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

Tanta University

Status and phase: Enrolling; Phase 2

Conditions: Non-Alcoholic Fatty Liver Disease

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

Study type: Interventional

Funder types: Other

Identifiers

NCT06863376

1478

Details and patient eligibility

About

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.

Enrollment: 46 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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46 participants in 2 patient groups

Control group

Active Comparator group

Description:

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

Treatment:

Other: Physical activity, walking, and calorie restriction

Carbocistiene group

Active Comparator group

Description:

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

Treatment:

Other: Physical activity, walking, and calorie restriction

Drug: Carbocysteine 375 MG