Efficacy and Safety of Montelukast in Non Alcoholic Steatohepatitis (NASH)

August 30, 2020 updated by: Dr. Tarek Mohamed Mostafa, Tanta University

Clinical Study Evaluating the Efficacy and Safety of Montelukast in the Treatment of Non-Alcoholic Steatohepatitis (NASH)

the current study is to evaluate the efficacy and safety of Montelukast in the treatment of patients with non-alcoholic steatohepatitis (NASH).

Study Overview

Status

Completed

Intervention / Treatment

Detailed Description

This is a randomized, prospective placebo-controlled study that will be conducted on 44 patients who fulfill the selection criteria and will be classified randomly into two groups.

Group 1 (Control group n= 22): Patients will receive Placebo once daily at bedtime.

Group 2 (Treatment group n= 22): Patients will receive Montelukast 10 mg daily at bedtime.

The treatment duration will be 12 weeks. Patients will be recruited from National Liver Institute and Fever, Liver and GIT disease Shebin El-Kom hospital, Egypt. All participants will be informed about the nature of the study. The patients will give their informed consent.The study will be approved by Research Ethics Committee of faculty of pharmacy -Tanta University. Data of all patients will be private and confidential. Any unexpected risk will be reported to patients and ethical committee on time

Study Type

Interventional

Enrollment (Actual)

44

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • El-Gharbia
      • Tanta, El-Gharbia, Egypt, 31527
        • Dr. Tarek Mohamed Mostafa

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Adult (>18 years) overweight/obese subjects who have persistently abnormal aminotransferase level in two separate occasions over the past six months.

NAFLD will be assumed in patients with moderately elevated aminotransferase activities (<3x the upper limit of normal).

There is evidence of hepatic steatosis by imaging (increased liver echogenicity (bright), stronger echoes in the hepatic parenchyma, vessel blurring, and narrowing of the lumen of the hepatic veins) and there is no cause for secondary hepatic fat accumulation such as significant alcohol consumption, use of steatogenic medication or hereditary disorders. Patients with fibroscan score >7 kPa and <14 kPa will be included in the study.

Exclusion Criteria:

  • Alcohol abusers.
  • Presence of evidence for viral or autoimmune hepatitis.
  • Diabetic patients.
  • Patients with Wilson's disease and patients with hemochromatosis.
  • Patients with decompensated liver disease.
  • Patients show hypersensitivity to studied medications.
  • Patients taking medication known to cause steatosis.
  • Patients with other comorbid conditions that could potentially elevate transaminase, such as congestive heart failure, malignancy.
  • Pregnancy and lactating women.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: group 1
(Control group n= 22): Patients will receive Placebo once daily at bedtime for 12 weeks..
Placebo tabled every day
EXPERIMENTAL: Group 2

Treatment group n= 22): Patients will receive Montelukast 10 mg daily at bedtime.

The treatment duration will be 12 weeks.

Montelukast 10 mg daily at bed time.
Other Names:
  • Singulair

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
serum 8-Hydroxy2-deoxyguanisine (8-OHdG)
Time Frame: 12 Weeks
Quantitative detection of human 8-OHdG will be done using commercially available Enzyme-linked Immunosorbent assay kits.
12 Weeks
TNF-α.
Time Frame: 12 Weeks
Quantitative detection of TNF-α will be done using commercially available Enzyme-linked Immunosorbent assay kits.
12 Weeks
Alanine aminotransferase (ALT).
Time Frame: 12 Weeks
ALT will be measured by colorimetric method.
12 Weeks
Aspartate aminotransferase (AST)
Time Frame: 12 Weeks
AST will be measured by colorimetric method.
12 Weeks
ɤ-glutamyltranspeptidase(GGT)
Time Frame: 12 Weeks
ɤ-glutamyltranspeptidase(GGT) will be measured by colorimetric method.
12 Weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

August 20, 2019

Primary Completion (ACTUAL)

August 30, 2020

Study Completion (ACTUAL)

August 30, 2020

Study Registration Dates

First Submitted

August 30, 2020

First Submitted That Met QC Criteria

August 30, 2020

First Posted (ACTUAL)

September 3, 2020

Study Record Updates

Last Update Posted (ACTUAL)

September 3, 2020

Last Update Submitted That Met QC Criteria

August 30, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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