Coronary Heart Disease
Conditions
Brief 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
Detailed 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).
Interventions
DRUGYangxinshi pill
0.6g/tablet
DRUGconventional coronary heart disease medicine
the conventional treatment includes medicines treating coronary heart disease
DRUGPlacebos
Yangxinshi simulant
Sponsors
Affiliated Hospital of Changchun University of Chinese Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
40 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| change in the maximum volume of O2 consumption | from baseline to 6 months | measured by gas analyzer |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| change in exercise tolerance | from baseline to 6 months | assessed by the distance (in meters) walked on 6-minute walk test |
| change in left ventricular ejection fraction (in percentage) | from baseline to 6 months | assessed by echocardiographic examination |
Other
| Measure | Time frame | Description |
|---|---|---|
| Adverse events | 24 months | Number of treatment-related adverse events as assessed by CTCAE4.0 |
Countries
China
Contacts
Primary ContactXiaoping Meng, Doctor
Outcome results
None listed