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UnknownNCT02875639

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

Status
Unknown
Phase
Phase 2
Study type
Interventional
Enrollment
180 (estimated)
Sponsor
Zhu Mingjun · Academic / Other
Sex
All
Age
40 Years – 75 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
DRUGYiqi prescription
DRUGHuoxue prescription
DRUGBuyang huanwu decoction
DRUGQISHEN YIQI DRIPPING PILLS
DRUGPlacebo 1Placebo 1:a drug which imitated QISHEN YIQI DRIPPING PILLS,but do not have active ingredient,just have the excipient.
DRUGPlacebo 2Placebo 2:a drug which imitated Buyang huanwu decoction,but do not have active ingredient,just have the excipient.

Timeline

Start date
2016-06-01
Primary completion
2019-12-01
Completion
2019-12-01
First posted
2016-08-23
Last updated
2016-08-23

Locations

1 site across 1 country: China

Source: ClinicalTrials.gov record NCT02875639. Inclusion in this directory is not an endorsement.