|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
19 February 2015 |
|
Main ID: |
NCT01178372 |
|
Date of registration:
|
09/08/2010 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
Secondary Prophylaxis of Hepatic Encephalopathy in Cirrhosis
HE |
|
Scientific title:
|
Secondary Prophylaxis of Hepatic Encephalopathy in Cirrhosis: An Open Label, Randomized Controlled Trial of Lactulose, Probiotics and No-therapy |
|
Date of first enrolment:
|
September 2008 |
|
Target sample size:
|
|
|
Recruitment status: |
Recruiting |
|
URL:
|
http://clinicaltrials.gov/show/NCT01178372 |
|
Study type:
|
Interventional |
|
Study design:
|
N/A
|
|
Phase:
|
Phase 4
|
|
|
Countries of recruitment
|
|
India
| | | | | | | |
|
Contacts
|
|
Name:
|
Barjesh C Sharma, MD,DM |
|
Address:
|
|
|
Telephone:
|
9718599203 |
|
Email:
|
drbcsharma@hotmail.com |
|
Affiliation:
|
|
|
|
Name:
|
Barjesh C Sharma, MD,DM |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
G B Pant Hospital New Delhi 110002 |
| |
|
Key inclusion & exclusion criteria
|
Inclusion Criteria:
- Patients with cirrhosis and previous history of recovery from hepatic encephalopathy
Exclusion Criteria:
- history of taking lactulose in the past 6 weeks.
- alcohol intake during the past 6 weeks or during follow up
- patients on secondary prophylaxis for spontaneous bacterial peritonitis
- previous TIPS or shunt surgery
- significant comorbid illness such as heart, respiratory, or renal failure
- any neurologic diseases such as alzheimer's disease, parkinson's disease and
nonhepatic metabolic encephalopathies.
Age minimum:
18 Years
Age maximum:
75 Years
Gender:
Both
|
|
Health Condition(s) or Problem(s) studied
|
|
Hepatic Encephalopathy
|
|
Intervention(s)
|
|
Drug: Lactulose
|
|
Drug: Probiotics(VSL#3)
|
|
Primary Outcome(s)
|
|
episode of overt hepatic encephalopathy
[Time Frame: 6 months]
|
|
Secondary Outcome(s)
|
|
side effects to therapy
[Time Frame: 6 months]
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|