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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title:

Brief Summary: 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 Summary: 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.
Sponsor: Zhu Mingjun

Current Primary Outcome:

  • N-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 ]


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Minnesota heart failure quality of life scale [ Time Frame: 0,3rd,9th month ]
    baseline, 3 months after treatment and follow-up 6 months
  • sST2，Galectin3,PT,APTT,FBg,TT,TnT,CK,GLUT-1.GLUT-4,H-FABP [ Time Frame: 0，3rd month ]
    the expression of these may be related to "Qi"
  • TXA2,PGI2,CD31,CD18,CD11b,R,K,MA [ Time Frame: 0，3rd month ]
    the expression of these may be related to "Xue"
  • hs-CRP,IL-1β,IL-6,TNF-α,ICAM-1,VCAM-1,MCP-1,NO,ET-1 [ Time Frame: 0，3rd month ]
    the expression of these may be related to "Mai"
  • Echocardiography [ Time Frame: 0,3rd,9th month ]
    baseline, 3 months after treatment and follow-up 6 months
  • Cardiac magnetic resonance [ Time Frame: 0，3rd month ]
    baseline, 3 months after treatment
  • Vascular ultrasound [ Time Frame: 0，3rd month ]
    baseline, and after 3 months treatment
  • Endothelial function [ Time Frame: 0，3rd month ]
    baseline, and after 3 months treatment
  • Cardiac function classification, NYHA [ Time Frame: 0,1st,Sec,3rd,6th,9th,month ]
    baseline, 3 months after treatment and follow-up 6 months
  • ultrasonic cardiogram [ Time Frame: 0,3rd,9th month ]
    baseline, 3 months after treatment and follow-up 6 months
  • 6MWT distance [ Time Frame: 0,3rd,9th month ]
    baseline, 3 months after treatment and follow-up 6 months
  • Traditional Chinese Medicine Syndrome Score Scale (TCMSSS) [ Time Frame: 0,3rd,9th month ]
    baseline, 3 months after treatment and follow-up 6 months
  • blood and urine routine tests,liver and renal function tests,serum [ Time Frame: 0,3rd,month ]
    safety evaluation
  • electrolytes,electrocardiogram (ECG) [ Time Frame: 0,3rd,month ]
    safety evaluation
  • Composite endpoint [ Time Frame: 1st,3rd,6th,9th, month ]
    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.


Original Secondary Outcome: Same as current

Information By: The First Affiliated Hospital of Henan University of Traditional Chinese Medicine

Dates:
Date Received: August 2, 2016
Date Started: June 2016
Date Completion: December 2019
Last Updated: August 17, 2016
Last Verified: August 2016