| 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 (in lay language) | Trial on the efficacy of metformin in the treatment of Non-alcoholic steatohepatitis | |
| Acronym, if any | None | |
| Brief title, if any | None | |
| Any
other number(s) assigned to the trial and issuing authoruty, if any (eg. sponsor, other trial registry) |
RG/2004/M/05 issued by NSF | |
| Disease or Health Condition(s) studied | Non - alcoholic steatohepatitis (NASH) | |
| What is the research question being addressed? | Does metformin improve histology in NASH ? | |
| Study design | Prospective double blind placebo controlled | |
| Intervention(s) planned | Liver biopsy before and after metformin for 6 months | |
| Inclusion criteria | * Patients with clinical, biochemical, radiological and histological evidence of NASH * No history of other possible aetiological factors for steatohepatitis such as significant alcohol consumption, medications | |
| Exclusion criteria | * Patients with diabetes mellitus * Patients with significantly elevated levels of total cholesterol and triglycerides requiring lipid lowering treatment * Patients with severe obesity * Patients with history of significant alcohol ingestion patients with history of taking medications known to cause NASH. * Patients with any other liver diseases * Patients with contraindications for metformin * Pregnant females * All patients with contraindications for liver biopsy | |
| Target number / sample size | 170 patients | |
| Primary outcome(s) | End of treatment with metformin or placebo for 6 months | |
| Primary outcome(s) - time of assessment(s) | ||
| Secondary outcome(s) | None | |
| Secondary outcome(s) - time of assessment(s) | ||
| Countries of recruitment | Sri Lanka | |
| Anticipated start date | 01/01/2004 | |
| Anticipated end date | 31/12/2008 | |
| Recruitment status | Current | |
| State of ethics review approval | Ethical approval granted by Ethical Review Committee Faculty of Medicine,University of Kelaniya | |
| Funding source(s) | National Science Foundation, Sri Lanka | |
| Applicant's Email | anuradhadassanayake@hotmail.com | |
| Approval Status | Approved | |
| Contact Person for Scientific Queries / Principal investigator | Dr Anuradha Dassanayake
Senior Lecturer Department of Pharmacology, Faculty of Medicine, PO Box 6, Talagolla Road, Ragama +94 112961157 +94 11295618 anuradhadassanayake@hotmail.com |
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| Primary Study Sponsor/ Organization | Faculty of Medicine, University of Kelaniya, PO Box 6, Talagolla Road, Ragama
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| Contact Person for Public Queries | Dr Anuradha Dassanayake Senior Lecturer in Pharmacology Faculty of Medicine, P.O. Box 6, Talagolla Road, Ragama +94 112961157 +94 112956188 anuradhadassanayake@hotmail.com |
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| Secondary Study Sponsor(s), (if any) | National Science Foundation 47/5 , Maitland place, Colombo 7 +94 112696771 +94 112691691 info@sf.ac.lk www.nsf.ac.lk |
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