Erdosteine in the Treatment of Nonalcoholic Fatty Liver Disease

Evaluating the Safety and Efficacy of Erdosteine in the Treatment of Nonalcoholic Fatty Liver Disease Patients

Nonalcoholic fatty liver disease (NAFLD) is a global public health concern, and the leading cause of chronic liver disease, especially in developed countries (1). NAFLD is characterized by lipid accumulation in the liver not attributed to other causes. NAFLD is characterized by excessive hepatic fat accumulation without other recognized causes of increased fat content (e.g., alcohol, virus, drugs, and autoimmunity). According to the Clinical Practice Guidelines of the European Association for the Study of the Liver, the diagnosis of NAFLD requires the exclusion of daily alcohol consumption >30 g for men and >20 g for women

Study Overview

• Status: Recruiting
• Conditions: Fatty Liver
• Intervention / Treatment: Other: Standard Therapy; Drug: Erdosteine

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• Egypt
  • Tanta, Egypt, 31527
    • Recruiting
    • Tanta Unuversity
    • Sub-Investigator: Mostafa M Bahaa, PhD
    • Contact: Mostafa M I Bahaa, PhD; Phone Number: 0201025538337; Email: mbahaa@horus.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

Either male or female adult patients (>18 years) with fatty liver diagnosis by using upper abdominal ultrasound echography (US).

Exclusion Criteria:

Pregnant and/or lactating women, excessive alcohol use (defined as an average alcohol intake > 30 g per day in men and > 20 g per day in women).

Other etiology of chronic liver diseases such as viral hepatitis, drug-induced hepatitis, and autoimmune hepatitis.

Patients suffering from chronic kidney disease, hyper/hypoparathyroidism. Hypersensitivity to erdostiene.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control group; 25 patients received the standard conventional therapy in addition to placebo for 3 months.	Other: Standard Therapy; • The standard conventional therapy in both groups included regular exercise in the form of any physical activity as walking, cycling, etc. for 30-45 minutes minimum 5 days per week in addition to calorie restriction in overweight and obese patients (1200-1500 and 1000-1200 kcal/day for men and women, respectively).
Active Comparator: Erdosteine group; 25 patients were given the standard conventional therapy plus erdostiene 300 mg two times daily.	Other: Standard Therapy; • The standard conventional therapy in both groups included regular exercise in the form of any physical activity as walking, cycling, etc. for 30-45 minutes minimum 5 days per week in addition to calorie restriction in overweight and obese patients (1200-1500 and 1000-1200 kcal/day for men and women, respectively).; Drug: Erdosteine; Erdosteine is an oral mucoactive agent with antioxidant and anti-inflammatory properties that also reduces bacterial adhesiveness and enhances the effects of antibiotic therapy, all of these properties may be useful for the prevention and treatment of COPD exacerbations

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The change in the degree of steatosis in the ultrasound (US) is the primary endpoint.	The change in the degree of steatosis in the US is the primary endpoint.	3 months
The change in fibrosis risk scores	According to the Brunt criteria, fibrosis is classified in stages from stage 0 to stage 4.	3 months

Collaborators and Investigators

• Sponsor: Tanta University

Study record dates

Study Major Dates

• Study Start (Actual): November 20, 2025
• Primary Completion (Estimated): November 20, 2026
• Study Completion (Estimated): November 20, 2026

Study Registration Dates

• First Submitted: November 15, 2025
• First Submitted That Met QC Criteria: November 20, 2025
• First Posted (Estimated): November 21, 2025

Study Record Updates

• Last Update Posted (Actual): December 10, 2025
• Last Update Submitted That Met QC Criteria: December 3, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Diseases; Fatty Liver; Health Services Administration; Health Care Quality, Access, and Evaluation; Quality of Health Care; Quality Indicators, Health Care; Standard of Care; erdosteine
• Other Study ID Numbers: 98467

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No