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

NCT05576428 | Unknown

• 1 other identifier: NAFLD-NAC
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

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.

Conditions

NAFLD

Outcome Measures

Primary Outcomes (1)

• Change in Alanine transaminase,aspartate aminotransferase

  Change in Alanine transaminase,aspartate aminotransferase

  12 weeks

Secondary Outcomes (1)

• Side Effects of NAC

  12 weeks

Study Arms (2)

DIET& EXERCISE

ACTIVE COMPARATOR

diet plan \& daily 20 minutes brisk walking.

Behavioral: Diet and exercise

N Acetylcysteine WITH DIET & EXERCISE

EXPERIMENTAL

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

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

Interventions

Diet and exercise BEHAVIORAL

diet and exercise in patients of NAFLD

DIET& EXERCISE; N Acetylcysteine WITH DIET & EXERCISE

NAC with diet and exercise DRUG

NAC with diet and exercise in patients of NAFLD

N Acetylcysteine WITH DIET & EXERCISE

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Dow University of Health Sciences: lead

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Interventions

Diet; Exercise

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: October 8, 2022
• First Posted: October 12, 2022
• Study Start: November 1, 2022
• Primary Completion: April 30, 2023
• Study Completion: May 15, 2023
• Last Updated: October 28, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share