Erdosteine in the Treatment of Nonalcoholic Fatty Liver Disease

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1/PHASE2

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-11-20

Study Completion Date

2026-11-20

Brief Summary

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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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Detailed Description

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Conditions

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Fatty Liver

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Control group

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

Group Type ACTIVE_COMPARATOR

Standard Therapy

Intervention Type 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 group

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

Group Type ACTIVE_COMPARATOR

Standard Therapy

Intervention Type 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

Intervention Type 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

Interventions

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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).

Intervention Type OTHER

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

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No