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
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 4
- 主要终点
- Comparative difference in number of monthly migraine days.
研究概览
简要总结
It is a randomized,double blind, placebo controlled, multi-center, comparative, interventional,prospective clinical study to evaluate efficacy and safety of MIGRA365 Capsulein Participants Suffering from Episodic Migraine. The study will be carried outat 4 to 5 centers in India. Subjects will be asked to take givenproduct (MIGRA365 capsule or matchingplacebo) in a dose of 1 capsule twice daily orally aftermeals with water for 3 months. Primary objective of the study will be to assesscomparative difference in number of monthly migrainedays. Secondary objectives of the study will be to assess comparativechange in mild/ moderate / severe migraine days based, comparativedifference in 50% responder rate for the reduction of migrainedays, comparative difference in associated symptoms, comparativeassessment of use of rescue medications, comparativedifference in insomnia,comparative difference in anxiety level, globalassessment of overall change, global assessment of tolerability of studyproducts, assessmentof adverse events and safety laboratory investigations on Screening Visit (up to Day 30), Baseline Visit (Day0), Day 15 (Telephonic Follow up, Visit 1 (Day 30), Day 45 (Telephonic Followup), Visit 2 (Day 60), Day 75 (Telephonic Follow up), Visit 3 (Day 90)
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 49.00 Year(s)（—）
- 性别
- All
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Comparative difference in number of monthly migraine days.
时间窗: Screening Visit (up to Day 30), Baseline Visit (Day 0), Day 15 (Telephonic Follow up, Visit 1 (Day 30), Day 45 (Telephonic Follow up), Visit 2 (Day 60), Day 75 (Telephonic Follow up), Visit 3 (Day 90)
次要结局
- 1.Comparative change in mild , moderate , severe migraine days(2.Comparative difference in 50% responder rate for the reduction of migraine days)