CTRI/2019/05/018966Not yet recruitingPhase 2
A Double Blind Randomised Controlled trial comparing Lactulose plus Rifaximin with Lactulose plus Rifaximin plus L-Ornithine L- Aspartate in treatment of Overt Hepatic Encephalopathy(Grade III-Grade IV) in patients with cirrhosis
Department of Gastroenterology G B Pant Hospital0 sites0 target enrollmentStarted: TBDLast updated:
Trial Snapshot
- Phase
- Phase 2
- Status
- Not yet recruiting
- Sponsor
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
Inclusion Criteria
- •1. Age of patients 18-70 years.
- •2. 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.Wilsonâ??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 â?? L â??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
Investigators
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