Evaluating the Safety and Efficacy of Carbocisteine in the Treatment of Nonalcoholic Fatty Liver Disease Patients

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-65
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. NAFLD is characterized by lipid accumulation in the liver not attributed to other causes. Lifestyle interventions, including dietary modification and exercise, remain the cornerstone of NAFLD treatment. Pharmacological treatments aimed primarily at improving liver disease should generally be limited to those with biopsy-proven NASH and fibrosis.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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, autoimmune hepatitis.

patients suffering from chronic kidney disease, and hyper/hypoparathyroidism

Trial design

Design model

Parallel

Treatments tested in this trial

  • Carbocysteine 375 MG

    Drug

    Carbocysteine is a muco-active drug with free radical scavenging and anti-inflammatory properties. It is actually approved for clinical use as adjunctive therapy of respiratory tract disorders

  • Physical activity, walking, and calorie restriction

    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

Treatment groups

46 Participants
are divided into 2 treatment groups
Group A: Control groupActive comparator 1 intervention
Group B: Carbocistiene groupActive comparator 2 interventions

Trial outcomes

Primary outcomes

1

The change in the degree of steatosis in the Ultra Sound

The change in the degree of steatosis in the Ultra Sound

Time frame
3 months

Secondary outcomes

Other outcomes

Sponsors and contacts

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