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Efficacy and Safety of Montelukast in Non Alcoholic Steatohepatitis (NASH) | Clinical Trials | Clareo Health

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

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

NCT04537780•Tanta University

View on ClinicalTrials.gov

Summary

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

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

Eligibility

Age

20 - 70 years

Sex

ALL

Healthy Volunteers

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.

Locations (1)

Dr. Tarek Mohamed Mostafa

Tanta, El-Gharbia, Egypt

Key Dates

Start Date

August 20, 2019

Primary Completion Date

August 30, 2020

Completion Date

August 30, 2020

Last Updated

September 3, 2020

Enrollment

ACTUAL participants

Conditions

Non Alcoholic Steatohepatitis

Interventions

Placebo

OTHER

Montelukast

DRUG

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TERMINATED

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 3, 2020Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Comparative Study Between Febuxostat Versus Vitamin E in Non-alcoholic Steatohepatitis Patients With Hyperuricemia

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