{
  "schema_version": "chamgap-public-criteria-1.0",
  "title": "Lotus plumule tea or single-ingredient plumule extract × Improvement of sleep quality in adults with insomnia",
  "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 identity, attribution or scope is verified in retained material. This is separate from clinical sufficiency or certification.",
    "Partly verified": "Some information is verified, but actual methods, denominators or procedures remain unverified.",
    "Unverified": "Required clinical material/values are unverified within this reading scope. This does not establish an effect of 0, harmlessness or incomplete table preparation.",
    "Conflicting data": "Disagreement between reports in the original record, distinct from differences in dose or timing themselves.",
    "Not applicable": "Extension obligations outside the narrow PSQI question are not applied. This does not replace unread material.",
    "Not applicable (alias)": "Gray alias for Not applicable.",
    "Not read": "External original material was not directly read in this work. This is separate from reading retained summaries.",
    "Review incomplete": "Incomplete individual review for table preparation, separate from unverified clinical material."
  },
  "requirements": [
    {
      "item_id": "N01",
      "question_type": "Evidence condition",
      "question": "Which lotus-plumule sleep-quality question does this table address?",
      "needed": "Exact canonical manuscript and URL for the claim, plant part, formulation, population, endpoint and comparison.",
      "role": "Required",
      "role_reason": "Needed to avoid combining different plant parts and endpoints into one effect because the plant name is shared.",
      "application_exception": "Retain the empty subclaim list; do not automatically create separate tables for every formulation or safety clue.",
      "criterion": "Connect the original claim location to a concurrent-comparison question about oral single-ingredient lotus plumule, adults with insomnia and PSQI.",
      "basis": "Existing method principles distinguish population, plant part, product, dose, duration, comparator, denominators, missingness, PSQI measurement, within/between-group analysis, intervals, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.",
      "condition_origin": "These oral single-ingredient lotus-plumule/adult-insomnia/PSQI conditions were developed with knowledge of the retained content and frozen before application. This does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.",
      "proposed_research": "Fix inclusion/exclusion boundaries and check whether other plant parts, combinations, exposure or mechanistic material enter this question."
    },
    {
      "item_id": "N02",
      "question_type": "Evidence condition",
      "question": "Is the actual capsule equivalent to tea or a standardized single-plumule extract?",
      "needed": "Thai capsule ingredients, embryo identification, cultivar/origin, extraction/manufacture, quality tests and tea/extract comparisons.",
      "role": "Required",
      "role_reason": "Needed to avoid transferring capsule before-and-after findings to tea or all lotus products.",
      "application_exception": "Lotus seed flesh, leaf, root and Rhodiola mixtures are not the same single-ingredient plumule product.",
      "criterion": "Verify actual content, single-ingredient composition, extraction, standardization and tea/extract equivalence for the green embryo of mature seeds.",
      "basis": "Existing method principles distinguish population, plant part, product, dose, duration, comparator, denominators, missingness, PSQI measurement, within/between-group analysis, intervals, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.",
      "condition_origin": "These oral single-ingredient lotus-plumule/adult-insomnia/PSQI conditions were developed with knowledge of the retained content and frozen before application. This does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.",
      "proposed_research": "Compare batch composition, identification and chemical analyses; classify different formulations in separate eligibility strata."
    },
    {
      "item_id": "N03",
      "question_type": "Evidence condition",
      "question": "Are the actual dose and dosing frequency in the sleep-quality study verified?",
      "needed": "Thai-trial capsule content, daily amount/frequency, administration records and adherence material.",
      "role": "Required",
      "role_reason": "Needed to avoid attributing PSQI values to a particular regimen without administration conditions.",
      "application_exception": "The higenamine-exposure dose of 0.8 g taken 3 times daily is not the sleep-quality study dose.",
      "criterion": "Connect nominal dose, actual intake, adherence and frequency to the single-plumule sleep-quality study.",
      "basis": "Existing method principles distinguish population, plant part, product, dose, duration, comparator, denominators, missingness, PSQI measurement, within/between-group analysis, intervals, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.",
      "condition_origin": "These oral single-ingredient lotus-plumule/adult-insomnia/PSQI conditions were developed with knowledge of the retained content and frozen before application. This does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.",
      "proposed_research": "Compare product labeling with actual administration records and separate material using different doses."
    },
    {
      "item_id": "N04",
      "question_type": "Evidence condition",
      "question": "Are administration duration and assessment times for single-plumule PSQI verified?",
      "needed": "Thai-trial administration/assessment schedule, visit table and follow-up duration.",
      "role": "Required",
      "role_reason": "Needed to avoid borrowing the interval between measurements from another study.",
      "application_exception": "The 3 days in the separate exposure study are not the Thai PSQI observation period.",
      "criterion": "Connect administration start/end, the before-and-after PSQI interval and observation duration to direct sleep-quality material.",
      "basis": "Existing method principles distinguish population, plant part, product, dose, duration, comparator, denominators, missingness, PSQI measurement, within/between-group analysis, intervals, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.",
      "condition_origin": "These oral single-ingredient lotus-plumule/adult-insomnia/PSQI conditions were developed with knowledge of the retained content and frozen before application. This does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.",
      "proposed_research": "Compare actual visits and assessment dates, distinguishing end-of-treatment from post-discontinuation follow-up."
    },
    {
      "item_id": "N05",
      "question_type": "Evidence condition",
      "question": "Are insomnia diagnosis, severity and target population in the 50-person study verified?",
      "needed": "Thai participants’ age, insomnia diagnosis/selection, baseline disease, medicines and PSQI distribution.",
      "role": "Required",
      "role_reason": "An insomnia-patient label does not make every adult-insomnia population equivalent.",
      "application_exception": "The 6 healthy men and combination-product sleep-disturbance population cannot replace the direct insomnia population.",
      "criterion": "Compare age, insomnia selection criteria, severity and disease/medicine exclusions with the adult-insomnia question.",
      "basis": "Existing method principles distinguish population, plant part, product, dose, duration, comparator, denominators, missingness, PSQI measurement, within/between-group analysis, intervals, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.",
      "condition_origin": "These oral single-ingredient lotus-plumule/adult-insomnia/PSQI conditions were developed with knowledge of the retained content and frozen before application. This does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.",
      "proposed_research": "Compare original inclusion/exclusion criteria and baseline distribution; do not generalize to unverified populations."
    },
    {
      "item_id": "N06",
      "question_type": "Evidence condition",
      "question": "Can purposive recruitment, exclusions and selection effects be verified?",
      "needed": "Recruitment notices, selected/excluded counts, consent/participation flow and baseline characteristics.",
      "role": "Required",
      "role_reason": "Needed to avoid assuming that changes in selected before-and-after data represent general patient responses.",
      "application_exception": "Do not calculate bias direction or magnitude solely from purposive sampling.",
      "criterion": "Describe recruitment source, contact/participation and exclusion flow, and purposive selection.",
      "basis": "Existing method principles distinguish population, plant part, product, dose, duration, comparator, denominators, missingness, PSQI measurement, within/between-group analysis, intervals, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.",
      "condition_origin": "These oral single-ingredient lotus-plumule/adult-insomnia/PSQI conditions were developed with knowledge of the retained content and frozen before application. This does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.",
      "proposed_research": "Reconstruct recruitment-to-analysis flow and compare participation/exclusion reasons and population distributions."
    },
    {
      "item_id": "N07",
      "question_type": "Evidence condition",
      "question": "Was an eligible concurrent-comparison trial of single-ingredient plumule identified?",
      "needed": "Single-plumule versus suitable placebo/control trial reports, allocation/analysis and PSQI results by group.",
      "role": "Required (causal efficacy)",
      "role_reason": "Needed to distinguish before-and-after change from the selected plumule’s comparative contribution.",
      "application_exception": "Unverified in the previous search does not prove permanent worldwide absence of literature or an effect of 0.",
      "criterion": "Verify eligible material with a concurrent comparator, allocation and between-group estimation for the same question.",
      "basis": "Existing method principles distinguish population, plant part, product, dose, duration, comparator, denominators, missingness, PSQI measurement, within/between-group analysis, intervals, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.",
      "condition_origin": "These oral single-ingredient lotus-plumule/adult-insomnia/PSQI conditions were developed with knowledge of the retained content and frozen before application. This does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.",
      "proposed_research": "Plan subsequent research as a comparison with defined product, population and timing, separating natural history, regression and expectancy effects."
    },
    {
      "item_id": "N08",
      "question_type": "Evidence condition",
      "question": "Can allocation, concealment and assessor blinding for comparative PSQI efficacy be verified?",
      "needed": "Eligible comparative-trial allocation/concealment procedures and placebo/assessment-blinding documents.",
      "role": "Required",
      "role_reason": "Needed to verify whether subjective score change was separated from expectancy effects.",
      "application_exception": "Do not arbitrarily assign completed RCT allocation or crossover/cluster non-applicability to this single-arm design.",
      "criterion": "Examine actual random sequence, allocation concealment, participant/assessor blinding and expectancy effects.",
      "basis": "Existing method principles distinguish population, plant part, product, dose, duration, comparator, denominators, missingness, PSQI measurement, within/between-group analysis, intervals, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.",
      "condition_origin": "These oral single-ingredient lotus-plumule/adult-insomnia/PSQI conditions were developed with knowledge of the retained content and frozen before application. This does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.",
      "proposed_research": "Compare implementation with the protocol and address expectancy/measurement influences on subjective PSQI in the analysis plan."
    },
    {
      "item_id": "N09",
      "question_type": "Evidence condition",
      "question": "Are sleep medicines, lifestyle changes and adherence distinguished from PSQI changes?",
      "needed": "Sleep medicines/disease treatment, lifestyle/concurrent interventions, adherence, rescue treatment and change records.",
      "role": "Required",
      "role_reason": "Needed to avoid attributing factors changing alongside plumule use to the plumule itself.",
      "application_exception": "Missing information does not establish that concomitant treatment or lifestyle changes were absent.",
      "criterion": "Verify relationships between concomitant medicines, sleep hygiene, concurrent interventions, discontinuation/adherence and PSQI analysis.",
      "basis": "Existing method principles distinguish population, plant part, product, dose, duration, comparator, denominators, missingness, PSQI measurement, within/between-group analysis, intervals, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.",
      "condition_origin": "These oral single-ingredient lotus-plumule/adult-insomnia/PSQI conditions were developed with knowledge of the retained content and frozen before application. This does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.",
      "proposed_research": "Create a timeline of concurrent treatment/lifestyle changes; examine changes in both groups and adherence handling in an eligible comparison."
    },
    {
      "item_id": "N10",
      "question_type": "Evidence condition",
      "question": "Are the PSQI version, collection and assessment conditions verified?",
      "needed": "PSQI tool/language version, assessment procedures, scoring and measurement schedule.",
      "role": "Required",
      "role_reason": "Needed to avoid treating an endpoint name alone as verification of actual measurement conditions.",
      "application_exception": "Do not convert ISI, sleep diaries, animal sleep time or urinary higenamine into the same PSQI result.",
      "criterion": "Verify PSQI version/language, collection method, assessor, measurement interval and interpretation.",
      "basis": "Existing method principles distinguish population, plant part, product, dose, duration, comparator, denominators, missingness, PSQI measurement, within/between-group analysis, intervals, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.",
      "condition_origin": "These oral single-ingredient lotus-plumule/adult-insomnia/PSQI conditions were developed with knowledge of the retained content and frozen before application. This does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.",
      "proposed_research": "Compare scale and collection methods; verify measurement/expectancy effects and missing-item handling."
    },
    {
      "item_id": "N11",
      "question_type": "Evidence condition",
      "question": "Which analysis and time points do the Thai PSQI values represent?",
      "needed": "Original PSQI tables, measurement times, analysis population, ± definition and change-analysis results.",
      "role": "Required",
      "role_reason": "Needed to retain original numbers without arbitrarily extending their attribution.",
      "application_exception": "Do not calculate a new before-and-after difference, CI or between-group effect.",
      "criterion": "Connect before-and-after values, testing, denominators and timing; distinguish between-group effects.",
      "basis": "Existing method principles distinguish population, plant part, product, dose, duration, comparator, denominators, missingness, PSQI measurement, within/between-group analysis, intervals, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.",
      "condition_origin": "These oral single-ingredient lotus-plumule/adult-insomnia/PSQI conditions were developed with knowledge of the retained content and frozen before application. This does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.",
      "proposed_research": "Compare original tables exactly and separate paired analysis from between-group comparison."
    },
    {
      "item_id": "N12",
      "question_type": "Evidence condition",
      "question": "Are the paired-P analysis population, test and actual comparative efficacy verified?",
      "needed": "Paired-test type, assumptions, analysis n, handling rules and between-group comparison results.",
      "role": "Required",
      "role_reason": "Needed to avoid establishing plumule contribution or between-group differences from within-group P alone.",
      "application_exception": "Do not convert paired P < .05 into an exact P, equivalence, no difference or treatment-effect magnitude.",
      "criterion": "Distinguish within-group paired testing, analysis denominator and model from concurrent between-group effects.",
      "basis": "Existing method principles distinguish population, plant part, product, dose, duration, comparator, denominators, missingness, PSQI measurement, within/between-group analysis, intervals, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.",
      "condition_origin": "These oral single-ingredient lotus-plumule/adult-insomnia/PSQI conditions were developed with knowledge of the retained content and frozen before application. This does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.",
      "proposed_research": "Compare original testing/analysis plans with tables; do not transfer within-group significance into a between-group difference."
    },
    {
      "item_id": "N13",
      "question_type": "Evidence condition",
      "question": "Are the ± type and comparative-effect CI verified?",
      "needed": "± definition, before-and-after correlation/paired variance, analysis n, reported CI and derivation methods.",
      "role": "Required",
      "role_reason": "Needed to avoid arbitrarily interpreting printed ± as CI or SD.",
      "application_exception": "Do not calculate a new CI, standardized effect or paired variance from the current material.",
      "criterion": "Verify the SD/SE or other ± definition, paired variance, denominator and comparative-effect interval.",
      "basis": "Existing method principles distinguish population, plant part, product, dose, duration, comparator, denominators, missingness, PSQI measurement, within/between-group analysis, intervals, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.",
      "condition_origin": "These oral single-ingredient lotus-plumule/adult-insomnia/PSQI conditions were developed with knowledge of the retained content and frozen before application. This does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.",
      "proposed_research": "Compare original table notes and statistical methods; interpret only verified intervals."
    },
    {
      "item_id": "N14",
      "question_type": "Evidence condition",
      "question": "Are completion, PSQI-analysis and missing-data denominators among the 50 verified?",
      "needed": "Thai participation flow, before-and-after measurement n, completion/withdrawal reasons, analysis population and missing-data handling.",
      "role": "Required",
      "role_reason": "Needed to avoid automatically using the reported 50 as complete-case paired-analysis n.",
      "application_exception": "The separate combination-product flow of 20 and 13 is not the Thai analysis denominator.",
      "criterion": "Distinguish participation, completion, measurement at each time, paired analysis and withdrawal-handling denominators.",
      "basis": "Existing method principles distinguish population, plant part, product, dose, duration, comparator, denominators, missingness, PSQI measurement, within/between-group analysis, intervals, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.",
      "condition_origin": "These oral single-ingredient lotus-plumule/adult-insomnia/PSQI conditions were developed with knowledge of the retained content and frozen before application. This does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.",
      "proposed_research": "Trace denominators from participation to paired analysis; examine interpretation limits from missingness/withdrawal handling."
    },
    {
      "item_id": "N15",
      "question_type": "Evidence condition",
      "question": "Can a PSQI important-difference threshold be compared with the comparative interval?",
      "needed": "Important-difference evidence for the population, prespecified criteria and actual between-group estimate/CI.",
      "role": "Required",
      "role_reason": "Needed to avoid assigning clinical sufficiency solely from change magnitude or significance.",
      "application_exception": "Do not arbitrarily set minimum participant counts, duration or an important difference.",
      "criterion": "Compare a previously justified PSQI important-difference threshold with a between-group interval.",
      "basis": "Existing method principles distinguish population, plant part, product, dose, duration, comparator, denominators, missingness, PSQI measurement, within/between-group analysis, intervals, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.",
      "condition_origin": "These oral single-ingredient lotus-plumule/adult-insomnia/PSQI conditions were developed with knowledge of the retained content and frozen before application. This does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.",
      "proposed_research": "Verify the threshold source and population, then compare the eligible comparative-trial interval with it."
    },
    {
      "item_id": "N16",
      "question_type": "Evidence condition",
      "question": "Do planned PSQI, timing and analyses match the actual report?",
      "needed": "Thai-study registration identifier, protocol, analysis plan and endpoint/timing change history.",
      "role": "Required",
      "role_reason": "Needed to reveal material required to assess selection of favorable times or analyses.",
      "application_exception": "Failure to verify does not establish non-registration or selective reporting.",
      "criterion": "Directly compare registration, protocol and analysis plan with results and reasons for changes.",
      "basis": "Existing method principles distinguish population, plant part, product, dose, duration, comparator, denominators, missingness, PSQI measurement, within/between-group analysis, intervals, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.",
      "condition_origin": "These oral single-ingredient lotus-plumule/adult-insomnia/PSQI conditions were developed with knowledge of the retained content and frozen before application. This does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.",
      "proposed_research": "Tabulate planned endpoints/timing/analysis against original results, recording changes and uncompared areas."
    },
    {
      "item_id": "N17",
      "question_type": "Evidence condition",
      "question": "Can unique family and result identities of the three reports be verified?",
      "needed": "Original bibliography, trial/registration identifiers and duplicate-report/participant links for the three reports.",
      "role": "Required",
      "role_reason": "Needed to avoid counting 3 reports as 3 independent PSQI replications.",
      "application_exception": "The presence of identifier strings does not establish actual external bibliography/registration verification.",
      "criterion": "Verify family links and independence using bibliography, registration, population/intervention, timing and analysis.",
      "basis": "Existing method principles distinguish population, plant part, product, dose, duration, comparator, denominators, missingness, PSQI measurement, within/between-group analysis, intervals, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.",
      "condition_origin": "These oral single-ingredient lotus-plumule/adult-insomnia/PSQI conditions were developed with knowledge of the retained content and frozen before application. This does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.",
      "proposed_research": "Create a family-identity table, separating single-plumule PSQI, higenamine exposure and combination material; check recitation of the same results."
    },
    {
      "item_id": "N18",
      "question_type": "Evidence condition",
      "question": "Are independent controlled replications of single-plumule PSQI verified?",
      "needed": "Eligible single-plumule comparative trials, independent families, between-group results and condition differences.",
      "role": "Required (replicated efficacy)",
      "role_reason": "Needed to avoid converting report counts into independent replication of comparative efficacy.",
      "application_exception": "Unverified controlled material does not prove absent or failed efficacy replication.",
      "criterion": "Verify independent-family results for matching population, plant part, formulation and PSQI comparison.",
      "basis": "Existing method principles distinguish population, plant part, product, dose, duration, comparator, denominators, missingness, PSQI measurement, within/between-group analysis, intervals, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.",
      "condition_origin": "These oral single-ingredient lotus-plumule/adult-insomnia/PSQI conditions were developed with knowledge of the retained content and frozen before application. This does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.",
      "proposed_research": "Compare unique trials and contrary/no-difference results; do not add adjacent material as replication."
    },
    {
      "item_id": "N19",
      "question_type": "Evidence condition",
      "question": "Were positive before-and-after observations and their limitations retained together?",
      "needed": "Original locations of before-and-after results, interpretation limits, combination findings and inclusion/exclusion reasons.",
      "role": "Required (result preservation)",
      "role_reason": "Needed to avoid deleting positive original observations or converting them into causal efficacy.",
      "application_exception": "Differences between numbers from different formulations/endpoints are not automatically conflicting data.",
      "criterion": "Explain large before-and-after changes and adjacent positive results alongside comparator/attribution limits.",
      "basis": "Existing method principles distinguish population, plant part, product, dose, duration, comparator, denominators, missingness, PSQI measurement, within/between-group analysis, intervals, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.",
      "condition_origin": "These oral single-ingredient lotus-plumule/adult-insomnia/PSQI conditions were developed with knowledge of the retained content and frozen before application. This does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.",
      "proposed_research": "Tabulate direction together with design/attribution; favorable material must not erase controlled-efficacy gaps."
    },
    {
      "item_id": "N20",
      "question_type": "Evidence condition",
      "question": "Do Rhodiola-combination results answer the single-plumule effect question?",
      "needed": "Combination composition, population, completion/withdrawal, original ISI/PSQI results and component-isolation comparison.",
      "role": "Required (attribution boundary)",
      "role_reason": "Needed to avoid attributing positive combination/other-part results to the selected single ingredient.",
      "application_exception": "Do not automatically use the 13 completers as the sleep-quality effect denominator for all 20 enrolled.",
      "criterion": "Distinguish combination ingredients, plant part, single-arm design, 20 enrolled/13 completed and endpoint applicability.",
      "basis": "Existing method principles distinguish population, plant part, product, dose, duration, comparator, denominators, missingness, PSQI measurement, within/between-group analysis, intervals, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.",
      "condition_origin": "These oral single-ingredient lotus-plumule/adult-insomnia/PSQI conditions were developed with knowledge of the retained content and frozen before application. This does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.",
      "proposed_research": "Keep combination results in a separate eligibility stratum; design component-isolation comparisons if single-plumule contribution is needed."
    },
    {
      "item_id": "N21",
      "question_type": "Evidence condition",
      "question": "Is higenamine material kept out of PSQI efficacy?",
      "needed": "Healthy-male exposure, urinary higenamine results and PSQI applicability boundaries.",
      "role": "Required (endpoint attribution)",
      "role_reason": "Needed to avoid combining a different endpoint with efficacy solely because it concerns human lotus-plumule exposure.",
      "application_exception": "Do not convert the study-era WADA threshold into verification of current rules or insomnia efficacy.",
      "criterion": "Separate urinary exposure from sleep-quality endpoints even when human exposure and plant part match.",
      "basis": "Existing method principles distinguish population, plant part, product, dose, duration, comparator, denominators, missingness, PSQI measurement, within/between-group analysis, intervals, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.",
      "condition_origin": "These oral single-ingredient lotus-plumule/adult-insomnia/PSQI conditions were developed with knowledge of the retained content and frozen before application. This does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.",
      "proposed_research": "Compare endpoint/population eligibility, keeping exposure/safety material separate from efficacy results."
    },
    {
      "item_id": "N22",
      "question_type": "Evidence condition",
      "question": "Is animal sedation required as a direct result for human PSQI?",
      "needed": "Original narrative locations and population, plant-part and endpoint descriptions for animal/mechanistic references.",
      "role": "Supplementary; required only for mechanistic extensions",
      "role_reason": "A boundary needed to avoid extending related mechanisms into human sleep-quality effects.",
      "application_exception": "Do not impose animal-sedation trials as an efficacy requirement for the current main question.",
      "criterion": "Distinguish animal/other-part mechanisms from direct adult PSQI comparisons.",
      "basis": "Existing method principles distinguish population, plant part, product, dose, duration, comparator, denominators, missingness, PSQI measurement, within/between-group analysis, intervals, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.",
      "condition_origin": "These oral single-ingredient lotus-plumule/adult-insomnia/PSQI conditions were developed with knowledge of the retained content and frozen before application. This does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.",
      "proposed_research": "Review applicability boundaries in the original explanation; connect separate eligible material only when direct human trials exist."
    },
    {
      "item_id": "N23",
      "question_type": "Evidence condition",
      "question": "Must an optimal dose be established for the original question?",
      "needed": "Direct dose comparisons, actual product/dose and analysis plans only if an optimal dose is claimed.",
      "role": "Supplementary; required only for dose extensions",
      "role_reason": "Needed to distinguish unverified dose from an obligation to study optimal dosing.",
      "application_exception": "The actual direct-study dose gap remains in N03; non-applicability does not fill it.",
      "criterion": "Separate the narrow comparative-efficacy question from dose-optimization obligations.",
      "basis": "Existing method principles distinguish population, plant part, product, dose, duration, comparator, denominators, missingness, PSQI measurement, within/between-group analysis, intervals, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.",
      "condition_origin": "These oral single-ingredient lotus-plumule/adult-insomnia/PSQI conditions were developed with knowledge of the retained content and frozen before application. This does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.",
      "proposed_research": "If an extension is requested, separately plan fixed-formulation dose comparisons and simultaneous safety/sleep-quality assessment."
    },
    {
      "item_id": "N24",
      "question_type": "Evidence condition",
      "question": "Does the current question include persistence after discontinuation?",
      "needed": "Discontinuation/long-term follow-up schedule, product and group results if persistence is claimed.",
      "role": "Supplementary; required only for persistence extensions",
      "role_reason": "Needed to avoid establishing maintenance effects from before-and-after changes alone.",
      "application_exception": "Do not replace unverified direct-study duration/assessment timing with non-applicability of long-term follow-up.",
      "criterion": "Separate end-of-treatment sleep quality from post-discontinuation/long-term effects.",
      "basis": "Existing method principles distinguish population, plant part, product, dose, duration, comparator, denominators, missingness, PSQI measurement, within/between-group analysis, intervals, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.",
      "condition_origin": "These oral single-ingredient lotus-plumule/adult-insomnia/PSQI conditions were developed with knowledge of the retained content and frozen before application. This does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.",
      "proposed_research": "For an extension, plan end-of-treatment/post-discontinuation measurements of the same product, separating persistence from additional treatment."
    },
    {
      "item_id": "N25",
      "question_type": "Evidence condition",
      "question": "Are specific subgroup-effect obligations applied?",
      "needed": "Prespecified subgroups, denominators and interaction analysis/direct comparisons if subgroup effects are claimed.",
      "role": "Supplementary; required only for subgroup extensions",
      "role_reason": "Needed to avoid establishing effects in every vulnerable group from the reported 50.",
      "application_exception": "Retain basic population conditions and vulnerable-population safety gaps separately.",
      "criterion": "Separate the adult-insomnia question from sex/disease/age-specific effect-modification claims.",
      "basis": "Existing method principles distinguish population, plant part, product, dose, duration, comparator, denominators, missingness, PSQI measurement, within/between-group analysis, intervals, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.",
      "condition_origin": "These oral single-ingredient lotus-plumule/adult-insomnia/PSQI conditions were developed with knowledge of the retained content and frozen before application. This does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.",
      "proposed_research": "For new subgroup questions, separately examine prior hypotheses, interactions and denominators."
    },
    {
      "item_id": "N26",
      "question_type": "Evidence condition",
      "question": "Are clinical events or hypnotic replacement mandatory for PSQI improvement?",
      "needed": "Direct event/treatment/medication-change comparisons and result definitions if a clinical extension is claimed.",
      "role": "Supplementary; required only for clinical extensions",
      "role_reason": "Needed to avoid establishing hypnotic replacement or treatment from before-and-after PSQI changes.",
      "application_exception": "Do not impose every event trial as mandatory for a score question.",
      "criterion": "Separate sleep-quality scores from insomnia treatment, hypnotic replacement and other clinical results.",
      "basis": "Existing method principles distinguish population, plant part, product, dose, duration, comparator, denominators, missingness, PSQI measurement, within/between-group analysis, intervals, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.",
      "condition_origin": "These oral single-ingredient lotus-plumule/adult-insomnia/PSQI conditions were developed with knowledge of the retained content and frozen before application. This does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.",
      "proposed_research": "When a separate clinical question is authorized, design score, event and medicine-use outcomes separately."
    },
    {
      "item_id": "N27",
      "question_type": "Evidence condition",
      "question": "Can palpitation collection, denominators and discontinuations be verified?",
      "needed": "Thai-trial adverse-event tables, collection methods, exposure/follow-up denominators and palpitation/discontinuation records.",
      "role": "Supplementary; required for harm claims",
      "role_reason": "Needed to avoid converting a mild report in 1 person into overall safety or incidence.",
      "application_exception": "Do not calculate a new incidence from 1/50 or fill unverified events with 0.",
      "criterion": "Verify reported-event wording, people/event counts, observation duration, systematic collection, severity and discontinuation.",
      "basis": "Existing method principles distinguish population, plant part, product, dose, duration, comparator, denominators, missingness, PSQI measurement, within/between-group analysis, intervals, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.",
      "condition_origin": "These oral single-ingredient lotus-plumule/adult-insomnia/PSQI conditions were developed with knowledge of the retained content and frozen before application. This does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.",
      "proposed_research": "Compare original event tables and collection procedures, distinguishing spontaneous/systematic reporting and exposure/completion denominators."
    },
    {
      "item_id": "N28",
      "question_type": "Evidence condition",
      "question": "Are palpitation timing, alternative causes and comparative risk verified?",
      "needed": "Palpitation onset dates, administration/discontinuation, recovery, concomitant medicines/disease and comparator events.",
      "role": "Supplementary; required for causal/comparative harm claims",
      "role_reason": "Needed to avoid establishing causality or increased risk solely from reporting during exposure.",
      "application_exception": "Do not assume rechallenge, recovery or absence of alternative causes.",
      "criterion": "Examine administration, onset, discontinuation/recovery, concomitant factors, baseline/alternative explanations and actual comparisons.",
      "basis": "Existing method principles distinguish population, plant part, product, dose, duration, comparator, denominators, missingness, PSQI measurement, within/between-group analysis, intervals, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.",
      "condition_origin": "These oral single-ingredient lotus-plumule/adult-insomnia/PSQI conditions were developed with knowledge of the retained content and frozen before application. This does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.",
      "proposed_research": "Examine event timelines and alternative causes; distinguish uncontrolled signals from causality or risk ratios."
    },
    {
      "item_id": "N29",
      "question_type": "Evidence condition",
      "question": "Does the 6-person exposure study answer current rules or harms in insomnia patients?",
      "needed": "Exposure product/composition, urine collection/analysis, study-era reporting threshold and separate current official rules/clinical-harm material.",
      "role": "Supplementary; required for exposure/doping and harm claims",
      "role_reason": "Needed to avoid transferring healthy-person urine results into insomnia-patient harms or current doping judgments.",
      "application_exception": "Current rules are not consulted in this work. The 6-person result belongs to the historical urinary-exposure study.",
      "criterion": "Separate actual exposure, urinary endpoint, denominator/duration and study-era criteria from current rules/clinical harms.",
      "basis": "Existing method principles distinguish population, plant part, product, dose, duration, comparator, denominators, missingness, PSQI measurement, within/between-group analysis, intervals, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.",
      "condition_origin": "These oral single-ingredient lotus-plumule/adult-insomnia/PSQI conditions were developed with knowledge of the retained content and frozen before application. This does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.",
      "proposed_research": "Compare original exposure tables with historical criteria; separate current-rule verification and clinical events into other reviews."
    },
    {
      "item_id": "N30",
      "question_type": "Evidence condition",
      "question": "Are direct long-term, vulnerable-population and interaction safety data verified?",
      "needed": "Product-specific long-term follow-up, vulnerable-population, interaction, rare/serious-event and discontinuation material.",
      "role": "Supplementary; required for safety extensions",
      "role_reason": "Needed to avoid extending limited before-and-after/healthy-person exposure into overall safety.",
      "application_exception": "Unverified harms do not establish harmlessness; do not create personal dosing instructions or a new safety grade.",
      "criterion": "Verify exposure, collection and denominators for pregnancy/lactation, cardiovascular disease, concomitant use and long-term/rare events.",
      "basis": "Existing method principles distinguish population, plant part, product, dose, duration, comparator, denominators, missingness, PSQI measurement, within/between-group analysis, intervals, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.",
      "condition_origin": "These oral single-ingredient lotus-plumule/adult-insomnia/PSQI conditions were developed with knowledge of the retained content and frozen before application. This does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.",
      "proposed_research": "Distinguish follow-up/observational designs by required safety scope; assess suitability of population, exposure and event collection."
    },
    {
      "item_id": "N31",
      "question_type": "Evidence condition",
      "question": "Are funding, company relationships and independence of the three reports verified?",
      "needed": "Original report-specific funding/support, author affiliation, COI, patent and product-provision sections.",
      "role": "Supplementary; required for independence claims",
      "role_reason": "Needed to avoid converting company support or unverified funding into independent funding or absence of bias.",
      "application_exception": "Do not automatically delete results because a company relationship exists.",
      "criterion": "Separately verify raw-material/manufacturing support, author employment, funding, patents and COI for each report.",
      "basis": "Existing method principles distinguish population, plant part, product, dose, duration, comparator, denominators, missingness, PSQI measurement, within/between-group analysis, intervals, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.",
      "condition_origin": "These oral single-ingredient lotus-plumule/adult-insomnia/PSQI conditions were developed with knowledge of the retained content and frozen before application. This does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.",
      "proposed_research": "Compare support forms and disclosure scope report by report, distinguishing independent-family and independent-funding claims."
    },
    {
      "item_id": "N32",
      "question_type": "Evidence condition",
      "question": "Is failure to identify an eligible trial limited to the retained search scope?",
      "needed": "Retained review date, search/editorial scope and unverified wording, plus search records if an actual later search occurs.",
      "role": "Required (scope preservation)",
      "role_reason": "Needed to avoid expanding prior unverified findings into absence of all literature.",
      "application_exception": "Do not use the current original-verdict review date as a new-search or external-access date.",
      "criterion": "Retain the original review date, retained-material-only scope and absence-not-proven state, distinguishing new searches.",
      "basis": "Existing method principles distinguish population, plant part, product, dose, duration, comparator, denominators, missingness, PSQI measurement, within/between-group analysis, intervals, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.",
      "condition_origin": "These oral single-ingredient lotus-plumule/adult-insomnia/PSQI conditions were developed with knowledge of the retained content and frozen before application. This does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.",
      "proposed_research": "Compare the historical search/retention scope; record new search dates, scope and inclusion/exclusion only when a new-evidence event is authorized."
    },
    {
      "item_id": "N33",
      "question_type": "Evidence condition",
      "question": "Are summary reading and historical/current paper or abstract access separated?",
      "needed": "Current original summary/locations, the 3 original URLs, historical research wording and original access records if available.",
      "role": "Required (reading record)",
      "role_reason": "Needed to avoid converting link existence or historical full-text wording into current full-text reading.",
      "application_exception": "Individual access level/location/date are absent from citations; do not infer access dates from the overall review date.",
      "criterion": "Separately record current summary/locations, external URLs, historical research wording and unverified access dates.",
      "basis": "Existing method principles distinguish population, plant part, product, dose, duration, comparator, denominators, missingness, PSQI measurement, within/between-group analysis, intervals, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.",
      "condition_origin": "These oral single-ingredient lotus-plumule/adult-insomnia/PSQI conditions were developed with knowledge of the retained content and frozen before application. This does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.",
      "proposed_research": "Compare existence, acquisition, actual reading and dates by material; connect the reader view to the actual summary values and file fingerprints read."
    },
    {
      "item_id": "N34",
      "question_type": "Evidence condition",
      "question": "Were original ?, unrecorded values and current/previous human-evidence states retained?",
      "needed": "Original grade, score, axes, editorial review, grade rationale and correction record.",
      "role": "Required (original-verdict preservation)",
      "role_reason": "Needed to avoid upgrading conversion review into a new final clinical verdict or score.",
      "application_exception": "Do not present current false human-study-absence and historical previous true as the same current claim.",
      "criterion": "Preserve original grade/score/axes, evidence status and previous editorial axes without alteration.",
      "basis": "Existing method principles distinguish population, plant part, product, dose, duration, comparator, denominators, missingness, PSQI measurement, within/between-group analysis, intervals, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.",
      "condition_origin": "These oral single-ingredient lotus-plumule/adult-insomnia/PSQI conditions were developed with knowledge of the retained content and frozen before application. This does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.",
      "proposed_research": "Compare current/previous states and correction events, distinguishing human-evidence existence, unverified controls and unestimated effects."
    },
    {
      "item_id": "N35",
      "question_type": "Evidence condition",
      "question": "Are independent repeated-harm claims also required?",
      "needed": "Unique events, families, products, event definitions and recitation links only if repeated harm is claimed.",
      "role": "Supplementary; required only for repeated-harm claims",
      "role_reason": "Needed to avoid combining palpitations and urinary higenamine as repeated occurrences of the same harm.",
      "application_exception": "Retain harm signals and safety gaps without estimating repeated-event counts.",
      "criterion": "Separate the narrow sleep-quality question from obligations for repeated-harm signals.",
      "basis": "Existing method principles distinguish population, plant part, product, dose, duration, comparator, denominators, missingness, PSQI measurement, within/between-group analysis, intervals, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.",
      "condition_origin": "These oral single-ingredient lotus-plumule/adult-insomnia/PSQI conditions were developed with knowledge of the retained content and frozen before application. This does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.",
      "proposed_research": "For an extension, link unique reports of the same event/product and exclude regulatory recitations as independent events."
    }
  ]
}