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

April 9, 2012 updated by: Barjesh Chander Sharma, Govind Ballabh Pant Hospital

Serum Endotoxins, Inflammatory Mediators and MR Spectroscopy Before and After Treatment in Minimal Hepatic Encephalopathy

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
    • Delhi
      • New Delhi, Delhi, India, 110060
        • BC Sharma

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years to 70 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Lactulose
Group L receives lactulose Group NL receives placebo
Drug: Lactulose
Syrup 30 ml BD for 12 weeks
Other Names:
  • Duphalac , Looz
Placebo Comparator: Placebo
Group NL receives placebo
Drug: placebo
Syrup, 30 ml BD for 3 months in Gr. NL

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Improvement of minimal hepatic encephalopathy
Time Frame: Baseline and at 12 weeks
Baseline and at 12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
correlation between inflammatory mediators and grades of encephalopathy
Time Frame: Baseline and at 12 weeks
To measure values of inflammatory mediators in different grades of encephalopathy
Baseline and at 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Govind Ballabh Pant Hospital

Investigators

  • Principal Investigator: Barjesh c Sharma, DM, GB Pant Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2011

Primary Completion (Actual)

February 1, 2012

Study Completion (Actual)

February 1, 2012

Study Registration Dates

First Submitted

September 11, 2011

First Submitted That Met QC Criteria

October 2, 2011

First Posted (Estimate)

October 5, 2011

Study Record Updates

Last Update Posted (Estimate)

April 10, 2012

Last Update Submitted That Met QC Criteria

April 9, 2012

Last Verified

April 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • endotoxins in MHE

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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