Improvement of Migraine Severity and Frequency With Migraineguard ™
Migraineguard ™ Supplement Reduces the Severity and Frequency of Migraine , a Randomized, Placebo-controlled, Double-blind, Trial
1 other identifier
interventional
120
1 country
1
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Apr 2020
Shorter than P25 for not_applicable
1 active site
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
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 31, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
November 25, 2020
CompletedFirst Submitted
Initial submission to the registry
February 13, 2021
CompletedFirst Posted
Study publicly available on registry
February 17, 2021
CompletedMarch 18, 2021
March 1, 2021
7 months
February 13, 2021
March 16, 2021
Conditions
Keywords
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 COMPARATORActive supplement treatment , MigraineGuard capsule containing Coq10 , Magnesium ,Vit B2 , Skullcap Extract , Feverfew Extract , Piperine
Placebo for MigraineGuard
PLACEBO COMPARATORPlacebo capsules non identifiable from Migraineguard capsules were used as control comparator
Interventions
2 Capsules per day for 7 Months
Eligibility Criteria
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
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
AMIR A DOWLATSHAHI, PHD
HERBACURE NATURAL INC
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