Stable angina pectoris of coronary heart disease
Conditions
Interventions
Experimental Group:Compound Chuanxiong Tablets (produced by Shandong Phoenix Pharmaceutical Co., Ltd., National Medicine Approval Number Z20080345): Take 4 tablets each time, 3 times a day, orally hal
Control Group:Ginkgo Biloba Tablets (produced by Yantai Rongchang Pharmaceutical Co., Ltd., National Medicine Approval Number Z20063922): Take 1 tablet each time, 3 times a day, orally half an hour af
Sponsors
Beijing Hospital of Traditional Chinese Medicine Affiliated to Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 85 Years
Inclusion criteria
Inclusion criteria: (1) Meeting the diagnostic criteria for Western medicine SAP, with reference to the *Guidelines for the Diagnosis and Treatment of Stable Coronary Artery Disease* (2018); (2) Meeting the diagnostic criteria for the Traditional Chinese Medicine syndrome of Blood Stasis Obstructing the Heart, with reference to the *Guidelines for TCM Diagnosis and Treatment of Stable Angina Pectoris of Coronary Heart Disease* (2019); (3) Patients with stable angina pectoris of coronary heart disease classified as grade I to III, based on the Canadian Cardiovascular Society (CCS) Angina Severity Classification; (4) Experiencing angina symptoms and having at least one of the following pieces of evidence for the diagnosis of coronary heart disease: 1) A clear history of myocardial infarction; 2) Previous coronary revascularization therapy; 3) Coronary angiography or coronary CTA indicating at least one coronary artery stenosis with lumen stenosis =50%, or static/dynamic or pharmacological stress nuclear myocardial scan diagnosing myocardial ischemia due to coronary heart disease; 4) Male patients with a positive treadmill exercise test within the past three months; (5) Having an average of =2 angina episodes per week in the month prior to enrollment; (6) Subjects numbered 1–72: Undergo a treadmill exercise test during screening, with positive indicators appearing 3–12 minutes after the start of exercise; (7) No use of anti-anginal medications (excluding permitted concomitant medications and nitroglycerin) within the two weeks prior to enrollment; (8) Age between 18 and 85 years, inclusive, regardless of gender; (9) Volunteers who agree to participate and sign an informed consent form.
Exclusion criteria
Exclusion criteria: (1) Those with severe lesions in the left main coronary artery but without effective treatment. (2) 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, congenital long QT syndrome. (3) Those with NYHA class III or IV congestive heart failure or acute pulmonary edema, with left ventricular ejection fraction less than 50% as shown by echocardiography. (4) Non-sinus rhythm, or with existing arrhythmias (such as second or third degree atrioventricular block, bundle branch block, pre-excitation syndrome, atrial fibrillation, atrial flutter, sick sinus syndrome, etc.), or with implanted pacemaker or cardioverter defibrillator. (5) Those who underwent CABG or PCI within the previous three months. (6) Patients with severe and uncontrolled hypertension (=160/100 mmHg), or with hypotension (=90/60 mmHg). (7) Other reasons affecting ST-T changes in electrocardiogram, such as effects of digitalis drugs, electrolyte disorders, etc. (8) Those with one or more of the following abnormalities: severe primary diseases of the liver (ALT and/or AST > 1.5 times the upper limit of normal), kidney (Scr > 1.5 times the upper limit of normal), hematological system, etc., and patients with mental disorders. (9) Those with poor control of diabetes, fasting blood glucose greater than 8 mmol/L. (10) Pregnant or lactating women or those who have recently prepared for pregnancy. (11) Patients with legally recognized disabilities (blind, deaf, mute, intellectual disability, mental disorder, etc.). (12) Those who are allergic to the components of this preparation. (13) Those who are currently participating in or have participated in other drug clinical trials within 4 weeks. (14) Those suspected or confirmed to have a history of alcohol or drug abuse, or other situations that may reduce the possibility of enrollment or make the enrollment process complicated, such as frequent changes in work environment that may lead to loss of follow-up. (15) Patients considered not suitable for participating in this clinical trial by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| TCM Syndrome Level Assessment;TCM Syndrome Efficacy Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Angina Symptom Score;Nitroglycerin Discontinuation/Reduction Rate;Efficacy of Individual Symptoms in TCM Syndromes;Seattle Angina Questionnaire;Electrocardiogram Efficacy;Treadmill Exercise Test Efficacy;Angina Symptom Efficacy; | — |
Countries
China
Contacts
Public ContactHongxu Liu
Beijing Hospital of Traditional Chinese Medicine Affiliated to Capital Medical University
Outcome results
None listed