The Effect of Pentoxifylline on Liver Function Tests in Fatty Liver Disease

The Effect of Pentoxifylline on Liver Function Tests in Non-alcoholic Fatty Liver Disease Patients Refereed to Sina Hospital Gastroenterology Clinic

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02283710

Enrollment

120

Registered

2014-11-05

Start date

2013-05-31

Completion date

2014-05-31

Last updated

2014-11-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fatty Liver

Keywords

Pentoxifylline, Aminotransferase, Steatohepatitis

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.

Detailed description

This randomized double blind clinical trial was performed in patients with the evidence of fatty liver in ultrasonography. After excluding other causes, participants with persistent elevated serum aminotransferase levels were presumed to have NAFLD. Those with NAFLD liver fat score greater than (-0.64) were enrolled. They were randomly assigned to lifestyle modification alone or lifestyle modification plus Pentoxifylline groups. Fasting serum glucose, alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase, triglyceride, cholesterol, high and low-density lipoprotein,homeostasis model assessment-insulin resistance(HOMA-IR), and anthropometric measurements (body mass index and waist circumference) were checked at baseline and six months later.

Interventions

DRUGPentoxifylline

Pentoxifylline 600 mg BD

BEHAVIORALLifestyle modification

obtaining ideal body weight by calorie restriction diet and programmed physical activity.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
Change from baseline serum alanine aminotransferase at 6 months	6 months

Secondary

Measure	Time frame
Change from baseline serum aspartate aminotransferase at 6 months	6 months

Countries

Iran

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026