NAFLDNCT05576428
Efficacy of N-Acetylcysteine in Improving/Normalizing ALT & AST in Patients of NAFLD
A study testing Diet and exercise and NAC with diet and exercise in people with NAFLD, run by Dow University of Health Sciences.
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… Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- NAFLD
- What is being tested?
- Diet and exercise and NAC with diet and exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2022to 15 May 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- • 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
Who cannot join
- • 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
About this study
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.
Read the 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 .
- Conditions
- NAFLD
- Being tested
- Diet and exercise, NAC with diet and exercise
- Medical subject headings
- Non-alcoholic Fatty Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diet and exerciseBehavioural
diet and exercise in patients of NAFLD
NAC with diet and exerciseDrug
NAC with diet and exercise in patients of NAFLD
| Study group | Role | What they receive |
|---|---|---|
| DIET& EXERCISE | Active comparator | diet plan \& daily 20 minutes brisk walking. Receives: Behavioral: Diet and exercise |
| N Acetylcysteine WITH DIET & EXERCISE | Experimental | NAC 200mg BD along with diet plan \& exercise. Receives: Behavioral: Diet and exercise; Drug: NAC with diet and exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Alanine transaminase,aspartate aminotransferase
Change in Alanine transaminase,aspartate aminotransferase
Measured: 12 weeks
Secondary outcomes (1)
Side Effects of NAC
Side Effects of NAC
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2022
- Study start1 Nov 2022 (estimated)
- Primary completion30 Apr 2023 (estimated)
- Study completion15 May 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NAFLDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dow University of Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tazeen Rasheed, Dow University of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05576428
- Sponsor's protocol ID
- NAFLD-NAC
- Status last verified
- Oct 2022
- First submitted
- 8 Oct 2022
- Last updated
- 28 Oct 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of N-Acetylcysteine in Improving/Normalizing ALT & AST in Patients of NAFLD
- ClinicalTrials.gov ID
- NCT05576428
- Acronym / sponsor ID
- NAFLD-NAC
- Conditions
- NAFLD
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Dow University of Health SciencesUniversity, hospital or other
- Study start
- 1 Nov 2022 (estimated)
- Primary completion
- 30 Apr 2023 (estimated)
- Study completion
- 15 May 2023 (estimated)
- First posted
- 12 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DIET& EXERCISE | Active comparator | Behavioral: Diet and exercisediet plan \& daily 20 minutes brisk walking. |
| N Acetylcysteine WITH DIET & EXERCISE | Experimental | Behavioral: Diet and exercise, Drug: NAC with diet and exerciseNAC 200mg BD along with diet plan \& exercise. |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- • Patients of both genders between the ages of 20 years and 60 years, giving consent to be included in the study.
Key exclusion criteria (6 listed)
- • Patients having other causes of steatosis eg, excessive alcohol consumption,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diet and exercisediet and exercise in patients of NAFLD | Behavioural | DIET& EXERCISE, N Acetylcysteine WITH DIET & EXERCISE |
| NAC with diet and exerciseNAC with diet and exercise in patients of NAFLD | Drug | N Acetylcysteine WITH DIET & EXERCISE |
Primary outcome
Change in Alanine transaminase,aspartate aminotransferase
Time frame: 12 weeks
Change in Alanine transaminase,aspartate aminotransferase
1 secondary outcome
Side Effects of NAC
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Diet and exercise and NAC with diet and exercise in people with NAFLD, run by Dow University of Health Sciences.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Alanine transaminase,aspartate aminotransferase (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2022.