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

Not Applicable

Not yet recruiting

• Conditions: NAFLD
• Interventions: Behavioral: Diet and exercise; Drug: NAC with diet and exercise

• Registration Number: NCT05576428
• Lead Sponsor: Dow University of Health Sciences

Brief Summary

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.

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 Timeline

• Status Verified: 2022-10
• Study First Submitted: 2022-10-08
• Study First Submitted QC: 2022-10-08
• Study First Posted: 2022-10-12
• Last Update Submitted: 2022-10-26
• Last Update Posted: 2022-10-28
• Study Start: 2022-11-01
• Primary Completion: 2023-04-30
• Study Completion: 2023-05-15

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
DIET& EXERCISE	Diet and exercise	diet plan \& daily 20 minutes brisk walking.
N Acetylcysteine WITH DIET & EXERCISE	Diet and exercise	NAC 200mg BD along with diet plan \& exercise.
N Acetylcysteine WITH DIET & EXERCISE	NAC with diet and exercise	NAC 200mg BD along with diet plan \& exercise.

Primary Outcome Measures

Name	Time	Method
Change in Alanine transaminase,aspartate aminotransferase	12 weeks	Change in Alanine transaminase,aspartate aminotransferase

Secondary Outcome Measures

Name	Time	Method
Side Effects of NAC	12 weeks	Side Effects of NAC