{ "schema_version": "chamgap-public-evidence-check-1.0", "public_id": "v3080-main", "verdict_number": "3080", "title": "Whole lotus rhizome or defined lotus-root juice × Reduction of menstrual blood loss in heavy menstrual bleeding", "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 heavy menstrual bleeding. Diagnosis, baseline and selection criteria in an eligible direct trial are unverified", "intervention": "Oral whole edible Nelumbo nucifera rhizome or defined lotus-root juice. Distinguish nodes, carbonized products, other parts and combination prescriptions; actual direct-trial formulation is unverified", "dose": "Actual intake, frequency and adherence linked to an eligible direct heavy-menstrual-bleeding trial are unverified", "comparator": "Actual direct heavy-menstrual-bleeding trial comparator and background treatment are unverified. S01’s cucumber comparator concerns a different antioxidant endpoint", "endpoint": "Intended endpoints are PBAC or objective menstrual blood loss. Actual direct measurements, between-group results, denominators and intervals are unverified", "duration": "Actual direct-trial administration duration, baseline/follow-up menstrual cycles and measurement times are unverified", "excluded_extensions": [ "Do not transfer S01’s antioxidant and DNA-damage markers from an older-adult randomized food-comparison pilot to menstrual-blood-loss results. Exact randomized/completed denominators and actual funding/conflicts are unverified.", "S02’s traditional/preclinical review is not a direct comparative heavy-menstrual-bleeding trial. No participant recruitment by the review itself does not mean no participants in all included human research. Do not transfer records for leaves, nodes, carbonized products or combination prescriptions to clinical efficacy of whole lotus rhizome or juice.", "S03’s 1 reported anaphylaxis case after lotus-root ingestion is a separate safety signal. Actual intake, cooking/juice status, timeline, diagnosis, co-exposures, total exposed denominator and incidence are unverified. No new frequency or causality is calculated or adjudicated.", "Retain the original ?, unrecorded score and Caution. Distinguish food-use experience from therapeutic-amount juice safety; pregnancy, lactation, liver/kidney disease, anticoagulants/antiplatelets and long-term safety are unverified. Do not extend to optimal dose, persistence after stopping, anemia treatment or replacement of standard care." ] }, "requirements": [ { "item_id": "N01", "question_type": "Evidence condition", "question": "Which independent claim does this table address?", "needed": "Identification records for the original claim, plant part, formulation, route, population and endpoint.", "role": "Required", "role_reason": "This prevents different parts and effects of one plant from being merged into the menstrual-blood-loss question.", "application_exception": "If actual trial formulations of defined juice and food become known, retain their differences without inventing new claims from currently unverified combinations.", "criterion": "Link the current original menstrual-blood-loss claim to its population, plant part and route, distinguishing other effects.", "basis": "Existing method principles distinguish population, plant part, processing, formulation, dose, duration, comparator, denominators, missingness, bleeding measurement, between-group analysis, intervals, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.", "condition_origin": "These conditions for oral whole edible lotus rhizome or defined juice and bleeding in adults with heavy menstrual bleeding were developed with knowledge of retained content and frozen before application. This does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.", "proposed_research": "Classify new material by original-claim eligibility and consider a separate table only for an actually different question.", "current_reports": [], "existence": "Retained bilingual research and bibliographic summaries exist. Current existence, public availability, acquisition and reading of external papers, registration, 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 concerns reduced menstrual blood loss in adults with heavy menstrual bleeding who orally consume whole edible lotus rhizome or defined lotus-root juice. Hemostatic claims for leaves, plumule, rhizome nodes, carbonized products and combination prescriptions are excluded.", "condition_status": "Met", "status_reason": "The original claim identity and exclusion boundaries are linked to retained material. This does not verify a direct clinical effect.", "missingness": "The claim boundary is verified. Actual trial formulation, amount, comparator and duration remain unverified in subsequent conditions.", "uncertainty": "Whether the same boundaries can be maintained when direct-trial material is added.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "Identification records for the original claim, plant part, formulation, route, population and endpoint." }, { "item_id": "N02", "question_type": "Evidence condition", "question": "Is the trial intervention whole edible rhizome, distinguished from nodes and carbonized products?", "needed": "Trial-product botanical identity, plant part, processing and manufacturing records.", "role": "Required", "role_reason": "Hemostatic contexts for nodes or carbonized products can otherwise become claims of therapeutic efficacy for whole lotus rhizome.", "application_exception": "Retain traditional records as context; they do not replace identification of the trial-product plant part.", "criterion": "Verify from actual trial part and processing records that the intervention is whole edible Nelumbo nucifera rhizome.", "basis": "Existing method principles distinguish population, plant part, processing, formulation, dose, duration, comparator, denominators, missingness, bleeding measurement, between-group analysis, intervals, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.", "condition_origin": "These conditions for oral whole edible lotus rhizome or defined juice and bleeding in adults with heavy menstrual bleeding were developed with knowledge of retained content and frozen before application. This does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.", "proposed_research": "Compare acquired product documents with trial methods, classifying whole rhizome, nodes and carbonized products separately.", "current_reports": [ "S02" ], "existence": "Retained bilingual research and bibliographic summaries exist. Current existence, public availability, acquisition and reading of external papers, registration, 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 part is explicitly the whole edible underground rhizome, but actual part and processing records for an eligible heavy-menstrual-bleeding trial product are not retained.", "condition_status": "Partly verified", "status_reason": "The intended and excluded parts are known, but actual direct-trial intervention identity is unverified.", "missingness": "Raw-material and processing information for a heavy-menstrual-bleeding trial product is missing. This does not mean other parts are ineffective.", "uncertainty": "Agreement between the current definition and actual trial products.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "Trial-product botanical identity, plant part, processing and manufacturing records." }, { "item_id": "N03", "question_type": "Evidence condition", "question": "Are the direct trial's food or juice formulation and inclusion of other active ingredients verified?", "needed": "Trial-formulation manufacturing, raw-material amount, extraction or juicing conditions, other active ingredients and product-supply records.", "role": "Required", "role_reason": "Results for undefined lotus-root juice or combination prescriptions cannot be attributed to the contribution of whole lotus rhizome alone.", "application_exception": "Do not automatically treat food and juice as equivalent; reconsider applicability when actual specification differences are identified.", "criterion": "Verify manufacturing, content and combination status of the actual administered food or defined juice from original trial material.", "basis": "Existing method principles distinguish population, plant part, processing, formulation, dose, duration, comparator, denominators, missingness, bleeding measurement, between-group analysis, intervals, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.", "condition_origin": "These conditions for oral whole edible lotus rhizome or defined juice and bleeding in adults with heavy menstrual bleeding were developed with knowledge of retained content and frozen before application. This does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.", "proposed_research": "Build trial-specific product specifications distinguishing food, defined juice, other-part extracts and combination prescriptions.", "current_reports": [], "existence": "Retained bilingual research and bibliographic summaries exist. Current existence, public availability, acquisition and reading of external papers, registration, 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 material poses whole food or defined lotus-root juice as the question and states that an eligible trial formulation is unverified. Combination prescriptions are excluded.", "condition_status": "Partly verified", "status_reason": "Permitted formulations in the question are known, but actual product specifications and single-intervention status are unverified.", "missingness": "Manufacturing, content and combination-product information for a direct trial is not retained.", "uncertainty": "Food/juice equivalence and the specific contribution of lotus rhizome.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "Trial-formulation manufacturing, raw-material amount, extraction or juicing conditions, other active ingredients and product-supply records." }, { "item_id": "N04", "question_type": "Evidence condition", "question": "Are direct-comparison participants adults with heavy menstrual bleeding, with diagnosis and baseline status verified?", "needed": "Heavy-menstrual-bleeding diagnostic criteria, participant characteristics, bleeding causes and baseline PBAC or objective blood-loss records.", "role": "Required", "role_reason": "Older antioxidant-trial participants and adults with heavy menstrual bleeding are different populations.", "application_exception": "Retain populations with different diagnoses or bleeding causes as indirect rather than deleting them or declaring no effect.", "criterion": "Verify the actual heavy-menstrual-bleeding definition, age, bleeding causes, baseline menstrual blood loss and inclusion/exclusion criteria.", "basis": "Existing method principles distinguish population, plant part, processing, formulation, dose, duration, comparator, denominators, missingness, bleeding measurement, between-group analysis, intervals, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.", "condition_origin": "These conditions for oral whole edible lotus rhizome or defined juice and bleeding in adults with heavy menstrual bleeding were developed with knowledge of retained content and frozen before application. This does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.", "proposed_research": "Compare participant characteristics with the adult heavy-menstrual-bleeding population; retain separate results or applicability limits for mixed populations.", "current_reports": [ "S01" ], "existence": "Retained bilingual research and bibliographic summaries exist. Current existence, public availability, acquisition and reading of external papers, registration, 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 population is adults with heavy menstrual bleeding. S01 concerns antioxidant outcomes in older adults; diagnosis and baseline characteristics in a direct heavy-menstrual-bleeding trial are unverified.", "condition_status": "Partly verified", "status_reason": "Only the intended population name is known; actual eligible-population diagnosis, baseline and selection information are unverified.", "missingness": "Diagnostic criteria and baseline bleeding information for the direct population are missing.", "uncertainty": "Applicability to particular causes and severities of heavy menstrual bleeding.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "Heavy-menstrual-bleeding diagnostic criteria, participant characteristics, bleeding causes and baseline PBAC or objective blood-loss records." }, { "item_id": "N05", "question_type": "Evidence condition", "question": "Is there a comparison of added lotus rhizome against an appropriate control on the same background treatment?", "needed": "Direct-trial group interventions and controls, standard treatment, co-treatment and rescue-treatment records.", "role": "Required", "role_reason": "The contribution of lotus rhizome cannot be determined without actual comparators and background treatments.", "application_exception": "Do not require placebo as the only eligible control; specify control conditions and the actual effect of interest.", "criterion": "Verify actual comparators, common treatments and the contrast of interest in a heavy-menstrual-bleeding trial.", "basis": "Existing method principles distinguish population, plant part, processing, formulation, dose, duration, comparator, denominators, missingness, bleeding measurement, between-group analysis, intervals, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.", "condition_origin": "These conditions for oral whole edible lotus rhizome or defined juice and bleeding in adults with heavy menstrual bleeding were developed with knowledge of retained content and frozen before application. This does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.", "proposed_research": "Compare group interventions to define the contrast for adding lotus rhizome and examine other treatment differences separately.", "current_reports": [ "S01" ], "existence": "Retained bilingual research and bibliographic summaries exist. Current existence, public availability, acquisition and reading of external papers, registration, 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 heavy-menstrual-bleeding trial comparator is unverified in retained material. S01's cucumber comparator addresses a different antioxidant-marker question.", "condition_status": "Unverified", "status_reason": "Material verifying the direct menstrual-blood-loss comparator and balance of treatments is missing.", "missingness": "An actual between-group contrast is unavailable, so S01's food comparator cannot serve as a heavy-menstrual-bleeding comparator.", "uncertainty": "The comparative effect of added lotus rhizome and the contribution of other treatments.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "Direct-trial group interventions and controls, standard treatment, co-treatment and rescue-treatment records." }, { "item_id": "N06", "question_type": "Evidence condition", "question": "Are actual lotus-rhizome or juice intake and adherence linked to menstrual-blood-loss material verified?", "needed": "Group-specific raw-material amount, juice concentration, intake frequency, actual consumption and adherence records.", "role": "Required", "role_reason": "Food-use experience or amounts from other studies cannot establish actual exposure to therapeutic juice.", "application_exception": "Do not invent a therapeutic or minimum amount; keep doses for other endpoints separate.", "criterion": "Verify nominal and actual intake, frequency and adherence in a direct trial.", "basis": "Existing method principles distinguish population, plant part, processing, formulation, dose, duration, comparator, denominators, missingness, bleeding measurement, between-group analysis, intervals, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.", "condition_origin": "These conditions for oral whole edible lotus rhizome or defined juice and bleeding in adults with heavy menstrual bleeding were developed with knowledge of retained content and frozen before application. This does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.", "proposed_research": "Link product specifications and consumption records to examine exposure corresponding to the direct endpoint.", "current_reports": [], "existence": "Retained bilingual research and bibliographic summaries exist. Current existence, public availability, acquisition and reading of external papers, registration, 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 an eligible human heavy-menstrual-bleeding trial is unverified. Safety considerations for food use and repeated therapeutic-amount juice consumption are distinguished.", "condition_status": "Unverified", "status_reason": "Actual intake, frequency and adherence linked to direct bleeding results are unverified.", "missingness": "Original material establishing exposure to the therapeutic formulation is missing.", "uncertainty": "Dose-related effects, harms and applicability.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "Group-specific raw-material amount, juice concentration, intake frequency, actual consumption and adherence records." }, { "item_id": "N07", "question_type": "Evidence condition", "question": "Are administration duration, menstrual-blood measurement cycles and visit times verified?", "needed": "Administration and follow-up schedules, with baseline and follow-up cycle bleeding measurements.", "role": "Required", "role_reason": "Menstrual-blood-loss results cannot be compared as the same outcome without measurement cycles and exposure duration.", "application_exception": "Do not invent an appropriate minimum duration or required cycle count. Long-term persistence is a separate extension.", "criterion": "Verify direct-trial administration duration, baseline and follow-up menstrual cycles and measurement times.", "basis": "Existing method principles distinguish population, plant part, processing, formulation, dose, duration, comparator, denominators, missingness, bleeding measurement, between-group analysis, intervals, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.", "condition_origin": "These conditions for oral whole edible lotus rhizome or defined juice and bleeding in adults with heavy menstrual bleeding were developed with knowledge of retained content and frozen before application. This does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.", "proposed_research": "Link visits and menstrual-cycle timelines to assess whether contrasts concern matching times.", "current_reports": [], "existence": "Retained bilingual research and bibliographic summaries exist. Current existence, public availability, acquisition and reading of external papers, registration, 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": "Eligible-trial duration and bleeding-measurement cycles are unverified in retained material.", "condition_status": "Unverified", "status_reason": "Without a direct-trial administration and measurement schedule, effects within matching menstrual cycles cannot be assessed.", "missingness": "Administration duration, measurement cycles and follow-up material are missing.", "uncertainty": "Matching duration and persistence after stopping.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "Administration and follow-up schedules, with baseline and follow-up cycle bleeding measurements." }, { "item_id": "N08", "question_type": "Evidence condition", "question": "Are the direct heavy-menstrual-bleeding trial design, allocation, concealment and baseline balance verified?", "needed": "Direct-trial methods, allocation procedures, group baseline tables and design documents.", "role": "Required", "role_reason": "Randomization in a related antioxidant RCT does not establish a comparative menstrual-blood-loss design.", "application_exception": "Retain nonrandomized material with design limits; do not replace unverified design with non-applicability of crossover or cluster designs.", "criterion": "Verify the actual comparative design, allocation procedures, concealment and baseline balance for the direct endpoint.", "basis": "Existing method principles distinguish population, plant part, processing, formulation, dose, duration, comparator, denominators, missingness, bleeding measurement, between-group analysis, intervals, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.", "condition_origin": "These conditions for oral whole edible lotus rhizome or defined juice and bleeding in adults with heavy menstrual bleeding were developed with knowledge of retained content and frozen before application. This does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.", "proposed_research": "Compare actual allocation and group baseline information for the endpoint of interest, retaining unverified procedures.", "current_reports": [ "S01" ], "existence": "Retained bilingual research and bibliographic summaries exist. Current existence, public availability, acquisition and reading of external papers, registration, 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": "S01 is recorded as a randomized food-comparison pilot in older adults. The design of an eligible direct comparative menstrual-blood-loss trial is unverified.", "condition_status": "Unverified", "status_reason": "A randomized-trial label for another endpoint cannot provide allocation evidence for the direct efficacy question.", "missingness": "Direct-trial design, allocation, concealment and baseline tables are missing.", "uncertainty": "The scope for assessing confounding or allocation problems.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "Direct-trial methods, allocation procedures, group baseline tables and design documents." }, { "item_id": "N09", "question_type": "Evidence condition", "question": "Are actual PBAC or objective menstrual-blood-loss tools, units and assessment procedures verified?", "needed": "Bleeding-measurement tools and units, assessor procedures, group collection within matching cycles and blinding records.", "role": "Required", "role_reason": "This prevents confusion between an intended endpoint specification and actual measured results.", "application_exception": "Do not automatically convert PBAC to objective loss or judge failure solely because blinding is impossible.", "criterion": "Verify direct-outcome methods, tools, units, scale direction, assessor blinding and collection procedures.", "basis": "Existing method principles distinguish population, plant part, processing, formulation, dose, duration, comparator, denominators, missingness, bleeding measurement, between-group analysis, intervals, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.", "condition_origin": "These conditions for oral whole edible lotus rhizome or defined juice and bleeding in adults with heavy menstrual bleeding were developed with knowledge of retained content and frozen before application. This does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.", "proposed_research": "Link PBAC scores and objective blood loss as separate measures and examine measurement-condition differences.", "current_reports": [ "S02" ], "existence": "Retained bilingual research and bibliographic summaries exist. Current existence, public availability, acquisition and reading of external papers, registration, 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": "Retained material specifies PBAC or objective menstrual blood loss as intended endpoints, but actual tools, units and measurement procedures are unverified.", "condition_status": "Unverified", "status_reason": "Only candidate endpoints are identified; actual measured results and assessment procedures are unverified.", "missingness": "Direct-outcome measurement methods, scales, units and assessment conditions are missing.", "uncertainty": "Distinguishing measurement differences from actual bleeding changes.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "Bleeding-measurement tools and units, assessor procedures, group collection within matching cycles and blinding records." }, { "item_id": "N10", "question_type": "Evidence condition", "question": "Are co-medication, standard treatment, rescue treatment and group-specific changes verified in direct material?", "needed": "Group gynecological treatments, other interventions, rescue treatment, adherence and analytical handling records.", "role": "Required", "role_reason": "Bleeding changes caused by other treatments could otherwise be attributed to lotus-rhizome efficacy.", "application_exception": "There is no need to prohibit all co-treatment; assess it according to the actual effect of interest and group-specific handling.", "criterion": "Verify concurrent treatments, changes, rescue treatment and their handling by group in a menstrual-blood-loss trial.", "basis": "Existing method principles distinguish population, plant part, processing, formulation, dose, duration, comparator, denominators, missingness, bleeding measurement, between-group analysis, intervals, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.", "condition_origin": "These conditions for oral whole edible lotus rhizome or defined juice and bleeding in adults with heavy menstrual bleeding were developed with knowledge of retained content and frozen before application. This does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.", "proposed_research": "Link treatment changes and lotus-rhizome exposure over time to examine factors mixed into the actual contrast of interest.", "current_reports": [], "existence": "Retained bilingual research and bibliographic summaries exist. Current existence, public availability, acquisition and reading of external papers, registration, 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": "Retained material states that lotus rhizome cannot be advertised as a replacement for standard gynecological treatments such as hormonal therapy. Direct-trial common-treatment and rescue-treatment records are missing.", "condition_status": "Unverified", "status_reason": "Advertising boundaries do not replace group co-treatment, change and analysis information.", "missingness": "Actual concurrent treatments and group-specific changes are missing.", "uncertainty": "The sole contribution of lotus rhizome to bleeding changes.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "Group gynecological treatments, other interventions, rescue treatment, adherence and analytical handling records." }, { "item_id": "N11", "question_type": "Evidence condition", "question": "Are randomized, completed and analyzed denominators verified for direct heavy-menstrual-bleeding results?", "needed": "Direct-trial participant flow and analysis counts by group and endpoint.", "role": "Required", "role_reason": "Retained report counts and participants in other human studies are not direct-analysis denominators.", "application_exception": "Do not use the absence of participants recruited by a review or the 1 allergy case as an efficacy denominator for heavy menstrual bleeding.", "criterion": "Distinguish and verify recruited, allocated, completed, measured and analyzed denominators by group for direct results.", "basis": "Existing method principles distinguish population, plant part, processing, formulation, dose, duration, comparator, denominators, missingness, bleeding measurement, between-group analysis, intervals, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.", "condition_origin": "These conditions for oral whole edible lotus rhizome or defined juice and bleeding in adults with heavy menstrual bleeding were developed with knowledge of retained content and frozen before application. This does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.", "proposed_research": "Link recruitment to analysis of the relevant bleeding endpoint without adding participant counts from other reports.", "current_reports": [ "S01", "S02", "S03" ], "existence": "Retained bilingual research and bibliographic summaries exist. Current existence, public availability, acquisition and reading of external papers, registration, 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": "Group denominators for menstrual-blood-loss results are unverified. S01's randomized and completed counts are also unverified, and S03's 1 person is a safety case report.", "condition_status": "Unverified", "status_reason": "Actual analysis counts in an eligible direct trial are missing, preventing assessment of power, precision or total participants.", "missingness": "Direct recruitment, allocation, completion and analysis counts are missing.", "uncertainty": "Denominator attribution and the selected analysis-population scope.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "Direct-trial participant flow and analysis counts by group and endpoint." }, { "item_id": "N12", "question_type": "Evidence condition", "question": "Are missing direct bleeding results, dropout reasons and handling methods verified?", "needed": "Direct-trial group dropout reasons, cycle-specific missing measurements, missing-data handling and sensitivity-analysis records.", "role": "Required", "role_reason": "Actual participant flow and missing-data material are needed to assess whether only completer results remain.", "application_exception": "Do not interpret missing dropout information in related research as no dropout in a direct trial.", "criterion": "Verify missing menstrual-blood-loss measurements, loss to follow-up, exclusion reasons and group missing-data handling.", "basis": "Existing method principles distinguish population, plant part, processing, formulation, dose, duration, comparator, denominators, missingness, bleeding measurement, between-group analysis, intervals, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.", "condition_origin": "These conditions for oral whole edible lotus rhizome or defined juice and bleeding in adults with heavy menstrual bleeding were developed with knowledge of retained content and frozen before application. This does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.", "proposed_research": "Link flow and result tables to examine the direction of missing measurements and actual handling scope.", "current_reports": [], "existence": "Retained bilingual research and bibliographic summaries exist. Current existence, public availability, acquisition and reading of external papers, registration, 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": "An eligible direct trial is unverified, so missing bleeding measurements, loss to follow-up, exclusions and handling methods cannot be verified.", "condition_status": "Unverified", "status_reason": "Direct-trial participant flow and results needed to assess missingness are missing.", "missingness": "Group dropout, missingness and handling information are missing.", "uncertainty": "The influence of missingness on the contrast of interest.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "Direct-trial group dropout reasons, cycle-specific missing measurements, missing-data handling and sensitivity-analysis records." }, { "item_id": "N13", "question_type": "Evidence condition", "question": "Is it verified whether bleeding results estimate between-group final values or changes?", "needed": "Group bleeding values, between-group analysis tables and models, and ITT or adherence-effect definitions.", "role": "Required", "role_reason": "The direction of reduced bleeding alone cannot establish the comparative effect measure or analysis.", "application_exception": "Do not assign ITT, PP or adjusted effects to material that does not specify its analysis.", "criterion": "Verify group order, final-value or change analyses, between-group analysis, adjustment and analysis populations for direct results.", "basis": "Existing method principles distinguish population, plant part, processing, formulation, dose, duration, comparator, denominators, missingness, bleeding measurement, between-group analysis, intervals, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.", "condition_origin": "These conditions for oral whole edible lotus rhizome or defined juice and bleeding in adults with heavy menstrual bleeding were developed with knowledge of 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 question's contrast of interest with actual analyses, separating within-group change from between-group effects.", "current_reports": [ "S02" ], "existence": "Retained bilingual research and bibliographic summaries exist. Current existence, public availability, acquisition and reading of external papers, registration, 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": "Actual between-group analysis and effect definitions for PBAC or objective menstrual blood loss are unverified.", "condition_status": "Unverified", "status_reason": "Without direct values and models, a reduction direction cannot serve as a between-group effect estimate.", "missingness": "Group order, original values, final values or changes, analysis populations and adjustment information are missing.", "uncertainty": "Which comparative effect can be estimated.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "Group bleeding values, between-group analysis tables and models, and ITT or adherence-effect definitions." }, { "item_id": "N14", "question_type": "Evidence condition", "question": "Are direct menstrual-blood-loss effect estimates, variability and confidence intervals verified?", "needed": "Endpoint-specific group result tables, variability types, denominators and between-group estimates and intervals.", "role": "Required", "role_reason": "Significance or a trial label alone cannot establish effect size and precision.", "application_exception": "Do not calculate bleeding effects or intervals from other markers, or infer SD and SE.", "criterion": "Verify direct-comparison measures, units, estimates, denominators, SD or SE and confidence intervals in original material.", "basis": "Existing method principles distinguish population, plant part, processing, formulation, dose, duration, comparator, denominators, missingness, bleeding measurement, between-group analysis, intervals, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.", "condition_origin": "These conditions for oral whole edible lotus rhizome or defined juice and bleeding in adults with heavy menstrual bleeding were developed with knowledge of retained content and frozen before application. This does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.", "proposed_research": "Link estimates to measures, times and denominators, leaving unverified intervals without new calculation.", "current_reports": [ "S01", "S02" ], "existence": "Retained bilingual research and bibliographic summaries exist. Current existence, public availability, acquisition and reading of external papers, registration, 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": "Retained material lacks effect estimates, variability and confidence intervals for an eligible direct bleeding comparison. S02 is also summarized as not providing clinical PBAC or objective-loss results.", "condition_status": "Unverified", "status_reason": "Direct numerical information needed to assess effect size and precision is missing.", "missingness": "The relevant values are unverified in retained summaries. Whole-paper nonreporting has not been newly established.", "uncertainty": "The range and precision of possible effects.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "Endpoint-specific group result tables, variability types, denominators and between-group estimates and intervals." }, { "item_id": "N15", "question_type": "Evidence condition", "question": "Are important differences and patient-related criteria needed to interpret bleeding changes verified?", "needed": "Evidence for important PBAC or objective-blood-loss differences, with the trial's estimates and intervals.", "role": "Required", "role_reason": "Whether bleeding decreases and whether its magnitude matters to patients are different judgments.", "application_exception": "Leave currently undetermined importance criteria as such; do not turn unverified information into a clinically negligible effect.", "criterion": "Verify the relationship between justified important differences for the chosen measure and actual estimated intervals.", "basis": "Existing method principles distinguish population, plant part, processing, formulation, dose, duration, comparator, denominators, missingness, bleeding measurement, between-group analysis, intervals, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.", "condition_origin": "These conditions for oral whole edible lotus rhizome or defined juice and bleeding in adults with heavy menstrual bleeding were developed with knowledge of retained content and frozen before application. This does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.", "proposed_research": "If justified importance criteria become available, compare them with actual intervals without adopting arbitrary minimum effects or sample sizes.", "current_reports": [], "existence": "Retained bilingual research and bibliographic summaries exist. Current existence, public availability, acquisition and reading of external papers, registration, 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 bleeding estimates, intervals and important-difference criteria are unverified in retained material.", "condition_status": "Unverified", "status_reason": "Both effects and importance criteria are missing, preventing comparison of clinical meaning.", "missingness": "Justification of measure-specific important differences and intervals for direct results is missing.", "uncertainty": "Whether bleeding changes are meaningful to patients.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "Evidence for important PBAC or objective-blood-loss differences, with the trial's estimates and intervals." }, { "item_id": "N16", "question_type": "Evidence condition", "question": "Can direct-trial registration, protocol, planned endpoints and actual results be compared?", "needed": "Direct-trial identifiers, original registration, protocol, analysis plan, amendments and actual results.", "role": "Required", "role_reason": "Related bibliographies do not establish a direct trial's advance plan or a selective-reporting comparison.", "application_exception": "Do not turn unacquired registration into confirmed nonregistration or selective reporting, or uniformly require trial registration for reviews and case reports.", "criterion": "Verify an eligible direct trial's identity, registration and plans against actual bleeding endpoints, times and analyses.", "basis": "Existing method principles distinguish population, plant part, processing, formulation, dose, duration, comparator, denominators, missingness, bleeding measurement, between-group analysis, intervals, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.", "condition_origin": "These conditions for oral whole edible lotus rhizome or defined juice and bleeding in adults with heavy menstrual bleeding were developed with knowledge of retained content and frozen before application. This does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.", "proposed_research": "Link trial identity first, then compare planned and actual endpoints, times and analyses, distinguishing unacquired material.", "current_reports": [ "S01", "S02", "S03" ], "existence": "Retained bilingual research and bibliographic summaries exist. Current existence, public availability, acquisition and reading of external papers, registration, 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 registration fields of the three retained evidence records say unverified. An eligible direct trial and its registration and plans are unidentified.", "condition_status": "Unverified", "status_reason": "Missing direct-trial identity and original plans prevent comparison of planned endpoints and analyses with results.", "missingness": "Direct-trial identifiers, registration, protocol and analysis plans have not been acquired.", "uncertainty": "Agreement between advance plans and selected analyses.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "Direct-trial identifiers, original registration, protocol, analysis plan, amendments and actual results." }, { "item_id": "N17", "question_type": "Evidence condition", "question": "Can unique families, duplication and independent replication of direct menstrual-blood-loss trials be verified?", "needed": "Direct-trial identifiers and report links, review included-study lists, recruitment and institution information.", "role": "Required (direct-efficacy replication verification)", "role_reason": "This prevents the three related reports from being counted as three independent heavy-menstrual-bleeding trials.", "application_exception": "Retain reviews and cases in their respective roles without estimating unique direct trials or participant totals. H07 informs only the boundary against re-citing the safety case as replication.", "criterion": "Verify eligible direct-trial identifiers, associated reports, recruited populations and endpoint/time family relationships.", "basis": "Existing method principles distinguish population, plant part, processing, formulation, dose, duration, comparator, denominators, missingness, bleeding measurement, between-group analysis, intervals, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.", "condition_origin": "These conditions for oral whole edible lotus rhizome or defined juice and bleeding in adults with heavy menstrual bleeding were developed with knowledge of retained content and frozen before application. This does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.", "proposed_research": "Link reports and study families, distinguishing re-citation of the same population or results from independent replication.", "current_reports": [ "S01", "S02", "S03" ], "existence": "Retained bilingual research and bibliographic summaries exist. Current existence, public availability, acquisition and reading of external papers, registration, 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": "S01 is a human pilot for another endpoint, S02 a review and S03 a safety case report. Eligible direct bleeding-trial identity is unverified, so unique direct-trial and independent-replication counts remain unrecorded.", "condition_status": "Unverified", "status_reason": "Report roles are distinguished, but material establishing direct-trial families is missing.", "missingness": "Direct trials, families, replication and total unique participants are unverified.", "uncertainty": "Unverified direct replication and duplication through re-citation.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "Direct-trial identifiers and report links, review included-study lists, recruitment and institution information." }, { "item_id": "N18", "question_type": "Evidence condition", "question": "Can favorable, no-difference and unfavorable results for the same direct bleeding question be verified?", "needed": "All relevant direct-trial bleeding result tables, analyses, corrections and opposing reports.", "role": "Required", "role_reason": "A summary lacking clinical results is not an observation of a null effect or equivalence.", "application_exception": "Safety signals differ from null direct-bleeding results; do not extend an unidentified direct trial to a worldwide absence of effect.", "criterion": "Verify actual results regardless of direction for matching intervention, population, bleeding endpoint and time.", "basis": "Existing method principles distinguish population, plant part, processing, formulation, dose, duration, comparator, denominators, missingness, bleeding measurement, between-group analysis, intervals, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.", "condition_origin": "These conditions for oral whole edible lotus rhizome or defined juice and bleeding in adults with heavy menstrual bleeding were developed with knowledge of retained content and frozen before application. This does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.", "proposed_research": "Compare results at matching contrasts and times without turning numerical differences for other questions into conflicts.", "current_reports": [ "S02", "S03" ], "existence": "Retained bilingual research and bibliographic summaries exist. Current existence, public availability, acquisition and reading of external papers, registration, 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": "Retained records describe unidentified direct bleeding trials. The absence of clinical bleeding results in S02 is not evidence of a null effect, and S03's allergy event is safety context.", "condition_status": "Unverified", "status_reason": "Without direct results for the same question, favorable, no-difference and unfavorable between-group outcomes cannot be compared.", "missingness": "Directions, magnitudes and opposing reports for direct bleeding results are unverified.", "uncertainty": "Possible confusion between absence of effect and absence of material.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "All relevant direct-trial bleeding result tables, analyses, corrections and opposing reports." }, { "item_id": "N19", "question_type": "Evidence condition", "question": "Can S01's oxidative and DNA-damage results apply directly to menstrual blood loss?", "needed": "S01 original-trial population, measurements and result tables, with separate direct bleeding material.", "role": "Supplementary (related human-study applicability boundary)", "role_reason": "The existence of human lotus-rhizome research differs from direct heavy-menstrual-bleeding efficacy.", "application_exception": "Older-adult oxidative and DNA-damage markers are not directly applied to the current bleeding question. Not applicable concerns only direct application of this result.", "criterion": "Verify S01's actual population, endpoints and result role, explaining differences from direct bleeding results.", "basis": "Existing method principles distinguish population, plant part, processing, formulation, dose, duration, comparator, denominators, missingness, bleeding measurement, between-group analysis, intervals, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.", "condition_origin": "These conditions for oral whole edible lotus rhizome or defined juice and bleeding in adults with heavy menstrual bleeding were developed with knowledge of retained content and frozen before application. This does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.", "proposed_research": "Code antioxidant and DNA-damage markers separately from menstrual blood loss to compare directness.", "current_reports": [ "S01" ], "existence": "Retained bilingual research and bibliographic summaries exist. Current existence, public availability, acquisition and reading of external papers, registration, 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": "S01 concerns oxidative and DNA-damage markers in a randomized food-comparison pilot in older adults. Its retained summary records no menstrual-blood-loss result.", "condition_status": "Not applicable", "status_reason": "S01's observed endpoint and population do not match the bleeding question, so direct application of that result is not applicable.", "missingness": "Direct application is not applicable. Separate direct menstrual-blood-loss material remains unverified.", "uncertainty": "Extrapolation from antioxidant-marker changes to menstrual blood loss.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "S01 original-trial population, measurements and result tables, with separate direct bleeding material." }, { "item_id": "N20", "question_type": "Evidence condition", "question": "Are S01's population, design, actual randomized and completed denominators, funding and conflicts verified?", "needed": "S01 participant flow, original result tables, funding, product supply and author disclosures.", "role": "Supplementary (related-report identity and attribution)", "role_reason": "An academic-research classification alone cannot establish denominators and independent funding.", "application_exception": "This is not direct-efficacy material, so verifying its denominators does not replace direct-effect conditions.", "criterion": "Verify S01's population, design, randomized and completed denominators and actual funding and conflict disclosures.", "basis": "Existing method principles distinguish population, plant part, processing, formulation, dose, duration, comparator, denominators, missingness, bleeding measurement, between-group analysis, intervals, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.", "condition_origin": "These conditions for oral whole edible lotus rhizome or defined juice and bleeding in adults with heavy menstrual bleeding were developed with knowledge of 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 related report's actual denominators and funding without transferring them to direct heavy-menstrual-bleeding denominators or independence.", "current_reports": [ "S01" ], "existence": "Retained bilingual research and bibliographic summaries exist. Current existence, public availability, acquisition and reading of external papers, registration, 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": "S01 records older adults, but exact randomized and completed denominators and actual funding and COI are unverified in existing records.", "condition_status": "Partly verified", "status_reason": "Reported design and population context are verified, but actual denominators and conflict information are not.", "missingness": "S01's flow, actual funding and disclosure documents are absent from retained summaries.", "uncertainty": "The size and independence of the reported recruited population.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "S01 participant flow, original result tables, funding, product supply and author disclosures." }, { "item_id": "N21", "question_type": "Evidence condition", "question": "Can S02's traditional and preclinical review serve as a direct heavy-menstrual-bleeding comparative trial?", "needed": "Review text, included-material list and original material from a separate eligible direct comparative trial.", "role": "Supplementary (traditional-use context)", "role_reason": "A traditional metrorrhagia record does not become a modern PBAC comparison.", "application_exception": "The narrative review itself is not a trial recruiting clinical participants. Actual identities of included studies need separate comparison.", "criterion": "Verify S02's design and provision of clinical results, distinguishing it from a direct comparative trial.", "basis": "Existing method principles distinguish population, plant part, processing, formulation, dose, duration, comparator, denominators, missingness, bleeding measurement, between-group analysis, intervals, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.", "condition_origin": "These conditions for oral whole edible lotus rhizome or defined juice and bleeding in adults with heavy menstrual bleeding were developed with knowledge of retained content and frozen before application. This does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.", "proposed_research": "Distinguish traditional and preclinical review records from clinical-trial reports and link identified included studies to families.", "current_reports": [ "S02" ], "existence": "Retained bilingual research and bibliographic summaries exist. Current existence, public availability, acquisition and reading of external papers, registration, 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": "S02 is a traditional-use and preclinical narrative review. Its summary states that the review itself recruited no clinical participants and provides no clinical PBAC or objective menstrual-blood-loss results.", "condition_status": "Not applicable", "status_reason": "Using this review itself as a direct comparative bleeding trial does not meet design and result applicability conditions.", "missingness": "Direct-trial application of the review itself is not applicable. Individual directness and family information for included material were not newly verified.", "uncertainty": "The risk of transferring traditional narratives to comparative effects.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "Review text, included-material list and original material from a separate eligible direct comparative trial." }, { "item_id": "N22", "question_type": "Evidence condition", "question": "Do traditional hemostatic records concern the same part, processing and disease as whole edible lotus rhizome or juice?", "needed": "Traditional records and relevant review sections, actual parts, processing, prescription composition and disease definitions.", "role": "Supplementary (consistency of indirect records)", "role_reason": "Lotus-leaf uterine-bleeding records, nodes, carbonized products and combination prescriptions could otherwise be merged into one intervention.", "application_exception": "Retain other-part records as background without adopting them as clinical results for the current intervention.", "criterion": "Compare traditional parts, processing and diseases with whole edible underground rhizome and the current bleeding endpoint.", "basis": "Existing method principles distinguish population, plant part, processing, formulation, dose, duration, comparator, denominators, missingness, bleeding measurement, between-group analysis, intervals, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.", "condition_origin": "These conditions for oral whole edible lotus rhizome or defined juice and bleeding in adults with heavy menstrual bleeding were developed with knowledge of retained content and frozen before application. This does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.", "proposed_research": "Classify records by part, processing and disease, marking matches and differences from the whole-lotus-root-juice question.", "current_reports": [ "S02" ], "existence": "Retained bilingual research and bibliographic summaries exist. Current existence, public availability, acquisition and reading of external papers, registration, 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": "Retained material distinguishes classical hemostatic use, lotus-leaf uterine-bleeding records, nodes, carbonized products and combination prescriptions from the current intervention. Exact part and processing mappings for individual S02 traditional records are unverified.", "condition_status": "Partly verified", "status_reason": "Major stated differences are verified, but comparisons of individual traditional-record identity, part and processing are missing.", "missingness": "Exact mappings of individual traditional originals to their forms of use are missing.", "uncertainty": "Similarity between traditional records and defined juice.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "Traditional records and relevant review sections, actual parts, processing, prescription composition and disease definitions." }, { "item_id": "N23", "question_type": "Evidence condition", "question": "Are S03's anaphylaxis event definition, diagnosis and collection context verified?", "needed": "S03 diagnostic evidence, medical history, event timeline, reporting methods and original text.", "role": "Supplementary (safety separate from efficacy)", "role_reason": "Retain the human allergy signal while maintaining the verified level of diagnosis and causality.", "application_exception": "Do not require a case report to provide incidence data; retain it as safety context. This condition adds no mandatory efficacy-trial count.", "criterion": "Verify original event definitions, diagnosis and collection level for the reported post-ingestion anaphylaxis.", "basis": "Existing method principles distinguish population, plant part, processing, formulation, dose, duration, comparator, denominators, missingness, bleeding measurement, between-group analysis, intervals, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.", "condition_origin": "These conditions for oral whole edible lotus rhizome or defined juice and bleeding in adults with heavy menstrual bleeding were developed with knowledge of retained content and frozen before application. This does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.", "proposed_research": "Link actual case-event descriptions to identification procedures, distinguishing signals, comparative risks and causality.", "current_reports": [ "S03" ], "existence": "Retained bilingual research and bibliographic summaries exist. Current existence, public availability, acquisition and reading of external papers, registration, 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": "S03 records 1 human case of anaphylaxis after lotus-root ingestion. Detailed diagnostic and collection procedures are unverified in this retained summary.", "condition_status": "Partly verified", "status_reason": "The original event description and case existence are verified, but actual diagnostic and collection details remain unverified.", "missingness": "Diagnostic evidence and detailed original case material remain unread.", "uncertainty": "Event-identification level and the scope of causal interpretation.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "S03 diagnostic evidence, medical history, event timeline, reporting methods and original text." }, { "item_id": "N24", "question_type": "Evidence condition", "question": "Are S03's actual intake, preparation and event timeline verified?", "needed": "Case intake, product or food form, timeline, withdrawal and re-exposure records.", "role": "Supplementary (safety-signal exposure boundary)", "role_reason": "A food-ingestion case cannot automatically serve as direct harm material for defined therapeutic-amount juice.", "application_exception": "Do not infer missing dose, preparation or latency, or invent improvement after withdrawal or re-exposure.", "criterion": "Verify case exposure amount, cooking or juice form, ingestion, onset, recovery, withdrawal and re-exposure times.", "basis": "Existing method principles distinguish population, plant part, processing, formulation, dose, duration, comparator, denominators, missingness, bleeding measurement, between-group analysis, intervals, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.", "condition_origin": "These conditions for oral whole edible lotus rhizome or defined juice and bleeding in adults with heavy menstrual bleeding were developed with knowledge of retained content and frozen before application. This does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.", "proposed_research": "Compare actual exposure and event timelines without determining causality from temporal order alone.", "current_reports": [ "S03" ], "existence": "Retained bilingual research and bibliographic summaries exist. Current existence, public availability, acquisition and reading of external papers, registration, 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 context of an event after lotus-root ingestion is retained, but exact dose, preparation, onset, recovery, withdrawal and re-exposure timelines are unverified.", "condition_status": "Partly verified", "status_reason": "Only the broad direction of ingestion followed by the event is known; formulation, amount and detailed temporal relations are unverified.", "missingness": "Original S03 exposure amount, preparation and detailed timeline material is missing.", "uncertainty": "Whether direct application to harm from defined juice is possible.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "Case intake, product or food form, timeline, withdrawal and re-exposure records." }, { "item_id": "N25", "question_type": "Evidence condition", "question": "Are exposed-person denominators, observation periods and comparisons available to interpret anaphylaxis frequency?", "needed": "Total exposed and affected counts, exposure and follow-up durations, collection systems and comparison conditions.", "role": "Supplementary; required for incidence claims", "role_reason": "A report of 1 person does not establish the exposed-population denominator or incidence magnitude.", "application_exception": "Retain cases without controls or exposed denominators as signals. Do not require numerical harm-incidence certainty for the current efficacy question.", "criterion": "Verify frequency information linking people with events to exposed-person denominators, duration, collection systems and comparators.", "basis": "Existing method principles distinguish population, plant part, processing, formulation, dose, duration, comparator, denominators, missingness, bleeding measurement, between-group analysis, intervals, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.", "condition_origin": "These conditions for oral whole edible lotus rhizome or defined juice and bleeding in adults with heavy menstrual bleeding were developed with knowledge of retained content and frozen before application. This does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.", "proposed_research": "Assess only reported frequencies linked to denominators and time; do not convert case counts into incidence.", "current_reports": [ "S03" ], "existence": "Retained bilingual research and bibliographic summaries exist. Current existence, public availability, acquisition and reading of external papers, registration, 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": "S03 concerns 1 person, but total lotus-root-exposure denominators, duration and background comparisons are missing. The manuscript also explicitly states that incidence is unverified.", "condition_status": "Unverified", "status_reason": "Event counts alone cannot establish occurrence frequency or comparative risk.", "missingness": "Exposed-person denominators, duration, event-collection systems and comparisons are missing.", "uncertainty": "Harm frequency and the influence of selective reporting.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "Total exposed and affected counts, exposure and follow-up durations, collection systems and comparison conditions." }, { "item_id": "N26", "question_type": "Evidence condition", "question": "Are the case's other foods, medications, allergy status and alternative explanations verified?", "needed": "Case food and medication co-exposures, baseline allergies and diseases, and alternative-cause assessment records.", "role": "Supplementary (causal-interpretation boundary)", "role_reason": "A report of an association with lotus root alone cannot establish a sole cause or confirmed causality.", "application_exception": "Without alternative-cause information, do not state that no other causes existed.", "criterion": "Verify concurrent exposures, baseline allergies, other causes and assessment methods for the reported event.", "basis": "Existing method principles distinguish population, plant part, processing, formulation, dose, duration, comparator, denominators, missingness, bleeding measurement, between-group analysis, intervals, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.", "condition_origin": "These conditions for oral whole edible lotus rhizome or defined juice and bleeding in adults with heavy menstrual bleeding were developed with knowledge of 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, baseline status and diagnostic evidence, distinguishing assessed alternatives from unverified candidates.", "current_reports": [ "S03" ], "existence": "Retained bilingual research and bibliographic summaries exist. Current existence, public availability, acquisition and reading of external papers, registration, 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": "S03 is summarized as lotus-root-associated anaphylaxis; details of concurrent foods, medication, baseline allergies and assessment of alternative causes are not retained.", "condition_status": "Unverified", "status_reason": "Missing alternative-exposure and diagnostic material prevents assessment of sole causal contribution.", "missingness": "Original co-exposure, baseline-status and alternative-cause assessment material is missing.", "uncertainty": "The sole contribution of lotus root and the extent of established causality.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "Case food and medication co-exposures, baseline allergies and diseases, and alternative-cause assessment records." }, { "item_id": "N27", "question_type": "Evidence condition", "question": "Is material available on therapeutic-amount juice in pregnancy, lactation, liver or kidney disease and drug interactions?", "needed": "Population-specific exposure and harm collection for therapeutic-amount juice, long-term observation and anticoagulant or antiplatelet interaction material.", "role": "Supplementary; required for the relevant safety extension", "role_reason": "Food experience or a case involving 1 person cannot establish safety in all populations and long-term exposure.", "application_exception": "Do not require all rare-harm studies for the narrow efficacy claim or create personal intake instructions.", "criterion": "Verify direct safety information for relevant special populations, long-term use and drug interactions at matching formulation and exposure levels.", "basis": "Existing method principles distinguish population, plant part, processing, formulation, dose, duration, comparator, denominators, missingness, bleeding measurement, between-group analysis, intervals, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.", "condition_origin": "These conditions for oral whole edible lotus rhizome or defined juice and bleeding in adults with heavy menstrual bleeding were developed with knowledge of retained content and frozen before application. This does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.", "proposed_research": "If existing safety material becomes available, compare applicability by food versus therapeutic juice, vulnerable populations and concurrent drugs.", "current_reports": [ "S03" ], "existence": "Retained bilingual research and bibliographic summaries exist. Current existence, public availability, acquisition and reading of external papers, registration, 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": "Retained material distinguishes food-use experience from therapeutic-amount juice safety. Pregnancy, lactation, kidney and liver disease, and anticoagulant or antiplatelet interactions are unverified.", "condition_status": "Unverified", "status_reason": "Direct safety material for the relevant vulnerable populations, drugs and therapeutic formulation is unverified.", "missingness": "Material matching the stated vulnerable-population and interaction scopes is missing.", "uncertainty": "Long-term and population-specific safety of therapeutic juice.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "Population-specific exposure and harm collection for therapeutic-amount juice, long-term observation and anticoagulant or antiplatelet interaction material." }, { "item_id": "N28", "question_type": "Evidence condition", "question": "Are actual funding, product supply and author interests verified for the three reports?", "needed": "Original S01, S02 and S03 funding, product-supply, author-affiliation, patent and COI disclosures.", "role": "Supplementary; required for independence claims", "role_reason": "Academic-research or review classifications do not prove actual independence.", "application_exception": "Do not automatically exclude material with identified conflicts or automatically treat no conflicts as no bias.", "criterion": "Verify actual funding, product supply, employment, patents and disclosure levels for each report.", "basis": "Existing method principles distinguish population, plant part, processing, formulation, dose, duration, comparator, denominators, missingness, bleeding measurement, between-group analysis, intervals, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.", "condition_origin": "These conditions for oral whole edible lotus rhizome or defined juice and bleeding in adults with heavy menstrual bleeding were developed with knowledge of retained content and frozen before application. This does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.", "proposed_research": "Link funding and disclosure levels to each report without turning missing information into independent funding or absence of bias.", "current_reports": [ "S01", "S02", "S03" ], "existence": "Retained bilingual research and bibliographic summaries exist. Current existence, public availability, acquisition and reading of external papers, registration, 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": "S01 and S02 are classified as academic research or review, but actual funding and COI are unverified. S03 funding and COI details are also unverified.", "condition_status": "Unverified", "status_reason": "Beyond manuscript type classifications, material verifying actual funding, supply, employment and disclosures is missing.", "missingness": "Actual report-specific funding and conflict disclosures have not been acquired.", "uncertainty": "Independent funding, institutions and the scope of result attribution.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "Original S01, S02 and S03 funding, product-supply, author-affiliation, patent and COI disclosures." }, { "item_id": "N29", "question_type": "Evidence condition", "question": "Were actually read material, external papers and abstracts, and individual historical access dates distinguished?", "needed": "Original retained input, citation locations, material types, actual access and reading events, and report-specific historical access records.", "role": "Required (record scope)", "role_reason": "A bibliographic URL and original verdict review date do not prove current full-text reading or individual historical access dates.", "application_exception": "Access not attempted is not inaccessibility, and a PubMed URL is not a publisher full-text URL.", "criterion": "Separate current retained-summary reading from unattempted external access and unread material by item; leave absent historical access dates unrecorded.", "basis": "Existing method principles distinguish population, plant part, processing, formulation, dose, duration, comparator, denominators, missingness, bleeding measurement, between-group analysis, intervals, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.", "condition_origin": "These conditions for oral whole edible lotus rhizome or defined juice and bleeding in adults with heavy menstrual bleeding were developed with knowledge of retained content and frozen before application. This does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.", "proposed_research": "For newly acquired material, link identity, type, read locations and dates without promoting summary reading to full-text reading.", "current_reports": [ "S01", "S02", "S03" ], "existence": "Retained bilingual research and bibliographic summaries exist. Current existence, public availability, acquisition and reading of external papers, registration, 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 summary's Korean, English and full structure were read. No new external access or reading occurred. The three citations lack individual access-level and access-date fields; the original review date 2026-09-08 is separate.", "condition_status": "Met", "status_reason": "Actual actions and material-specific reading scopes are distinguished without inferring individual historical dates.", "missingness": "Separation of reading records is verified. Current verification of external full texts and abstracts and individual historical access levels remain unverified.", "uncertainty": "Current external-material content and actual historical access levels.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "Original retained input, citation locations, material types, actual access and reading events, and report-specific historical access records." }, { "item_id": "N30", "question_type": "Evidence condition", "question": "Can actual original search queries, execution dates, results and selection scope be verified?", "needed": "Historical search queries, dates, results and selection records, with an explanation of the retained scope.", "role": "Required (interpretation of unverified information)", "role_reason": "Failure to identify a study in a search differs from the absence of all clinical research or effects.", "application_exception": "No new search is performed in the current conversion, and original-search completeness is not certified.", "criterion": "Verify actual date-specific queries, results and selection records as well as original sources and terms, limiting absence language to that scope.", "basis": "Existing method principles distinguish population, plant part, processing, formulation, dose, duration, comparator, denominators, missingness, bleeding measurement, between-group analysis, intervals, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.", "condition_origin": "These conditions for oral whole edible lotus rhizome or defined juice and bleeding in adults with heavy menstrual bleeding were developed with knowledge of retained content and frozen before application. This does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.", "proposed_research": "If search records are acquired, compare historical selection scope; distinguish additional searches as separately authorized events.", "current_reports": [], "existence": "Retained bilingual research and bibliographic summaries exist. Current existence, public availability, acquisition and reading of external papers, registration, 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 manuscript reports PubMed and ClinicalTrials.gov searches combining plant parts, bleeding and PBAC. Evidence scope is limited to retained sources and the absence-proven flag is false. No new search occurred in this work.", "condition_status": "Partly verified", "status_reason": "Retained search context and absence limits are known, but original date-specific results, selection logs and completeness are unverified.", "missingness": "Detailed historical queries, execution dates and selection logs are missing. Worldwide absence is not claimed.", "uncertainty": "Possible omissions in the retained search and the current literature state.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "Historical search queries, dates, results and selection records, with an explanation of the retained scope." }, { "item_id": "N31", "question_type": "Evidence condition", "question": "Are the original ?, unrecorded score, pre/post-correction human-study flags and review status preserved?", "needed": "Original current grade, score, axes, evidence status, correction and editorial-review material, with change history.", "role": "Required (historical preservation)", "role_reason": "Current versus historical no-human-study flags could be mistaken for changed efficacy evidence or a new verdict.", "application_exception": "The original grade is a historical citation, not an inherited condition status, efficacy probability or new score.", "criterion": "Preserve actual types of original verdict, score and axes, with correction and review history, without certifying a new verdict.", "basis": "Existing method principles distinguish population, plant part, processing, formulation, dose, duration, comparator, denominators, missingness, bleeding measurement, between-group analysis, intervals, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.", "condition_origin": "These conditions for oral whole edible lotus rhizome or defined juice and bleeding in adults with heavy menstrual bleeding were developed with knowledge of retained content and frozen before application. This does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.", "proposed_research": "For change events, compare version-specific originals and separately record display corrections, new clinical evidence and regrading.", "current_reports": [], "existence": "Retained bilingual research and bibliographic summaries exist. Current existence, public availability, acquisition and reading of external papers, registration, 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 grade is ?, score is unrecorded and the no-human-study flag is false. Editorial records retain the historical true value and specify legacy-grade review with grade revalidation false. Evidence status records related human studies as true, direct efficacy and eligible comparisons as false, and proven absence as false.", "condition_status": "Met", "status_reason": "Original values, types and pre/post-correction differences are preserved exactly without certification as a new final grade.", "missingness": "Historical preservation is verified. Clinical re-review of the original grade is incomplete.", "uncertainty": "Interpretation of the existing grade and flags and future review.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "Original current grade, score, axes, evidence status, correction and editorial-review material, with change history." }, { "item_id": "N32", "question_type": "Evidence condition", "question": "Was ID1965's cough and sputum question distinguished from the current menstrual-blood-loss claim?", "needed": "Manuscript adjacent-claim identifiers and endpoint boundaries; actual material for that question in future separately scoped work.", "role": "Required (claim unit)", "role_reason": "Bronchitis-related cough and sputum and menstrual blood loss are different endpoints even for the same lotus rhizome or juice.", "application_exception": "Do not open ID1965's individual file in this work; record only the current manuscript's mention.", "criterion": "Distinguish the other effect of the same intervention explicitly described in the current manuscript as an independent question.", "basis": "Existing method principles distinguish population, plant part, processing, formulation, dose, duration, comparator, denominators, missingness, bleeding measurement, between-group analysis, intervals, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.", "condition_origin": "These conditions for oral whole edible lotus rhizome or defined juice and bleeding in adults with heavy menstrual bleeding were developed with knowledge of retained content and frozen before application. This does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.", "proposed_research": "If authorized to address the adjacent question, review its original and material independently without automatically inheriting efficacy evidence from this table.", "current_reports": [], "existence": "Retained bilingual research and bibliographic summaries exist. Current existence, public availability, acquisition and reading of external papers, registration, 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 manuscript explains that ID1965 concerns bronchitis-related cough and sputum for the same whole lotus rhizome or juice, so it is not a duplicate. That individual original was not read in this work.", "condition_status": "Met", "status_reason": "The other-effect boundary described in the current manuscript is preserved, with original-material nonreading explicit.", "missingness": "The current table's question separation is verified. Individual ID1965 evidence and content verification were not performed.", "uncertainty": "The actual scope of a separate adjacent-manuscript review.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "Manuscript adjacent-claim identifiers and endpoint boundaries; actual material for that question in future separately scoped work." }, { "item_id": "N33", "question_type": "Evidence condition", "question": "Are optimal dose and persistence after stopping required as additional conditions for this narrow bleeding question?", "needed": "Actual direct-trial dose and duration material; direct dose comparisons and post-withdrawal follow-up only when addressing extensions.", "role": "Supplementary (extension boundary)", "role_reason": "This prevents unverified direct bleeding material from becoming judgments about optimal dose or long-term effects.", "application_exception": "Optimal dose and post-withdrawal persistence are not additional mandatory conditions for the current main question. Actual exposure and measurement duration remain addressed in N06 and N07.", "criterion": "Distinguish verification of actual original-claim dose and duration from extensions concerning optimal dose and persistence after stopping.", "basis": "Existing method principles distinguish population, plant part, processing, formulation, dose, duration, comparator, denominators, missingness, bleeding measurement, between-group analysis, intervals, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.", "condition_origin": "These conditions for oral whole edible lotus rhizome or defined juice and bleeding in adults with heavy menstrual bleeding were developed with knowledge of retained content and frozen before application. This does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.", "proposed_research": "If direct comparisons become available, examine original effects, dose comparisons and persistence as separate contrasts of interest.", "current_reports": [], "existence": "Retained bilingual research and bibliographic summaries exist. Current existence, public availability, acquisition and reading of external papers, registration, 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 main question concerns direct comparison of menstrual blood loss. Actual eligible dose and duration are unverified, and direct material establishing optimal dose or persistence is also unavailable.", "condition_status": "Not applicable", "status_reason": "Optimal-dose and post-withdrawal persistence extensions are not additional mandatory conditions for the selected narrow main question.", "missingness": "Additional mandatory application of those extensions is not applicable. Direct material on actual dose and duration remains unverified.", "uncertainty": "Direct material needed for future extensions.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "Actual direct-trial dose and duration material; direct dose comparisons and post-withdrawal follow-up only when addressing extensions." }, { "item_id": "N34", "question_type": "Evidence condition", "question": "Are blood-loss results being extended to verified anemia treatment or replacement of standard care?", "needed": "Original bleeding result tables and separate anemia or standard-treatment comparisons, with original advertising boundaries.", "role": "Supplementary (clinical-extension boundary)", "role_reason": "Blood-loss results would not automatically prove anemia correction or replacement of standard care.", "application_exception": "Do not require anemia or standard-treatment-replacement studies as additional mandatory conditions for the current bleeding endpoint.", "criterion": "Distinguish the selected menstrual-blood-loss endpoint from separate clinical questions about anemia treatment and treatment replacement.", "basis": "Existing method principles distinguish population, plant part, processing, formulation, dose, duration, comparator, denominators, missingness, bleeding measurement, between-group analysis, intervals, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.", "condition_origin": "These conditions for oral whole edible lotus rhizome or defined juice and bleeding in adults with heavy menstrual bleeding were developed with knowledge of retained content and frozen before application. This does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.", "proposed_research": "Even if direct results become available, assess other anemia and treatment-replacement endpoints and comparators as separate eligible questions.", "current_reports": [], "existence": "Retained bilingual research and bibliographic summaries exist. Current existence, public availability, acquisition and reading of external papers, registration, 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 manuscript states that lotus root cannot be advertised as a hemostatic food, menstrual-loss reducer, anemia treatment or replacement for standard gynecological care. This table is limited to the menstrual-blood-loss question.", "condition_status": "Not applicable", "status_reason": "Independent efficacy judgments for anemia treatment and treatment replacement are outside the current main question's applicability.", "missingness": "Extension of the current endpoint is not applicable. Preserving original boundaries does not mean anemia or treatment-replacement material has been verified.", "uncertainty": "Directness for future separate clinical questions.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "Original bleeding result tables and separate anemia or standard-treatment comparisons, with original advertising boundaries." } ], "reports": [ { "report_id": "S01", "title": "Ji 2015 older-adult lotus-rhizome/cucumber antioxidant pilot", "url": "https://pubmed.ncbi.nlm.nih.gov/26193861/", "report_type": "Retained bibliography/evidence summary of a randomized food-comparison pilot with a different population and endpoint", "existence": "Retained bilingual research and bibliographic summaries exist. Current existence, public availability, acquisition and reading of external papers, registration, 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.", "study_family": "Local link for a related antioxidant trial, not a direct heavy-menstrual-bleeding trial family. Original bibliography, registration and family identity were not externally compared in this work.", "independent_replication": "S01’s related human antioxidant pilot, S02’s narrative review and S03’s safety case report have different roles. Do not count 3 reports as 3 independent comparative heavy-menstrual-bleeding trials or sum participants. Unique trial, participant and direct-efficacy-trial counts are unrecorded.", "observed_result": "Retained summary: a randomized pilot comparing lotus rhizome with cucumber in older adults, addressing oxidative and DNA-damage markers. The retained summary contains no menstrual-blood-loss result. Exact randomized/completed counts and actual funding/COI are unverified. PMID 26193861, PMCID PMC12878895 and DOI 10.1007/s12603-015-0524-x are retained identifiers.", "result_level": "Distinguish the record of related human research from direct bleeding efficacy. Do not transfer another endpoint’s randomization or cucumber control to direct heavy-menstrual-bleeding design or results. Whole-paper nonreporting was not newly established.", "source_evidence_date": "2026-09-08", "materials": [ { "material_type": "PubMed bibliography/abstract entry; actual current availability scope unverified", "public_status": "Current public availability unverified", "access_status": "External access not attempted; not acquired", "acquired": false, "actually_read": "Not read", "as_of": "2026-10-05", "qualification": "This is the retained original PubMed URL. Current access, acquisition and reading were not attempted. A bibliographic link does not establish full-text reading. Past manuscript review descriptions are historical records. They do not establish actual external paper, abstract or registration reading or independent clinical certification in this work. 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": "Paper full text; actual full-text URL unrecorded", "public_status": "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 actual full-text URL is unrecorded and distinct from the bibliographic URL. No new full-text link was constructed from identifiers; current access, acquisition and reading were not attempted. Past manuscript review descriptions are historical records. They do not establish actual external paper, abstract or registration reading or independent clinical certification in this work. 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/26193861/" } ] }, { "report_id": "S02", "title": "Paudel and Panth 2015 lotus traditional/preclinical narrative review", "url": "https://pubmed.ncbi.nlm.nih.gov/27057194/", "report_type": "Retained bibliography/evidence summary of a narrative review of traditional-use and preclinical contexts", "existence": "Retained bilingual research and bibliographic summaries exist. Current existence, public availability, acquisition and reading of external papers, registration, 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.", "study_family": "Review and included-material family relationships and overlap are unverified. Do not count the review itself as a direct comparative bleeding trial.", "independent_replication": "S01’s related human antioxidant pilot, S02’s narrative review and S03’s safety case report have different roles. Do not count 3 reports as 3 independent comparative heavy-menstrual-bleeding trials or sum participants. Unique trial, participant and direct-efficacy-trial counts are unrecorded.", "observed_result": "Retained summary: a narrative review of traditional hemostatic use, metrorrhagia and preclinical contexts. The review itself recruited no clinical participants and is summarized as providing no clinical PBAC or objective menstrual-blood-loss results. Individual traditional-record part, processing and disease mappings and actual funding/COI are unverified. PMCID PMC4710907 and DOI 10.1155/2015/789124 are retained identifiers.", "result_level": "Retain as traditional/preclinical background. Non-applicability of the review itself as a direct trial means neither no participants in all included human research nor a null effect.", "source_evidence_date": "2026-09-08", "materials": [ { "material_type": "PubMed bibliography/abstract entry; actual current availability scope unverified", "public_status": "Current public availability unverified", "access_status": "External access not attempted; not acquired", "acquired": false, "actually_read": "Not read", "as_of": "2026-10-05", "qualification": "This is the retained original PubMed URL. Current access, acquisition and reading were not attempted. A bibliographic link does not establish full-text reading. Past manuscript review descriptions are historical records. They do not establish actual external paper, abstract or registration reading or independent clinical certification in this work. 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": "Paper full text; actual full-text URL unrecorded", "public_status": "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 actual full-text URL is unrecorded and distinct from the bibliographic URL. No new full-text link was constructed from identifiers; current access, acquisition and reading were not attempted. Past manuscript review descriptions are historical records. They do not establish actual external paper, abstract or registration reading or independent clinical certification in this work. 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/27057194/" } ] }, { "report_id": "S03", "title": "Nishimura-Tagui 2020 anaphylaxis case after lotus-root ingestion", "url": "https://pubmed.ncbi.nlm.nih.gov/32232879/", "report_type": "Retained bibliography/evidence summary of a human allergy safety case, separate from efficacy", "existence": "Retained bilingual research and bibliographic summaries exist. Current existence, public availability, acquisition and reading of external papers, registration, 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.", "study_family": "Local link for 1 reported case; the total exposed denominator and independent replication are unverified.", "independent_replication": "S01’s related human antioxidant pilot, S02’s narrative review and S03’s safety case report have different roles. Do not count 3 reports as 3 independent comparative heavy-menstrual-bleeding trials or sum participants. Unique trial, participant and direct-efficacy-trial counts are unrecorded.", "observed_result": "Retained summary: 1 reported anaphylaxis case after lotus-root ingestion. Intake, cooking/juice status, onset/recovery/withdrawal/re-exposure timeline, diagnosis, concurrent foods/drugs, alternative causes, total exposed denominator, incidence, funding and COI are unverified. PMID 32232879 and DOI 10.1111/1346-8138.15329 are retained identifiers.", "result_level": "Retain as a safety signal without converting it to direct heavy-menstrual-bleeding efficacy, a null result, established causality or incidence. Do not newly determine harm from defined therapeutic-amount juice or personal risk.", "source_evidence_date": "2026-09-08", "materials": [ { "material_type": "PubMed bibliography/abstract entry; actual current availability scope unverified", "public_status": "Current public availability unverified", "access_status": "External access not attempted; not acquired", "acquired": false, "actually_read": "Not read", "as_of": "2026-10-05", "qualification": "This is the retained original PubMed URL. Current access, acquisition and reading were not attempted. A bibliographic link does not establish full-text reading. Past manuscript review descriptions are historical records. They do not establish actual external paper, abstract or registration reading or independent clinical certification in this work. 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": "Paper full text; actual full-text URL unrecorded", "public_status": "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 actual full-text URL is unrecorded and distinct from the bibliographic URL. No new full-text link was constructed from identifiers; current access, acquisition and reading were not attempted. Past manuscript review descriptions are historical records. They do not establish actual external paper, abstract or registration reading or independent clinical certification in this work. 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/32232879/" } ] } ], "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 item’s boundary or record is verified from retained material; this does not verify a clinical effect.", "Partly verified": "Only some required information is verified; actual remaining evidence gaps are distinguished.", "Unverified": "Required information is unverified within the retained material read. This does not mean no studies or an effect of 0.", "Not applicable": "Only the specified applicability exception applies; this does not replace unread or insufficient material.", "Not read": "External material content was not read in this work; this differs from access failure or paper nonreporting." }, "study_overlap": { "state": "Unverified", "unique_trial_count": null, "unique_participant_count": null, "reason": "S01’s related human antioxidant pilot, S02’s narrative review and S03’s safety case report have different roles. Do not count 3 reports as 3 independent comparative heavy-menstrual-bleeding trials or sum participants. Unique trial, participant and direct-efficacy-trial counts are unrecorded." }, "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 34 items. No new clinical search, verification-state change or scoring was performed." } ], "language": "en", "translation_date": "2026-10-28" }