stable angina pectoris
Conditions
Interventions
Control group:Compound Danshen Tablets
Sponsors
The First Affiliated Hospital of Henan University of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Meet the diagnostic criteria for coronary heart disease in Western medicine (meet any of the following criteria): (1) Previously received coronary artery reconstruction treatment, including percutaneous coronary intervention and coronary artery repair Pulse bypass surgery; (2) Coronary angiography or coronary CT angiography results indicate at least one coronary artery Arterial stenosis with lumen stenosis = 50%; (3) There is a clear history of myocardial infarction in the past. 2. Meets the diagnostic criteria for stable exertional angina pectoris, according to the Canadian Cardiovascular Society (CCS) Patients with angina pectoris classified as grade I, II, and III; 3. Patients with traditional Chinese medicine syndrome differentiation of blood stasis syndrome; 4. Those who can complete the exercise tablet test and have a positive result in the tablet exercise test at the time of enrollment (Applicable to the tablet exercise test group); 5. Age: between 18 and 75 years old; 6. Voluntarily sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Individuals who are allergic to the components of the experimental drug or have an allergic constitution; 2. Screening for a history of myocardial infarction within the past 3 months, stable angina (CCS grade IV), and their People with heart disease; 3. Select patients who have undergone coronary angioplasty or coronary artery bypass surgery within 3 months; 4. Coexistence of arrhythmia (such as second and third degree atrioventricular block, atrial fibrillation, atrial flutter, sick sinus) Syndrome, pre excitation syndrome, complete left bundle branch block, etc. are not suitable for participating in this trial Testers, or those with built-in pacemakers or defibrillators. 5. Merge clinically significant valve disease, congenital heart disease, pulmonary hypertension, chronic heart disease Obstructive pulmonary disease, aortic dissection, hypertrophic cardiomyopathy, acute myocarditis, pericarditis; 6. For patients with NYHA grade IV or acute pulmonary edema, cardiac ultrasound examination is required Check the prompt EF = 35%; 7. Select patients who have taken digitalis within the previous month; 8. Individuals with mental disorders and inability to cooperate, epilepsy, menopausal syndrome, hyperthyroidism, gallbladder heart syndrome Researchers believe that reflux of the stomach and esophagus, hiatal hernia, and other conditions may affect clinical evaluators Serious diseases that affect survival (such as tumors); 9. Screening period with poorly controlled hypertension (sitting systolic blood pressure = 180mmHg, sitting diastolic blood pressure) Pressure = 110mmHg); 10. Those who have undergone major surgeries within the past month; 11. Combine other clinical conditions that may increase the risk of bleeding, such as significant organ dysfunction in the past six months Blood history (such as cerebral hemorrhage, upper gastrointestinal bleeding, etc.), decreased platelet count, coagulation function Abnormal, currently undergoing oral anticoagulant therapy, etc; 12. Active liver disease, or continuous elevation of serum transaminase for unknown reasons, or screening Test for either aspartate aminotransferase (AST) or alanine aminotransferase (ALT) Patients with a measurement value greater than 2 times the upper limit of normal, or those assessed by the researcher as unsuitable for participation in this study Person; 13. Patients with abnormal renal function assessment during screening and deemed unsuitable for participation in this study by the researchers Person; Cr or BUN>1.5 times the upper limit of normal values; 14. Participants in other clinical drug trials within the past month prior to screening; 15. Pregnant or lactating women; Within 3 months after the end of the experiment, there are plans to conceive or donate sperm/eggs, or the experiment ends Not agreeing to strict contraceptive measures for myself and my spouse within the next 3 months; 17. Other circumstances that the researcher deems unsuitable for participation in this experiment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Comparison of the difference between the total score of the Seattle Angina Pectoris Scale and the baseline value after 8 weeks of administration; | — |
Secondary
| Measure | Time frame |
|---|---|
| Comparison of the therapeutic effects of traditional Chinese medicine syndromes and the main symptoms of traditional Chinese medicine (chest tightness, chest pain, and dark lips and tongue) before and after treatment;Comparison of the difference between the total score of the Seattle Angina Pectoris Scale and the baseline value after 4 weeks of administration;Seattle Angina Pectoris Scale scoring items (degree of physical activity restriction, stable angina status, heart rate) Changes in scores of angina attacks, treatment satisfaction, and disease awareness compared to baseline;Comparison of angina symptom scores before and after treatment;Comparison of 24-hour total myocardial ischemic load (Holter) before and after treatment;Evaluation of exercise tablet related indicators before and after treatment (duration, time required to induce ST segment depression by 0.1mv, maximum ST segment depression value, maximum load, Duke activity tablet score); | — |
Countries
China
Contacts
Public ContactZhu Mingjun
The First Affiliated Hospital of Henan University of Traditional Chinese Medicine
Outcome results
None listed