Health Condition 1: G439- Migraine, unspecified
Conditions
Interventions
None listed
Sponsors
Transformative Learning Solutions Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 1. Comparative change in mild , moderate , severe migraine days 2. Comparative difference in 50% responder rate for the reduction of migraine days 3. Comparative difference in associated symptoms 4. Comparative assessment of use of rescue medications 5. Comparative difference in insomnia 6. Comparative difference in anxiety level 7. Global assessment of overall change 8. Global assessment of tolerability of study products 9. Assessment of adverse events. 10. Assessment of safety laboratory investigations 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) | — |
Countries
India
Contacts
Public ContactDr Sanjay Tamoli
Target Institute of Medical Education and Research Pvt. Ltd.
Outcome results
None listed