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

University of Roma La Sapienza

Status: Unknown

Conditions: Migraine Disorders

Treatments: Dietary Supplement: Placebo; Dietary Supplement: PACR

Study type: Interventional

Funder types: Other

Identifiers

NCT03190044

ParMig Study

Details and patient eligibility

About

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.

Enrollment: 82 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No 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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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82 participants in 2 patient groups, including a placebo group

Migraineurs (verum)

Experimental group

Description:

One pill per day of PACR: magnesium 281,25 mg; partenium 150 mg (partenolides 1200mcg); andrographis 100 mg (andrographolides 10 mg); co-enzyme Q10 20 mg; riboflavin 4,8 mg.

Treatment:

Dietary Supplement: PACR

Migranineurs (placebo)

Placebo Comparator group

Description:

One pill per day of placebo: Cellulose

Treatment:

Dietary Supplement: Placebo