Efficacy and safety of Xuefu Zhuyu Granules combined with Western medicine in the treatment of angina pectoris of coronary heart disease: A study protocol of a randomized, double-blind, placebo-controlled clinical trial
- Registration Number
- TCTR20220906002
- Lead Sponsor
- Dong Liu
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending (Not yet recruiting)
- Sex
- All
- Target Recruitment
- 52
(1) Meet the diagnostic criteria of coronary heart disease angina pectoris in traditional Chinese medicine and Western medicine, coronary angiography or coronary angiography showed at least one coronary artery stenosis and catheter stenosis at least 50%;
(2) Aged at least 18 years old, and at least 70 years old;
(3) Canadian Cardiovascular Society (CCS) classification of angina pectoris is grade I-III;
(4) Angina pectoris attack frequency at least 2 times/week, and less than or equal to 6 times/day;
(5) Patients agreed to join this study, and signed informed consent.
(1) Patients who have undergone coronary artery bypass surgery;
(2) Patients with other serious diseases (such as severe cardiopulmonary dysfunction, tumor, etc.) or ALT, AST or Cr reaching 1.5 times of the normal upper limit
(3) Patients with other diseases that may increase the risk of bleeding (such as cerebral hemorrhage, upper gastrointestinal bleeding), the platelet count decreased, coagulation dysfunction, etc.
(4) Pregnant, preparing for pregnancy or lactating women;
(5) Patients are allergic to the use of drugs in the study;
(6) Participated in or are participating in other clinical trials in the past 1 month.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Cardiac function indexes: LVEDD, LVESD and LVEF will be measured by color doppler ultrasonic diagnostic apparatus 24 weeks Cardiac function indexes: LVEDD, LVESD and LVEF will be measured by color doppler ultrasonic diagnostic apparatus
- Secondary Outcome Measures
Name Time Method Blood lipid levels: Fasting veins of the patients will be collected in the morning before and after treatment and during follow-up, and blood lipid index, including TC TG; 24 weeks LDL-C and HDL-C, were measured by an automatic biochemical analyzer