Clinical study on MIGRA365 Capsule in Migraine
- Conditions
- Health Condition 1: G439- Migraine, unspecified
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 0
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Comparative difference in number of monthly migraine days.Timepoint: 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)
- Secondary Outcome Measures
Name Time Method 1.Comparative change in mild , moderate , severe migraine days <br/ ><br>2.Comparative difference in 50% responder rate for the reduction of migraine days <br/ ><br>3.Comparative difference in associated symptoms <br/ ><br>4.Comparative assessment of use of rescue medications <br/ ><br>5.Comparative difference in insomnia <br/ ><br>6.Comparative difference in anxiety level <br/ ><br>7.Global assessment of overall change <br/ ><br>8.Global assessment of tolerability of study products <br/ ><br>9.Assessment of adverse events. <br/ ><br>10.Assessment of safety laboratory investigations <br/ ><br>Timepoint: 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)