| CTRI Number |
CTRI/2016/08/007187 [Registered on: 16/08/2016] Trial Registered Retrospectively |
| Last Modified On: |
27/07/2017 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Biological
Ayurveda
Diagnostic
Preventive |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
Public Title of Study
Modification(s)
|
Checking effect of an ayurvedic treatment on urine and serum metabolites in hyperlipidemic patients |
|
Scientific Title of Study
|
Investigation of metabolomics changes in serum and urine during treatment hyperlipidemia using classical ayurvedic formulation |
|
Secondary IDs if Any
|
| Secondary ID |
Registry |
| NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
|
| Name |
Dr Rajesh Dabur |
| Address |
National Research Institute of Basic Ayurvedic Sciences (NRIBAS), (CCRAS, Ministry of AYUESH, Govt of India), Kothrud, Pune-411038, Maharashtra.
Pune
MAHARASHTRA
411038
India |
| Phone |
|
| Fax |
|
| Email |
rajeshdabur@yahoo.com |
|
Details Contact Person
Scientific Query
Modification(s)
|
| Name |
Mr Amey Shirolkar |
| Address |
Department of Biochemistry, National Research Institute of Basic Ayurvedic Sciences (NRIBAS), (CCRAS, Ministry of AYUESH, Govt of India), Kothrud, Pune-411038, Maharashtra.
Pune
MAHARASHTRA
411038
India |
| Phone |
|
| Fax |
|
| Email |
amey_593@rediffmail.com |
|
Details Contact Person
Public Query
Modification(s)
|
| Name |
Dr Rajesh Dabur |
| Address |
National Research Institute of Basic Ayurvedic Sciences (NRIBAS), (CCRAS, Ministry of AYUESH, Govt of India), Kothrud, Pune-411038, Maharashtra.
Pune
MAHARASHTRA
411038
India |
| Phone |
|
| Fax |
|
| Email |
rajeshdabur@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Central Council for Research in Ayurvedic Sciences (CCRAS), Ministry of AYUSH, Government of India. |
|
Primary Sponsor
Modification(s)
|
| Name |
Central Council for Research in Ayurvedic Sciences |
| Address |
Ministry of AYUSH, Jawahar Lal Nehru Bhartiya Chikitsa Avum Homeopathy Anusandhan Bhavan
No.61-65, Institutional Area, Opp. D Block, Janakpuri, New Delhi - 110058 (India) Telephone : 91-011-28525852 |
| Type of Sponsor |
Government funding agency |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 1 |
| Contact Person |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Rajesh Dabur |
National Research Institute of Basic Ayurvedic Sciences (NRIBAS) |
Department of Biochemistry, National Research Institute of Basic Ayurvedic Sciences (NRIBAS), Kothrud, Pune-411038, Maharashtra.
Pune
|
91-20-25383138
rajeshdabur@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Padmashree Dr D. Y. Patil college of Ayurveda & Research center, Pimpri, Pune-411018. |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
hyperlipidemia, triglyceride 300 mg/dL and cholesterol in the range of 130- 230 mg/dL |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
1)Aqueous extract of Tinospora cordifolia (Willd.) Miers
2)Metformin as a standard drug |
1)Aqueous extract of Tinospora cordifolia (Willd.) Miers
100 ml/day/person for 14 days (3.0 g dry weight)
2)Metformin as a standard drug 850mg/day/person for 14 days
|
| Comparator Agent |
healthy individuals |
triglyceride 300 mg/dL, free from all related disorders and abnormalities |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
triglyceride >300 mg/dL and cholesterol in the range of 130- 230 mg/dL, must be free of anyother clinically significant diseases and addictions |
|
| ExclusionCriteria |
| Details |
A history of coronary heart disease or stroke, serum creatinine 1.5 mg/dl, albuminuria 40 μg/min, and use of lipid-lowering drugs, aspirin, or other antihypertensive agents |
|
|
Method of Generating Random Sequence
|
Stratified randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Changes in blood biochemical parameters, urine and plasma chemical composition in terms of proteins and metabolites |
0 and 14th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Suppression of blood high lipid content linked disorders |
0 and 14th day |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50" |
|
Phase of Trial
|
Phase 1/ Phase 2 |
|
Date of First Enrollment (India)
|
01/03/2011 |
| Date of First Enrollment (Global) |
No Date Specified |
|
Estimated Duration of Trial
|
Years="0"
Months="0"
Days="21" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
1) Ashwani Mittal, Rajesh Dabur. Alcohol and Alcoholism,2015,50(3):271-281.
2) Suman Kumari, Ashwani Mittal, Rajesh Dabur. Steroids,2016,114:68-77.
3) Amey R Shirolkar, Rajesh Dabur. Indian Journal of Pharmaceutical Education and Research.2016,50(3):451-57.
4) Amey Shirolkar, Bhawana Sharma, Suman Lata, Rajesh Dabur. Biomedicine & Pharmacotherapy. 2016,83: 1265-1277.
5) Dabur R, Mittal A. Alcohol. 2016,52:71-8.
6) Sharma B, Dabur R. Alcohol Alcohol. 2016,51(1):1-10. |
|
Brief Summary
|
This study is a randomized, double blind, parallel group, uni-centre study of efficacy of Aqueous extract of Tinospora cordifolia (Willd.) Miers 100 ml/day/person (3.0 g dry weight) and Metformin as a standard drug 850mg/day/person for 14 days daily 40 patients with obesity and hyperlipidemia. The primary outcome measured changes in blood biochemical parameters, urine and plasma chemical composition in terms of proteins and etabolites. The secondary outcome was suppression of blood high lipid content linked disorders. |
