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

NCT ID: NCT05576428

Last Updated: 2022-10-28

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-11-01
• Study Completion Date: 2023-05-15

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 .

Conditions

NAFLD

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

DIET& EXERCISE

diet plan \& daily 20 minutes brisk walking.

Group Type: ACTIVE_COMPARATOR

Diet and exercise

Intervention Type: BEHAVIORAL

diet and exercise in patients of NAFLD

N Acetylcysteine WITH DIET & EXERCISE

NAC 200mg BD along with diet plan \& exercise.

Group Type: EXPERIMENTAL

Diet and exercise

Intervention Type: BEHAVIORAL

diet and exercise in patients of NAFLD

NAC with diet and exercise

Intervention Type: DRUG

NAC with diet and exercise in patients of NAFLD

Interventions

Diet and exercise

diet and exercise in patients of NAFLD

Intervention Type: BEHAVIORAL

NAC with diet and exercise

NAC with diet and exercise in patients of NAFLD

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Dow University of Health Sciences

OTHER

Sponsor Role: lead

Responsible Party

Tazeen Rasheed

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

NAFLD-NAC

Identifier Type: -

Identifier Source: org_study_id