Efficacy of N-Acetylcysteine in Improving/Normalizing ALT... | NCT05576428

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

NCT05576428

Sponsor

Dow University of Health Sciences

Status

Unknown status

Last Update Posted

Oct 28, 2022Actual

Enrollment

100Estimated

Phase

Not Applicable

Conditions

NAFLD

Interventions

Diet and exercise
NAC with diet and exercise

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 1, 2022Estimated

Primary Completion Date

Apr 30, 2023Estimated

Completion Date

May 15, 2023Estimated

First Submitted Date

Oct 8, 2022

First Submission Date that Met QC Criteria

Oct 8, 2022

First Posted Date

Oct 12, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 26, 2022

Last Update Posted Date

Oct 28, 2022Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Tazeen Rasheed, Associate Professor, Dow University of Health SciencesPrincipal Investigator

Lead Sponsor

Dow University of Health SciencesOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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 .

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Diet and exercise	Behavioral	diet and exercise in patients of NAFLD	DIET& EXERCISE N Acetylcysteine WITH DIET & EXERCISE

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in Alanine transaminase,aspartate aminotransferase	Change in Alanine transaminase,aspartate aminotransferase	12 weeks

Secondary Outcomes

Measure	Description	Time Frame
Side Effects of NAC	Side Effects of NAC	12 weeks

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D065626	Non-alcoholic Fatty Liver Disease

Ancestor Terms

ID	Term
D005234	Fatty Liver
D008107	Liver Diseases
D004066	Digestive System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D004032	Diet
D015444	Exercise

Ancestor Terms

ID	Term
D009747	Nutritional Physiological Phenomena
D000066888	Diet, Food, and Nutrition
D010829	Physiological Phenomena
D009043	Motor Activity

Browse Leaves

Not provided

Browse Branches

Not provided