Home » Trials » SLCTR/2007/002
Prospective double blind randomized placebo controlled trial on the efficacy of metformin in the treatment of NASH
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SLCTR Registration Number
SLCTR/2007/002
Date of Registration
The date of last modification
Apr 30, 2019
View original TRDS
Trial Status
Scientific Title of Trial
Prospective double blind randomized placebo controlled trial on the efficacy of metformin in the treatment of NASH
Public Title of Trial
Trial on the efficacy of metformin in the treatment of Non-alcoholic steatohepatitis
Disease or Health Condition(s) Studied
Non - alcoholic steatohepatitis (NASH)
Scientific Acronym
None
Public Acronym
None
Brief title
None
Universal Trial Number
None
Any other number(s) assigned to the trial and issuing authority
RG/2004/M/05 issued by NSF
What is the research question being addressed?
Does metformin improve histology in NASH ?
Type of study
Interventional
Study design
Allocation
Randomized controlled trial
Masking
Double blinded
Control
Placebo
Assignment
Parallel
Purpose
Treatment
Study Phase
Not Available
Intervention(s) planned
Liver biopsy before and after metformin for 6 months
Inclusion criteria
Exclusion criteria
Primary outcome(s)
|
1.
End of treatment with metformin or placebo for 6 months |
[ at 6 months ] |
Secondary outcome(s)
|
1.
None |
[ None ] |
Target number/sample size
170
Countries of recruitment
Sri Lanka
Anticipated start date
2004-01-01
Anticipated end date
2008-12-31
Date of first enrollment
Date of study completion
Recruitment status
Recruiting
Funding source
National Science Foundation, Sri Lanka
Regulatory approvals
Status
Approved
Date of Approval
2003-09-29
Approval number
Not Available
Details of Ethics Review Committee
| Name: | Ethics Review Committee, Faculty of Medicine, University of Kelaniya |
| Institutional Address: | PO Box 6, Thalagolla Road, Ragama Sri Lanka |
| Telephone: | +94-11-2961267 |
| Email: | erckelaniya@gmail.com |
Contact person for Scientific Queries/Principal Investigator
Dr Anuradha Dassanayake
Senior Lecturer
Department of Pharmacology,
Faculty of Medicine, University of Kelaniya
PO Box 6, Talagolla Road, Ragama
+94 112961157
+94 112956188
anuradhadassanayake@hotmail.com
Contact Person for Public Queries
Dr Anuradha Dassanayake
Senior Lecturer
Department of Pharmacology,
Faculty of Medicine, University of Kelaniya
PO Box 6, Talagolla Road, Ragama
+94 112961157
+94 112956188
anuradhadassanayake@hotmail.com
Primary study sponsor/organization
Faculty of Medicine, University of Kelaniya,
PO Box 6, Talagolla Road, Ragama
Secondary study sponsor (If any)
National Science Foundation
47/5 , Maitland place,
Colombo 7
+94 112696771
+94 112691691
info@sf.ac.lk
www.nsf.ac.lk
Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?
IPD sharing plan description
Not Available
Study protocol available
Protocol version and date
Not Available
Protocol URL
Not Available
Results summary available
No
Date of posting results
Date of study completion
Final sample size
Date of first publication
Link to results
Brief summary of results
