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a clinical trial to compare the efficacy of two drug combination (rifaximin and lactulose) against one drug (lactulose) in patients having hepatic encephalopathy

a randomized controlled trial comparing the efficacy of a combination of rifaximin and lactulose with lactulose only in the treatment of overt hepatic encephalopathy - RILAHE

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2016/08/007215
Enrollment
90
Registered
2016-08-19
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

Health Condition 1: null- overt hepatic encephalopathy

Interventions

Intervention1: Rifaximin tablets 400 mg: One Rifaximine tablet of 400 mg to be given orally thrice daily for 10 days or till discharge, whichever is earlier Control Intervention1: Placebo tablets: One

Sponsors

North Bengal Medical College and Hospital
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Adult patients with diagnosed chronic liver disease having encephalopathy (grade I to IV), after exclusion of metabolic/infective causes, admitted in the general medicine ward of North Bengal Medical College and Hospital during the study period.

Exclusion criteria

Exclusion criteria: •Age 60yrs •Presence of any diagnosed neuropsychiatric illness and/or current use of antipsychotic/antidepressant medications •Presence of any intestinal obstruction or inflammatory bowel disease •Diagnosed hypersensitivity to rifamycin or disaccharides •Serum creatinine > 1.5mg/dl •Electrolyte abnormality (sodium 150 mEq/l) •Minimal hepatic encephalopathy [Conn grade 0] •Hypoglycaemia ( capillary blood glucose •Consent not given

Design outcomes

Primary

MeasureTime frame
Improvement in neurological status by Conn scoreTimepoint: At discharge or at the end of 10 days, whichever is earlier

Secondary

MeasureTime frame
not applicableTimepoint: not applicable

Countries

India

Contacts

Public ContactDr Shakeb Hasan

North Bengal Medical College and Hospital

dr_saikat@rediffmail.com03532585309

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026