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Health Related Quality of Life in Patient With Chronic Liver Disease and Effect of Probiotics in the Treatment of MHE and Health Related Quality of Life
This study is a randomized, open, parallel group, active comparator, single center trial. Objectives of the study are hereby given below: * To study the health related quality of life (HRQOL) in patients with chronic liver disease. * To assess the prevalence of minimal hepatic encephalopathy (MHE) in patients with chronic liver disease and assessment of HRQOL in patients with MHE. * To compare the effect of probiotics and lactulose in the treatment of MHE * To assess the effect of probiotics and lactulose on the HRQOL in patients with MHE.
Details
| Lead sponsor | CD Pharma India Pvt. Ltd. |
|---|---|
| Phase | Phase 2/Phase 3 |
| Status | COMPLETED |
| Enrolment | 120 |
| Start date | 2009-10 |
| Completion | 2012-10 |
Conditions
- Chronic Liver Disease
- Hepatic Encephalopathy
Interventions
- VSL#3
- Lactulose
Primary outcomes
- To compare the effect of probiotics and lactulose based on normalization of the abnormal test parameters, Neuropsychometric tests, P3ERP, EEG, venous ammonia levels, Development of overt encephalopathy and other complications and HRQOL — 2 months
Countries
India