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Short course steroids in alcohol associated hepatitis

Seven day versus fourteen-day corticosteroid in patients with severe alcohol-associated hepatitis- A Double blind randomized controlled trial - STASH II

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/03/083463
Enrollment
146
Registered
2025-03-26
Start date
Unknown
Completion date
Unknown
Last updated
2026-08-03

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: Steroid for 7 day: Prednisolone will be given for 7 days followed by placebo for next 7 days Control Intervention1: steroid for 14 days: Prednisolone 40 mg will be given for 14 days and

Sponsors

AIG Hospitals
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.AAH patients with age 18 to 80 years 2.AAH patients with MELD greater than 21 and mDF greater than 32 3.Patients with infection at baseline will be included if they have controlled infection.

Exclusion criteria

Exclusion criteria: 1.patients less than 18 years of age and greater than 80 years 2. Patients with HIV 3.patients who are no willing to provide consent 4.Hepatocellular carcinoma, portal vein thrombosis or hepatic venous outflow tract obstruction 5.Active peptic ulcer disease 6.Acute kidney injury where creatinine should not exceed 1.5mg/dl 7.Recent / ongoing bleed 8.Patients with concomitant other liver diseases including hepatitis B, C

Design outcomes

Primary

MeasureTime frame
Incidence of infectionTimepoint: Day 28 and 90

Secondary

MeasureTime frame
1.Efficacy in each group (MELD17) 2.Number of responders in each group 3.source,site & outcomes of infection in each group 4.Incidenceof AKI in each group 5.Compare the proportion of patients requiring readmissions in each group 5.compare adverse events in each groupTimepoint: Day 28 & 90

Countries

India

Contacts

Public ContactDr Anand V Kulkarni

AIG Hospitals

anandvk90@gmail.com8553322434

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Aug 10, 2026