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

NCT06863376 | Recruiting Phase 2

• 1 other identifier: 1478
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

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

Outcome Measures

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

  3 months

Study Arms (2)

Control group

ACTIVE COMPARATOR

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

Other: Physical activity, walking, and calorie restriction

Carbocistiene group

ACTIVE COMPARATOR

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

Drug: Carbocysteine 375 MG; Other: Physical activity, walking, and calorie restriction

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

Carbocistiene group

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

Carbocistiene group; Control group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Tanta Unuversity

Tanta, 31527, Egypt

RECRUITING

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Interventions

Carbocysteine; Exercise; Walking

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Cysteine; Amino Acids, Sulfur; Sulfur Compounds; Organic Chemicals; Amino Acids, Dicarboxylic; Amino Acids; Amino Acids, Peptides, and Proteins; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Locomotion

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: double blinded
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Study Record Dates

• First Submitted: March 1, 2025
• First Posted: March 7, 2025
• Study Start: March 1, 2025
• Primary Completion (Estimated): March 20, 2027
• Study Completion (Estimated): April 20, 2027
• Last Updated: May 4, 2026

Record last verified: 2026-05

Locations

EG (1)