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

Phase 2

Recruiting

• Conditions: Non-Alcoholic Fatty Liver Disease
• Interventions: Other: Physical activity, walking, and calorie restriction; Drug: Carbocysteine 375 MG

• Registration Number: NCT06863376
• Lead Sponsor: Tanta University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-03
• Study Start: 2025-03-01
• Study First Submitted: 2025-03-01
• Study First Submitted QC: 2025-03-05
• Study First Posted: 2025-03-07
• Last Update Submitted: 2025-03-16
• Last Update Posted: 2025-03-18
• Primary Completion: 2026-03-20
• Study Completion: 2026-04-20

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 46

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	Physical activity, walking, and calorie restriction	Patients will receive the standard conventional therapy in addition to placebo for 3 months.
Carbocistiene group	Carbocysteine 375 MG	Patients will be given the standard conventional therapy plus carbocistiene 375 mg two times daily.
Carbocistiene group	Physical activity, walking, and calorie restriction	Patients will be given the standard conventional therapy plus carbocistiene 375 mg two times daily.

Primary Outcome Measures

Name	Time	Method
The change in the degree of steatosis in the Ultra Sound	3 months	The change in the degree of steatosis in the Ultra Sound

Trial Locations

Locations (1)

Tanta Unuversity; 🇪🇬 Tanta, Egypt