Clinical Trial: Rifaximin Plus Lactulose Versus Lactulose Alone for the Treatment of Hepatic Encephalopathy: a Double Blind Randomized Trial
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Rifaximin Plus Lactulose Versus Lactulose Alone for the Treatment of Hepatic Encephalopathy: a Double Blind Randomized Trial
Brief Summary: The study will be double blind with respect to rifaximin, and randomization will be performed using tables of computer-generated random numbers. All subjects will be followed up till the recovery of HE (primary end point) or 10 days whichever is earlier. In the Lactulose group (group A) patients will receive 30-60 ml of lactulose in 2 or 3 divided doses so that patient passes 2-3 semisoft stools per day along with placebo . In the lactulose plus rifaximin group (group B) patients will receive cap rifaximin 400mg three times a day along with lactulose. Primary endpoints will be recovery of overt HE patients who will not recover from HE after 10 days will be continued on the same treatment. Total duration of the study is 1 year.
Detailed Summary:
Sponsor: Institute of Liver and Biliary Sciences, India
Current Primary Outcome: Reversal of hepatic encephalopathy [ Time Frame: 10 days ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Death [ Time Frame: 10 days ]
- duration of hospital stay [ Time Frame: 10 days ]
Original Secondary Outcome:
- Death [ Time Frame: 10 days ]
- duration of hospital stay
Information By: Institute of Liver and Biliary Sciences, India
Dates:
Date Received: October 5, 2010
Date Started: October 2010
Date Completion:
Last Updated: April 2, 2013
Last Verified: June 2012
