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

Zhu Mingjun

Status and phase: Unknown; Phase 2

Conditions: Ischemic Heart Failure

Treatments: Drug: Placebo 2; Drug: QISHEN YIQI DRIPPING PILLS; Drug: Yiqi prescription; Drug: Buyang huanwu decoction; Drug: Huoxue prescription; Drug: Placebo 1

Study type: Interventional

Funder types: Other

Identifiers

NCT02875639

2015CB554401

Details and patient eligibility

About

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.

Full 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.

Enrollment: 180 estimated patients

Sex: All

Ages: 40 to 75 years old

Volunteers: No Healthy Volunteers

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;

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

180 participants in 5 patient groups

tonifying qi group

Experimental group

Description:

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

Treatment:

Drug: Yiqi prescription

Drug: Placebo 1

activating blood group

Experimental group

Description:

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

Treatment:

Drug: Huoxue prescription

Drug: Placebo 1

qi and blood group

Experimental group

Description:

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

Treatment:

Drug: Buyang huanwu decoction

Drug: Placebo 1

QISHEN YIQI DRIPPING PILLS group

Active Comparator group

Description:

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

Treatment:

Drug: Placebo 2

Drug: QISHEN YIQI DRIPPING PILLS

placebo group

Sham Comparator group

Description:

which treated by the simulation of Chinese patent medicine (major components:excipient)

Treatment:

Drug: Placebo 2

Drug: Placebo 1