Stable angina pectoris of coronary heart disease
Conditions
Interventions
Experimental group:Yangxin Shengmai Granules+Yixinshu Tablet Simulation Agent
Control group:Yixinshu Tablet+ Yangxin Shengmai Granules Simulation Agent
Sponsors
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: (1) Meets the diagnostic criteria for stable angina pectoris of coronary heart disease, with at least one of the following criteria: ? A clear history of myocardial infarction in the past; ? Previous coronary artery revascularization; ? Coronary angiography or coronary angiography results indicating at least one coronary artery stenosis with lumen stenosis =50%; ? Coronary heart disease myocardial ischemia diagnosed by cardiac magnetic resonance imaging or radionuclide myocardial perfusion imaging; (2) Meets the criteria for syndrome differentiation of Qi-Yin deficiency in traditional Chinese medicine; (3) The severity of angina pectoris is classified as Grade I to III according to the Canadian Cardiovascular Society (CCS); (4) The duration of angina pectoris is more than 6 months; (5) The frequency of angina pectoris is = 2 times per week; (6) Age between 18 and 70 years old (including 18 and 70 years old), regardless of gender; (7) Fully informed and voluntarily signs the informed consent form.
Exclusion criteria
Exclusion criteria: (1) Presence of any one of the following conditions: severe cardiovascular and cerebrovascular diseases (cerebrovascular accident, acute myocardial infarction or heart failure within 6 months, heart function grade IV, within 6 months after revascularization surgery; large aneurysm or dissecting aneurysm; second-degree or higher atrioventricular block, sick sinus syndrome, and other malignant or potentially malignant arrhythmias); hypertrophic cardiomyopathy and other types of cardiomyopathy; aortic valve stenosis and other heart valve diseases; congenital heart disease; constrictive pericarditis, pericardial tamponade, intracranial hypertension, cerebral hemorrhage or craniocerebral trauma; (2) Pulmonary embolism; respiratory failure; chronic renal insufficiency, immunodeficiency diseases; (3) Presence of other diseases that prohibit treadmill exercise testing: active endocarditis; symptomatic aortic valve stenosis; decompensated heart failure; acute pulmonary thrombus formation or pulmonary infarction; acute non-cardiac dysfunction that affects the exercise test or is aggravated by the exercise test; acute myocarditis or pericarditis; physical disorders affecting safety or exercise capacity (only applicable to subjects requiring treadmill exercise testing); (4) Poorly controlled hypertension (systolic blood pressure = 160 mmHg or diastolic blood pressure = 100 mmHg after treatment); fasting blood glucose > 8 mmol/L; (5) Any laboratory test indicator before screening meets the following criteria: Admission liver and kidney function tests indicate: ALT, AST > 2 times the upper limit of normal, Cr > 1.5 times the upper limit of normal (refer to the normal range of laboratory tests at the research center) Other clinically significant laboratory test abnormalities, and the investigator determines that the subject is not suitable for inclusion (6) Use of traditional Chinese medicine or proprietary Chinese medicine that has a therapeutic effect on stable angina pectoris of coronary heart disease within 1 week; (7) Physical or mental illness that prevents cooperation (such as blindness, deafness, muteness, intellectual disability, mental disorder, etc.), or severe diseases that affect survival (such as tumors, etc.); (8) Suspicion or confirmed history of alcohol or drug abuse; (9) Pregnant or lactating women, or those unwilling to use contraceptive measures during the trial period and within 1 month after the end of the trial; (10) Patients who have participated in other drug clinical trials within 3 months before enrollment; (11) Allergic constitution or allergy to known components of the drug; (12) Other factors determined by the investigator as unsuitable for inclusion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Seattle Angina Questionnaiire; | — |
Secondary
| Measure | Time frame |
|---|---|
| treadmill exercise test;Nitroglycerin Withdrawal Rate;Severity grading of angina pectoris;SAQ Individual Item Score;The SF-36 Quality of Life Scale Score;Angina Pectoris Symptom Score;TCM Syndrome Score; | — |
Countries
China
Contacts
Public ContactLi Jun
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Outcome results
None listed