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

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.

Study Overview

• Status: Recruiting
• Conditions: Non-Alcoholic Fatty Liver Disease
• Intervention / Treatment: Other: Physical activity, walking, and calorie restriction; Drug: Carbocysteine 375 MG

• Study Type: Interventional
• Enrollment (Estimated): 46
• Phase: Phase 2

Contacts and Locations

Study Locations

• Egypt
  • Tanta, Egypt, 31527
    • Recruiting
    • Tanta Unuversity
    • Sub-Investigator: Mostafa M Bahaa, PhD
    • Contact: Mostafa M I Bahaa, PhD; Phone Number: 0201025538337; Email: mbahaa@horus.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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
• Hypersensitivity to carbocistiene.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control group; Patients will receive the standard conventional therapy in addition to placebo for 3 months.	Other: Physical activity, walking, and calorie restriction; • 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
Active Comparator: Carbocistiene group; Patients will be given the standard conventional therapy plus carbocistiene 375 mg two times daily.	Other: Physical activity, walking, and calorie restriction; • 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; Drug: Carbocysteine 375 MG; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The change in the degree of steatosis in the Ultra Sound	The change in the degree of steatosis in the Ultra Sound	3 months

Collaborators and Investigators

• Sponsor: Tanta University

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2025
• Primary Completion (Estimated): March 20, 2027
• Study Completion (Estimated): April 20, 2027

Study Registration Dates

• First Submitted: March 1, 2025
• First Submitted That Met QC Criteria: March 5, 2025
• First Posted (Actual): March 7, 2025

Study Record Updates

• Last Update Posted (Actual): May 4, 2026
• Last Update Submitted That Met QC Criteria: May 1, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease; Amino Acids, Peptides, and Proteins; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Sulfur Compounds; Organic Chemicals; Amino Acids; Amino Acids, Dicarboxylic; Cysteine; Amino Acids, Sulfur; Locomotion; Carbocysteine; Exercise; Walking
• Other Study ID Numbers: 1478

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No