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

Required evidence, verification status and materials actually read
Item	AVerification status	BReading scope	CReview item	DCurrent findings	EWhy unverified	FRequired materials and conditions	GFurther research
1	Met	Full text not readStored summary read	N01 · Evidence conditionWhich lotus-plumule sleep-quality question does this table address?Required	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. S01 S02 S03	The original claim, claim conditions and summary note specify population, plant-part and endpoint boundaries. This verifies claim identity, not a treatment effect.	Exact canonical manuscript and URL for the claim, plant part, formulation, population, endpoint and comparison.	Fix inclusion/exclusion boundaries and check whether other plant parts, combinations, exposure or mechanistic material enter this question.
2	Partly verified	Full text not readStored summary read	N02 · Evidence conditionIs the actual capsule equivalent to tea or a standardized single-plumule extract?Required	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. S01	Plant part and capsule names are available, but actual composition, batch information and formulation comparisons are absent.	Thai capsule ingredients, embryo identification, cultivar/origin, extraction/manufacture, quality tests and tea/extract comparisons.	Compare batch composition, identification and chemical analyses; classify different formulations in separate eligibility strata.
3	Unverified	Full text not readStored summary read	N03 · Evidence conditionAre the actual dose and dosing frequency in the sleep-quality study verified?Required	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. S01 S02	Actual dose, frequency and adherence for the direct PSQI study are absent from the retained record.	Thai-trial capsule content, daily amount/frequency, administration records and adherence material.	Compare product labeling with actual administration records and separate material using different doses.
4	Unverified	Full text not readStored summary read	N04 · Evidence conditionAre administration duration and assessment times for single-plumule PSQI verified?Required	Before-and-after PSQI is reported, but exact single-plumule administration duration and measurement times are unverified. The 3-day higenamine exposure is separate. S01 S02	Duration in the original claim conditions remains unverified for an eligible controlled trial; the direct before-and-after study schedule is also unavailable.	Thai-trial administration/assessment schedule, visit table and follow-up duration.	Compare actual visits and assessment dates, distinguishing end-of-treatment from post-discontinuation follow-up.
5	Partly verified	Full text not readStored summary read	N05 · Evidence conditionAre insomnia diagnosis, severity and target population in the 50-person study verified?Required	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. S01 S02 S03	The intended population and patient count are known, but matching clinical selection criteria and representativeness remain unverified.	Thai participants’ age, insomnia diagnosis/selection, baseline disease, medicines and PSQI distribution.	Compare original inclusion/exclusion criteria and baseline distribution; do not generalize to unverified populations.
6	Partly verified	Full text not readStored summary read	N06 · Evidence conditionCan purposive recruitment, exclusions and selection effects be verified?Required	The Thai study is recorded as a purposively sampled single-arm pilot. Recruitment source, contacted/excluded counts and baseline balance are unverified. S01	Sampling method is identified, but information is insufficient to assess selection flow and effects.	Recruitment notices, selected/excluded counts, consent/participation flow and baseline characteristics.	Reconstruct recruitment-to-analysis flow and compare participation/exclusion reasons and population distributions.
7	Unverified	Full text not readStored summary read	N07 · Evidence conditionWas an eligible concurrent-comparison trial of single-ingredient plumule identified?Required (causal efficacy)	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. S01	The evidence-status record identifies direct human evidence but no eligible controlled efficacy study. Material establishing controlled efficacy is still needed.	Single-plumule versus suitable placebo/control trial reports, allocation/analysis and PSQI results by group.	Plan subsequent research as a comparison with defined product, population and timing, separating natural history, regression and expectancy effects.
8	Unverified	Full text not readStored summary read	N08 · Evidence conditionCan allocation, concealment and assessor blinding for comparative PSQI efficacy be verified?Required	The retained direct study has no randomization, placebo or concurrent comparator. Allocation/blinding material separating expectancy effects is unverified. S01	A single-arm before-and-after design cannot establish allocation/measurement control required for the selected causal comparison.	Eligible comparative-trial allocation/concealment procedures and placebo/assessment-blinding documents.	Compare implementation with the protocol and address expectancy/measurement influences on subjective PSQI in the analysis plan.
9	Unverified	Full text not readStored summary read	N09 · Evidence conditionAre sleep medicines, lifestyle changes and adherence distinguished from PSQI changes?Required	The current single-arm summary lacks information on sleep medicines, lifestyle changes, concomitant treatment, adherence and their handling. S01	Records are insufficient to evaluate other explanations for before-and-after change.	Sleep medicines/disease treatment, lifestyle/concurrent interventions, adherence, rescue treatment and change records.	Create a timeline of concurrent treatment/lifestyle changes; examine changes in both groups and adherence handling in an eligible comparison.
10	Partly verified	Full text not readStored summary read	N10 · Evidence conditionAre the PSQI version, collection and assessment conditions verified?Required	The direct-material endpoint is before-and-after PSQI. Scale version, language, collection, blinding, item handling and exact measurement schedule are unverified. S01 S02 S03	The PSQI endpoint and before-and-after report exist, but actual measurement procedures remain unverified.	PSQI tool/language version, assessment procedures, scoring and measurement schedule.	Compare scale and collection methods; verify measurement/expectancy effects and missing-item handling.
11	Partly verified	Full text not readStored summary read	N11 · Evidence conditionWhich analysis and time points do the Thai PSQI values represent?Required	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. S01	Reported numbers and paired P can be retained, but analysis, timing and variance definitions are incomplete.	Original PSQI tables, measurement times, analysis population, ± definition and change-analysis results.	Compare original tables exactly and separate paired analysis from between-group comparison.
12	Partly verified	Full text not readStored summary read	N12 · Evidence conditionAre the paired-P analysis population, test and actual comparative efficacy verified?Required	Paired P < .05 is recorded. Test type, analysis n, model/assumptions are unverified; without a concurrent comparator it provides no between-group efficacy estimate. S01	A within-group test is indicated, but the analysis specification and causal comparison remain unverified.	Paired-test type, assumptions, analysis n, handling rules and between-group comparison results.	Compare original testing/analysis plans with tables; do not transfer within-group significance into a between-group difference.
13	Unverified	Full text not readStored summary read	N13 · Evidence conditionAre the ± type and comparative-effect CI verified?Required	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. S01	Recorded ± alone cannot establish required precision or a comparative-effect interval.	± definition, before-and-after correlation/paired variance, analysis n, reported CI and derivation methods.	Compare original table notes and statistical methods; interpret only verified intervals.
14	Partly verified	Full text not readStored summary read	N14 · Evidence conditionAre completion, PSQI-analysis and missing-data denominators among the 50 verified?Required	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. S01 S03	Participant count is known, but analysis denominator and losses for this result remain unverified.	Thai participation flow, before-and-after measurement n, completion/withdrawal reasons, analysis population and missing-data handling.	Trace denominators from participation to paired analysis; examine interpretation limits from missingness/withdrawal handling.
15	Unverified	Full text not readStored summary read	N15 · Evidence conditionCan a PSQI important-difference threshold be compared with the comparative interval?Required	Large before-and-after PSQI change is recorded, but a justified important-difference threshold for this population and actual between-group CI are unverified. S01	Evidence is unavailable to evaluate comparative sleep-quality efficacy magnitude, precision and clinical importance.	Important-difference evidence for the population, prespecified criteria and actual between-group estimate/CI.	Verify the threshold source and population, then compare the eligible comparative-trial interval with it.
16	Unverified	Full text not readStored summary read	N16 · Evidence conditionDo planned PSQI, timing and analyses match the actual report?Required	PMID, DOI and registration identifiers for S01 are unverified, as is the registration field. Planned and actual reports could not be compared. S01	No record establishes acquisition/verification of plan/registration documents and identifiers.	Thai-study registration identifier, protocol, analysis plan and endpoint/timing change history.	Tabulate planned endpoints/timing/analysis against original results, recording changes and uncompared areas.
17	Partly verified	Full text not readStored summary read	N17 · Evidence conditionCan unique family and result identities of the three reports be verified?Required	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. S01 S02 S03	Report roles can be distinguished, but complete unique-family and duplicate-identity verification remains.	Original bibliography, trial/registration identifiers and duplicate-report/participant links for the three reports.	Create a family-identity table, separating single-plumule PSQI, higenamine exposure and combination material; check recitation of the same results.
18	Unverified	Full text not readStored summary read	N18 · Evidence conditionAre independent controlled replications of single-plumule PSQI verified?Required (replicated efficacy)	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. S01 S02 S03	Material establishing an independent controlled comparison of the same question is unavailable.	Eligible single-plumule comparative trials, independent families, between-group results and condition differences.	Compare unique trials and contrary/no-difference results; do not add adjacent material as replication.
19	Met	Full text not readStored summary read	N19 · Evidence conditionWere positive before-and-after observations and their limitations retained together?Required (result preservation)	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. S01 S03	The interpretation-limits field and report results/weight present positive observations with limitations. This verifies result preservation.	Original locations of before-and-after results, interpretation limits, combination findings and inclusion/exclusion reasons.	Tabulate direction together with design/attribution; favorable material must not erase controlled-efficacy gaps.
20	Met	Full text not readStored summary read	N20 · Evidence conditionDo Rhodiola-combination results answer the single-plumule effect question?Required (attribution boundary)	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. S03	The combination composition, flow, endpoints and exclusion reasons are explicit in the third evidence report. Verification concerns attribution boundaries.	Combination composition, population, completion/withdrawal, original ISI/PSQI results and component-isolation comparison.	Keep combination results in a separate eligibility stratum; design component-isolation comparisons if single-plumule contribution is needed.
21	Met	Full text not readStored summary read	N21 · Evidence conditionIs higenamine material kept out of PSQI efficacy?Required (endpoint attribution)	S02 concerns urinary higenamine in 6 healthy men, not sleep. Its original evidence weight is limited to safety context. S02	Population, endpoint and safety role are explicit in the second evidence report and second citation.	Healthy-male exposure, urinary higenamine results and PSQI applicability boundaries.	Compare endpoint/population eligibility, keeping exposure/safety material separate from efficacy results.
22	Not applicable	Full text not readStored summary read	N22 · Evidence conditionIs animal sedation required as a direct result for human PSQI?Supplementary; required only for mechanistic extensions	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.	The main question concerns comparative adult PSQI efficacy, so animal mechanisms are not applied as a sufficiency requirement. Narrative boundaries remain.	Original narrative locations and population, plant-part and endpoint descriptions for animal/mechanistic references.	Review applicability boundaries in the original explanation; connect separate eligible material only when direct human trials exist.
23	Not applicable	Full text not readStored summary read	N23 · Evidence conditionMust an optimal dose be established for the original question?Supplementary; required only for dose extensions	The original question concerns comparative sleep-quality efficacy and does not claim an optimal dose. Actual administration-dose missingness remains. S01	Additional optimal-dose extension obligations are outside the current question.	Direct dose comparisons, actual product/dose and analysis plans only if an optimal dose is claimed.	If an extension is requested, separately plan fixed-formulation dose comparisons and simultaneous safety/sleep-quality assessment.
24	Not applicable	Full text not readStored summary read	N24 · Evidence conditionDoes the current question include persistence after discontinuation?Supplementary; required only for persistence extensions	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. S01	Separate maintenance-effect extension obligations are not imposed on the original question.	Discontinuation/long-term follow-up schedule, product and group results if persistence is claimed.	For an extension, plan end-of-treatment/post-discontinuation measurements of the same product, separating persistence from additional treatment.
25	Not applicable	Full text not readStored summary read	N25 · Evidence conditionAre specific subgroup-effect obligations applied?Supplementary; required only for subgroup extensions	The original question concerns adult-insomnia PSQI, without a specific subgroup-effect claim. Unverified pregnancy/cardiovascular safety does not constitute an effect-modification result. S01	Specific subgroup comparative-efficacy extension obligations are outside the original question.	Prespecified subgroups, denominators and interaction analysis/direct comparisons if subgroup effects are claimed.	For new subgroup questions, separately examine prior hypotheses, interactions and denominators.
26	Not applicable	Full text not readStored summary read	N26 · Evidence conditionAre clinical events or hypnotic replacement mandatory for PSQI improvement?Supplementary; required only for clinical extensions	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. S01	Clinical-event/hypnotic-replacement extension obligations are not applied to this score question.	Direct event/treatment/medication-change comparisons and result definitions if a clinical extension is claimed.	When a separate clinical question is authorized, design score, event and medicine-use outcomes separately.
27	Partly verified	Full text not readStored summary read	N27 · Evidence conditionCan palpitation collection, denominators and discontinuations be verified?Supplementary; required for harm claims	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. S01	A report in 1 person and mild wording are available, but collection, denominator/duration and discontinuation verification remain.	Thai-trial adverse-event tables, collection methods, exposure/follow-up denominators and palpitation/discontinuation records.	Compare original event tables and collection procedures, distinguishing spontaneous/systematic reporting and exposure/completion denominators.
28	Unverified	Full text not readStored summary read	N28 · Evidence conditionAre palpitation timing, alternative causes and comparative risk verified?Supplementary; required for causal/comparative harm claims	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. S01	Timing, alternative-cause and comparator information are insufficient to assess event causality/comparative risk.	Palpitation onset dates, administration/discontinuation, recovery, concomitant medicines/disease and comparator events.	Examine event timelines and alternative causes; distinguish uncontrolled signals from causality or risk ratios.
29	Partly verified	Full text not readStored summary read	N29 · Evidence conditionDoes the 6-person exposure study answer current rules or harms in insomnia patients?Supplementary; required for exposure/doping and harm claims	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. S02	Dose, frequency/duration and urinary results exist, but application to current rules and clinical harms remains separately unverified.	Exposure product/composition, urine collection/analysis, study-era reporting threshold and separate current official rules/clinical-harm material.	Compare original exposure tables with historical criteria; separate current-rule verification and clinical events into other reviews.
30	Unverified	Full text not readStored summary read	N30 · Evidence conditionAre direct long-term, vulnerable-population and interaction safety data verified?Supplementary; required for safety extensions	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. S01 S02	Direct safety data matching these vulnerable populations, long-term use or interactions are unverified in the record.	Product-specific long-term follow-up, vulnerable-population, interaction, rare/serious-event and discontinuation material.	Distinguish follow-up/observational designs by required safety scope; assess suitability of population, exposure and event collection.
31	Partly verified	Full text not readStored summary read	N31 · Evidence conditionAre funding, company relationships and independence of the three reports verified?Supplementary; required for independence claims	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. S01 S02 S03	Reported company relationships are known, but complete funding, patents, COI and independence verification remains.	Original report-specific funding/support, author affiliation, COI, patent and product-provision sections.	Compare support forms and disclosure scope report by report, distinguishing independent-family and independent-funding claims.
32	Met	Full text not readStored summary read	N32 · Evidence conditionIs failure to identify an eligible trial limited to the retained search scope?Required (scope preservation)	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. S01 S02 S03	Original dates, scope, absence-not-proven state and editorial scope specify limits on absence wording. This verifies search-scope preservation.	Retained review date, search/editorial scope and unverified wording, plus search records if an actual later search occurs.	Compare the historical search/retention scope; record new search dates, scope and inclusion/exclusion only when a new-evidence event is authorized.
33	Met	Full text not readStored summary read	N33 · Evidence conditionAre summary reading and historical/current paper or abstract access separated?Required (reading record)	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. S01 S02 S03	Current actions, retained original URLs, historical wording and absent access fields are recorded separately. Verification is limited to reading-record consistency.	Current original summary/locations, the 3 original URLs, historical research wording and original access records if available.	Compare existence, acquisition, actual reading and dates by material; connect the reader view to the actual summary values and file fingerprints read.
34	Met	Full text not readStored summary read	N34 · Evidence conditionWere original ?, unrecorded values and current/previous human-evidence states retained?Required (original-verdict preservation)	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. S01 S02 S03	Original types/values and current/previous/correction wording are explicit in the source. Table status does not clinically certify those original values.	Original grade, score, axes, editorial review, grade rationale and correction record.	Compare current/previous states and correction events, distinguishing human-evidence existence, unverified controls and unestimated effects.
35	Not applicable	Full text not readStored summary read	N35 · Evidence conditionAre independent repeated-harm claims also required?Supplementary; required only for repeated-harm claims	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. S01 S02	Repeated-harm extension obligations are not applied to the current PSQI question. The two signals are not added as repeated events.	Unique events, families, products, event definitions and recitation links only if repeated harm is claimed.	For an extension, link unique reports of the same event/product and exclude regulatory recitations as independent events.

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35 itemsWhat the statuses mean

Assessment scope

Stored-material review date: 2026-10-05
Original evidence review date: 2026-09-08
Scope actually checked: Retained Korean/English summaries and case-specific condition/application records. Full papers, supplements, registrations, plans and original data were not read.
What the dates mean: 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.
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.

Evidence and sources

The links below lead to the sources. A link alone does not mean the original source was read or its latest publication status verified.

S01 · Makmoon 2024 lotus-plumule capsules/insomnia PSQI report

Official source

Material type: Retained bibliography/evidence summary of a direct human single-arm before-and-after study
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 stored 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.
Study overlap and 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.

Public availability, access and reading status by material
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

Material type: Retained bibliography/evidence summary of a healthy-person single-arm exposure study
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 stored 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.
Study overlap and 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.

Public availability, access and reading status by material
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

Material type: Retained bibliography/evidence summary of a different-part combination single-arm study
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 stored 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.
Study overlap and 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.

Public availability, access and reading status by material
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.

Report counts versus independent study counts

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.

Review criteria

Version 1.0 · Criteria record date 2026-10-05. These are Chamgap's own application conditions, informed by the referenced methods. They do not constitute official assessment-tool certification or a new efficacy score.

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

Required materials and conditions: Exact canonical manuscript and URL for the claim, plant part, formulation, population, endpoint and comparison.
Conditions for verification: Connect the original claim location to a concurrent-comparison question about oral single-ingredient lotus plumule, adults with insomnia and PSQI.
Requirement and applicability: Required
Application exceptions: Retain the empty subclaim list; do not automatically create separate tables for every formulation or safety clue.
Why this condition is needed: Needed to avoid combining different plant parts and endpoints into one effect because the plant name is shared.
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.

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

Required materials and conditions: Thai capsule ingredients, embryo identification, cultivar/origin, extraction/manufacture, quality tests and tea/extract comparisons.
Conditions for verification: Verify actual content, single-ingredient composition, extraction, standardization and tea/extract equivalence for the green embryo of mature seeds.
Requirement and applicability: Required
Application exceptions: Lotus seed flesh, leaf, root and Rhodiola mixtures are not the same single-ingredient plumule product.
Why this condition is needed: Needed to avoid transferring capsule before-and-after findings to tea or all lotus products.
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.

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

Required materials and conditions: Thai-trial capsule content, daily amount/frequency, administration records and adherence material.
Conditions for verification: Connect nominal dose, actual intake, adherence and frequency to the single-plumule sleep-quality study.
Requirement and applicability: Required
Application exceptions: The higenamine-exposure dose of 0.8 g taken 3 times daily is not the sleep-quality study dose.
Why this condition is needed: Needed to avoid attributing PSQI values to a particular regimen without administration conditions.
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.

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

Required materials and conditions: Thai-trial administration/assessment schedule, visit table and follow-up duration.
Conditions for verification: Connect administration start/end, the before-and-after PSQI interval and observation duration to direct sleep-quality material.
Requirement and applicability: Required
Application exceptions: The 3 days in the separate exposure study are not the Thai PSQI observation period.
Why this condition is needed: Needed to avoid borrowing the interval between measurements from another study.
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.

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

Required materials and conditions: Thai participants’ age, insomnia diagnosis/selection, baseline disease, medicines and PSQI distribution.
Conditions for verification: Compare age, insomnia selection criteria, severity and disease/medicine exclusions with the adult-insomnia question.
Requirement and applicability: Required
Application exceptions: The 6 healthy men and combination-product sleep-disturbance population cannot replace the direct insomnia population.
Why this condition is needed: An insomnia-patient label does not make every adult-insomnia population equivalent.
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.

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

Required materials and conditions: Recruitment notices, selected/excluded counts, consent/participation flow and baseline characteristics.
Conditions for verification: Describe recruitment source, contact/participation and exclusion flow, and purposive selection.
Requirement and applicability: Required
Application exceptions: Do not calculate bias direction or magnitude solely from purposive sampling.
Why this condition is needed: Needed to avoid assuming that changes in selected before-and-after data represent general patient responses.
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.

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

Required materials and conditions: Single-plumule versus suitable placebo/control trial reports, allocation/analysis and PSQI results by group.
Conditions for verification: Verify eligible material with a concurrent comparator, allocation and between-group estimation for the same question.
Requirement and applicability: Required (causal efficacy)
Application exceptions: Unverified in the previous search does not prove permanent worldwide absence of literature or an effect of 0.
Why this condition is needed: Needed to distinguish before-and-after change from the selected plumule’s comparative contribution.
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.

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

Required materials and conditions: Eligible comparative-trial allocation/concealment procedures and placebo/assessment-blinding documents.
Conditions for verification: Examine actual random sequence, allocation concealment, participant/assessor blinding and expectancy effects.
Requirement and applicability: Required
Application exceptions: Do not arbitrarily assign completed RCT allocation or crossover/cluster non-applicability to this single-arm design.
Why this condition is needed: Needed to verify whether subjective score change was separated from expectancy effects.
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.

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

Required materials and conditions: Sleep medicines/disease treatment, lifestyle/concurrent interventions, adherence, rescue treatment and change records.
Conditions for verification: Verify relationships between concomitant medicines, sleep hygiene, concurrent interventions, discontinuation/adherence and PSQI analysis.
Requirement and applicability: Required
Application exceptions: Missing information does not establish that concomitant treatment or lifestyle changes were absent.
Why this condition is needed: Needed to avoid attributing factors changing alongside plumule use to the plumule itself.
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.

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

Required materials and conditions: PSQI tool/language version, assessment procedures, scoring and measurement schedule.
Conditions for verification: Verify PSQI version/language, collection method, assessor, measurement interval and interpretation.
Requirement and applicability: Required
Application exceptions: Do not convert ISI, sleep diaries, animal sleep time or urinary higenamine into the same PSQI result.
Why this condition is needed: Needed to avoid treating an endpoint name alone as verification of actual measurement conditions.
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.

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

Required materials and conditions: Original PSQI tables, measurement times, analysis population, ± definition and change-analysis results.
Conditions for verification: Connect before-and-after values, testing, denominators and timing; distinguish between-group effects.
Requirement and applicability: Required
Application exceptions: Do not calculate a new before-and-after difference, CI or between-group effect.
Why this condition is needed: Needed to retain original numbers without arbitrarily extending their attribution.
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.

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

Required materials and conditions: Paired-test type, assumptions, analysis n, handling rules and between-group comparison results.
Conditions for verification: Distinguish within-group paired testing, analysis denominator and model from concurrent between-group effects.
Requirement and applicability: Required
Application exceptions: Do not convert paired P < .05 into an exact P, equivalence, no difference or treatment-effect magnitude.
Why this condition is needed: Needed to avoid establishing plumule contribution or between-group differences from within-group P alone.
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.

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

Required materials and conditions: ± definition, before-and-after correlation/paired variance, analysis n, reported CI and derivation methods.
Conditions for verification: Verify the SD/SE or other ± definition, paired variance, denominator and comparative-effect interval.
Requirement and applicability: Required
Application exceptions: Do not calculate a new CI, standardized effect or paired variance from the current material.
Why this condition is needed: Needed to avoid arbitrarily interpreting printed ± as CI or SD.
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.

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

Required materials and conditions: Thai participation flow, before-and-after measurement n, completion/withdrawal reasons, analysis population and missing-data handling.
Conditions for verification: Distinguish participation, completion, measurement at each time, paired analysis and withdrawal-handling denominators.
Requirement and applicability: Required
Application exceptions: The separate combination-product flow of 20 and 13 is not the Thai analysis denominator.
Why this condition is needed: Needed to avoid automatically using the reported 50 as complete-case paired-analysis n.
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.

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

Required materials and conditions: Important-difference evidence for the population, prespecified criteria and actual between-group estimate/CI.
Conditions for verification: Compare a previously justified PSQI important-difference threshold with a between-group interval.
Requirement and applicability: Required
Application exceptions: Do not arbitrarily set minimum participant counts, duration or an important difference.
Why this condition is needed: Needed to avoid assigning clinical sufficiency solely from change magnitude or significance.
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.

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

Required materials and conditions: Thai-study registration identifier, protocol, analysis plan and endpoint/timing change history.
Conditions for verification: Directly compare registration, protocol and analysis plan with results and reasons for changes.
Requirement and applicability: Required
Application exceptions: Failure to verify does not establish non-registration or selective reporting.
Why this condition is needed: Needed to reveal material required to assess selection of favorable times or analyses.
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.

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

Required materials and conditions: Original bibliography, trial/registration identifiers and duplicate-report/participant links for the three reports.
Conditions for verification: Verify family links and independence using bibliography, registration, population/intervention, timing and analysis.
Requirement and applicability: Required
Application exceptions: The presence of identifier strings does not establish actual external bibliography/registration verification.
Why this condition is needed: Needed to avoid counting 3 reports as 3 independent PSQI replications.
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.

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

Required materials and conditions: Eligible single-plumule comparative trials, independent families, between-group results and condition differences.
Conditions for verification: Verify independent-family results for matching population, plant part, formulation and PSQI comparison.
Requirement and applicability: Required (replicated efficacy)
Application exceptions: Unverified controlled material does not prove absent or failed efficacy replication.
Why this condition is needed: Needed to avoid converting report counts into independent replication of comparative efficacy.
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.

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

Required materials and conditions: Original locations of before-and-after results, interpretation limits, combination findings and inclusion/exclusion reasons.
Conditions for verification: Explain large before-and-after changes and adjacent positive results alongside comparator/attribution limits.
Requirement and applicability: Required (result preservation)
Application exceptions: Differences between numbers from different formulations/endpoints are not automatically conflicting data.
Why this condition is needed: Needed to avoid deleting positive original observations or converting them into causal efficacy.
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.

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

Required materials and conditions: Combination composition, population, completion/withdrawal, original ISI/PSQI results and component-isolation comparison.
Conditions for verification: Distinguish combination ingredients, plant part, single-arm design, 20 enrolled/13 completed and endpoint applicability.
Requirement and applicability: Required (attribution boundary)
Application exceptions: Do not automatically use the 13 completers as the sleep-quality effect denominator for all 20 enrolled.
Why this condition is needed: Needed to avoid attributing positive combination/other-part results to the selected single ingredient.
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.

N21 · Is higenamine material kept out of PSQI efficacy?

Required materials and conditions: Healthy-male exposure, urinary higenamine results and PSQI applicability boundaries.
Conditions for verification: Separate urinary exposure from sleep-quality endpoints even when human exposure and plant part match.
Requirement and applicability: Required (endpoint attribution)
Application exceptions: Do not convert the study-era WADA threshold into verification of current rules or insomnia efficacy.
Why this condition is needed: Needed to avoid combining a different endpoint with efficacy solely because it concerns human lotus-plumule exposure.
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.

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

Required materials and conditions: Original narrative locations and population, plant-part and endpoint descriptions for animal/mechanistic references.
Conditions for verification: Distinguish animal/other-part mechanisms from direct adult PSQI comparisons.
Requirement and applicability: Supplementary; required only for mechanistic extensions
Application exceptions: Do not impose animal-sedation trials as an efficacy requirement for the current main question.
Why this condition is needed: A boundary needed to avoid extending related mechanisms into human sleep-quality effects.
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.

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

Required materials and conditions: Direct dose comparisons, actual product/dose and analysis plans only if an optimal dose is claimed.
Conditions for verification: Separate the narrow comparative-efficacy question from dose-optimization obligations.
Requirement and applicability: Supplementary; required only for dose extensions
Application exceptions: The actual direct-study dose gap remains in N03; non-applicability does not fill it.
Why this condition is needed: Needed to distinguish unverified dose from an obligation to study optimal dosing.
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.

N24 · Does the current question include persistence after discontinuation?

Required materials and conditions: Discontinuation/long-term follow-up schedule, product and group results if persistence is claimed.
Conditions for verification: Separate end-of-treatment sleep quality from post-discontinuation/long-term effects.
Requirement and applicability: Supplementary; required only for persistence extensions
Application exceptions: Do not replace unverified direct-study duration/assessment timing with non-applicability of long-term follow-up.
Why this condition is needed: Needed to avoid establishing maintenance effects from before-and-after changes alone.
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.

N25 · Are specific subgroup-effect obligations applied?

Required materials and conditions: Prespecified subgroups, denominators and interaction analysis/direct comparisons if subgroup effects are claimed.
Conditions for verification: Separate the adult-insomnia question from sex/disease/age-specific effect-modification claims.
Requirement and applicability: Supplementary; required only for subgroup extensions
Application exceptions: Retain basic population conditions and vulnerable-population safety gaps separately.
Why this condition is needed: Needed to avoid establishing effects in every vulnerable group from the reported 50.
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.

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

Required materials and conditions: Direct event/treatment/medication-change comparisons and result definitions if a clinical extension is claimed.
Conditions for verification: Separate sleep-quality scores from insomnia treatment, hypnotic replacement and other clinical results.
Requirement and applicability: Supplementary; required only for clinical extensions
Application exceptions: Do not impose every event trial as mandatory for a score question.
Why this condition is needed: Needed to avoid establishing hypnotic replacement or treatment from before-and-after PSQI changes.
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.

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

Required materials and conditions: Thai-trial adverse-event tables, collection methods, exposure/follow-up denominators and palpitation/discontinuation records.
Conditions for verification: Verify reported-event wording, people/event counts, observation duration, systematic collection, severity and discontinuation.
Requirement and applicability: Supplementary; required for harm claims
Application exceptions: Do not calculate a new incidence from 1/50 or fill unverified events with 0.
Why this condition is needed: Needed to avoid converting a mild report in 1 person into overall safety or incidence.
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.

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

Required materials and conditions: Palpitation onset dates, administration/discontinuation, recovery, concomitant medicines/disease and comparator events.
Conditions for verification: Examine administration, onset, discontinuation/recovery, concomitant factors, baseline/alternative explanations and actual comparisons.
Requirement and applicability: Supplementary; required for causal/comparative harm claims
Application exceptions: Do not assume rechallenge, recovery or absence of alternative causes.
Why this condition is needed: Needed to avoid establishing causality or increased risk solely from reporting during exposure.
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.

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

Required materials and conditions: Exposure product/composition, urine collection/analysis, study-era reporting threshold and separate current official rules/clinical-harm material.
Conditions for verification: Separate actual exposure, urinary endpoint, denominator/duration and study-era criteria from current rules/clinical harms.
Requirement and applicability: Supplementary; required for exposure/doping and harm claims
Application exceptions: Current rules are not consulted in this work. The 6-person result belongs to the historical urinary-exposure study.
Why this condition is needed: Needed to avoid transferring healthy-person urine results into insomnia-patient harms or current doping judgments.
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.

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

Required materials and conditions: Product-specific long-term follow-up, vulnerable-population, interaction, rare/serious-event and discontinuation material.
Conditions for verification: Verify exposure, collection and denominators for pregnancy/lactation, cardiovascular disease, concomitant use and long-term/rare events.
Requirement and applicability: Supplementary; required for safety extensions
Application exceptions: Unverified harms do not establish harmlessness; do not create personal dosing instructions or a new safety grade.
Why this condition is needed: Needed to avoid extending limited before-and-after/healthy-person exposure into overall safety.
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.

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

Required materials and conditions: Original report-specific funding/support, author affiliation, COI, patent and product-provision sections.
Conditions for verification: Separately verify raw-material/manufacturing support, author employment, funding, patents and COI for each report.
Requirement and applicability: Supplementary; required for independence claims
Application exceptions: Do not automatically delete results because a company relationship exists.
Why this condition is needed: Needed to avoid converting company support or unverified funding into independent funding or absence of bias.
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.

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

Required materials and conditions: Retained review date, search/editorial scope and unverified wording, plus search records if an actual later search occurs.
Conditions for verification: Retain the original review date, retained-material-only scope and absence-not-proven state, distinguishing new searches.
Requirement and applicability: Required (scope preservation)
Application exceptions: Do not use the current original-verdict review date as a new-search or external-access date.
Why this condition is needed: Needed to avoid expanding prior unverified findings into absence of all literature.
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.

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

Required materials and conditions: Current original summary/locations, the 3 original URLs, historical research wording and original access records if available.
Conditions for verification: Separately record current summary/locations, external URLs, historical research wording and unverified access dates.
Requirement and applicability: Required (reading record)
Application exceptions: Individual access level/location/date are absent from citations; do not infer access dates from the overall review date.
Why this condition is needed: Needed to avoid converting link existence or historical full-text wording into current full-text reading.
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.

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

Required materials and conditions: Original grade, score, axes, editorial review, grade rationale and correction record.
Conditions for verification: Preserve original grade/score/axes, evidence status and previous editorial axes without alteration.
Requirement and applicability: Required (original-verdict preservation)
Application exceptions: Do not present current false human-study-absence and historical previous true as the same current claim.
Why this condition is needed: Needed to avoid upgrading conversion review into a new final clinical verdict or score.
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.

N35 · Are independent repeated-harm claims also required?

Required materials and conditions: Unique events, families, products, event definitions and recitation links only if repeated harm is claimed.
Conditions for verification: Separate the narrow sleep-quality question from obligations for repeated-harm signals.
Requirement and applicability: Supplementary; required only for repeated-harm claims
Application exceptions: Retain harm signals and safety gaps without estimating repeated-event counts.
Why this condition is needed: Needed to avoid combining palpitations and urinary higenamine as repeated occurrences of the same harm.
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.

Referenced methods and the sections actually reviewed

M03 · Cochrane Handbook 6.5 (2024), chapter updated 2023-08

Official methodology · §3.1, §3.2.1–3.2.3, MECIR C5/C7/C13

Referenced principle: Clearly record the question, eligibility conditions and reasons for changes; distinguish intervention variants.
Extent of review: 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

Official methodology · §4.5, §4.6.1–4.6.3, MECIR C42

Referenced principle: Link studies and reports separately; do not omit studies solely because results are unreported.
Extent of review: 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

Official methodology · §8.1–8.2.3, Table 8.2.a

Referenced principle: Fix the result and effect of interest when examining randomization, deviations, missingness, measurement and selective reporting.
Extent of review: 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

Official methodology · §15.2.4, §15.3.1–15.3.3

Referenced principle: Distinguish effect estimates, intervals, importance and applicability. Sample size alone does not determine precision.
Extent of review: 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

Official methodology · §19.1.2, §19.2.1–19.2.4

Referenced principle: Harm questions may require different designs, populations and follow-up from efficacy questions. Case reports do not establish incidence.
Extent of review: 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/material version 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.

The stored-material review date (2026-10-05) and original evidence review date (2026-09-08) were retained unchanged.

Researcher downloads

These materials provide the same evidence, scope and verification status as this page.

View all item details

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

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.
Verification status: Met
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.
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.
Remaining uncertainty: The question identity and exclusions are verified. Eligible comparative trials and product equivalence remain gaps in other rows.
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.
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?

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.
Verification status: Partly verified
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.
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.
Remaining uncertainty: Beyond the embryo/capsule names, material is needed on actual single-ingredient composition, content, quality and equivalence to tea/extract.
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.
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?

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.
Verification status: Unverified
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.
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.
Remaining uncertainty: Sleep-study capsule dose, dosing frequency and adherence must be obtained; exposure-study dosing cannot fill the gap.
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.
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?

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.
Verification status: Unverified
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.
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.
Remaining uncertainty: The direct PSQI study schedule and assessment interval are needed; 3 days cannot be used as that duration.
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.
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?

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.
Verification status: Partly verified
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.
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.
Remaining uncertainty: Age, insomnia criteria, baseline conditions and exclusions for the 50 participants are needed.
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.
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?

Current findings: The Thai study is recorded as a purposively sampled single-arm pilot. Recruitment source, contacted/excluded counts and baseline balance are unverified.
Verification status: Partly verified
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.
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.
Remaining uncertainty: Material remains needed on actual purposive recruitment, exclusions and participant selection.
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.
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?

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.
Verification status: Unverified
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.
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.
Remaining uncertainty: An actual eligible comparative trial and between-group estimate are needed. Human evidence existing does not fill this gap.
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.
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?

Current findings: The retained direct study has no randomization, placebo or concurrent comparator. Allocation/blinding material separating expectancy effects is unverified.
Verification status: Unverified
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.
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.
Remaining uncertainty: Actual allocation, concealment and assessment-control material appropriate to concurrent comparative efficacy is needed.
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.
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?

Current findings: The current single-arm summary lacks information on sleep medicines, lifestyle changes, concomitant treatment, adherence and their handling.
Verification status: Unverified
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.
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.
Remaining uncertainty: Direct-study concurrent interventions, concomitant treatment, adherence and their analytical handling are needed.
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.
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?

Current findings: The direct-material endpoint is before-and-after PSQI. Scale version, language, collection, blinding, item handling and exact measurement schedule are unverified.
Verification status: Partly verified
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.
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.
Remaining uncertainty: The actual PSQI tool, collection conditions and assessment schedule are needed.
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.
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?

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.
Verification status: Partly verified
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.
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.
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.
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.
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?

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.
Verification status: Partly verified
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.
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.
Remaining uncertainty: Actual paired-test methods, denominator and between-group analysis appropriate to comparative efficacy are needed.
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.
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?

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.
Verification status: Unverified
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.
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.
Remaining uncertainty: Variance notes, paired variance, denominator and actual reported interval are needed.
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.
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?

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.
Verification status: Partly verified
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.
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.
Remaining uncertainty: Actual measurement/completion/analysis n and missingness/withdrawal records for the 50-person material are needed.
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.
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?

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.
Verification status: Unverified
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.
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.
Remaining uncertainty: An important-difference threshold for the population and a comparative-effect interval are needed.
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.
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?

Current findings: PMID, DOI and registration identifiers for S01 are unverified, as is the registration field. Planned and actual reports could not be compared.
Verification status: Unverified
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.
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.
Remaining uncertainty: Agreement and change reasons between registration/plans and actual PSQI reporting are needed.
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.
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?

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.
Verification status: Partly verified
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.
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.
Remaining uncertainty: Unique families, registration identities and recitation/duplication relationships of the three reports must be verified.
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.
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?

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.
Verification status: Unverified
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.
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.
Remaining uncertainty: Eligible comparative results from independent families and trial-link material are needed.
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.
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?

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.
Verification status: Met
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.
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.
Remaining uncertainty: Positive original observations and their limits are attributed. Controlled-efficacy and precision gaps remain.
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.
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?

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.
Verification status: Met
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.
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.
Remaining uncertainty: The combination role and direct-evidence exclusion are verified. Single-plumule contribution or an effect for all 20 is not established.
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.
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?

Current findings: S02 concerns urinary higenamine in 6 healthy men, not sleep. Its original evidence weight is limited to safety context.
Verification status: Met
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.
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.
Remaining uncertainty: The safety-context role and PSQI-efficacy exclusion are verified. Current rules and clinical harms remain separate.
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.
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?

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.
Verification status: Not applicable
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.
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.
Remaining uncertainty: The mechanistic-extension obligation is Not applicable. Animal originals remain unread; direct human effects are not verified.
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.
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?

Current findings: The original question concerns comparative sleep-quality efficacy and does not claim an optimal dose. Actual administration-dose missingness remains.
Verification status: Not applicable
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.
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.
Remaining uncertainty: Dose-optimization obligations are Not applicable. Actual sleep-study dose remains separately unverified.
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.
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?

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.
Verification status: Not applicable
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.
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.
Remaining uncertainty: Persistence/long-term efficacy obligations are Not applicable; the duration gap remains in N04.
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.
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?

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.
Verification status: Not applicable
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.
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.
Remaining uncertainty: Subgroup-effect obligations are Not applicable. Baseline population/selection and vulnerable-population safety gaps remain separate.
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.
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?

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.
Verification status: Not applicable
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.
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.
Remaining uncertainty: Extension obligations are Not applicable; hypnotic replacement or treatment effects have not been verified.
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.
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?

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.
Verification status: Partly verified
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.
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.
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.
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.
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?

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.
Verification status: Unverified
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.
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.
Remaining uncertainty: Administration, onset, discontinuation/recovery, alternative explanations and comparison material remain needed.
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.
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?

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.
Verification status: Partly verified
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.
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.
Remaining uncertainty: Product-specific composition, exposure/analysis, differences between historical/current criteria and direct clinical-harm material in insomnia patients are needed.
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.
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?

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.
Verification status: Unverified
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.
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.
Remaining uncertainty: Direct vulnerable-population, long-term exposure, interaction and event-collection material is needed.
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.
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?

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.
Verification status: Partly verified
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.
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.
Remaining uncertainty: Report-specific cash/in-kind support, patents, COI and independence material is needed.
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.
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?

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.
Verification status: Met
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.
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.
Remaining uncertainty: Retained scope and dates are connected. Worldwide current literature absence and current original-paper verification were not established.
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.
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?

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.
Verification status: Met
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.
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.
Remaining uncertainty: Current summary reading and unread external material are distinguished. Historical material-specific access level/date and current external responses/originals remain unverified.
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.
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?

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.
Verification status: Met
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.
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.
Remaining uncertainty: Original pending values and historical states are retained. No new grade, score, between-group effect or clinical certification was created.
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.
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?

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.
Verification status: Not applicable
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.
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.
Remaining uncertainty: Repeated-harm obligations are Not applicable. Harm/safety gaps remain in N27–N30.
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.
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