{
  "schema_version": "chamgap-public-criteria-1.0",
  "title": "Whole lotus rhizome or defined lotus-root juice × Reduction of menstrual blood loss in heavy menstrual bleeding",
  "language": "en",
  "translation_date": "2026-10-28",
  "criteria_version": "1.0",
  "criteria_date": "2026-10-05",
  "condition_origin": "Chamgap's own application conditions",
  "method_sources": [
    {
      "id": "M03",
      "version": "Cochrane Handbook 6.5 (2024), chapter updated 2023-08",
      "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-03",
      "section": "§3.1, §3.2.1–3.2.3, MECIR C5/C7/C13",
      "official_principle": "Clearly record the question, eligibility conditions and reasons for changes; distinguish intervention variants.",
      "review_level": "Retained method-application records were reused. External originals were not reread and method content was not reassessed."
    },
    {
      "id": "M04",
      "version": "Cochrane Handbook 6.5.1 (2025), chapter updated 2025-03",
      "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-04",
      "section": "§4.5, §4.6.1–4.6.3, MECIR C42",
      "official_principle": "Link studies and reports separately; do not omit studies solely because results are unreported.",
      "review_level": "Retained method-application records were reused. External originals were not reread and method content was not reassessed."
    },
    {
      "id": "M08",
      "version": "Cochrane Handbook 6.5 (2024), chapter updated 2019-10",
      "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-08",
      "section": "§8.1–8.2.3, Table 8.2.a",
      "official_principle": "Fix the result and effect of interest when examining randomization, deviations, missingness, measurement and selective reporting.",
      "review_level": "Retained method-application records were reused. External originals were not reread and method content was not reassessed."
    },
    {
      "id": "M15",
      "version": "Cochrane Handbook 6.5 (2024), chapter updated 2023-08",
      "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-15",
      "section": "§15.2.4, §15.3.1–15.3.3",
      "official_principle": "Distinguish effect estimates, intervals, importance and applicability. Sample size alone does not determine precision.",
      "review_level": "Retained method-application records were reused. External originals were not reread and method content was not reassessed."
    },
    {
      "id": "M19",
      "version": "Cochrane Handbook 6.5 (2024), chapter updated 2019-10",
      "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-19",
      "section": "§19.1.2, §19.2.1–19.2.4",
      "official_principle": "Harm questions may require different designs, populations and follow-up from efficacy questions. Case reports do not establish incidence.",
      "review_level": "Retained method-application records were reused. External originals were not reread and method content was not reassessed."
    }
  ],
  "status_dictionary": {
    "Met": "The 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."
  },
  "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."
    },
    {
      "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."
    },
    {
      "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."
    },
    {
      "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."
    },
    {
      "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."
    },
    {
      "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."
    },
    {
      "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."
    },
    {
      "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."
    },
    {
      "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."
    },
    {
      "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."
    },
    {
      "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."
    },
    {
      "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."
    },
    {
      "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."
    },
    {
      "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."
    },
    {
      "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."
    },
    {
      "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."
    },
    {
      "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."
    },
    {
      "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."
    },
    {
      "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."
    },
    {
      "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."
    },
    {
      "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."
    },
    {
      "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."
    },
    {
      "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."
    },
    {
      "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."
    },
    {
      "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."
    },
    {
      "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."
    },
    {
      "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."
    },
    {
      "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."
    },
    {
      "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."
    },
    {
      "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."
    },
    {
      "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."
    },
    {
      "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."
    },
    {
      "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."
    },
    {
      "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."
    }
  ]
}