CTRI/2021/12/039005尚未招募2 期
Comparison of efficacy of add on oral serratiopepitadase for reducing severity of headache during the acute phase of perilesional edema in calcified neurocysticercosis: an open labeled randomized controlled trial
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 102
- 试验地点
- 1
- 主要终点
- HIT score in both arms
研究概览
简要总结
This trial will explore the efficacy of add on oral serratiopeptidase 5 mg BD for seven days in reducing the severity of headache in children with calcified neurocysticercosis aged 5-18 years with perilesional oedema in acute stage, when measured on day 7 by Headache impact test-6 score
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
- 5.00 Year(s) 至 18.00 Year(s)（—）
- 性别
- All
入选标准
- •Calcified NCC Perilesional edema on CT or MRI brain Headache for at least 48 hours, not attributable to any other etiology.
排除标准
- •Viable Neurocysticercosis Absence of perilesional oedema on neuroimaging Any coexisting primary or secondary headache etiology Previously documented allergy to serratiopeptidase.
结局指标
主要结局
HIT score in both arms
时间窗: At baseline and at 1 week follow up
次要结局
- Reduction in HIT score in both arms on day 14 on follow up as compared to baseline(Reduction in HIT score in both arms on day 14 on follow up as compared to baseline)
研究者
研究点 (1)
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