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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-08-20

Study Completion Date

2020-08-30

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).

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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

Conditions

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Non Alcoholic Steatohepatitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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group 1

(Control group n= 22): Patients will receive Placebo once daily at bedtime for 12 weeks..

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Placebo tabled every day

Group 2

Treatment group n= 22): Patients will receive Montelukast 10 mg daily at bedtime.

The treatment duration will be 12 weeks.

Group Type EXPERIMENTAL

Montelukast

Intervention Type DRUG

Montelukast 10 mg daily at bed time.

Interventions

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Placebo

Placebo tabled every day

Intervention Type OTHER

Montelukast

Montelukast 10 mg daily at bed time.

Intervention Type DRUG

Other Intervention Names

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Singulair

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.

Minimum Eligible Age

20 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No