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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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SLCTR |
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Last refreshed on:
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27 May 2013 |
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Main ID: |
SLCTR/2007/002 |
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Date of registration:
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23/02/2007 |
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Primary sponsor: |
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Public title:
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Trial on the efficacy of metformin in the treatment of Non-alcoholic steatohepatitis
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Scientific title:
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Prospective double blind randomized placebo controlled trial on the efficacy of metformin in the treatment of NASH |
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Date of first enrolment:
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1/1/2004 |
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Target sample size:
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170 patients |
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Recruitment status: |
Recruiting |
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URL:
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http://www.slctr.lk/trial_details.asp?reg_id={412A34E2-00EC-4349-B75B-96477DC63E6E} |
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Study type:
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Interventional |
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Study design:
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Prospective double blind placebo controlled
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Countries of recruitment
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Sri Lanka
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Contacts
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Name:
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Dr Anuradha Dassanayake
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Address:
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Department of Pharmacology, Faculty of Medicine,
PO Box 6, Talagolla Road, Ragama
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Telephone:
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+94 112961157 |
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Email:
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anuradhadassanayake@hotmail.com |
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Affiliation:
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Senior Lecturer |
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Name:
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Dr Anuradha Dassanayake
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Address:
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Faculty of Medicine, P.O. Box 6, Talagolla Road, Ragama
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Telephone:
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+94 112961157 |
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Email:
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anuradhadassanayake@hotmail.com |
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Affiliation:
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Senior Lecturer in Pharmacology |
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Key inclusion & exclusion criteria
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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
Age minimum:
Age maximum:
Gender:
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Health Condition(s) or Problem(s) studied
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Non - alcoholic steatohepatitis (NASH)
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Intervention(s)
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Liver biopsy before and after metformin for 6 months
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Primary Outcome(s)
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End of treatment with metformin or placebo for 6 months
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Secondary ID(s)
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RG/2004/M/05 issued by NSF
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Source(s) of Monetary Support
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National Science Foundation, Sri Lanka
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