- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04537780
Efficacy and Safety of Montelukast in Non Alcoholic Steatohepatitis (NASH)
Clinical Study Evaluating the Efficacy and Safety of Montelukast in the Treatment of Non-Alcoholic Steatohepatitis (NASH)
Study Overview
Status
Conditions
Intervention / Treatment
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
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
El-Gharbia
-
Tanta, El-Gharbia, Egypt, 31527
- Dr. Tarek Mohamed Mostafa
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
PLACEBO_COMPARATOR: group 1
(Control group n= 22): Patients will receive Placebo once daily at bedtime for 12 weeks..
|
Placebo tabled every day
|
EXPERIMENTAL: Group 2
Treatment group n= 22): Patients will receive Montelukast 10 mg daily at bedtime. The treatment duration will be 12 weeks. |
Montelukast 10 mg daily at bed time.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
serum 8-Hydroxy2-deoxyguanisine (8-OHdG)
Time Frame: 12 Weeks
|
Quantitative detection of human 8-OHdG will be done using commercially available Enzyme-linked Immunosorbent assay kits.
|
12 Weeks
|
TNF-α.
Time Frame: 12 Weeks
|
Quantitative detection of TNF-α will be done using commercially available Enzyme-linked Immunosorbent assay kits.
|
12 Weeks
|
Alanine aminotransferase (ALT).
Time Frame: 12 Weeks
|
ALT will be measured by colorimetric method.
|
12 Weeks
|
Aspartate aminotransferase (AST)
Time Frame: 12 Weeks
|
AST will be measured by colorimetric method.
|
12 Weeks
|
ɤ-glutamyltranspeptidase(GGT)
Time Frame: 12 Weeks
|
ɤ-glutamyltranspeptidase(GGT) will be measured by colorimetric method.
|
12 Weeks
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Liver Diseases
- Fatty Liver
- Non-alcoholic Fatty Liver Disease
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Anti-Asthmatic Agents
- Respiratory System Agents
- Leukotriene Antagonists
- Hormone Antagonists
- Cytochrome P-450 CYP1A2 Inducers
- Cytochrome P-450 Enzyme Inducers
- Montelukast
Other Study ID Numbers
- Montelukast
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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