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

August 17, 2016 updated by: Zhu Mingjun
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

180

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Henan
      • Zhengzhou, Henan, China, 450000
        • Recruiting
        • First affiliated hospital, Henan University of Traditional Chinese medicine
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: tonifying qi group
tonifying qi group:which treated by a kind of Chinese patent medicine (major components: Huangqi,Dangsheng,and so on)
Drug: Yiqi prescription
Drug: Placebo 1
Placebo 1：a drug which imitated QISHEN YIQI DRIPPING PILLS,but do not have active ingredient,just have the excipient.
Experimental: activating blood group
which treated by a kind of Chinese patent medicine (major components: Honghua,Taoren,Danggui，and so on)
Drug: Placebo 1
Placebo 1：a drug which imitated QISHEN YIQI DRIPPING PILLS,but do not have active ingredient,just have the excipient.
Drug: Huoxue prescription
Experimental: qi and blood group
which treated by a kind of Chinese patent medicine (major components: Huangqi,Dangsheng，Honghua,Taoren,Danggui，and so on)
Drug: Placebo 1
Placebo 1：a drug which imitated QISHEN YIQI DRIPPING PILLS,but do not have active ingredient,just have the excipient.
Drug: Buyang huanwu decoction
Active Comparator: QISHEN YIQI DRIPPING PILLS group
which treated by a kind of Chinese patent medicine (major components: Huangqi,Dangsheng，and so on)
Drug: QISHEN YIQI DRIPPING PILLS
Drug: Placebo 2
Placebo 2：a drug which imitated Buyang huanwu decoction,but do not have active ingredient,just have the excipient.
Sham Comparator: placebo group
which treated by the simulation of Chinese patent medicine (major components:excipient)
Drug: Placebo 1
Placebo 1：a drug which imitated QISHEN YIQI DRIPPING PILLS,but do not have active ingredient,just have the excipient.
Drug: Placebo 2
Placebo 2：a drug which imitated Buyang huanwu decoction,but do not have active ingredient,just have the excipient.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
N-terminal pronatriuretic peptide（NT-proBNP）
Time Frame: 0 month
0 month
N-terminal pronatriuretic peptide（NT-proBNP）
Time Frame: 3rd month
3rd month
N-terminal pronatriuretic peptide（NT-proBNP）
Time Frame: 9th month
9th month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Minnesota heart failure quality of life scale
Time Frame: 0,3rd,9th month
baseline, 3 months after treatment and follow-up 6 months
0,3rd,9th month
sST2，Galectin3,PT,APTT,FBg,TT,TnT,CK,GLUT-1.GLUT-4,H-FABP
Time Frame: 0，3rd month
the expression of these may be related to "Qi"
0，3rd month
TXA2,PGI2,CD31,CD18,CD11b,R,K,MA
Time Frame: 0，3rd month
the expression of these may be related to "Xue"
0，3rd month
hs-CRP,IL-1β,IL-6,TNF-α,ICAM-1,VCAM-1,MCP-1,NO,ET-1
Time Frame: 0，3rd month
the expression of these may be related to "Mai"
0，3rd month
Echocardiography
Time Frame: 0,3rd,9th month
baseline, 3 months after treatment and follow-up 6 months
0,3rd,9th month
Cardiac magnetic resonance
Time Frame: 0，3rd month
baseline, 3 months after treatment
0，3rd month
Vascular ultrasound
Time Frame: 0，3rd month
baseline, and after 3 months treatment
0，3rd month
Endothelial function
Time Frame: 0，3rd month
baseline, and after 3 months treatment
0，3rd month
Cardiac function classification, NYHA
Time Frame: 0,1st,Sec,3rd,6th,9th,month
baseline, 3 months after treatment and follow-up 6 months
0,1st,Sec,3rd,6th,9th,month
ultrasonic cardiogram
Time Frame: 0,3rd,9th month
baseline, 3 months after treatment and follow-up 6 months
0,3rd,9th month
6MWT distance
Time Frame: 0,3rd,9th month
baseline, 3 months after treatment and follow-up 6 months
0,3rd,9th month
Traditional Chinese Medicine Syndrome Score Scale (TCMSSS)
Time Frame: 0,3rd,9th month
baseline, 3 months after treatment and follow-up 6 months
0,3rd,9th month
blood and urine routine tests,liver and renal function tests,serum
Time Frame: 0,3rd,month
safety evaluation
0,3rd,month
electrolytes,electrocardiogram (ECG)
Time Frame: 0,3rd,month
safety evaluation
0,3rd,month
Composite endpoint
Time Frame: 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.
1st,3rd,6th,9th, month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zhu Mingjun

Investigators

  • Study Director: Zhu M jun, First affiliated hospital, Henan University of Traditional Chinese medicine
  • Principal Investigator: Wang Y xia, First affiliated hospital, Henan University of Traditional Chinese medicine
  • Principal Investigator: Li Bin, First affiliated hospital, Henan University of Traditional Chinese medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2016

Primary Completion (Anticipated)

December 1, 2019

Study Completion (Anticipated)

December 1, 2019

Study Registration Dates

First Submitted

August 2, 2016

First Submitted That Met QC Criteria

August 17, 2016

First Posted (Estimate)

August 23, 2016

Study Record Updates

Last Update Posted (Estimate)

August 23, 2016

Last Update Submitted That Met QC Criteria

August 17, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2015CB554401

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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