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Main
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Note: This record shows only 22 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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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT02283710 |
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Date of registration:
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01/11/2014 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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The Effect of Pentoxifylline on Liver Function Tests in Fatty Liver Disease
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Scientific title:
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The Effect of Pentoxifylline on Liver Function Tests in Non-alcoholic Fatty Liver Disease Patients Refereed to Sina Hospital Gastroenterology Clinic |
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Date of first enrolment:
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May 2013 |
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Target sample size:
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120 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT02283710 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Caregiver, Outcomes Assessor), Primary Purpose: Treatment
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Phase:
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Phase 2
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Countries of recruitment
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Iran, Islamic Republic of
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Contacts
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Name:
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Raika Jamali, M.D. |
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Address:
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Telephone:
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Email:
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Affiliation:
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Tehran University of Medical Sciences |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
Patients with persistent elevated aminotransferase levels and the evidence of fatty liver
in ultrasonography, who were referred to a gastroenterology clinic.
Exclusion Criteria:
- alcohol use (more than 20 gram per day in men and 10 gram per day in women per day),
- heart disease (ischemic or congestive),
- hepatic disease (viral hepatitis, autoimmune hepatitis, wilson disease,
hemochromatosis, liver mass lesion),
- renal disease (serum creatinine concentration of > 1.5 mg/dl),
- any severe systemic co-morbidities, neoplasm,
- using any hepatotoxic medication during the past 3 months,
- pregnant or lactating women.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Fatty Liver
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Intervention(s)
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Behavioral: Lifestyle modification
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Drug: Pentoxifylline
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Primary Outcome(s)
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Change from baseline serum alanine aminotransferase at 6 months
[Time Frame: 6 months]
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Secondary Outcome(s)
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Change from baseline serum aspartate aminotransferase at 6 months
[Time Frame: 6 months]
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Secondary ID(s)
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9011160012
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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