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

Phase 2

• Conditions: Ischemic Heart Failure
• Interventions: Drug: Huoxue prescription; Drug: Buyang huanwu decoction; Drug: QISHEN YIQI DRIPPING PILLS; Drug: Yiqi prescription; Drug: Placebo 2; Drug: Placebo 1

• Registration Number: NCT02875639
• Lead Sponsor: Zhu Mingjun

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 Description

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 Timeline

• Study Start: 2016-06
• Status Verified: 2016-08
• Study First Submitted: 2016-08-02
• Study First Submitted QC: 2016-08-17
• Last Update Submitted: 2016-08-17
• Study First Posted: 2016-08-23
• Last Update Posted: 2016-08-23
• Primary Completion: 2019-12
• Study Completion: 2019-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 180

Inclusion Criteria

1. Age 40 to 75;
2. Patients with ischemic heart failure： LVEF less than or equal to 45% measured by echocardiography in modified Simpson method
3. Qi deficiency and blood stasis syndrome;
4. New York Heart Association (NYHA) Class II to Ⅲ ;
5. Submitted informed consent

Exclusion Criteria

1. Combin the pulmonary embolism, or acute coronary syndrome (acs) ,or acute cerebrovascular disease;
2. Combin other heart diseases: valvular heart disease, dilated cardiomyopathy, hypertension heart disease, pulmonary heart disease,congenital heart disease;
3. Hypertension and diabetes patients treated with drugs but not controlled within standard limit;
4. Severe hepatic and renal dysfunction, malnutrition, malignant tumour;
5. Active tuberculosis or rheumatoid diseases;
6. Nosohemia, organ transplantation,uremia;
7. Psychosis and drug abuse;
8. Allergic to the drugs or one component medicine of the drugs of this study ;
9. Participated in other trials within 1 month ;
10. Being pregnant, planning for pregnancy or breastfeeding;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
placebo group	Placebo 2	which treated by the simulation of Chinese patent medicine (major components:excipient)
tonifying qi group	Placebo 1	tonifying qi group:which treated by a kind of Chinese patent medicine (major components: Huangqi,Dangsheng,and so on)
activating blood group	Huoxue prescription	which treated by a kind of Chinese patent medicine (major components: Honghua,Taoren,Danggui，and so on)
qi and blood group	Buyang huanwu decoction	which treated by a kind of Chinese patent medicine (major components: Huangqi,Dangsheng，Honghua,Taoren,Danggui，and so on)
qi and blood group	Placebo 1	which treated by a kind of Chinese patent medicine (major components: Huangqi,Dangsheng，Honghua,Taoren,Danggui，and so on)
QISHEN YIQI DRIPPING PILLS group	QISHEN YIQI DRIPPING PILLS	which treated by a kind of Chinese patent medicine (major components: Huangqi,Dangsheng，and so on)
QISHEN YIQI DRIPPING PILLS group	Placebo 2	which treated by a kind of Chinese patent medicine (major components: Huangqi,Dangsheng，and so on)
placebo group	Placebo 1	which treated by the simulation of Chinese patent medicine (major components:excipient)
tonifying qi group	Yiqi prescription	tonifying qi group:which treated by a kind of Chinese patent medicine (major components: Huangqi,Dangsheng,and so on)
activating blood group	Placebo 1	which treated by a kind of Chinese patent medicine (major components: Honghua,Taoren,Danggui，and so on)

Primary Outcome Measures

Name	Time	Method
N-terminal pronatriuretic peptide（NT-proBNP）	9th month

Secondary Outcome Measures

Name	Time	Method
Composite endpoint	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.
Minnesota heart failure quality of life scale	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	0，3rd month	the expression of these may be related to "Qi"
TXA2,PGI2,CD31,CD18,CD11b,R,K,MA	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	0，3rd month	the expression of these may be related to "Mai"
Echocardiography	0,3rd,9th month	baseline, 3 months after treatment and follow-up 6 months
Cardiac magnetic resonance	0，3rd month	baseline, 3 months after treatment
Vascular ultrasound	0，3rd month	baseline, and after 3 months treatment
Endothelial function	0，3rd month	baseline, and after 3 months treatment
Cardiac function classification, NYHA	0,1st,Sec,3rd,6th,9th,month	baseline, 3 months after treatment and follow-up 6 months
ultrasonic cardiogram	0,3rd,9th month	baseline, 3 months after treatment and follow-up 6 months
6MWT distance	0,3rd,9th month	baseline, 3 months after treatment and follow-up 6 months
Traditional Chinese Medicine Syndrome Score Scale (TCMSSS)	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	0,3rd,month	safety evaluation
electrolytes,electrocardiogram (ECG)	0,3rd,month	safety evaluation

Trial Locations

Locations (1)

First affiliated hospital, Henan University of Traditional Chinese medicine; 🇨🇳 Zhengzhou, Henan, China