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Effect of prednisolone (drug) and GCSF (injecting) for alcohol related liver disease

Efficacy of monotherapy vs combination therapy of corticosteroids and/or GCSF in Severe Alcoholic Hepatitis patients -A Randomized Controlled Trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2019/08/020966
Enrollment
126
Registered
2019-08-29
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: K701- Alcoholic hepatitis

Interventions

Intervention1: GCSF with Prednisolone: Granulocytes-Colony Stimulating Factor 300 mcg for 7 days followed by 300 mcg every 3 days Prednisolone 40 mg for initial 7 days Intervention2: Granulocytes-Colo

Sponsors

Institute of Liver and Biliary Sciences
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Severe alcoholic hepatitis patients [Maddreyâ??s score > 32] aged between 18 to 65 years

Exclusion criteria

Exclusion criteria: 1) Presence of active infections 2) Acute GI bleed 3) Hepatorenal syndrome 4) Patient unwilling DF >90 5) Autoimmune hepatitis 6) Hepatitis B, Hepatitis C, HIV cases 7) Pregnancy • HLH • Hb 25000

Design outcomes

Primary

MeasureTime frame
Increase in Survival at 90 daysTimepoint: 90 days—

Secondary

MeasureTime frame
Improvement in indices of liver disease severity at day 28 and 180Timepoint: day 28 and day 180—

Countries

India

Contacts

Public ContactDr Shiv Kumar Sarin

Institute of Liver and Biliary Sciences

shivsarin@gmail.com01146300000

Outcome results

None listed

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