Erdosteine in the Treatment of Nonalcoholic Fatty Liver Disease

NCT07242222 | Recruiting Phase 1

• 1 other identifier: 98467
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Fatty Liver

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Control group

ACTIVE COMPARATOR

25 patients received the standard conventional therapy in addition to placebo for 3 months.

Other: Standard Therapy

Erdosteine group

ACTIVE COMPARATOR

25 patients were given the standard conventional therapy plus erdostiene 300 mg two times daily.

Other: Standard Therapy; Drug: Erdosteine

Interventions

Standard Therapy OTHER

• 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).

Control group; Erdosteine group

Erdosteine DRUG

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

Erdosteine group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Tanta Unuversity

Tanta, 31527, Egypt

RECRUITING

MeSH Terms

Conditions

Fatty Liver

Interventions

Standard of Care; erdosteine

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Study Record Dates

• First Submitted: November 15, 2025
• First Posted: November 21, 2025
• Study Start: November 20, 2025
• Primary Completion (Estimated): November 20, 2026
• Study Completion (Estimated): November 20, 2026
• Last Updated: December 10, 2025

Record last verified: 2025-12

Locations

EG (1)