Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
36 participants
INTERVENTIONAL
2014-12-31
2015-04-30
Brief Summary
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Detailed Description
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Study design:The study is Prospective, Randomized, Controlled, Open-Label, Pilot study.
Method: The study will include a total of 36 patients with grade II-III Hepatic Encephalopathy, and an informed consent will be obtained from every patient before being included.
All the patients will receive oral lactulose, plus either nitazoxanide, metronidazole or rifaximine.
A- All patients will be subjected to the following at baseline:
* Patient's full history
* Liver disease staging using Model for End stage Liver Disease (MELD) score
* Measurement of serum electrolytes (Na+, K+, Ca2+)
B- All patients will be subjected to the following at baseline and at the end of treatment:
* Measuring Blood ammonia level
* Measuring liver function tests (AST, Total bilirubin, international normalized ratio (INR), Serum albumin, prothrombin time (PT)), serum creatinine and complete blood count (CBC)
* Assessing severity of Hepatic Encephalopathy using Clinical Hepatic Encephalopathy Staging Scale (CHESS)
C- Monitoring tolerability up to 30 days after the last dose D- Assessment of quality of life using Chronic Liver Disease Questionnaire (CLDQ)
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Nitazoxanide group
12 patients will receive the following for 7 days:
* Oral lactulose
* 500 mg nitazoxanide tablets twice daily
Nitazoxanide
500 mg nitazoxanide tablets twice daily
Oral lactulose
Oral lactulose (65%)
Metronidazole group
12 patients will receive the following for 7 days:
* Oral lactulose
* 250 mg metronidazole tablets every 8 hours
Oral lactulose
Oral lactulose (65%)
Metronidazole
250 mg metronidazole tablets every 8 hours
Rifaximine group
12 patients will receive the following for 7 days:
* Oral lactulose
* Two 200 mg rifaximine tablets every 8 hours
Oral lactulose
Oral lactulose (65%)
Rifaximine
Two 200 mg rifaximine tablets every 8 hours
Interventions
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Nitazoxanide
500 mg nitazoxanide tablets twice daily
Oral lactulose
Oral lactulose (65%)
Metronidazole
250 mg metronidazole tablets every 8 hours
Rifaximine
Two 200 mg rifaximine tablets every 8 hours
Eligibility Criteria
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Inclusion Criteria
* Patients with grade II-III Hepatic Encephalopathy.
Exclusion Criteria
* Patients with major psychiatric illness.
* Patients receiving benzodiazepines, narcotics, alcohol and marijuana.
* Patients with compromised renal or biliary functions.
* Patients known to have AIDS.
* Patients receiving medications highly bound to plasma proteins eg. Warfarin.
* Patients with known hypersensitivity to nitazoxanide.
* Pregnant or lactating women.
18 Years
65 Years
ALL
No
Sponsors
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Al-Azhar University
OTHER
Ain Shams University
OTHER
Responsible Party
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Asmaa Abdel Aziz ElRakaybi
Teaching assistant
Principal Investigators
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Asmaa A. Elrakaybi, Bachelor
Role: PRINCIPAL_INVESTIGATOR
Ain Shams University
Locations
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Faculty of medicine, Ain Shams University
Cairo, , Egypt
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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PHCL400
Identifier Type: -
Identifier Source: org_study_id
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