Improvement of Migraine Severity and Frequency With Migraineguard ™

Not Applicable

Completed

• Conditions: Migraine; Headache
• Interventions: Dietary Supplement: Migraineguard

• Registration Number: NCT04759040
• Lead Sponsor: Herbacure Natural

Brief Summary

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

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.

Study Timeline

• Study Start: 2020-04-01
• Primary Completion: 2020-10-31
• Study Completion: 2020-11-25
• Study First Submitted: 2021-02-13
• Study First Submitted QC: 2021-02-13
• Study First Posted: 2021-02-17
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-16
• Last Update Posted: 2021-03-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MigraineGuard	Migraineguard	Active supplement treatment , MigraineGuard capsule containing Coq10 , Magnesium ,Vit B2 , Skullcap Extract , Feverfew Extract , Piperine
Placebo for MigraineGuard	Migraineguard	Placebo capsules non identifiable from Migraineguard capsules were used as control comparator

Primary Outcome Measures

Name	Time	Method
Number of patient experiencing migraine attack reduction by at least 50 percent in one month .	7 months	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.
Severity of migraine headache reduction after & Months	7 Months	Reduction of Migraine severity After 7 months of supplementation

Secondary Outcome Measures

Name	Time	Method
Adverse Reactions	7 months	Report of any adverse reaction due to supplementation during the study

Trial Locations

Locations (1)

Herbacure Natural; 🇨🇦 Burnaby, British Columbia, Canada