A Fixed Combination of Magnesium, Partenium, Andrographis, Co-enzyme Q10 and Riboflavin (PACR) as Prophylactic Treatment for Migraine: a Randomized Controlled Double Blind Study (ParMig Study)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Migraine Disorders
- Sponsor
- University of Roma La Sapienza
- Enrollment
- 82
- Locations
- 1
- Primary Endpoint
- Migraine improvement in terms of responder rate
- Last Updated
- 7 years ago
Overview
Brief Summary
Migraine is a highly disabling disorder that affects hundreds of millions of people around the world. Yet, a little number of prophylactic treatments are available still now. The limited number of available drugs leads to a wide use of nutraceutical compounds in migraine therapy. To improve the efficacy, some of these nutraceuticals were combined. So far, we do not know if these combinations are really more effective than the single compounds alone, or an anti-synergic effect could be present because of a reciprocal antagonism of effects. For this reason, we decided to test the efficacy of a fixed combination of magnesium, partenium, andrographis, co-enzyme Q10 and riboflavin (PACR) as prophylactic treatment for migraine in a randomized controlled double blind study.
Investigators
Cherubino DI LORENZO
Research Fellow
University of Roma La Sapienza
Eligibility Criteria
Inclusion Criteria
- •diagnosis of migraine (with or without aura)
- •both genders
- •age between 18 and 65 y.o.
- •more than 1 year of migraine history
- •no other headache conditions
- •a migraine frequency between 2 and 8 per month
Exclusion Criteria
- •Prophylactic treatments in the last 3 months
- •pregnancy or lactation
- •other medical conditions that requires a daily drug assumption
- •intolerance or allergic reactions to some of compounds of the product.
Outcomes
Primary Outcomes
Migraine improvement in terms of responder rate
Time Frame: 3 months
Number of subjects that at least have a reduction of 50% in terms of migraine frequency
Secondary Outcomes
- Migraine improvement in terms of frequencies(3 months)