Improvement of Migraine Severity and Frequency With Migraineguard ™

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

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.

Study Overview

• Status: Completed
• Conditions: Migraine; Headache
• Intervention / Treatment: Dietary supplement: Migraineguard

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 Type: Interventional
• Enrollment (Actual): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • British Columbia
    • Burnaby, British Columbia, Canada, V3J 1N3
      • Herbacure Natural

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 61 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Herbacure Natural
• Investigators: Study Director: AMIR A DOWLATSHAHI, PHD, HERBACURE NATURAL INC

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2020
• Primary Completion (Actual): October 31, 2020
• Study Completion (Actual): November 25, 2020

Study Registration Dates

• First Submitted: February 13, 2021
• First Submitted That Met QC Criteria: February 13, 2021
• First Posted (Actual): February 17, 2021

Study Record Updates

• Last Update Posted (Actual): March 18, 2021
• Last Update Submitted That Met QC Criteria: March 16, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: headache; migraine
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Headache Disorders, Primary; Headache Disorders; Migraine Disorders; Headache
• Other Study ID Numbers: MIGRAINEGUARD

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No