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Clinical Trials/NCT03190044
NCT03190044
Unknown
Not Applicable

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)

University of Roma La Sapienza1 site in 1 country82 target enrollmentJune 6, 2017

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.

Registry
clinicaltrials.gov
Start Date
June 6, 2017
End Date
December 31, 2019
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
University of Roma La Sapienza
Responsible Party
Principal Investigator
Principal Investigator

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)

Study Sites (1)

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