CTRI/2009/091/000876未知4 期
A randomized, controlled trial to study the efficacy of steroids versus steroids and pentoxifylline in severe acute alcoholic hepatitis
Dr Sandeep Sidhu ProfessorDepartment of GastroenterologyDMC and Hospital, Ludhiana. PunjabTel: 0161- 2402855 Cell: 9814025085, Fax: 0161-2302620Email- dmcgastro@in.com1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 待定
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Reduction in Mortality
研究概览
简要总结
This study is a randomized single centre trail evaluating the difference in the efficacy of a combination of corticosteroids (tab Prednisolone 40 mg/day) and pentoxifylline (400 mg, thrice a day, per oral) versus corticosteroids alone for reducing short term (28 days) mortality in patients with severe alcoholic hepatitis. The primary outcome measures will be reduction in short term mortality, while the secondary outcome measures would be improvement in hepatic function.
研究设计
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
入选标准
- •Patients of alcoholic hepatitis with modified Maddrey?s Discriminant factor (DF) ≥ 32.
排除标准
- •Improvement in DF with symptomatic treatment for 5-7 daysPositive viral serology for HAV, HBV, HCV or HEVConcomitant bacterial or fungal infectionsActive gastrointestinal haemorrhageSevere cardiovascular or pulmonary diseasesNeoplastic and other inflammatory conditions.
结局指标
主要结局
Reduction in Mortality
时间窗: 4 weeks
次要结局
- Improvement in Hepatic functions(4 weeks)
研究者
研究点 (1)
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