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

Study Overview
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Brief Summary
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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

Detailed Description
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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: Mets, Anaerobic threshold（AT）measured by cardiopulmonary exercise test； Changes of other composite indicators of treadmill exercise test or cardiopulmonary exercise test； The maximum walking distance of 6-minute walk test; Changes of Seattle Angina Questionnaire; Hamilton Depression Scale/ Hamilton Anxiety Scale. The safety evaluation criteria is: Adverse event and serious adverse event; Vital signs; Resting 12 lead ECG; Blood routine examination , urine routine examination、liver and renal function examination(AST、ALT、BUN、Cr).

Official Title
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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

Conditions
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Coronary Heart Disease

Intervention / Treatment
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* Drug: Yangxinshi pill
* Drug: conventional coronary heart disease medicine
* Drug: Placebos


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 40   75, gender is not limited Have a clear history or ECG of hospital myocardial infarction , diagnosed as coronary heart disease by imaging diagnosis Sign the informed consent voluntarily Exclusion Criteria: History of hospitalization for acute coronary syndrome in past 3 months Uncontrolled grade 3 hypertension（≥180/100mmHg）or hypotension（<90/60mmHg） History of stroke (cerebral hemorrhage, subarachnoid hemorrhage, cerebral thrombosis, cerebral embolism and stroke of unknown type) or lower extremity arterial disease in the past 6 months In past 6 months, have medical history of: pregnancy, prepare or suspected of pregnancy, abortion, breastfeeding or after childbirth Combined episode bronchial asthma or chronic obstructive pulmonary disease, bradycardia (resting heart rate <60bpm) or atrioventricular block Severely allergic constitution, known or likely to be allergic to the test drug or its components Known bleeding tendency or hemorrhagic disease Patients with severe liver and kidney dysfunction (creatinine clearance ≤ 40ml / min or in the active stage of kidney disease, serum aminotransferase ≥ 2 × upper limit of clinical reference), other life-threatening serious primary or psychiatric diseases and malignant tumors Any other situations that researchers believe may affect the clinical research

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Treatment group<br>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 | Drug: Yangxinshi pill<br>* 0.6g/tablet<br>* Other names: STATE MEDICAL PERMISSION No.Z37021103;Drug: conventional coronary heart disease medicine<br>* the conventional treatment includes medicines treating coronary heart disease<br>* Other names: glyceryl trinitrate， beta-Blocking agent，etc;|
| Placebo Comparator: Control group<br>The patients of the control group are treated with conventional coronary heart disease medicine plus the placebos-Yangxinshi simulant | Drug: conventional coronary heart disease medicine<br>* the conventional treatment includes medicines treating coronary heart disease<br>* Other names: glyceryl trinitrate， beta-Blocking agent，etc;Drug: Placebos<br>* Yangxinshi simulant<br>* Other names: Yangxinshi simulant;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in the maximum volume of O2 consumption | measured by gas analyzer | from baseline to 6 months | 

Secondary Outcome Measures

| Outcome Measure | 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 | from baseline to 6 months |