NCT01293903

Study of Qiliqiangxin Capsule to Treat Dilated Cardiomyopathy

A Multi-center, Randomized, Double, Placebo-controlled, Parallel Group Study of Improving Heart Function and Immunoregulation Effects of Qiliqiangxin Capsule in Patients With Dilated Cardiomyopathy

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 374 (actual)
• Sponsor: Huazhong University of Science and Technology · Academic / Other
• Sex: All
• Age: 14 Years – 70 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2012-01-01
• Primary completion: 2015-12-31
• Completion: 2016-09-30
• First posted: 2011-02-11
• Last updated: 2017-08-29

Locations

1 site across 1 country: China