Efficacy and Safety of Nitazoxanide in Preventing Recurrence of Hepatic Encephalopathy

Tanta University

Status and phase: Enrolling; Phase 3

Conditions: Hepatic Encephalopathy

Treatments: Drug: Rifaximin; Drug: Nitazoxanide

Study type: Interventional

Funder types: Other

Identifiers

NCT04161053

Encephalopathy

Details and patient eligibility

About

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

Full description

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

Enrollment: 60 estimated patients

Sex: All

Ages: 20 to 65 years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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60 participants in 2 patient groups

Rifaximin

Active Comparator group

Description:

550 mg Rifaximin tablets twice daily for six months.

Treatment:

Drug: Rifaximin

Nitazoxanide

Experimental group

Description:

500 mg Nitazoxanide tablets twice daily for six months.

Treatment:

Drug: Nitazoxanide