Improvement of Migraine Severity and Frequency With Migraineguard ™

Study Overview
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Brief Summary
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Numerous treatments have been recommended for the prevention of migraine. The purpose of this randomized double-blind placebo controlled trial was to assess the efficacy of MIGRAINEGUARD ™ supplement by Herbacure Natural containing a combination of COQ10 , magnesium, riboflavin ,feverfew , Skullcap and black pepper as prophylactic treatment for migraine.

Detailed Description
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Our team will assess MIGRAINEGUARD ™ , a migraine prevention supplement marketed Herbacure Natural for individual suffering from multiple migraine attacks in one month . The purpose of this 7-months , randomized, double-blind, placebo controlled study is to evaluate the efficacy and safety of MIGRAINEGUARD ™ produced by Herbacure Natural , A Canadian company based in Vancouver , BC , in reducing migraine headache severity and frequency of attacks compared to placebo when used every day, as a preventative solution for migraine and to assess and monitor the safety of its usage for adverse effects. The primary end-point is the severity and the frequency reduction of migraine attacks. The secondary end-points will be the existence of adverse reaction.

Official Title
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Migraineguard ™ Supplement Reduces the Severity and Frequency of Migraine , a Randomized, Placebo-controlled, Double-blind, Trial

Conditions
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Migraine, Headache

Intervention / Treatment
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* Dietary Supplement: Migraineguard


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult aged 18 to 65 years Female and Male Based on IHS criteria ,are diagnosed with migraine (criteria of the International Classification of Headaches Disorders) Individuals with minimum of 3 severe to extreme migraine attacks during the last 3 months . Generally in good health Exclusion Criteria: Individuals taking any preventive treatment for migraine Excessive usage of painkillers Cancer & Head injury and trauma Any medical condition that may impact the validity of collected information Previous usage of Botox within 6 months of study Last week usage of triptans

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

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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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: MigraineGuard<br>Active supplement treatment , MigraineGuard capsule containing Coq10 , Magnesium ,Vit B2 , Skullcap Extract , Feverfew Extract , Piperine | Dietary Supplement: Migraineguard<br>* 2 Capsules per day for 7 Months<br>|
| Placebo Comparator: Placebo for MigraineGuard<br>Placebo capsules non identifiable from Migraineguard capsules were used as control comparator | Dietary Supplement: Migraineguard<br>* 2 Capsules per day for 7 Months<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patient experiencing migraine attack reduction by at least 50 percent in one month . | Number of patient experiencing migraine attack reduction by at least 50 percent in one month . Migraineurs with 50 percent migraine attack decrease are considered Responders to supplement. | 7 months | 
| Severity of migraine headache reduction after & Months | Reduction of Migraine severity After 7 months of supplementation | 7 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Reactions | Report of any adverse reaction due to supplementation during the study | 7 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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migraine, headache