Ornithine L-Aspartate for prevention of hepatic encephalopathy
- Conditions
- Health Condition 1: null- Cirrhotics with Hepatic Encephalopathy
- Registration Number
- CTRI/2014/08/004836
- Lead Sponsor
- Win Medicare Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 150
•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
•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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method â?¢Superiority of L-Ornithine L-Aspartate compared to placebo in the efficacy of prevention of overt HE recurrence.Timepoint: one week to 3 months
- Secondary Outcome Measures
Name Time Method â?¢Time taken for first breakthrough episode of overt hepatic encephalopathy <br/ ><br>â?¢Time to first overt hepatic encephalopathy-related hospital admission <br/ ><br>Timepoint: one week to 3 months