Menstrual Migraine, Menstrual Migraine (MM) Headaches, Migraine, Migraine Disability, Migraine Disease, Migraine Disorder, Migraine Headache, Migraine in Adults
Conditions
Keywords
quality of life, productivity, disability, CGRP, headache, migraine, nutraceuticals, dietary supplement, migraceuticals
Brief summary
The purpose of this study is to evaluate the impact of the Migraceutics® phase-specific dietary supplement regimen on quality of life, work productivity, and biomarkers in adult migraineurs.
Interventions
DIETARY_SUPPLEMENTFoundational dietary supplement
Foundational dietary supplement, self-administered daily.
DIETARY_SUPPLEMENTLuteal phase dietary supplement add-on
Add-on dietary supplement, self-administered to women with menstrual migraine during the luteal phase of their menstruation cycle.
DIETARY_SUPPLEMENTMigraine phase dietary supplement add-on
Add-on dietary supplement, self-administered during the symptomatic migraine phase.
DIETARY_SUPPLEMENTReference dietary supplement
Reference comparator supplement, self-administered daily.
Sponsors
Miracle Wellness LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Self-reported history of migraine, based on the International Headache Society (IHS) International Classification of Headache Disorders, 3rd edition (ICHD-3) diagnostic criteria for migraine. * Being able to take oral supplements. * Agreeing to maintain their regular lifestyle. * Access to internet and telephone.
Exclusion criteria
* Pregnancy or lactation. * Presence of any active medical condition or diagnosis other than episodic migraine, including liver or kidney disease or condition. * Use of overlapping supplements or interacting medications. * Known allergies to study ingredients. * Daily use of alcohol, tobacco, or recreational drugs. * Participation in any other clinical or interventional study within 30 days prior to baseline or concurrently.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes from baseline in migraine-related quality of life | Baseline, Month 1 through Month 6 | Changes from baseline in migraine-related quality of life as measured by the mean Headache Impact Test (HIT-6) total score. HIT-6 has six questions, which are rated using a five-level scale: Never (6 points), Rarely (8 points), Sometimes (10 points), Very Often (11 points), and Always (13 points). Total scores can range from 36 to 78, with higher totals reflecting a more significant impact. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of self-reported migraine days per month | Baseline, Month 1 through Month 6 | The number of calendar days within a 28-day (or pre-specified) period on which a participant experiences any migraine. |
| Distribution of participants experiencing changes in monthly migraine days | Baseline, Month 1 through Month 6 | Distribution of participants in various levels of change (e.g., ≥25%, ≥50%, ≥75%, 100% change) from baseline. |
| Use of over-the-counter or prescription migraine or headache medication | Baseline, Month 1 through Month 6 | Mean number of migraine days associated with use of over-the-counter or prescription migraine or headache medication |
| Migraine symptoms participants experienced | Baseline, Month 1 through Month 6 | Mean monthly number of migraine symptoms. |
| Self-reported migraine symptom severity | Baseline, Month 1 through Month 6 | Self-reported migraine symptom severity scores. Participants rate each of their reported symptoms on a scale from 0 to 10 how bad these symptoms were at their worst. 0: I did not have this symptom, and 10: it was the worst imaginable |
| Mean number of migraine hours | Baseline, Month 1 through Month 6 | Mean number of hours in the past 30 days on which a migraine occurred |
| Number of missed work and/or school days due to migraine | Baseline, Month 1 through Month 6 | Number of missed work and/or school days per month (self-reported) |
Countries
United States
Contacts
CONTACTPrincipal Investigator
Outcome results
None listed