Stable angina pectoris (qi deficiency blood stasis)
Conditions
Interventions
Sponsors
Xiyuan Hospital of China Academy of Chinese Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Patients who meet the diagnostic criteria of coronary heart disease in Western Medicine (in accordance with any of the following items): (1) He had received coronary revascularization, including percutaneous coronary intervention and coronary artery bypass grafting; (2) The results of coronary angiography or coronary CT angiography showed that at least one coronary artery was stenosed and the lumen stenosis was more than 50%; (3) Myocardial ischemia was diagnosed by dynamic or static or drug loading radionuclide myocardial scanning; (4) There was a clear history of myocardial infarction. (Note: the results of one of the above four items provided by the tertiary hospital can be used as diagnostic evidence, and the copy is attached to the research medical record.) 2. Patients who meet the diagnostic criteria of Western medicine for stable angina pectoris; 3. Patients who meet the syndrome differentiation standard of qi deficiency and blood stasis; 4. Patients with angina pectoris attack more than 3 times a week before screening or one month before enrollment, and the Canadian Cardiovascular Society (CCS) angina pectoris classification was II ~ III; 5. Patients with myocardial ischemic attack more than 2 times during 24-hour Holter monitoring in baseline period (diagnostic criteria of myocardial ischemic attack are as follows: ST segment horizontal depression or oblique depression, amplitude >= 1.0 mm, duration >= 1 min, and interval between two adjacent myocardial ischemic attacks >= 1 min); 6. Patients who have used beta blockers before should use them regularly for more than one month; 7. Outpatients or inpatients aged between 18 and 70 years (including boundary value); 8. Patients of childbearing age agree to use a medically acceptable non drug method for contraception or abstinence within 3 months after signing the informed consent form to the last medication; 9. Patients understand and abide by the research process, which is sufficient to complete all the tests and examinations required by the protocol, communicate well with the researchers, participate in the trial voluntarily, and sign the informed consent form. Those who do not meet one of the above conditions are not allowed to enter the study.
Exclusion criteria
Exclusion criteria: Those who meet any of the following conditions before screening or enrollment will not be eligible for this study: 1. Patients with clinically significant valve disease, congenital heart disease, pulmonary hypertension, chronic obstructive pulmonary disease, stroke, dissecting aneurysm, hypertrophic cardiomyopathy, acute myocarditis, pericarditis; 2. Patients with non sinus rhythm or with arrhythmia (such as grade II and III atrioventricular block, atrial fibrillation, atrial flutter, sick sinus syndrome, preexcitation syndrome, complete left bundle branch block, etc.) who are not suitable for the trial, or those with pacemaker or cardioverter; 3. Patients with NYHA grade III or IV, or patients with acute pulmonary edema; 4. Select the patients who received coronary angioplasty or coronary artery bypass grafting in the first 3 months; 5. Patients with unstable angina within 3 months before screening; 6. Patients with poor blood pressure control (sitting systolic blood pressure >= 160 mmHg or = 100 mmHg or 6.5%); 8. Patients with other serious diseases, such as tumor, which may hinder their enrollment or affect their survival; 9. Patients who took digitalis within one month before screening; 10. Patients with liver dysfunction, i.e. aspartate aminotransferase (AST) and alanine aminotransferase (ALT), are more than twice the normal upper limit, or the researchers believe that patients with liver damage should not participate in the study; 11. Patients with renal insufficiency, i.e. creatinine (SCR) levels higher than the upper limit of the reference range, or the extent to which the researchers believe that patients should not participate in the study; 12. Patients with platelet count less than 100 * 10^9 / L; 13. Patients with gastrointestinal or other visceral bleeding or coagulation dysfunction within one month before screening; 14. Patients who are allergic to two or more drugs or foods, or patients who are known to be allergic to the test drug (including its ingredients); 15. Patients with a history of epilepsy or psychosis; 16. Patients who have participated in clinical drug trials within 3 months before screening; 17. Patients with drug abuse history within 12 months before screening; 18. Patients with pregnant, planned or lactating women; 19. Other patients not specified but considered by the researchers as unsuitable to participate in this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of patients with 0 angina attacks; | — |
Secondary
| Measure | Time frame |
|---|---|
| The change of nitroglycerin withdrawal rate and nitroglycerin use from baseline ;Proportion of patients with angina symptoms resolved and remained constant for at least 4 weeks ;Changes in the number, duration, and severity of angina pectoris from baseline;The change of fatigue (simple fatigue scale score) compared with the baseline ;The proportion of patients with the number of angina attacks decreased to 0-1 ;Changes of Seattle Angina Scale score (SAQ) from baseline ;Changes of TCM syndrome score compared with baseline ;The changes of myocardial ischemic attacks and total myocardial ischemic load compared with baseline during dynamic electrocardiogram monitoring 24 hours after the end of medication ;The changes of TCM syndromes and signs scores compared with the baseline; | — |
Countries
China
Contacts
Public ContactHao Xu
Xiyuan Hospital of China Academy of Chinese Medical Sciences
Outcome results
None listed