Rifaximin Plus Lactulose Versus Lactulose Alone for the Treatment of Hepatic Encephalopathy: a Double Blind Randomized Trial
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.
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
|Official Title:||Rifaximin Plus Lactulose Versus Lactulose Alone for the Treatment of Hepatic Encephalopathy: a Double Blind Randomized Trial|
- Reversal of hepatic encephalopathy [ Time Frame: 10 days ] [ Designated as safety issue: No ]
- Death [ Time Frame: 10 days ] [ Designated as safety issue: No ]
- duration of hospital stay [ Time Frame: 10 days ] [ Designated as safety issue: No ]
|Study Start Date:||October 2010|
|Study Completion Date:||October 2012|
|Primary Completion Date:||September 2012 (Final data collection date for primary outcome measure)|
|Experimental: Rifaximin plus lactulose||
Drug: Rifaximin plus lactulose
Rifaximin 400 mg three times a day Lactulose 30-60 ml in two or three divided doses.
Active Comparator: lactulose
Lactulose 30-60 ml in two or three divided doses.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01218568
|Institute of Liver & Biliary Sciences (ILBS)|
|New Delhi, Delhi, India, 110 070|