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Clinical Effects of New Approach on Patients With Non-alcoholic Steatohepatitis

NCT06105060 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 175

Last updated 2025-02-06

No results posted yet for this study

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 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.

Conditions

  • Non-alcoholic Steatohepatitis

Interventions

DRUG

Rosuvastatin 20mg

to evaluate and compare the protective outcomes of using Rosuvastatin, Vitamin E, and N-acetyl cysteine in Egyptian patients with NASH.

Sponsors & Collaborators

  • Beni-Suef University

    lead OTHER

Principal Investigators

  • Asmaa Mohammed Hussein, Assis.Prof · Beni-Suef University

  • Mona Ahmed Emam, Lecturer · Beni-Suef University

  • Hasnaa Osama Hamed, Lecturer · Beni-Suef University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-12-17
Primary Completion
2024-06-17
Completion
2024-06-27

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06105060 on ClinicalTrials.gov