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Effects of Yangxinshi Pills on the Exercise Tolerance of the Patients With Coronary Heart Disease

Coronary Heart Disease Clinical Trial

Official title:
Yangxinshi Pills Plus Conventional Treatment Versus Placebo Plus Conventional Treatment on the Exercise Tolerance of the Patients With Coronary Heart Disease: a Multi-center,Randomised Controlled Clinical Trial

Clinical Trial Summary

Compared with conventional treatment of the coronary heart disease,the aim of the research is to find out if the addition of Yangxinshi pills on the basis of conventional treatment can improve exercise tolerance of patients with coronary heart disease, improve quality of life or restore social function and mental health

Clinical Trial Description

90 outpatients with clear diagnosis of coronary heart diseases will be recruited in the trial and randomized into two group.

One group are treated with Yangxinshi pills (provided by Qingdao Growtful Pharmaceutical Co., Ltd.) plus conventional medicine, the other group are treated with placebo plus conventional medicine.

The primary end point is VO2max measured by cardiopulmonary exercise test after 3 months of treatment.

The secondary endpoint is:

1. Mets, Anaerobic threshold（AT）measured by cardiopulmonary exercise test；

2. Changes of other composite indicators of treadmill exercise test or cardiopulmonary exercise test；

3. The maximum walking distance of 6-minute walk test;

4. Changes of Seattle Angina Questionnaire;

5. Hamilton Depression Scale/ Hamilton Anxiety Scale.

The safety evaluation criteria is:

1. Adverse event and serious adverse event;

2. Vital signs;

3. Resting 12 lead ECG;

4. Blood routine examination , urine routine examination、liver and renal function examination(AST、ALT、BUN、Cr). ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03478332
Study type Interventional
Source Affiliated Hospital of Changchun University of Chinese Medicine
Contact Xiaoping Meng, Doctor
Phone 8618994127461
Email 18994127461@163.com
Status Recruiting
Phase Phase 2
Start date June 1, 2017
Completion date August 25, 2020
View Details
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