NCT04537780

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)

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 44 (actual)
• Sponsor: Tanta University · Academic / Other
• Sex: All
• Age: 20 Years – 70 Years
• Healthy volunteers: Not accepted

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

Conditions

• Non Alcoholic Steatohepatitis

Interventions

Type	Name	Description
OTHER	Placebo	Placebo tabled every day
DRUG	Montelukast	Montelukast 10 mg daily at bed time.

Timeline

• Start date: 2019-08-20
• Primary completion: 2020-08-30
• Completion: 2020-08-30
• First posted: 2020-09-03
• Last updated: 2020-09-03

Locations

1 site across 1 country: Egypt