| CTRI Number |
CTRI/2015/01/005397 [Registered on: 14/01/2015] Trial Registered Retrospectively |
| Last Modified On: |
09/01/2015 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A plant based Ayurvedic medicine used for the prevention and management of various risk factors responsible for occurrence of Coronary Heart Disease. |
|
Scientific Title of Study
|
A randomized double blind controlled clinical trial of an Ayurvedic formulation for the prevention and management of coronary heart disease. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Z.18017/55/2010-DCC (AYUSH) |
Other |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Prof G P Dubey |
| Designation |
Professor of Eminence |
| Affiliation |
Interdisciplinary School of Indian System of Medicine, SRM University |
| Address |
Interdisciplinary School of Indian System of Medicine, SRM University, Kattankulathur, Tamil Nadu
Kancheepuram
TAMIL NADU
603 203
India |
| Phone |
9450963942 |
| Fax |
|
| Email |
gpdubey13@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof K Ilango |
| Designation |
Professor & Dean |
| Affiliation |
Interdisciplinary School of Indian System of Medicine |
| Address |
Dean, Interdisciplinary School of Indian System of Medicine, SRM University, Kattankulathur, Tamil Nadu
Kancheepuram
TAMIL NADU
603 203
India |
| Phone |
9042728777 |
| Fax |
|
| Email |
ilangok67@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr R C Satish Kumar |
| Designation |
Assistant Professor |
| Affiliation |
Interdisciplinary School of Indian System of Medicine, SRM University |
| Address |
Interdisciplinary School of Indian System of Medicine, SRM University, Kattankulathur, Tamil Nadu
Kancheepuram
TAMIL NADU
603 203
India |
| Phone |
09884845887 |
| Fax |
|
| Email |
ayursatish@gmail.com |
|
|
Source of Monetary or Material Support
|
| Venkatesh Natural Products, Pvt. Ltd., Chhindwara, Jabalpur, Madhya Pradesh |
|
|
Primary Sponsor
|
| Name |
Department of Science Technology |
| Address |
Dept. of Science & Technology Govt. of India Technology Bhawan,
New Mehrauli Road New Delhi-110016 |
| Type of Sponsor |
Government funding agency |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Prof N Sethuraman |
Regsitrar, SRM University, Kattankulathur, Tamil Nadu |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Prof G P Dubey |
Interdisciplinary School of Indian System of Medicine |
Room No. 4, 4th Floor, Interdisciplinary School of Indian System of Medicine, SRM University, Kattankulathur
Kancheepuram
TAMIL NADU |
9450963942
gpdubey13@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SRM University |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Coronary Heart Disease, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional Drug Atrovastatin 10mg twice per day. |
Conventional drug Atrovastatin 10mg morning at 9.00 AM and 10mg evening at 9.00PM were given to diagnosed cases of Coronary Heart Disease. The present study was conducted as per International regulatory norms and effect of test formulation of evaluated on various CHD risk factor like abnormal lipids, elevated inflammatory markers, hyperhomocysteinemia, endothelial dysfunction, coronary artery thickening including plasminogen activator inhibitor and tissue plasminogen activator inhibitor. Further, the effect of test formulation was evaluated on blood pressure, pulse rate, respiration rate and sleep pattern. |
| Intervention |
Test formulation 500mg twice per day for a period of six months |
The standard hydro-alcoholic extract of shade dried root of Withania somnifera (250mg/day), rhizome of Costus speciosus (200mg/day), bark of Terminalia arjuna (275mg/day) and fruits of Hippophae rhamnoides (225mg/day) were utilized for the preparation of combined formulation and given 500mg morning (9.00 AM) and 500mg evening (9.00PM) for a period of 6 months. Before human consumption the toxicological studies were conducted in pre-clinical studies as per ICH standards. Further, the in-vitro and in-vivo efficacy studies were done to assess its biological properties. In preliminary clinical trial the efficacy of test formulation was assessed on lipid (total cholesterol, HDL-c, LDL-c including triglycerides, homocysteine concentration, inflammatory markers (IL-6, TNF-α, hsCRP), brachial artery thickening, PAI, tPAI etc. ) |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
Diagnosed cases of CHD consenting to participate in clinical drug trial program were included in the study.
These CHD patient showing dyslipidemia, atherosclerotic, ischemic changes, elevated homocysteine and inflammatory markers, concentration with certain psychological complaints mainly sleep disturbances were treated with test formulation.
The diagnosis of CHD patients were done on the basis of clinical as well as laboratory findings. |
|
| ExclusionCriteria |
| Details |
Patients suffering from chronic illness like T.B., Rheumatoid arthritis, diagnosed IHD cases; Type-1 diabetic patients; Evidence of hypo or hyperthyroidism; Age above 75 years. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The test formulation has shown Cardio-protective property through its anti-atherosclerotic, anti-inflammatory, anti-obesity activity |
Parameters measured at baseline (initial), 3 months and 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The test formulation has shown reduction in anxiety level as well as improved sleep pattern among CHD patients |
Parameters measured at baseline (initial), 3 months and 6 months |
|
|
Target Sample Size
|
Total Sample Size="1000"
Sample Size from India="1000"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
02/01/2009 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="5"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
42. Agrawal A, Rajamanikam GV, Attrey DP, Dubey GP “Role of a poly herbal formulation in the prevention and management of coronary heart disease. Advances in natural products-Importance in Health and Economy. Eds- Zaheer Ahmed & Ahsana Dar, Centre for Science & Technology of the Non-aligned and other developing countries (NAM S&T Centre), Daya Publishing House New Delhi. PP 136-153, 2008.
39. Agrawal A, Dubey G.P.: Elevated Plasma Homocysteine and CRP - the risk factors for atherosclerotic vascular disease – its modification by an Ayurvedic medicine in National workshop on Standardization of traditional Indian medicine for global acceptance as per ‘WHO’ guidelines, supported by PRDSF programme, Deptt. of Science & Technology, Govt. of India, Organized by Centre of Psychosomatic & Biofeedback Medicine, Institute of Medical Sciences, BHU & Sri Ramchandra Medical College & Research Institute, Chennai, PP 201-214, 2006. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The test formulation has shown
anti-atherosclerotic, anti-inflammatory and anti-obesity activity when given to
diagnosed CHD patients. Further, it has shown HDL-c enhancing and triglycerides
reducing effects. When the effect of test formulation assessed on lipid
profile, inflammatory markers, endothelin, PAI, tPAI including brachial artery
thickening, has revealed
cardioprotective potentials. It improved the sleep and mental performance
of CHD patients also. The test formulation is safe and can be given for longer
time |