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

Ischemic Heart Failure Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02875639
• Other study ID #: 2015CB554401
• Status: Recruiting
• Phase: Phase 2
• First received: August 2, 2016
• Last updated: August 17, 2016
• Start date: June 2016
• Est. completion date: December 2019

Study information

• Verified date: August 2016
• Source: The First Affiliated Hospital of Henan University of Traditional Chinese Medicine
• Contact: Wang Y xia
• Phone: 13838571596
• Email: wyxchzhq[@]163.com
• Is FDA regulated: No
• Health authority: China:Ministry of Science and Technology of the People's Republic of China
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 180
• Est. completion date: December 2019
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 75 Years

Eligibility

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 ? ;

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Heart Failure
• Ischemic Heart Failure

Intervention

Drug:
• Yiqi prescription

• Huoxue prescription

• Buyang huanwu decoction

• QISHEN YIQI DRIPPING PILLS

• Placebo 1
Placebo 1:a drug which imitated QISHEN YIQI DRIPPING PILLS,but do not have active ingredient,just have the excipient.
• Placebo 2
Placebo 2:a drug which imitated Buyang huanwu decoction,but do not have active ingredient,just have the excipient.

Locations

Country	Name	City	State
China	First affiliated hospital, Henan University of Traditional Chinese medicine	Zhengzhou	Henan

Sponsors (1)

Lead Sponsor	Collaborator
Zhu Mingjun

Country where clinical trial is conducted

China, 

References & Publications (1)

WRITING COMMITTEE MEMBERS, Yancy CW, Jessup M, Bozkurt B, Butler J, Casey DE Jr, Drazner MH, Fonarow GC, Geraci SA, Horwich T, Januzzi JL, Johnson MR, Kasper EK, Levy WC, Masoudi FA, McBride PE, McMurray JJ, Mitchell JE, Peterson PN, Riegel B, Sam F, Stev — View Citation

Outcome

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