Nonalcoholic Steatohepatitis (NASH) Clinical Trial
Official title:
A Randomized Study to Compare the Efficacy of Vitamin E, Ursodeoxycholic Acid and Pentoxyfylline on Egyptian Patients With Non-alcoholic Fatty Liver Disease Using (IL6 and CCL2) as a Predictors of Non-alcoholic Steatohepatitis
Verified date | July 2021 |
Source | Kafrelsheikh University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 102 |
Est. completion date | January 10, 2021 |
Est. primary completion date | May 20, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Egypt | Hepatology, gastroenterology and infectious diseases department at Kafrelsheikh University Hospital | Cairo |
Lead Sponsor | Collaborator |
---|---|
Kafrelsheikh University |
Egypt,
Younossi Z, Tacke F, Arrese M, Chander Sharma B, Mostafa I, Bugianesi E, Wai-Sun Wong V, Yilmaz Y, George J, Fan J, Vos MB. Global Perspectives on Nonalcoholic Fatty Liver Disease and Nonalcoholic Steatohepatitis. Hepatology. 2019 Jun;69(6):2672-2682. doi — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Resolution of NASH | Relieve clinical symptoms and prevent progression | 3 months | |
Secondary | Normalization of hepatic aminotransferases(ALT and AST) | ALT and AST return to normal values | 3 months |
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