Migraine
Conditions
Interventions
Treatment group:Xingnao Zhitong Pills
Sponsors
Hunan Provincia Hospital of Integrated Traditional Chinese and Western Medicine ( The Affiliated Hospital of Hunan Academy of Traditional Chinese Medicine)
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: (1) Age between 18 and 65 years old, with migraine onset before the age of 50; (2) Meet the diagnostic criteria for migraine with or without aura as per the Chinese Guidelines for Migraine Diagnosis and Treatment, with a history of =12 months; (3) Comply with the above TCM syndrome differentiation criteria; (4) Experience =2 migraine attacks per month in the past 3 months; (5) The patient or their legal representative voluntarily participates in the trial and signs the informed consent form.
Exclusion criteria
Exclusion criteria: (1) A history of inadequate response to three or more drugs used for migraine preventive treatment; (2) Use of prohibited substances or opioids (such as morphine, oxycodone, fentanyl, etc.); (3) Diagnosis of major depressive disorder (Hamilton Depression Rating Scale HAMD-17 score = 24).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in the average monthly migraine days from baseline during the 12-week treatment period.; | — |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of subjects achieving a =50% reduction in migraine days;Change from baseline in the average migraine pain intensity (VAS) score;Effect of Xingnao Zhitong Pills on the frequency of acute-phase analgesic use;Change from baseline in the patient's quality of life (HIT-6) score;Change from baseline in the Migraine Disability Assessment (MIDAS) score;Change from baseline in the Traditional Chinese Medicine syndrome efficacy score;Proportion of adverse events; | — |
Countries
China
Contacts
Public ContactXie le
Hunan Provincia Hospital of Integrated Traditional Chinese and Western Medicine ( The Affiliated Hospital of Hunan Academy of Traditional Chinese Medicine)
Outcome results
None listed