Evidence map›Paper›PMID 31429790›Full record

ArticleTrials2019

Effectiveness of Yi-Zhi-An-Shen granules on cognition and sleep quality in older adults with amnestic mild cognitive impairment: protocol for a randomized, double-blind, placebo-controlled trial.

Shengnan Yue, Ting He, Baiyang Li, Yanqin Qu, Hongmei Peng, Jinxin Chen, Ming Lei, Chongli Chen, Wenbin Wu

Registry-linked trialOpen access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in Trials, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03601000 (Efficacy Study of Yi-Zhi-An-Shen Granules For Older Adults With Amnestic Mild Cognitive Impairment), which is not on this map. Cited by 8 papers.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed
0.6field-weighted citation impact, top 39% 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.

NCT03601000 phase1 / phase2completednot on this map

Efficacy Study of Yi-Zhi-An-Shen Granules For Older Adults With Amnestic Mild Cognitive Impairment: a Randomized, Double-blind, Placebo-controlled Study

TypeinterventionalSponsorChengdu University of Traditional Chinese MedicineRan2018 to 2019Enrolled80ConditionsCognitive DysfunctionArmsYi-Zhi-An-Shen, Placebo
3 · Its place in the literature

Who cites it

8 citing papers in PubMed, 11 citations in OpenAlex.

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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

9 authors at 1 institution in 1 country.

Shengnan YueSchool of Clinical Medicine, Chengdu University of Traditional Chinese Medicine, No. 1177 Liu-tai Avenue, Chengdu, 611137, Sichuan Province, People's Republic of China.
Ting HeSchool of Clinical Medicine, Chengdu University of Traditional Chinese Medicine, No. 1177 Liu-tai Avenue, Chengdu, 611137, Sichuan Province, People's Republic of China.
Baiyang LiSchool of Clinical Medicine, Chengdu University of Traditional Chinese Medicine, No. 1177 Liu-tai Avenue, Chengdu, 611137, Sichuan Province, People's Republic of China.
Yanqin QuSchool of Clinical Medicine, Chengdu University of Traditional Chinese Medicine, No. 1177 Liu-tai Avenue, Chengdu, 611137, Sichuan Province, People's Republic of China.
Hongmei PengSchool of Clinical Medicine, Chengdu University of Traditional Chinese Medicine, No. 1177 Liu-tai Avenue, Chengdu, 611137, Sichuan Province, People's Republic of China.
Jinxin ChenSchool of Clinical Medicine, Chengdu University of Traditional Chinese Medicine, No. 1177 Liu-tai Avenue, Chengdu, 611137, Sichuan Province, People's Republic of China.
Ming LeiDepartment of Geriatrics, Hospital of Chengdu University of Traditional Chinese Medicine, No. 39 Shi-er-qiao Road, Chengdu, 610072, Sichuan Province, People's Republic of China.
Chongli ChenDepartment of Geriatrics, Hospital of Chengdu University of Traditional Chinese Medicine, No. 39 Shi-er-qiao Road, Chengdu, 610072, Sichuan Province, People's Republic of China.
Wenbin WuSchool of Clinical Medicine, Chengdu University of Traditional Chinese Medicine, No. 1177 Liu-tai Avenue, Chengdu, 611137, Sichuan Province, People's Republic of China. wwb1201@vip.sina.com.ORCID http://orcid.org/0000-0001-8784-6137
Chengdu University of Traditional Chinese Medicine · CN

Funding

Cadres Health Care Research Program of Sichuan Province (CN) 2017-501Cadres Health Care Research Program of Sichuan Province (CN) 2018-504Chengdu Science and Technology Bureau JDZX2015298State Administration of Traditional Chinese Medicine of the People's Republic of China JDZX2015298
6 · The paper itself

Abstract

backgroundAmnestic mild cognitive impairment (aMCI) is a syndrome characterized by significant forgetfulness that does not meet the criteria of dementia. Individuals with aMCI are at greater risk of progressing to dementia. Current studies suggest that good sleep quality is linked with preserved cognition in the elderly, and sleep complaints are common among the elderly with amnesia. Therefore, improving their sleep may be helpful for maintaining and improving their cognitive capacity. According to the theory of traditional Chinese medicine, Yi-Zhi-An-Shen is an herbal compound which may ameliorate forgetfulness and sleep disorders. As growing evidence indicates that the gut microbiome is associated with major mental symptoms, a hypothesis was proposed that Yi-Zhi-An-Shen granules (YZASG) might work by alternating microbial abundance and diversity. In this study, the investigators intend to assess the efficacy of YZASG on global cognition in the elderly suffering from aMCI and evaluate its safety as well as its potential mechanisms via sleep quality, fecal microbial 16S ribosomal DNA and metagenomics analyses, and serum markers. METHODS/

designThis study is a randomized, double-blind, placebo-controlled clinical trial. A total of 80 patients (aged 60-85 years) will be recruited and allocated randomly to a treatment group and a placebo group in a 1:1 ratio and will then be administered YZASG or isodose placebo three times a day. The intervention course is 16 weeks, with an 18 months follow-up. The primary outcome is the Alzheimer's Disease Assessment Scale-Cognitive Subscale. Secondary outcome measures are the Mini-Mental State Examination, Montreal Cognitive Assessment, Pittsburgh Sleep Quality Index, serum concentrations of immunological factors and inflammatory cytokines, and fecal microbiota. Fecal microbiota will only be collected at the baseline and endpoint of the intervention. DISCUSSION: The results of this trial will be conducive to assessing the safety and effectiveness on cognition of YZASG in intervening aMCI among the elderly and determining if it takes effect via the improvement of sleep quality, regulation of gut microbiota, and concentration of certain serum markers.

trial registrationClinicalTrials.gov, NCT03601000 . Registered on 26 July 2018.

Indexed as

AgedAged, 80 and overAmnesiaBiomarkersChinaCognitionCognitive DysfunctionDouble-Blind MethodDrugs, Chinese HerbalFemaleGastrointestinal MicrobiomeHumansHypnotics and SedativesInflammation MediatorsMaleMemoryBiomarkersDrugs, Chinese HerbalHypnotics and SedativesInflammation MediatorsNootropic Agentsyi-zhi-an-shenAmnestic mild cognitive impairmentGut microbiomeOlder adultsSleep

Identifiers

PMID31429790
PMCPMC6701140
OpenAlexW2969846376

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

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.