Effectiveness and Neural Mechanism of Naoan Dripping Pills for Migraine: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- Responder rate
研究概览
简要总结
This is a randomized, double-blind, placebo-controlled clinical trial. Its main purpose is to investigate the effects and neural mechanism of Naoan dripping pills on migraine patients by utilizing fMRI and DTI method, as well as headache evaluation measures such as responder rate, headache duration, PRO scale, etc.
详细描述
Naoan dripping pills, which is a Chinese patent medicine proved effectively in treating migraine on clinic, but its neural mechanism remains unknown. This study is expected to validate the effectiveness and explore its neural mechanism by fMRI and DTI so as to provide evidence for physicians to promote the appropriate use of Naoan dripping pills treatment for migraine patients. Patients will be randomly assigned to either Naoan dripping pills group or placebo group, they will receive Naoan dripping pills/Placebo treatment for 12 weeks. Clinical evaluation will be performed at baseline, every 4 weeks during treatment and the follow-up week(16 weeks) . MRI scans are performed at baseline, and 12 weeks later. Responder rate (defined as the percentage of subjects in a treatment group with 50 % or greater reduction in attack frequency during treatment compared with the baseline period) and fMRI and DTI imaging changes after treatment are defined as primary outcome. In addition, 10 healthy controls will also undergo MRI scanning at baseline to determine abnormal brain activity and structure in migraine patients.
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
- Quadruple (Participant, Care Provider, 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
- 是
入选标准
- •Subject has migraine without aura or with typical aura according to criteria of the International Headache Society (IHS)
- •Subject has been diagnosed with qi deficiency syndrome and/or blood stasis syndrome in TCM
- •Subject has onset of migraine occurring before age 50
- •Subject has a history of migraine headaches for at least 1 year
- •In recent 3 months, subject has 2 to 8 headache attacks every 4 weeks
- •Age ≥ 18 years and ≤ 65 years
- •Right-handers
- •Subject has signed informed consent
排除标准
- •Subject takes painkillers more than 10 days a month for headache attacks
- •Subject who was／is in possess of Naoan dripping pills therapy but the treatment is ineffective
- •Allergic to Naoan dripping pills
- •subject's taken, within 12 weeks before enrollment, migraine prevention drugs drugs such as β-blocker, calcium channel inhibitor，Anti-epileptic drugs，antidepressants or 5-HT receptor blocker
- •Alcohol or drug abusers
- •Subject suffers from other primary headaches as specified by IHS criteria
- •Subject has medical condition such as severe heart disease, stroke, kidney disease, liver disease, hepatic or renal impairment, hematologic disease
- •Subject has psychological or mental disorder, Hamilton Anxiety Scale（HAMA）≥7，Hamilton Depression Scale（HAMD）≥7
- •Subject has language impairment or cognitive impairment, unable to read, understand or record information in study diaries and questionnaires
- •Pregnant or breast feeding subjects
- •Subjects with contraindications for undergoing MRI scans (e.g. Claustrophobic, patients with heart pacemaker )
研究组 & 干预措施
Naoan dripping pills for migraine
Drug: Naoan dripping pills, Chinese patent medicine，pill. Patients will receive treatment with Naoan dripping pills for 12 weeks, Fenbid can be taken if headache is unbearable Procedure: MRI scanning（fMRI and DTI）
干预措施: Naoan dripping pills (Drug)
Placebo
Drug: Placebo, pill. Patients will receive treatment with placebo for 12 weeks, Fenbid can be taken if headache is unbearable Procedure: MRI scanning （fMRI and DTI）
干预措施: Placebo (Drug)
结局指标
主要结局
Responder rate
时间窗: 12 weeks
Defined as the percentage of subjects in a treatment group with 50 % or greater reduction in attack frequency during treatment compared with the baseline period
次要结局
- Duration of migraine attacks(12 weeks and 16 weeks)
- Patient reported outcome (PRO) scale of migraine(12 weeks and 16 weeks)
- Change in fractional anisotropy (FA) assessed by DTI(Baseline and 12 weeks)
- Intensity of headache(12 weeks and 16 weeks)
- Number of migraine days per evaluation interval(12 weeks and 16 weeks)
- Drug consumption for symptomatic or acute treatment(12 weeks and 16 weeks)
- Change in functional connectivity assessed by Resting-state fMRI(Baseline and 12 weeks)
研究者
Ying Gao
Vice president of Dongzhimen Hospital
Dongzhimen Hospital, Beijing