Misoprostol for Non-alcoholic Steatohepatitis- a Randomized Control Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Change From Baseline in endotoxin levels
研究概览
简要总结
The aim of this randomised control trial is to evaluate the effect of Misoprostol in treating patients with NASH.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Double-blind
入排标准
- 年龄范围
- 25 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients between age 25 and 64 years
- •Patients having NAFLD as evident by a radiologic test like ultrasound/fibroscan/CT scan etc.
- •ALT level of 1.5 times ULN
- •If already known case of NAFLD, then patient should be on stable doses of Vitamin E, oral hypoglycemics or anti-lipidemic drugs, with no change in medication during 6 months prior to recruitment.
排除标准
- •Patients with age less than 18 yrs or more than 80 yrs,
- •Women of childbearing age
- •Clinically significant acute or chronic liver disease unrelated to NAFLD
- •Evidence of hepatitis B and C
- •Evidence of primary biliary cirrhosis, primary sclerosing cholangitis, or biliary obstruction
- •Autoimmune hepatitis
- •Drug-induced steatohepatitis (ingestion of drugs known to produce hepatic steatosis including corticosteroids, high-dose estrogens, methotrexate, tetracycline or amiodarone in the previous 6 months)
- •Any cardiovascular event or evidence of active CVS disease
- •Type 1 Diabetes
- •Those consuming alcohol of over 20 grams/day for males and 10 grams/day for females
- •Severe end-organ damage
- •Human immunodeficiency virus (HIV) infection
- •Compensated and decompensated cirrhosis
- •Patients with uncontrolled diabetes
- •Mental instability or incompetence
研究组 & 干预措施
Misoprostol
600 mcg of Misoprostol per day in three divided doses was given to the patients in the treatment group for a period of two months
干预措施: Misoprostol (Drug)
Placebo
Placebo was given to the patients three times daily for a duration of two months
干预措施: Placebo (Drug)
结局指标
主要结局
Change From Baseline in endotoxin levels
时间窗: Baseline to 2 Months
The change in endotoxin levels measured in endotoxin units per milliliter (EU/mL) from baseline was ascertained by performing paired sample t-test.
Change From Baseline in liver function tests
时间窗: Baseline to 2 Months
The change in serum alanine aminotransferase (ALT) measured in international units per liter (IU/L), aspartate aminotransferase (AST) in IU/L, gamma-glutamyl transferase (GGT) in IU/L, alkaline phosphatase (ALP) in IU/L, total bilirubin in milligrams per decilitre (mg/dl), direct bilirubin in mg/dl and indirect bilirubin in mg/dl from baseline was ascertained by performing paired sample t-test.
Change From Baseline in Interleukin-6 (IL-6)
时间窗: Baseline to 2 Months
The change in Interleukin-6 measured in picograms per milliliter (pg/ml) from baseline was ascertained by performing paired sample t-test.
次要结局
- Change From Baseline in hepatic steatosis(Baseline to 2 Months)
- Change From Baseline in hepatic fibrosis(Baseline to 2 Months)
- Change From Baseline in dyslipidemia(Baseline to 2 Months)
- Change From Baseline in Insulin resistance(Baseline to 2 Months)
- Incidence of Adverse Events(Baseline to 2 Months)
研究者
DR MEHREEN SIYAL
Principal Investigator
Ziauddin University