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Recruiting NCT06863376

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

Phase II Interventional Non-Alcoholic Fatty Liver Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Carbocysteine 375 MG, Physical activity, walking, and calorie restriction.
Who it may be relevant to
Registry conditions: Non-Alcoholic Fatty Liver Disease. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Egypt
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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

  • Drug Carbocysteine 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
  • Other Physical 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

Primary outcome measures

  • The change in the degree of steatosis in the Ultra Sound [Time frame: 3 months]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

Egypt · 1 center
  • Tanta Unuversity — Tanta

Identifiers

NCT: NCT06863376 · 1478

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗