{ "schema_version": "chamgap-public-evidence-check-1.0", "public_id": "v3079-main", "verdict_number": "3079", "title": "Lotus plumule tea or single-ingredient plumule extract × Improvement of sleep quality in adults with insomnia", "view_version": "1.0", "view_created_date": "2026-10-28", "criteria_version": "1.0", "criteria_date": "2026-10-05", "review_date": "2026-10-05", "legacy_evidence_date": "2026-09-08", "review_scope": { "materials_read": "Retained Korean/English summaries and case-specific condition/application records", "clinical_papers_directly_read": false, "new_clinical_search": false, "limitation": "Prepared from retained summaries and condition-application records. External abstracts, full texts, registration, protocols and analysis plans remain unread. Historical review records do not establish current independent clinical validation.", "date_meaning": "The original review date is 2026-09-08, the historical correction date is 2026-09-14 and the case-record review date is 2026-10-05. Historical access level and access date for individual external materials are not recorded; current access was not attempted." }, "claim_context": { "population": "Adults with insomnia symptoms; direct material records 50 patients with insomnia, but exact age, diagnosis and selection criteria are unverified", "comparator": "The identified 50-person single-arm study has no concurrent comparator, randomization or placebo. A separate eligible controlled trial is unverified within the retained search scope", "endpoint": "The intended endpoint is concurrent between-group comparison of PSQI sleep quality. Retained material reports before-and-after PSQI; actual measurement procedures, analysis denominators and precision are unverified", "intervention": "Oral single-ingredient lotus plumule (green embryo of mature Nelumbo nucifera seed). Direct material concerns Thai capsules; actual equivalence with tea or standardized single extracts is unverified", "dose": "Actual dose, frequency and adherence in the direct PSQI study are unverified", "duration": "Actual administration duration and measurement times in the direct PSQI study are unverified", "excluded_extensions": [ "Retain single-arm PSQI 15.24 ± 1.19 → 1.82 ± 0.69, paired P < .05 exactly as reported. No new change, CI or between-group effect is calculated. The reported 50 does not establish exact paired-analysis n; ± type, dose and duration remain unverified.", "The higenamine exposure of 0.8 g taken 3 times daily for 3 days in 6 healthy men is not the PSQI study dose or duration. Exceeding the study-era WADA reporting threshold is a historical urinary result, not current-rule verification or established clinical harm.", "The 2:1 Rhodiola-root/lotus-seed combination is separate before-and-after material with 20 enrolled and 13 completed. Do not transfer other-part/combination effects to single-plumule contribution or use 13 as the denominator for an effect in all 20.", "Retain the original ?, unrecorded score and Caution. Mild palpitations in 1 person do not establish a new incidence or causal harm; long-term use, pregnancy/lactation, cardiovascular disease and interactions remain unverified. Do not extend to optimal dose, persistence, subgroups, clinical events or hypnotic replacement." ] }, "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.", "current_reports": [ "S01", "S02", "S03" ], "existence": "Retained bilingual research and bibliographic summaries exist. Current existence, public availability, acquisition and reading of external papers, registration, plans and original product, funding and harm material have not been separately established.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.", "observation": "The original claim is improved sleep quality in adults with insomnia. The question is limited to PSQI after oral single-ingredient lotus plumule versus an actual concurrent comparator; equivalence between tea, capsules and standardized extracts remains separately unverified.", "condition_status": "Met", "status_reason": "The original claim, claim conditions and summary note specify population, plant-part and endpoint boundaries. This verifies claim identity, not a treatment effect.", "missingness": "The question identity and exclusions are verified. Eligible comparative trials and product equivalence remain gaps in other rows.", "uncertainty": "The question identity and exclusions are verified. Eligible comparative trials and product equivalence remain gaps in other rows.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "Exact canonical manuscript and URL for the claim, plant part, formulation, population, endpoint and comparison." }, { "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.", "current_reports": [ "S01" ], "existence": "Retained bilingual research and bibliographic summaries exist. Current existence, public availability, acquisition and reading of external papers, registration, plans and original product, funding and harm material have not been separately established.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.", "observation": "Retained material identifies the green embryo of mature Nelumbo nucifera seeds and Thai lotus-plumule capsules. Cultivar, origin, capsule composition/standardization and equivalence to the requested tea or single extract are unverified.", "condition_status": "Partly verified", "status_reason": "Plant part and capsule names are available, but actual composition, batch information and formulation comparisons are absent.", "missingness": "Beyond the embryo/capsule names, material is needed on actual single-ingredient composition, content, quality and equivalence to tea/extract.", "uncertainty": "Beyond the embryo/capsule names, material is needed on actual single-ingredient composition, content, quality and equivalence to tea/extract.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "Thai capsule ingredients, embryo identification, cultivar/origin, extraction/manufacture, quality tests and tea/extract comparisons." }, { "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.", "current_reports": [ "S01", "S02" ], "existence": "Retained bilingual research and bibliographic summaries exist. Current existence, public availability, acquisition and reading of external papers, registration, plans and original product, funding and harm material have not been separately established.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.", "observation": "Dose in the original claim conditions is unverified. The 0.8 g taken 3 times daily belongs to a separate higenamine-exposure study in 6 healthy men and is not transferred to the Thai sleep-quality study.", "condition_status": "Unverified", "status_reason": "Actual dose, frequency and adherence for the direct PSQI study are absent from the retained record.", "missingness": "Sleep-study capsule dose, dosing frequency and adherence must be obtained; exposure-study dosing cannot fill the gap.", "uncertainty": "Sleep-study capsule dose, dosing frequency and adherence must be obtained; exposure-study dosing cannot fill the gap.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "Thai-trial capsule content, daily amount/frequency, administration records and adherence material." }, { "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.", "current_reports": [ "S01", "S02" ], "existence": "Retained bilingual research and bibliographic summaries exist. Current existence, public availability, acquisition and reading of external papers, registration, plans and original product, funding and harm material have not been separately established.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.", "observation": "Before-and-after PSQI is reported, but exact single-plumule administration duration and measurement times are unverified. The 3-day higenamine exposure is separate.", "condition_status": "Unverified", "status_reason": "Duration in the original claim conditions remains unverified for an eligible controlled trial; the direct before-and-after study schedule is also unavailable.", "missingness": "The direct PSQI study schedule and assessment interval are needed; 3 days cannot be used as that duration.", "uncertainty": "The direct PSQI study schedule and assessment interval are needed; 3 days cannot be used as that duration.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "Thai-trial administration/assessment schedule, visit table and follow-up duration." }, { "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.", "current_reports": [ "S01", "S02", "S03" ], "existence": "Retained bilingual research and bibliographic summaries exist. Current existence, public availability, acquisition and reading of external papers, registration, plans and original product, funding and harm material have not been separately established.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.", "observation": "The Thai material records 50 patients with insomnia; the original question concerns adults with insomnia symptoms. Exact age, diagnosis, severity and exclusions are absent from the current summary.", "condition_status": "Partly verified", "status_reason": "The intended population and patient count are known, but matching clinical selection criteria and representativeness remain unverified.", "missingness": "Age, insomnia criteria, baseline conditions and exclusions for the 50 participants are needed.", "uncertainty": "Age, insomnia criteria, baseline conditions and exclusions for the 50 participants are needed.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "Thai participants’ age, insomnia diagnosis/selection, baseline disease, medicines and PSQI distribution." }, { "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.", "current_reports": [ "S01" ], "existence": "Retained bilingual research and bibliographic summaries exist. Current existence, public availability, acquisition and reading of external papers, registration, plans and original product, funding and harm material have not been separately established.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.", "observation": "The Thai study is recorded as a purposively sampled single-arm pilot. Recruitment source, contacted/excluded counts and baseline balance are unverified.", "condition_status": "Partly verified", "status_reason": "Sampling method is identified, but information is insufficient to assess selection flow and effects.", "missingness": "Material remains needed on actual purposive recruitment, exclusions and participant selection.", "uncertainty": "Material remains needed on actual purposive recruitment, exclusions and participant selection.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "Recruitment notices, selected/excluded counts, consent/participation flow and baseline characteristics." }, { "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.", "current_reports": [ "S01" ], "existence": "Retained bilingual research and bibliographic summaries exist. Current existence, public availability, acquisition and reading of external papers, registration, plans and original product, funding and harm material have not been separately established.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.", "observation": "The retained direct material is a 50-person single-arm study without a concurrent comparator, randomization or placebo. No eligible controlled single-plumule trial was identified in the retained search.", "condition_status": "Unverified", "status_reason": "The evidence-status record identifies direct human evidence but no eligible controlled efficacy study. Material establishing controlled efficacy is still needed.", "missingness": "An actual eligible comparative trial and between-group estimate are needed. Human evidence existing does not fill this gap.", "uncertainty": "An actual eligible comparative trial and between-group estimate are needed. Human evidence existing does not fill this gap.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "Single-plumule versus suitable placebo/control trial reports, allocation/analysis and PSQI results by group." }, { "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.", "current_reports": [ "S01" ], "existence": "Retained bilingual research and bibliographic summaries exist. Current existence, public availability, acquisition and reading of external papers, registration, plans and original product, funding and harm material have not been separately established.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.", "observation": "The retained direct study has no randomization, placebo or concurrent comparator. Allocation/blinding material separating expectancy effects is unverified.", "condition_status": "Unverified", "status_reason": "A single-arm before-and-after design cannot establish allocation/measurement control required for the selected causal comparison.", "missingness": "Actual allocation, concealment and assessment-control material appropriate to concurrent comparative efficacy is needed.", "uncertainty": "Actual allocation, concealment and assessment-control material appropriate to concurrent comparative efficacy is needed.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "Eligible comparative-trial allocation/concealment procedures and placebo/assessment-blinding documents." }, { "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.", "current_reports": [ "S01" ], "existence": "Retained bilingual research and bibliographic summaries exist. Current existence, public availability, acquisition and reading of external papers, registration, plans and original product, funding and harm material have not been separately established.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.", "observation": "The current single-arm summary lacks information on sleep medicines, lifestyle changes, concomitant treatment, adherence and their handling.", "condition_status": "Unverified", "status_reason": "Records are insufficient to evaluate other explanations for before-and-after change.", "missingness": "Direct-study concurrent interventions, concomitant treatment, adherence and their analytical handling are needed.", "uncertainty": "Direct-study concurrent interventions, concomitant treatment, adherence and their analytical handling are needed.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "Sleep medicines/disease treatment, lifestyle/concurrent interventions, adherence, rescue treatment and change records." }, { "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.", "current_reports": [ "S01", "S02", "S03" ], "existence": "Retained bilingual research and bibliographic summaries exist. Current existence, public availability, acquisition and reading of external papers, registration, plans and original product, funding and harm material have not been separately established.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.", "observation": "The direct-material endpoint is before-and-after PSQI. Scale version, language, collection, blinding, item handling and exact measurement schedule are unverified.", "condition_status": "Partly verified", "status_reason": "The PSQI endpoint and before-and-after report exist, but actual measurement procedures remain unverified.", "missingness": "The actual PSQI tool, collection conditions and assessment schedule are needed.", "uncertainty": "The actual PSQI tool, collection conditions and assessment schedule are needed.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "PSQI tool/language version, assessment procedures, scoring and measurement schedule." }, { "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.", "current_reports": [ "S01" ], "existence": "Retained bilingual research and bibliographic summaries exist. Current existence, public availability, acquisition and reading of external papers, registration, plans and original product, funding and harm material have not been separately established.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.", "observation": "The Thai material reports 15.24 ± 1.19 → 1.82 ± 0.69, paired P < .05. These are before-and-after values, with no between-group effect estimate because no concurrent comparator existed. Exact analysis n, timing and the meaning of ± are unverified.", "condition_status": "Partly verified", "status_reason": "Reported numbers and paired P can be retained, but analysis, timing and variance definitions are incomplete.", "missingness": "Analysis n, measurement times and the meaning of ± for the original values must be verified. Large change is not evidence of a controlled treatment effect.", "uncertainty": "Analysis n, measurement times and the meaning of ± for the original values must be verified. Large change is not evidence of a controlled treatment effect.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "Original PSQI tables, measurement times, analysis population, ± definition and change-analysis results." }, { "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.", "current_reports": [ "S01" ], "existence": "Retained bilingual research and bibliographic summaries exist. Current existence, public availability, acquisition and reading of external papers, registration, plans and original product, funding and harm material have not been separately established.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.", "observation": "Paired P < .05 is recorded. Test type, analysis n, model/assumptions are unverified; without a concurrent comparator it provides no between-group efficacy estimate.", "condition_status": "Partly verified", "status_reason": "A within-group test is indicated, but the analysis specification and causal comparison remain unverified.", "missingness": "Actual paired-test methods, denominator and between-group analysis appropriate to comparative efficacy are needed.", "uncertainty": "Actual paired-test methods, denominator and between-group analysis appropriate to comparative efficacy are needed.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "Paired-test type, assumptions, analysis n, handling rules and between-group comparison results." }, { "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.", "current_reports": [ "S01" ], "existence": "Retained bilingual research and bibliographic summaries exist. Current existence, public availability, acquisition and reading of external papers, registration, plans and original product, funding and harm material have not been separately established.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.", "observation": "PSQI ±1.19 and ±0.69 are retained, but SD/SE type is unspecified. Paired variance, before-and-after correlation and between-group CI are unverified in this record.", "condition_status": "Unverified", "status_reason": "Recorded ± alone cannot establish required precision or a comparative-effect interval.", "missingness": "Variance notes, paired variance, denominator and actual reported interval are needed.", "uncertainty": "Variance notes, paired variance, denominator and actual reported interval are needed.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "± definition, before-and-after correlation/paired variance, analysis n, reported CI and derivation methods." }, { "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.", "current_reports": [ "S01", "S03" ], "existence": "Retained bilingual research and bibliographic summaries exist. Current existence, public availability, acquisition and reading of external papers, registration, plans and original product, funding and harm material have not been separately established.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.", "observation": "The direct material records 50 patients with insomnia. Exact n measured at each time, completing or included in paired analysis, and missingness/withdrawal handling are unverified.", "condition_status": "Partly verified", "status_reason": "Participant count is known, but analysis denominator and losses for this result remain unverified.", "missingness": "Actual measurement/completion/analysis n and missingness/withdrawal records for the 50-person material are needed.", "uncertainty": "Actual measurement/completion/analysis n and missingness/withdrawal records for the 50-person material are needed.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "Thai participation flow, before-and-after measurement n, completion/withdrawal reasons, analysis population and missing-data 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.", "current_reports": [ "S01" ], "existence": "Retained bilingual research and bibliographic summaries exist. Current existence, public availability, acquisition and reading of external papers, registration, plans and original product, funding and harm material have not been separately established.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.", "observation": "Large before-and-after PSQI change is recorded, but a justified important-difference threshold for this population and actual between-group CI are unverified.", "condition_status": "Unverified", "status_reason": "Evidence is unavailable to evaluate comparative sleep-quality efficacy magnitude, precision and clinical importance.", "missingness": "An important-difference threshold for the population and a comparative-effect interval are needed.", "uncertainty": "An important-difference threshold for the population and a comparative-effect interval are needed.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "Important-difference evidence for the population, prespecified criteria and actual between-group estimate/CI." }, { "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.", "current_reports": [ "S01" ], "existence": "Retained bilingual research and bibliographic summaries exist. Current existence, public availability, acquisition and reading of external papers, registration, plans and original product, funding and harm material have not been separately established.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.", "observation": "PMID, DOI and registration identifiers for S01 are unverified, as is the registration field. Planned and actual reports could not be compared.", "condition_status": "Unverified", "status_reason": "No record establishes acquisition/verification of plan/registration documents and identifiers.", "missingness": "Agreement and change reasons between registration/plans and actual PSQI reporting are needed.", "uncertainty": "Agreement and change reasons between registration/plans and actual PSQI reporting are needed.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "Thai-study registration identifier, protocol, analysis plan and endpoint/timing change history." }, { "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.", "current_reports": [ "S01", "S02", "S03" ], "existence": "Retained bilingual research and bibliographic summaries exist. Current existence, public availability, acquisition and reading of external papers, registration, plans and original product, funding and harm material have not been separately established.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.", "observation": "The original bibliography contains 3 citations. Thai PSQI, healthy-male higenamine and Rhodiola-combination reports differ in role, population and endpoint. Original material IDs/family-link keys are absent; Thai identifiers are unverified. Unique study/participant counts are not established.", "condition_status": "Partly verified", "status_reason": "Report roles can be distinguished, but complete unique-family and duplicate-identity verification remains.", "missingness": "Unique families, registration identities and recitation/duplication relationships of the three reports must be verified.", "uncertainty": "Unique families, registration identities and recitation/duplication relationships of the three reports must be verified.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "Original bibliography, trial/registration identifiers and duplicate-report/participant links for the three reports." }, { "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.", "current_reports": [ "S01", "S02", "S03" ], "existence": "Retained bilingual research and bibliographic summaries exist. Current existence, public availability, acquisition and reading of external papers, registration, plans and original product, funding and harm material have not been separately established.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.", "observation": "Retained direct PSQI material is single-arm; eligible controlled trials are unverified. The other two reports concern higenamine exposure and a combination product, providing no independent single-plumule comparative PSQI replication.", "condition_status": "Unverified", "status_reason": "Material establishing an independent controlled comparison of the same question is unavailable.", "missingness": "Eligible comparative results from independent families and trial-link material are needed.", "uncertainty": "Eligible comparative results from independent families and trial-link material are needed.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "Eligible single-plumule comparative trials, independent families, between-group results and condition differences." }, { "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.", "current_reports": [ "S01", "S03" ], "existence": "Retained bilingual research and bibliographic summaries exist. Current existence, public availability, acquisition and reading of external papers, registration, plans and original product, funding and harm material have not been separately established.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.", "observation": "The large Thai before-and-after change and combination-product improvement are retained. Lack of placebo/concurrent controls and plant-part/formulation differences are separately explained; no new null conclusion or effect of 0 is created for the same question.", "condition_status": "Met", "status_reason": "The interpretation-limits field and report results/weight present positive observations with limitations. This verifies result preservation.", "missingness": "Positive original observations and their limits are attributed. Controlled-efficacy and precision gaps remain.", "uncertainty": "Positive original observations and their limits are attributed. Controlled-efficacy and precision gaps remain.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "Original locations of before-and-after results, interpretation limits, combination findings and inclusion/exclusion reasons." }, { "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.", "current_reports": [ "S03" ], "existence": "Retained bilingual research and bibliographic summaries exist. Current existence, public availability, acquisition and reading of external papers, registration, plans and original product, funding and harm material have not been separately established.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.", "observation": "The 2:1 Rhodiola-root/lotus-seed combination study enrolled 20 and had 13 completers, reporting before-and-after improvement in ISI, PSQI and diaries without placebo. Different plant part, product and comparator exclude it from direct single-plumule efficacy.", "condition_status": "Met", "status_reason": "The combination composition, flow, endpoints and exclusion reasons are explicit in the third evidence report. Verification concerns attribution boundaries.", "missingness": "The combination role and direct-evidence exclusion are verified. Single-plumule contribution or an effect for all 20 is not established.", "uncertainty": "The combination role and direct-evidence exclusion are verified. Single-plumule contribution or an effect for all 20 is not established.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "Combination composition, population, completion/withdrawal, original ISI/PSQI results and component-isolation comparison." }, { "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.", "current_reports": [ "S02" ], "existence": "Retained bilingual research and bibliographic summaries exist. Current existence, public availability, acquisition and reading of external papers, registration, plans and original product, funding and harm material have not been separately established.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.", "observation": "S02 concerns urinary higenamine in 6 healthy men, not sleep. Its original evidence weight is limited to safety context.", "condition_status": "Met", "status_reason": "Population, endpoint and safety role are explicit in the second evidence report and second citation.", "missingness": "The safety-context role and PSQI-efficacy exclusion are verified. Current rules and clinical harms remain separate.", "uncertainty": "The safety-context role and PSQI-efficacy exclusion are verified. Current rules and clinical harms remain separate.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "Healthy-male exposure, urinary higenamine results and PSQI applicability boundaries." }, { "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.", "current_reports": [], "existence": "Retained bilingual research and bibliographic summaries exist. Current existence, public availability, acquisition and reading of external papers, registration, plans and original product, funding and harm material have not been separately established.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.", "observation": "The original narrative mentions animal sedation under PMID 19010651 and mechanisms involving lotus root, leaves and other material. No separate report for it occurs among the 3 citations; animal originals were not opened and no new report ID was created.", "condition_status": "Not applicable", "status_reason": "The main question concerns comparative adult PSQI efficacy, so animal mechanisms are not applied as a sufficiency requirement. Narrative boundaries remain.", "missingness": "The mechanistic-extension obligation is Not applicable. Animal originals remain unread; direct human effects are not verified.", "uncertainty": "The mechanistic-extension obligation is Not applicable. Animal originals remain unread; direct human effects are not verified.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "Original narrative locations and population, plant-part and endpoint descriptions for animal/mechanistic references." }, { "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.", "current_reports": [ "S01" ], "existence": "Retained bilingual research and bibliographic summaries exist. Current existence, public availability, acquisition and reading of external papers, registration, plans and original product, funding and harm material have not been separately established.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.", "observation": "The original question concerns comparative sleep-quality efficacy and does not claim an optimal dose. Actual administration-dose missingness remains.", "condition_status": "Not applicable", "status_reason": "Additional optimal-dose extension obligations are outside the current question.", "missingness": "Dose-optimization obligations are Not applicable. Actual sleep-study dose remains separately unverified.", "uncertainty": "Dose-optimization obligations are Not applicable. Actual sleep-study dose remains separately unverified.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "Direct dose comparisons, actual product/dose and analysis plans only if an optimal dose is claimed." }, { "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.", "current_reports": [ "S01" ], "existence": "Retained bilingual research and bibliographic summaries exist. Current existence, public availability, acquisition and reading of external papers, registration, plans and original product, funding and harm material have not been separately established.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.", "observation": "The original question is sleep-quality improvement; it does not establish post-discontinuation persistence or long-term maintenance. Actual duration for current PSQI material is unverified.", "condition_status": "Not applicable", "status_reason": "Separate maintenance-effect extension obligations are not imposed on the original question.", "missingness": "Persistence/long-term efficacy obligations are Not applicable; the duration gap remains in N04.", "uncertainty": "Persistence/long-term efficacy obligations are Not applicable; the duration gap remains in N04.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "Discontinuation/long-term follow-up schedule, product and group results if persistence is claimed." }, { "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.", "current_reports": [ "S01" ], "existence": "Retained bilingual research and bibliographic summaries exist. Current existence, public availability, acquisition and reading of external papers, registration, plans and original product, funding and harm material have not been separately established.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.", "observation": "The original question concerns adult-insomnia PSQI, without a specific subgroup-effect claim. Unverified pregnancy/cardiovascular safety does not constitute an effect-modification result.", "condition_status": "Not applicable", "status_reason": "Specific subgroup comparative-efficacy extension obligations are outside the original question.", "missingness": "Subgroup-effect obligations are Not applicable. Baseline population/selection and vulnerable-population safety gaps remain separate.", "uncertainty": "Subgroup-effect obligations are Not applicable. Baseline population/selection and vulnerable-population safety gaps remain separate.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "Prespecified subgroups, denominators and interaction analysis/direct comparisons if subgroup effects are claimed." }, { "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.", "current_reports": [ "S01" ], "existence": "Retained bilingual research and bibliographic summaries exist. Current existence, public availability, acquisition and reading of external papers, registration, plans and original product, funding and harm material have not been separately established.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.", "observation": "The original advertising boundary states that traditional use, animal sleep or uncontrolled PSQI cannot justify hypnotic-replacement or insomnia-treatment claims. The current question concerns comparative PSQI efficacy.", "condition_status": "Not applicable", "status_reason": "Clinical-event/hypnotic-replacement extension obligations are not applied to this score question.", "missingness": "Extension obligations are Not applicable; hypnotic replacement or treatment effects have not been verified.", "uncertainty": "Extension obligations are Not applicable; hypnotic replacement or treatment effects have not been verified.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "Direct event/treatment/medication-change comparisons and result definitions if a clinical extension is claimed." }, { "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.", "current_reports": [ "S01" ], "existence": "Retained bilingual research and bibliographic summaries exist. Current existence, public availability, acquisition and reading of external papers, registration, plans and original product, funding and harm material have not been separately established.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.", "observation": "The original safety record reports 1 person with mild palpitations in the 50-person pilot. Systematic collection, exact exposure/follow-up denominator, onset/discontinuation and other event totals are unverified.", "condition_status": "Partly verified", "status_reason": "A report in 1 person and mild wording are available, but collection, denominator/duration and discontinuation verification remain.", "missingness": "Direct adverse-event collection, denominator/duration and discontinuation material is needed. A report in 1 person does not establish safety or comparative risk.", "uncertainty": "Direct adverse-event collection, denominator/duration and discontinuation material is needed. A report in 1 person does not establish safety or comparative risk.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "Thai-trial adverse-event tables, collection methods, exposure/follow-up denominators and palpitation/discontinuation records." }, { "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.", "current_reports": [ "S01" ], "existence": "Retained bilingual research and bibliographic summaries exist. Current existence, public availability, acquisition and reading of external papers, registration, plans and original product, funding and harm material have not been separately established.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.", "observation": "Palpitations were reported in 1 person, but timing, recovery/rechallenge, baseline cardiovascular condition, concomitant factors and concurrent controls are absent from the summary. Causality and comparative risk are not established.", "condition_status": "Unverified", "status_reason": "Timing, alternative-cause and comparator information are insufficient to assess event causality/comparative risk.", "missingness": "Administration, onset, discontinuation/recovery, alternative explanations and comparison material remain needed.", "uncertainty": "Administration, onset, discontinuation/recovery, alternative explanations and comparison material remain needed.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "Palpitation onset dates, administration/discontinuation, recovery, concomitant medicines/disease and comparator events." }, { "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.", "current_reports": [ "S02" ], "existence": "Retained bilingual research and bibliographic summaries exist. Current existence, public availability, acquisition and reading of external papers, registration, plans and original product, funding and harm material have not been separately established.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.", "observation": "The record states that 6 healthy men all exceeded the study-era WADA reporting threshold after 0.8 g taken 3 times daily for 3 days. This is not a sleep endpoint; current anti-doping rules, insomnia-patient risk and clinical harms are unverified.", "condition_status": "Partly verified", "status_reason": "Dose, frequency/duration and urinary results exist, but application to current rules and clinical harms remains separately unverified.", "missingness": "Product-specific composition, exposure/analysis, differences between historical/current criteria and direct clinical-harm material in insomnia patients are needed.", "uncertainty": "Product-specific composition, exposure/analysis, differences between historical/current criteria and direct clinical-harm material in insomnia patients are needed.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "Exposure product/composition, urine collection/analysis, study-era reporting threshold and separate current official rules/clinical-harm material." }, { "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.", "current_reports": [ "S01", "S02" ], "existence": "Retained bilingual research and bibliographic summaries exist. Current existence, public availability, acquisition and reading of external papers, registration, plans and original product, funding and harm material have not been separately established.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.", "observation": "The original safety label is Caution. Pregnancy, lactation, cardiovascular disease, drug interactions and long-term safety are not established. The limited records of 50 and 6 participants do not resolve this scope.", "condition_status": "Unverified", "status_reason": "Direct safety data matching these vulnerable populations, long-term use or interactions are unverified in the record.", "missingness": "Direct vulnerable-population, long-term exposure, interaction and event-collection material is needed.", "uncertainty": "Direct vulnerable-population, long-term exposure, interaction and event-collection material is needed.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "Product-specific long-term follow-up, vulnerable-population, interaction, rare/serious-event and discontinuation material." }, { "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.", "current_reports": [ "S01", "S02", "S03" ], "existence": "Retained bilingual research and bibliographic summaries exist. Current existence, public availability, acquisition and reading of external papers, registration, plans and original product, funding and harm material have not been separately established.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.", "observation": "S01 records Panaosod raw-material/manufacturing support and a company-laboratory author; separate cash funding, patents and complete COI are unverified. S02 funding details are unverified; S03 records LG H&H employee authors.", "condition_status": "Partly verified", "status_reason": "Reported company relationships are known, but complete funding, patents, COI and independence verification remains.", "missingness": "Report-specific cash/in-kind support, patents, COI and independence material is needed.", "uncertainty": "Report-specific cash/in-kind support, patents, COI and independence material is needed.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "Original report-specific funding/support, author affiliation, COI, patent and product-provision sections." }, { "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.", "current_reports": [ "S01", "S02", "S03" ], "existence": "Retained bilingual research and bibliographic summaries exist. Current existence, public availability, acquisition and reading of external papers, registration, plans and original product, funding and harm material have not been separately established.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.", "observation": "The original review date is 2026-09-08 and correction date is 2026-09-14. Evidence scope is retained material only, without proof of absence. The retained record describes a 2026-10-05 local-summary conversion, without a new search or external reading.", "condition_status": "Met", "status_reason": "Original dates, scope, absence-not-proven state and editorial scope specify limits on absence wording. This verifies search-scope preservation.", "missingness": "Retained scope and dates are connected. Worldwide current literature absence and current original-paper verification were not established.", "uncertainty": "Retained scope and dates are connected. Worldwide current literature absence and current original-paper verification were not established.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "Retained review date, search/editorial scope and unverified wording, plus search records if an actual later search occurs." }, { "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.", "current_reports": [ "S01", "S02", "S03" ], "existence": "Retained bilingual research and bibliographic summaries exist. Current existence, public availability, acquisition and reading of external papers, registration, plans and original product, funding and harm material have not been separately established.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.", "observation": "The retained record describes reading the Korean/English source summaries, evidence and bibliography. Historical research wording mentions Thai full-text/abstract and PMID review but lacks material-specific access level/location/date. The 3 external URLs were not attempted, acquired or read; responses and identifiers were not verified.", "condition_status": "Met", "status_reason": "Current actions, retained original URLs, historical wording and absent access fields are recorded separately. Verification is limited to reading-record consistency.", "missingness": "Current summary reading and unread external material are distinguished. Historical material-specific access level/date and current external responses/originals remain unverified.", "uncertainty": "Current summary reading and unread external material are distinguished. Historical material-specific access level/date and current external responses/originals remain unverified.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "Current original summary/locations, the 3 original URLs, historical research wording and original access records if available." }, { "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.", "current_reports": [ "S01", "S02", "S03" ], "existence": "Retained bilingual research and bibliographic summaries exist. Current existence, public availability, acquisition and reading of external papers, registration, plans and original product, funding and harm material have not been separately established.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.", "observation": "Current grade ?, unrecorded score/efficacy axes and false human-study-absence flag are retained. Evidence status identifies direct human material, no eligible controlled comparison and no proof of absence. Previous true is historical; unvalidated grade and legacy-grade-under-review states remain.", "condition_status": "Met", "status_reason": "Original types/values and current/previous/correction wording are explicit in the source. Table status does not clinically certify those original values.", "missingness": "Original pending values and historical states are retained. No new grade, score, between-group effect or clinical certification was created.", "uncertainty": "Original pending values and historical states are retained. No new grade, score, between-group effect or clinical certification was created.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "Original grade, score, axes, editorial review, grade rationale and correction record." }, { "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.", "current_reports": [ "S01", "S02" ], "existence": "Retained bilingual research and bibliographic summaries exist. Current existence, public availability, acquisition and reading of external papers, registration, plans and original product, funding and harm material have not been separately established.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.", "observation": "Palpitations in 1 person and urinary exposure in healthy people are different observations. The current main question does not claim independent repetition of the same harm or its incidence.", "condition_status": "Not applicable", "status_reason": "Repeated-harm extension obligations are not applied to the current PSQI question. The two signals are not added as repeated events.", "missingness": "Repeated-harm obligations are Not applicable. Harm/safety gaps remain in N27–N30.", "uncertainty": "Repeated-harm obligations are Not applicable. Harm/safety gaps remain in N27–N30.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "Unique events, families, products, event definitions and recitation links only if repeated harm is claimed." } ], "reports": [ { "report_id": "S01", "title": "Makmoon 2024 lotus-plumule capsules/insomnia PSQI report", "url": "https://he02.tci-thaijo.org/index.php/ttm/article/view/268242", "report_type": "Retained bibliography/evidence summary of a direct human single-arm before-and-after study", "existence": "Retained bilingual research and bibliographic summaries exist. Current existence, public availability, acquisition and reading of external papers, registration, plans and original product, funding and harm material have not been separately established.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.", "study_family": "Provisional local family link for the Thai PSQI report. Original bibliography, registration and unique-family identity were not externally compared in this work.", "independent_replication": "S01 is single-plumule PSQI, S02 healthy-person urinary exposure and S03 a different-part combination, linked as local contexts. Do not count 3 reports as 3 independent comparative PSQI trials or sum participant counts. Unique study/participant and direct independent-replication counts are unrecorded.", "observed_result": "Retained report: purposively sampled single-arm study of 50 patients with insomnia; PSQI 15.24 ± 1.19 → 1.82 ± 0.69, paired P < .05. No randomization, placebo or concurrent comparator. Dose, duration, exact completion/analysis n and ± type are unverified. It records mild palpitations in 1 person, Panaosod raw-material/manufacturing support and a company-laboratory author. Separate cash funding, patents, complete COI, PMID, DOI and registration are unverified.", "result_level": "Direct human lotus-plumule capsule before-and-after report; between-group efficacy cannot be estimated. Large change establishes neither causal efficacy nor absence of effect. Palpitation incidence/causality is not newly calculated or adjudicated.", "source_evidence_date": "2026-09-08", "materials": [ { "material_type": "Journal-paper entry page; actual current full-text/abstract availability scope unverified", "public_status": "Entry recorded; current public availability unverified", "access_status": "External access not attempted; not acquired", "acquired": false, "actually_read": "Not read", "as_of": "2026-10-05", "qualification": "A retained original URL; current access, acquisition and reading were not attempted. Link existence does not establish abstract/full-text reading. Past manuscript descriptions of full-text/abstract review and cross-checking are historical records. They do not establish actual external paper/bibliography/registration reading or independent clinical certification in this work. The original review date is 2026-09-08, the historical correction date is 2026-09-14 and the case-record review date is 2026-10-05. Historical access level and access date for individual external materials are not recorded; current access was not attempted." }, { "material_type": "Retained bilingual research/bibliographic summaries and historical review record", "public_status": "Retained copy acquired; summary read", "access_status": "Retained copy acquired; summary read", "acquired": true, "actually_read": "Stored existing review summary read", "as_of": "2026-10-05", "qualification": "Actual summary values and locations in the retained copy were read. Distinguish these from external paper-original bytes. Past manuscript descriptions of full-text/abstract review and cross-checking are historical records. They do not establish actual external paper/bibliography/registration reading or independent clinical certification in this work. The original review date is 2026-09-08, the historical correction date is 2026-09-14 and the case-record review date is 2026-10-05. Historical access level and access date for individual external materials are not recorded; current access was not attempted." } ], "links": [ { "label": "Official source", "url": "https://he02.tci-thaijo.org/index.php/ttm/article/view/268242" } ] }, { "report_id": "S02", "title": "Yen 2020 lotus-plumule/urinary higenamine exposure report", "url": "https://pubmed.ncbi.nlm.nih.gov/31973198/", "report_type": "Retained bibliography/evidence summary of a healthy-person single-arm exposure study", "existence": "Retained bilingual research and bibliographic summaries exist. Current existence, public availability, acquisition and reading of external papers, registration, plans and original product, funding and harm material have not been separately established.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.", "study_family": "Provisional local family link for healthy-person exposure, not a direct PSQI-efficacy family. Original bibliography/registration identity was not externally compared in this work.", "independent_replication": "S01 is single-plumule PSQI, S02 healthy-person urinary exposure and S03 a different-part combination, linked as local contexts. Do not count 3 reports as 3 independent comparative PSQI trials or sum participant counts. Unique study/participant and direct independent-replication counts are unrecorded.", "observed_result": "Retained report: 6 healthy men all exceeded the study-era WADA reporting threshold after 0.8 g taken 3 times daily for 3 days. The endpoint is urinary higenamine, not sleep. It is described as academic research/product analysis, but actual funding details are unverified. PMID 31973198, PMCID PMC7070534 and DOI 10.3390/nu12020285 are retained identifiers.", "result_level": "Plant part and human exposure are relevant, but the efficacy endpoint differs. Do not transfer this to current anti-doping rules, insomnia-patient harms, clinical causality or improved sleep.", "source_evidence_date": "2026-09-08", "materials": [ { "material_type": "PubMed paper abstract/bibliography entry; actual current availability scope unverified", "public_status": "Entry recorded; current public availability unverified", "access_status": "External access not attempted; not acquired", "acquired": false, "actually_read": "Not read", "as_of": "2026-10-05", "qualification": "A retained original URL; current access, acquisition and reading were not attempted. Link existence does not establish abstract/full-text reading. Past manuscript descriptions of full-text/abstract review and cross-checking are historical records. They do not establish actual external paper/bibliography/registration reading or independent clinical certification in this work. The original review date is 2026-09-08, the historical correction date is 2026-09-14 and the case-record review date is 2026-10-05. Historical access level and access date for individual external materials are not recorded; current access was not attempted." }, { "material_type": "Retained bilingual research/bibliographic summaries and historical review record", "public_status": "Retained copy acquired; summary read", "access_status": "Retained copy acquired; summary read", "acquired": true, "actually_read": "Stored existing review summary read", "as_of": "2026-10-05", "qualification": "Actual summary values and locations in the retained copy were read. Distinguish these from external paper-original bytes. Past manuscript descriptions of full-text/abstract review and cross-checking are historical records. They do not establish actual external paper/bibliography/registration reading or independent clinical certification in this work. The original review date is 2026-09-08, the historical correction date is 2026-09-14 and the case-record review date is 2026-10-05. Historical access level and access date for individual external materials are not recorded; current access was not attempted." } ], "links": [ { "label": "PubMed", "url": "https://pubmed.ncbi.nlm.nih.gov/31973198/" } ] }, { "report_id": "S03", "title": "Kim 2024 Rhodiola/lotus-seed combination report", "url": "https://pubmed.ncbi.nlm.nih.gov/38931222/", "report_type": "Retained bibliography/evidence summary of a different-part combination single-arm study", "existence": "Retained bilingual research and bibliographic summaries exist. Current existence, public availability, acquisition and reading of external papers, registration, plans and original product, funding and harm material have not been separately established.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.", "study_family": "Provisional local family link for a combination report, not direct single-plumule PSQI replication. Original-paper identity and unique-family relationships were not externally compared in this work.", "independent_replication": "S01 is single-plumule PSQI, S02 healthy-person urinary exposure and S03 a different-part combination, linked as local contexts. Do not count 3 reports as 3 independent comparative PSQI trials or sum participant counts. Unique study/participant and direct independent-replication counts are unrecorded.", "observed_result": "Retained report: 2:1 Rhodiola-root/lotus-seed combination, 20 enrolled and 13 completed. ISI, PSQI and sleep diaries improved before versus after; no placebo comparator. LG H&H employee authors are recorded. PMID 38931222, PMCID PMC11206944 and DOI 10.3390/nu16121867 are retained identifiers.", "result_level": "Excluded from direct efficacy for plant-part, combination-product and comparator mismatch. Combination before-and-after improvement does not identify single-plumule contribution; completers do not replace an effect estimate for all enrolled participants.", "source_evidence_date": "2026-09-08", "materials": [ { "material_type": "PubMed paper abstract/bibliography entry; actual current availability scope unverified", "public_status": "Entry recorded; current public availability unverified", "access_status": "External access not attempted; not acquired", "acquired": false, "actually_read": "Not read", "as_of": "2026-10-05", "qualification": "A retained original URL; current access, acquisition and reading were not attempted. Link existence does not establish abstract/full-text reading. Past manuscript descriptions of full-text/abstract review and cross-checking are historical records. They do not establish actual external paper/bibliography/registration reading or independent clinical certification in this work. The original review date is 2026-09-08, the historical correction date is 2026-09-14 and the case-record review date is 2026-10-05. Historical access level and access date for individual external materials are not recorded; current access was not attempted." }, { "material_type": "Retained bilingual research/bibliographic summaries and historical review record", "public_status": "Retained copy acquired; summary read", "access_status": "Retained copy acquired; summary read", "acquired": true, "actually_read": "Stored existing review summary read", "as_of": "2026-10-05", "qualification": "Actual summary values and locations in the retained copy were read. Distinguish these from external paper-original bytes. Past manuscript descriptions of full-text/abstract review and cross-checking are historical records. They do not establish actual external paper/bibliography/registration reading or independent clinical certification in this work. The original review date is 2026-09-08, the historical correction date is 2026-09-14 and the case-record review date is 2026-10-05. Historical access level and access date for individual external materials are not recorded; current access was not attempted." } ], "links": [ { "label": "PubMed", "url": "https://pubmed.ncbi.nlm.nih.gov/38931222/" } ] } ], "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." }, "study_overlap": { "state": "Unverified", "unique_trial_count": null, "unique_participant_count": null, "reason": "S01 is single-plumule PSQI, S02 healthy-person urinary exposure and S03 a different-part combination, linked as local contexts. Do not count 3 reports as 3 independent comparative PSQI trials or sum participant counts. Unique study/participant and direct independent-replication counts are unrecorded." }, "history": [ { "date": "2026-10-28", "kind": "Separation of public-facing pages and materials", "view_version": "1.0", "change": "The public view and materials were prepared from the existing 35 items. No new clinical search, verification-state change or scoring was performed." } ], "language": "en", "translation_date": "2026-10-28" }