Clinical trial NCT04537780: Efficacy and Safety of Montelukast in Non Alcoholic Steatohepatitis (NASH)
Official title: Clinical Study Evaluating the Efficacy and Safety of Montelukast in the Treatment of Non-Alcoholic Steatohepatitis (NASH)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Non Alcoholic Steatohepatitis
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2020-09-03
Enrollment: 44
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

Brief 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

Eligibility 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.

Primary outcomes:
measure: serum 8-Hydroxy2-deoxyguanisine (8-OHdG)
timeFrame: 12 Weeks
measure: TNF-α.
timeFrame: 12 Weeks
measure: Alanine aminotransferase (ALT).
timeFrame: 12 Weeks
measure: Aspartate aminotransferase (AST)
timeFrame: 12 Weeks
measure: ɤ-glutamyltranspeptidase(GGT)
timeFrame: 12 Weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Dr. Tarek Mohamed Mostafa
state: El-Gharbia
Study officials:
affiliation: Tanta University
name: Tarek M Mostafa, Ass. Prof.
role: STUDY_DIRECTOR
References:
citation: Said MM, Bosland MC. The anti-inflammatory effect of montelukast, a cysteinyl leukotriene receptor-1 antagonist, against estradiol-induced nonbacterial inflammation in the rat prostate. Naunyn Schmiedebergs Arch Pharmacol. 2017 Feb;390(2):197-205. doi: 10.1007/s00210-016-1325-4. Epub 2016 Dec 1.
citation: Kuru S, Kismet K, Barlas AM, Tuncal S, Celepli P, Surer H, Ogus E, Ertas E. The Effect of Montelukast on Liver Damage in an Experimental Obstructive Jaundice Model. Viszeralmedizin. 2015 Apr;31(2):131-8. doi: 10.1159/000375434. Epub 2015 Apr 9.