Serum Endotoxins, Inflammatory Mediators and MR Spectroscopy Before and After Treatment in Minimal Hepatic Encephalopathy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Improvement of minimal hepatic encephalopathy
研究概览
简要总结
The purpose of this study is to examine S.endotoxins , inflammatory mediators and Magnetic Resonance Spectroscopy (MRS) before and after treatment in patients of cirrhosis and minimal hepatic encephalopathy.
详细描述
60 patients of cirrhosis with Minimal Hepatic Encephalopathy (MHE) who fulfills the inclusion & exclusion criteria will be the part of study. Study patients will be divided in to two groups ( n=30 in each group).
Group L patients will receive lactulose therapy while Group NL will receive placebo. After 3 months , S.endotoxins , inflammatory mediators and MRS will be repeated in each group.
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
- None
入排标准
- 年龄范围
- 15 Years 至 70 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of Cirrhosis (Age 15 yr -70 yr )
排除标准
- •Recent history of gastrointestinal bleed in last 6 weeks
- •Active ongoing infection
- •Creatinine >1.5mg%
- •Electrolyte impairment. (S. Sodium < 130 meq/L, S. Potassium 3.5 meq/L or >5.0meq/L)
- •H/O use of psychotropic drugs in last 6 weeks
- •Recent alcohol use (< 6 week )
- •H/O TIPS or shunt surgery.
- •Hepatocellular Carcinoma
- •Severe comorbidity as Congestive Heart Failure, Pulmonary disease, Neurological and Psychiatric problems impairing quality of life
- •Poor vision precluding neuropsychological assessment
研究组 & 干预措施
Lactulose
Group L receives lactulose Group NL receives placebo
干预措施: Lactulose (Drug)
Placebo
Group NL receives placebo
干预措施: placebo (Drug)
结局指标
主要结局
Improvement of minimal hepatic encephalopathy
时间窗: Baseline and at 12 weeks
次要结局
- correlation between inflammatory mediators and grades of encephalopathy(Baseline and at 12 weeks)
研究者
Barjesh Chander Sharma
Professor
Govind Ballabh Pant Hospital