Actively Recruiting
Evaluating the Safety and Efficacy of Erdosteine in the Treatment of Nonalcoholic Fatty Liver Disease Patients
Led by Tanta University · Updated on 2025-12-10
50
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Nonalcoholic fatty liver disease (NAFLD) is a major cause of chronic liver disease worldwide, especially in developed countries. It involves fat buildup in the liver not caused by alcohol, viruses, drugs, or autoimmune conditions. This trial evaluates the safety and effectiveness of erdosteine, a drug with antioxidant and anti-inflammatory effects, in treating NAFLD patients. Participants will be randomly assigned to one of two groups: one group receives standard conventional therapy plus a placebo, and the other receives standard therapy plus erdosteine 300 mg twice daily for three months. Standard therapy includes regular physical activity such as walking or cycling for 30-45 minutes at least five days a week, along with calorie restriction tailored for men and women based on weight. During the study, participants will be monitored over three months with ultrasounds to assess changes in liver fat accumulation and fibrosis risk scores. Researchers will track these primary outcomes to understand the impact of treatments. The trial includes adults aged 18 to 60 and involves double-blind procedures to ensure unbiased results.
CONDITIONS
Brief Title
Erdosteine in the Treatment of Nonalcoholic Fatty Liver Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult men or women over 18 years old
- Diagnosed with fatty liver disease by upper abdominal ultrasound
- Able to participate in regular physical activity and calorie restriction as part of standard therapy
You will not qualify if you...
- Pregnant or lactating women
- Excessive alcohol consumption (over 30 g/day for men, over 20 g/day for women)
- Other chronic liver diseases such as viral hepatitis, drug-induced hepatitis, or autoimmune hepatitis
- Chronic kidney disease
- Hyperparathyroidism or hypoparathyroidism
- Known hypersensitivity to erdosteine medication
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 3 months
Participants receive either the standard conventional therapy with placebo or the standard conventional therapy plus erdosteine medication.
Regular visits during the 3 months of treatment
Trial Site Locations
Total: 1 location
1
Tanta Unuversity
Tanta, Egypt, 31527
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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