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Exploring the therapeutic mechanism of Batuanjin in the treatment of elderly stable angina pectoris based on gut microbiota - lipid metabolism spectrum

Registration number：

ITMCTR2200006443

Date of Last Refreshed on：

2022-08-08

Date of Registration：

2022-08-08

Registration Status：

Prospective registration

Public title：

Exploring the therapeutic mechanism of Batuanjin in the treatment of elderly stable angina pectoris based on gut microbiota - lipid metabolism spectrum

English Acronym：

Scientific title：

Exploring the therapeutic mechanism of Batuanjin in the treatment of elderly stable angina pectoris based on gut microbiota - lipid metabolism spectrum

Scientific title acronym：

Study subject ID：

The registration number of the Partner Registry or other register：

ChiCTR2200062450 ; ChiMCTR2200006443

Applicant：

Jin Xiao

Study leader：

Wu Min

Applicant telephone：

18804075251

Study leader's telephone：

13671206090

Applicant Fax：

Study leader's fax：

Applicant E-mail：

jinxiaojx0320@163.com

Study leader's E-mail：

wumin19762000@126.com

Study leader's website(voluntary supply)：

Study leader's website
(voluntary supply)：

Applicant address：

No.5, Beixiange Street, Xicheng District, Beijing

Study leader's address：

No.5, Beixiange Street, Xicheng District, Beijing

Applicant postcode：

100053

Study leader's postcode：

100053

Applicant's institution：

Guang'anmen Hospital of Chinese Academy of traditional Chinese Medicine

Approved by ethic committee：

Approved No. of ethic committee：

2022-121-KY

Approved file of Ethical Committee：

View

Name of the ethic committee：

Ethics Committee of Guang'anmen Hospital of Chinese Academy of traditional Chinese Medicine

Date of approved by ethic committee：

2022/6/24 0:00:00

Contact Name of the ethic committee：

Qiao Jie

Contact Address of the ethic committee：

No.5, Beixiange Street, Xicheng District, Beijing, China.

Contact phone of the ethic committee：

010-88001552

Contact email of the ethic committee：

gamhec@126.com

Primary sponsor：

Guang'anmen Hospital of Chinese Academy of traditional Chinese Medicine

Primary sponsor's address：

No.5, Beixiange Street, Xicheng District, Beijing

Secondary sponsor：

Country：

China

Province：

Beijing

City：

Institution
hospital：

Guang'anmen Hospital of Chinese Academy of traditional Chinese Medicine

Address：

No.5, Beixiange Street, Xicheng District, Beijing, China.

Source(s) of funding：

Raise funds independently

Target disease：

Stable angina pectoris

Target disease code：

Study type：

Interventional study

Study design：

randomized controlled trial(parallel group design)

Study phase：

Others

Objectives of Study：

To observe the therapeutic effect of Baduanjin on elderly patients with stable angina pectoris and the effect of intestinal flora, and to explore the related mechanism.

Description for medicine or protocol of treatment in detail：

Inclusion criteria

(1) meet the diagnostic criteria of stable angina pectoris published by Chinese Medical Association in 2018 "guidelines for diagnosis and treatment of chronic stable angina Pectoris". (2) between 60 and 80 years old. (3) patients with severe angina pectoris classified as I~III by Canadian Cardiovascular Association (CCS). (4) those who sign the informed consent form. Those who have the above four items at the same time are included in the scope of the test.

Exclusion criteria：

(1) severe arrhythmia and moderate cardiac insufficiency (EF < 40%) (2) Hypertension is more than 180/100mmHg (3) patients with AMI history or percutaneous coronary intervention (PCI), coronary artery bypass grafting (CABG), severe trauma and cerebrovascular accident in recent 3 months. (4) patients with severe shock and severe primary organ diseases such as liver, kidney and lung. (5) patients with obvious infection, fever and severe anemia. (6) severe joint disease, which is not suitable for those who exercise eight-paragraph jingle. (7) use antibiotics or participate in any probiotics or laxatives research in the 3 months prior to the study.(8) There were no gastrointestinal diseases such as diarrhea and ulcerative colitis in the past two months.

Study execute time：

From 2021-11-30

To      2024-11-30

Recruiting time：

From 2022-10-01

To      2023-11-01

Interventions：

90

Group：

Control Group

Sample size：

Intervention：

On the basis of basic treatment and health education, cooperate with free exercise. The main mode of exercise is 3~6mets (medium intensity) free exercise, and the exercise frequency is not less than 30min 3-5 times a week, lasting for eight weeks.

Intervention code：

90

Group：

Baduanjin Group

Sample size：

Intervention：

On the basis of basic treatment and health education, cooperate with Baduanjin exercise. The main exercise mode is 3~6mets (medium intensity) Qigong Baduanjin exercise, the exercise frequency is 3-5 times a week, not less than 30min each time, lasting for eight weeks.

Intervention code：

Total sample size ： 180

Countries of recruitment
and research settings：

Country：

China

Province：

Beijing

City：

Institution/hospital：

Guang'anmen Hospital of Chinese Academy of traditional Chinese Medicine

Level of the institution：

Tertiary A

Outcomes：

Outcome：

changes of trimethylamine oxide

Type：

Secondary indicator

Measure time point of outcome：

week -1-0, week 8

Measure method：

Outcome：

Changes of non-targeted lipid metabolism

Type：

Secondary indicator

Measure time point of outcome：

week -1-0, week 8

Measure method：

Outcome：

Serum hypersensitive C-reactive protein

Type：

Secondary indicator

Measure time point of outcome：

week -1-0, week 8

Measure method：

Outcome：

Seattle angina grading

Type：

Secondary indicator

Measure time point of outcome：

week -1-0, week 4, week 8，month 3, month 6

Measure method：

Outcome：

Changes in gut microbial composition

Type：

Secondary indicator

Measure time point of outcome：

week -1-0, week 8

Measure method：

Outcome：

Dosage

Type：

Secondary indicator

Measure time point of outcome：

week -1-0, week 4, week 8，month 3, month 6

Measure method：

Outcome：

Quality of Life Questionnaire(SF-36)

Type：

Secondary indicator

Measure time point of outcome：

week -1-0, week 4, week 8，month 3, month 6

Measure method：

Outcome：

total effective rate of angina pectoris symptoms

Type：

Primary indicator

Measure time point of outcome：

week -1-0, week 4, week 8，month 3, month 6

Measure method：

Outcome：

The TCM syndrome scores

Type：

Secondary indicator

Measure time point of outcome：

week -1-0, week 4, week 8，month 3, month 6

Measure method：

Outcome：

Duration

Type：

Secondary indicator

Measure time point of outcome：

week -1-0, week 4, week 8，month 3, month 6

Measure method：

Outcome：

Electrocardiogram

Type：

Secondary indicator

Measure time point of outcome：

week -1-0, week 8

Measure method：

Outcome：

blood lipid levels

Type：

Secondary indicator

Measure time point of outcome：

week -1-0, week 8

Measure method：

Outcome：

Attack frequency

Type：

Secondary indicator

Measure time point of outcome：

week -1-0, week 4, week 8，month 3, month 6

Measure method：

Outcome：

Stopping rate of nitroglycerin

Type：

Secondary indicator

Measure time point of outcome：

week -1-0, week 4, week 8，month 3, month 6

Measure method：

Collecting sample(s)
from participants：

Sample Name：

stool

Tissue：

Fate of sample 

Destruction after use

Note：

Sample Name：

blood

Tissue：

Fate of sample 

Destruction after use

Note：

Not yet recruiting

60
Min age years
80
Max age years

Recruiting status：

Participant age：

Gender：

Both

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

Use SAS9.0 statistical software to generate random number table. Each subject will assign a random number from the random number table and assign it to two groups according to the random number obtained.

Blinding：

open

IPD sharing：

No

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

by publication

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

CRF will remain in the hospital, and researchers, ethics committees and research-related managers will be allowed to access your medical records. Manage electronic data using the ResMan database.

Data Managemen Committee：

Yes

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

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