| CTRI Number |
CTRI/2019/10/021710 [Registered on: 18/10/2019] Trial Registered Prospectively |
| Last Modified On: |
08/03/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Use of Arjuna ksheerpaka in patients who have undergone Bypass surgery |
|
Scientific Title of Study
|
“Clinical efficacy of Arjuna ksheerpaka [A traditional Ayurvedic formulation of stem bark of Terminalia Arjuna (Roxb. ex DC.) Wight & Arn. ] to standard treatment care in post CABG patients. A double blind, randomized placebo controlled pilot study†|
| Trial Acronym |
CABG_TAK |
|
Secondary IDs if Any
|
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Gautam Sharma |
| Designation |
Professor Incharge |
| Affiliation |
All India Institute of Medical Sciences (AIIMS) |
| Address |
Centre of Integrative Medicine and Research(CIMR),
Room Number 7004, 7th Floor,
Convergence Block,
All India Institute of Medical Sciences (AIIMS)
New Delhi
South
DELHI
110029
India |
| Phone |
01126549326 |
| Fax |
|
| Email |
drsharmagautam@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Gautam Sharma |
| Designation |
Professor Incharge |
| Affiliation |
All India Institute of Medical Sciences (AIIMS) |
| Address |
Centre of Integrative Medicine and Research(CIMR),
Room Number 7004, 7th Floor,
Convergence Block,
All India Institute of Medical Sciences (AIIMS)
New Delhi
South
DELHI
110029
India |
| Phone |
01126549326 |
| Fax |
|
| Email |
drsharmagautam@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Gautam Sharma |
| Designation |
Professor Incharge |
| Affiliation |
All India Institute of Medical Sciences (AIIMS) |
| Address |
Centre of Integrative Medicine and Research(CIMR),
Room Number 7004, 7th Floor,
Convergence Block,
All India Institute of Medical Sciences (AIIMS)
New Delhi
South
DELHI
110029
India |
| Phone |
01126549326 |
| Fax |
|
| Email |
drsharmagautam@gmail.com |
|
|
Source of Monetary or Material Support
|
| Ministry of AYUSH, Government of India |
|
|
Primary Sponsor
|
| Name |
Centre for Integrative Medicine and Research CIMR |
| Address |
Centre for Integrative Medicine and Research (CIMR), All India Institute of Medical Sciences (AIIMS), New Delhi |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dabur India Limited |
Dabur India Limited, 22,Site IV,Sahibabad,Ghaziabad,UP,India-201010
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Gautam Sharma |
All India Institute of Medical Sciences (AIIMS) |
Room number 7004,
7th Floor,
Centre for Integrative Medicine and Research (CIMR),
Convergence Block,
All India Institute of Medical Sciences (AIIMS), Ansari Nagar, New Delhi
South
DELHI |
01126549326
drsharmagautam@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| AIIMS IEC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I257||Atherosclerosis of coronary arterybypass graft(s) and coronary artery of transplanted heart with angina pectoris, Post Coronary Artery Bypass Graft Surgery, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Arjuna Ksheerpaka with Standard Treatment of care |
The active treatment will be a supplement of sachet containing concentrated Arjuna ksheerapaka extract granules and excipients. None of the excipients are known to be biologically active. Two medicine kits will be given to each patient at baseline as well as first follow-up visit at 12 weeks, containing 180 sachets which includes 12 extra sachets to last extra 6 days in case of delayed follow-up visit. The subjects will be advised to have these sachets twice a day for a period of 24 weeks without any fail. Adherence to the study medication will be monitored by log book and self-report.Preparation and standardization of Terminalia arjuna Ksheerpaka extract will be done by Dabur India Limited, India. |
| Comparator Agent |
Placebo with Standard Treatment of Care |
Placebo in the form of granules will be used containing Lactose and excipients. None of the excipients are known to be biologically active. The active treatment and placebo sachetswill be carefully matched in color, taste, texture, shape and size and supplied in medicine kits, containing 180 sachets. Two medicine kits will be given to each patient at baseline as well as first follow-up visit at 12 weeks, containing 180 sachets which includes 12 extra sachets to last extra 6 days in case of delayed follow-up visit. The subjects will be advised to have these sachets twice a day for a period of 24 weeks without any fail. Adherence to the study medication will be monitored by log book and self-report. Preparation and standardization of lactose (as placebo) will be done by Dabur India Limited, India. |
|
Inclusion Criteria
Modification(s)
|
| Age From |
35.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
a) All ambulatory patients within 5 year of CABG surgery after a review period of 3 months.
b) Both Genders,
c) Age between 35-70 years,
d) Patients with uncomplicated peri-operative course e.g. Perioperative myocardial infarction, Infection, Bleeding, Non-healing sternum etc.
e) NYHA function class I & II symptoms
f) LVEF less than 50 % on 2D echocardiography continuing with standard medical therapy
|
|
| ExclusionCriteria |
| Details |
a) Patients undergoing any other regimen apart from the prescribed conventional management.
b) Patients having Lactose intolerance.
c) Acute and Chronic hepatic / renal failure with or without dialysis.
d) Patients with accelerated Hypertension & HbA1c >10%.
e) NYHA function class III and IV symptoms.
f) Hypothyroidism (Serum TSH >4.1µIU/ml).
g) Liver dysfunction (serum bilirubin > 1.5 times upper limit of normal or serum transaminase > 3 times upper limit of normal).
h) Patients having neurodegenerative & major psychiatric disorders.
i) Patients enrolled in any other study or consuming any other investigational drug.
j) Patient with ICD and CRT devices.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
Primary Outcome
Modification(s)
|
| Outcome |
TimePoints |
1. Assessment of improvement in left ventricular function by
2D echocardiography - Ejection Fraction, ventricular volumes, wall thickness, wall stress, ventricular strain, diastolic function E/E, LV mass |
At baseline, 12 weeks and 24 weeks after intervention. |
|
Secondary Outcome
Modification(s)
|
| Outcome |
TimePoints |
| Health related Quality of Life by SF 36 |
At baseline, 12 weeks and 24 weeks after intervention. |
| Cardiac marker- NT-pro BNP |
At baseline, 12 weeks and 24 weeks after intervention. |
| Plasma Cytokine (Interleukin-6, Interleukin-10 ) |
At baseline, 12 weeks and 24 weeks after intervention. |
| Changes in NYHA functional class |
At baseline, 12 weeks and 24 weeks after intervention. |
| Recurrence of hospitalisation events |
At baseline, 12 weeks and 24 weeks after intervention. |
| Major adverse cardiac and cerebrovascular events which includes Mortality, Morbidity, revascularization, stroke & myocardial infarction |
At baseline, 12 weeks and 24 weeks after intervention. |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="100" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
18/10/2019 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="3"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
None as of now |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
Aim of the Study
This program aims at optimizing to facilitate better clinical outcome and quality of life through use of Terminalia Arjuna Ksheerpaka and facilitating better long-term adaptation, alleviating inflammation and better cardiac functioning in Post CABG surgery through a study program run by specially trained team of people, including doctors, nurses etc.. Method of study This program adheres to evidence-based therapies that have been validated in well-conducted scientific studies. Patient information will be prospectively collected at baseline, 12 weeks and at 24 weeks and will be well documented. The programme will closely monitor the patients with compliance to their recommendations, their need for hospital visits, admissions and other outcomes . Advice and reminders will be given to improve compliance with drug therapy. patients will have to undergo the following tests:
o Echocardiography (ECHO) o 6 minute walk test. o A Questionnaire to assess improvement in quality of life called SF 36 o Blood tests for some biochemical markers.
The trial will be a double-blinded study, where the participants and investigators will be blinded throughout the study and those involved in administering interventions, data entry will be blinded to group assignments. |