Improvement of Migraine Severity and Frequency With Migraineguard ™

NCT ID: NCT04759040

Last Updated: 2021-03-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-04-01

Study Completion Date

2020-11-25

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.

Conditions

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Migraine Headache

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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MigraineGuard

Active supplement treatment , MigraineGuard capsule containing Coq10 , Magnesium ,Vit B2 , Skullcap Extract , Feverfew Extract , Piperine

Group Type ACTIVE_COMPARATOR

Migraineguard

Intervention Type DIETARY_SUPPLEMENT

2 Capsules per day for 7 Months

Placebo for MigraineGuard

Placebo capsules non identifiable from Migraineguard capsules were used as control comparator

Group Type PLACEBO_COMPARATOR

Migraineguard

Intervention Type DIETARY_SUPPLEMENT

2 Capsules per day for 7 Months

Interventions

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Migraineguard

2 Capsules per day for 7 Months

Intervention Type DIETARY_SUPPLEMENT

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Herbacure Natural

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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AMIR A DOWLATSHAHI, PHD

Role: STUDY_DIRECTOR

HERBACURE NATURAL INC

Locations

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Herbacure Natural

Burnaby, British Columbia, Canada

Site Status

Countries

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Canada

Other Identifiers

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MIGRAINEGUARD

Identifier Type: -

Identifier Source: org_study_id

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