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

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 ENCEPHALOPATHY Acronym: RIME

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2009/091/000979

Enrollment

100

Registered

2009-12-02

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: Rifaximin: Rifaximin 1200 mg per day for 8 weeks, orally Control Intervention1: Placebo:

Eligibility

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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)

Design outcomes

Secondary

Measure	Time frame
Improvement in quality of lifeTimepoint: 8 weeks	—

Primary

Measure	Time frame
Improvement in psycohomotor test performanceTimepoint: 8 weeks	—

Countries

India

Contacts

Public ContactDr Sandeep Sidhu

Professor

dmcgastro@in.com0161- 2402855

Outcome results