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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| tonifying qi group | Experimental | tonifying qi group:which treated by a kind of Chinese patent medicine (major components: Huangqi,Dangsheng,and so on) |
|
| activating blood group | Experimental | which treated by a kind of Chinese patent medicine (major components: Honghua,Taoren,Danggui,and so on) |
|
| qi and blood group | Experimental | which treated by a kind of Chinese patent medicine (major components: Huangqi,Dangsheng,Honghua,Taoren,Danggui,and so on) |
|
| QISHEN YIQI DRIPPING PILLS group | Active Comparator | which treated by a kind of Chinese patent medicine (major components: Huangqi,Dangsheng,and so on) |
|
| placebo group | Sham Comparator | which treated by the simulation of Chinese patent medicine (major components:excipient) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Yiqi prescription | Drug |
| ||
| Huoxue prescription |
| Measure | Description | Time Frame |
|---|---|---|
| N-terminal pronatriuretic peptide(NT-proBNP) | 0 month | |
| N-terminal pronatriuretic peptide(NT-proBNP) | 3rd month | |
| N-terminal pronatriuretic peptide(NT-proBNP) | 9th month |
| Measure | Description | Time Frame |
|---|---|---|
| Minnesota heart failure quality of life scale | 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 | the expression of these may be related to "Qi" |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Wang Y xia | Contact | 13838571596 | wyxchzhq@163.com | |
| Li Bin | Contact | 13633811795 | libinnvhai@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Zhu M jun | First affiliated hospital, Henan University of Traditional Chinese medicine | Study Director |
| Wang Y xia | First affiliated hospital, Henan University of Traditional Chinese medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| First affiliated hospital, Henan University of Traditional Chinese medicine | Recruiting | Zhengzhou | Henan | 450000 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23741058 | Result | 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, Stevenson LW, Tang WH, Tsai EJ, Wilkoff BL; American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines. 2013 ACCF/AHA guideline for the management of heart failure: a report of the American College of Cardiology Foundation/American Heart Association Task Force on practice guidelines. Circulation. 2013 Oct 15;128(16):e240-327. doi: 10.1161/CIR.0b013e31829e8776. Epub 2013 Jun 5. No abstract available. | |
| 39175547 |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| C460102 | buyang huanwu |
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|
| Buyang huanwu decoction | Drug |
|
| QISHEN YIQI DRIPPING PILLS | Drug |
|
| Placebo 1 | Drug | Placebo 1:a drug which imitated QISHEN YIQI DRIPPING PILLS,but do not have active ingredient,just have the excipient. |
|
| Placebo 2 | Drug | Placebo 2:a drug which imitated Buyang huanwu decoction,but do not have active ingredient,just have the excipient. |
|
| 0,3rd month |
| TXA2,PGI2,CD31,CD18,CD11b,R,K,MA | 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 | the expression of these may be related to "Mai" | 0,3rd month |
| Echocardiography | baseline, 3 months after treatment and follow-up 6 months | 0,3rd,9th month |
| Cardiac magnetic resonance | baseline, 3 months after treatment | 0,3rd month |
| Vascular ultrasound | baseline, and after 3 months treatment | 0,3rd month |
| Endothelial function | baseline, and after 3 months treatment | 0,3rd month |
| Cardiac function classification, NYHA | baseline, 3 months after treatment and follow-up 6 months | 0,1st,Sec,3rd,6th,9th,month |
| ultrasonic cardiogram | baseline, 3 months after treatment and follow-up 6 months | 0,3rd,9th month |
| 6MWT distance | baseline, 3 months after treatment and follow-up 6 months | 0,3rd,9th month |
| Traditional Chinese Medicine Syndrome Score Scale (TCMSSS) | 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 | safety evaluation | 0,3rd,month |
| electrolytes,electrocardiogram (ECG) | safety evaluation | 0,3rd,month |
| 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 |
| Li Bin | First affiliated hospital, Henan University of Traditional Chinese medicine | Principal Investigator |
| Derived |
| Zhao Z, Jin X, Li Y, Wang X, Cui Y, Zhang B, Kang Y, Zhang G, Chu Q, Zhang J. Efficacy and safety of fospropofol disodium sedation for same-day bidirectional endoscopy in elderly patients: protocol for a prospective, single-center, randomized, double-blind, non-inferiority trial. Front Pharmacol. 2024 Aug 8;15:1378081. doi: 10.3389/fphar.2024.1378081. eCollection 2024. |
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |