Efficacy and Safety of Danzhen in the Preventive Treatment of Migraine:A Prospective "Real-World" Study.
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 3,300
- 试验地点
- 1
- 主要终点
- A 50% or greater reduction in headache days/month during the third treatment month of maintenance phase relative to baseline phase with one of the study drugs.
研究概览
简要总结
The purpose is to evaluate the effectiveness and safety profile of Danzhen for the prophylaxis of migraine in a "real-world" setting.
详细描述
In adults between 18- and 65-years in China,the prevalence of migraine is 9.3% in general. Migraine is a heterogeneous condition that may produce a range of symptom profiles and various degrees of disability.The disability resulting from migraine can be severe imposing a considerable health burden upon the sufferer and society. The purpose of this study, using topiramate as the control, is to evaluate the effectiveness and safety of Danzhen for the prophylaxis of migraine in a "real-world"setting.Patients are asked to maintain a detailed headache diary via headache diary APP throughout the treatment period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients older than or equal to 18 years and less than 70 years.
- •The diagnosis of migraine is made according to 2004 The International Classification of Headache Disorders: 2nd edition (ICHD-II) .
- •Consent form signed by the participant or his/her authorized surrogate.
排除标准
- •Patients had primary or secondary headache disorders other than migraine.
- •Female subjects of childbearing age will be excluded if they were pregnant, lactating or planning apregnancy in the next year or if they were not using an adequate form of birth control.
- •Patients will be excluded if they had significant medical or psychiatric disease,or taking another antidepressant for any reason and not able to discontinue.
- •Patients used other preventive pharmacological agents during the 1 month prior to baseline period.
研究组 & 干预措施
Experimental:Danzhen
The treatment with Danzhen is 3 tablets triple daily.
干预措施: Danzhen (Drug)
Active Comparator:Topiramate
The treatment with TPM is initiated at a 50 mg daily dose and sequentially increase every 7 days, as tolerated, in 25 mg increments up to a target dose of 150 mg total/day.
干预措施: Topiramate (Drug)
结局指标
主要结局
A 50% or greater reduction in headache days/month during the third treatment month of maintenance phase relative to baseline phase with one of the study drugs.
时间窗: at baseline phase/the third treatment month of maintenance phase
次要结局
- The decrease of numbers of rescue medication doses used/month(at baseline phase/the third treatment month of maintenance phase)
- The decrease of disability days of migraine/month(at baseline phase/the third treatment month of maintenance phase)
- The percentage of discontinued the drug because of side effects(at the third treatment month of maintenance phase)
- A 30% or greater reduction in headache time(at baseline phase/the third treatment month of maintenance phase)
- Compliance(at the third treatment month of maintenance phase)
- Beck Depression Inventory (BDI) scores(at the third treatment month of maintenance phase)