Study of Qiliqiangxin Capsule to Treat Dilated Cardiomyopathy

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.

Conditions

• Dilated Cardiomyopathy
• Heart Failure

Interventions

DRUG

Qiliqiangxin capsule

Qiliqiangxin capsule is administrated based on the standard heart failure treatment in China. Dosage: 1.2g/times. Frequency: 3 times/day. Duration: The whole study period.

DRUG

Placebo

Placebo, similar in color and taste to Qiliqiangxin capsule, is administrated based on the standard heart failure treatment in China. Dosage: 1.2g/times. Frequency: 3 times/day. Duration: The whole study period.

Sponsors & Collaborators

• Fudan University

  collaborator OTHER

• First Affiliated Hospital of Harbin Medical University

  collaborator OTHER

• First Affiliated Hospital Xi'an Jiaotong University

  collaborator OTHER

• Shandong Provincial Hospital

  collaborator OTHER_GOV

• The First Affiliated Hospital with Nanjing Medical University

  collaborator OTHER

• First Affiliated Hospital of Guangxi Medical University

  collaborator OTHER

• The First Affiliated Hospital of Zhengzhou University

  collaborator OTHER

• Ministry of Science and Technology of the People´s Republic of China

  collaborator OTHER_GOV

• China National Center for Cardiovascular Diseases

  collaborator OTHER_GOV

• RenJi Hospital

  collaborator OTHER

• Second Affiliated Hospital of Xi'an Jiaotong University

  collaborator OTHER

• The Second Affiliated Hospital of Harbin Medical University

  collaborator OTHER

• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

  collaborator OTHER

• Tongji Hospital

  collaborator OTHER

• Wuhan University

  collaborator OTHER

• Henan Provincial People's Hospital

  collaborator OTHER

• Jining Medical University

  collaborator OTHER

• Second Hospital of Shanxi Medical University

  collaborator OTHER

• Shanxi Cardiovascular Hospital

  collaborator OTHER

• Wuhan Pu-Ai Hospital

  collaborator OTHER

• Tianyou Hospital Affiliated to Wuhan University of Science and Technology

  collaborator OTHER

• Yunyang Medical College

  collaborator OTHER

• China Three Gorges University, Yichang, China

  collaborator OTHER

• Xiangyang Central Hospital

  collaborator OTHER

• Wuhan No.1 Hospital

  collaborator OTHER

• Jingzhou Central Hospital

  collaborator OTHER

• Huazhong University of Science and Technology

  lead OTHER

Principal Investigators

• Yu-Hua Liao, Docter · Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

14 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2012-01-31

Primary Completion

2015-12-31

Completion

2016-09-30

Countries

• China

Study Locations