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Recruiting NCT04161053

Efficacy and Safety of Nitazoxanide in Preventing Recurrence of Hepatic Encephalopathy

Phase III Interventional Hepatic Encephalopathy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Rifaximin, Nitazoxanide.
Who it may be relevant to
Registry conditions: Hepatic Encephalopathy. Basic parameters: 20 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Egypt
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

Efficacy and Safety of Nitazoxanide in preventing recurrence of Hepatic Encephalopathy.

Detailed description

Clinical Study Evaluating the Efficacy and Safety of Nitazoxanide in preventing recurrence of Hepatic Encephalopathy.

Interventions

  • Drug Rifaximin
    Rifaximin 550 mg twice daily for 6 months
  • Drug Nitazoxanide
    Nitazoxanide 500 mg twice daily for 6 months

Primary outcome measures

  • Number of encephalopathy episodes during treatment [Time frame: 6 months]

Eligibility criteria

Inclusion criteria

  • Cirrhotic patient with at least one previous episode of hepatic encephalopathy.
  • Adult Patients aging from 20 to 65 years old

Exclusion criteria

  • Active GIT bleeding.
  • Major psychiatric illness (psychosis \& epilepsy).
  • Renal insufficiency (S.Cr 2mg/dl).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Prevention

Study locations

Egypt · 1 center
  • Sherief Abd-Elsalam — Tanta

Identifiers

NCT: NCT04161053 · Encephalopathy

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗