NCT04080947已完成1 期
The Leukotriene Receptor Antagonist Montelukast in the Treatment of Non-alcoholic Steatohepatitis: A Proof-of-Concept, Randomized, Double-Blind, Placebo-Controlled Trial
Sadat City University1 个研究点 分布在 1 个国家目标入组 56 人开始时间: 2019年8月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- Fibro-scan score
研究概览
简要总结
The aim of the current study is to evaluate the safety and efficay of Montelukast in treatment of patients with fatty liver disease.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
Control group
Placebo Comparator
26 patients will receive placebo (Control group)
干预措施: Control group (Drug)
Montelukast group
Experimental
26 patients will receive montelukast 10 mg/ day
干预措施: Montelukast group (Drug)
结局指标
主要结局
Fibro-scan score
时间窗: At baseline and after 12 weeks of intervention
change in liver stiffness measurement (Fibro-scan score)
Liver Panel
时间窗: after 12 weeks of intervention
Alanine aminotransferase (ALT) and Aspartate Aminotransferase (AST) will be evaluated in U/L
次要结局
- HOMA-IR(after 12 weeks of intervention)
- TNF-Alpha(after 12 weeks of intervention)
- 8-OHdG(after 12 weeks of intervention)
- hyaluronic acid(after 12 weeks of intervention)
- TGF-β1(after 12 weeks of intervention)
- Assessment of drugs tolerability: Side effects(after 12 weeks of intervention)
研究者
Mahmoud Samy Abdallah
Lecturer of Clinical Pharmacy, PhD.
Sadat City University
研究点 (1)
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