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Randomized double-blind controlled prospective study on the efficacy of Yizhi Decoction in the treatment of Alzheimer's disease

Registration number：

ITMCTR2100005157

Date of Last Refreshed on：

2021-08-09

Date of Registration：

2021-08-09

Registration Status：

Prospective registration

Public title：

Randomized double-blind controlled prospective study on the efficacy of Yizhi Decoction in the treatment of Alzheimer's disease

English Acronym：

Scientific title：

Randomized double-blind controlled prospective study on the efficacy of Yizhi Decoction in the treatment of Alzheimer's disease

Scientific title acronym：

Study subject ID：

The registration number of the Partner Registry or other register：

ChiCTR2100049771 ; ChiMCTR2100005157

Applicant：

Zeng Yan

Study leader：

Zeng Yan

Applicant telephone：

+86 15972921169

Study leader's telephone：

+86 15972921169

Applicant Fax：

Study leader's fax：

Applicant E-mail：

yanzeng11@foxmail.com

Study leader's E-mail：

yanzeng11@foxmail.com

Study leader's website(voluntary supply)：

Study leader's website
(voluntary supply)：

Applicant address：

2 Huangjiahu Road West, Hongshan District, Wuhan, Hubei, China

Study leader's address：

2 Huangjiahu Road West, Hongshan District, Wuhan, Hubei, China

Applicant postcode：

Study leader's postcode：

Applicant's institution：

Wuhan University of Science and Technology

Approved by ethic committee：

Approved No. of ethic committee：

202173

Approved file of Ethical Committee：

View

Name of the ethic committee：

Ethics Committee of Wuhan University of Science and Technology

Date of approved by ethic committee：

2021/7/26 0:00:00

Contact Name of the ethic committee：

Contact Address of the ethic committee：

2 Huangjiahu Road West, Hongshan District, Wuhan, Hubei, China

Contact phone of the ethic committee：

Contact email of the ethic committee：

Primary sponsor：

Wuhan University of Science and Technology

Primary sponsor's address：

2 Huangjiahu Road West, Hongshan District, Wuhan, Hubei, China

Secondary sponsor：

Country：

China

Province：

Hubei

City：

Wuhan

Institution
hospital：

Brain Science and Advanced Technology Institute, Wuhan University of Science and Technology

Address：

2 Huangjiahu Road West, Hongshan District

Source(s) of funding：

National Natural Science Foundation of China

Target disease：

Alzheimer's disease

Target disease code：

Study type：

Interventional study

Study design：

Case-Control study

Study phase：

New Treatment Measure Clinical Study

Objectives of Study：

To test the curative effect of Yizhi Decoction on AD, and to explore the improvement effect of clinical symptoms and abnormal pathological changes in AD patients after using Yizhi Decoction.

Description for medicine or protocol of treatment in detail：

Inclusion criteria

1. Residents of the community, those who participate in the community elderly physical examination; 2. The age is 65-85 years old; 3. Expected survival period > 1 year; 4. No tumor, congenital or acquired immunodeficiency disease, congestive heart failure, angina pectoris, myocardial infarction, uncontrolled hypertension or arrhythmia and other serious heart diseases, active hepatitis, liver cirrhosis and other serious liver diseases , Any serious kidney disease such as glomerulonephritis, nephrotic syndrome, uremia, etc., without chronic diarrhea; 5. Blood routine and electrocardiogram were in the normal range when entering the group, the upper limit of liver and kidney function measurements was <=1.5 times the normal value, blood pressure systolic blood pressure <160mmHg, diastolic blood pressure <100mmHg; 6. Patients with mild to moderate AD, patients with mild cognitive impairment; 7. Elderly patients with depression; 8. Informed consent of patients or their guardians.

Exclusion criteria：

1. Patients with suicidal tendencies, that is, those with a score of >= 2 on the third item of the Hamilton Depression Scale; 2. Those with a history of drug allergy; 3. Alcoholism and/or psychoactive substances, drug abusers and dependents (including sleeping pills); 4. Those who do not use the prescribed medication, cannot judge the efficacy or incomplete data, etc., which affect the judgment of efficacy and safety; 5. Those who are unable to understand the contents of the scale due to insufficient awareness, language barriers, intelligence and education level (below primary school education); 6. Visual or hearing impairment prevents the test or assessor.

Study execute time：

From 2021-09-01

To      2022-12-31

Recruiting time：

From 2021-09-01

To      2021-09-30

Interventions：

45

Group：

Yiqi health care Decoction group

Sample size：

Intervention：

Take Yiqi health care soup once a day after breakfast

Intervention code：

45

Group：

Yizhi Decoction group

Sample size：

Intervention：

Take Yizhi Decoction once a day after breakfast

Intervention code：

Total sample size ： 90

Countries of recruitment
and research settings：

Country：

China

Province：

Hubei

City：

Wuhan

Institution/hospital：

Community Health Service Center of qingling

Level of the institution：

Country：

China

Province：

Hubei

City：

Dawu

Institution/hospital：

Dawu Hospital of traditional Chinese Medicine

Level of the institution：

Secondary A

Country：

China

Province：

Hubei

City：

Wuhan

Institution/hospital：

Community Health Service Center of liyuan

Level of the institution：

Outcomes：

Outcome：

Biochemical detection index

Type：

Primary indicator

Measure time point of outcome：

Measure method：

Outcome：

Psychoaffective assessment

Type：

Primary indicator

Measure time point of outcome：

Measure method：

Outcome：

General cognitive tests

Type：

Primary indicator

Measure time point of outcome：

Measure method：

Outcome：

Proteomic detection

Type：

Primary indicator

Measure time point of outcome：

Measure method：

Outcome：

Anthropometric indexes

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

Cognitive domain test

Type：

Primary indicator

Measure time point of outcome：

Measure method：

Outcome：

Family histories

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

Demographics and socioeconomic position

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

TCM Constitution Classification

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

Imaging Characteristics

Type：

Primary indicator

Measure time point of outcome：

Measure method：

Outcome：

Coating on the tongue

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

Behavior characteristics

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

Previous histories

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

Activities of daily living and basic activities of daily living

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

Genetic detection

Type：

Primary indicator

Measure time point of outcome：

Measure method：

Collecting sample(s)
from participants：

Sample Name：

Blood

Tissue：

Fate of sample 

Destruction after use

Note：

Not yet recruiting

65
Min age years
85
Max age years

Recruiting status：

Participant age：

Gender：

Both

Randomization Procedure (please state who generates the random number sequence and by what method)：

The patients will be numbered according to their respective enrollment order. At the beginning of the study, the project staff will decide the subjects to receive treatment (Yizhi Decoction group and Yiqi health care Decoction group) according to the random numbers provided by the computer. The subjects who&#32

Blinding：

IPD sharing：

Yes

The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：

December 2022

Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：

The basic data and cognitive evaluation data are paper files, which will be entered into the database later; Biochemical, proteomic, genomic and imaging test data shall be provided by the testing institution after testing; All data were managed by specialized researchers.

Data Managemen Committee：

Not yet

Publication information of the protocol/research results report
(name of the journal, volume, issue, pages, time; or website):

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