Status:
COMPLETED
Efficacy of Combination Therapy of Glucocorticoids and Bovine Colostrum in Treatment of Severe Alcoholic Hepatitis.
Lead Sponsor:
Dayanand Medical College and Hospital
Conditions:
Severe Alcoholic Hepatitis in 'Extremis'- Defined by mDF>54
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
Severe Alcoholic hepatitis (SAH), defined by modified Maddrey's Discriminant Function (DF) ≥32, is associated with significant morbidity and mortality. Of the various treatment modalities evaluated fo...
Detailed Description
Severe alcoholic hepatitis is associated with significant morbidity and mortality. Diagnosis: The diagnosis of (AH) is made by the following criteria11 I.Chronic active alcohol abuse - \> 80 grams i...
Eligibility Criteria
Inclusion
- Severe Alcoholic hepatitis (mDF \> 54)
- Age 18-65 Year
- 4\. Actively consuming alcohol within 6 weeks of entry into the study
Exclusion
- Failure to obtain informed consent
- Active infection or sepsis
- Other concomitant causes of liver disease: viral hepatitis, autoimmune liver disease, metabolic liver disease, vascular liver disease
- HIV positive
- Cow milk allergy or severe lactose intolerance
- Active Gastrointestinal bleeding
- Acute kidney injury at time of randomization with Creatinine \> 1.5 mg/dL
- Evidence of acute pancreatitis or biliary obstruction
- Subjects who are pregnant or lactating
- Significant systemic cardio-pulmonary illness
- Patients requiring the use of vasopressors or inotropic support in 12 hours prior to randomization
- Treatment for alcoholic hepatitis within 1 month of study entry with corticosteroids use\>1 week.
- Any patient who has received any investigational drug or device within 30 days entering into the study
Key Trial Info
Start Date :
September 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2015
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT02265328
Start Date
September 1 2014
End Date
June 1 2015
Last Update
September 15 2015
Active Locations (1)
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1
Dyanand Medical College and Hospital
Ludhiana, Punjab, India, 141001