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

Phase 1

Completed

• Conditions: Steatohepatitis, Nonalcoholic
• Interventions: Drug: Control group; Drug: Montelukast group

• Registration Number: NCT04080947
• Lead Sponsor: Sadat City University

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2019-08-01
• Study First Submitted: 2019-08-31
• Study First Submitted QC: 2019-09-04
• Study First Posted: 2019-09-06
• Primary Completion: 2021-08-31
• Status Verified: 2022-03
• Study Completion: 2022-03-15
• Last Update Submitted: 2022-03-15
• Last Update Posted: 2022-03-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 56

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	Control group	26 patients will receive placebo (Control group)
Montelukast group	Montelukast group	26 patients will receive montelukast 10 mg/ day

Primary Outcome Measures

Name	Time	Method
Fibro-scan score	At baseline and after 12 weeks of intervention	change in liver stiffness measurement (Fibro-scan score)
Liver Panel	after 12 weeks of intervention	Alanine aminotransferase (ALT) and Aspartate Aminotransferase (AST) will be evaluated in U/L

Secondary Outcome Measures

Name	Time	Method
HOMA-IR	after 12 weeks of intervention	Homeostatic Model Assessment of Insulin Resistance
TNF-Alpha	after 12 weeks of intervention	Serum level of TNF-Alpha
8-OHdG	after 12 weeks of intervention	Serum level of 8-OHdG
hyaluronic acid	after 12 weeks of intervention	Serum level of hyaluronic acid
TGF-β1	after 12 weeks of intervention	Serum level of TGF-β1
Assessment of drugs tolerability: Side effects	after 12 weeks of intervention	Side effects of montelukast

Trial Locations

Locations (1)

Faculty of Medicine; 🇪🇬 Shibīn Al Kawm, Menoufia, Egypt