Double Blind Randomized Trial to Compare Gurmar (Gymnema Sylvestre) With Metformin in Type 2 Diabetes
Overview[ - collapse ][ - ]
| Purpose | The study plans to compare the glucose-lowering effect of gurmar, a herbal preparation, with metformin in patients with type 2 diabetes |
|---|---|
| Condition | Type 2 Diabetes Mellitus |
| Intervention | Drug: Gurmar Drug: Metformin |
| Phase | N/A |
| Sponsor | Postgraduate Institute of Medical Education and Research |
| Responsible Party | Postgraduate Institute of Medical Education and Research |
| ClinicalTrials.gov Identifier | NCT00396851 |
| First Received | November 6, 2006 |
| Last Updated | November 6, 2006 |
| Last verified | November 2006 |
Tracking Information[ + expand ][ + ]
| First Received Date | November 6, 2006 |
|---|---|
| Last Updated Date | November 6, 2006 |
| Start Date | January 2007 |
| Estimated Primary Completion Date | Not Provided |
| Current Primary Outcome Measures | Not Provided |
| Current Secondary Outcome Measures | Not Provided |
Descriptive Information[ + expand ][ + ]
| Brief Title | Double Blind Randomized Trial to Compare Gurmar (Gymnema Sylvestre) With Metformin in Type 2 Diabetes |
|---|---|
| Official Title | Not Provided |
| Brief Summary | The study plans to compare the glucose-lowering effect of gurmar, a herbal preparation, with metformin in patients with type 2 diabetes |
| Detailed Description | Not Provided |
| Study Type | Interventional |
| Study Phase | N/A |
| Study Design | Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment |
| Condition | Type 2 Diabetes Mellitus |
| Intervention | Drug: Gurmar Drug: Metformin |
| Study Arm (s) | Not Provided |
Recruitment Information[ + expand ][ + ]
| Recruitment Status | Not yet recruiting |
|---|---|
| Estimated Enrollment | 100 |
| Estimated Completion Date | Not Provided |
| Estimated Primary Completion Date | Not Provided |
| Eligibility Criteria | Inclusion Criteria: - Newly detected type 2 diabetes - Fasting plasma glucose >126mg/dl - HbA1c > 7% Exclusion Criteria: - Serious comorbid illnesss - History of drug abuse - History of recent weight loss |
| Gender | Both |
| Ages | 25 Years |
| Accepts Healthy Volunteers | No |
| Contacts | Contact: Samir Malhotra, MD, DM +91-172-27552433 samirmalhotra345@yahoo.com |
| Location Countries | India |
Administrative Information[ + expand ][ + ]
| NCT Number | NCT00396851 |
|---|---|
| Other Study ID Numbers | Pharma 6/700 |
| Has Data Monitoring Committee | Not Provided |
| Information Provided By | Postgraduate Institute of Medical Education and Research |
| Study Sponsor | Postgraduate Institute of Medical Education and Research |
| Collaborators | Indian Council of Medical Research International Clinical Epidemiology Network (INCLEN) TRUST |
| Investigators | Study Chair: Deepak Bhasin, MD,DM PGIMERPrincipal Investigator: Anil Bhansali PGIMER |
| Verification Date | November 2006 |
Locations[ + expand ][ + ]
| PGIMER | Chandigarh, India, 160012 Contact: Samir Malhotra | samirmalhotra345@yahoo.comSub-Investigator: Promila Pandhi, MD,DM Not yet recruiting |
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