Erdosteine in the Treatment of Nonalcoholic Fatty Liver Disease

ConditionFatty Liver

Trial statusRecruiting

Trial phasePhase 1, Phase 2

Trial typeInterventional

Biological sexAll

Age18-60

SponsorTanta University

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

Standard Therapy
Other intervention
• 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

Treatment groups

50 Participants

are divided into 2 treatment groups

Group A: Control groupActive comparator 1 intervention

Group B: Erdosteine groupActive comparator 2 interventions

Trial outcomes

Primary outcomes

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.

Time frame

3 months

The change in fibrosis risk scores

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

Time frame

3 months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Tanta University

Lead sponsor

Source ClinicalTrials.gov

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