Back to resultsEffect of Lactulose on Minimal Hepatic Encephalopathy and Health-Related Quality of Life
Primary Purpose
Minimal Hepatic Encephalopathy, Hepatic Encephalopathy
Status
Completed
Phase
Phase 4
Locations
India
Study Type
Interventional
Intervention
Lactulose
Sponsored by
About this trial
This is an interventional treatment trial for Minimal Hepatic Encephalopathy focused on measuring Minimal hepatic encephalopathy, Hepatic encephalopathy, Subclinical hepatic encephalopathy, Health related quality of life
Eligibility 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.
Sites / Locations
- Postgraduate Institute of Medical Education and Research
Outcomes
Primary Outcome Measures
Improvement in minimal hepatic encephalopathy and health related quality of life
Secondary Outcome Measures
Full Information
NCT ID
NCT00375375
First Posted
September 12, 2006
Last Updated
March 1, 2007
Sponsor
Postgraduate Institute of Medical Education and Research
1. Study Identification
Unique Protocol Identification Number
NCT00375375
Brief Title
Effect of Lactulose on Minimal Hepatic Encephalopathy and Health-Related Quality of Life
Study Type
Interventional
2. Study Status
Record Verification Date
March 2007
Overall Recruitment Status
Completed
Study Start Date
January 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2004 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Postgraduate Institute of Medical Education and Research
4. Oversight
5. Study Description
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.)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Minimal Hepatic Encephalopathy, Hepatic Encephalopathy
Keywords
Minimal hepatic encephalopathy, Hepatic encephalopathy, Subclinical hepatic encephalopathy, Health related quality of life
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Lactulose
Primary Outcome Measure Information:
Title
Improvement in minimal hepatic encephalopathy and health related quality of life
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Radha K Dhiman, MD,DM, FACG
Organizational Affiliation
Postgraduate Institute of Medical Education and Research, Chandigarh-160012, India
Official's Role
Principal Investigator
Facility Information:
Facility Name
Postgraduate Institute of Medical Education and Research
City
Chandigarh
State/Province
UT
ZIP/Postal Code
160012
Country
India
12. IPD Sharing Statement
Citations:
PubMed Identifier
17326150
Citation
Prasad S, Dhiman RK, Duseja A, Chawla YK, Sharma A, Agarwal R. Lactulose improves cognitive functions and health-related quality of life in patients with cirrhosis who have minimal hepatic encephalopathy. Hepatology. 2007 Mar;45(3):549-59. doi: 10.1002/hep.21533.
Results Reference
result
Learn more about this trial
Effect of Lactulose on Minimal Hepatic Encephalopathy and Health-Related Quality of Life
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