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

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

Detailed Description
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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

Official Title
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Clinical Study Evaluating the Efficacy and Safety of Montelukast in the Treatment of Non-Alcoholic Steatohepatitis (NASH)

Conditions
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Non Alcoholic Steatohepatitis

Intervention / Treatment
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* Other: Placebo
* Drug: Montelukast


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: group 1<br>(Control group n= 22): Patients will receive Placebo once daily at bedtime for 12 weeks.. | Other: Placebo<br>* Placebo tabled every day<br>|
| Experimental: Group 2<br>Treatment group n= 22): Patients will receive Montelukast 10 mg daily at bedtime. The treatment duration will be 12 weeks. | Drug: Montelukast<br>* Montelukast 10 mg daily at bed time.<br>* Other names: Singulair;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| serum 8-Hydroxy2-deoxyguanisine (8-OHdG) | Quantitative detection of human 8-OHdG will be done using commercially available Enzyme-linked Immunosorbent assay kits. | 12 Weeks | 
| TNF-α. | Quantitative detection of TNF-α will be done using commercially available Enzyme-linked Immunosorbent assay kits. | 12 Weeks | 
| Alanine aminotransferase (ALT). | ALT will be measured by colorimetric method. | 12 Weeks | 
| Aspartate aminotransferase (AST) | AST will be measured by colorimetric method. | 12 Weeks | 
| ɤ-glutamyltranspeptidase(GGT) | ɤ-glutamyltranspeptidase(GGT) will be measured by colorimetric method. | 12 Weeks |