Regulation of Immunological Cytokines by Qiliqiangxin Capsule in Dilated Cardiomyopathy Patients

Regulation of Immunological Cytokines by Qiliqiangxin Capsule in Dilated Cardiomyopathy patients--a Randomized Double Blind Clinical Trial

Purpose :Research into the impact of Qiliqiangxin capsule on IFN-γ，IL-4，NT-proBNP in dilated cardiomyopathy patients with heart failure.

Methods :Data were collected from the patients with idiopathic dilated cardiomyopathy ( cardiac function NYHA Ⅱ-Ⅳ) in the first affiliated hospital of Harbin Medical University from May 2012 to April 2014. These 30 cases were treated under the recommendations of normal diagnosis and treatment in cardiomyopathy. This experiment was randomized double-blinded，the experimental interferences were avoided and patients were divided into the experimental group and the placebo group. The patients in experimental group received the relevant tests and inspections before the beginning of experiment，signed the informed consent. Then the investigators get the venous blood centrifugalization and cryopreservation. The patients take the medicine qiliqiangxin three times per day，four tablets at a time. Afrer a month，the investigators evaluated the symptoms，the function of heart，blood pressure，heart rate and keep blood specimens. Three and six month later，electrocardiogram and echocardiography were taken and the determination of the NT - proBNP was done. The placebo group was followed up in the same way.

Study Overview

• Status: Completed
• Conditions: Congestive Heart Failure
• Intervention / Treatment: Drug: Qiliqiangxin Capsule

• Study Type: Observational
• Enrollment (Actual): 30

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

congestive heart failure.

Description

Inclusion Criteria:

• Congetive heart failure

Exclusion Criteria:

• Valvular heart diseases

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
the experimental group; The patients in experimental group received the relevant tests and inspections before the beginning of experiment，signed the informed consent. Then we get the venous blood centrifugalization and cryopreservation. The patients take the medicine qiliqiangxin three times per day，four tablets at a time. Afrer a month，we evaluated the symptoms，the function of heart，blood pressure，heart rate and keep blood specimens. Three and six month later，electrocardiogram and echocardiography were taken and the determination of the NT - proBNP was done.	Drug: Qiliqiangxin Capsule
the placebo group; The placebo group was followed up in the same way.	Drug: Qiliqiangxin Capsule

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
cytokine level at 3 months	3 months

Collaborators and Investigators

• Sponsor: Harbin Medical University

Study record dates

Study Major Dates

• Study Start: May 1, 2012
• Primary Completion (Actual): April 1, 2014
• Study Completion (Actual): April 1, 2014

Study Registration Dates

• First Submitted: November 2, 2014
• First Submitted That Met QC Criteria: November 4, 2014
• First Posted (Estimate): November 5, 2014

Study Record Updates

• Last Update Posted (Estimate): November 5, 2014
• Last Update Submitted That Met QC Criteria: November 4, 2014
• Last Verified: November 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Genetic Diseases, Inborn; Cardiomegaly; Laminopathies; Heart Failure; Cardiomyopathies; Cardiomyopathy, Dilated
• Other Study ID Numbers: 2013 (Other Grant/Funding Number: Food Innovation Center)