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Steroid in alcoholic hepatitis

Tapering vs standard dose of corticosteroids in severe alcohol-associated hepatitis – an open labelled randomized control trial.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/03/050521
Enrollment
250
Registered
2023-03-09
Start date
Unknown
Completion date
Unknown
Last updated
2024-09-16

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

Conditions

Health Condition 1: K701- Alcoholic hepatitis

Interventions

Intervention1: corticosteroids: standard steroid dose of oral prednisolone 40mg once daily for 28 days Control Intervention1: corticoteroid: a tapering dose of oral prednisolone 40mg once daily of tap

Sponsors

AIG Hospitals
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: WIth MELD score >21 and/or mDF >32 Patients with infection at baseline will be included if they have controlled infection.

Exclusion criteria

Exclusion criteria: 1)Age 70 years 2)Active Infection 3)Acute Kidney Injury (creatinine >1.5 mg/dl) 4)Recent / ongoing bleed 5)Active peptic ulcer disease 6)Hepatocellular carcinoma, portal vein thrombosis or hepatic venous outflow tract obstruction 7)Patients with concomitant other liver diseases including hepatitis B, C, NAFLD 8)Patients with HIV 9)Patients who are no willing to provide consent

Design outcomes

Primary

MeasureTime frame
To compare the incidence of infectionTimepoint: at day 28 and day 90

Secondary

MeasureTime frame
Change in severity scoreTimepoint: in both groups - at Day 4,Day 7,Day 28 and Day 90;Compare the adverse events in each groupTimepoint: At Day 90;Compare the incidence of acute kidney injury in each groupTimepoint: At Day 90;Compare the incidence of mortalityTimepoint: at 90 days in both the groups;Compare the number of responders in both the groupsTimepoint: At Day 7;Compare the source, site, and outcomes of infectionTimepoint: At Day 90;To compare the proportion of patients requiring readmissions in each groupTimepoint: at day 90

Countries

India

Contacts

Public ContactAnand V Kulkarni

AIG Hospitals

dranand.v@aighospitals.com

Outcome results

None listed

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