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Effect of Lactulose on Minimal Hepatic Encephalopathy and Health-Related Quality of Life

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00375375
Enrollment
80
Registered
2006-09-13
Start date
2004-01-31
Completion date
2004-12-31
Last updated
2007-03-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatic Encephalopathy, Minimal Hepatic Encephalopathy

Keywords

Minimal hepatic encephalopathy, Hepatic encephalopathy, Subclinical hepatic encephalopathy, Health related quality of life

Brief summary

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.

Detailed description

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.)

Interventions

DRUGLactulose

Sponsors

Post Graduate Institute of Medical Education and Research, Chandigarh
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

* All the patients diagnosed as having cirrhosis of liver

Exclusion criteria

* Overt HE or a history of overt HE; * History of recent (\< 6 weeks) alcohol intake; * Infection, recent (\< 6 weeks) antibiotic use or gastrointestinal bleeding; * History of recent (\< 6 weeks) use of drugs affecting psychometric * Performances like benzodiazepens, antiepileptics, psychotropic drugs; * History of shunt surgery or transjugular intrahepatic portosystemic shunt for portal hypertension; * Electrolyte imbalance; * Renal impairment; * Presence of hepatocellular carcinoma; * Severe medical problems such as congestive heart failure, pulmonary disease, neurological or psychiatric disorder, etc., that could influence quality-of-life measurement; * Inability to perform NP tests and to complete the SIP questionnaire due to bad vision.

Design outcomes

Primary

MeasureTime frame
Improvement in minimal hepatic encephalopathy and health related quality of life

Countries

India

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026