chronic stable angina
Conditions
Interventions
test group:Danzhufuyuan granules orally and Conventional Treatment in Western medicine
Sponsors
China Science and Technology Development Center for Chinese Medicine
Eligibility
Sex/Gender
All
Age
40 Years to 70 Years
Inclusion criteria
Inclusion criteria: (1) Patient must be between the ages of 40 and 70 years; (2) Patient must meet the western diagnostic criteria and can provide sufficient evidence of coronary artery disease(meeting anyone or more of the following criteria) : ? Had undergone coronary angiography or coronary CTA examination indicating lumen diameter stenosis of at least one major branch of coronary artery =50%; ? There was a clear and well-documented history of old myocardial infarction for over 3 months; ? Had received coronary revascularization (PCI or CABG).; (3) Patient must meet the western diagnostic criteria for chronic stable angina pectoris; (4) Patient must have more than 2 angina attacks per week in the past 3 months; (5) Moderate angina pectoris(Class II or Class III ,Grading of Angina Pectoris by the Canadian Cardiovascular Society Classification System); (6) Patient must meet the clinical diagnostic criteria of intermingle phlegm and blood stasis of coronary heart disease; (7) Patient must be able to perform treadmill Exercise Test, and get a positive result at the time of enrollment; (8) All TCM interventions (including TCM decoction, granules, Proprietary Chinese medicine, acupuncture, etc.) should be stopped for at least 2 weeks; (9) Patient must be able to give voluntary written informed consent.
Exclusion criteria
Exclusion criteria: Patients with anyone or more of the following exclusion criterias will not be allowed to participate in this clinical trial. (1) Patients who had acute coronary syndrome (including acute myocardial infarction or unstable angina) within 2 months prior to enrollment, or had received revascularization within 3 months prior to enrollment, or plan to receive revascularization during the study period; (2) Patients could not perform treadmill Exercise Test for various reasons, including absolute and relative contraindications to perform treadmill Exercise Test: acute myocardial infarction (within 2 days); Uncontrolled unstable angina pectoris; Uncontrolled arrhythmias that cause symptoms and abnormal hemodynamics; Acute endocarditis; Severe aortic stenosis; Decompensation of heart failure; Acute pulmonary embolism, pulmonary infarction, or deep vein thrombosis; Acute pericarditis or myocarditis; Acute aortic dissection; Due to physical disability, there are safety risks when participating in the flat test or unable to complete the exercise flat test; Known obstruction of the left main coronary artery; Moderate to severe aortic stenosis without definite symptoms; Ventricular rate uncontrolled tachycardia; High or complete atrioventricular block; Obstructive hypertrophic cardiomyopathy; Recent stroke or transient ischemic attack; Mental abnormality can not cooperate; Systolic blood pressure =160mmHg or diastolic blood pressure =100mmHg in resting state; Uncorrected clinical conditions (severe anemia, electrolyte disturbances and hyperthyroidism); (3) Clinically significant co-morbidities, including serious primary diseases such as respiratory, hematological system or malignant tumor, or renal insufficiency (serum creatinine (Cr) > 221umol/L in males and 177umol/L in females ); (4) Patients with history of bleeding tendency, cerebral hemorrhage, or seizure disorders that required anticonvulsant medication; (5) Active liver disease, or accompanied by unexplained continuous elevation of serum aminotransferase, or the detection value of either alanine aminotransferase (ALT) and aspartate aminotransferase (AST) >2 times the upper limit of normal reference value; (6) Females of childbearing must who are pregnant, in breast feeding or have fertility requirements; (7) Inability to discontinue existing chronic nitrate regiment; (8) Participation in any other clinical trial; (9) Patients with a recent history (within the last 2 years) of alcoholism or known history of drug dependence; (10) In the opinion of the investigator, Those patient unable, to comply fully with the trial requirement, Other circumstances that the investigator considers inappropriate for the study, including, but not limited to, patients who are unable to fully comply with the trial requirement or with e potential safety concerns .
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Syndrome score of intermingle phlegm and blood stasis in patients with coronary heart disease;Variation of Total Exercise Duration between Week 8 and Week 0 compared with the control group. ; | — |
Secondary
| Measure | Time frame |
|---|---|
| Duke treadmill Exercise Score (DTS);The change of the score of The Seattle Angina scale between Week 4 \ Week 8 and Week 0 compared with the control group;The average weekly nitroglycerin consumption of the baseline \Week 4 and Week 8 compared with the control group;Maximum ST segment decline value;Maximum load;Canadian Cardiovascular Association (CCS) Angina severity classification;Variation of Total Exercise Duration between Week 4 and Week 0 compared with the control group ;The average weekly angina attacks of the baseline \Week 4 and Week 8 compared with the control group;The total time for inducing ST segment to move down 0.1mV; | — |
Countries
China
Contacts
Public ContactHu Jingqing
Outcome results
None listed