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RecruitingNCT06863376Updated May 4, 2026

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

A Phase 2 interventional study of Carbocysteine 375 MG and Physical activity, walking, and calorie restriction in Non-Alcoholic Fatty Liver Disease, sponsored by Tanta University. Recruiting at 1 site in Egypt. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-05-04.

Sponsored by Tanta University · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Started Mar 2025; still recruiting 1 year 7 months later.
Phase
Phase 2
Study type
Interventional
Enrollment
46
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Non-Alcoholic Fatty Liver Disease
03

In context

Non-alcoholic Fatty Liver Disease

1,474 studies on the registry are indexed under Non-alcoholic Fatty Liver Disease; 303 are open to participants now.

This study's planned enrollment of 46 is below the median of 60 across 1,072 interventional studies indexed under Non-alcoholic Fatty Liver Disease.

Browse Non-alcoholic Fatty Liver Disease studies →

Lead sponsor

Tanta University is the lead sponsor of 963 studies on the registry; 304 are open to participants now.

Of its 16 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
46 participants (estimated)

Study arms

  • Active comparator
    Control group

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

    Other: Physical activity, walking, and calorie restriction

  • Active comparator
    Carbocistiene group

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

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

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

06

What researchers measure

Primary outcomes

  1. The change in the degree of steatosis in the Ultra Sound

    The change in the degree of steatosis in the Ultra Sound

    Time frame: 3 months

07

Study locations

1 of 1 sites recruiting
  • Tanta Unuversity
    Tanta, 31527, Egypt
    • Mostafa M I Bahaa, PhD · Contact · mbahaa@horus.edu.eg · 0201025538337
    • Mostafa M Bahaa, PhD · Sub investigator
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 4, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06863376
Lead sponsor
Tanta University
Responsible party
Mostafa Bahaa (Lecturer, Tanta University) — Principal investigator
First posted
Mar 7, 2025
Start date
Mar 1, 2025
Primary completion
Mar 20, 2027 (estimated)
Completion
Apr 20, 2027 (estimated)
Last update
May 4, 2026

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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