Migraine
Conditions
Keywords
Migraine, Naoan dripping pills, Traditional Chinese Medicine, fMRI, Randomized Controlled trial
Brief summary
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.
Detailed description
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.
Interventions
DRUGNaoan dripping pills
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）
DRUGPlacebo
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)
Sponsors
Zhejiang Liaoyuan Pharmaceutical Co., Ltd.
Dongzhimen Hospital, Beijing
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* 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
Exclusion criteria
* 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 )
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Responder rate | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in fractional anisotropy (FA) assessed by DTI | Baseline and 12 weeks | 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 |
| Duration of migraine attacks | 12 weeks and 16 weeks | To compare the reduction of duration of migraine attacks after 12 weeks' treatment in two groups |
| Intensity of headache | 12 weeks and 16 weeks | To compare the change of the duration of migraine attacks (mild, moderate, severe) after 12 weeks' treatment in two groups |
| Change in functional connectivity assessed by Resting-state fMRI | Baseline and 12 weeks | 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 |
| Number of migraine days per evaluation interval | 12 weeks and 16 weeks | To compare the reduction of the number of migraine days per evaluation interval after 12 weeks' treatment in two groups |
| Drug consumption for symptomatic or acute treatment | 12 weeks and 16 weeks | To compare the change of drug consumption for symptomatic or acute treatment after 12 weeks' treatment in two groups |
| Patient reported outcome (PRO) scale of migraine | 12 weeks and 16 weeks | To compare the change of Patient reported scores after 12 weeks' treatment in two groups |
Countries
China
Outcome results
None listed