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

Last updated: August 17, 2016
Sponsor: Zhu Mingjun
Overall Status: Trial Status Unknown

Phase

2

Condition

Coronary Artery Disease

Chest Pain

Myocardial Ischemia

Treatment

N/A

Clinical Study ID

NCT02875639
2015CB554401
  • Ages 40-75
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Age 40 to 75;

  2. Patients with ischemic heart failure： LVEF less than or equal to 45% measured byechocardiography 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

Exclusion Criteria:

  1. Combin the pulmonary embolism, or acute coronary syndrome (acs) ,or acutecerebrovascular 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 withinstandard 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

Total Participants: 180
Study Start date:
June 01, 2016
Estimated Completion Date:
December 31, 2019

Study 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.

Connect with a study center

  • First affiliated hospital, Henan University of Traditional Chinese medicine

    Zhengzhou, Henan 450000
    China

    Active - Recruiting

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