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

Study Overview
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Brief Summary
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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.

Official Title
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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)

Conditions
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Migraine Disorders

Intervention / Treatment
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* Dietary Supplement: PACR
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Migraineurs (verum)<br>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. | Dietary Supplement: PACR<br>* Daily assumption of PACR for a 3-month period<br>|
| Placebo Comparator: Migranineurs (placebo)<br>One pill per day of placebo: Cellulose | Dietary Supplement: Placebo<br>* Daily assumption of placebo<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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