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The study aimed to find out how well corticosteroids alone work versus corticosteroids and GCSF together in treating people with severe alcoholic hepatitis

A randomized controlled trial to compare the efficacy of Corticosteroid monotherapy and combination therapy with corticosteroids and GCSF in severe alcoholic hepatitis patients - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/09/073866
Enrollment
60
Registered
2024-09-12
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: Prednisolone and Granulocyte colony stimulating factor: Granulocyte colony stimulating factor (GCSF) 300 mcg sub cutaneous daily and Prednisolone 40mg daily for 7 days, favorable to Lil

Sponsors

Bharati Vidyapeeth Deemed to be University Medical CollegePune
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Severe alcoholic hepatitis patients with Maddreys Score more than 32 Age between 18 to 65 yrs

Exclusion criteria

Exclusion criteria: Patients with ongoing infections Patients with pregnancy Patients with severe renal derangement of serum creatinine more than 2.5 Patients with active gastrointestinal bleed Patients with viral hepatitis

Design outcomes

Primary

MeasureTime frame
To compare mortality risk in steroid group and steroid plus granulocyte stimulating factor groupTimepoint: Mortality risk will be assessed at 30 days and 90 days

Secondary

MeasureTime frame
To compare the values of MELD scores in steroid group & steroid plus granulocyte stimulating factor groupTimepoint: To compare MELD score at 30 days & 90 days

Countries

India

Contacts

Public ContactDr Akhil K Nagpal

Bharati Vidyapeeth (Deemed to be) University Medical College

akhilnags55@gmail.com8412000082

Outcome results

None listed

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