Overview

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

Status:
Active, not recruiting
Trial end date:
2021-12-31
Target enrollment:
0
Participant gender:
All
Summary
The aim of the current study is to evaluate the safety and efficay of Montelukast in treatment of patients with fatty liver disease.
Phase:
Phase 1/Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Sadat City University
Treatments:
Montelukast
Criteria
Inclusion Criteria:

- The inclusion criteria were adult patients (age >18 years old) of both sexes,
overweight/obese subjects with presence of evidence of hepatic steatosis by imaging
(increased liver echogenicity, stronger echoes in the hepatic parenchyma, vessel blurring,
and narrowing of the lumen of the hepatic veins). Patients with mild to moderate elevation
in aminotransferase activities (> 2 but <5 times upper limit of normal), hepatic steatosis
index (HIS) >36, Fibro-scan score >7 kpa and <12.5 kpa (F0-F3), and HAIR score of 2 or 3
were included in the study.

Exclusion Criteria:

- The exclusion criteria included smokers, patients with secondary hepatic fat accumulation
which results from using steatogenic medications or hereditary disorders. Alcohol
consumers, patients with Wilson's disease, hemochromatosis, viral hepatitis, decompensated
liver disease, inflammatory diseases, diabetes, depression and patients with other comorbid
conditions that elevate transaminases (congestive heart failure and malignancy) pregnancy
and lactating women were excluded