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| Name | Class |
|---|---|
| Gianluca Coppola | UNKNOWN |
| Francesco Pierelli | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Migraineurs (verum) | Experimental | 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. |
|
| Migranineurs (placebo) | Placebo Comparator | One pill per day of placebo: Cellulose |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PACR | Dietary Supplement | Daily assumption of PACR for a 3-month period |
| |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Cherubino Di Lorenzo, PhD | Contact | +393286783246 | cherubino.dilorenzo@uniroma1.it | |
| Gianluca Coppola, PhD | Contact | gianluca.coppola@uniroma1.it |
| Name | Affiliation | Role |
|---|---|---|
| Francesco Pierelli, MD | University of Roma La Sapienza | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Policlinico Umberto I | Recruiting | Rome | 00161 | Italy |
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| ID | Term |
|---|---|
| D008881 | Migraine Disorders |
| ID | Term |
|---|---|
| D051270 | Headache Disorders, Primary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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Placebo and 'verum' pills have the similar shape and colour.
| Placebo |
| Dietary Supplement |
Daily assumption of placebo |
|
| D009422 | Nervous System Diseases |