S. Endotoxin, Inflammatory Mediators and MRS Before and After Treatment in MHE (endtxninHE)
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Serum Endotoxins, Inflammatory Mediators and MR Spectroscopy Before and After Treatment in Minimal Hepatic Encephalopathy|
- Improvement of minimal hepatic encephalopathy [ Time Frame: Baseline and at 12 weeks ] [ Designated as safety issue: Yes ]
- correlation between inflammatory mediators and grades of encephalopathy [ Time Frame: Baseline and at 12 weeks ] [ Designated as safety issue: Yes ]To measure values of inflammatory mediators in different grades of encephalopathy
|Study Start Date:||October 2011|
|Study Completion Date:||February 2012|
|Primary Completion Date:||February 2012 (Final data collection date for primary outcome measure)|
Placebo Comparator: Lactulose
Group L receives lactulose Group NL receives placebo
Syrup 30 ml BD for 12 weeks
Other Name: Duphalac , Looz
Placebo Comparator: Placebo
Group NL receives placebo
Syrup, 30 ml BD for 3 months in Gr. NL
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.