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

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ClinicalTrials.gov Identifier: NCT02875639
Recruitment Status : Recruiting
First Posted : August 23, 2016
Last Update Posted : August 23, 2016
Sponsor:
Information provided by (Responsible Party):
Zhu Mingjun, The First Affiliated Hospital of Henan University of Traditional Chinese Medicine

Brief 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.

Condition or disease Intervention/treatment Phase
Ischemic Heart Failure Drug: Yiqi prescription Drug: Huoxue prescription Drug: Buyang huanwu decoction Drug: QISHEN YIQI DRIPPING PILLS Drug: Placebo 1 Drug: Placebo 2 Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Care Provider, Investigator)
Primary Purpose: Treatment
Study Start Date : June 2016
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

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: Huoxue 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: qi and blood group
which treated by a kind of Chinese patent medicine (major components: Huangqi,Dangsheng,Honghua,Taoren,Danggui,and so on)
Drug: Buyang huanwu decoction
Drug: Placebo 1
Placebo 1:a drug which imitated QISHEN YIQI DRIPPING PILLS,but do not have active ingredient,just have the excipient.

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.




Primary Outcome Measures :
  1. N-terminal pronatriuretic peptide(NT-proBNP) [ Time Frame: 0 month ]
  2. N-terminal pronatriuretic peptide(NT-proBNP) [ Time Frame: 3rd month ]
  3. N-terminal pronatriuretic peptide(NT-proBNP) [ Time Frame: 9th month ]

Secondary Outcome Measures :
  1. Minnesota heart failure quality of life scale [ Time Frame: 0,3rd,9th month ]
    baseline, 3 months after treatment and follow-up 6 months

  2. 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"

  3. TXA2,PGI2,CD31,CD18,CD11b,R,K,MA [ Time Frame: 0,3rd month ]
    the expression of these may be related to "Xue"

  4. 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"

  5. Echocardiography [ Time Frame: 0,3rd,9th month ]
    baseline, 3 months after treatment and follow-up 6 months

  6. Cardiac magnetic resonance [ Time Frame: 0,3rd month ]
    baseline, 3 months after treatment

  7. Vascular ultrasound [ Time Frame: 0,3rd month ]
    baseline, and after 3 months treatment

  8. Endothelial function [ Time Frame: 0,3rd month ]
    baseline, and after 3 months treatment

  9. Cardiac function classification, NYHA [ Time Frame: 0,1st,Sec,3rd,6th,9th,month ]
    baseline, 3 months after treatment and follow-up 6 months

  10. ultrasonic cardiogram [ Time Frame: 0,3rd,9th month ]
    baseline, 3 months after treatment and follow-up 6 months

  11. 6MWT distance [ Time Frame: 0,3rd,9th month ]
    baseline, 3 months after treatment and follow-up 6 months

  12. Traditional Chinese Medicine Syndrome Score Scale (TCMSSS) [ Time Frame: 0,3rd,9th month ]
    baseline, 3 months after treatment and follow-up 6 months

  13. blood and urine routine tests,liver and renal function tests,serum [ Time Frame: 0,3rd,month ]
    safety evaluation

  14. electrolytes,electrocardiogram (ECG) [ Time Frame: 0,3rd,month ]
    safety evaluation

  15. 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.



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Ages Eligible for Study:   40 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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;

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02875639


Contacts
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Contact: Wang Y xia 13838571596 wyxchzhq@163.com
Contact: Li Bin 13633811795 libinnvhai@163.com

Locations
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China, Henan
First affiliated hospital, Henan University of Traditional Chinese medicine Recruiting
Zhengzhou, Henan, China, 450000
Contact: Wang Y xia    13838571596    wyxchzhq@163.com   
Contact: Li Bin    13633811795    libinnvhai@163.com   
Sponsors and Collaborators
Zhu Mingjun
Investigators
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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 of Results:
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Responsible Party: Zhu Mingjun, Professor,chief physicians,the director of Henan University of Traditional Chinese Medicine, The First Affiliated Hospital of Henan University of Traditional Chinese Medicine
ClinicalTrials.gov Identifier: NCT02875639     History of Changes
Other Study ID Numbers: 2015CB554401
First Posted: August 23, 2016    Key Record Dates
Last Update Posted: August 23, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Zhu Mingjun, The First Affiliated Hospital of Henan University of Traditional Chinese Medicine:
Ischemic Heart Failure
coronary artery disease
qi deficiency and blood stasis

Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases