Prophylaxis of hepatic encephalopathy in acute variceal bleed in patients with cirrhosis: an open label randomized trial of lactulose versus Rifaximin

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2013/07/003845

Enrollment

120

Registered

2013-07-29

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- Cirrhotic patients with acute variceal bleed

Interventions

Intervention1: lactulose: Lactulose 30 ml three times or dose adjusted 2-3 loose stools daily for 7 days Control Intervention1: lactulose versus rifaximin: lactulose is nonabsorbable disaccharide and

Eligibility

Inclusion criteria

Inclusion criteria: with acute variceal bleed without overt encephalopathy

Exclusion criteria

Exclusion criteria: with acute variceal bleed with overt encephalopathy; acute non variceal bleed,other neurological disorders

Design outcomes

Primary

Measure	Time frame
Development of hepatic encephalopathyTimepoint: Within 7 days of therapy	—

Secondary

Measure	Time frame
Development of rebleed Any adverse effectsTimepoint: Death	—

Countries

India

Contacts

Public ContactDr B C Sharma

G.B.Pant Hospital

drbcsharma@hotmail.com9718599203

Outcome results

None listed

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