Effect of Lactulose on Minimal Hepatic Encephalopathy and Health-Related Quality of Life
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|ClinicalTrials.gov Identifier: NCT00375375|
Recruitment Status : Completed
First Posted : September 13, 2006
Last Update Posted : March 2, 2007
Minimal hepatic encephalopathy (MHE) has a negative effect on patients’ daily functioning. No study has so far investigated the effect of treatment related improvement in cognitive functions on health related quality-of-life (HRQOL). This study was carried out to determine the influence of treatment on psychomotor performance and on HRQOL in patients with MHE.
The mean number of abnormal NP tests decreased significantly in patients in treated group compared with patients in untreated group MANOVA for time and treatment, P =.001). Mean total SIP score improved among patients in the treated group after 3 months compared with patients in untreated group after 3 months (MANOVA for time and treatment, P=.002). Improvement in HRQOL was related to the improvement in psychometry. In conclusion, treatment with lactulose improves both cognitive functions and HRQOL in cirrhotic patients with MHE.
|Condition or disease||Intervention/treatment||Phase|
|Minimal Hepatic Encephalopathy Hepatic Encephalopathy||Drug: Lactulose||Phase 4|
The study has been published in March 2007 in Hepatology
Lactulose Improves Cognitive Functions and Health-Related Quality of Life in Patients with Cirrhosis WhoHave Minimal Hepatic Encephalopathy.Srinivasa Prasad, Radha K. Dhiman, Ajay Duseja, Yogesh K. Chawla, Arpita Sharma, and Ritesh Agarwal. (HEPATOLOGY 2007;45:549-559.)
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||80 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Study Start Date :||January 2004|
|Study Completion Date :||December 2004|
- Improvement in minimal hepatic encephalopathy and health related quality of life
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00375375
|Postgraduate Institute of Medical Education and Research|
|Chandigarh, UT, India, 160012|
|Principal Investigator:||Radha K Dhiman, MD,DM, FACG||Postgraduate Institute of Medical Education and Research, Chandigarh-160012, India|