The Leukotriene Receptor Antagonist Montelukast in the Treatment of Non-alcoholic Steatohepatitis

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-08-01

Study Completion Date

2022-03-15

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The aim of the current study is to evaluate the safety and efficay of Montelukast in treatment of patients with fatty liver disease.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

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

NCT04537780

Non Alcoholic Steatohepatitis

COMPLETED PHASE4

Evaluation the Safety and Efficacy of Cilostazol in Treatment of Patients With Fatty Liver Disease

NCT04761848

Fatty Liver, Nonalcoholic

WITHDRAWN PHASE1/PHASE2

Efficacy and Tolerability of Lubiprostone in Patients With Nonalcoholic Fatty Liver Disease

NCT05768334

NAFLD

COMPLETED PHASE3

Erdosteine in the Treatment of Nonalcoholic Fatty Liver Disease

NCT07242222

Fatty Liver

RECRUITING PHASE1/PHASE2

Study to Assess the Efficacy, Safety and Tolerability of LCQ908 in NAFLD Patients

NCT01811472

Non-alcoholic Fatty Liver Disease (NAFLD)

COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Steatohepatitis, Nonalcoholic

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Control group

26 patients will receive placebo (Control group)

Group Type PLACEBO_COMPARATOR

Control group

Intervention Type DRUG

patients received matching-image placebo once daily at bedtime for 12 weeks.

Montelukast group

26 patients will receive montelukast 10 mg/ day

Group Type EXPERIMENTAL

Montelukast group

Intervention Type DRUG

patients received montelukast (10-mg chewable tablet) once daily at bedtime for 12 weeks.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Control group

patients received matching-image placebo once daily at bedtime for 12 weeks.

Intervention Type DRUG

Montelukast group

patients received montelukast (10-mg chewable tablet) once daily at bedtime for 12 weeks.

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

Inclusion Criteria:

\- The inclusion criteria were adult patients (age \>18 years old) of both sexes, overweight/obese subjects with presence of evidence of hepatic steatosis by imaging (increased liver echogenicity, stronger echoes in the hepatic parenchyma, vessel blurring, and narrowing of the lumen of the hepatic veins). Patients with mild to moderate elevation in aminotransferase activities (\> 2 but \<5 times upper limit of normal), hepatic steatosis index (HIS) \>36, Fibro-scan score \>7 kpa and \<12.5 kpa (F0-F3), and HAIR score of 2 or 3 were included in the study.

Exclusion Criteria:

\- The exclusion criteria included smokers, patients with secondary hepatic fat accumulation which results from using steatogenic medications or hereditary disorders. Alcohol consumers, patients with Wilson's disease, hemochromatosis, viral hepatitis, decompensated liver disease, inflammatory diseases, diabetes, depression and patients with other comorbid conditions that elevate transaminases (congestive heart failure and malignancy) pregnancy and lactating women were excluded

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No