Status:
COMPLETED
Effect of Lactulose on Minimal Hepatic Encephalopathy and Health-Related Quality of Life
Lead Sponsor:
Post Graduate Institute of Medical Education and Research, Chandigarh
Conditions:
Minimal Hepatic Encephalopathy
Hepatic Encephalopathy
Eligibility:
All Genders
Phase:
PHASE4
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...
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.Sr...
Eligibility Criteria
Inclusion
- All the patients diagnosed as having cirrhosis of liver
Exclusion
- 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.
Key Trial Info
Start Date :
January 1 2004
Trial Type :
INTERVENTIONAL
End Date :
December 1 2004
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT00375375
Start Date
January 1 2004
End Date
December 1 2004
Last Update
March 2 2007
Active Locations (1)
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1
Postgraduate Institute of Medical Education and Research
Chandigarh, Uttarakhand, India, 160012