NCT02035111已完成4 期
To Evaluate the Safety and the Efficacy of Tianshu Capsule Treating Migraine in a Randomized, Placebo-Controlled, Double-blind, Multicenter Study.
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 947
- 试验地点
- 20
- 主要终点
- Change in the frequency of attack of Migraine Per 4 weeks at Week 16 from baseline
研究概览
简要总结
The purpose of this study is to evaluate the safety and the efficacy of Tianshu capsule treating Migraine Headache.
详细描述
Primary headache disorders,particularly migraine is globally prevalent. Many studies show the burdens they impose: pain, disability, reduced quality of life (QoL), marked impairment of participation in work and social activities, and heavy financial costs.
The purpose of this study is to evaluate the safety and the efficacy of Tianshu capsule treating Migraine Headache. To provide a safe and effective treatment of Migraine Headache.
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
- Triple (Participant, Investigator, Outcomes Assessor)
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
- •Must meet the Migraine diagnosis.
- •Age of onset should be before age 50 years.
- •Migraine must have been occurring for 1 year preceding entry into the trial.
- •The number of migraine attack should be no less than 6 for a period of 3 months prior to Screening stage.
- •The number of migraine days is to be 2-8 for a period of 1 month prior to screening for entry into the trial.
- •Migraine days should be less than 15 for a period of 1 month prior to screening for entry into the trial.
- •Participant can understand and complete the Headache diary.
- •All participants signed the informed consent.
排除标准
- •Other migraine prophylactic medication is continued 3 months prior to the drug trial.
- •Participants who have taken Tianshu capsule during 1 month prior to Screening stage.
- •The number of acute treatment for migraine is more than 10 per month.
- •Participants who have taken antipsychotics or antidepressant medications (unless only for migraine prophylaxis) during the previous 3 months.
- •Participants who abuse alcohol or other drugs.
- •Participants who are resistant to all acute migraine drugs prescribed optimally.
- •hypotension or uncontrolled hypertension.
- •Severe infections.
- •Malignancy.
- •Significant medical history of such as cardiac disease, cerebrovascular disease, liver disease, nephropathy etc.
- •Known allergies or serious side effects with Tianshu capsule in the past.
- •Breastfeeding, pregnant and potentially fertile women participant.
- •History of cluster headaches, tension-type headache, vascular headache with non-migraine, drug - dependence headache.
- •Secondary headaches, including hypertension, post-traumatic brain syndrome etc.
- •Participants who have taken migraine prophylactic medication regularly during 1 month prior to Screening stage.
- •Participants who are taking part in other clinical trials.
研究组 & 干预措施
Tianshu capsule
Experimental
Four Tianshu capsules (0.34 g per capsule) by oral three times a day for 12 weeks.
干预措施: Tianshu capsule (Drug)
Sugar pill
Placebo Comparator
Four sugar pills (0.34 g per capsule) by oral three times a day for 12 weeks.
干预措施: Sugar pill (Drug)
结局指标
主要结局
Change in the frequency of attack of Migraine Per 4 weeks at Week 16 from baseline
时间窗: -4w,0,4w,8w,12w,16w
次要结局
- Change in degree of pain of Migraine Per 4 weeks at Week 16 from baseline.(-4w,0,4w,8w,12w,16w)
- Proportion of subjects whose number or days of migraine attacks reduce at least 50%.(-4w,0,4w,8w,12w,16w)
- Change in number of concomitant migrainous symptoms attacks Per 4 weeks at Week 16 from baseline.(-4w,0,4w,8w,12w,16w)
- Change in seizure duration of Migraine Per 4 weeks at Week 16 from baseline.(-4w,0,4w,8w,12w,16w)
- Change in the days using acute therapy of Migraine Per 4 weeks at Week 16 from baseline.(-4w,0,4w,8w,12w,16w)
- Safety assessments will be based on adverse event reports and the results of vital sign measurements, electrocardiogram, and clinical laboratory tests.(0, 12w)
研究者
研究点 (20)
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