Home » Trials » SLCTR/2007/002


Prospective double blind randomized placebo controlled trial on the efficacy of metformin in the treatment of NASH -

SLCTR Registration Number

SLCTR/2007/002


Date of Registration

23 Feb 2007

The date of last modification

Feb 20, 2013


View original TRDS


Trial Status



Application Summary


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 of Health Condition(s) Studied

Non - alcoholic steatohepatitis (NASH)


Scientific Acronym

None


Public Acronym

None


Brief title

None


Universal Trail Number

None


Any other number(s) assigned to the trial and issuing authority

RG/2004/M/05 issued by NSF


Trial Details


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


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


Primary outcome(s)

End of treatment with metformin or placebo for 6 months


Primary outcome(s) - Time of assessment(s)

at 6 months


Secondary outcome

None


Secondary outcome(s) - Time of assessment(s)

None



Target number/sample size

170


Countries of recruitment

Sri Lanka


Anticipated start date

2004-01-01


Anticipated end date

2008-12-31


Recruitment status

Recruiting


State of ethics review approval

Ethical approval granted by Ethical Review Committee Faculty of Medicine,University of Kelaniya


Funding source

National Science Foundation, Sri Lanka



Contact & Sponsor Information


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