Overview

Comparing the Effects of Vitamin E, Ursodeoxycholic Acid and Pentoxyfylline on Egyptian Non-alcoholic Steatohepatitis (NASH) Patients

Status:
Completed
Trial end date:
2021-01-10
Target enrollment:
0
Participant gender:
All
Summary
We conducted a 3-month, randomized, single-blind study in 102 Egyptian NASH patients who were divided into three groups; group 1 included 34 patients received Vit. E 400 mg twice a day, group 2 included 34 patients received UDCA 250 mg twice a day and group 3 included 34 patients received PTX 400 mg twice daily for 3 months. The following parameters were measured both before and after intervention intake; liver aminotransferases (AST, ALT), cytokine and chemokine (IL6 and CCL2/MPC-1), albumin, total bilirubin, direct bilirubin, total cholesterol, triglyceride, LDL, HDL.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Kafrelsheikh University
Treatments:
alpha-Tocopherol
Pentoxifylline
Tocopherols
Ursodeoxycholic Acid
Vitamin E
Criteria
Inclusion Criteria:

- Patients were enrolled in the study

1. if they are > 18 years old

2. had evidence for NASH; persistently elevated alanine aminotransferase (ALT) >1.5
times the upper limit of normal)

3. imaging (ultrasound) showing fatty infiltration, and histological evidence of
NASH after biopsy (macrovascular steatosis, ballooning degeneration of
hepatocytes, scattered lobular inflammation and apoptotic bodies).

Exclusion Criteria:

- Patients were ruled out if they had

1. history of alcohol dependence

2. treatment with drugs known to induce NASH (e.g. amiodarone, calcium channel
blocker, tamoxifen, oral anticoagulation, methotrexate , steroids and estrogen)

3. positive serologic markers for known chronic liver diseases (hepatitis B surface
antigen, anti-hepatitis C virus antibody antinuclear antibody)

4. human immunodeficiency virus (HIV) infection

5. Diabetes

6. decompensated liver disease defined as serum bilirubin level >1 mg/dL, albumin
level ˂3.5 g/dL, and international normalized ratio (INR) ≥1.7.