NCT02570633已完成不适用
Double-blind Placebo-controlled Clinical Trial of Ginger (Zingiber Officinale) in Prophylactic Migraine Treatment
Federal University of Minas Gerais2 个研究点 分布在 1 个国家目标入组 107 人开始时间: 2015年4月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 107
- 试验地点
- 2
- 主要终点
- Change in the frequency of migraine attacks.
研究概览
简要总结
The main objective of the study is to evaluate ginger efficacy as an prophylactic treatment of migraine.
详细描述
Patients with the diagnosis of migraine according to the IHS criteria will receive capsules of 200 mg of ginger extract (5% active ingredient) or placebo (cellulose) to be taken three times a day for 12 weeks.
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
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged between 18 and 60 years old;
- •Migraine diagnosis;
- •Agree to sign the informed consent.
排除标准
- •Patients with headaches not characterized as migraine;
- •Pregnant or lactating women;
- •Fertile and sexually active women who do not use contraception;
- •Abuse of painkillers, alcohol or other drugs;
- •People with hypersensitivity to ginger compounds;
- •People with severe neurological diseases (e.g. epilepsy)
- •People in use of anticoagulant drugs.
结局指标
主要结局
Change in the frequency of migraine attacks.
时间窗: 12 weeks
Frequency of migraine attacks will be assessed by headache diary.
次要结局
- Change in migraine impact in the last month.(4 weeks)
- Change in migraine impact in the last three months.(12 weeks)
- Changes in the serum levels of biomarkers.(12 weeks)
- Changes in Resting Energy Expenditure(4, 8 and 12 weeks)
研究者
Antonio L Teixeira Jr
PhD
Federal University of Minas Gerais
研究点 (2)
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