Actively Recruiting
Clinical Study Evaluating the Safety and Efficacy of Esomeprazole in Treatment of Non-alcoholic Steatohepatitis
Led by Sadat City University · Updated on 2024-05-22
46
Participants Needed
1
Research Sites
99 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The aim of the study is to test the implication of esomeprazole as a possible potential therapy for patients with NASH through evaluating its effect on ultrasound and fibrosis risk scores, serum levels of liver fibrosis biomarkers (fibronectin 1), insulin resistance, metabolic and inflammatory parameters.
CONDITIONS
Official Title
Clinical Study Evaluating the Safety and Efficacy of Esomeprazole in Treatment of Non-alcoholic Steatohepatitis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Both males and females.
- Diabetic and non-diabetic patients.
- Age over 18 years old.
- Overweight and obese patients with BMI between 25 and less than 40 kg/m2.
- Patients with heartburn, peptic ulcer, gastroesophageal reflux disease, erosive esophagitis, Zollinger-Ellison syndrome, or helicobacter pylori infection.
- Patients diagnosed with NASH based on liver ultrasonography, mild to moderate elevation in aminotransferase activities (greater than 2 but less than 5 times upper limit of normal), hepatic steatosis index over 36, and HAIR score of 2 or 3.
You will not qualify if you...
- History of hypersensitivity to esomeprazole.
- Patients with BMI 40 kg/m2 or higher.
- Taking warfarin, clopidogrel, digoxin, diazepam, or phenytoin due to drug interactions.
- Infected with HIV and taking antiretroviral medicines or rilpivirine.
- History of viral hepatitis, autoimmune hepatitis, sclerosing cholangitis, biliary obstruction, primary biliary cirrhosis, hemochromatosis, Wilson's disease, or alpha-1 antitrypsin deficiency.
- Taking medications linked to steatosis such as NSAIDs, amiodarone, tamoxifen, estrogen, sodium valproate, corticosteroids, or methotrexate.
- Having cancer or a history of cancer.
- Having cardiovascular diseases.
- Pregnant or lactating females.
AI-Screening
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Trial Site Locations
Total: 1 location
1
National Liver Institute
Shibīn al Kawm, Egypt
Actively Recruiting
Research Team
A
aya hesham eltabbakh, bachelor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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