# Lotus plumule tea or single-ingredient plumule extract × Improvement of sleep quality in adults with insomnia

Verdict 3079 · Evidence Check

Stored-material review date: 2026-10-05  
Original evidence review date: 2026-09-08  
Review-criteria version: 1.0  
Public page/material preparation date: 2026-10-28

Clinical papers were not read directly; existing review summaries were checked. No new clinical-literature search was performed. Unverified does not mean that research is absent or that there is no effect.

## Assessment scope

- Population: Adults with insomnia symptoms; direct material records 50 patients with insomnia, but exact age, diagnosis and selection criteria are unverified
- Ingredient, formulation and route: 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
- 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
- Measured outcome: 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
- Duration: Actual administration duration and measurement times in the direct PSQI study are unverified
- Questions outside this scope: 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.

## Checklist items

### N01 · Which lotus-plumule sleep-quality question does this table address?

Verification status: Met  
Reading scope: 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.

- Current findings: 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.
- Why unverified: The original claim, claim conditions and summary note specify population, plant-part and endpoint boundaries. This verifies claim identity, not a treatment effect.
- Reason for missing information: The question identity and exclusions are verified. Eligible comparative trials and product equivalence remain gaps in other rows.
- Required materials and conditions: Exact canonical manuscript and URL for the claim, plant part, formulation, population, endpoint and comparison.
- Materials to obtain first: Exact canonical manuscript and URL for the claim, plant part, formulation, population, endpoint and comparison.
- Further research: Fix inclusion/exclusion boundaries and check whether other plant parts, combinations, exposure or mechanistic material enter this question.
- Conditions for verification: Connect the original claim location to a concurrent-comparison question about oral single-ingredient lotus plumule, adults with insomnia and PSQI.
- Why this condition is needed: Needed to avoid combining different plant parts and endpoints into one effect because the plant name is shared.
- Application exceptions: Retain the empty subclaim list; do not automatically create separate tables for every formulation or safety clue.
- Remaining uncertainty: The question identity and exclusions are verified. Eligible comparative trials and product equivalence remain gaps in other rows.
- Referenced methods: 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.
- Related sources: S01, S02, S03

### N02 · Is the actual capsule equivalent to tea or a standardized single-plumule extract?

Verification status: Partly verified  
Reading scope: 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.

- Current findings: 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.
- Why unverified: Plant part and capsule names are available, but actual composition, batch information and formulation comparisons are absent.
- Reason for missing information: Beyond the embryo/capsule names, material is needed on actual single-ingredient composition, content, quality and equivalence to tea/extract.
- Required materials and conditions: Thai capsule ingredients, embryo identification, cultivar/origin, extraction/manufacture, quality tests and tea/extract comparisons.
- Materials to obtain first: Thai capsule ingredients, embryo identification, cultivar/origin, extraction/manufacture, quality tests and tea/extract comparisons.
- Further research: Compare batch composition, identification and chemical analyses; classify different formulations in separate eligibility strata.
- Conditions for verification: Verify actual content, single-ingredient composition, extraction, standardization and tea/extract equivalence for the green embryo of mature seeds.
- Why this condition is needed: Needed to avoid transferring capsule before-and-after findings to tea or all lotus products.
- Application exceptions: Lotus seed flesh, leaf, root and Rhodiola mixtures are not the same single-ingredient plumule product.
- Remaining uncertainty: Beyond the embryo/capsule names, material is needed on actual single-ingredient composition, content, quality and equivalence to tea/extract.
- Referenced methods: 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.
- Related sources: S01

### N03 · Are the actual dose and dosing frequency in the sleep-quality study verified?

Verification status: Unverified  
Reading scope: 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.

- Current findings: 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.
- Why unverified: Actual dose, frequency and adherence for the direct PSQI study are absent from the retained record.
- Reason for missing information: Sleep-study capsule dose, dosing frequency and adherence must be obtained; exposure-study dosing cannot fill the gap.
- Required materials and conditions: Thai-trial capsule content, daily amount/frequency, administration records and adherence material.
- Materials to obtain first: Thai-trial capsule content, daily amount/frequency, administration records and adherence material.
- Further research: Compare product labeling with actual administration records and separate material using different doses.
- Conditions for verification: Connect nominal dose, actual intake, adherence and frequency to the single-plumule sleep-quality study.
- Why this condition is needed: Needed to avoid attributing PSQI values to a particular regimen without administration conditions.
- Application exceptions: The higenamine-exposure dose of 0.8 g taken 3 times daily is not the sleep-quality study dose.
- Remaining uncertainty: Sleep-study capsule dose, dosing frequency and adherence must be obtained; exposure-study dosing cannot fill the gap.
- Referenced methods: 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.
- Related sources: S01, S02

### N04 · Are administration duration and assessment times for single-plumule PSQI verified?

Verification status: Unverified  
Reading scope: 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.

- Current findings: Before-and-after PSQI is reported, but exact single-plumule administration duration and measurement times are unverified. The 3-day higenamine exposure is separate.
- Why unverified: Duration in the original claim conditions remains unverified for an eligible controlled trial; the direct before-and-after study schedule is also unavailable.
- Reason for missing information: The direct PSQI study schedule and assessment interval are needed; 3 days cannot be used as that duration.
- Required materials and conditions: Thai-trial administration/assessment schedule, visit table and follow-up duration.
- Materials to obtain first: Thai-trial administration/assessment schedule, visit table and follow-up duration.
- Further research: Compare actual visits and assessment dates, distinguishing end-of-treatment from post-discontinuation follow-up.
- Conditions for verification: Connect administration start/end, the before-and-after PSQI interval and observation duration to direct sleep-quality material.
- Why this condition is needed: Needed to avoid borrowing the interval between measurements from another study.
- Application exceptions: The 3 days in the separate exposure study are not the Thai PSQI observation period.
- Remaining uncertainty: The direct PSQI study schedule and assessment interval are needed; 3 days cannot be used as that duration.
- Referenced methods: 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.
- Related sources: S01, S02

### N05 · Are insomnia diagnosis, severity and target population in the 50-person study verified?

Verification status: Partly verified  
Reading scope: 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.

- Current findings: 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.
- Why unverified: The intended population and patient count are known, but matching clinical selection criteria and representativeness remain unverified.
- Reason for missing information: Age, insomnia criteria, baseline conditions and exclusions for the 50 participants are needed.
- Required materials and conditions: Thai participants’ age, insomnia diagnosis/selection, baseline disease, medicines and PSQI distribution.
- Materials to obtain first: Thai participants’ age, insomnia diagnosis/selection, baseline disease, medicines and PSQI distribution.
- Further research: Compare original inclusion/exclusion criteria and baseline distribution; do not generalize to unverified populations.
- Conditions for verification: Compare age, insomnia selection criteria, severity and disease/medicine exclusions with the adult-insomnia question.
- Why this condition is needed: An insomnia-patient label does not make every adult-insomnia population equivalent.
- Application exceptions: The 6 healthy men and combination-product sleep-disturbance population cannot replace the direct insomnia population.
- Remaining uncertainty: Age, insomnia criteria, baseline conditions and exclusions for the 50 participants are needed.
- Referenced methods: 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.
- Related sources: S01, S02, S03

### N06 · Can purposive recruitment, exclusions and selection effects be verified?

Verification status: Partly verified  
Reading scope: 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.

- Current findings: The Thai study is recorded as a purposively sampled single-arm pilot. Recruitment source, contacted/excluded counts and baseline balance are unverified.
- Why unverified: Sampling method is identified, but information is insufficient to assess selection flow and effects.
- Reason for missing information: Material remains needed on actual purposive recruitment, exclusions and participant selection.
- Required materials and conditions: Recruitment notices, selected/excluded counts, consent/participation flow and baseline characteristics.
- Materials to obtain first: Recruitment notices, selected/excluded counts, consent/participation flow and baseline characteristics.
- Further research: Reconstruct recruitment-to-analysis flow and compare participation/exclusion reasons and population distributions.
- Conditions for verification: Describe recruitment source, contact/participation and exclusion flow, and purposive selection.
- Why this condition is needed: Needed to avoid assuming that changes in selected before-and-after data represent general patient responses.
- Application exceptions: Do not calculate bias direction or magnitude solely from purposive sampling.
- Remaining uncertainty: Material remains needed on actual purposive recruitment, exclusions and participant selection.
- Referenced methods: 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.
- Related sources: S01

### N07 · Was an eligible concurrent-comparison trial of single-ingredient plumule identified?

Verification status: Unverified  
Reading scope: 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.

- Current findings: 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.
- Why unverified: The evidence-status record identifies direct human evidence but no eligible controlled efficacy study. Material establishing controlled efficacy is still needed.
- Reason for missing information: An actual eligible comparative trial and between-group estimate are needed. Human evidence existing does not fill this gap.
- Required materials and conditions: Single-plumule versus suitable placebo/control trial reports, allocation/analysis and PSQI results by group.
- Materials to obtain first: Single-plumule versus suitable placebo/control trial reports, allocation/analysis and PSQI results by group.
- Further research: Plan subsequent research as a comparison with defined product, population and timing, separating natural history, regression and expectancy effects.
- Conditions for verification: Verify eligible material with a concurrent comparator, allocation and between-group estimation for the same question.
- Why this condition is needed: Needed to distinguish before-and-after change from the selected plumule’s comparative contribution.
- Application exceptions: Unverified in the previous search does not prove permanent worldwide absence of literature or an effect of 0.
- Remaining uncertainty: An actual eligible comparative trial and between-group estimate are needed. Human evidence existing does not fill this gap.
- Referenced methods: 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.
- Related sources: S01

### N08 · Can allocation, concealment and assessor blinding for comparative PSQI efficacy be verified?

Verification status: Unverified  
Reading scope: 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.

- Current findings: The retained direct study has no randomization, placebo or concurrent comparator. Allocation/blinding material separating expectancy effects is unverified.
- Why unverified: A single-arm before-and-after design cannot establish allocation/measurement control required for the selected causal comparison.
- Reason for missing information: Actual allocation, concealment and assessment-control material appropriate to concurrent comparative efficacy is needed.
- Required materials and conditions: Eligible comparative-trial allocation/concealment procedures and placebo/assessment-blinding documents.
- Materials to obtain first: Eligible comparative-trial allocation/concealment procedures and placebo/assessment-blinding documents.
- Further research: Compare implementation with the protocol and address expectancy/measurement influences on subjective PSQI in the analysis plan.
- Conditions for verification: Examine actual random sequence, allocation concealment, participant/assessor blinding and expectancy effects.
- Why this condition is needed: Needed to verify whether subjective score change was separated from expectancy effects.
- Application exceptions: Do not arbitrarily assign completed RCT allocation or crossover/cluster non-applicability to this single-arm design.
- Remaining uncertainty: Actual allocation, concealment and assessment-control material appropriate to concurrent comparative efficacy is needed.
- Referenced methods: 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.
- Related sources: S01

### N09 · Are sleep medicines, lifestyle changes and adherence distinguished from PSQI changes?

Verification status: Unverified  
Reading scope: 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.

- Current findings: The current single-arm summary lacks information on sleep medicines, lifestyle changes, concomitant treatment, adherence and their handling.
- Why unverified: Records are insufficient to evaluate other explanations for before-and-after change.
- Reason for missing information: Direct-study concurrent interventions, concomitant treatment, adherence and their analytical handling are needed.
- Required materials and conditions: Sleep medicines/disease treatment, lifestyle/concurrent interventions, adherence, rescue treatment and change records.
- Materials to obtain first: Sleep medicines/disease treatment, lifestyle/concurrent interventions, adherence, rescue treatment and change records.
- Further research: Create a timeline of concurrent treatment/lifestyle changes; examine changes in both groups and adherence handling in an eligible comparison.
- Conditions for verification: Verify relationships between concomitant medicines, sleep hygiene, concurrent interventions, discontinuation/adherence and PSQI analysis.
- Why this condition is needed: Needed to avoid attributing factors changing alongside plumule use to the plumule itself.
- Application exceptions: Missing information does not establish that concomitant treatment or lifestyle changes were absent.
- Remaining uncertainty: Direct-study concurrent interventions, concomitant treatment, adherence and their analytical handling are needed.
- Referenced methods: 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.
- Related sources: S01

### N10 · Are the PSQI version, collection and assessment conditions verified?

Verification status: Partly verified  
Reading scope: 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.

- Current findings: The direct-material endpoint is before-and-after PSQI. Scale version, language, collection, blinding, item handling and exact measurement schedule are unverified.
- Why unverified: The PSQI endpoint and before-and-after report exist, but actual measurement procedures remain unverified.
- Reason for missing information: The actual PSQI tool, collection conditions and assessment schedule are needed.
- Required materials and conditions: PSQI tool/language version, assessment procedures, scoring and measurement schedule.
- Materials to obtain first: PSQI tool/language version, assessment procedures, scoring and measurement schedule.
- Further research: Compare scale and collection methods; verify measurement/expectancy effects and missing-item handling.
- Conditions for verification: Verify PSQI version/language, collection method, assessor, measurement interval and interpretation.
- Why this condition is needed: Needed to avoid treating an endpoint name alone as verification of actual measurement conditions.
- Application exceptions: Do not convert ISI, sleep diaries, animal sleep time or urinary higenamine into the same PSQI result.
- Remaining uncertainty: The actual PSQI tool, collection conditions and assessment schedule are needed.
- Referenced methods: 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.
- Related sources: S01, S02, S03

### N11 · Which analysis and time points do the Thai PSQI values represent?

Verification status: Partly verified  
Reading scope: 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.

- Current findings: 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.
- Why unverified: Reported numbers and paired P can be retained, but analysis, timing and variance definitions are incomplete.
- Reason for missing information: 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.
- Required materials and conditions: Original PSQI tables, measurement times, analysis population, ± definition and change-analysis results.
- Materials to obtain first: Original PSQI tables, measurement times, analysis population, ± definition and change-analysis results.
- Further research: Compare original tables exactly and separate paired analysis from between-group comparison.
- Conditions for verification: Connect before-and-after values, testing, denominators and timing; distinguish between-group effects.
- Why this condition is needed: Needed to retain original numbers without arbitrarily extending their attribution.
- Application exceptions: Do not calculate a new before-and-after difference, CI or between-group effect.
- Remaining 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.
- Referenced methods: 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.
- Related sources: S01

### N12 · Are the paired-P analysis population, test and actual comparative efficacy verified?

Verification status: Partly verified  
Reading scope: 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.

- Current findings: Paired P < .05 is recorded. Test type, analysis n, model/assumptions are unverified; without a concurrent comparator it provides no between-group efficacy estimate.
- Why unverified: A within-group test is indicated, but the analysis specification and causal comparison remain unverified.
- Reason for missing information: Actual paired-test methods, denominator and between-group analysis appropriate to comparative efficacy are needed.
- Required materials and conditions: Paired-test type, assumptions, analysis n, handling rules and between-group comparison results.
- Materials to obtain first: Paired-test type, assumptions, analysis n, handling rules and between-group comparison results.
- Further research: Compare original testing/analysis plans with tables; do not transfer within-group significance into a between-group difference.
- Conditions for verification: Distinguish within-group paired testing, analysis denominator and model from concurrent between-group effects.
- Why this condition is needed: Needed to avoid establishing plumule contribution or between-group differences from within-group P alone.
- Application exceptions: Do not convert paired P < .05 into an exact P, equivalence, no difference or treatment-effect magnitude.
- Remaining uncertainty: Actual paired-test methods, denominator and between-group analysis appropriate to comparative efficacy are needed.
- Referenced methods: 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.
- Related sources: S01

### N13 · Are the ± type and comparative-effect CI verified?

Verification status: Unverified  
Reading scope: 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.

- Current findings: 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.
- Why unverified: Recorded ± alone cannot establish required precision or a comparative-effect interval.
- Reason for missing information: Variance notes, paired variance, denominator and actual reported interval are needed.
- Required materials and conditions: ± definition, before-and-after correlation/paired variance, analysis n, reported CI and derivation methods.
- Materials to obtain first: ± definition, before-and-after correlation/paired variance, analysis n, reported CI and derivation methods.
- Further research: Compare original table notes and statistical methods; interpret only verified intervals.
- Conditions for verification: Verify the SD/SE or other ± definition, paired variance, denominator and comparative-effect interval.
- Why this condition is needed: Needed to avoid arbitrarily interpreting printed ± as CI or SD.
- Application exceptions: Do not calculate a new CI, standardized effect or paired variance from the current material.
- Remaining uncertainty: Variance notes, paired variance, denominator and actual reported interval are needed.
- Referenced methods: 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.
- Related sources: S01

### N14 · Are completion, PSQI-analysis and missing-data denominators among the 50 verified?

Verification status: Partly verified  
Reading scope: 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.

- Current findings: 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.
- Why unverified: Participant count is known, but analysis denominator and losses for this result remain unverified.
- Reason for missing information: Actual measurement/completion/analysis n and missingness/withdrawal records for the 50-person material are needed.
- Required materials and conditions: Thai participation flow, before-and-after measurement n, completion/withdrawal reasons, analysis population and missing-data handling.
- Materials to obtain first: Thai participation flow, before-and-after measurement n, completion/withdrawal reasons, analysis population and missing-data handling.
- Further research: Trace denominators from participation to paired analysis; examine interpretation limits from missingness/withdrawal handling.
- Conditions for verification: Distinguish participation, completion, measurement at each time, paired analysis and withdrawal-handling denominators.
- Why this condition is needed: Needed to avoid automatically using the reported 50 as complete-case paired-analysis n.
- Application exceptions: The separate combination-product flow of 20 and 13 is not the Thai analysis denominator.
- Remaining uncertainty: Actual measurement/completion/analysis n and missingness/withdrawal records for the 50-person material are needed.
- Referenced methods: 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.
- Related sources: S01, S03

### N15 · Can a PSQI important-difference threshold be compared with the comparative interval?

Verification status: Unverified  
Reading scope: 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.

- Current findings: Large before-and-after PSQI change is recorded, but a justified important-difference threshold for this population and actual between-group CI are unverified.
- Why unverified: Evidence is unavailable to evaluate comparative sleep-quality efficacy magnitude, precision and clinical importance.
- Reason for missing information: An important-difference threshold for the population and a comparative-effect interval are needed.
- Required materials and conditions: Important-difference evidence for the population, prespecified criteria and actual between-group estimate/CI.
- Materials to obtain first: Important-difference evidence for the population, prespecified criteria and actual between-group estimate/CI.
- Further research: Verify the threshold source and population, then compare the eligible comparative-trial interval with it.
- Conditions for verification: Compare a previously justified PSQI important-difference threshold with a between-group interval.
- Why this condition is needed: Needed to avoid assigning clinical sufficiency solely from change magnitude or significance.
- Application exceptions: Do not arbitrarily set minimum participant counts, duration or an important difference.
- Remaining uncertainty: An important-difference threshold for the population and a comparative-effect interval are needed.
- Referenced methods: 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.
- Related sources: S01

### N16 · Do planned PSQI, timing and analyses match the actual report?

Verification status: Unverified  
Reading scope: 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.

- Current findings: PMID, DOI and registration identifiers for S01 are unverified, as is the registration field. Planned and actual reports could not be compared.
- Why unverified: No record establishes acquisition/verification of plan/registration documents and identifiers.
- Reason for missing information: Agreement and change reasons between registration/plans and actual PSQI reporting are needed.
- Required materials and conditions: Thai-study registration identifier, protocol, analysis plan and endpoint/timing change history.
- Materials to obtain first: Thai-study registration identifier, protocol, analysis plan and endpoint/timing change history.
- Further research: Tabulate planned endpoints/timing/analysis against original results, recording changes and uncompared areas.
- Conditions for verification: Directly compare registration, protocol and analysis plan with results and reasons for changes.
- Why this condition is needed: Needed to reveal material required to assess selection of favorable times or analyses.
- Application exceptions: Failure to verify does not establish non-registration or selective reporting.
- Remaining uncertainty: Agreement and change reasons between registration/plans and actual PSQI reporting are needed.
- Referenced methods: 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.
- Related sources: S01

### N17 · Can unique family and result identities of the three reports be verified?

Verification status: Partly verified  
Reading scope: 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.

- Current findings: 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.
- Why unverified: Report roles can be distinguished, but complete unique-family and duplicate-identity verification remains.
- Reason for missing information: Unique families, registration identities and recitation/duplication relationships of the three reports must be verified.
- Required materials and conditions: Original bibliography, trial/registration identifiers and duplicate-report/participant links for the three reports.
- Materials to obtain first: Original bibliography, trial/registration identifiers and duplicate-report/participant links for the three reports.
- Further research: Create a family-identity table, separating single-plumule PSQI, higenamine exposure and combination material; check recitation of the same results.
- Conditions for verification: Verify family links and independence using bibliography, registration, population/intervention, timing and analysis.
- Why this condition is needed: Needed to avoid counting 3 reports as 3 independent PSQI replications.
- Application exceptions: The presence of identifier strings does not establish actual external bibliography/registration verification.
- Remaining uncertainty: Unique families, registration identities and recitation/duplication relationships of the three reports must be verified.
- Referenced methods: 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.
- Related sources: S01, S02, S03

### N18 · Are independent controlled replications of single-plumule PSQI verified?

Verification status: Unverified  
Reading scope: 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.

- Current findings: 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.
- Why unverified: Material establishing an independent controlled comparison of the same question is unavailable.
- Reason for missing information: Eligible comparative results from independent families and trial-link material are needed.
- Required materials and conditions: Eligible single-plumule comparative trials, independent families, between-group results and condition differences.
- Materials to obtain first: Eligible single-plumule comparative trials, independent families, between-group results and condition differences.
- Further research: Compare unique trials and contrary/no-difference results; do not add adjacent material as replication.
- Conditions for verification: Verify independent-family results for matching population, plant part, formulation and PSQI comparison.
- Why this condition is needed: Needed to avoid converting report counts into independent replication of comparative efficacy.
- Application exceptions: Unverified controlled material does not prove absent or failed efficacy replication.
- Remaining uncertainty: Eligible comparative results from independent families and trial-link material are needed.
- Referenced methods: 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.
- Related sources: S01, S02, S03

### N19 · Were positive before-and-after observations and their limitations retained together?

Verification status: Met  
Reading scope: 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.

- Current findings: 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.
- Why unverified: The interpretation-limits field and report results/weight present positive observations with limitations. This verifies result preservation.
- Reason for missing information: Positive original observations and their limits are attributed. Controlled-efficacy and precision gaps remain.
- Required materials and conditions: Original locations of before-and-after results, interpretation limits, combination findings and inclusion/exclusion reasons.
- Materials to obtain first: Original locations of before-and-after results, interpretation limits, combination findings and inclusion/exclusion reasons.
- Further research: Tabulate direction together with design/attribution; favorable material must not erase controlled-efficacy gaps.
- Conditions for verification: Explain large before-and-after changes and adjacent positive results alongside comparator/attribution limits.
- Why this condition is needed: Needed to avoid deleting positive original observations or converting them into causal efficacy.
- Application exceptions: Differences between numbers from different formulations/endpoints are not automatically conflicting data.
- Remaining uncertainty: Positive original observations and their limits are attributed. Controlled-efficacy and precision gaps remain.
- Referenced methods: 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.
- Related sources: S01, S03

### N20 · Do Rhodiola-combination results answer the single-plumule effect question?

Verification status: Met  
Reading scope: 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.

- Current findings: 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.
- Why unverified: The combination composition, flow, endpoints and exclusion reasons are explicit in the third evidence report. Verification concerns attribution boundaries.
- Reason for missing information: The combination role and direct-evidence exclusion are verified. Single-plumule contribution or an effect for all 20 is not established.
- Required materials and conditions: Combination composition, population, completion/withdrawal, original ISI/PSQI results and component-isolation comparison.
- Materials to obtain first: Combination composition, population, completion/withdrawal, original ISI/PSQI results and component-isolation comparison.
- Further research: Keep combination results in a separate eligibility stratum; design component-isolation comparisons if single-plumule contribution is needed.
- Conditions for verification: Distinguish combination ingredients, plant part, single-arm design, 20 enrolled/13 completed and endpoint applicability.
- Why this condition is needed: Needed to avoid attributing positive combination/other-part results to the selected single ingredient.
- Application exceptions: Do not automatically use the 13 completers as the sleep-quality effect denominator for all 20 enrolled.
- Remaining uncertainty: The combination role and direct-evidence exclusion are verified. Single-plumule contribution or an effect for all 20 is not established.
- Referenced methods: 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.
- Related sources: S03

### N21 · Is higenamine material kept out of PSQI efficacy?

Verification status: Met  
Reading scope: 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.

- Current findings: S02 concerns urinary higenamine in 6 healthy men, not sleep. Its original evidence weight is limited to safety context.
- Why unverified: Population, endpoint and safety role are explicit in the second evidence report and second citation.
- Reason for missing information: The safety-context role and PSQI-efficacy exclusion are verified. Current rules and clinical harms remain separate.
- Required materials and conditions: Healthy-male exposure, urinary higenamine results and PSQI applicability boundaries.
- Materials to obtain first: Healthy-male exposure, urinary higenamine results and PSQI applicability boundaries.
- Further research: Compare endpoint/population eligibility, keeping exposure/safety material separate from efficacy results.
- Conditions for verification: Separate urinary exposure from sleep-quality endpoints even when human exposure and plant part match.
- Why this condition is needed: Needed to avoid combining a different endpoint with efficacy solely because it concerns human lotus-plumule exposure.
- Application exceptions: Do not convert the study-era WADA threshold into verification of current rules or insomnia efficacy.
- Remaining uncertainty: The safety-context role and PSQI-efficacy exclusion are verified. Current rules and clinical harms remain separate.
- Referenced methods: 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.
- Related sources: S02

### N22 · Is animal sedation required as a direct result for human PSQI?

Verification status: Not applicable  
Reading scope: 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.

- Current findings: 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.
- Why unverified: The main question concerns comparative adult PSQI efficacy, so animal mechanisms are not applied as a sufficiency requirement. Narrative boundaries remain.
- Reason for missing information: The mechanistic-extension obligation is Not applicable. Animal originals remain unread; direct human effects are not verified.
- Required materials and conditions: Original narrative locations and population, plant-part and endpoint descriptions for animal/mechanistic references.
- Materials to obtain first: Original narrative locations and population, plant-part and endpoint descriptions for animal/mechanistic references.
- Further research: Review applicability boundaries in the original explanation; connect separate eligible material only when direct human trials exist.
- Conditions for verification: Distinguish animal/other-part mechanisms from direct adult PSQI comparisons.
- Why this condition is needed: A boundary needed to avoid extending related mechanisms into human sleep-quality effects.
- Application exceptions: Do not impose animal-sedation trials as an efficacy requirement for the current main question.
- Remaining uncertainty: The mechanistic-extension obligation is Not applicable. Animal originals remain unread; direct human effects are not verified.
- Referenced methods: 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.
- Related sources: 

### N23 · Must an optimal dose be established for the original question?

Verification status: Not applicable  
Reading scope: 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.

- Current findings: The original question concerns comparative sleep-quality efficacy and does not claim an optimal dose. Actual administration-dose missingness remains.
- Why unverified: Additional optimal-dose extension obligations are outside the current question.
- Reason for missing information: Dose-optimization obligations are Not applicable. Actual sleep-study dose remains separately unverified.
- Required materials and conditions: Direct dose comparisons, actual product/dose and analysis plans only if an optimal dose is claimed.
- Materials to obtain first: Direct dose comparisons, actual product/dose and analysis plans only if an optimal dose is claimed.
- Further research: If an extension is requested, separately plan fixed-formulation dose comparisons and simultaneous safety/sleep-quality assessment.
- Conditions for verification: Separate the narrow comparative-efficacy question from dose-optimization obligations.
- Why this condition is needed: Needed to distinguish unverified dose from an obligation to study optimal dosing.
- Application exceptions: The actual direct-study dose gap remains in N03; non-applicability does not fill it.
- Remaining uncertainty: Dose-optimization obligations are Not applicable. Actual sleep-study dose remains separately unverified.
- Referenced methods: 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.
- Related sources: S01

### N24 · Does the current question include persistence after discontinuation?

Verification status: Not applicable  
Reading scope: 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.

- Current findings: 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.
- Why unverified: Separate maintenance-effect extension obligations are not imposed on the original question.
- Reason for missing information: Persistence/long-term efficacy obligations are Not applicable; the duration gap remains in N04.
- Required materials and conditions: Discontinuation/long-term follow-up schedule, product and group results if persistence is claimed.
- Materials to obtain first: Discontinuation/long-term follow-up schedule, product and group results if persistence is claimed.
- Further research: For an extension, plan end-of-treatment/post-discontinuation measurements of the same product, separating persistence from additional treatment.
- Conditions for verification: Separate end-of-treatment sleep quality from post-discontinuation/long-term effects.
- Why this condition is needed: Needed to avoid establishing maintenance effects from before-and-after changes alone.
- Application exceptions: Do not replace unverified direct-study duration/assessment timing with non-applicability of long-term follow-up.
- Remaining uncertainty: Persistence/long-term efficacy obligations are Not applicable; the duration gap remains in N04.
- Referenced methods: 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.
- Related sources: S01

### N25 · Are specific subgroup-effect obligations applied?

Verification status: Not applicable  
Reading scope: 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.

- Current findings: The original question concerns adult-insomnia PSQI, without a specific subgroup-effect claim. Unverified pregnancy/cardiovascular safety does not constitute an effect-modification result.
- Why unverified: Specific subgroup comparative-efficacy extension obligations are outside the original question.
- Reason for missing information: Subgroup-effect obligations are Not applicable. Baseline population/selection and vulnerable-population safety gaps remain separate.
- Required materials and conditions: Prespecified subgroups, denominators and interaction analysis/direct comparisons if subgroup effects are claimed.
- Materials to obtain first: Prespecified subgroups, denominators and interaction analysis/direct comparisons if subgroup effects are claimed.
- Further research: For new subgroup questions, separately examine prior hypotheses, interactions and denominators.
- Conditions for verification: Separate the adult-insomnia question from sex/disease/age-specific effect-modification claims.
- Why this condition is needed: Needed to avoid establishing effects in every vulnerable group from the reported 50.
- Application exceptions: Retain basic population conditions and vulnerable-population safety gaps separately.
- Remaining uncertainty: Subgroup-effect obligations are Not applicable. Baseline population/selection and vulnerable-population safety gaps remain separate.
- Referenced methods: 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.
- Related sources: S01

### N26 · Are clinical events or hypnotic replacement mandatory for PSQI improvement?

Verification status: Not applicable  
Reading scope: 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.

- Current findings: 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.
- Why unverified: Clinical-event/hypnotic-replacement extension obligations are not applied to this score question.
- Reason for missing information: Extension obligations are Not applicable; hypnotic replacement or treatment effects have not been verified.
- Required materials and conditions: Direct event/treatment/medication-change comparisons and result definitions if a clinical extension is claimed.
- Materials to obtain first: Direct event/treatment/medication-change comparisons and result definitions if a clinical extension is claimed.
- Further research: When a separate clinical question is authorized, design score, event and medicine-use outcomes separately.
- Conditions for verification: Separate sleep-quality scores from insomnia treatment, hypnotic replacement and other clinical results.
- Why this condition is needed: Needed to avoid establishing hypnotic replacement or treatment from before-and-after PSQI changes.
- Application exceptions: Do not impose every event trial as mandatory for a score question.
- Remaining uncertainty: Extension obligations are Not applicable; hypnotic replacement or treatment effects have not been verified.
- Referenced methods: 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.
- Related sources: S01

### N27 · Can palpitation collection, denominators and discontinuations be verified?

Verification status: Partly verified  
Reading scope: 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.

- Current findings: 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.
- Why unverified: A report in 1 person and mild wording are available, but collection, denominator/duration and discontinuation verification remain.
- Reason for missing information: Direct adverse-event collection, denominator/duration and discontinuation material is needed. A report in 1 person does not establish safety or comparative risk.
- Required materials and conditions: Thai-trial adverse-event tables, collection methods, exposure/follow-up denominators and palpitation/discontinuation records.
- Materials to obtain first: Thai-trial adverse-event tables, collection methods, exposure/follow-up denominators and palpitation/discontinuation records.
- Further research: Compare original event tables and collection procedures, distinguishing spontaneous/systematic reporting and exposure/completion denominators.
- Conditions for verification: Verify reported-event wording, people/event counts, observation duration, systematic collection, severity and discontinuation.
- Why this condition is needed: Needed to avoid converting a mild report in 1 person into overall safety or incidence.
- Application exceptions: Do not calculate a new incidence from 1/50 or fill unverified events with 0.
- Remaining uncertainty: Direct adverse-event collection, denominator/duration and discontinuation material is needed. A report in 1 person does not establish safety or comparative risk.
- Referenced methods: 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.
- Related sources: S01

### N28 · Are palpitation timing, alternative causes and comparative risk verified?

Verification status: Unverified  
Reading scope: 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.

- Current findings: 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.
- Why unverified: Timing, alternative-cause and comparator information are insufficient to assess event causality/comparative risk.
- Reason for missing information: Administration, onset, discontinuation/recovery, alternative explanations and comparison material remain needed.
- Required materials and conditions: Palpitation onset dates, administration/discontinuation, recovery, concomitant medicines/disease and comparator events.
- Materials to obtain first: Palpitation onset dates, administration/discontinuation, recovery, concomitant medicines/disease and comparator events.
- Further research: Examine event timelines and alternative causes; distinguish uncontrolled signals from causality or risk ratios.
- Conditions for verification: Examine administration, onset, discontinuation/recovery, concomitant factors, baseline/alternative explanations and actual comparisons.
- Why this condition is needed: Needed to avoid establishing causality or increased risk solely from reporting during exposure.
- Application exceptions: Do not assume rechallenge, recovery or absence of alternative causes.
- Remaining uncertainty: Administration, onset, discontinuation/recovery, alternative explanations and comparison material remain needed.
- Referenced methods: 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.
- Related sources: S01

### N29 · Does the 6-person exposure study answer current rules or harms in insomnia patients?

Verification status: Partly verified  
Reading scope: 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.

- Current findings: 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.
- Why unverified: Dose, frequency/duration and urinary results exist, but application to current rules and clinical harms remains separately unverified.
- Reason for missing information: Product-specific composition, exposure/analysis, differences between historical/current criteria and direct clinical-harm material in insomnia patients are needed.
- Required materials and conditions: Exposure product/composition, urine collection/analysis, study-era reporting threshold and separate current official rules/clinical-harm material.
- Materials to obtain first: Exposure product/composition, urine collection/analysis, study-era reporting threshold and separate current official rules/clinical-harm material.
- Further research: Compare original exposure tables with historical criteria; separate current-rule verification and clinical events into other reviews.
- Conditions for verification: Separate actual exposure, urinary endpoint, denominator/duration and study-era criteria from current rules/clinical harms.
- Why this condition is needed: Needed to avoid transferring healthy-person urine results into insomnia-patient harms or current doping judgments.
- Application exceptions: Current rules are not consulted in this work. The 6-person result belongs to the historical urinary-exposure study.
- Remaining uncertainty: Product-specific composition, exposure/analysis, differences between historical/current criteria and direct clinical-harm material in insomnia patients are needed.
- Referenced methods: 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.
- Related sources: S02

### N30 · Are direct long-term, vulnerable-population and interaction safety data verified?

Verification status: Unverified  
Reading scope: 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.

- Current findings: 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.
- Why unverified: Direct safety data matching these vulnerable populations, long-term use or interactions are unverified in the record.
- Reason for missing information: Direct vulnerable-population, long-term exposure, interaction and event-collection material is needed.
- Required materials and conditions: Product-specific long-term follow-up, vulnerable-population, interaction, rare/serious-event and discontinuation material.
- Materials to obtain first: Product-specific long-term follow-up, vulnerable-population, interaction, rare/serious-event and discontinuation material.
- Further research: Distinguish follow-up/observational designs by required safety scope; assess suitability of population, exposure and event collection.
- Conditions for verification: Verify exposure, collection and denominators for pregnancy/lactation, cardiovascular disease, concomitant use and long-term/rare events.
- Why this condition is needed: Needed to avoid extending limited before-and-after/healthy-person exposure into overall safety.
- Application exceptions: Unverified harms do not establish harmlessness; do not create personal dosing instructions or a new safety grade.
- Remaining uncertainty: Direct vulnerable-population, long-term exposure, interaction and event-collection material is needed.
- Referenced methods: 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.
- Related sources: S01, S02

### N31 · Are funding, company relationships and independence of the three reports verified?

Verification status: Partly verified  
Reading scope: 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.

- Current findings: 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.
- Why unverified: Reported company relationships are known, but complete funding, patents, COI and independence verification remains.
- Reason for missing information: Report-specific cash/in-kind support, patents, COI and independence material is needed.
- Required materials and conditions: Original report-specific funding/support, author affiliation, COI, patent and product-provision sections.
- Materials to obtain first: Original report-specific funding/support, author affiliation, COI, patent and product-provision sections.
- Further research: Compare support forms and disclosure scope report by report, distinguishing independent-family and independent-funding claims.
- Conditions for verification: Separately verify raw-material/manufacturing support, author employment, funding, patents and COI for each report.
- Why this condition is needed: Needed to avoid converting company support or unverified funding into independent funding or absence of bias.
- Application exceptions: Do not automatically delete results because a company relationship exists.
- Remaining uncertainty: Report-specific cash/in-kind support, patents, COI and independence material is needed.
- Referenced methods: 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.
- Related sources: S01, S02, S03

### N32 · Is failure to identify an eligible trial limited to the retained search scope?

Verification status: Met  
Reading scope: 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.

- Current findings: 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.
- Why unverified: Original dates, scope, absence-not-proven state and editorial scope specify limits on absence wording. This verifies search-scope preservation.
- Reason for missing information: Retained scope and dates are connected. Worldwide current literature absence and current original-paper verification were not established.
- Required materials and conditions: Retained review date, search/editorial scope and unverified wording, plus search records if an actual later search occurs.
- Materials to obtain first: Retained review date, search/editorial scope and unverified wording, plus search records if an actual later search occurs.
- Further research: Compare the historical search/retention scope; record new search dates, scope and inclusion/exclusion only when a new-evidence event is authorized.
- Conditions for verification: Retain the original review date, retained-material-only scope and absence-not-proven state, distinguishing new searches.
- Why this condition is needed: Needed to avoid expanding prior unverified findings into absence of all literature.
- Application exceptions: Do not use the current original-verdict review date as a new-search or external-access date.
- Remaining uncertainty: Retained scope and dates are connected. Worldwide current literature absence and current original-paper verification were not established.
- Referenced methods: 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.
- Related sources: S01, S02, S03

### N33 · Are summary reading and historical/current paper or abstract access separated?

Verification status: Met  
Reading scope: 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.

- Current findings: 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.
- Why unverified: Current actions, retained original URLs, historical wording and absent access fields are recorded separately. Verification is limited to reading-record consistency.
- Reason for missing information: Current summary reading and unread external material are distinguished. Historical material-specific access level/date and current external responses/originals remain unverified.
- Required materials and conditions: Current original summary/locations, the 3 original URLs, historical research wording and original access records if available.
- Materials to obtain first: Current original summary/locations, the 3 original URLs, historical research wording and original access records if available.
- Further research: Compare existence, acquisition, actual reading and dates by material; connect the reader view to the actual summary values and file fingerprints read.
- Conditions for verification: Separately record current summary/locations, external URLs, historical research wording and unverified access dates.
- Why this condition is needed: Needed to avoid converting link existence or historical full-text wording into current full-text reading.
- Application exceptions: Individual access level/location/date are absent from citations; do not infer access dates from the overall review date.
- Remaining uncertainty: Current summary reading and unread external material are distinguished. Historical material-specific access level/date and current external responses/originals remain unverified.
- Referenced methods: 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.
- Related sources: S01, S02, S03

### N34 · Were original ?, unrecorded values and current/previous human-evidence states retained?

Verification status: Met  
Reading scope: 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.

- Current findings: 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.
- Why unverified: Original types/values and current/previous/correction wording are explicit in the source. Table status does not clinically certify those original values.
- Reason for missing information: Original pending values and historical states are retained. No new grade, score, between-group effect or clinical certification was created.
- Required materials and conditions: Original grade, score, axes, editorial review, grade rationale and correction record.
- Materials to obtain first: Original grade, score, axes, editorial review, grade rationale and correction record.
- Further research: Compare current/previous states and correction events, distinguishing human-evidence existence, unverified controls and unestimated effects.
- Conditions for verification: Preserve original grade/score/axes, evidence status and previous editorial axes without alteration.
- Why this condition is needed: Needed to avoid upgrading conversion review into a new final clinical verdict or score.
- Application exceptions: Do not present current false human-study-absence and historical previous true as the same current claim.
- Remaining uncertainty: Original pending values and historical states are retained. No new grade, score, between-group effect or clinical certification was created.
- Referenced methods: 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.
- Related sources: S01, S02, S03

### N35 · Are independent repeated-harm claims also required?

Verification status: Not applicable  
Reading scope: 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.

- Current findings: 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.
- Why unverified: Repeated-harm extension obligations are not applied to the current PSQI question. The two signals are not added as repeated events.
- Reason for missing information: Repeated-harm obligations are Not applicable. Harm/safety gaps remain in N27–N30.
- Required materials and conditions: Unique events, families, products, event definitions and recitation links only if repeated harm is claimed.
- Materials to obtain first: Unique events, families, products, event definitions and recitation links only if repeated harm is claimed.
- Further research: For an extension, link unique reports of the same event/product and exclude regulatory recitations as independent events.
- Conditions for verification: Separate the narrow sleep-quality question from obligations for repeated-harm signals.
- Why this condition is needed: Needed to avoid combining palpitations and urinary higenamine as repeated occurrences of the same harm.
- Application exceptions: Retain harm signals and safety gaps without estimating repeated-event counts.
- Remaining uncertainty: Repeated-harm obligations are Not applicable. Harm/safety gaps remain in N27–N30.
- Referenced methods: 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.
- Related sources: S01, S02

## Evidence and sources

### S01

Makmoon 2024 lotus-plumule capsules/insomnia PSQI report

[Official source](https://he02.tci-thaijo.org/index.php/ttm/article/view/268242)

Materials actually 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.  
Findings recorded in the summary: 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.  
Record 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.  
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.

| Material | Public availability | Access status | Actually read | Notes |
|---|---|---|---|---|
| Journal-paper entry page; actual current full-text/abstract availability scope unverified | Entry recorded; current public availability unverified | External access not attempted; not acquired | Not read | 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. |
| Retained bilingual research/bibliographic summaries and historical review record | Retained copy acquired; summary read | Retained copy acquired; summary read | Stored existing review summary read | 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. |

### S02

Yen 2020 lotus-plumule/urinary higenamine exposure report

[PubMed](https://pubmed.ncbi.nlm.nih.gov/31973198/)

Materials actually 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.  
Findings recorded in the summary: 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.  
Record 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.  
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.

| Material | Public availability | Access status | Actually read | Notes |
|---|---|---|---|---|
| PubMed paper abstract/bibliography entry; actual current availability scope unverified | Entry recorded; current public availability unverified | External access not attempted; not acquired | Not read | 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. |
| Retained bilingual research/bibliographic summaries and historical review record | Retained copy acquired; summary read | Retained copy acquired; summary read | Stored existing review summary read | 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. |

### S03

Kim 2024 Rhodiola/lotus-seed combination report

[PubMed](https://pubmed.ncbi.nlm.nih.gov/38931222/)

Materials actually 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.  
Findings recorded in the summary: 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.  
Record 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.  
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.

| Material | Public availability | Access status | Actually read | Notes |
|---|---|---|---|---|
| PubMed paper abstract/bibliography entry; actual current availability scope unverified | Entry recorded; current public availability unverified | External access not attempted; not acquired | Not read | 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. |
| Retained bilingual research/bibliographic summaries and historical review record | Retained copy acquired; summary read | Retained copy acquired; summary read | Stored existing review summary read | 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. |

## Review criteria and methods

These are Chamgap's own application conditions, informed by the relevant sections of official methodological guidance. They do not constitute official assessment-tool certification or a new efficacy score.

- M03 [Cochrane Handbook 6.5 (2024), chapter updated 2023-08](https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-03) · §3.1, §3.2.1–3.2.3, MECIR C5/C7/C13 · Clearly record the question, eligibility conditions and reasons for changes; distinguish intervention variants. · Retained method-application records were reused. External originals were not reread and method content was not reassessed.
- M04 [Cochrane Handbook 6.5.1 (2025), chapter updated 2025-03](https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-04) · §4.5, §4.6.1–4.6.3, MECIR C42 · Link studies and reports separately; do not omit studies solely because results are unreported. · Retained method-application records were reused. External originals were not reread and method content was not reassessed.
- M08 [Cochrane Handbook 6.5 (2024), chapter updated 2019-10](https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-08) · §8.1–8.2.3, Table 8.2.a · Fix the result and effect of interest when examining randomization, deviations, missingness, measurement and selective reporting. · Retained method-application records were reused. External originals were not reread and method content was not reassessed.
- M15 [Cochrane Handbook 6.5 (2024), chapter updated 2023-08](https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-15) · §15.2.4, §15.3.1–15.3.3 · Distinguish effect estimates, intervals, importance and applicability. Sample size alone does not determine precision. · Retained method-application records were reused. External originals were not reread and method content was not reassessed.
- M19 [Cochrane Handbook 6.5 (2024), chapter updated 2019-10](https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-19) · §19.1.2, §19.2.1–19.2.4 · Harm questions may require different designs, populations and follow-up from efficacy questions. Case reports do not establish incidence. · Retained method-application records were reused. External originals were not reread and method content was not reassessed.

## What the statuses mean

- 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.

## Change history

2026-10-28 · Public page/materials 1.0. The public view and materials were prepared from the existing 35 items. No new clinical search, verification-state change or scoring was performed.