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

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.

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Key information

Conditions

Non-Alcoholic Fatty Liver Disease Digestive System Diseases Fatty Liver Liver Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Tanta Unuversity

Tanta, 31527, Egypt

Location status: Recruiting

Location contact

Mostafa M Bahaa, PhD

SUB_INVESTIGATOR

Mostafa M I Bahaa, PhD

CONTACT

[email protected]

0201025538337

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

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

Primary outcomes

The change in the degree of steatosis in the Ultra Sound

Time frame: 3 months

The change in the degree of steatosis in the Ultra Sound

Sponsors and collaborators

Lead sponsor

Tanta University

Other

Registry information

Important dates

Study start: 2025
Primary completion: 2027
Study completion: 2027
First posted: Mar 7, 2025
Registry last updated: May 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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