A clinical trial to study the efficacy of Rifaximin in improving the quality of life and treating encephalopathy in patients with cirrhosis and minimal hepatic encephalopathy
- Registration Number
- CTRI/2009/091/000979
- Lead Sponsor
- Dr Sandeep Sidhu Professor Department of Gastroenterology DMC and Hospital, Ludhiana. Punjab Tel: 0161- 2402855 Cell: 9814025085, Fax: 0161-2302620 Email- dmcgastro@in.com
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 100
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
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)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Improvement in psycohomotor test performanceTimepoint: 8 weeks
- Secondary Outcome Measures
Name Time Method Improvement in quality of lifeTimepoint: 8 weeks