Rifaximin Plus Lactulose Versus Lactulose Alone for the Treatment of Hepatic Encephalopathy: a Double Blind Randomized Trial
- Conditions
- Hepatic Encephalopathy
- Interventions
- Registration Number
- NCT01218568
- Lead Sponsor
- Institute of Liver and Biliary Sciences, India
- 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
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 120
- Cirrhosis
- Age 18-80
- Hepatic encephalopathy grade II-IV
- Informed consent
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Rifaximin plus lactulose Rifaximin plus lactulose - lactulose Lactulose 30-60ml/day
- Primary Outcome Measures
Name Time Method Reversal of hepatic encephalopathy 10 days
- Secondary Outcome Measures
Name Time Method Death 10 days duration of hospital stay 10 days
Trial Locations
- Locations (1)
Institute of Liver & Biliary Sciences (ILBS)
🇮🇳New Delhi, Delhi, India