A Clinical Research of Qi Deficiency and Blood Stasis Syndrome (Different Disease With Syndrome)
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- N-terminal pronatriuretic peptide（NT-proBNP）
研究概览
简要总结
The main purpose of this research is to reveal the curative effect mechanism of Yiqihuoxue prescription which treat the disease of qi deficiency and blood stasis. And at the same time this study also try to confirm yiqi huoxue fang qi deficiency blood stasis treatment of coronary heart disease (CHD) heart failure the curative effect and security.
详细描述
Modern research has shown that the main mechanism of the qi deficiency and blood stasis of coronary disease combined with cardiac failure is the disorder Nerve-endocrine-immune network mechanism, disorder of energy metabolism, blood coagulation/anticoagulation imbalances, vascular endothelial injury and the expression of inflammatory factors and cytokines disorder, etc. Some studies have identified that the Chinese traditional medicine of supplementing qi and activating blood circulation drugs could adjust the nerve - endocrine - immune network, improve endothelial function, improve ventricular remodeling, ameliorate heart function, alleviate the clinical symptoms, enhance the quality of life, and so on. This study by comparing the curative effect of Yi-Qi Formula, Huoxue prescription and two prescription of yiqi huoxue (buyang huanwu decoction and Qishen Yiqi Drop Pill) on improving energy metabolism, ameliorating heart function, adjusting the blood coagulation and the expression of cell adhesion factor, improving endothelial function, to reveal the curative effect mechanism of Yiqihuoxue prescription which treat the disease of qi deficiency and blood stasis, and confirm the TCM theory that "Qi and blood are correlated.
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 (Care Provider, Investigator)
入排标准
- 年龄范围
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 40 to 75;
- •Patients with ischemic heart failure： LVEF less than or equal to 45% measured by echocardiography in modified Simpson method
- •Qi deficiency and blood stasis syndrome;
- •New York Heart Association (NYHA) Class II to Ⅲ ;
- •Submitted informed consent
排除标准
- •Combin the pulmonary embolism, or acute coronary syndrome (acs) ,or acute cerebrovascular disease;
- •Combin other heart diseases: valvular heart disease, dilated cardiomyopathy, hypertension heart disease, pulmonary heart disease,congenital heart disease;
- •Hypertension and diabetes patients treated with drugs but not controlled within standard limit;
- •Severe hepatic and renal dysfunction, malnutrition, malignant tumour;
- •Active tuberculosis or rheumatoid diseases;
- •Nosohemia, organ transplantation,uremia;
- •Psychosis and drug abuse;
- •Allergic to the drugs or one component medicine of the drugs of this study ;
- •Participated in other trials within 1 month ;
- •Being pregnant, planning for pregnancy or breastfeeding;
研究组 & 干预措施
activating blood group
which treated by a kind of Chinese patent medicine (major components: Honghua,Taoren,Danggui，and so on)
干预措施: Huoxue prescription (Drug)
tonifying qi group
tonifying qi group:which treated by a kind of Chinese patent medicine (major components: Huangqi,Dangsheng,and so on)
干预措施: Yiqi prescription (Drug)
tonifying qi group
tonifying qi group:which treated by a kind of Chinese patent medicine (major components: Huangqi,Dangsheng,and so on)
干预措施: Placebo 1 (Drug)
activating blood group
which treated by a kind of Chinese patent medicine (major components: Honghua,Taoren,Danggui，and so on)
干预措施: Placebo 1 (Drug)
qi and blood group
which treated by a kind of Chinese patent medicine (major components: Huangqi,Dangsheng，Honghua,Taoren,Danggui，and so on)
干预措施: Buyang huanwu decoction (Drug)
qi and blood group
which treated by a kind of Chinese patent medicine (major components: Huangqi,Dangsheng，Honghua,Taoren,Danggui，and so on)
干预措施: Placebo 1 (Drug)
QISHEN YIQI DRIPPING PILLS group
which treated by a kind of Chinese patent medicine (major components: Huangqi,Dangsheng，and so on)
干预措施: QISHEN YIQI DRIPPING PILLS (Drug)
QISHEN YIQI DRIPPING PILLS group
which treated by a kind of Chinese patent medicine (major components: Huangqi,Dangsheng，and so on)
干预措施: Placebo 2 (Drug)
placebo group
which treated by the simulation of Chinese patent medicine (major components:excipient)
干预措施: Placebo 1 (Drug)
placebo group
which treated by the simulation of Chinese patent medicine (major components:excipient)
干预措施: Placebo 2 (Drug)
结局指标
主要结局
N-terminal pronatriuretic peptide（NT-proBNP）
时间窗: 9th month
次要结局
- Composite endpoint(1st,3rd,6th,9th, month)
- Minnesota heart failure quality of life scale(0,3rd,9th month)
- sST2，Galectin3,PT,APTT,FBg,TT,TnT,CK,GLUT-1.GLUT-4,H-FABP(0，3rd month)
- TXA2,PGI2,CD31,CD18,CD11b,R,K,MA(0，3rd month)
- hs-CRP,IL-1β,IL-6,TNF-α,ICAM-1,VCAM-1,MCP-1,NO,ET-1(0，3rd month)
- Echocardiography(0,3rd,9th month)
- Cardiac magnetic resonance(0，3rd month)
- Vascular ultrasound(0，3rd month)
- Endothelial function(0，3rd month)
- Cardiac function classification, NYHA(0,1st,Sec,3rd,6th,9th,month)
- ultrasonic cardiogram(0,3rd,9th month)
- 6MWT distance(0,3rd,9th month)
- Traditional Chinese Medicine Syndrome Score Scale (TCMSSS)(0,3rd,9th month)
- blood and urine routine tests,liver and renal function tests,serum(0,3rd,month)
- electrolytes,electrocardiogram (ECG)(0,3rd,month)
研究者
Zhu Mingjun
Professor,chief physicians,the director of Henan University of Traditional Chinese Medicine
The First Affiliated Hospital of Henan University of Traditional Chinese Medicine