| CTRI Number |
CTRI/2010/091/000415 [Registered on: 11/05/2010] |
| Last Modified On: |
05/02/2016 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
Type of Study
Modification(s)
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
Public Title of Study
Modification(s)
|
A clinical trial to study the effect of Arjuna in heart failure patients |
Scientific Title of Study
Modification(s)
|
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
|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
|
| Name |
SK Maulik |
| Designation |
|
| Affiliation |
|
| Address |
Department of Pharmacology
All India Institute of Medical Sciences
New Delhi
DELHI
110029
India |
| Phone |
01126593540 |
| Fax |
01126588641 |
| Email |
skmaulik@gmail.com |
|
Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
SK Maulik |
| Designation |
|
| Affiliation |
All India Institute of Medical Sciences |
| Address |
Department of Pharmacology
All India Institute of Medical Sciences
New Delhi
DELHI
110029
India |
| Phone |
01126593540 |
| Fax |
01126588641 |
| Email |
skmaulik@gmail.com |
|
Details of Contact Person
Public Query
Modification(s)
|
| Name |
S Seth |
| Designation |
|
| Affiliation |
|
| Address |
Department of Cardiology
All India Institute of Medical Sciences
New Delhi
DELHI
110029
India |
| Phone |
01126594970 |
| Fax |
01126588641 |
| Email |
drsandeepseth@hotmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Biotechnology, Government of India |
|
Primary Sponsor
Modification(s)
|
| Name |
Department of Biotechnology Government of India |
| Address |
CGO Complex, Lodhi Road, New Delhi |
| Type of Sponsor |
Government funding agency |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Department of Pharmacology AIIMS |
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| S Seth |
All India Institute of Medical Sciences |
Ansari Nagar,-110029
New Delhi
DELHI |
01126584970
01126588641
sdrsandeepseth@hotmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee, AIIMS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Patients with chronic stable heart failure (Class II with EF<40%) , |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
PLACEBO |
One Capsule BID for 12 weeks |
| Intervention |
Standardised water extract of the bark powder of Terminalia arjuna |
750mg BID for 12 weeks |
|
|
Inclusion Criteria
|
| Age From |
|
| Age To |
|
| Gender |
|
| Details |
Patients (18 years and above) with chronic stable heart failure (stable for three months) with a left ventricular ejection fraction of less than 40 %. |
|
| ExclusionCriteria |
| Details |
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
|
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement in left ventricular function with reduction in left ventricular dimensions.
|
12 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 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 |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India=""
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
Date Missing |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
12/06/2010 |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
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.
|