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

Dow University of Health Sciences

Status: Not yet enrolling

Conditions: NAFLD

Treatments: Drug: NAC with diet and exercise; Behavioral: Diet and exercise

Study type: Interventional

Funder types: Other

Identifiers

NCT05576428

NAFLD-NAC

Details and patient eligibility

About

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.

Full 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 .

Enrollment: 100 estimated patients

Sex: All

Ages: 20 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

DIET& EXERCISE

Active Comparator group

Description:

diet plan \& daily 20 minutes brisk walking.

Treatment:

Behavioral: Diet and exercise

N Acetylcysteine WITH DIET & EXERCISE

Experimental group

Description:

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

Treatment:

Behavioral: Diet and exercise

Drug: NAC with diet and exercise