Hepatic Encephalopathy Clinical Trial
Official title:
The Clinical Effects of Nitazoxanide in Hepatic Encephalopathy Patients: A Pilot Study
Evaluating the efficacy and safety of nitazoxanide in comparison to standard treatment in patients with grade II-III hepatic encephalopathy (HE). Also, Evaluating the effect of administering nitazoxanide on the improvement of patient's quality of life.
Nitazoxanide (NTZ) is a thiazolide anti-infective with activity against anaerobic bacteria,
protozoa and viruses. A pilot prospective study at the 2008 American Association for the
Study of Liver Diseases meeting showing clinical improvement in HE among cirrhotic patients
who received nitazoxanide and lactulose. Based on the excellent safety profile of NTZ, the
present pilot study is conducted hopefully to prove the efficacy of nitazoxanide in treating
patients experiencing HE grade II-III.
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)
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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