Evidence map›Paper›PMID 36461035›Full record

ArticleBMC complementary medicine and therapies2022

Effects of Kami Guibi-tang in patients with mild cognitive impairment: study protocol for a phase III, randomized, double-blind, and placebo-controlled trial.

Hee-Yeon Shin, Tae-Bin Yim, Hye-Min Heo, Geon-Ho Jahng, Seungwon Kwon, Seung-Yeon Cho, Seong-Uk Park, Woo-Sang Jung, Sang-Kwan Moon, Chang-Nam Ko and 1 more

Open access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in BMC complementary medicine and therapies, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
0.3field-weighted citation impact, top 33% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

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

2 citing papers in PubMed, 1 citations in OpenAlex.

  1. Trial
  2. Article
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 at 3 institutions in 1 country.

Hee-Yeon ShinDepartment of Internal Korean Medicine, Korean Medicine Center, CHA university Bundang Medical Center, 59, Yatap-ro, Bundang-gu, Seongnam-si, Gyeonggi-do, 13496, Republic of Korea.
Tae-Bin YimDepartment of Clinical Korean Medicine, Graduate School, Kyung Hee University, 26 Kyungheedae-ro, Dongdaemun-gu, Seoul, 02447, Republic of Korea.
Hye-Min HeoDepartment of Clinical Korean Medicine, Graduate School, Kyung Hee University, 26 Kyungheedae-ro, Dongdaemun-gu, Seoul, 02447, Republic of Korea.
Geon-Ho JahngDepartment of Radiology, Kyung Hee University Hospital at Gangdong, College of Medicine, Kyung Hee University, 892, Dongnam-ro, Gangdong-gu, Seoul, 05278, Republic of Korea.
Seungwon KwonDepartment of Cardiology and Neurology, College of Korean Medicine, Kyung Hee University, 26 Kyungheedae-ro, Dongdaemun-gu, Seoul, 02447, Republic of Korea.
Seung-Yeon ChoStroke and Neurological Disorders Center, Kyung Hee University Hospital at Gangdong, 892, Dongnam-ro, Gangdong-gu, Seoul, 05278, Republic of Korea.
Seong-Uk ParkStroke and Neurological Disorders Center, Kyung Hee University Hospital at Gangdong, 892, Dongnam-ro, Gangdong-gu, Seoul, 05278, Republic of Korea.
Woo-Sang JungDepartment of Cardiology and Neurology, College of Korean Medicine, Kyung Hee University, 26 Kyungheedae-ro, Dongdaemun-gu, Seoul, 02447, Republic of Korea.
Sang-Kwan MoonDepartment of Cardiology and Neurology, College of Korean Medicine, Kyung Hee University, 26 Kyungheedae-ro, Dongdaemun-gu, Seoul, 02447, Republic of Korea.
Chang-Nam KoStroke and Neurological Disorders Center, Kyung Hee University Hospital at Gangdong, 892, Dongnam-ro, Gangdong-gu, Seoul, 05278, Republic of Korea.
Jung-Mi ParkStroke and Neurological Disorders Center, Kyung Hee University Hospital at Gangdong, 892, Dongnam-ro, Gangdong-gu, Seoul, 05278, Republic of Korea. pajama@khu.ac.kr.
Kyung Hee University · KRKyung Hee University Hospital at Gangdong · KRCHA University Bundang Medical Center · KR

Funding

Korea Health Industry Development Institute HI21C2516
6 · The paper itself

Abstract

backgroundAmnestic mild cognitive impairment (aMCI) is often considered a precursor to Alzheimer's disease (AD) and represents a key therapeutic target for early intervention of AD. However, no treatments have been approved for MCI at present. Our previous pilot study has shown that Kami Guibi-tang (KGT), a traditional herbal prescription widely used in Korean medicine for treating amnesia, might be beneficial for improving general cognitive function of aMCI patients. We will conduct a larger-scale clinical trial to validate the findings of our pilot study and further examine the efficacy and safety of KGT in aMCI.

methodsThis trial is designed as a randomized, double-blind, placebo-controlled clinical trial. A total of 84 aMCI patients will be recruited and randomized into the treatment and control groups. Participants will be administered either KGT or placebo granules for 24 weeks, with a follow-up period of 12 weeks after the last treatment. Primary outcomes will include changes in cognitive performance assessed using a neuropsychological test battery, called the Seoul Neuropsychological Screening Battery, between the baseline, post-intervention visit, and follow-up visit (24th and 36th week, respectively). Secondary outcomes will involve the rate of progression to AD, changes in neuroimaging signals assessed using structural magnetic resonance imaging (MRI), resting-state functional MRI (rs-fMRI), and task-based fMRI, and changes in blood biomarkers measured by the ratio of plasma amyloid-β 42/40 levels (Aβ42/Aβ40) between the baseline and post-intervention visit (24th week). For safety assessments, blood chemistry tests and electrocardiograms (ECG) will also be performed. DISCUSSION: This study aims to provide confirmatory evidence of the effect of the Korean herbal medicine, KGT, on improving cognitive function in patients with aMCI. We will identify the possible mechanisms underlying the effects of KGT using neuroimaging signals and blood biomarkers.

trial registrationKorean Clinical Trial Registry ( https://cris.nih.go.kr/cris/search/detailSearch.do/16918; Registration number: KCT0007039; Date of registration: February 24, 2022).

Indexed as

Alzheimer DiseaseCognitive DysfunctionAmnesiaClinical Trials, Phase III as TopicDrugs, Chinese HerbalHumansPilot ProjectsRandomized Controlled Trials as TopicDrugs, Chinese Herbalguibi-tangAmnestic mild cognitive impairment (aMCI)Functional magnetic resonance imaging (fMRI)Herbal formulaHerbal medicineKami Guibi-tangKorean medicineMild cognitive impairment (MCI)Neuropsychological test

Identifiers

PMID36461035
PMCPMC9717542
OpenAlexW4311185590

What OpenQuestion holds

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LicenceCC BY
Read underepoch 390

Registered trials

None linked

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.