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

Primary Purpose

NAFLD

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Diet and exercise
NAC with diet and exercise
Sponsored by
Dow University of Health Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for NAFLD

Eligibility Criteria

20 Years - 60 Years (Adult)All SexesDoes not accept 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Experimental

    Arm Label

    DIET& EXERCISE

    N Acetylcysteine WITH DIET & EXERCISE

    Arm Description

    diet plan & daily 20 minutes brisk walking.

    NAC 200mg BD along with diet plan & exercise.

    Outcomes

    Primary Outcome Measures

    Change in Alanine transaminase,aspartate aminotransferase
    Change in Alanine transaminase,aspartate aminotransferase

    Secondary Outcome Measures

    Side Effects of NAC
    Side Effects of NAC

    Full Information

    First Posted
    October 8, 2022
    Last Updated
    October 26, 2022
    Sponsor
    Dow University of Health Sciences
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05576428
    Brief Title
    Efficacy of N-Acetylcysteine in Improving/Normalizing ALT & AST in Patients of NAFLD
    Official Title
    Efficacy of N-Acetylcysteine in Improving/Normalizing ALT & AST in Patients of NAFLD
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    November 1, 2022 (Anticipated)
    Primary Completion Date
    April 30, 2023 (Anticipated)
    Study Completion Date
    May 15, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Dow University of Health Sciences

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    No

    5. Study Description

    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 .

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    NAFLD

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    100 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    DIET& EXERCISE
    Arm Type
    Active Comparator
    Arm Description
    diet plan & daily 20 minutes brisk walking.
    Arm Title
    N Acetylcysteine WITH DIET & EXERCISE
    Arm Type
    Experimental
    Arm Description
    NAC 200mg BD along with diet plan & exercise.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Diet and exercise
    Intervention Description
    diet and exercise in patients of NAFLD
    Intervention Type
    Drug
    Intervention Name(s)
    NAC with diet and exercise
    Intervention Description
    NAC with diet and exercise in patients of NAFLD
    Primary Outcome Measure Information:
    Title
    Change in Alanine transaminase,aspartate aminotransferase
    Description
    Change in Alanine transaminase,aspartate aminotransferase
    Time Frame
    12 weeks
    Secondary Outcome Measure Information:
    Title
    Side Effects of NAC
    Description
    Side Effects of NAC
    Time Frame
    12 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    No
    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

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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

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