The Effect of Pentoxifylline on Liver Function Tests in Fatty Liver Disease
1 other identifier
interventional
120
1 country
1
Brief Summary
This randomized double blind clinical trial was performed in patients with non-alcoholic fatty liver disease.They were randomly assigned to lifestyle modification alone or lifestyle modification plus Pentoxifylline groups. Liver function tests, metabolic profile and anthropometric measurements were checked at baseline and six months later.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started May 2013
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2014
CompletedFirst Submitted
Initial submission to the registry
November 1, 2014
CompletedFirst Posted
Study publicly available on registry
November 5, 2014
CompletedNovember 6, 2014
November 1, 2014
1 year
November 1, 2014
November 5, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change from baseline serum alanine aminotransferase at 6 months
6 months
Secondary Outcomes (1)
Change from baseline serum aspartate aminotransferase at 6 months
6 months
Study Arms (2)
Pentoxifylline + lifestyle modification
EXPERIMENTALPentoxifylline for 6 months plus obtaining ideal body weight by calorie restriction diet and programmed physical activity.
Lifestyle modification
EXPERIMENTALObtaining ideal body weight by calorie restriction diet and programmed physical activity.
Interventions
obtaining ideal body weight by calorie restriction diet and programmed physical activity.
Eligibility Criteria
You may qualify if:
- Patients with persistent elevated aminotransferase levels and the evidence of fatty liver in ultrasonography, who were referred to a gastroenterology clinic.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Gastroenterology clinic, Sina Hospital
Tehran, Tehran Province, Iran
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Raika Jamali, M.D.
Tehran University of Medical Sciences
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- CARE PROVIDER, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor of Medicine
Study Record Dates
First Submitted
November 1, 2014
First Posted
November 5, 2014
Study Start
May 1, 2013
Primary Completion
May 1, 2014
Study Completion
May 1, 2014
Last Updated
November 6, 2014
Record last verified: 2014-11