MigraineNCT04759040
Improvement of Migraine Severity and Frequency With Migraineguard ™
A study testing Migraineguard in people with Migraine and Headache, run by Herbacure Natural at 1 site in Canada.
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… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- What is being tested?
- Migraineguard
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteCanada
- Study dates
- 1 Apr 2020to 25 Nov 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Being tested
- Migraineguard
- Keywords
- migraine, headache
- Medical subject headings
- Migraine Disorders, Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MigraineguardDietary supplement
2 Capsules per day for 7 Months
| Study group | Role | What they receive |
|---|---|---|
| MigraineGuard | Active comparator | Active supplement treatment , MigraineGuard capsule containing Coq10 , Magnesium ,Vit B2 , Skullcap Extract , Feverfew Extract , Piperine Receives: Dietary Supplement: Migraineguard |
| Placebo for MigraineGuard | Placebo comparator | Placebo capsules non identifiable from Migraineguard capsules were used as control comparator Receives: Dietary Supplement: Migraineguard |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 7 months
Severity of migraine headache reduction after & Months
Reduction of Migraine severity After 7 months of supplementation
Measured: 7 Months
Secondary outcomes (1)
Adverse Reactions
Report of any adverse reaction due to supplementation during the study
Measured: 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2021
- Study start1 Apr 2020
- Primary completion31 Oct 2020
- Study completion25 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MigraineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Herbacure Natural
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- AMIR A DOWLATSHAHI, PHD, Study director, HERBACURE NATURAL INC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04759040
- Sponsor's protocol ID
- MIGRAINEGUARD
- Status last verified
- Mar 2021
- First submitted
- 13 Feb 2021
- Last updated
- 18 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Migraineguard ™ Supplement Reduces the Severity and Frequency of Migraine , a Randomized, Placebo-controlled, Double-blind, Trial
- ClinicalTrials.gov ID
- NCT04759040
- Acronym / sponsor ID
- MIGRAINEGUARD
- Keywords
- migraine, headache
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Herbacure NaturalIndustry (pharma, biotech, devices)
- Study start
- 1 Apr 2020 (actual)
- Primary completion
- 31 Oct 2020 (actual)
- Study completion
- 25 Nov 2020 (actual)
- First posted
- 17 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MigraineGuard | Active comparator | Dietary Supplement: MigraineguardActive supplement treatment , MigraineGuard capsule containing Coq10 , Magnesium ,Vit B2 , Skullcap Extract , Feverfew Extract , Piperine |
| Placebo for MigraineGuard | Placebo comparator | Dietary Supplement: MigraineguardPlacebo capsules non identifiable from Migraineguard capsules were used as control comparator |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Migraineguard2 Capsules per day for 7 Months | Dietary supplement | MigraineGuard, Placebo for MigraineGuard |
Primary outcome
Number of patient experiencing migraine attack reduction by at least 50 percent in one month .
Time frame: 7 months
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
Time frame: 7 Months
Reduction of Migraine severity After 7 months of supplementation
1 secondary outcome
Adverse Reactions
Time frame: 7 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
AMIR A DOWLATSHAHI, PHD study director
HERBACURE NATURAL INC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Migraineguard in people with Migraine and Headache, run by Herbacure Natural at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patient experiencing migraine attack reduction by at least 50 percent in one month . (time frame: 7 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2021.