Back to resultsN-acetyl Cysteine and Patients With Non-alcoholic Fatty Liver Disease
Primary Purpose
Simple Steatosis Non Fatty Liver
Status
Recruiting
Phase
Phase 3
Locations
Egypt
Study Type
Interventional
Intervention
N acetyl cysteine with weight reduction
Sponsored by
About this trial
This is an interventional treatment trial for Simple Steatosis Non Fatty Liver
Eligibility Criteria
Inclusion Criteria:
- Males or females aged 18-60 years diagnosed with NAFLD
Exclusion Criteria:
- History of alcohol consumption, drug addiction or the use of medications known to precipitate steatohepatitis.
- Patients with schistosomiasis, active hepatitis B or C, autoimmune and metabolic diseases.
- current Consumption of any antioxidant supplements and hepatotoxic drug.
- Pregnancy or lactation or expecting to get pregnant during the study.
- Medical, psychological, or pharmacological factors interfering with the collection or interpretation of study data.
- Active Cancer patients.
- Anyone having hypersensitivity to N-acetylcysteine.
- Anyone already taking N-acetylcysteine.
Sites / Locations
- NHTMRIRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
intervention
control
Arm Description
NAC and weight reduction program
weight reduction program only
Outcomes
Primary Outcome Measures
assessment of the effect of NAC on leptin
leptin as insulin resistance marker in NAFLD
Secondary Outcome Measures
assessment of the effect of NAC on MDA
MDA as oxidative stress marker in NAFLD
Full Information
NCT ID
NCT05589584
First Posted
October 18, 2022
Last Updated
October 18, 2022
Sponsor
Ain Shams University
1. Study Identification
Unique Protocol Identification Number
NCT05589584
Brief Title
N-acetyl Cysteine and Patients With Non-alcoholic Fatty Liver Disease
Official Title
Effect of N-acetyl Cysteine on Markers of Oxidative Stress and Insulin Resistance in Patients With Non-alcoholic Fatty Liver Disease
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 2022 (Anticipated)
Primary Completion Date
March 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
5. Study Description
Brief Summary
Effect of N-acetyl cysteine on markers of oxidative stress and insulin resistance in patients with Non-alcoholic fatty liver disease
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Simple Steatosis Non Fatty Liver
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
intervention
Arm Type
Experimental
Arm Description
NAC and weight reduction program
Arm Title
control
Arm Type
No Intervention
Arm Description
weight reduction program only
Intervention Type
Drug
Intervention Name(s)
N acetyl cysteine with weight reduction
Intervention Description
high dose 2400mg/day
Primary Outcome Measure Information:
Title
assessment of the effect of NAC on leptin
Description
leptin as insulin resistance marker in NAFLD
Time Frame
3 months
Secondary Outcome Measure Information:
Title
assessment of the effect of NAC on MDA
Description
MDA as oxidative stress marker in NAFLD
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Males or females aged 18-60 years diagnosed with NAFLD
Exclusion Criteria:
History of alcohol consumption, drug addiction or the use of medications known to precipitate steatohepatitis.
Patients with schistosomiasis, active hepatitis B or C, autoimmune and metabolic diseases.
current Consumption of any antioxidant supplements and hepatotoxic drug.
Pregnancy or lactation or expecting to get pregnant during the study.
Medical, psychological, or pharmacological factors interfering with the collection or interpretation of study data.
Active Cancer patients.
Anyone having hypersensitivity to N-acetylcysteine.
Anyone already taking N-acetylcysteine.
Facility Information:
Facility Name
NHTMRI
City
Cairo
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Asmaa Ramadan
Phone
01111091159
Email
asmaa.kotb@pharma.asu.edu.eg
12. IPD Sharing Statement
Learn more about this trial
N-acetyl Cysteine and Patients With Non-alcoholic Fatty Liver Disease
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