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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
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:
The safety evaluation criteria is:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment group | Active Comparator | The aim of the arm is to test if the addition of Yangxinshi pills to the conventional coronary heart disease medicine will improve the exercise tolerance of the coronary heart disease |
|
| Control group | Placebo Comparator | The patients of the control group are treated with conventional coronary heart disease medicine plus the placebos-Yangxinshi simulant |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Yangxinshi pill | Drug | 0.6g/tablet |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| change in the maximum volume of O2 consumption | measured by gas analyzer | from baseline to 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| change in exercise tolerance | assessed by the distance (in meters) walked on 6-minute walk test | from baseline to 6 months |
| change in left ventricular ejection fraction (in percentage) | assessed by echocardiographic examination |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events | Number of treatment-related adverse events as assessed by CTCAE4.0 | 24 months |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiaoping Meng, Doctor | Contact | 8618994127461 | 18994127461@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Xiaoping Meng, Doctor | Changchun Traditional Medicine University Affiliated Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Changchun Traditional Medicine University Affiliated Hospital | Recruiting | Changchun | Jilin | 130021 | China |
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| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| C000628007 | Yangxinshi |
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| conventional coronary heart disease medicine | Drug | the conventional treatment includes medicines treating coronary heart disease |
|
|
| Placebos | Drug | Yangxinshi simulant |
|
|
| from baseline to 6 months |