NCT06105060CompletedEarly phase 1
Clinical Effects of New Approach on Patients With Non-alcoholic Steatohepatitis
Clinical and Biochemical Study of the Effects of Rosuvastatin, Vitamin E, and N-Acetyl Cysteine on Patients With Non-alcoholic Steatohepatitis: a Randomized Controlled Trial
Source: ClinicalTrials.gov · Last updated 6 Feb 2025
Brief summary (registry, in English)
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 would be an improved degree of fibrosis with no worsening of NASH or NASH resolution with no worsening of fibrosis and steatosis that the study considered successful if either 1ry endpoint is met. The secondary endpoint of this study is the improvement of biochemical markers related to steatosis, inflammation, oxidative stress, insulin resistance, and liver fibrosis.
- Status (registry)
- Completed
- Phase (registry)
- Early phase 1
- Study type
- Interventional
- Enrollment
- 175 (actual)
- First submitted
- 3 Oct 2023
- Start date
- 17 Dec 2023
- Primary completion date
- 17 Jun 2024
- Lead sponsor
- Beni-Suef University
- NCT number
- NCT06105060
What you commit to
- Study type: Interventional · Early phase 1
- Participants enrolled: 175
- From 17 Dec 2023 to the primary completion date, 17 Jun 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior or planned bariatric surgery.
- Use of other drugs known to have possible positive effects on steatosis.
Other illness
- 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).
- 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.
- If there are any conditions where fibroscan could be contra-indicated. The patients refuse participating or completing study.
Lab values
- Uncontrolled diabetes defined as Hemoglobin A1c 9.5% or higher.
Other
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Tanta University Hospital Coordinator of this site? Confirm its status | Tanta | Egypt | Unknown status |
Related publications
- New Approach Combination-Dosed Therapy for Nonalcoholic Steatohepatitis Versus Vitamin E: A Randomized Controlled Trial.Clin Ther · 2025 · PMID 40480879
- A Comparative Study of N-Acetyl Cysteine, Rosuvastatin, and Vitamin E in the Management of Patients with Non-Alcoholic Steatohepatitis: A Randomized Controlled Trial.Pharmaceuticals (Basel) · 2025 · PMID 40430469
This page is information, not medical advice. Discuss any trial with your doctor.