Status:
COMPLETED
The Leukotriene Receptor Antagonist Montelukast in the Treatment of Non-alcoholic Steatohepatitis
Lead Sponsor:
Sadat City University
Conditions:
Steatohepatitis, Nonalcoholic
Eligibility:
All Genders
18-60 years
Phase:
PHASE1
PHASE2
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.
Eligibility Criteria
Inclusion
- \- 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
- \- 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
Key Trial Info
Start Date :
August 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 15 2022
Estimated Enrollment :
56 Patients enrolled
Trial Details
Trial ID
NCT04080947
Start Date
August 1 2019
End Date
March 15 2022
Last Update
March 16 2022
Active Locations (1)
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1
Faculty of Medicine
Shibīn al Kawm, Menoufia, Egypt, 13829