Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prednisolone+G-CSF | Experimental | Prednisolone 40 mg/day for initial 7 days G-CSF300 microgram daily for 7 days |
|
| Prednisolone | Active Comparator | Prednisolone 40 mg/day for 7 days |
|
| Granulocytes-Colony Stimulating Factor | Experimental | Granulocytes-Colony Stimulating Factor 300 mcg for 7 days followed by 300 mcg every 3 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gcsf | Drug | Granulocytes-Colony Stimulating Factor 300 mcg for 7 days followed by 300 mcg every 3 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| increase in Survival at 90 days in all the groups. | 90 days |
| 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dr Ajay Mishra, MD | Contact | 01146300000 | ajaymishrapandit@gmail.com |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute of Liver and Biliary Sciences | Recruiting | New Delhi | National Capital Territory of Delhi | 110070 | India |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D006519 | Hepatitis, Alcoholic |
| ID | Term |
|---|---|
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D008108 | Liver Diseases, Alcoholic |
Not provided
Not provided
| ID | Term |
|---|---|
| D016179 | Granulocyte Colony-Stimulating Factor |
| D011239 | Prednisolone |
| ID | Term |
|---|---|
| D003115 | Colony-Stimulating Factors |
| D006023 | Glycoproteins |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Prednisolone | Drug | Prednisolone 40 mg for initial 7 days |
|
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 |
| D020751 |
| Alcohol-Induced Disorders |
| D019973 | Alcohol-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D016298 |
| Hematopoietic Cell Growth Factors |
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011506 | Proteins |
| D001685 | Biological Factors |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |