A prospective randomized control trial to compare the safety and efficacy of single dose prednisolone versus divided dose prednisolone in first episode of nephrotic syndrome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Comparison of effect of single dose versus divided dose prednisolone on HPA axis at 6 weeks of treatment in children with first episode of nephrotic syndrome.
研究概览
简要总结
This study is a randomized parallel group active control trial comparing the safety and efficacy of prednisolone[2mg/kg/day]in daily single dose versus divided dose for 6 months in 60 patients with first episode of nephrotic syndrome that will be conducted in Institute Of Child Health,kolkata.The primary outcome measured will be comparison of effect of single dose versus divided dose prednisolone on HPA axis at the completion of 6 week daily treatment . The secondary outcomes will be documentation of time to remission and documentation of number of relapses and the time to first relapse(if any)in the two study groups till 6 months after completion of steroid therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 1.00 Year(s) 至 12.00 Year(s)（—）
- 性别
- All
入选标准
- •All children between 1 to 12 years , with first episode steroid naïve nephrotic syndrome and being commenced on prednisolone were included in this study.
排除标准
- •1.Children with previous history of nephrotic syndrome 2.Children already on steroids.
- •3.Children with allergy to egg or egg components .
- •4.Children below 1yr and above 12yrs.
结局指标
主要结局
Comparison of effect of single dose versus divided dose prednisolone on HPA axis at 6 weeks of treatment in children with first episode of nephrotic syndrome.
时间窗: 6 weeks
次要结局
- Documentation of the time to remission [Remission: urine albumin nil or trace (or proteinuria 4 mg/m2/h) for 3 consecutive early morning specimens](2. Documentation of number of relapses and the time to first relapse (if any) in the two study groups till 6 months after completion of steroid therapy.)