Turmeric as Treatment in Epilepsy
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Number of epilepsy patients enrolled in study
研究概览
简要总结
This is a single center open-label pilot clinical trial of patients 1-70 years of age with greater than 6 seizures per month diagnosed with Dravet Syndrome, Lennox-Gastaut Syndrome, Tuberous Sclerosis, or focal seizures. Twenty patients will be enrolled and treated with a stable dose of orally administered turmeric oil daily for 3 months. Patients and caregivers will be asked to keep a seizure diary logging all clinical events during the course of the study. Serum comprehensive metabolic panel, complete blood count with differential, and antiseizure medication levels, will be monitored at baseline, 1.5 months, and at the end of 3 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 1 Year 至 70 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with greater than greater than six seizures per month diagnosed with Dravet Syndrome, Lennox-Gastaut Syndrome, Tuberous Sclerosis, or focal seizures followed at NYU CEC.
排除标准
- •Patients expected to have changes to any medications or supplements during study period
- •exposure to any investigational agent in the month prior to study entry
- •pregnant or breast feeding women, positive pregnancy test
- •history of non-compliance
- •known drug or alcohol dependence
- •known baseline hematologic
- •liver function
- •renal function
- •absorption
- •absorption
研究组 & 干预措施
Turmeric Oil
stable dose of orally administered turmeric oil
干预措施: Turmeric (Dietary Supplement)
结局指标
主要结局
Number of epilepsy patients enrolled in study
时间窗: 3 months
feasibility of recruiting patients into a prospective study designed to evaluate the effect of orally ingested turmeric oil on seizures.
次要结局
- Number of epilepsy seizures post epilepsy treatment with turmeric(3 months)