Status:
COMPLETED
Rifaximin Plus Lactulose Versus Lactulose Alone for the Treatment of Hepatic Encephalopathy: a Double Blind Randomized Trial
Lead Sponsor:
Institute of Liver and Biliary Sciences, India
Conditions:
Hepatic Encephalopathy
Eligibility:
All Genders
18-80 years
Phase:
NA
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 H...
Eligibility Criteria
Inclusion
- Cirrhosis
- Age 18-80
- Hepatic encephalopathy grade II-IV
- Informed consent
Exclusion
- Degenerative CNS disease or major psychiatric illness
- Serum creatinine \> 1.5 mg/dl
- Active alcohol intake \<4 weeks prior to present episode
- Others metabolic encephalopathies
- Hepatocellular Carcinoma
- Severe comorbidity such as CHF, Pulmonary disease, Neurological \& Psychiatric problems impairing quality of life
Key Trial Info
Start Date :
October 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2012
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT01218568
Start Date
October 1 2010
End Date
October 1 2012
Last Update
April 4 2013
Active Locations (1)
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1
Institute of Liver & Biliary Sciences (ILBS)
New Delhi, National Capital Territory of Delhi, India, 110 070