Magnesium, Partenium, Andrographis, Co-enzyme Q10 and Riboflavin (PACR) in Migraine Prophylaxis

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)

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03190044

Acronym

ParMig

Enrollment

Registered

2017-06-16

Start date

2017-06-06

Completion date

2019-12-31

Last updated

2018-12-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Migraine Disorders

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.

Interventions

DIETARY_SUPPLEMENTPACR

Daily assumption of PACR for a 3-month period

DIETARY_SUPPLEMENTPlacebo

Daily assumption of placebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

SINGLE (Caregiver)

Masking description

Placebo and 'verum' pills have the similar shape and colour.

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Migraine improvement in terms of responder rate	3 months	Number of subjects that at least have a reduction of 50% in terms of migraine frequency

Secondary

Measure	Time frame	Description
Migraine improvement in terms of frequencies	3 months	reduction of migraine in terms of number of attacks, headache days, and number of analgesics per month.

Countries

Italy

Contacts

Primary ContactCherubino Di Lorenzo, PhD

cherubino.dilorenzo@uniroma1.it+393286783246

Backup ContactGianluca Coppola, PhD

gianluca.coppola@uniroma1.it

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026