A clinical trial to study the effect of Arjuna in heart failure patients
- Conditions
- Patients with chronic stable heart failure (Class II with EF<40%)
- Registration Number
- CTRI/2010/091/000415
- Lead Sponsor
- Department of Biotechnology Government of India
- Brief Summary
In Indian Traditional Medicine (Ayurveda), the stem bark of the tree Terminalia arjuna (arjuna) has been known to be effective in different cardiac ailments. Various animal studies have demonstrated its significant cardiotonic, antioxidant and hypolipidemic activities. A number of small clinical studies have also suggested its activity in ischemic heart disease and heart failure. A randomised, double blind, placebo-controlled trial has been designed to evaluate the efficacy of a standardised water extract of the stem bark of T. arjuna in the treatment of left ventricular dysfunction. The objectives of the proposal include i) evaluation of its efficacy on cardiac functions in patients of heart failure, along with ii) changes in its major prognostic biomarkers , like plasma brain natriuretic peptide (BNP), tissue necrotic factor-alpha, interleukin-6 and iii) serum antioxidants. The study will be carried out in 100 patients over 12 weeks, with monitoring of different cardiac, hepatic and renal functions at predetermined intervals. The proposed study will provide significant scientific credence to the widely claimed therapeutic benefits of Terminalia arjuna.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 100
Patients (18 years and above) with chronic stable heart failure (stable for three months) with a left ventricular ejection fraction of less than 40 %.
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. 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.2.Improvement in the Kansas City Cardiomyopathy Questionnaire to assess improvement in quality of life.3.Reduction in plasma markers of congestive heart failure including serum cytokines, BNP and hsCRP. 4.Effects on endogenous antioxidants. 12 weeks
Trial Locations
- Locations (1)
All India Institute of Medical Sciences
🇮🇳Delhi, DELHI, India
All India Institute of Medical Sciences🇮🇳Delhi, DELHI, IndiaS SethPrincipal investigator01126584970sdrsandeepseth@hotmail.com