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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
180
First affiliated hospital, Henan University of Traditional Chinese medicine
Zhengzhou, Henan, China
RECRUITINGN-terminal pronatriuretic peptide(NT-proBNP)
Time frame: 0 month
N-terminal pronatriuretic peptide(NT-proBNP)
Time frame: 3rd month
N-terminal pronatriuretic peptide(NT-proBNP)
Time frame: 9th month
Minnesota heart failure quality of life scale
baseline, 3 months after treatment and follow-up 6 months
Time frame: 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"
Time frame: 0,3rd month
TXA2,PGI2,CD31,CD18,CD11b,R,K,MA
the expression of these may be related to "Xue"
Time frame: 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"
Time frame: 0,3rd month
Echocardiography
baseline, 3 months after treatment and follow-up 6 months
Time frame: 0,3rd,9th month
Cardiac magnetic resonance
baseline, 3 months after treatment
Time frame: 0,3rd month
Vascular ultrasound
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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.
baseline, and after 3 months treatment
Time frame: 0,3rd month
Endothelial function
baseline, and after 3 months treatment
Time frame: 0,3rd month
Cardiac function classification, NYHA
baseline, 3 months after treatment and follow-up 6 months
Time frame: 0,1st,Sec,3rd,6th,9th,month
ultrasonic cardiogram
baseline, 3 months after treatment and follow-up 6 months
Time frame: 0,3rd,9th month
6MWT distance
baseline, 3 months after treatment and follow-up 6 months
Time frame: 0,3rd,9th month
Traditional Chinese Medicine Syndrome Score Scale (TCMSSS)
baseline, 3 months after treatment and follow-up 6 months
Time frame: 0,3rd,9th month
blood and urine routine tests,liver and renal function tests,serum
safety evaluation
Time frame: 0,3rd,month
electrolytes,electrocardiogram (ECG)
safety evaluation
Time frame: 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.
Time frame: 1st,3rd,6th,9th, month