CTRI/2024/06/068371尚未招募4 期
Efficacy and tolerability of Modified Atkins diet in drug refractory epilepsy among adolescents and adults
Dr Victo Varghese1 个研究点 分布在 1 个国家目标入组 62 人开始时间: 2024年6月17日最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 62
- 试验地点
- 1
- 主要终点
- Seizure frequency
研究概览
简要总结
This is a randomized, open labelled, parallel group, single center trial comparing the efficacy and tolerability of Modified Atkins diet combined with standard medical therapy versus standard medical therapy for 3 months among 62 (31+31)adolescents and adults with drug refractory epilepsy. Primary outcome is measured in terms of seizure frequency, Side effects of dietary therapy, Quality of life in epilepsy-problems(QOLIE-P) Index at 3 months.
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
- 13.00 Year(s) 至 55.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients with Drug refractory epilepsy (as per ILAE definition) Patients who agree for regular follow up and ready to maintain seizure diary.
排除标准
- •Previous dietary intervention Medical illness incompatible with intervention Pregnant or lactating woman Patients being evaluated for epilepsy surgery Clinical suspicion of inborn errors of metabolism Patients who defer consent.
结局指标
主要结局
Seizure frequency
时间窗: 3 months
Adverse effects of diet
时间窗: 3 months
次要结局
- Quality Of Life In Epilepsy - Problems (QOLIE 10 P) Index(3 months)
研究者
Dr Victo Varghese
PGIMER, Chandigarh
研究点 (1)
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