BCAA vs. Rifaximin in Patients With Cirrhosis for Secondary Prophylaxis of HE

Recruiting Phase 4 Interventional Study
Hepatic Encephalopathy Decompensated Cirrhosis Minimal Hepatic Encephalopathy
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 – 65
Sex
Any
Trial phase
Phase 4
Study type
Interventional
Purpose
Treatment
Participants needed
336 (estimated)
Sponsor
Post Graduate Institute of Medical Education and Research, Chandigarh · Other
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About This Trial
Rationale * Patients who recover from an episode of overt HE(OHE) are at risk of recurrent episodes of HE and persistent minimal hepatic encephalopathy, impacting their daily functioning and mental health. * A multicentric pan-India team will evaluate the role of oral branched-chain amino acids (BCAA) vs Rifaximin as secondary prophylaxis following overt HE as compared with improvement in cogniti…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: 1. Cirrhosis defined by standard clinical, ultrasonographic findings and/or histological criteria. Cirrhosis of any etiology may be included. However, patients with cirrhosis due to autoimmune hepatitis must be on stable corticosteroid doses for ≥3-month period before study incl…
Contacts

Madhumita Premkumar

+9101722754777

drmadhumitap@gmail.com

CONTACT