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

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.

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.

tonifying qi group:which treated by a kind of Chinese patent medicine (major components: Huangqi,Dangsheng,and so on)

which treated by a kind of Chinese patent medicine (major components: Honghua,Taoren,Danggui，and so on)

which treated by a kind of Chinese patent medicine (major components: Huangqi,Dangsheng，Honghua,Taoren,Danggui，and so on)

Placebo 1：a drug which imitated QISHEN YIQI DRIPPING PILLS,but do not have active ingredient,just have the excipient.

Placebo 2：a drug which imitated Buyang huanwu decoction,but do not have active ingredient,just have the excipient.

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.

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;

WRITING COMMITTEE MEMBERS; Yancy CW, Jessup M, Bozkurt B, Butler J, Casey DE Jr, Drazner MH, Fonarow GC, Geraci SA, Horwich T, Januzzi JL, Johnson MR, Kasper EK, Levy WC, Masoudi FA, McBride PE, McMurray JJ, Mitchell JE, Peterson PN, Riegel B, Sam F, Stevenson LW, Tang WH, Tsai EJ, Wilkoff BL; American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines. 2013 ACCF/AHA guideline for the management of heart failure: a report of the American College of Cardiology Foundation/American Heart Association Task Force on practice guidelines. Circulation. 2013 Oct 15;128(16):e240-327. doi: 10.1161/CIR.0b013e31829e8776. Epub 2013 Jun 5. No abstract available.