A Clinical Research of Qi Deficiency and Blood Stasis Syndrome (Different Disease With Syndrome)

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Conditions
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Ischemic Heart Failure

Intervention / Treatment
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* Drug: Yiqi prescription
* Drug: Huoxue prescription
* Drug: Buyang huanwu decoction
* Drug: QISHEN YIQI DRIPPING PILLS
* Drug: Placebo 1
* Drug: Placebo 2


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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;

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: tonifying qi group<br>tonifying qi group:which treated by a kind of Chinese patent medicine (major components: Huangqi,Dangsheng,and so on) | Drug: Yiqi prescription<br> <br> Drug: Placebo 1<br>* Placebo 1：a drug which imitated QISHEN YIQI DRIPPING PILLS,but do not have active ingredient,just have the excipient.<br>|
| Experimental: activating blood group<br>which treated by a kind of Chinese patent medicine (major components: Honghua,Taoren,Danggui，and so on) | Drug: Huoxue prescription<br> <br> Drug: Placebo 1<br>* Placebo 1：a drug which imitated QISHEN YIQI DRIPPING PILLS,but do not have active ingredient,just have the excipient.<br>|
| Experimental: qi and blood group<br>which treated by a kind of Chinese patent medicine (major components: Huangqi,Dangsheng，Honghua,Taoren,Danggui，and so on) | Drug: Buyang huanwu decoction<br> <br> Drug: Placebo 1<br>* Placebo 1：a drug which imitated QISHEN YIQI DRIPPING PILLS,but do not have active ingredient,just have the excipient.<br>|
| Active Comparator: QISHEN YIQI DRIPPING PILLS group<br>which treated by a kind of Chinese patent medicine (major components: Huangqi,Dangsheng，and so on) | Drug: QISHEN YIQI DRIPPING PILLS<br> <br> Drug: Placebo 2<br>* Placebo 2：a drug which imitated Buyang huanwu decoction,but do not have active ingredient,just have the excipient.<br>|
| Sham Comparator: placebo group<br>which treated by the simulation of Chinese patent medicine (major components:excipient) | Drug: Placebo 1<br>* Placebo 1：a drug which imitated QISHEN YIQI DRIPPING PILLS,but do not have active ingredient,just have the excipient.<br>Drug: Placebo 2<br>* Placebo 2：a drug which imitated Buyang huanwu decoction,but do not have active ingredient,just have the excipient.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| N-terminal pronatriuretic peptide（NT-proBNP） |  | 0 month | 
| N-terminal pronatriuretic peptide（NT-proBNP） |  | 3rd month | 
| N-terminal pronatriuretic peptide（NT-proBNP） |  | 9th month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Minnesota heart failure quality of life scale | baseline, 3 months after treatment and follow-up 6 months | 0,3rd,9th month | 
| sST2，Galectin3,PT,APTT,FBg,TT,TnT,CK,GLUT-1.GLUT-4,H-FABP | the expression of these may be related to Qi | 0，3rd month | 
| TXA2,PGI2,CD31,CD18,CD11b,R,K,MA | the expression of these may be related to Xue | 0，3rd month | 
| hs-CRP,IL-1β,IL-6,TNF-α,ICAM-1,VCAM-1,MCP-1,NO,ET-1 | the expression of these may be related to Mai | 0，3rd month | 
| Echocardiography | baseline, 3 months after treatment and follow-up 6 months | 0,3rd,9th month | 
| Cardiac magnetic resonance | baseline, 3 months after treatment | 0，3rd month | 
| Vascular ultrasound | baseline, and after 3 months treatment | 0，3rd month | 
| Endothelial function | baseline, and after 3 months treatment | 0，3rd month | 
| Cardiac function classification, NYHA | baseline, 3 months after treatment and follow-up 6 months | 0,1st,Sec,3rd,6th,9th,month | 
| ultrasonic cardiogram | baseline, 3 months after treatment and follow-up 6 months | 0,3rd,9th month | 
| 6MWT distance | baseline, 3 months after treatment and follow-up 6 months | 0,3rd,9th month | 
| Traditional Chinese Medicine Syndrome Score Scale (TCMSSS) | baseline, 3 months after treatment and follow-up 6 months | 0,3rd,9th month | 
| blood and urine routine tests,liver and renal function tests,serum | safety evaluation | 0,3rd,month | 
| electrolytes,electrocardiogram (ECG) | safety evaluation | 0,3rd,month | 
| Composite endpoint | all-cause death, frequency of emergency/re-admission to hospital due to HF, frequency of re-admission due to cardiovascular disease, acute coronary syndrome, severe arrhythmia, cardiac shock, revascularization, stroke, pulmonary embolism and peripheral vascular incidences, etc. | 1st,3rd,6th,9th, month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ischemic Heart Failure, coronary artery disease, qi deficiency and blood stasis