NCT01218568

Rifaximin Plus Lactulose Versus Lactulose Alone for the Treatment of Hepatic Encephalopathy: a Double Blind Randomized Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: Institute of Liver and Biliary Sciences, India · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hepatic Encephalopathy

Interventions

Type	Name	Description
DRUG	Rifaximin plus lactulose	Rifaximin 400 mg three times a day Lactulose 30-60 ml in two or three divided doses.
DRUG	Lactulose	Lactulose 30-60 ml in two or three divided doses.

Timeline

• Start date: 2010-10-01
• Primary completion: 2012-09-01
• Completion: 2012-10-01
• First posted: 2010-10-11
• Last updated: 2013-04-04

Locations

1 site across 1 country: India