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

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06863376

Enrollment

Registered

2025-03-07

Start date

2025-03-01

Completion date

2027-04-20

Last updated

2026-05-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-Alcoholic Fatty Liver Disease

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.

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Masking description

double blinded

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

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.

Design outcomes

Primary

Measure	Time frame	Description
The change in the degree of steatosis in the Ultra Sound	3 months	The change in the degree of steatosis in the Ultra Sound

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 5, 2026