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"Study of lactulose plus albumin in comparison to lactulose alone in treatment of neurocognitive changes due to chronic liver disease (hepatic encephalopathy) .

â??A randomized controlled trial comparing lactulose plus albumin versus lactulose alone for the treatment of hepatic encephalopathyâ??.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2015/01/005456
Enrollment
120
Registered
2015-01-23
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- hepatic encephalopathy

Interventions

Intervention1: lactulose plus albumin for 10 days : patients will receive 1.5 g albumin/kg /day along with lactulose 20-30 ml , 2-3 times Control Intervention1: lactulose for 10 days: lactulose will

Sponsors

G B PANT HOSPITAL
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: • Cirrhosis • Age 18-80 • Hepatic encephalopathy grade II-IV • Informed consent

Exclusion criteria

Exclusion criteria: 1.Degenerative CNS disease or major psychiatric illness 2. Serum creatinine > 1.5 mg/dl 3. Active alcohol intake 4. Others metabolic encephalopathies 5. Hepatocellular Carcinoma 6. Severe comorbidity such as CHF, Pulmonary disease, Neurological & Psychiatric problems impairing quality of life 7. Patients who are having sensitivity to albumin or contraindication of albumin

Design outcomes

Primary

MeasureTime frame
Reversal of hepatic encephalopathyTimepoint: Reversal of hepatic encephalopathy within 10 days—

Secondary

MeasureTime frame
1. Mortality 2. Hospital stay Timepoint: within 10 days—

Countries

India

Contacts

Public ContactDR ALOK SANGAM

MAMC, NEW DELHI

drbcsharma@hotmail.com9718599203

Outcome results

None listed

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