N-Acetylcysteine Impact on Liver Enzymes in NAFLD Patients
Diet and exercise
+ NAC with diet and exercise
Digestive System Diseases+1
+ Fatty Liver
+ Liver Diseases
Treatment Study
Summary
Study start date: November 1, 2022
Actual date on which the first participant was enrolled.Non-alcoholic fatty liver disease (NAFLD) is a common condition that affects many people worldwide. It's characterized by fat build-up in the liver, which can lead to liver dysfunction. Currently, there's no approved treatment for NAFLD, and those with increased liver enzymes are at a higher risk of developing serious complications like cirrhosis and end-stage liver disease. This study aims to explore the potential benefits of a drug called N-acetyl cysteine (NAC) in improving liver function in NAFLD patients with raised liver enzymes (ALT and AST). The study focuses on adults with NAFLD, as confirmed by an ultrasound, and elevated liver enzymes. Participants in this study will be divided into two groups. The first group will follow a diet plan and engage in daily brisk walking for 20 minutes. The second group will receive NAC (200mg twice daily) in addition to following the same diet plan and exercise routine. The drug will be provided to the participants at no cost. Over 12 weeks, researchers will monitor liver function tests and any potential side effects of NAC. The primary goal is to evaluate if NAC can lead to a positive change in liver enzymes (ALT and AST) compared to diet and exercise alone.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.100 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 20 to 60 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Inclusion Criteria: * • Patients of both genders between the ages of 20 years and 60 years, giving consent to be included in the study. * Patients having fatty liver on ultrasound with raised ALT and AST levels Exclusion Criteria: * • Patients having other causes of steatosis eg, excessive alcohol consumption, * Patients taking steatogenic medications such as, methotrexate , corticosteroids etc. * Patients suffering from other diseases that could increase ALT levels eg. Viral hepatitis, HIV, autoimmune liver diseases, infiltrative liver diseases. * Patients suffering from malignancies. * Patients who are not compliant to the medicine. * Pregnant and nursing females
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
Active ComparatorGroup II
ExperimentalStudy Objectives
Primary Objectives
Secondary Objectives