An interventional study of PACR and Placebo in Migraine Disorders, sponsored by University of Roma La Sapienza. Status unknown at 1 site in Italy. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2018-12-11.
Sponsored by University of Roma La Sapienza · Not applicable, Interventional, and Prevention
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.
1,528 studies on the registry are indexed under Migraine Disorders; 299 are open to participants now.
This study's planned enrollment of 82 is close to the median of 80 across 1,175 interventional studies indexed under Migraine Disorders.
Browse Migraine Disorders studies →University of Roma La Sapienza is the lead sponsor of 388 studies on the registry; 55 are open to participants now.
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Exclusion Criteria:
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
One pill per day of placebo: Cellulose
Dietary Supplement: Placebo
Daily assumption of PACR for a 3-month period
Daily assumption of placebo
Migraine improvement in terms of responder rate
Number of subjects that at least have a reduction of 50% in terms of migraine frequency
Time frame: 3 months
Migraine improvement in terms of frequencies
reduction of migraine in terms of number of attacks, headache days, and number of analgesics per month.
Time frame: 3 months
Plan to share: No
No publications or documents are linked to this record.
This study is status unknown, as verified in Dec 2018. You cannot join it, but the record below documents what was studied.
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University of Roma La Sapienza