Efficacy of Monotherapy vs Combination Therapy of Corticosteroids With GCSF in Severe Alcoholic Hepatitis Patients.

Study Overview
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Brief Summary
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The patients of Severe Alcoholic Hepatitis (SAH) will be included in study based on inclusion and exclusion criteria. The patients will be then randomized in 3 groups for therapy. They will receive either steroid or Granulocyte-Colony Stimulating Factor (GCSF) or both. They will be followed for atleast 90 days for improvements in symptoms and various predefined parameters. Primary outcome will be improvement in survival at 90 Days. Patients will be monitored at every follow up for disease progression and complications of therapy. The study results will be analyzed for differences in survival rate and complications in different groups to propose new therapeutic guideline in SAH patients.

Official Title
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Efficacy of Monotherapy vs Combination Therapy of Corticosteroids With GCSF in Severe Alcoholic Hepatitis Patients -A Randomized Controlled Trial.

Conditions
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Alcoholic Hepatitis

Intervention / Treatment
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* Drug: Gcsf
* Drug: Prednisolone


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Severe alcoholic hepatitis patients [Maddrey's score > 32] aged between 18 to 65 years. Exclusion Criteria: Presence of active infections Acute Gastrointestinal bleed Hepatorenal syndrome Patient unwilling Discriminant Function >90 Autoimmune hepatitis Hepatitis B, Hepatitis C, Human immunodeficiency Virus cases Pregnancy Hemophagocytic lymphohistiocytosis (HLH) Hb<8 and baseline White Blood Cell>25000

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Prednisolone+G-CSF<br>Prednisolone 40 mg/day for initial 7 days G-CSF300 microgram daily for 7 days | Drug: Gcsf<br>* Granulocytes-Colony Stimulating Factor 300 mcg for 7 days followed by 300 mcg every 3 days<br>Drug: Prednisolone<br>* Prednisolone 40 mg for initial 7 days<br>|
| Active Comparator: Prednisolone<br>Prednisolone 40 mg/day for 7 days | Drug: Prednisolone<br>* Prednisolone 40 mg for initial 7 days<br>|
| Experimental: Granulocytes-Colony Stimulating Factor<br>Granulocytes-Colony Stimulating Factor 300 mcg for 7 days followed by 300 mcg every 3 days | Drug: Gcsf<br>* Granulocytes-Colony Stimulating Factor 300 mcg for 7 days followed by 300 mcg every 3 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| increase in Survival at 90 days in all the groups. |  | 90 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in CTP (Child-Pugh Score) in all the groups. | CTP- Child-Turcotte-Pugh score ranges from 5 to 15, lowest is best and highest is worst. | Day 28 | 
| Improvement in CTP (Child-Pugh Score) in all the groups. | CTP- Child-Turcotte-Pugh score ranges from 5 to 15, lowest is best and highest is worst. | Day 180 | 
| Improvement in MELD (Model for End Stage Liver Disease) in all the groups. | A disease severity scoring system for adults with liver disease, designed to improve the organ allocation in transplantation based on the severity of liver disease rather than the length of time on the waiting list. A MELD score is a number that ranges from 6 to 40, based on lab tests. | Day 28 | 
| Improvement in MELD (Model for End Stage Liver Disease) in all the groups. | A disease severity scoring system for adults with liver disease, designed to improve the organ allocation in transplantation based on the severity of liver disease rather than the length of time on the waiting list. A MELD score is a number that ranges from 6 to 40, based on lab tests. | Day 180 |