drugset / Trial / NCT01293903
Study of Qiliqiangxin Capsule to Treat Dilated Cardiomyopathy
Phase 4
Completed
374 enrolled
Huazhong University of Science and Technology
China National Center for Cardiovascular Diseases · collabChina Three Gorges University, Yichang, China · collabFirst Affiliated Hospital Xi'an Jiaotong University · collabFirst Affiliated Hospital of Guangxi Medical University · collabFirst Affiliated Hospital of Harbin Medical University · collabFudan University · collabHenan Provincial People's Hospital · collabJingzhou Central Hospital · collabJining Medical University · collabMinistry of Science and Technology of the People´s Republic of China · collabRenJi Hospital · collabSecond Affiliated Hospital of Xi'an Jiaotong University · collabSecond Hospital of Shanxi Medical University · collabShandong Provincial Hospital · collabShanxi Cardiovascular Hospital · collabThe First Affiliated Hospital of Zhengzhou University · collabThe First Affiliated Hospital with Nanjing Medical University · collabThe Second Affiliated Hospital of Harbin Medical University · collabTianyou Hospital Affiliated to Wuhan University of Science and Technology · collabTongji Hospital · collabUnion Hospital, Tongji Medical College, Huazhong University of Science and Technology · collabWuhan No.1 Hospital · collabWuhan Pu-Ai Hospital · collabWuhan University · collabXiangyang Central Hospital · collabYunyang Medical College · collab
RandomizedParallel-groupQuadruple-blindTreatment
Summary
The pathogenesis of dilated cardiomyopathy (DCM) leading to heart failure is closely associated with autoimmunity dysfunction. A few studies represented that Qiliqiangxin capsule, a Chinese medicine, could enhance heart function in chronic heart failure and regulate the balance of TNF-a and IL-10 in myocardial infarction. In this study, to explore the effects of Qiliqiangxin capsule on the improving heart function and immunoregulation in patients with DCM, patients were recruited, anti-heart autoantibodies and some representative cytokines were assayed by enzyme-linked immuno sorbent assay (ELISA), and the efficacy of heart function improvement was compared between Qiliqiangxin capsule and placebo under the standard treatment of DCM.
Timeline
- Start
- 2012-01
- Primary completion
- 2015-12-31
- Completion
- 2016-09-30
Publications
- Background Tang H, Zhong Y, Zhu Y, Zhao F, Cui X, Wang Z. Low responder T cell susceptibility to the suppressive function of regulatory T cells in patients with dilated cardiomyopathy. Heart. 2010 May;96(10):765-71. doi: 10.1136/hrt.2009.184945.
- Background Yuan J, Yu M, Lin QW, Cao AL, Yu X, Dong JH, Wang JP, Zhang JH, Wang M, Guo HP, Cheng X, Liao YH. Th17 cells contribute to viral replication in coxsackievirus B3-induced acute viral myocarditis. J Immunol. 2010 Oct 1;185(7):4004-10. doi: 10.4049/jimmunol.1001718. Epub 2010 Aug 27.
- Background Xiao H, Wang M, Du Y, Yuan J, Cheng X, Chen Z, Zou A, Wei F, Zhao G, Liao YH. Arrhythmogenic autoantibodies against calcium channel lead to sudden death in idiopathic dilated cardiomyopathy. Eur J Heart Fail. 2011 Mar;13(3):264-70. doi: 10.1093/eurjhf/hfq198. Epub 2010 Nov 2.
- Background Xiao H, Song Y, Li Y, Liao YH, Chen J. Qiliqiangxin regulates the balance between tumor necrosis factor-alpha and interleukin-10 and improves cardiac function in rats with myocardial infarction. Cell Immunol. 2009;260(1):51-5. doi: 10.1016/j.cellimm.2009.09.001. Epub 2009 Sep 11.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Qiliqiangxin capsule | Traditional medicine (herbal / TCM) | 1.2 g | — |