migraine
Conditions
Interventions
Control Group:Placebo
Experimental Group:Sishunfang Granules
Sponsors
Dongzhimen Hospital of Beijing University of Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: (1) Meeting the diagnostic criteria for migraine without aura or typical aura migraine according to the International Classification of Headache Disorders 3rd Edition (ICHD-3); (2) Aged between 18 and 65 years (inclusive); (3) Onset of migraine before the age of 50 years; (4) =1-year history of migraine; (5) Experienced 2-8 migraine attacks with moderate to severe headache (VAS = 4) in the past 4 weeks with an interval of =48 hours between any two attacks; (6) The subject is able to distinguish migraines from other types of headaches (e.g. tension-type headache); (7) During migraine attacks the subject experiences at least one of the following symptoms: aversion to wind spontaneous sweating intolerance to cold with cold extremities mental fatigue or palpitations; (8) The subject voluntarily agrees to participate and provides informed consent either signed personally or by a direct relative on their behalf.
Exclusion criteria
Exclusion criteria: (1)Migraine occurring on =15 days over the past 4 weeks; (2)Use of pain-relief medication on =10 days over the past 4 weeks; (3)Presence of severe primary diseases affecting the cardiovascular digestive or hematological systems; (4)History of epilepsy stroke other organic neurological disorders or psychiatric illness; (5)Headache confirmed to be caused by organic diseases such as subarachnoid hemorrhage cerebral hemorrhage cerebral infarction vascular malformation arteritis hypertension atherosclerosis or other related conditions; (6)Presence of severe liver or kidney diseases or abnormal liver and kidney function test results (ALT AST = 1.5 times the upper limit of normal or Cr > the upper limit of normal); (7)Significant symptoms of anxiety or depression (HAMA = 15 or HAMD = 18); (8)Cognitive impairment inability to read or understand the content of the assessment scales poor treatment adherence (e.g. inability to maintain treatment) or difficulty in completing efficacy evaluations; (9)Use of a stable dose of prophylactic migraine medication for less than 3 months; (10)Pregnant breastfeeding or planning to conceive; (11)Currently participating in other clinical trials.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of Patients with Headache Relief 2 Hours After Medication; | — |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of patients with the most distressing associated symptoms relieved within 2 hours;Proportion of patients with sustained headache relief from 2 to 24 hours;Changes in patients' VAS scores for pain at pre-medication and at 0.5h 1.0h 2.0h 4.0h 24h and 48h post-medication;Headache recurrence rate from 2 to 48 hours;Proportion of patients with headache relief within 2 hours;Traditional Chinese Medicine (TCM) clinical syndrome score;Onset time defined as the time (in minutes) from medication to relief of headache or associated symptoms;Proportion of patients with sustained headache relief from 2 to 48 hours;Proportion of patients with sustained headache freedom from 2 to 24 hours;Proportion of patients with sustained headache freedom from 2 to 48 hours; | — |
Countries
China
Contacts
Public ContactKegang Cao
Dongzhimen Hospital Beijing University of Chinese Medicine
Outcome results
None listed