RecruitingPhase 2NCT06863376

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

Sponsor

Tanta University

Enrollment

46 participants

Start Date

Mar 1, 2025

Study Type

INTERVENTIONAL

Conditions

Non-Alcoholic Fatty Liver Disease

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.

Eligibility

Min Age: 18 YearsMax Age: 65 Years

Inclusion Criteria1

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

Exclusion Criteria5

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.

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Interventions

DRUGCarbocysteine 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

OTHERPhysical 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