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

Non Alcoholic Steatohepatitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04537780
• Other study ID #: Montelukast
• Status: Completed
• Phase: Phase 4
• Start date: August 20, 2019
• Est. completion date: August 30, 2020

Study information

• Verified date: August 2020
• Source: Tanta University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: August 30, 2020
• Est. primary completion date: August 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Fatty Liver
• Non Alcoholic Steatohepatitis
• Non-alcoholic Fatty Liver Disease

Intervention

Other:
• Placebo
Placebo tabled every day

Drug:
• Montelukast
Montelukast 10 mg daily at bed time.

Locations

Country	Name	City	State
Egypt	Dr. Tarek Mohamed Mostafa	Tanta	El-Gharbia

Sponsors (1)

Lead Sponsor	Collaborator
Tanta University

Country where clinical trial is conducted

Egypt, 

References & Publications (2)

Kuru S, Kismet K, Barlas AM, Tuncal S, Celepli P, Surer H, Ogus E, Ertas E. The Effect of Montelukast on Liver Damage in an Experimental Obstructive Jaundice Model. Viszeralmedizin. 2015 Apr;31(2):131-8. doi: 10.1159/000375434. Epub 2015 Apr 9. — View Citation

Said MM, Bosland MC. The anti-inflammatory effect of montelukast, a cysteinyl leukotriene receptor-1 antagonist, against estradiol-induced nonbacterial inflammation in the rat prostate. Naunyn Schmiedebergs Arch Pharmacol. 2017 Feb;390(2):197-205. doi: 10.1007/s00210-016-1325-4. Epub 2016 Dec 1. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	serum 8-Hydroxy2-deoxyguanisine (8-OHdG)	Quantitative detection of human 8-OHdG will be done using commercially available Enzyme-linked Immunosorbent assay kits.	12 Weeks
Primary	TNF-a.	Quantitative detection of TNF-a will be done using commercially available Enzyme-linked Immunosorbent assay kits.	12 Weeks
Primary	Alanine aminotransferase (ALT).	ALT will be measured by colorimetric method.	12 Weeks
Primary	Aspartate aminotransferase (AST)	AST will be measured by colorimetric method.	12 Weeks
Primary	?-glutamyltranspeptidase(GGT)	?-glutamyltranspeptidase(GGT) will be measured by colorimetric method.	12 Weeks