Efficacy of N-Acetylcysteine in Improving/Normalizing ALT & AST in Patients of NAFLD

Currently researches are focusing on the effect of antioxidants in the treatment of non-alcoholic fatty liver disease (NAFLD). Since N-acetyl cysteine (NAC) has been proven to have antioxidant and anti-inflammatory properties, therefore, we will conduct this study to determine the effect of NAC in patients of NAFLD with raised liver enzymes.

Study Overview

• Status: Not yet recruiting
• Conditions: NAFLD
• Intervention / Treatment: Behavioral: Diet and exercise; Drug: NAC with diet and exercise

Detailed Description

The prevalence of non-alcoholic fatty liver disease (NAFLD) is increasing globally, and presents a challenge for the medical community since it has no FDA approved treatment. An important feature of non-alcoholic fatty liver disease (NAFLD) is hepatic steatosis leading to hepatic dysfunction . It has been reported that NAFLD patients with increased liver enzymes have a greater risk of developing complications like cirrhosis and end-stage liver disease. since N-acetyl cysteine (NAC) has been proven to have antioxidant and anti-inflammatory properties, therefore, we will conduct this study to determine the effect of NAC in patients of NAFLD with raised liver enzymes (ALT, AST). Patients presenting with ultrasound showing fatty liver with raised liver enzymes will be recruited. They will be randomized into two groups (group A and group B).

The odd number patients will be allocated group A and even number patients will be allocated to group B.

Group A: patients in this group will be advised to follow a diet plan & daily 20 minutes brisk walking.

Group B: Patients in this group will be given NAC 200mg BD along with diet plan & exercise. This drug will be provided to the patients by the investigators free of cost.

The liver function tests and side effects of NAC will be followed at 12 weeks .

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 56 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: DIET& EXERCISE; diet plan & daily 20 minutes brisk walking.	Behavioral: Diet and exercise; diet and exercise in patients of NAFLD
Experimental: N Acetylcysteine WITH DIET & EXERCISE; NAC 200mg BD along with diet plan & exercise.	Behavioral: Diet and exercise; diet and exercise in patients of NAFLD; Drug: NAC with diet and exercise; NAC with diet and exercise in patients of NAFLD

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Alanine transaminase,aspartate aminotransferase	Change in Alanine transaminase,aspartate aminotransferase	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Side Effects of NAC	Side Effects of NAC	12 weeks

Collaborators and Investigators

• Sponsor: Dow University of Health Sciences

Study record dates

Study Major Dates

• Study Start (Anticipated): November 1, 2022
• Primary Completion (Anticipated): April 30, 2023
• Study Completion (Anticipated): May 15, 2023

Study Registration Dates

• First Submitted: October 8, 2022
• First Submitted That Met QC Criteria: October 8, 2022
• First Posted (Actual): October 12, 2022

Study Record Updates

• Last Update Posted (Actual): October 28, 2022
• Last Update Submitted That Met QC Criteria: October 26, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease
• Other Study ID Numbers: NAFLD-NAC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• 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