Stable angina pectoris of coronary heart disease (syndrome of blood stasis in the heart vessel)
Conditions
Interventions
Experimental group:Compound Chuanxiong Tablets: 4 tablets each time, 3 times a day
to be taken after meals, with a treatment course of 8 weeks.
Control group:Simulant of Compound Chuanxiong Tablets, 4 tablets each time, 3 times a day
Sponsors
Dongzhimen Hospital, Beijing University of Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 85 Years
Inclusion criteria
Inclusion criteria: 1. Meeting the diagnostic criteria for stable angina pectoris of coronary heart disease in Western medicine; 2. Meeting the diagnostic criteria for the syndrome of heart blood stasis in traditional Chinese medicine; 3. Having angina pectoris symptoms, along with at least one of the following pieces of evidence for diagnosing coronary heart disease: a. A clear history of myocardial infarction in the past; b. Having undergone coronary revascularization therapy; c. Coronary angiography or coronary CTA examination indicating that at least one coronary artery has stenosis with a lumen stenosis of >=50%; 4. Patients with stable angina pectoris of coronary heart disease classified as Grade I - III; 5. Those who, during the treadmill exercise test conducted at screening, show positive indicators within 3 - 12 minutes after the start of exercise (Note: Male subjects evaluated by the treadmill exercise test need to meet this criterion during the screening period); 6. For those who were using beta - blockers or calcium ion antagonists before screening, they must have been using a stable dose for at least 4 weeks, and it is expected that the usage and dosage will remain unchanged during the study period; 7. Having an average of >=2 angina pectoris attacks per week in the month before screening; 8. Being 18 <= age <= 85 years old when signing the informed consent form, regardless of gender;
Exclusion criteria
Exclusion criteria: 1.Patients who have taken blood-activating and stasis-resolving Chinese patent medicines, and/or Chinese patent medicines, Chinese herbal decoctions, granules, or medical institution preparations indicated for angina pectoris within 1 week before randomization; or those who have used nitrates regularly for a long time. 2. Patients with known severe lesions in the left main coronary artery without effective treatment. 3. Patients with clinically significant valvular diseases, congenital heart diseases, pulmonary embolism, chronic obstructive pulmonary disease, bronchial asthma, new-onset acute stroke within one month, dissecting aneurysm, sick sinus syndrome, hypertrophic obstructive cardiomyopathy, acute myocarditis/pericarditis, or congenital long QT syndrome. 4. Patients with any of the following conditions at screening: congestive heart failure with NYHA class III or IV or acute pulmonary edema; left ventricular ejection fraction = 160 mmHg or = 100 mmHg or 1.5 times the upper limit of normal), renal function (Scr > 1.5 times the upper limit of normal), PT or TT > 3 seconds beyond the normal range, or APTT > 10 seconds beyond the normal range. 9. Patients with poorly controlled diabetes mellitus and fasting blood glucose > 8 mmol/L. 10. Pregnant or lactating women, or women planning to become pregnant in the near future. 11. Patients with other mental or physical diseases who cannot cooperate with the researcher to complete the study. 12. Patients allergic to the components of this preparation. 13. Patients who are currently participating in other clinical trials of drugs or have participated in such trials within 4 weeks. 14. Patients with a suspected or confirmed history of alcohol or drug abuse. 15. Other conditions that, in the researcher's judgment, may reduce the possibility of enrollment or complicate enrollment, such as frequent changes in the working environment which may easily lead to loss to follow-up. Those who voluntarily participate in the trial and sign the informed consent form.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The change in the total score of the Seattle Angina Questionnaire after 8 weeks of treatment compared with the baseline value; | — |
Secondary
| Measure | Time frame |
|---|---|
| The change in the total score of the Seattle Angina Questionnaire after 4 weeks of treatment compared with the baseline value;The changes in scores of each dimension of the Seattle Angina Questionnaire compared with the baseline values after 4 and 8 weeks of treatment;The withdrawal rate of nitroglycerin tablets after 4 and 8 weeks of treatment;The rate of patients whose TCM syndrome scores decreased by >=30% compared with the baseline scores after 8 weeks of treatment;The changes in the Short Form 36 Health Survey (SF-36) scores compared with the baseline values after 4 and 8 weeks of treatment;Treadmill exercise electrocardiogram test1. The change in total exercise time after 8 weeks of treatment compared with the baseline value; 2. The change in Duke score after 8 weeks of treatment compared with the baseline value; | — |
Countries
China
Contacts
Public ContactLijing Zhang
Dongzhimen Hospital, Beijing University of Chinese Medicine
Outcome results
None listed