Completed

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

What is being tested

Rosuvastatin 20mg

Drug

Who is being recruted

Digestive System Diseases+1

+ Fatty Liver

+ Liver Diseases

Over 18 Years

+13 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Placebo-ControlledEarly Phase 1

Interventional

Study Start: December 2023

See protocol details

Summary

Principal SponsorBeni-Suef University

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: December 17, 2023

Actual date on which the first participant was enrolled.

This clinical trial is exploring new treatment options for a liver condition called non-alcoholic steatohepatitis (NASH), which is a severe form of non-alcoholic fatty liver disease (NAFLD). NAFLD occurs when too much fat builds up in the liver without the influence of heavy alcohol use, often linked to obesity and type 2 diabetes. There are currently no approved medications for NASH, which can lead to serious complications like liver cirrhosis or cancer. The study is testing the effects of three different treatments: Rosuvastatin, Vitamin E, and N-Acetyl Cysteine (NAC). These substances are being investigated for their potential to reduce liver inflammation and damage by lowering cholesterol and combating oxidative stress. Participants in this trial receive one or more of the treatments being studied. Rosuvastatin is a statin medication taken orally, known to lower cholesterol levels. Vitamin E is a powerful antioxidant recommended for liver health, and N-Acetyl Cysteine is known to reduce oxidative stress and inflammation. The trial assesses how these treatments impact the liver and whether they can reduce the symptoms of NASH, such as liver fibrosis and inflammation. The study aims to find a well-tolerated and effective therapy for this condition, potentially leading to improved health outcomes for patients with NASH.

Official TitleClinical and Biochemical Study of the Effects of Rosuvastatin, Vitamin E, and N-Acetyl Cysteine on Patients With Non-alcoholic Steatohepatitis: a Randomized Controlled Trial

NCT06105060

Principal SponsorBeni-Suef University

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

175 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Digestive System DiseasesFatty LiverLiver DiseasesNon-alcoholic Fatty Liver Disease

Criteria

4 inclusion criteria required to participate

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.

9 exclusion criteria prevent from participating

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.

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

4 intervention groups are designated in this study

25% chance of being blinded to the placebo group

Treatment Groups

Group I

Active Comparator

40 patients will receive Crestor (Rosuvastatin 20mg/day orally for 6 months).

Group II

Active Comparator

40 patients will receive high dose of NATURAL TRUTH'S NAC cap 2400 mg /day for 6 months.

Group III

Active Comparator

40 patients will receive "NAC dose 2400 mg" and "Rosuvastatin 20mg /day" for 6 months.

Group IV

Placebo

40 patients will receive Vitamin E 400 mg twice daily for 6 months.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Tanta university hospital

Tanta, EgyptOpen Tanta university hospital in Google Maps

CompletedOne Study Center