We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00375375
First Posted: September 13, 2006
Last Update Posted: March 2, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Postgraduate Institute of Medical Education and Research
  Purpose

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 Intervention Phase
Minimal Hepatic Encephalopathy Hepatic Encephalopathy Drug: Lactulose Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Postgraduate Institute of Medical Education and Research:

Primary Outcome Measures:
  • Improvement in minimal hepatic encephalopathy and health related quality of life

Estimated Enrollment: 80
Study Start Date: January 2004
Estimated Study Completion Date: December 2004
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.)

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

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


Locations
India
Postgraduate Institute of Medical Education and Research
Chandigarh, UT, India, 160012
Sponsors and Collaborators
Postgraduate Institute of Medical Education and Research
Investigators
Principal Investigator: Radha K Dhiman, MD,DM, FACG Postgraduate Institute of Medical Education and Research, Chandigarh-160012, India
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00375375     History of Changes
Other Study ID Numbers: Minimal hepatic encephalopathy
First Submitted: September 12, 2006
First Posted: September 13, 2006
Last Update Posted: March 2, 2007
Last Verified: March 2007

Keywords provided by Postgraduate Institute of Medical Education and Research:
Minimal hepatic encephalopathy
Hepatic encephalopathy
Subclinical hepatic encephalopathy
Health related quality of life

Additional relevant MeSH terms:
Brain Diseases
Hepatic Encephalopathy
Central Nervous System Diseases
Nervous System Diseases
Liver Failure
Hepatic Insufficiency
Liver Diseases
Digestive System Diseases
Brain Diseases, Metabolic
Metabolic Diseases
Lactulose
Gastrointestinal Agents