Study of Curative Effect Evaluation of Shexiang Baoxin Pill on Coronary Artery Disease Not Amenable to Revascularization on the Basis of Western Medicine Therapy
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 440
- 主要终点
- Mortality
研究概览
简要总结
The purpose of this study is to determine whether Shexiang Baoxin Pill is effective in the treatment of coronary artery disease not amenable to revascularization on the basis of western medicine therapy.
详细描述
The western medicine treatment for CAD not amenable to revascularization is limited. Shexiang Baoxin Pill, a kind of Chinese patent medicine has been used for treating coronary artery disease in clinical practice in China for many years.
Shexiang baoxin pill(SBP) is applicable to "Qi deficiency and blood stasis syndrome" in traditional Chinese medicine. Recent experimental research has indicated that SBP can improve myocardial ischemia and promote therapeutic angiogenesis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 45 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants are aged between 45 and 75 years, diagnosed with sever CAD through coronary arteriography which shows that the left main coronary artery and three-vessel have sever diffuse stenosis, calcification or vascular ectasia, be in accordance with Traditional Chinese Medicine syndrome of "Qi deficiency and blood stasis syndrome" or "phlegm and stasis mu-tual obstruction syndrome".
排除标准
- •Patients with severe valvular disease, congenital cardiomyopathy decompensation
- •Patients with CAD complicated with severe multiple organ disease such as severe heart failure, severe lung, liver or renal dysfunction, peptic ulcer in active stage, or intracranial hemorrhage
- •Patients that use high-dose steroids due to connective tissue disease
- •Patients with serious infections
- •Patients with malignant tumor
- •Patients with hematopoietic diseases
- •Pregnant or lactating women.
研究组 & 干预措施
Shexiang baoxin pill
Shexiang baoxin 22.5mg pill by mouth,2 pills three times daily for 6 months & Conventional western medicine (including Aspirin Enteric-coated Tablets, Clopidogrel Hydrogen Sulfate 75 MG Oral Tablet, Atorvastatin Calcium, Isosorbide Mononitrate Tab 20 MG, Metoprolol Tartrate Tab 25 MG, Trimetazidine Dihydrochloride Tablets)
干预措施: Shexiang Baoxin pill (Drug)
Shexiang baoxin pill
Shexiang baoxin 22.5mg pill by mouth,2 pills three times daily for 6 months & Conventional western medicine (including Aspirin Enteric-coated Tablets, Clopidogrel Hydrogen Sulfate 75 MG Oral Tablet, Atorvastatin Calcium, Isosorbide Mononitrate Tab 20 MG, Metoprolol Tartrate Tab 25 MG, Trimetazidine Dihydrochloride Tablets)
干预措施: Aspirin Enteric-coated Tablets (Drug)
Shexiang baoxin pill
Shexiang baoxin 22.5mg pill by mouth,2 pills three times daily for 6 months & Conventional western medicine (including Aspirin Enteric-coated Tablets, Clopidogrel Hydrogen Sulfate 75 MG Oral Tablet, Atorvastatin Calcium, Isosorbide Mononitrate Tab 20 MG, Metoprolol Tartrate Tab 25 MG, Trimetazidine Dihydrochloride Tablets)
干预措施: Clopidogrel Hydrogen Sulfate 75 MG Oral Tablet (Drug)
Shexiang baoxin pill
Shexiang baoxin 22.5mg pill by mouth,2 pills three times daily for 6 months & Conventional western medicine (including Aspirin Enteric-coated Tablets, Clopidogrel Hydrogen Sulfate 75 MG Oral Tablet, Atorvastatin Calcium, Isosorbide Mononitrate Tab 20 MG, Metoprolol Tartrate Tab 25 MG, Trimetazidine Dihydrochloride Tablets)
干预措施: Atorvastatin Calcium (Drug)
Shexiang baoxin pill
Shexiang baoxin 22.5mg pill by mouth,2 pills three times daily for 6 months & Conventional western medicine (including Aspirin Enteric-coated Tablets, Clopidogrel Hydrogen Sulfate 75 MG Oral Tablet, Atorvastatin Calcium, Isosorbide Mononitrate Tab 20 MG, Metoprolol Tartrate Tab 25 MG, Trimetazidine Dihydrochloride Tablets)
干预措施: Isosorbide Mononitrate Tab 20 MG (Drug)
Shexiang baoxin pill
Shexiang baoxin 22.5mg pill by mouth,2 pills three times daily for 6 months & Conventional western medicine (including Aspirin Enteric-coated Tablets, Clopidogrel Hydrogen Sulfate 75 MG Oral Tablet, Atorvastatin Calcium, Isosorbide Mononitrate Tab 20 MG, Metoprolol Tartrate Tab 25 MG, Trimetazidine Dihydrochloride Tablets)
干预措施: Metoprolol Tartrate Tab 25 MG (Drug)
Shexiang baoxin pill
Shexiang baoxin 22.5mg pill by mouth,2 pills three times daily for 6 months & Conventional western medicine (including Aspirin Enteric-coated Tablets, Clopidogrel Hydrogen Sulfate 75 MG Oral Tablet, Atorvastatin Calcium, Isosorbide Mononitrate Tab 20 MG, Metoprolol Tartrate Tab 25 MG, Trimetazidine Dihydrochloride Tablets)
干预措施: Trimetazidine Dihydrochloride Tablets (Drug)
SBP placebo
Placebo shexiang baoxin 22.5mg pill by mouth,2 pills three times daily for 6 months & Conventional western medicine (including Aspirin Enteric-coated Tablets, Clopidogrel Hydrogen Sulfate 75 MG Oral Tablet, Atorvastatin Calcium, Isosorbide Mononitrate Tab 20 MG, Metoprolol Tartrate Tab 25 MG, Trimetazidine Dihydrochloride Tablets)
干预措施: SBP placebo (Drug)
SBP placebo
Placebo shexiang baoxin 22.5mg pill by mouth,2 pills three times daily for 6 months & Conventional western medicine (including Aspirin Enteric-coated Tablets, Clopidogrel Hydrogen Sulfate 75 MG Oral Tablet, Atorvastatin Calcium, Isosorbide Mononitrate Tab 20 MG, Metoprolol Tartrate Tab 25 MG, Trimetazidine Dihydrochloride Tablets)
干预措施: Aspirin Enteric-coated Tablets (Drug)
SBP placebo
Placebo shexiang baoxin 22.5mg pill by mouth,2 pills three times daily for 6 months & Conventional western medicine (including Aspirin Enteric-coated Tablets, Clopidogrel Hydrogen Sulfate 75 MG Oral Tablet, Atorvastatin Calcium, Isosorbide Mononitrate Tab 20 MG, Metoprolol Tartrate Tab 25 MG, Trimetazidine Dihydrochloride Tablets)
干预措施: Clopidogrel Hydrogen Sulfate 75 MG Oral Tablet (Drug)
SBP placebo
Placebo shexiang baoxin 22.5mg pill by mouth,2 pills three times daily for 6 months & Conventional western medicine (including Aspirin Enteric-coated Tablets, Clopidogrel Hydrogen Sulfate 75 MG Oral Tablet, Atorvastatin Calcium, Isosorbide Mononitrate Tab 20 MG, Metoprolol Tartrate Tab 25 MG, Trimetazidine Dihydrochloride Tablets)
干预措施: Atorvastatin Calcium (Drug)
SBP placebo
Placebo shexiang baoxin 22.5mg pill by mouth,2 pills three times daily for 6 months & Conventional western medicine (including Aspirin Enteric-coated Tablets, Clopidogrel Hydrogen Sulfate 75 MG Oral Tablet, Atorvastatin Calcium, Isosorbide Mononitrate Tab 20 MG, Metoprolol Tartrate Tab 25 MG, Trimetazidine Dihydrochloride Tablets)
干预措施: Isosorbide Mononitrate Tab 20 MG (Drug)
SBP placebo
Placebo shexiang baoxin 22.5mg pill by mouth,2 pills three times daily for 6 months & Conventional western medicine (including Aspirin Enteric-coated Tablets, Clopidogrel Hydrogen Sulfate 75 MG Oral Tablet, Atorvastatin Calcium, Isosorbide Mononitrate Tab 20 MG, Metoprolol Tartrate Tab 25 MG, Trimetazidine Dihydrochloride Tablets)
干预措施: Metoprolol Tartrate Tab 25 MG (Drug)
SBP placebo
Placebo shexiang baoxin 22.5mg pill by mouth,2 pills three times daily for 6 months & Conventional western medicine (including Aspirin Enteric-coated Tablets, Clopidogrel Hydrogen Sulfate 75 MG Oral Tablet, Atorvastatin Calcium, Isosorbide Mononitrate Tab 20 MG, Metoprolol Tartrate Tab 25 MG, Trimetazidine Dihydrochloride Tablets)
干预措施: Trimetazidine Dihydrochloride Tablets (Drug)
结局指标
主要结局
Mortality
时间窗: Six months after randomisation
Death caused by cardiovascular disease
次要结局
- B-type natriuretic peptide (BNP)(At baseline (before randomisation), and six months after randomisation.)
- Hospital readmission rates(At baseline (before randomisation), and six months after randomisation.)
- Ejection fraction percentage (EF%)(At baseline (before randomisation), and six months after randomisation.)
- C-reactive protein (CRP)(At baseline(before randomisation), and six months after randomisation.)
- E/A ratio(At baseline (before randomisation), and six months after randomisation.)
研究者
Jun Li
Director of Cardiology
Guang'anmen Hospital of China Academy of Chinese Medical Sciences