Back to resultsDouble Blind Randomized Trial to Compare Gurmar (Gymnema Sylvestre) With Metformin in Type 2 Diabetes
Primary Purpose
Type 2 Diabetes Mellitus
Status
Unknown status
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
Gurmar
Metformin
Sponsored by
About this trial
This is an interventional treatment trial for Type 2 Diabetes Mellitus
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
Sites / Locations
- PGIMER
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00396851
First Posted
November 6, 2006
Last Updated
November 6, 2006
Sponsor
Postgraduate Institute of Medical Education and Research
Collaborators
Indian Council of Medical Research, International Clinical Epidemiology Network (INCLEN) TRUST
1. Study Identification
Unique Protocol Identification Number
NCT00396851
Brief Title
Double Blind Randomized Trial to Compare Gurmar (Gymnema Sylvestre) With Metformin in Type 2 Diabetes
Study Type
Interventional
2. Study Status
Record Verification Date
November 2006
Overall Recruitment Status
Unknown status
Study Start Date
January 2007 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Postgraduate Institute of Medical Education and Research
Collaborators
Indian Council of Medical Research, International Clinical Epidemiology Network (INCLEN) TRUST
4. Oversight
5. Study Description
Brief Summary
The study plans to compare the glucose-lowering effect of gurmar, a herbal preparation, with metformin in patients with type 2 diabetes
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
100 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Gurmar
Intervention Type
Drug
Intervention Name(s)
Metformin
10. Eligibility
Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Samir Malhotra, MD, DM
Phone
+91-172-27552433
Email
samirmalhotra345@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Deepak Bhasin, MD,DM
Organizational Affiliation
Postgraduate Institute of Medical Education and Research
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Anil Bhansali
Organizational Affiliation
Postgraduate Institute of Medical Education and Research
Official's Role
Principal Investigator
Facility Information:
Facility Name
PGIMER
City
Chandigarh
ZIP/Postal Code
160012
Country
India
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Samir Malhotra
Email
samirmalhotra345@yahoo.com
First Name & Middle Initial & Last Name & Degree
Promila Pandhi, MD,DM
12. IPD Sharing Statement
Citations:
PubMed Identifier
32501595
Citation
Gnesin F, Thuesen ACB, Kahler LKA, Madsbad S, Hemmingsen B. Metformin monotherapy for adults with type 2 diabetes mellitus. Cochrane Database Syst Rev. 2020 Jun 5;6(6):CD012906. doi: 10.1002/14651858.CD012906.pub2.
Results Reference
derived
Learn more about this trial
Double Blind Randomized Trial to Compare Gurmar (Gymnema Sylvestre) With Metformin in Type 2 Diabetes
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