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NCT01446523 Clinical Trial

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

Hepatic Encephalopathy Clinical Trial

— endtxninHE  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01446523
Other study ID # endotoxins in MHE
Secondary ID
Status Completed
Phase N/A
First received September 11, 2011
Last updated April 9, 2012
Start date October 2011
Est. completion date February 2012

Study information
Verified date April 2012
Source Govind Ballabh Pant Hospital
Contact n/a
Is FDA regulated No
Health authority India: Ministry of Health
Study type Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 60
Est. completion date February 2012
Est. primary completion date February 2012
Accepts healthy volunteers No
Gender Both
Age group 15 Years to 70 Years
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• placebo
Syrup, 30 ml BD for 3 months in Gr. NL
• Lactulose
Syrup 30 ml BD for 12 weeks

Locations
Country Name City State
India BC Sharma New Delhi Delhi

Sponsors (1)
Lead Sponsor Collaborator
Govind Ballabh Pant Hospital

Country where clinical trial is conducted

India, 

Outcome
Type Measure Description Time frame Safety issue
Primary Improvement of minimal hepatic encephalopathy Baseline and at 12 weeks Yes
Secondary correlation between inflammatory mediators and grades of encephalopathy To measure values of inflammatory mediators in different grades of encephalopathy Baseline and at 12 weeks Yes
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