Magnesium, Vitamin B2, Feverfew, Andrographis Paniculata and Coenzyme Q10 for Episodic Migraine Prophylaxis

Study Overview
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Brief Summary
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To investigate efficacy and safety of a supplementation with a fixed combination of magnesium, vitamin B2, feverfew, andrographis paniculata and coenzyme Q10 (Vivinor®) in episodic migraine prevention, by an observational, prospective real-world study in 113 Greek patients with episodic migraine that were prospectively followed-up for three months. The primary endpoint was the change in monthly migraine days between baseline period (BL)and the third month of treatment (T3).

Detailed Description
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To investigate efficacy and safety of a supplementation with a fixed combination of magnesium, vitamin B2, feverfew, andrographis paniculata and coenzyme Q10 (Vivinor®) in episodic migraine prevention. An observational, prospective real-world study. After a one-month baseline period, Vivinor® was introduced in 113 Greek patients with episodic migraine that were prospectively followed-up for three months. The primary endpoint was the change in monthly migraine days between baseline period (BL)and the third month of treatment (T3). Secondary endpoints included changes in mean intensity of migraine and in days with use of acute migraine medications. Changes in scores of Migraine Disability Assessment questionnaire (MIDAS), Headache Impact Test-6 (HIT-6), Migraine Therapy Assessment questionnaire (MTAQ), MSQ-QOL (Migraine-Specific Quality of life questionnaire), HADS (Hospital Anxiety and Depression Scale) were also evaluated. Those with ≥50% reduction in monthly migraine days during T3 compared to BL were considered Vivinor®-responders.

Official Title
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Real World, Open Label Prospective Experience of Supplementation With a Fixed Combination of Magnesium, Vitamin B2, Feverfew, Andrographis Paniculata and Coenzyme Q10 for Episodic Migraine Prophylaxis

Conditions
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Migraine

Intervention / Treatment
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* Dietary Supplement: magnesium, vitamin B2, feverfew, andrographis paniculata and coenzyme Q10


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: established diagnosis of episodic migraine with or without aura for more than one year prior to study entry evidence of 4-14 migraine days per month during the last trimester prior to screening participants may had been either treatment- naive or not suitable for or had failed previous migraine pharmacological prophylactic treatments were able to fully understand protocol and study information provided by the investigators. enrolled patients should take no other preventive treatment or use any other migraine prophylactic method during the three months before entering the study and throughout the study period. Exclusion Criteria: older than 50 years of age at migraine onset evidence of MOH pregnant or nursing females history of tension-type, cluster or hemiplegic headache history of severe anaphylactic reactions to any of the intervention's ingredients evidence of severe systemic diseases history or evidence of major psychiatric disorder.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Dietary Supplement: magnesium, vitamin B2, feverfew, andrographis paniculata and coenzyme Q10|Supplementation per os|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in monthly migraine days | Change in monthly migraine days between baseline period (BL) and the third month of treatment (T3) | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean intensity of migraine | Changes in mean intensity of migraine between baseline period (BL) and the third month of treatment (T3) | 3 months | 
| days with use of acute migraine medications | Changes in days with use of acute migraine medications between baseline period (BL) and the third month of treatment (T3) | 3 months | 
| Migraine Disability Assessment questionnaire (MIDAS) | Changes in scores of Migraine Disability Assessment questionnaire (MIDAS) during T3 | 3 months | 
| Headache Impact Test-6 (HIT-6) | Changes in Headache Impact Test-6 (HIT-6) during T3 | 3 months | 
| Migraine Therapy Assessment questionnaire (MTAQ) | Changes in Migraine Therapy Assessment questionnaire (MTAQ) during T3 | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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episodic migraine, supplement, Vivinor, magnesium, vitamin B2, andrographis paniculata, coenzyme Q10