Efficacy of Monotherapy vs Combination Therapy of Corticosteroids With GCSF in Severe Alcoholic Hepatitis Patients -A Randomized Controlled Trial.
试验速览
- 阶段
- 不适用
- 入组人数
- 126
- 试验地点
- 1
- 主要终点
- increase in Survival at 90 days in all the groups.
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Severe alcoholic hepatitis patients [Maddrey's score > 32] aged between 18 to 65 years.
排除标准
- •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
研究组 & 干预措施
Granulocytes-Colony Stimulating Factor
Granulocytes-Colony Stimulating Factor 300 mcg for 7 days followed by 300 mcg every 3 days
干预措施: Gcsf (Drug)
Prednisolone+G-CSF
Prednisolone 40 mg/day for initial 7 days G-CSF300 microgram daily for 7 days
干预措施: Gcsf (Drug)
Prednisolone+G-CSF
Prednisolone 40 mg/day for initial 7 days G-CSF300 microgram daily for 7 days
干预措施: Prednisolone (Drug)
Prednisolone
Prednisolone 40 mg/day for 7 days
干预措施: Prednisolone (Drug)
结局指标
主要结局
increase in Survival at 90 days in all the groups.
时间窗: 90 days
次要结局
- Improvement in CTP (Child-Pugh Score) in all the groups.(Day 180)
- Improvement in MELD (Model for End Stage Liver Disease) in all the groups.(Day 180)