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To study the efficacy of high dose steroids and compare it with no steroids in patients with severe alcoholic hepatitis with is a type of alcohol associated liver disease

Evaluation of pulse dose corticosteroids in patients with severe alcoholic hepatitis - NIL

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/06/069359
Enrollment
90
Registered
2024-06-21
Start date
Unknown
Completion date
Unknown
Last updated
2024-07-22

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: Pulse dose Methylprednisolone: Patients assigned to the pulse dose steroids group will receive 500mg Methylprednisolone on day 1, day 3 and day 15 along with the standard of care. Lille

Sponsors

Dr Prachis Ashdhir
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: All the patients greater than 18years of age with diagnosed Severe Alcoholic hepatitis with mDF (Maddrey’s Discriminant function) greater than 32 with or without underlying cirrhosis are included.

Exclusion criteria

Exclusion criteria: Patients with evidence of active GI bleed,active Infections/ Sepsis,patients with mDF greater than 90,patients with encephalopathy,patients with AKI/ Renal failure,patients requiring inotropic support,not willing to give consent.presence of other liver diseases and pregnant women.

Design outcomes

Primary

MeasureTime frame
To identify and compare the survival of patients on standard of care treatment and pulse dose steroids.Timepoint: The patients and the outcomes will be assessed at 4th day, at 2 weeks, at 4 weeks and at 6 weeks.

Secondary

MeasureTime frame
To identify the appropriate dose and side effects profile of patients on pulse dose steroids.Timepoint: 6weeks

Countries

India

Contacts

Public ContactArun S Sankannavar

SMS Medical college and Attached Hospitals, Jaipur

arun.ssankannavar@gmail.com9481853997

Outcome results

None listed

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