A randomized, double blind, placebo controlled, multi-center, comparative, interventional, prospective clinical study to evaluate efficacy and safety of MIGRA365 Capsule in Participants Suffering from Episodic Migraine - NI

Transformative Learning Solutions Private Limited0 个研究点目标入组 0 人开始时间: 待定最近更新: 2023年7月25日

试验速览

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•1.Literate male and female, in otherwise good health condition,
•2.History of migraine headache disorder meeting International Classification of Headache Disorders ICHD 3 diagnostic criteria for migraine with aura or migraine without aura for greater than 12 months.
•3.Subjects willing to sign informed consent and to undergo all the study procedure

•1.Current diagnosis of chronic migraine according to ICHD-3
•2.History or current diagnosis of migraine with, retinal migraine, complications of migraine, tension-type headache, trigeminal autonomic cephalalgias, hypnic headache, hemicrania continua, or new daily persistent headache.
•3.History of headache attributed to another disorder (e.g., secondary headaches)
•4.Subjects with any other investigational products within 1 month prior to randomization;
•5.Subjects with uncontrolled diabetes mellitus and hypertension
•6.Subjects with known current tuberculosis, HIV, ischemic heart disease, cancer, kidney failure.
•7.Pregnant and lactating women
•8.Subjects with significant abnormal laboratory parameters as per the investigator
•9.Known hypersensitivity to any of the ingredients of MIGRA365 Capsule
•10.Other conditions, which in the opinion of the investigators, make patient unsuitable for enrolment or could interfere with his/her participation in, and completion of the study

发起方