Role of Prednisolone (drug) in Steroid (drug) Responsive Severe Alcoholic Hepatitis(liver disease).
Phase 2
- Conditions
- Health Condition 1: K758- Other specified inflammatory liverdiseases
- Registration Number
- CTRI/2024/01/061345
- Lead Sponsor
- Institute of Liver and Biliary Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
1. Persistence of mDF > 32 at day 28 of steroids
Exclusion Criteria
1. Active infection
2. Uncontrolled sugars
3. No consent
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To assess the proportion of steroid responsive SAH patients achieving remission by extended low dose Prednisolone (10mg/day) till day 90 in comparison to SMTTimepoint: 90 days
- Secondary Outcome Measures
Name Time Method 90 day readmission ratesTimepoint: 90 days;New onset infections, diabetesTimepoint: 90 days;To assess the effect of extended low dose steroids in steroid responsive SAH on CTP, MELD-Na, DFTimepoint: 90 days;To assess the effect of extended low dose steroids in steroid responsive SAH on transplant free survivalTimepoint: 90 days