Clinical Study Evaluating the Efficacy and Safety of Montelukast in the Treatment of Non-Alcoholic Steatohepatitis (NASH)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- serum 8-Hydroxy2-deoxyguanisine (8-OHdG)
研究概览
简要总结
the current study is to evaluate the efficacy and safety of Montelukast in the treatment of patients with non-alcoholic steatohepatitis (NASH).
详细描述
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
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
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
group 1
(Control group n= 22): Patients will receive Placebo once daily at bedtime for 12 weeks..
干预措施: Placebo (Other)
Group 2
Treatment group n= 22): Patients will receive Montelukast 10 mg daily at bedtime.
The treatment duration will be 12 weeks.
干预措施: Montelukast (Drug)
结局指标
主要结局
serum 8-Hydroxy2-deoxyguanisine (8-OHdG)
时间窗: 12 Weeks
Quantitative detection of human 8-OHdG will be done using commercially available Enzyme-linked Immunosorbent assay kits.
TNF-α.
时间窗: 12 Weeks
Quantitative detection of TNF-α will be done using commercially available Enzyme-linked Immunosorbent assay kits.
Alanine aminotransferase (ALT).
时间窗: 12 Weeks
ALT will be measured by colorimetric method.
ɤ-glutamyltranspeptidase(GGT)
时间窗: 12 Weeks
ɤ-glutamyltranspeptidase(GGT) will be measured by colorimetric method.
Aspartate aminotransferase (AST)
时间窗: 12 Weeks
AST will be measured by colorimetric method.
次要结局
未报告次要终点
研究者
Dr. Tarek Mohamed Mostafa
Principal Investigator
Tanta University