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Completed

NCT Number: NCT01446523

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

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.

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Key information

Conditions

Hepatic Encephalopathy Brain Diseases Brain Diseases, Metabolic Central Nervous System Diseases Digestive System Diseases Hepatic Insufficiency Liver Diseases Liver Failure Metabolic Diseases Nervous System Diseases Nutritional and Metabolic Diseases

Age range

15 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

BC Sharma

New Delhi, National Capital Territory of Delhi, 110060, India

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Placebo

Drug

Syrup, 30 ml BD for 3 months in Gr. NL

Lactulose

Drug

Syrup 30 ml BD for 12 weeks

Other names: Duphalac , Looz

Primary outcomes

  1. Improvement of minimal hepatic encephalopathy

    Time frame: Baseline and at 12 weeks

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Govind Ballabh Pant Hospital

Other Gov

Registry information

Official study title

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

Acronym: endtxninHE

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Oct 5, 2011
Registry last updated
Apr 10, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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