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

Not Applicable

• Conditions: Migraine Disorders
• Interventions: Dietary Supplement: Placebo; Dietary Supplement: PACR

• Registration Number: NCT03190044
• Lead Sponsor: University of Roma La Sapienza

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-06-06
• Study First Submitted: 2017-06-06
• Study First Submitted QC: 2017-06-15
• Study First Posted: 2017-06-16
• Status Verified: 2018-12
• Last Update Submitted: 2018-12-09
• Last Update Posted: 2018-12-11
• Primary Completion: 2019-12-30
• Study Completion: 2019-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 82

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Migranineurs (placebo)	Placebo	One pill per day of placebo: Cellulose
Migraineurs (verum)	PACR	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Policlinico Umberto I; 🇮🇹 Rome, Italy