Status:
COMPLETED
Clinical Effects of New Approach on Patients With Non-alcoholic Steatohepatitis
Lead Sponsor:
Beni-Suef University
Conditions:
Non-alcoholic Steatohepatitis
Eligibility:
All Genders
18+ years
Phase:
EARLY_PHASE1
Brief Summary
This study aims to evaluate and compare the protective outcomes of using Rosuvastatin, Vitamin E, and N-acetyl cysteine in Egyptian patients with NASH. The primary endpoint of this 6-month study woul...
Detailed Description
Nonalcoholic fatty liver disease (NAFLD) is the buildup of excessive fat in the liver without of extensive alcohol consumption and the lack of any secondary cause. The prevalence of NAFLD has risen dr...
Eligibility Criteria
Inclusion
- All patients are diagnosed to have fatty liver grading 1, 2 or 3 on abdominal ultrasound with Hepatic steatosis index \> 36 to be considered as a NAFLD patient.
- NASH diagnosis using Fibroscan detecting the degree of steatosis and fibrosis.
- NASH diagnosis is by non-invasive Scoring such as (FAST Score) Cytokeratin-18 \>240 U/L Mild to moderate elevation of hepatic liver enzymes: serum aminotransferases (\>2 but \<5 times upper normal limit)
- Stable dietary habits and physical activity pattern.
Exclusion
- Current or history of significant alcohol consumption.
- Use of drugs historically associated with nonalcoholic fatty liver disease (NAFLD) (amiodarone, methotrexate, systemic glucocorticoids, tetracyclines, tamoxifen, estrogens at doses greater than those used for hormone replacement, anabolic steroids, valproic acid, and other known hepatotoxins).
- Prior or planned bariatric surgery.
- Uncontrolled diabetes defined as Hemoglobin A1c 9.5% or higher.
- Evidence of other forms of chronic liver disease as Hepatitis B, Hepatitis C, Wilson's disease, Alpha-1-antitrypsin(A1AT) deficiency, Hemochromatosis, drug-induced liver disease.
- The presence of contra-indications of NAC or rosuvastatin.
- Pregnancy, planned pregnancy, potential for pregnancy and unwillingness to use effective birth control during the trial and breast feeding.
- Use of other drugs known to have possible positive effects on steatosis.
- If there are any conditions where fibroscan could be contra-indicated. The patients refuse participating or completing study.
Key Trial Info
Start Date :
December 17 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 27 2024
Estimated Enrollment :
175 Patients enrolled
Trial Details
Trial ID
NCT06105060
Start Date
December 17 2023
End Date
June 27 2024
Last Update
February 6 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Tanta university hospital
Tanta, Gharbyia, Egypt, 6620010