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

Mar 03, 2019


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 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


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

Treatment


Study Phase

Not Available


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)

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



State of Ethics Review Approval


Status

Approved


Date of Approval


Approval number


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 & 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

Trial Completion details


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