CTRI/2009/091/000979招募中4 期
PROSPECTIVE RANDOMIZED, DOUBLE BLIND PLACEBO CONTROLLED STUDY TO EVALUATE THE EFFECT OF RIFAXIMIN ON PSYCHOMETRIC TEST PERFORMANCE AND QUALITY OF LIFE IN PATIENTS WITH CIRRHOSIS AND MINIMAL HEPATIC ENCEPHALOPATHYAcronym: RIME
Dr Sandeep Sidhu Professor Department of Gastroenterology DMC and Hospital, Ludhiana. Punjab Tel: 0161- 2402855 Cell: 9814025085, Fax: 0161-2302620 Email- dmcgastro@in.com0 个研究点目标入组 100 人开始时间: 待定最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 100
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
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
- •Allergy to rifaximin, rifabutin, rifampin, or rifapentine
- •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.
- •Presence of overt hepatic encephalopathy (current or past)
研究者
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