retained bilingual research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material have not been separately established.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.", "observation": "The original key explanation specifies that a 400 mL test beverage with 1–2 g lotus-leaf hot-water extract is neither a hypertension blood-pressure trial nor the same formulation as ordinary tea. Equivalence data are unverified.", "condition_status": "Unverified", "status_reason": "Original beverage figures alone cannot establish equivalence with ordinary tea or direct blood-pressure exposure.", "missingness": "Original beverage figures alone cannot establish equivalence with ordinary tea or direct blood-pressure exposure.", "uncertainty": "Original beverage figures alone cannot establish equivalence with ordinary tea or direct blood-pressure exposure. No new effect, interval, denominator, incidence or grade was calculated or reassessed.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "Manufacture, composition, raw-material/extract quantity and intake for both formulations, plus direct blood-pressure population data" }, { "item_id": "N24", "question_type": "Evidence condition", "question": "Was in vitro ACE material retained separately from human blood-pressure results?", "needed": "In vitro design, participant description, enzyme endpoint and exclusion reason", "role": "Required", "role_reason": "Needed to avoid mixing the existence of a mechanism with a human treatment effect.", "application_exception": "No human participants is a design fact about this in vitro study. It does not mean 0 human lotus-related studies worldwide.", "criterion": "Retain the actual context of plant-part in vitro enzyme inhibition with no human participants; do not convert it into clinical blood-pressure figures.", "basis": "Existing method principles distinguish population, plant part, manufacture, drinking exposure, comparator, timing, denominators, missingness, measurement, between-group effects, intervals, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.", "condition_origin": "These conditions for lotus leaf tea/hot-water infusion and systolic blood pressure in adults with hypertension 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": "Connect mechanistic and clinical material by result type; examine human effect direction and magnitude using separate direct material.", "current_reports": [ "S02" ], "existence": "Retained bilingual research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material have not been separately established.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.", "observation": "The second report is an in vitro ACE-inhibition experiment across plant parts, recorded as having no human participants, an in vitro enzyme-inhibition endpoint and no human blood-pressure result. Its exclusion as mechanistic/in vitro material is retained.", "condition_status": "Met", "status_reason": "This item asks about distinguishing and retaining the study context. It does not verify in vitro precision or a human blood-pressure reduction.", "missingness": "None within this narrow record scope.", "uncertainty": "None within this narrow record scope. No new effect, interval, denominator, incidence or grade was calculated or reassessed.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "In vitro design, participant description, enzyme endpoint and exclusion reason" }, { "item_id": "N25", "question_type": "Evidence condition", "question": "To what extent are funding and author interests in the related reports verified?", "needed": "Study-funding, product-provision, employment, patent and conflict-of-interest sections for each report", "role": "Supplementary; required for interpreting independence", "role_reason": "Needed to avoid treating academic classification as proof of independent funding or industry support as automatic invalidation.", "application_exception": "Do not fill facts unverified in the retained material with evidence about other lotus parts, formulations, populations or endpoints. Unverified material does not prove an effect of 0 or the worldwide absence of research.", "criterion": "Verify actual study funding, product provision, employment, patents and interest disclosures in each report’s original material. Specify the funding/independence scope; category descriptions alone remain partial information.", "basis": "Existing method principles distinguish population, plant part, manufacture, drinking exposure, comparator, timing, denominators, missingness, measurement, between-group effects, intervals, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.", "condition_origin": "These conditions for lotus leaf tea/hot-water infusion and systolic blood pressure in adults with hypertension 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 funding and interest sections report by report; examine direct blood-pressure trial independence separately.", "current_reports": [ "S01", "S02" ], "existence": "Retained bilingual research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material have not been separately established.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.", "observation": "The Ye record describes industry sponsorship and company-employee authors. The ACE record describes academic research, while its retained English field explicitly leaves the actual funding source unverified. Detailed disclosures/funding scope remain unverified.", "condition_status": "Partly verified", "status_reason": "Some reported categories are available, but funding, product provision and complete disclosures remain unverified. Direct blood-pressure independence is also not established.", "missingness": "Some reported categories are available, but funding, product provision and complete disclosures remain unverified. Direct blood-pressure independence is also not established.", "uncertainty": "Some reported categories are available, but funding, product provision and complete disclosures remain unverified. Direct blood-pressure independence is also not established. No new effect, interval, denominator, incidence or grade was calculated or reassessed.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "Study-funding, product-provision, employment, patent and conflict-of-interest sections for each report" }, { "item_id": "N26", "question_type": "Evidence condition", "question": "Can harm collection, discontinuations and denominators for the same population and drink be verified?", "needed": "AE definitions, collection, exposure/follow-up, denominators and discontinuation data for the same population/formulation", "role": "Supplementary; required for interpreting harms/safety", "role_reason": "Needed to avoid turning unverified direct efficacy or absent harm figures into safety or 0 events.", "application_exception": "This table asks about blood-pressure comparisons. Harm material is not always mandatory for efficacy, but the gap must remain when making safety claims.", "criterion": "Verify actual exposure, follow-up, event definitions, collection, discontinuations, denominators by group and harm records in adults with hypertension.", "basis": "Existing method principles distinguish population, plant part, manufacture, drinking exposure, comparator, timing, denominators, missingness, measurement, between-group effects, intervals, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.", "condition_origin": "These conditions for lotus leaf tea/hot-water infusion and systolic blood pressure in adults with hypertension 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": "Examine efficacy and harm results separately; compare collection scope and missingness.", "current_reports": [ "S01", "S02" ], "existence": "Retained bilingual research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material have not been separately established.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.", "observation": "The original safety label is Caution. The retained record states that eligible trials were not available to establish hypertension-patient dose, long-term safety, special populations or concomitant interactions. Events, discontinuations, denominators and collection methods are unverified.", "condition_status": "Unverified", "status_reason": "Without harm-collection material for the same exposure/population, safety or incidence cannot be judged. Do not use counts in the two related reports as harm denominators.", "missingness": "Without harm-collection material for the same exposure/population, safety or incidence cannot be judged. Do not use counts in the two related reports as harm denominators.", "uncertainty": "Without harm-collection material for the same exposure/population, safety or incidence cannot be judged. Do not use counts in the two related reports as harm denominators. No new effect, interval, denominator, incidence or grade was calculated or reassessed.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "AE definitions, collection, exposure/follow-up, denominators and discontinuation data for the same population/formulation" }, { "item_id": "N27", "question_type": "Evidence condition", "question": "Are direct data available for vulnerable populations and concomitant-drug interactions?", "needed": "Population-specific exposure, baseline risk, concomitant medicines, interactions and follow-up material", "role": "Supplementary; required for safety interpretation in the corresponding population/concomitant use", "role_reason": "Needed to avoid treating single oral tea as proof of safety across all populations and drug combinations.", "application_exception": "Do not fill facts unverified in the retained material with evidence about other lotus parts, formulations, populations or endpoints. Unverified material does not prove an effect of 0 or the worldwide absence of research.", "criterion": "Verify actual populations, exposures and outcomes for pregnancy, lactation, liver/kidney disease and concomitant antihypertensive/glucose-lowering medicines.", "basis": "Existing method principles distinguish population, plant part, manufacture, drinking exposure, comparator, timing, denominators, missingness, measurement, between-group effects, intervals, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.", "condition_origin": "These conditions for lotus leaf tea/hot-water infusion and systolic blood pressure in adults with hypertension 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": "Examine special populations and concomitant use with separate eligibility; do not extrapolate from general participants.", "current_reports": [ "S01", "S02" ], "existence": "Retained bilingual research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material have not been separately established.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.", "observation": "The original safety explanation specifies gaps for pregnancy, lactation, liver/kidney disease and antihypertensive or glucose-lowering drug interactions. Actual separate material is not retained.", "condition_status": "Unverified", "status_reason": "No material establishes safety in populations/interactions outside the selected blood-pressure question. Do not create personal dosing or medication-replacement instructions.", "missingness": "No material establishes safety in populations/interactions outside the selected blood-pressure question. Do not create personal dosing or medication-replacement instructions.", "uncertainty": "No material establishes safety in populations/interactions outside the selected blood-pressure question. Do not create personal dosing or medication-replacement instructions. No new effect, interval, denominator, incidence or grade was calculated or reassessed.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "Population-specific exposure, baseline risk, concomitant medicines, interactions and follow-up material" }, { "item_id": "N28", "question_type": "Evidence condition", "question": "Is cardiovascular-event prevention assessed as a mandatory endpoint in this blood-pressure table?", "needed": "Direct event, comparator, follow-up and denominator data if an extension claim is made", "role": "Supplementary; required for clinical-event extensions", "role_reason": "Needed to distinguish a numerical-change question from event-prevention or medication-replacement questions.", "application_exception": "Do not always require event material. Not applicable is limited to the current extension scope; it does not establish absent event effects or safety.", "criterion": "When the selected claim is limited to systolic-blood-pressure comparison, treat event prevention as a separate direct claim rather than an always-mandatory blood-pressure endpoint.", "basis": "Existing method principles distinguish population, plant part, manufacture, drinking exposure, comparator, timing, denominators, missingness, measurement, between-group effects, intervals, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.", "condition_origin": "These conditions for lotus leaf tea/hot-water infusion and systolic blood pressure in adults with hypertension 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 event extension is requested, examine a separate independent boundary and required material.", "current_reports": [ "S01", "S02" ], "existence": "Retained bilingual research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material have not been separately established.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.", "observation": "The original claim here is reduced systolic blood pressure. Cardiovascular-event prevention, mortality and medication replacement are not added as endpoints of this table.", "condition_status": "Not applicable", "status_reason": "No event-prevention claim was assigned, so this extension obligation is Not applicable. Direct blood-pressure missingness was not changed to Not applicable.", "missingness": "No event-prevention claim was assigned, so this extension obligation is Not applicable. Direct blood-pressure missingness was not changed to Not applicable.", "uncertainty": "No event-prevention claim was assigned, so this extension obligation is Not applicable. Direct blood-pressure missingness was not changed to Not applicable. No new effect, interval, denominator, incidence or grade was calculated or reassessed.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "Direct event, comparator, follow-up and denominator data if an extension claim is made" }, { "item_id": "N29", "question_type": "Evidence condition", "question": "Does this table establish an optimal dose or persistence after discontinuation?", "needed": "Direct dose comparisons, post-discontinuation follow-up and prespecified subgroup material if an extension is claimed", "role": "Supplementary; required for dose/persistence extensions", "role_reason": "Needed to avoid confusing unverified main-trial dose with unrequested optimal-dose/persistence claims.", "application_exception": "Do not remove the need for actual main-trial dose/duration. Do not create arbitrary minimum-dose, duration or subgroup obligations.", "criterion": "If the original claim does not include dose optimization or post-discontinuation comparisons, do not add those judgments. Actual main-trial dose and duration remain separately required.", "basis": "Existing method principles distinguish population, plant part, manufacture, drinking exposure, comparator, timing, denominators, missingness, measurement, between-group effects, intervals, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.", "condition_origin": "These conditions for lotus leaf tea/hot-water infusion and systolic blood pressure in adults with hypertension 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": "Examine direct comparisons and follow-up within a new independent boundary for each extension question.", "current_reports": [ "S01", "S02" ], "existence": "Retained bilingual research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material have not been separately established.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.", "observation": "This table concerns systolic-blood-pressure comparisons; it does not establish an optimal dose, post-discontinuation persistence or all subgroup effects. Actual direct dose and duration remain unverified in N05 and N06.", "condition_status": "Not applicable", "status_reason": "Optimal dose and persistence are outside the original claim; only that extension obligation is Not applicable. Direct-trial dose/duration gaps remain.", "missingness": "Optimal dose and persistence are outside the original claim; only that extension obligation is Not applicable. Direct-trial dose/duration gaps remain.", "uncertainty": "Optimal dose and persistence are outside the original claim; only that extension obligation is Not applicable. Direct-trial dose/duration gaps remain. No new effect, interval, denominator, incidence or grade was calculated or reassessed.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "Direct dose comparisons, post-discontinuation follow-up and prespecified subgroup material if an extension is claimed" }, { "item_id": "N30", "question_type": "Evidence condition", "question": "Were retained summaries actually read distinguished from external-material reading status?", "needed": "Actual reading scope, original locations, file fingerprints and reading history for each material", "role": "Required", "role_reason": "Needed to avoid treating the presence of a URL, PMID, PMCID or NCT as successful reading of external full text.", "application_exception": "External access not attempted does not mean inaccessible. Summary-read badges refer only to exact retained locations and file fingerprints.", "criterion": "Separate actual reading of the retained summary from unattempted/unread external bibliography, abstracts, full papers and registration for each material.", "basis": "Existing method principles distinguish population, plant part, manufacture, drinking exposure, comparator, timing, denominators, missingness, measurement, between-group effects, intervals, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.", "condition_origin": "These conditions for lotus leaf tea/hot-water infusion and systolic blood pressure in adults with hypertension 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 access is actually performed, record a separate event, date and acquired scope, then update the badge.", "current_reports": [ "S01", "S02" ], "existence": "Retained bilingual research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material have not been separately established.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.", "observation": "The retained review records reading the full current input and designated locations for this item. External PubMed, paper, PMC, trial-registration and new method full texts were not accessed, acquired or read.", "condition_status": "Met", "status_reason": "This narrow distinction matches the actions recorded in the retained review. It does not establish verification of external-material contents.", "missingness": "None within this narrow record scope.", "uncertainty": "None within this narrow record scope. No new effect, interval, denominator, incidence or grade was calculated or reassessed.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "Actual reading scope, original locations, file fingerprints and reading history for each material" }, { "item_id": "N31", "question_type": "Evidence condition", "question": "Are historical reading levels and actual access dates of original materials verified report by report?", "needed": "Report-specific original-material access, acquisition, reading level, actual dates and material-type records", "role": "Required", "role_reason": "Needed to avoid issuing current or historical full-text reading status solely from dates or bibliography links.", "application_exception": "Do not fill facts unverified in the retained material with evidence about other lotus parts, formulations, populations or endpoints. Unverified material does not prove an effect of 0 or the worldwide absence of research.", "criterion": "Verify each original material’s access level/date or actual access log; distinguish them from global review and correction dates.", "basis": "Existing method principles distinguish population, plant part, manufacture, drinking exposure, comparator, timing, denominators, missingness, measurement, between-group effects, intervals, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.", "condition_origin": "These conditions for lotus leaf tea/hot-water infusion and systolic blood pressure in adults with hypertension 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 original access history is added, compare the included document’s history separately from its underlying original materials.", "current_reports": [ "S01", "S02" ], "existence": "Retained bilingual research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material have not been separately established.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.", "observation": "The two citations have no individual access level or access date. The original review date is 2026-09-08 and the English correction date is 2026-09-14. Report-specific actual access dates and historical full-text access remain unrecorded.", "condition_status": "Unverified", "status_reason": "Actual report-specific access and dates cannot be verified because they are absent from the original material. Do not inherit global dates as individual reading dates.", "missingness": "Actual report-specific access and dates cannot be verified because they are absent from the original material. Do not inherit global dates as individual reading dates.", "uncertainty": "Actual report-specific access and dates cannot be verified because they are absent from the original material. Do not inherit global dates as individual reading dates. No new effect, interval, denominator, incidence or grade was calculated or reassessed.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "Report-specific original-material access, acquisition, reading level, actual dates and material-type records" }, { "item_id": "N32", "question_type": "Evidence condition", "question": "To what extent are the scope and currency of the retained search record verified?", "needed": "Original search dates, strings, result lists, selection/exclusion records and registration-check scope", "role": "Required", "role_reason": "Needed to avoid expanding one search-record sentence into a complete current literature review or proof of worldwide research absence.", "application_exception": "Do not fill facts unverified in the retained material with evidence about other lotus parts, formulations, populations or endpoints. Unverified material does not prove an effect of 0 or the worldwide absence of research.", "criterion": "Verify original search dates, complete search strings, result lists and selection/exclusion procedures to reproduce the search for directly eligible comparisons. Databases and partial keywords alone require distinguishing verified parts from gaps.", "basis": "Existing method principles distinguish population, plant part, manufacture, drinking exposure, comparator, timing, denominators, missingness, measurement, between-group effects, intervals, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.", "condition_origin": "These conditions for lotus leaf tea/hot-water infusion and systolic blood pressure in adults with hypertension 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": "In subsequent updates, preserve search/selection histories separately and limit absence wording to checked scope and dates.", "current_reports": [ "S01", "S02" ], "existence": "Retained bilingual research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material have not been separately established.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.", "observation": "The original research-review description records PubMed/ClinicalTrials.gov combinations of Nelumbo/lotus leaf/tea/infusion/hypertension/blood pressure, NCT04651023, and animal/in vitro exclusions. Exact searches, result lists and search dates are absent from the current input; no new search was conducted.", "condition_status": "Partly verified", "status_reason": "Original databases, keywords and some exclusion context are verified, but reproducible complete searching, selection scope and currency are not.", "missingness": "Original databases, keywords and some exclusion context are verified, but reproducible complete searching, selection scope and currency are not.", "uncertainty": "Original databases, keywords and some exclusion context are verified, but reproducible complete searching, selection scope and currency are not. No new effect, interval, denominator, incidence or grade was calculated or reassessed.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "Original search dates, strings, result lists, selection/exclusion records and registration-check scope" }, { "item_id": "N33", "question_type": "Evidence condition", "question": "Were the original ?, unrecorded values and human-study absence flag distinguished from related human material?", "needed": "Original grade, score, axes, related human evidence, direct boundary and locations of absence wording", "role": "Required", "role_reason": "Needed to retain the original status without interpreting an absence flag as worldwide human-evidence absence or an effect of 0.", "application_exception": "Do not import absent evidence-status, editorial-review, material-list, study-family or evidence-cutoff fields from adjacent cases. Retain absent, unrecorded, false and empty-list states separately.", "criterion": "Retain the original grade ?, unrecorded score/axes and true human-study absence flag; separately explain the related human body-fat trial and unverified direct blood-pressure material.", "basis": "Existing method principles distinguish population, plant part, manufacture, drinking exposure, comparator, timing, denominators, missingness, measurement, between-group effects, intervals, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.", "condition_origin": "These conditions for lotus leaf tea/hot-water infusion and systolic blood pressure in adults with hypertension 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 the manuscript is corrected, retain whole before/after versions and event reasons; distinguish verdict changes from changes in table attribution.", "current_reports": [ "S01", "S02" ], "existence": "Retained bilingual research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material have not been separately established.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.", "observation": "The original grade is ?, the score and evidence axes are unrecorded, and the human-study absence flag is true. These original values are retained. The related Ye human body-fat trial exists, while direct blood-pressure comparisons remain unverified within the retained scope.", "condition_status": "Met", "status_reason": "This item asks about retaining original values and interpretation boundaries; that record was completed. No clinical regrading of the flag or verification of 0 studies worldwide was performed.", "missingness": "None within this narrow record scope.", "uncertainty": "None within this narrow record scope. No new effect, interval, denominator, incidence or grade was calculated or reassessed.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "Original grade, score, axes, related human evidence, direct boundary and locations of absence wording" }, { "item_id": "N34", "question_type": "Evidence condition", "question": "Were the English correction event and unchanged original-verdict scope retained?", "needed": "Before/after correction versions, change areas, event date and unchanged-grade record", "role": "Required", "role_reason": "Needed to avoid converting a translation/wording correction into new clinical evidence or verdict validation.", "application_exception": "If the whole historical pre-correction manuscript is absent from this input, do not claim new access/comparison. This concerns retention of the original correction record.", "criterion": "Connect the original record of the 2026-09-14 correction of 16 English evidence-table fields with retention of grade, score, citations and verdict date without new research or regrading.", "basis": "Existing method principles distinguish population, plant part, manufacture, drinking exposure, comparator, timing, denominators, missingness, measurement, between-group effects, intervals, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.", "condition_origin": "These conditions for lotus leaf tea/hot-water infusion and systolic blood pressure in adults with hypertension 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": "For later corrections, retain the whole original and record wording, added evidence and verdict changes as separate events.", "current_reports": [ "S01", "S02" ], "existence": "Retained bilingual research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material have not been separately established.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.", "observation": "The original correction record states that on 2026-09-14,16 placeholder fields in the English evidence table were replaced with concrete English matching the retained Korean, without new research or regrading; ?, score, citations and verdict date were retained.", "condition_status": "Met", "status_reason": "The original correction event record and retained scope are preserved. Historical external full-text checking or new clinical certification is not reissued.", "missingness": "None within this narrow record scope.", "uncertainty": "None within this narrow record scope. No new effect, interval, denominator, incidence or grade was calculated or reassessed.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "Before/after correction versions, change areas, event date and unchanged-grade record" }, { "item_id": "N35", "question_type": "Evidence condition", "question": "Can the related reports’ identifiers and study-family links actually be verified?", "needed": "Original-paper/registration identity comparisons and actual study-family/result links for each report", "role": "Required", "role_reason": "Needed to avoid counting related reports, registration and bibliography entries as independent blood-pressure trials or new participant families.", "application_exception": "S01/S02 are local bibliography-array tracking IDs, not original material-ID keys. Do not create new original-material collections from absent native material/study-family lists.", "criterion": "Compare actual report title, PMID, DOI, PMCID and NCT identities and study/endpoint links against original papers/registration. Local identifiers alone remain partial information with the uncompared scope explicit.", "basis": "Existing method principles distinguish population, plant part, manufacture, drinking exposure, comparator, timing, denominators, missingness, measurement, between-group effects, intervals, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.", "condition_origin": "These conditions for lotus leaf tea/hot-water infusion and systolic blood pressure in adults with hypertension 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 identifiers and originals; update same/different/unknown relationships only to the established level.", "current_reports": [ "S01", "S02" ], "existence": "Retained bilingual research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material have not been separately established.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.", "observation": "The retained bibliography identifies Ye 2022 with PMID 34852695, DOI 10.1080/14786419.2021.2010196 and NCT04651023. The other mechanistic report has PMID 37050065 and PMCID PMC10097295. These are retained local links; external identity and registration contents were not compared.", "condition_status": "Partly verified", "status_reason": "Local identifiers and related contexts exist, but external identity and family comparison against original papers/registration remain unverified. Directly eligible blood-pressure family and unique participant counts are unrecorded.", "missingness": "Local identifiers and related contexts exist, but external identity and family comparison against original papers/registration remain unverified. Directly eligible blood-pressure family and unique participant counts are unrecorded.", "uncertainty": "Local identifiers and related contexts exist, but external identity and family comparison against original papers/registration remain unverified. Directly eligible blood-pressure family and unique participant counts are unrecorded. No new effect, interval, denominator, incidence or grade was calculated or reassessed.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "Original-paper/registration identity comparisons and actual study-family/result links for each report" } ], "reports": [ { "report_id": "S01", "title": "Ye 2022 lotus-leaf hot-water-extract beverage/body-fat report", "url": "https://pubmed.ncbi.nlm.nih.gov/34852695/", "report_type": "Retained bibliography/evidence summary of a related human body-fat trial", "existence": "Retained bilingual research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material have not been separately established.", "study_family": "Local context link between a related body-fat report and retained registration identifier; actual original-paper/registration identity and family relationships were not compared in this work.", "observed_result": "Retained report record: Ye 2022 concerns body fat after a lotus-leaf hot-water-extract beverage, with 95 allocated participants and 60 overweight completers analyzed, industry sponsorship and company-employee authors. The endpoint is body-fat percentage; no blood-pressure efficacy result is present in the retained record. The 1–2 g extract/400 mL test beverage is not used as a hypertension dose for ordinary tea. NCT04651023 is the retained identifier of this related trial; its registration original was not read in this work.", "result_level": "A retained body-fat trial summary. Despite a similar formulation, population, effect and endpoint mismatch exclude it as direct blood-pressure evidence. Blood-pressure effects, denominators, dose and intervals were neither verified nor newly calculated.", "source_evidence_date": "2026-09-08", "materials": [ { "material_type": "Retained bilingual research/bibliographic summaries and historical review record", "public_status": "Retained copy acquired; summary read", "access_status": "Retained copy acquired; summary read", "acquired": true, "actually_read": "Stored existing review summary read", "as_of": "2026-10-05", "qualification": "Actual values and locations in the retained summary were read. Distinguish this from external clinical full-text bytes. Past manuscript descriptions of external 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." }, { "material_type": "PubMed bibliography/abstract entry point; actual public availability unverified", "public_status": "Material type recorded; current public availability unverified", "access_status": "External access not attempted; not acquired", "acquired": false, "actually_read": "Not read", "as_of": "2026-10-05", "qualification": "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. Past manuscript descriptions of external 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." }, { "material_type": "Full paper: direct URL and current access scope unverified", "public_status": "Material type recorded; current public availability unverified", "access_status": "External access not attempted; not acquired", "acquired": false, "actually_read": "Not read", "as_of": "2026-10-05", "qualification": "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. Past manuscript descriptions of external 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." }, { "material_type": "Original trial-registration material NCT04651023; direct URL unverified", "public_status": "Material type recorded; current public availability unverified", "access_status": "External access not attempted; not acquired", "acquired": false, "actually_read": "Not read", "as_of": "2026-10-05", "qualification": "The registration identifier is present only in the retained bibliography. A direct registration URL is unrecorded; actual page existence, content, access, acquisition and reading were not established in this work. Past manuscript descriptions of external 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." } ], "links": [ { "label": "PubMed", "url": "https://pubmed.ncbi.nlm.nih.gov/34852695/" } ], "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.", "independent_replication": "These are local context links for S01, a body-fat report, and S02, an in vitro report. Do not count the 2 reports as 2 direct blood-pressure trials. Original-paper/registration family relationships and directly eligible unique study/participant counts remain unverified." }, { "report_id": "S02", "title": "Seasonal/plant-part lotus in vitro ACE report", "url": "https://pubmed.ncbi.nlm.nih.gov/37050065/", "report_type": "Retained bibliography/evidence summary of a plant-part in vitro mechanistic study", "existence": "Retained bilingual research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material have not been separately established.", "study_family": "Local context link for a related in vitro report; original-paper identity and family relationships were not externally compared in this work. This is not a direct blood-pressure trial family.", "observed_result": "Retained report record: Seasonal Effects on Phenolic Contents and In Vitro Health-Promoting Bioactivities of Sacred Lotus is a plant-part in vitro ACE-inhibition study. It records no human participants, an in vitro enzyme-inhibition endpoint and no human blood-pressure result; it was excluded as mechanistic material. Although described as academic research, the retained English record explicitly leaves actual funding unverified. PMID 37050065 and PMCID PMC10097295 are local bibliographic identifiers; actual full-paper comparison was not performed in this work.", "result_level": "In vitro mechanistic material, not a human blood-pressure effect. Distinguish no human participants in this experiment from worldwide absence of human studies; academic research does not prove independent funding.", "source_evidence_date": "2026-09-08", "materials": [ { "material_type": "Retained bilingual research/bibliographic summaries and historical review record", "public_status": "Retained copy acquired; summary read", "access_status": "Retained copy acquired; summary read", "acquired": true, "actually_read": "Stored existing review summary read", "as_of": "2026-10-05", "qualification": "Actual values and locations in the retained summary were read. Distinguish this from external clinical full-text bytes. Past manuscript descriptions of external 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." }, { "material_type": "PubMed bibliography/abstract entry point; actual public availability unverified", "public_status": "Material type recorded; current public availability unverified", "access_status": "External access not attempted; not acquired", "acquired": false, "actually_read": "Not read", "as_of": "2026-10-05", "qualification": "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. Past manuscript descriptions of external 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." }, { "material_type": "Full paper: direct URL and current access scope unverified", "public_status": "Material type recorded; current public availability unverified", "access_status": "External access not attempted; not acquired", "acquired": false, "actually_read": "Not read", "as_of": "2026-10-05", "qualification": "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. Past manuscript descriptions of external 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." } ], "links": [ { "label": "PubMed", "url": "https://pubmed.ncbi.nlm.nih.gov/37050065/" } ], "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.", "independent_replication": "These are local context links for S01, a body-fat report, and S02, an in vitro report. Do not count the 2 reports as 2 direct blood-pressure trials. Original-paper/registration family relationships and directly eligible unique study/participant counts remain unverified." } ], "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 narrow record, identity attribution or action specified by the question is verified. Do not automatically extend this to direct efficacy, precision or safety certification.", "Partly verified": "Some actual information required by the question is verified, but funding, identity, search scope or other verification remains incomplete.", "Unverified": "The actual facts/material required by the question cannot be established from retained material. This does not mean an effect of 0, worldwide research absence or failed access.", "Not reported": "Limited to the explicit material/section actually read. Do not newly assign this status to an entire unread paper.", "Conflicting data": "Used when reports of the same actual fact disagree. Different endpoints or interpretation of an original absence flag are not automatically regraded as conflicting data.", "Not applicable": "Used only with a specific reason for an extension obligation outside the actual scope of the current independent question. It does not replace unverified direct material or unread external material.", "Inaccessible": "Used only for an actual failed-access event. Do not assign it to external access not attempted in this work.", "Review incomplete": "Limited to the scope of external original-material comparisons not yet performed. Do not retrospectively mark completed local-summary content reading as incomplete." }, "study_overlap": { "state": "Unverified", "unique_trial_count": null, "unique_participant_count": null, "reason": "These are local context links for S01, a body-fat report, and S02, an in vitro report. Do not count the 2 reports as 2 direct blood-pressure trials. Original-paper/registration family relationships and directly eligible unique study/participant counts remain unverified." }, "history": [ { "date": "2026-10-28", "kind": "Separation of public-facing pages and materials", "view_version": "1.0", "change": "The public view and materials were prepared from the existing 35 items. No new clinical search, verification-state change or scoring was performed." } ], "language": "en", "translation_date": "2026-10-28" }