跳至主要内容
临床试验/CTRI/2018/12/016615
CTRI/2018/12/016615尚未招募不适用

Estimation of Phenytoin Concentration in Epileptic Patients with Adequate Seizure Control in North-East India- a pilot study

NEIGRIHMS1 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2018年12月16日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
NEIGRIHMS
入组人数
15
试验地点
1
主要终点
This study will provide the target level of phenytoin that is required for obtaining satisfactory clinical outcome with minimal adverse effect in our setting.

研究概览

简要总结

Studies which have been conducted in India to evaluate the standard patient care through assessment of therapeutic drug monitoring in patients with seizure period are lacking. No such studies have been reported from North East region of India, so the rationale of   adequate seizure control with drugs is yet to be ascertained.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • All the cases of Epilepsy treated in the Department of Neurology who are seizure free in NEIGRIHMS will be included.

排除标准

  • Patients without phenytoin therapy
  • Patients with another AED.
  • Patients with concomitant diseases and medications.

结局指标

主要结局

This study will provide the target level of phenytoin that is required for obtaining satisfactory clinical outcome with minimal adverse effect in our setting.

时间窗: 3 months

次要结局

  • This will help our physicians in delivering better therapy unique to our population in this part of the country.(one year)

研究者

发起方
NEIGRIHMS
申办方类型
Research institution and hospital

研究点 (1)

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