Efficacy and safety of Tonifying Qi and Activating Blood Chinese herbal prescriptions for Myocardial Infarction: study protocol for a multi-centered RCT
- Conditions
- Myocardial Infarction
- Registration Number
- ITMCTR2100004952
- Lead Sponsor
- Beijing Hospital of Traditional Chinese Medicine Affiliated to Capital Medical University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- Not specified
1. Patients who meet the diagnostic criteria of Western medicine for acute myocardial infarction and the etiological criteria of atherosclerotic type;
2. Patients who meet the TCM diagnostic criteria of qi deficiency and blood stasis syndrome in the recovery stage of myocardial infarction;
3. Patients who have successful reperfusion therapy for 2 weeks;
4. Subjects aged 18 to 80 years;
5. Subjects who signed informed consent, etc.
1. For those patients with acut myocardial infarction Yin deficiency type;
2. Patients with severe liver or kidney insufficiency(ALT > 3 times of normal, SCR > 221 µ mol/L);
3. Patients with serious consumption state or malignant tumor, etc;
4. Pregnant or lactating women or those with pregnancy planning;
5. Suspected or definite allergy to test drug;
6. Participants in other clinical studies in recent 3 months;
7. Use any preparation containing the same ingredients within 2 weeks;
8. Patients who need continuous mechanical adjuvant therapy after successful interventional therapy.
Study & Design
- Study Type
- Interventional study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Readmission rate due to cardiovascular events;Platelet aggregation rate;Blood fat;Electrocardiograph;Routine stool examination;Non fatal myocardial infarction;N-terminal precursor brain natriuretic peptide;Coagulation function test;Incidence of heart failure;Renal function;Fatal cardiovascular events;Blood routine examination;Blood pressure;Seattle Angina inventory;Inflammatory markers;Liver function;Metabonomics;Non-fatal cardiovascular events;Heart rate;Six minute walk test;Recurrence rate;Cardiac ultrasound;All-cause mortality;Cardiovascular death;Immune index;Routine urine examination;Myocardial enzymes;Carotid ultrasound;Nonfatal stroke accidents;Curative effect of Chinese Medicine Syndrome;Curative effect of angina pectoris symptoms;
- Secondary Outcome Measures
Name Time Method