Minimal Hepatic EncephalopathyPhase 4NCT00375375
Effect of Lactulose on Minimal Hepatic Encephalopathy and Health-Related Quality of Life
A Phase 4 study testing Lactulose in people with Minimal Hepatic Encephalopathy and Hepatic Encephalopathy, run by Post Graduate Institute of Medical Education and Research, Chandigarh at 1 site in India.
Trial 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). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Minimal Hepatic Encephalopathy, Hepatic Encephalopathy
- What is being tested?
- Lactulose
- How many people
- 80 participants
- Where
- 1 siteIndia
- Study dates
- Jan 2004to Dec 2004
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- All the patients diagnosed as having cirrhosis of liver
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
India1 site
Postgraduate Institute of Medical Education and Research
Chandigarh, Uttarakhand, 160012
About this study
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.
Read the 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.)
- Being tested
- Lactulose
- Keywords
- Minimal hepatic encephalopathy, Hepatic encephalopathy, Subclinical hepatic encephalopathy, Health related quality of life
- Medical subject headings
- Hepatic Encephalopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LactuloseDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in minimal hepatic encephalopathy and health related quality of life
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2006 (estimated)
- Study startJan 2004
- Study completionDec 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Minimal Hepatic EncephalopathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 80 participants
Sponsor and investigators
- Lead sponsor
- Post Graduate Institute of Medical Education and Research, Chandigarh
- Sponsor type
- University, hospital or other
- Investigators
- Radha K Dhiman, MD,DM, FACG, Principal investigator, Postgraduate Institute of Medical Education and Research, Chandigarh-160012, India
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00375375
- Sponsor's protocol ID
- Minimal hepatic encephalopathy
- Status last verified
- Mar 2007
- First submitted
- 12 Sep 2006
- Last updated
- 2 Mar 2007
- Results posted
- No
Publications
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.
PubMed 17326150
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Lactulose on Minimal Hepatic Encephalopathy and Health-Related Quality of Life
- ClinicalTrials.gov ID
- NCT00375375
- Acronym / sponsor ID
- Minimal hepatic encephalopathy
- Keywords
- Minimal hepatic encephalopathy, Hepatic encephalopathy, Subclinical hepatic encephalopathy, Health related quality of life
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants
- Lead sponsor
- Post Graduate Institute of Medical Education and Research, ChandigarhUniversity, hospital or other
- Study start
- Jan 2004
- Study completion
- Dec 2004
- First posted
- 13 Sep 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- All the patients diagnosed as having cirrhosis of liver
Key exclusion criteria (11 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lactulose | Drug | – |
Primary outcome
Improvement in minimal hepatic encephalopathy and health related quality of life
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2007.
- Results publication: PubMed 17326150Prasad 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Radha K Dhiman, MD,DM, FACG principal investigator
Postgraduate Institute of Medical Education and Research, Chandigarh-160012, India
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Lactulose in people with Minimal Hepatic Encephalopathy and Hepatic Encephalopathy, run by Post Graduate Institute of Medical Education and Research, Chandigarh at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Mar 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement in minimal hepatic encephalopathy and health related quality of life. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00375375, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2007.