Double-blind Placebo-controlled Clinical Trial of Ginger (Zingiber Officinale) Addition to Ketoprofen for the Acute Treatment of Migraine Attacks
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 主要终点
- Change in Headache Severity.
研究概览
简要总结
The main objective of the study was to evaluate ginger efficacy as an adjuvant to ketoprofen for the treatment of headache and other symptoms related with migraine attacks.
详细描述
Patients with the diagnosis of migraine according to the International Headache Society (IHS) criteria were enrolled in the study during a migraine attack. Patients received two 200 mg capsules of dry ginger extract (5% active ingredient) or two capsules of placebo (cellulose) in addition to an intravenous dose of ketoprofen (100 milligrams - mg) to treat the migraine attack.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- •Migraine diagnosis for at least one year;
- •Migraine attack with moderate or severe pain intensity;
- •One to six migraine attacks per month.
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 drugs;
- •People with hypersensitivity to ginger;
- •People with other neurological diseases;
- •People in use of anticoagulant drugs;
- •People who have started the disease after 50 years old.
研究组 & 干预措施
Extract of ginger
People (both genders) who went to the emergency room of the Hospital Vera Cruz (Belo Horizonte, MG, BR) with a migraine attack received two capsules of ginger extract (containing 5% of gingerols) and intravenous ketoprofen (100mg).
干预措施: Extract of ginger (Dietary Supplement)
Extract of ginger
People (both genders) who went to the emergency room of the Hospital Vera Cruz (Belo Horizonte, MG, BR) with a migraine attack received two capsules of ginger extract (containing 5% of gingerols) and intravenous ketoprofen (100mg).
干预措施: Intravenous ketoprofen (Drug)
Cellulose
People (both genders) who went to the emergency room of the Hospital Vera Cruz (Belo Horizonte, MG, BR) with a migraine attack received two placebo capsules (cellulose) and intravenous ketoprofen (100mg).
干预措施: Cellulose (Other)
Cellulose
People (both genders) who went to the emergency room of the Hospital Vera Cruz (Belo Horizonte, MG, BR) with a migraine attack received two placebo capsules (cellulose) and intravenous ketoprofen (100mg).
干预措施: Intravenous ketoprofen (Drug)
结局指标
主要结局
Change in Headache Severity.
时间窗: 2 hours
The severity of headache was assessed with faces pain scale. It is a self-reported pain scale consisting of face drawings which have a score ranging from zero (absence of pain) to five (maximal intensity of pain). Higher scores mean a worse outcome.
次要结局
- Change in Serum Levels of Biomarkers.(2 hours)
研究者
Antonio L Teixeira Jr
PhD
Federal University of Minas Gerais