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: 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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
90
0.6g/tablet
the conventional treatment includes medicines treating coronary heart disease
Yangxinshi simulant
Changchun Traditional Medicine University Affiliated Hospital
Changchun, Jilin, China
RECRUITINGchange in the maximum volume of O2 consumption
measured by gas analyzer
Time frame: from baseline to 6 months
change in exercise tolerance
assessed by the distance (in meters) walked on 6-minute walk test
Time frame: from baseline to 6 months
change in left ventricular ejection fraction (in percentage)
assessed by echocardiographic examination
Time frame: from baseline to 6 months
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