Health Condition 1: G439- Migraine, unspecified
Conditions
Interventions
None listed
Sponsors
M Global Nutraceuticals
Eligibility
Inclusion criteria
Inclusion criteria: 1.Subjects of either sex 2.Age 18-65 years (both inclusive) 3.People who have severe pain at half portion of their head. 4.If female of childbearing potential, must be willing to practice an acceptable form of birth control for the duration of the study. 5.Are able to give written informed consent in a manner approved by the Institutional Ethics Committee and comply with the requirements of the study. 6.Are willing to avoid participation in any other interventional clinical trial for the duration of this study. 7.Are willing to refrain from using any lotions, gel, balm, other than those issued as part of the study, on the treatment areas during the treatment period.
Exclusion criteria
Exclusion criteria: 1.Are pregnant, breast-feeding, or planning to become pregnant during the study. 2.Cluster headache patients(its different from migraine) 3.Have participated in any interventional clinical trial in the previous 30 days. 4.Have a known sensitivity to any of the constituents of the test products . 5.Have a history of alcohol or illegal drug/substance abuse, or suspected alcohol or illegal drug/substance abuse in the past 2 years.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in the Subject Global AssessmentTimepoint: day 0 and Day 30 | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in Migraine Disability Assessment(MIDAS) scoreTimepoint: day 0 and Day 30;Change in Migraine Severity scores (MIGSEV)Timepoint: day 0 and Day 30;change in pain (0-4)Timepoint: day 0 and Day 30 | — |
Countries
India
Contacts
Public ContactPuneet Mittal
Mittal Global Clinical Trial Services
Outcome results
None listed