S. Endotoxin, Inflammatory Mediators and MRS Before and After Treatment in MHE (endtxninHE)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Barjesh Chander Sharma, Govind Ballabh Pant Hospital
ClinicalTrials.gov Identifier:
NCT01446523
First received: September 11, 2011
Last updated: April 9, 2012
Last verified: April 2012
  Purpose

The purpose of this study is to examine S.endotoxins , inflammatory mediators and Magnetic Resonance Spectroscopy (MRS) before and after treatment in patients of cirrhosis and minimal hepatic encephalopathy.


Condition Intervention
Hepatic Encephalopathy
Drug: placebo
Drug: Lactulose

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Serum Endotoxins, Inflammatory Mediators and MR Spectroscopy Before and After Treatment in Minimal Hepatic Encephalopathy

Resource links provided by NLM:


Further study details as provided by Govind Ballabh Pant Hospital:

Primary Outcome Measures:
  • Improvement of minimal hepatic encephalopathy [ Time Frame: Baseline and at 12 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • correlation between inflammatory mediators and grades of encephalopathy [ Time Frame: Baseline and at 12 weeks ] [ Designated as safety issue: Yes ]
    To measure values of inflammatory mediators in different grades of encephalopathy


Enrollment: 60
Study Start Date: October 2011
Study Completion Date: February 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Lactulose
Group L receives lactulose Group NL receives placebo
Drug: Lactulose
Syrup 30 ml BD for 12 weeks
Other Name: Duphalac , Looz
Placebo Comparator: Placebo
Group NL receives placebo
Drug: placebo
Syrup, 30 ml BD for 3 months in Gr. NL

Detailed Description:

60 patients of cirrhosis with Minimal Hepatic Encephalopathy (MHE) who fulfills the inclusion & exclusion criteria will be the part of study. Study patients will be divided in to two groups ( n=30 in each group).

Group L patients will receive lactulose therapy while Group NL will receive placebo. After 3 months , S.endotoxins , inflammatory mediators and MRS will be repeated in each group.

  Eligibility

Ages Eligible for Study:   15 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Clinical diagnosis of Cirrhosis (Age 15 yr -70 yr )

Exclusion Criteria:

  • Recent history of gastrointestinal bleed in last 6 weeks
  • Active ongoing infection
  • Creatinine >1.5mg%
  • Electrolyte impairment. (S. Sodium < 130 meq/L, S. Potassium 3.5 meq/L or >5.0meq/L)
  • H/O use of psychotropic drugs in last 6 weeks
  • Recent alcohol use (< 6 week )
  • H/O TIPS or shunt surgery.
  • Hepatocellular Carcinoma
  • Severe comorbidity as Congestive Heart Failure, Pulmonary disease, Neurological and Psychiatric problems impairing quality of life
  • Poor vision precluding neuropsychological assessment
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01446523

Locations
India
BC Sharma
New Delhi, Delhi, India, 110060
Sponsors and Collaborators
Govind Ballabh Pant Hospital
Investigators
Principal Investigator: Barjesh c Sharma, DM GB Pant Hospital
  More Information

No publications provided by Govind Ballabh Pant Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Barjesh Chander Sharma, Professor, Govind Ballabh Pant Hospital
ClinicalTrials.gov Identifier: NCT01446523     History of Changes
Other Study ID Numbers: endotoxins in MHE
Study First Received: September 11, 2011
Last Updated: April 9, 2012
Health Authority: India: Ministry of Health

Keywords provided by Govind Ballabh Pant Hospital:
endotoxins HE

Additional relevant MeSH terms:
Hepatic Encephalopathy
Brain Damage, Chronic
Delirium
Encephalitis
Neurotoxicity Syndromes
Liver Failure
Hepatic Insufficiency
Liver Diseases
Digestive System Diseases
Brain Diseases, Metabolic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Metabolic Diseases
Confusion
Neurobehavioral Manifestations
Neurologic Manifestations
Signs and Symptoms
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Central Nervous System Viral Diseases
Virus Diseases
Central Nervous System Infections
Poisoning
Substance-Related Disorders
Lactulose
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 28, 2014