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

NCT ID: NCT06863376

Last Updated: 2025-03-18

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 46 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-01
• Study Completion Date: 2026-04-20

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.

Conditions

Non-Alcoholic Fatty Liver Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Control group

Patients will receive the standard conventional therapy in addition to placebo for 3 months.

Group Type: ACTIVE_COMPARATOR

Physical activity, walking, and calorie restriction

Intervention Type: 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

Carbocistiene group

Patients will be given the standard conventional therapy plus carbocistiene 375 mg two times daily.

Group Type: ACTIVE_COMPARATOR

Carbocysteine 375 MG

Intervention Type: 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

Intervention Type: 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

Interventions

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

Intervention Type: DRUG

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

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tanta University

OTHER

Sponsor Role: lead

Responsible Party

Mostafa Bahaa

Lecturer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Tanta Unuversity

Tanta, , Egypt

Site Status: RECRUITING

Countries

Egypt

Facility Contacts

Mostafa M I Bahaa, PhD

Role: primary

mbahaa@horus.edu.eg

0201025538337

Other Identifiers

1478

Identifier Type: -

Identifier Source: org_study_id