Hepatic Encephalopathy
Conditions
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.
Interventions
Rifaximin 400 mg three times a day Lactulose 30-60 ml in two or three divided doses.
DRUGLactulose
Lactulose 30-60 ml in two or three divided doses.
Sponsors
Institute of Liver and Biliary Sciences, India
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Cirrhosis * Age 18-80 * Hepatic encephalopathy grade II-IV * Informed consent
Exclusion criteria
1. Degenerative CNS disease or major psychiatric illness 2. Serum creatinine \> 1.5 mg/dl 3. Active alcohol intake \<4 weeks prior to present episode 4. Others metabolic encephalopathies 5. Hepatocellular Carcinoma 6. Severe comorbidity such as CHF, Pulmonary disease, Neurological & Psychiatric problems impairing quality of life
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Reversal of hepatic encephalopathy | 10 days |
Secondary
| Measure | Time frame |
|---|---|
| Death | 10 days |
| duration of hospital stay | 10 days |
Countries
India
Outcome results
None listed