Evidence map›Paper›PMID 41862890›Full record

Trial reportBMC complementary medicine and therapies2026

Efficacy and safety of Kami Guibi-tang in older adults with insomnia and memory complaints: a randomized, double-blind, placebo-controlled pilot trial.

Kyeong-Hwa Lee, Min-Kyung Kim, Ye-Chae Hwang, Han-Gyul Lee, Seungwon Kwon, Seong-Uk Park, Woo-Sang Jung, Sang-Kwan Moon, Jung-Mi Park, Chang-Nam Ko and 1 more

Abstract readRandomized Controlled Trial
In one paragraph

Trial report in BMC complementary medicine and therapies, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

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0citing papers in PubMed
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1 · What the graph read from it

What it found

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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

11 authors.

Kyeong-Hwa LeeDepartment of Clinical Korean Medicine, Graduate School, Kyung Hee University, 26 Kyungheedae-Ro, Dongdaemun-Gu, 02447, Seoul, Republic of Korea.
Min-Kyung KimDepartment of Clinical Korean Medicine, Graduate School, Kyung Hee University, 26 Kyungheedae-Ro, Dongdaemun-Gu, 02447, Seoul, Republic of Korea.
Ye-Chae HwangDepartment of Clinical Korean Medicine, Graduate School, Kyung Hee University, 26 Kyungheedae-Ro, Dongdaemun-Gu, 02447, Seoul, Republic of Korea.
Han-Gyul LeeDepartment of Cardiology and Neurology, Kyung Hee University College of Korean Medicine, Kyung Hee University Medical Center, 26, Kyungheedae-Ro, Dongdaemun-Gu, Seoul, 02447, Republic of Korea.
Seungwon KwonDepartment of Cardiology and Neurology, Kyung Hee University College of Korean Medicine, Kyung Hee University Medical Center, 26, Kyungheedae-Ro, Dongdaemun-Gu, Seoul, 02447, Republic of Korea.
Seong-Uk ParkStroke and Neurological Disorders Center, Kyung Hee University College of Korean Medicine, Kyung Hee University Hospital, Gangdong, 892, Dongnam-Ro, Gangdong-Gu, Seoul, 05278, Republic of Korea.
Woo-Sang JungDepartment of Cardiology and Neurology, Kyung Hee University College of Korean Medicine, Kyung Hee University Medical Center, 26, Kyungheedae-Ro, Dongdaemun-Gu, Seoul, 02447, Republic of Korea.
Sang-Kwan MoonDepartment of Cardiology and Neurology, Kyung Hee University College of Korean Medicine, Kyung Hee University Medical Center, 26, Kyungheedae-Ro, Dongdaemun-Gu, Seoul, 02447, Republic of Korea.
Jung-Mi ParkStroke and Neurological Disorders Center, Kyung Hee University College of Korean Medicine, Kyung Hee University Hospital, Gangdong, 892, Dongnam-Ro, Gangdong-Gu, Seoul, 05278, Republic of Korea.
Chang-Nam KoStroke and Neurological Disorders Center, Kyung Hee University College of Korean Medicine, Kyung Hee University Hospital, Gangdong, 892, Dongnam-Ro, Gangdong-Gu, Seoul, 05278, Republic of Korea.
Seung-Yeon ChoStroke and Neurological Disorders Center, Kyung Hee University College of Korean Medicine, Kyung Hee University Hospital, Gangdong, 892, Dongnam-Ro, Gangdong-Gu, Seoul, 05278, Republic of Korea. sy.cho@khu.ac.kr.

Funding

Ministry of Health and Welfare, Republic of Korea RS-2022-KH127641
6 · The paper itself

Abstract

backgroundInsomnia, which is a common complaint among older adults, is associated with cognitive deterioration and a lower quality of life. Kami Guibi-tang (KGT), traditional Eastern herbal medicine, is known to be beneficial for sleep and cognitive health. However, its efficacy and safety in treating older adults with insomnia needs to be clearly established. This study evaluated the safety and efficacy of KGT in enhancing sleep quality and cognitive function of older adults with insomnia.

methodsA total of 34 elderly participants randomly received either KGT or placebo granules for 12 weeks. The primary endpoint was the change in Pittsburgh Sleep Quality Index (PSQI-K) score, while the secondary endpoints included changes in the Insomnia Severity Index-Korean (ISI-K), Seoul Neuropsychological Screening Battery-Dementia, Short-Form 36 Health Survey, and Short-Form Geriatric Depression Scale (S-GDS). Safety assessments included monitoring of blood pressure, pulse rate, body temperature, blood tests, electrocardiograms, and documentation of adverse events.

resultsWhile both KGT as well as the placebo groups demonstrated significant improvements in PSQI-K and ISI-K, the KGT group indicated greater cognitive benefits, especially in the domains associated with memory and executive processing. An improvement in the S-GDS was also observed in the KGT group. No side effects were linked to KGT.

conclusionsKGT can be considered as a safe and potentially effective therapeutic option for enhancing sleep and cognitive function among older adults suffering from insomnia. The added improvements shown by the KGT group in cognitive function and depressive symptoms indicate that KGT might provide broader benefits in addition to sleep enhancement.

trial registrationhttps://cris.nih.go.kr Registration Number: KCT0008391 (April 27, 2023).

Indexed as

Drugs, Chinese HerbalMemory DisordersSleep Initiation and Maintenance DisordersAgedAged, 80 and overCognitive EnhancementDouble-Blind MethodFemaleHumansMaleMemoryPilot ProjectsQuality of LifeSleep QualityDrugs, Chinese HerbalCognitive functionHerbal medicineInsomniaKami Guibi-tangSleep quality

Identifiers

PMID41862890
PMCPMC13126828

What OpenQuestion holds

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LicenceCC BY-NC-ND
Read underepoch 390

Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.