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Efficacy and Safety of Nitazoxanide in Preventing Recurrence of Hepatic Encephalopathy

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

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04161053
Enrollment
60
Registered
2019-11-13
Start date
2018-11-01
Completion date
2028-12-31
Last updated
2019-11-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatic Encephalopathy

Brief summary

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

DRUGRifaximin

Rifaximin 550 mg twice daily for 6 months

DRUGNitazoxanide

Nitazoxanide 500 mg twice daily for 6 months

Sponsors

Tanta University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
20 Years to 65 Years
Healthy volunteers
No

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).

Design outcomes

Primary

MeasureTime frameDescription
Number of encephalopathy episodes during treatment6 monthsThe number of encephalopathy episodes during treatment

Countries

Egypt

Contacts

Primary ContactSherief Abd-Elsalam, ass. prof.
sheriefabdelsalam@yahoo.com00201147773440
Backup Contactsherief abd-elsalam, ass. prof.
sherif_tropical@yahoo.com00201147773440

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026