临床试验/CTRI/2024/08/072001

CTRI/2024/08/072001尚未招募4 期

Efficacy of add on Melatonin on seizure outcome in Focal drug resistant epilepsy patients : A Randomized controlled trial.

Uppula Supriya1 个研究点分布在 1 个国家目标入组 126 人开始时间: 2024年8月15日最近更新: 2024年8月4日

试验速览

阶段: 4 期
状态: 尚未招募
发起方
入组人数: 126
试验地点: 1
主要终点: responder rate

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

In this study focal drug-resistant epilepsy patients will be randomized into intervention and control groups. patients in the intervention group receive melatonin and those in the control group receive placebo. patients will be followed up after 3 months to see the responder rate. other secondary outcomes like seizure free rate, seizure severity reduction, sleep parameters, quality of life will be assessed. This study is aimed at evaluating the efficacy of melatonin as add on antiepileptic in focal drug-resistant epilepsy patients.

研究设计

研究类型: Interventional
分配方式: Randomized
盲法: Participant and Outcome Assessor Blinded

入排标准

年龄范围: 18.00 Year(s) 至 99.00 Year(s)（—）
性别: All

入选标准

•1.Focal drug resistant epilepsy patients on stable treatment during previous month
•Recent seizure attacks [ â‰¥ 3 seizures per month / clusters of seizures].

排除标准

•1.Primary sleep disorders like severe OSA, narcolepsy, cataplexy
•Major depression
•Neuroendocrine tumors
•Rapidly growing brain tumors
•Uncontrolled diabetes
•Hepatic dysfunction
•Severe asthma
•Infertility
•Pregnancy and nursing women.

结局指标

主要结局

responder rate

时间窗: 3 months

次要结局

seizure free rate, seizure severity, sleep parameters, quality of life(3 months)

研究者

发起方

Uppula Supriya

申办方类型

Research institution and hospital

责任方

Principal Investigator

主要研究者

Manjari Tripathi

AIIMS,DELHI,INDIA

研究点 (1)

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