Clinical Study Evaluating the Efficacy and Safety of Nitazoxanide in Preventing Recurrence of Hepatic Encephalopathy

What this Trial Is About

This clinical trial investigates the efficacy and safety of Nitazoxanide in preventing the recurrence of Hepatic Encephalopathy in patients who have had at least one previous episode of this condition. The study is a Phase 3, randomized, quadruple-blinded trial comparing Nitazoxanide with Rifaximin as an active comparator. It is sponsored by Tanta University and aims to evaluate the number of encephalopathy episodes during a six-month treatment period. Participants will be randomly assigned to receive either 500 mg Nitazoxanide tablets or 550 mg Rifaximin tablets, both taken twice daily for six months. The study involves two treatment groups, each receiving their respective drug under close monitoring. This period allows assessment of how well Nitazoxanide works to prevent further episodes compared to Rifaximin. Throughout the study, participants will undergo regular assessments to monitor their health and track episodes of hepatic encephalopathy. Researchers will evaluate the primary outcome measure, which is the number of encephalopathy episodes during the six months of treatment. Safety and adherence will also be monitored to ensure participant well-being during the trial, which may last up to six months of active treatment.

Efficacy and Safety of Nitazoxanide in Preventing Recurrence of Hepatic Encephalopathy