CTRI/2014/08/004836尚未招募4 期
Secondary Prophylaxis of hepatic encephalopathy in cirrhosis:A double Blind randomized controlled trial of L-Ornithine L-Aspartate (LOLA) versus placebo - LOLA
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 150
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
- •Liver cirrhosis (Child B or Child C class)
- •History of recovery from episod of overt hepatic encephalopathy (West-Haven grade 1 and above) in last 12 months.
- •No evidence of overt hepatic encephalopathy at the time of enrollment
排除标准
- •History of taking lactulose, rifaximin, neomycin, metronidazole, HepaMerz or probiotics in past 6 weeks
- •Alcohol intake during past 6 weeks
- •Receiving secondary prophylaxis for spontaneous bacterial peritonitis
- •Previous transjugular intrahepatic portosystemic shunts or shunt surgery
- •Significant comorbid illness such as heart, respiratory or kidney failure, and neurological disease such as Alzheimerâ??s disease, Parkinsonâ??s disease and non hepatic metabolic encephalopathies
- •Receiving psychoactive drugs such as antidepressants and sedatives
- •Foreseeable risk of alcohol consumption during the study conduct.
- •Hepatocellular carcinoma
- •Anemia (Hemoglobin <8gm/dL)
- •Electrolyte abnormality (Serum sodium <125meq/L or serum potassium <2.5meq/L)
- •Intercurrent infection such as spontaneous bacterial peritonitis
- •Pregnancy, breast feeding or refusal to use a contraceptive method in women of child bearing age
- •Patients with foreseeable compliance <80% during study conduct monitored by counting sachets of Hepa-Merz and bottles of lactulose consumed every month.
研究者
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