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Primary Prophylaxis of Hepatic Encephalopathy in Patients With Cirrhosis

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2009 by Govind Ballabh Pant Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Govind Ballabh Pant Hospital
ClinicalTrials.gov Identifier:
NCT01175538
First received: August 2, 2010
Last updated: August 4, 2010
Last verified: October 2009
History of Changes

August 2, 2010
August 4, 2010
January 2008
June 2010   (final data collection date for primary outcome measure)
prevention of first episode of hepatic encephalopathy [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01175538 on ClinicalTrials.gov Archive Site
Side effects to lactulose and mortality [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Primary Prophylaxis of Hepatic Encephalopathy in Patients With Cirrhosis
Primary Prophylaxis of Hepatic Encephalopathy in Patients With Cirrhosis: an Open Labeled Randomized Controlled Trial of Lactulose Versus no Lactulose

To assess the effects of lactulose for the prevention of first episode of altered sensorium (hepatic encephalopathy, primary prophylaxis) in patients with cirrhosis.

Development of hepatic encephalopathy in a patient with cirrhosis is associated with poor survival rate of 10-70% at one year depending upon hepatic and renal functions. Treating patients to prevent development of first episode of hepatic encephalopathy is classified as primary prophylaxis of hepatic encephalopathy and preventing recurrence of hepatic encephalopathy in patients who had previous episode of hepatic encephalopathy is secondary prophylaxis of hepatic encephalopathy
Interventional
Phase 4
Primary Purpose: Treatment
Hepatic Encephalopathy
  • Drug: Lactulose
    In the Gp-L group, patients will receive 30-60 ml of lactulose in 2 or 3 divided doses so that patient passes 2-3 semisoft stools per day
    Other Name: lactulose
  • Drug: Lactulose
    lactulose will be used in 30-60ml/day
    Other Name: lactulose
Experimental: Lactulose
Interventions:
  • Drug: Lactulose
  • Drug: Lactulose
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
Not Provided
September 2010
June 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • cirrhotic patients(18-70yrs) who never had encephalopathy

Exclusion Criteria:

  • history of taking lactulose in the past 6 weeks
  • alcohol intake during the past 6 weeks
  • hepatocellular carcinoma
  • previous TIPS or shunt surgery
  • significant co morbid illness such as heart, respiratory, or renal failure
  • neurologic diseases such as alzheimer's disease, parkinson's disease and nonhepatic metabolic encephalopathies.
  • patients on psychoactive drugs such as antidepressants or sedatives
  • who restarted alcohol during follow up
Both
18 Years to 70 Years
No
Contact: Barjesh C Sharma, MD,DM 9718599203 drbcsharma@hotmail.com
India
 
NCT01175538
PS001
Yes
Prof Barjesh Chander Sharma, G B Pant Hospital
Govind Ballabh Pant Hospital
Not Provided
Principal Investigator: Barjesh C Sharma, MD,DM G B Pant Hospital New Delhi 110002
Govind Ballabh Pant Hospital
October 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP