drugset / Trial / NCT01008293
Effect of Probiotics in Treatment of Minimal Hepatic Encephalopathy (MHE) and Health Related Quality of Life
Phase 2/3
Completed
120 enrolled
CD Pharma India Pvt. Ltd.
All India Institute of Medical Sciences · collabIndian Council of Medical Research · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
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.
Timeline
- Start
- 2009-10
- Primary completion
- 2012-06
- Completion
- 2012-10
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Lactulose | Other / unclassified | 30 ml | — |
| Comparator | Lactulose | Other / unclassified | 60 ml | — |
| Subject | VSL#3 | Other / unclassified | 2 unknown | — |