Back to results

Improvement of Migraine Severity and Frequency With Migraineguard ™

Primary Purpose

Migraine, Headache

Status

Completed

Phase

Not Applicable

Locations

Canada

Study Type

Interventional

Intervention

Migraineguard

About this trial

This is an interventional prevention trial for Migraine focused on measuring migraine, headache

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Herbacure Natural

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

MigraineGuard

Placebo for MigraineGuard

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Severity of migraine headache reduction after & Months

Reduction of Migraine severity After 7 months of supplementation

Secondary Outcome Measures

Adverse Reactions

Report of any adverse reaction due to supplementation during the study

Full Information

NCT ID

NCT04759040

First Posted

February 13, 2021

Last Updated

March 16, 2021

Sponsor

Herbacure Natural

1. Study Identification

Unique Protocol Identification Number

NCT04759040

Brief Title

Improvement of Migraine Severity and Frequency With Migraineguard ™

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2021

Overall Recruitment Status

Completed

Study Start Date

April 1, 2020 (Actual)

Primary Completion Date

October 31, 2020 (Actual)

Study Completion Date

November 25, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Herbacure Natural

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Migraine, Headache

Keywords

migraine, headache

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare Provider

Allocation

Randomized

Enrollment

120 (Actual)

8. Arms, Groups, and Interventions

Arm Title

MigraineGuard

Arm Type

Active Comparator

Arm Description

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

Arm Title

Placebo for MigraineGuard

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Dietary Supplement

Intervention Name(s)

Migraineguard

Intervention Description

2 Capsules per day for 7 Months

Primary Outcome Measure Information:

Title

Number of patient experiencing migraine attack reduction by at least 50 percent in one month .

Description

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.

Time Frame

7 months

Title

Severity of migraine headache reduction after & Months

Description

Reduction of Migraine severity After 7 months of supplementation

Time Frame

7 Months

Secondary Outcome Measure Information:

Title

Adverse Reactions

Description

Report of any adverse reaction due to supplementation during the study

Time Frame

7 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

AMIR A DOWLATSHAHI, PHD

Organizational Affiliation

HERBACURE NATURAL INC

Official's Role

Study Director

Facility Information:

Facility Name

Herbacure Natural

City

Burnaby

State/Province

British Columbia

ZIP/Postal Code

V3J 1N3

Country

Canada

12. IPD Sharing Statement

Learn more about this trial

Improvement of Migraine Severity and Frequency With Migraineguard ™

We'll reach out to this number within 24 hrs