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

Z

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

Trial contacts and locations

1

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Central trial contact

Li Bin; Wang Y xia

Data sourced from clinicaltrials.gov

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