Ignite Creation Date:
2025-12-24 @ 5:43 PM
Ignite Modification Date:
2025-12-25 @ 3:11 PM
Study NCT ID:
NCT01218568
Status:
COMPLETED
Last Update Posted:
2013-04-04
First Post:
2010-10-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Rifaximin Plus Lactulose Versus Lactulose Alone for the Treatment of Hepatic Encephalopathy: a Double Blind Randomized Trial
Sponsor:
Institute of Liver and Biliary Sciences, India
Organization:
Study Overview
Official Title:
Rifaximin Plus Lactulose Versus Lactulose Alone for the Treatment of Hepatic Encephalopathy: a Double Blind Randomized Trial
Status:
COMPLETED
Status Verified Date:
2012-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 Description:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: