A study to see the effect of lactulose plus rifaximin versus lactulose plus rifaximin plus L Ornithine L Aspartate in treatment of brain dysfunction associated with chronic liver disease

Phase 2

Not yet recruiting

• Conditions: Hepatic fibrosis,

• Registration Number: CTRI/2019/05/018966
• Lead Sponsor: Department of Gastroenterology G B Pant Hospital

Brief Summary

This study is a randomized, double blind, parallel group, single centre trial comparing the safety and efficacy of lactulose plus rifaximin versus lactulose plus rifaximin plus L Ornithine L Aspartete in 124 patients wwith Cirrhosis with Hepatic encephalopathy Grade 3 or 4 as per West Haven’s criteria and will be conducted at single centre in India,

Theprimary outcome measure will be Reversal of HE orimprovement of HE by 2 grades (according to West Havens Criteria) and mentalstate grade after 5 days of treatment.

The Secondary Outcomes will be

1.     BloodAmmonia Levels

2.     SerumCytokines levels (time frame 5 days). Changes in serum cytokines measured atbaseline and after 5 days of treatment

a.      Interleukin1

b.     Interleukin6

c.      Interleukin10

d.     TNF

e.      S. Endotoxins

3.  Liver related death

4.  Death due to other causes

5.  Discontinuation due to adverseeffects

6.  Rate of Recovery from HE

7.  Length of hospital stay

8.  Mortality (time frame 4 weeks)

9.  Cause of Death

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2019-06-05
• Study Start: 2019-07-05

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 124

Inclusion Criteria

• Age of patients 18-70 years.
• Hepatic cirrhosis based on clinical, biochemical, radiological and/or histological data 3.
• Patients with overt acute grade 3 and 4 HE, according to the West Haven criteria, with or without precipitating factors.

Exclusion Criteria

• 1.Acute on chronic liver failure 2.Hepatocellular carcinoma 3.Wilson’s disease 4.Advanced cardiac or pulmonary disease 5.Neurologic disease (including head injury and drug intoxication) CNS active drugs.
• 6.Pregnancy or breast feeding 7.Cirrhotics with h/o HE already taking L-Ornithine – L –Aspartate 8.Presence of underlying chronic renal failure (serum creatinine > 1.5mg/dl) 9.Psychiatric illness; patients who are on sedatives and antidepressants 10.Those who do not give informed consent.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Reversal of HE or improvement of HE by 2 grades (according to West Havens Criteria) and mental state grade after 5 days of treatment	Reversal of HE or improvement of HE by 2 grades (according to West Havens Criteria) and mental state grade after 5 days of treatment

Secondary Outcome Measures

Name	Time	Method
Serum Cytokines levels	(IL-1,IL-6,IL-10,TNF-alpha,S. Endotoxins)
Death due to other causes	28 days
Rate of Recovery from HE	5 days
Length of hospital stay	28 days
Blood Ammonia Levels	5 days
Discontinuation due to adverse effects	5 days
Liver related death	28 days
Mortality (time frame 4 weeks)	28 days
Cause of Death	28 days

Trial Locations

Locations (1)

GB Pant Hospital New Delhi; 🇮🇳 Central, DELHI, India

GB Pant Hospital New Delhi

🇮🇳Central, DELHI, India

Dr B C Sharma

Principal investigator

7389529125

barjeshchandershama@gmail.com