Ocimum sanctum extract as an adjuvant therapy in persons with drug resistant epilepsy: A double blind, randomized, placebo controlled study

All India institute of medical science0 个研究点目标入组 0 人开始时间: 待定最近更新: 2023年4月3日

试验速览

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•1)Clinically diagnosed persons with drug resistant epilepsy (as per ILAE definition)
•2)Subjects with epilepsy on stable ASDs treatment regimen for at least 4 weeks
•3)Subject having seizure frequency at least 2 per month
•4)Subject of age 18 to 60 years of either gender.
•5)Ability to maintain seizure diary.

•Pregnant or seeking pregnancy, lactating women
•Associated neurological and clinically diagnosed psychiatric diseases other than epilepsy
•Progressive brain diseases
•Subject undergoing ASD tapering
•Subjects on any herbal drug/ ayurvedic supplementation in the past 3 months
•Subjects on drugs known to alter seizure threshold (e.g. INH, theophylline, metronidazole etc.)
•Subjects on antitubercular drugs or any other drugs known to cause interaction with ASDs (e.g. isoniazid, fluoxetine, fluvoxamine, clarithromycin, erythromycin, fluconazole etc.)
•Subject refused to give informed consent
•Subjects which require epileptic surgery in immediate next 3 months and those who had status epilepticus in the past 3 months
•H/o poor compliance to ASDs

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