Evaluation of the Migraceutics® Phase-Specific Dietary Supplement Regimen on Quality of Life, Work Productivity, and Biomarkers in Adult Migraineurs: The Migraceutics® START Study

N/ANot Yet RecruitingNCT07634146

Miracle Wellness LLC920 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Enrollment

920

Conditions

Migraine Migraine Disease Migraine Disorder Migraine Headache Migraine Disability Migraine in Adults Menstrual Migraine

Interventions

Foundational dietary supplementDIETARY_SUPPLEMENT

Foundational dietary supplement, self-administered daily.

Luteal phase dietary supplement add-onDIETARY_SUPPLEMENT

Add-on dietary supplement, self-administered to women with menstrual migraine during the luteal phase of their menstruation cycle.

Migraine phase dietary supplement add-onDIETARY_SUPPLEMENT

Add-on dietary supplement, self-administered during the symptomatic migraine phase.

Reference dietary supplementDIETARY_SUPPLEMENT

Reference comparator supplement, self-administered daily.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Changes from baseline in migraine-related quality of life

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.