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

Study Overview
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Brief Summary
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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
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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 .

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

Conditions
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NAFLD

Intervention / Treatment
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* Behavioral: Diet and exercise
* Drug: NAC with diet and exercise


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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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 |