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)
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 82
- 试验地点
- 2
- 主要终点
- Migraine improvement in terms of responder rate
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Care Provider)
盲法说明
Placebo and 'verum' pills have the similar shape and colour.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
Migraineurs (verum)
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.
干预措施: PACR (Dietary Supplement)
Migranineurs (placebo)
One pill per day of placebo: Cellulose
干预措施: Placebo (Dietary Supplement)
结局指标
主要结局
Migraine improvement in terms of responder rate
时间窗: 3 months
Number of subjects that at least have a reduction of 50% in terms of migraine frequency
次要结局
- Migraine improvement in terms of frequencies(3 months)
研究者
Cherubino DI LORENZO
Research Fellow
University of Roma La Sapienza