Cupping Therapy and SERKANGABIN Versus Conventional Treatment of Migraine Headache: a Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 391
- 试验地点
- 1
- 主要终点
- frequency of migraine attacks per week
研究概览
简要总结
Migraine is the most common recurrent headache. Current therapy of migraine headache consists of multiple drug groups for control of attack and prophylaxis against recurrent attacks. Emerging alternative medicine worldwide led investigators to evaluate the efficacy of cupping therapy plus SERKANGABIN syrup in treatment of migraine headache. Severity, duration and frequency of attacks of migraine headache evaluated in two groups during six months from presentation.
详细描述
In a randomized controlled trial investigators randomly assigned 76 patients with migraine to cupping therapy plus SERKANGABIN or to receive conventional medical treatment. The use of CAM in migraine is a growing phenomenon. Migraine patients seek and explore both conventional and CAM approaches. Wet cupping is an ancient medical technique still used in several contemporary societies. It is being used in management of hypertension, diabetes mellitus, and headaches, renal and biliary stones and for maintaining health. Little experimental study has been devoted to test its efficacy to treat migraine headache. Investigators planned this study for evaluation of therapeutic efficacy of wet cupping and an Iranian traditional medicine preparation, SERKANGABIN in treatment of migraine headache compared with current medicine protocols. SERKANGABIN is a preparation of honey, vinegar and distilled mint water that in traditional Iranian medicine is believed to have therapeutic effects in many diseases (diabetes mellitus, hypertension, hyperlipidemia, osteoarthritis, chronic obstructive airway disease, interstitial lung disease, hepatitis, fatty liver, ischemic heart disease, migraine, cerebrovascular diseases)
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
- None
入排标准
- 年龄范围
- 15 Years 至 50 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •migraine headache with or without aura
排除标准
- •uncontrolled hypertension
- •ischemic heart disease
- •cardiac arrhythmia or symptomatic Wolff-Parkinson-White syndrome
- •previous stroke or transient ischemic attack
- •severe liver or renal impairment
- •any other severe or disabling medical condition
- •history of alcohol or analgesic or psychotropic drug abuse
- •contraindication to or known hypersensitivity to study drugs
- •current use or use in the previous 2 weeks of MAO-inhibitors
- •a pain disorder other than migraine as the primary presenting problem
- •current psychological treatment, psychiatric disorder needing immediate or priority treatment
- •current or planned breast feeding or pregnancy or unwillingness to use an established contraceptive method
- •non compliance of patients
- •not presenting at times determined for treatment and evaluation
研究组 & 干预措施
cupping serkangabin
migraine cases treated by cupping and serkangabin syrup
干预措施: cupping and serkangabin syrup (Procedure)
conventional
migraine cases treated by conventional drug treatment protocols
干预措施: conventional migraine drug treatment (Drug)
结局指标
主要结局
frequency of migraine attacks per week
时间窗: 2 weeks after first presentation
endpoints evaluated in both study groups 2 weeks after first presentation and receiving treatment protocols
次要结局
- severity of migraine attacks(6 months after first presentation)
- frequency of migraine attacks(6 months after first presentation)
- duration of migraine attacks(6 months after first presentation)