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

NAFLD Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05576428
• Other study ID #: NAFLD-NAC
• Status: Not yet recruiting
• Phase: N/A
• Start date: November 1, 2022
• Est. completion date: May 15, 2023

Study information

• Verified date: October 2022
• Source: Dow University of Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 .

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: May 15, 2023
• Est. primary completion date: April 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• NAFLD
• Non-alcoholic Fatty Liver Disease

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Dow University of Health Sciences

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Alanine transaminase,aspartate aminotransferase	Change in Alanine transaminase,aspartate aminotransferase	12 weeks
Secondary	Side Effects of NAC	Side Effects of NAC	12 weeks