CTRI/2024/08/071841尚未招募2/3 期
Comparison between oral levetiracetam vs oral sodium valproate as a first line therapy in children with newly diagnosed epilepsy - a randomised controlled trial
Pandit bhagwat Dayal Sharma postgraduate institute of medical sciences rohtak1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年8月15日最近更新:
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- To compare the frequency of repeat seizure at 3 months post treatment in valproate and levetiracetam group
研究概览
简要总结
As there is very less data available for the treatment of childhood epilepsy . It is therefore a small effort from my side in contributing about the treatment of childhood epilepsy.In my study there will be comparison of 2 antiepileptic drugs -levetiracetam and sodium valproate role in managing childhood epilepsy in age group between 2-14 years and see the frequency of repeat seizure and adverse effect of both these drugs.
Hence with this study we will be able to see which drug is better in managing childhood epilepsy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 2.00 Year(s) 至 14.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Children aged 2-14 years with New diagnosed epilepsy.
排除标准
- •1.Age less than 2 and more than 14 years 2.Simple febrile seizure 3.Seizure secondary to other condition.
结局指标
主要结局
To compare the frequency of repeat seizure at 3 months post treatment in valproate and levetiracetam group
时间窗: 12 weeks
次要结局
- To see the adverse effects of both these drugs -levetiracetam & sodium valproate(12 weeks)
研究者
Deepak Pahal
Pandit bhagwat Dayal Sharma postgraduate institute of medical sciences Rohtak
研究点 (1)
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