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A cohort study on the treatment of coronary heart disease with the method of promoting qi and blood circulation (retrospective)

Registration number：

ITMCTR2023000063

Date of Last Refreshed on：

2023-12-04

Date of Registration：

2023-12-04

Registration Status：

Prospective registration

Public title：

A cohort study on the treatment of coronary heart disease with the method of promoting qi and blood circulation (retrospective)

English Acronym：

Scientific title：

A cohort study on the treatment of coronary heart disease with the method of promoting qi and blood circulation (retrospective)

Scientific title acronym：

Study subject ID：

The registration number of the Partner Registry or other register：

Applicant：

Mengjie Zhao

Study leader：

Fang Lu

Applicant telephone：

18811089951

Study leader's telephone：

13651132246

Applicant Fax：

Study leader's fax：

Applicant E-mail：

zhaomj0501@163.com

Study leader's E-mail：

deerfang@126.com

Study leader's website(voluntary supply)：

Study leader's website
(voluntary supply)：

Applicant address：

Xiyuan Hospital, No.1 Xiyuan Playground, Haidian District, Beijing

Study leader's address：

Xiyuan Hospital, No.1 Xiyuan Playground, Haidian District, Beijing

Applicant postcode：

100091

Study leader's postcode：

100091

Applicant's institution：

Xiyuan Hospital, China Academy of Chinese Medical Sciences

Approved by ethic committee：

Approved No. of ethic committee：

2023XLA048-1

Approved file of Ethical Committee：

View

Name of the ethic committee：

Medical Ethics Committee of Xiyuan Hospital, Chinese Academy of Traditional Chinese Medicine

Date of approved by ethic committee：

2023/4/25 0:00:00

Contact Name of the ethic committee：

Mingjie Zi

Contact Address of the ethic committee：

Xiyuan Hospital, No.1 Xiyuan Playground, Haidian District, Beijing

Contact phone of the ethic committee：

010-62835646

Contact email of the ethic committee：

xiyuanlunli@126.com

Primary sponsor：

Xiyuan Hospital, China Academy of Chinese Medical Sciences

Primary sponsor's address：

Xiyuan Hospital, No.1 Xiyuan Playground, Haidian District, Beijing

Secondary sponsor：

Country：

China

Province：

Beijing

City：

Institution
hospital：

Xiyuan Hospital, China Academy of Chinese Medical Sciences

Address：

Xiyuan Hospital, China Academy of Chinese Medical Sciences

Source(s) of funding：

Xiyuan Hospital, China Academy of Chinese Medical Sciences

Target disease：

Coronary heart disease

Target disease code：

Study type：

Observational study

Study design：

Cohort study

Study phase：

Retrospective study

Objectives of Study：

To discuss the clinical efficacy of Professor Weng Weiliang's application of the blood activation method in the treatment of coronary artery disease, and to develop a new treatment plan for patients with coronary artery disease.

Description for medicine or protocol of treatment in detail：

Inclusion criteria

(1) Compliance with Western medical diagnostic criteria for coronary heart disease; (2) Age ≥ 18 years old; (3) Completed treatment with complete medical records of initial and follow-up consultations.

Exclusion criteria：

(1) Patients with severe primary diseases such as combined hepatic and renal insufficiency, hematopoietic system abnormalities, and neurological diseases; (2) Pregnant or lactating women.

Study execute time：

From 2023-11-01

To      2024-11-01

Recruiting time：

From 2023-12-05

To      2024-11-01

Interventions：

202

Group：

Exposure group

Sample size：

Intervention：

Blood Activating Formula

Intervention code：

202

Group：

Non-exposure group

Sample size：

Intervention：

Non-Blood-activating Formula

Intervention code：

Total sample size ： 404

Countries of recruitment
and research settings：

Country：

China

Province：

Beijing

City：

Institution/hospital：

Xiyuan Hospital, China Academy of Chinese Medical Sciences

Level of the institution：

Tertiary A

Outcomes：

Outcome：

Angina Point Scale

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

Coronary Heart Disease Chinese Medicine Symptoms Score Scale

Type：

Primary indicator

Measure time point of outcome：

Measure method：

Collecting sample(s)
from participants：

Not yet recruiting

18
Min age years
100
Max age years

Recruiting status：

Participant age：

Gender：

Both

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

This study was a cohort study with no randomization method.

Blinding：

IPD sharing：

No

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

No sharing of raw data

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

Investigators completed a case report form for each enrolled case, and the completed case report form was reviewed by the clinical supervisor and entered online by the entry operator for data entry and management by the electronic data capture (EDC) system.

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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