A clinical trial to study the effect of Arjuna in heart failure patients
Phase 2
Completed
- Registration Number
- CTRI/2010/091/000415
- Lead Sponsor
- Department of Biotechnology Government of India
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 100
Inclusion Criteria
Patients (18 years and above) with chronic stable heart failure (stable for three months) with a left ventricular ejection fraction of less than 40 %.
Exclusion Criteria
1.History of MI or unstable angina within the last 4 weeks.
2.Revascularisation procedures (CABG OR PTCA) done in the past 3 months.
3.Planned for revascularisation in the next three months.
4.Recent stroke or TIA.
5.Uncontrolled hypertension (should be controlled before inclusion)
6.Pregnancy.
7.Other major organ dysfunction.
8.Primary valvular heart disease.
9.Evidence suggestive of ongoing or resolving carditis.
10.Evidence of coarctation of aorta or aortoarteritis.
11.Hypothyroidism
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Improvement in left ventricular function with reduction in left ventricular dimensions. <br><br>Timepoint: 12 weeks
- Secondary Outcome Measures
Name Time Method 1.Clinical improvement in the form of symptom class and distance covered in the 6 minute walk test.<br><br>2.Improvement in the Kansas City Cardiomyopathy Questionnaire to assess improvement in quality of life.<br><br>3.Reduction in plasma markers of congestive heart failure including serum cytokines, BNP and hsCRP. <br><br>4.Effects on endogenous antioxidants. <br>Timepoint: 12 weeks