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NCT Number: NCT07242222

Erdosteine in the Treatment of Nonalcoholic Fatty Liver Disease

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

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Key information

Conditions

Fatty Liver Digestive System Diseases Liver Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Tanta Unuversity

Tanta, 31527, Egypt

Location status: Recruiting

Location contact

Mostafa M Bahaa, PhD

SUB_INVESTIGATOR

Mostafa M I Bahaa, PhD

CONTACT

[email protected]

0201025538337

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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).

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

Primary outcomes

  1. The change in the degree of steatosis in the ultrasound (US) is the primary endpoint.

    Time frame: 3 months

    The change in the degree of steatosis in the US is the primary endpoint.

  2. The change in fibrosis risk scores

    Time frame: 3 months

    According to the Brunt criteria, fibrosis is classified in stages from stage 0 to stage 4.

Sponsors and collaborators

Lead sponsor

Tanta University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Nov 21, 2025
Registry last updated
Dec 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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