- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00375375
Effect of Lactulose on Minimal Hepatic Encephalopathy and Health-Related Quality of Life
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.
Study Overview
Status
Intervention / Treatment
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.)
Study Type
Enrollment
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
UT
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Chandigarh, UT, India, 160012
- Postgraduate Institute of Medical Education and Research
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
Improvement in minimal hepatic encephalopathy and health related quality of life
|
Collaborators and Investigators
Investigators
- Principal Investigator: Radha K Dhiman, MD,DM, FACG, Postgraduate Institute of Medical Education and Research, Chandigarh-160012, India
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Study Completion
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Minimal hepatic encephalopathy
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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