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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
34
Patients will take 20 pills(1000mg) after meal twice a day for 12 weeks, Fenbid can be taken if headache is unbearable, but make sure the records(including attack time, drug dosage, pain intensity and duration) are written down as detailed as possible. Procedure: MRI scanning (fMRI and DTI）
Patients will take 20 pills(1000mg) after meal twice a day for 12 weeks, Fenbid can be taken if headache is unbearable, but make sure the records(including attack time, drug dosage, pain intensity and duration) are written down as detailed as possible. Procedure: MRI scanning (fMRI and DTI)
Dongzhimen Hospital
Beijing, Beijing Municipality, China
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
Time frame: 12 weeks
Change in functional connectivity assessed by Resting-state fMRI
Investigate the differences in fractional anisotropy of migraine patients compared to healthy volunteers at baseline, and compare the changes of fractional anisotropy after 12 weeks' treatment in two groups
Time frame: Baseline and 12 weeks
Change in fractional anisotropy (FA) assessed by DTI
Investigate the differences in fractional anisotropy of migraine patients compared to healthy volunteers at baseline, and compare the changes of fractional anisotropy after 12 weeks' treatment in two groups
Time frame: Baseline and 12 weeks
Duration of migraine attacks
To compare the reduction of duration of migraine attacks after 12 weeks' treatment in two groups
Time frame: 12 weeks and 16 weeks
Intensity of headache
To compare the change of the duration of migraine attacks (mild, moderate, severe) after 12 weeks' treatment in two groups
Time frame: 12 weeks and 16 weeks
Patient reported outcome (PRO) scale of migraine
To compare the change of Patient reported scores after 12 weeks' treatment in two groups
Time frame: 12 weeks and 16 weeks
Number of migraine days per evaluation interval
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To compare the reduction of the number of migraine days per evaluation interval after 12 weeks' treatment in two groups
Time frame: 12 weeks and 16 weeks
Drug consumption for symptomatic or acute treatment
To compare the change of drug consumption for symptomatic or acute treatment after 12 weeks' treatment in two groups
Time frame: 12 weeks and 16 weeks