A clinical trial to study the effect of Arjuna in heart failure patients

Double-blind, randomised placebo controlled clinical trial to study the add-on efficacy of a standardised preparation of the water extract of Terminalia arjuna in patients with Left Ventricular Dysfunction, already receiving standard drug regimen

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2010/091/000415

Enrollment

100

Registered

2010-05-11

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: Standardised water extract of the bark powder of Terminalia arjuna: 750mg BID for 12 weeks Control Intervention1: PLACEBO: One Capsule BID for 12 weeks

Eligibility

Inclusion criteria

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

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

Design outcomes

Secondary

Measure	Time frame
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. Timepoint: 12 weeks	—

Primary

Measure	Time frame
Improvement in left ventricular function with reduction in left ventricular dimensions. Timepoint: 12 weeks	—

Countries

India

Contacts

Public ContactS Seth

All India Institute of Medical Sciences

skmaulik@gmail.com01126593540

Outcome results