NCT04759040

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2020

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2020

Completed
25 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 25, 2020

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

February 13, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 17, 2021

Completed
Last Updated

March 18, 2021

Status Verified

March 1, 2021

Enrollment Period

7 months

First QC Date

February 13, 2021

Last Update Submit

March 16, 2021

Conditions

Keywords

migraineheadache

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (1)

  • Adverse Reactions

    7 months

Study Arms (2)

MigraineGuard

ACTIVE COMPARATOR

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

Dietary Supplement: Migraineguard

Placebo for MigraineGuard

PLACEBO COMPARATOR

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

Dietary Supplement: Migraineguard

Interventions

MigraineguardDIETARY_SUPPLEMENT

2 Capsules per day for 7 Months

MigraineGuardPlacebo for MigraineGuard

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Herbacure Natural

Burnaby, British Columbia, V3J 1N3, Canada

Location

MeSH Terms

Conditions

Migraine DisordersHeadache

Condition Hierarchy (Ancestors)

Headache Disorders, PrimaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • AMIR A DOWLATSHAHI, PHD

    HERBACURE NATURAL INC

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 13, 2021

First Posted

February 17, 2021

Study Start

April 1, 2020

Primary Completion

October 31, 2020

Study Completion

November 25, 2020

Last Updated

March 18, 2021

Record last verified: 2021-03

Locations