Actively Recruiting

Phase 1
Phase 2
Age: 18Years - 60Years
All Genders
ID07242222

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

Age: 18Years - 60Years
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

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

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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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