Improvement of Migraine Severity and Frequency With Migraineguard ™

Migraine Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04759040
• Other study ID #: MIGRAINEGUARD
• Status: Completed
• Phase: N/A
• Start date: April 1, 2020
• Est. completion date: November 25, 2020

Study information

• Verified date: March 2021
• Source: Herbacure Natural
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: November 25, 2020
• Est. primary completion date: October 31, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Headache
• Migraine
• Migraine Disorders

Intervention

Dietary Supplement:
• Migraineguard
2 Capsules per day for 7 Months

Locations

Country	Name	City	State
Canada	Herbacure Natural	Burnaby	British Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Herbacure Natural

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Severity of migraine headache reduction after & Months	Reduction of Migraine severity After 7 months of supplementation	7 Months
Secondary	Adverse Reactions	Report of any adverse reaction due to supplementation during the study	7 months