Efficacy and Safety of Montelukast in Non Alcoholic Steatohepatitis (NASH)

• Status: Completed
• Trial end date: 2020-08-30
• Target enrollment: 0
• Participant gender: All

Summary

the current study is to evaluate the efficacy and safety of Montelukast in the treatment of patients with non-alcoholic steatohepatitis (NASH).

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Tanta University
• Treatments: Montelukast

Criteria

Inclusion Criteria:

• Adult (>18 years) overweight/obese subjects who have persistently abnormal aminotransferase level in two separate occasions over the past six months.

NAFLD will be assumed in patients with moderately elevated aminotransferase activities (<3x the upper limit of normal).

There is evidence of hepatic steatosis by imaging (increased liver echogenicity (bright), stronger echoes in the hepatic parenchyma, vessel blurring, and narrowing of the lumen of the hepatic veins) and there is no cause for secondary hepatic fat accumulation such as significant alcohol consumption, use of steatogenic medication or hereditary disorders. Patients with fibroscan score >7 kPa and <14 kPa will be included in the study.

Exclusion Criteria:

• Alcohol abusers.

• Presence of evidence for viral or autoimmune hepatitis.

• Diabetic patients.

• Patients with Wilson's disease and patients with hemochromatosis.

• Patients with decompensated liver disease.

• Patients show hypersensitivity to studied medications.

• Patients taking medication known to cause steatosis.

• Patients with other comorbid conditions that could potentially elevate transaminase, such as congestive heart failure, malignancy.

• Pregnancy and lactating women.