CTRI/2010/091/003045已完成4 期
To compare the efficacy of rifaximin and lactulose in improving minimal hepatic encephalopathy in patients with cirrhosis: a single blind, randomised, active-comparator, non-inferiority trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 112
- 试验地点
- 1
- 主要终点
- Improvement in psychometric test performance.
研究概览
简要总结
This study is a randomized, single blind, active comparator, non-inferiority single centre trial. It will compare the efficacy of rifaximin with lactulose in improving psychometric test performance in patients with cirrhosis with minimal hepatic encephalopathy, when given for a period of 3 months. The primary outcome measure will be improvement in psychometric test performance, and the secondary outcome measures would be improvement in health related quality of life, and tolerability of rifaximin and lactulose.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Age 18-65 years -Cirrhosis diagnosed on the basis of clinical features, biochemical, radiological and/or liver histology data.
- •Minimal hepatic encephalopathy diagnosed by abnormalities in psychometric tests.
排除标准
- •Known allergy to rifaximin/rifabutin or lactulose.-Current or recent (< 6 weeks) use of alcohol -Use of antibiotics within last 6 weeks-Use of lactulose, lactitol, L-ornithine L-aspartate, zinc, metronidazole, neomycin, or rifaximin within the last 6 weeks-Use of interferon or psychoactive drugs like benzodiazepines, psychotropic drugs, anti-epileptics within the last 6 weeks-Infection or gastrointestinal haemorrhage within the last 6 weeks-Advanced medical problems like congestive cardiac failure, advanced pulmonary disease or renal insufficiency or electrolyte imbalance-Hepatocellular carcinoma-History of porto-systemic shunt surgery or transjugular intrahepatic portosystemic shunt (TIPS)-Pregnancy and breastfeeding-Neurological or psychiatric problems which may influence quality of life measurement.-Poor vision or motor defects which interfere with the performance of psychometric tests.-Current or recent (< 6 months) history of overt hepatic encephalopathy.
- •This would be excluded by:oDetailed history taking from patient, friends/relativesoDetailed neurological examination to check for dysarthria, asterixis, ataxia and disorientationoFocus on lack of awareness, alertness, anxiety or euphoria (To rule out grade 1 hepatic encephalopathy)oMini-mental status examination score > 25-Women of child-bearing potential who is not using two effective methods of contraception.
结局指标
主要结局
Improvement in psychometric test performance.
时间窗: 3 months
次要结局
- Improvement in health related quality of life(3 months)
- Tolerability of rifaximin and lactulose(3 months)
研究者
研究点 (1)
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