NCT04080947

The Leukotriene Receptor Antagonist Montelukast in the Treatment of Non-alcoholic Steatohepatitis

The Leukotriene Receptor Antagonist Montelukast in the Treatment of Non-alcoholic Steatohepatitis: A Proof-of-Concept, Randomized, Double-Blind, Placebo-Controlled Trial

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 56 (actual)
• Sponsor: Sadat City University · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

The aim of the current study is to evaluate the safety and efficay of Montelukast in treatment of patients with fatty liver disease.

Conditions

• Steatohepatitis, Nonalcoholic

Interventions

Type	Name	Description
DRUG	Control group	patients received matching-image placebo once daily at bedtime for 12 weeks.
DRUG	Montelukast group	patients received montelukast (10-mg chewable tablet) once daily at bedtime for 12 weeks.

Timeline

• Start date: 2019-08-01
• Primary completion: 2021-08-31
• Completion: 2022-03-15
• First posted: 2019-09-06
• Last updated: 2022-03-16

Locations

1 site across 1 country: Egypt