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

Sponsor
Tanta University
Study ID
NCT06863376
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Non-Alcoholic Fatty Liver Disease

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • 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
    • 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

Study Details

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.

Key Dates

First listed
Mar 7, 2025
Start date
Mar 1, 2025
Status verified
May 2026
Primary completion
Mar 20, 2027
Completion
Apr 20, 2027

Study Design

Enrollment
46 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Control group
    Patients will receive the standard conventional therapy in addition to placebo for 3 months.
  • Active Comparator: Carbocistiene group
    Patients will be given the standard conventional therapy plus carbocistiene 375 mg two times daily.

Primary Outcome Measure

The change in the degree of steatosis in the Ultra Sound [ Time Frame: 3 months ]

Related Studies