The aim of the present study is to evaluate the efficacy and safety of pentoxifylline in the treatment of non-alcoholic steatohepatitis patients.
Nonalcoholic steatohepatitis(NASH) is the progressive form of Non-alcoholic fatty liver disease (NAFLD), is characterized by hepatocellular damage, inflammation, and liver fibrosis that can progress to cirrhosis, in 25% of patients, NAFLD progresses to NASH, which increases the risk for the development of cirrhosis, liver failure, and hepatocellular carcinoma. In patients with NASH, liver fibrosis is the main determinant of mortality. Pentoxifylline (PTX) is a xanthine derivative drug with a wide range of actions at the cellular and molecular level. PTX possess anti-inflammatory, antioxidant activities. PTX have potential role in improvement of NASH . Also, PTX inhibits a number of pro-inflammatory cytokines including interleukin-1, interleukin-6 and tumor necrosis factor (TNF-α ) which play an important role in the pathogenesis and progression of NASH.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
50
400 mg three times daily
Internal medicine and hepatology outpatient clinic at Ain Shams University Hospital.
Cairo, Egypt
improvement in liver aminotransferases(ALT and AST)
Difference between last and first measurements
Time frame: 6 months compared to the baseline
NAFLD fibrosis score (NFS)
Change in NAFLD fibrosis score (NFS) (lower score means better outcome).
Time frame: 6 months compared to the baseline
The Aspartate (AST) to Platelet Ratio Index (APRI) score:
Change in (APRI) score (lower score means better outcome).
Time frame: 6 months compared to the baseline
The Fibrosis-4 (FIB-4) values:
Change in (FIB-4) values (lower values means better outcome).
Time frame: 6 months compared to the baseline
Serum Alkaline Phosphatase level (ALP)
Change in ALP serum level as inflammatory markers of NASH
Time frame: 6 months compared to the baseline
Serum Gamma-glutamyl Transferase level (GGT)
Change in GGT serum level as inflammatory markers of NASH
Time frame: 6 months compared to the baseline
Serum total and direct bilirubin.
Change in levels of serum total and direct bilirubin.
Time frame: 6 months compared to the baseline
Waist circumference
Change in waist circumference
Time frame: 6 months compared to the baseline
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Change in anthropometric measures
including BMI etc.
Time frame: 6 months compared to the baseline
Lipid profile
Change in serum lipids
Time frame: 6 months compared to the baseline
Glycated hemoglobin (HbA1C)
Change in HbA1C level for patients with T2DM
Time frame: 6 months compared to the baseline
Fasting blood glucose level
Change in fasting blood glucose for patients with T2DM
Time frame: 6 months compared to the baseline
Drugs adverse events
Assessment of safety by reporting any adverse events
Time frame: 6 months compared to the baseline