The Clinical Effects of Nitazoxanide in Hepatic Encephalopathy Patients: A Pilot Study
试验速览
- 阶段
- 2 期
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Evaluating the efficacy of nitazoxanide in improving mental status (calculating CHESS score)
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult Patients from 18 to 65 years.
- •Patients with grade II-III Hepatic Encephalopathy.
排除标准
- •Patients with active GIT bleeding.
- •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.
研究组 & 干预措施
Nitazoxanide group
12 patients will receive the following for 7 days:
- Oral lactulose
- 500 mg nitazoxanide tablets twice daily
干预措施: Nitazoxanide (Drug)
Nitazoxanide group
12 patients will receive the following for 7 days:
- Oral lactulose
- 500 mg nitazoxanide tablets twice daily
干预措施: Oral lactulose (Drug)
Metronidazole group
12 patients will receive the following for 7 days:
- Oral lactulose
- 250 mg metronidazole tablets every 8 hours
干预措施: Oral lactulose (Drug)
Metronidazole group
12 patients will receive the following for 7 days:
- Oral lactulose
- 250 mg metronidazole tablets every 8 hours
干预措施: Metronidazole (Drug)
Rifaximine group
12 patients will receive the following for 7 days:
- Oral lactulose
- Two 200 mg rifaximine tablets every 8 hours
干预措施: Oral lactulose (Drug)
Rifaximine group
12 patients will receive the following for 7 days:
- Oral lactulose
- Two 200 mg rifaximine tablets every 8 hours
干预措施: Rifaximine (Drug)
结局指标
主要结局
Evaluating the efficacy of nitazoxanide in improving mental status (calculating CHESS score)
时间窗: 7 days
evaluating the efficacy by measuring serum ammonia and calculating CHESS score at baseline and at end of treatment
次要结局
- Evaluating the safety of nitazoxanide (estimation of treatment- related undesirable effects)(37 days)
- Effect of nitazoxanide on patient's quality of life (CLDQ score)(7 days)
研究者
Asmaa Abdel Aziz ElRakaybi
Teaching assistant
Ain Shams University