RecruitingPhase 1Phase 2NCT07242222

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


Sponsor

Tanta University

Enrollment

50 participants

Start Date

Nov 20, 2025

Study Type

INTERVENTIONAL

Conditions

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


Eligibility

Min Age: 18 YearsMax Age: 60 Years

Inclusion Criteria1

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

Exclusion Criteria3

  • 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.

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Interventions

OTHERStandard 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).

DRUGErdosteine

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


Locations(1)

Tanta Unuversity

Tanta, Egypt

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NCT07242222


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