drugset / Trial / NCT02464124
Nitazoxanide Plus Lactulose Versus Lactulose Alone Treatment of Hepatic Encephalopathy
RandomizedParallel-groupDouble-blindTreatment
Summary
Hepatic encephalopathy (HE) is a reversible neuropsychiatric syndrome associated with chronic and acute liver dysfunction. It is characterized by cognitive and motor deficits of varying severity. Treatment options include lactulose administered orally or by nasogastric tube or enema, non-absorbable antibiotics, and protein-restricted diets. Nitazoxanide is an oral agent indicated for the treatment of infectious diarrhea caused by Crytpsporidiumparvum and Giardia lamblia. Basu and colleagues presented 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.
Timeline
- Start
- 2016-01
- Primary completion
- 2017-12
- Completion
- 2017-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Nitazoxanide | Other / unclassified | 500 mg | Oral |
| Background | Lactulose | Other / unclassified | 30 ml | Oral |
| Background | Lactulose | Other / unclassified | 60 ml | Oral |