migraine
Conditions
Interventions
Test group:Naoan drop pills
control group:Naoan drop pill placebo
Healthy control group:No intervention
Sponsors
Dongzhimen Hospital Beijing University of Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: Case group: (migraine patients): (1) In line with the Western diagnostic criteria of migraine with or without typical aura; (2) meet the criteria of TCM syndrome diagnosis; (3) Age of first migraine attack =50 years; (4) duration =1 year; (5) The number of headache attacks in the basal line period in 4 weeks ranged from 2 to 6 times (including 2 and 6 times); (6) Age 18-65 years old, gender unlimited; (7) The patient gives informed consent and signs informed consent. Healthy Control group: healthy subjects. (1) persons aged between 18 and 65 years (including 18 and 65 years); (2) No definite diagnosis of migraine, tension headache, cluster headache and other primary and secondary headache history, and no family history of migraine; (3) I voluntarily participate and sign the informed consent.
Exclusion criteria
Exclusion criteria: Case group: (migraine patients): (1) Taking painkillers for headache attacks for more than 10 days per month; (2) The patients had taken migraine prevention drugs such as ß-blockers and caltong within 12 weeks prior to enrollment Channel blockers, antiepileptics, antidepressants and 5-HT receptor blockers, etc. (3) alcohol or other drug abusers; (4) Complicated with cardiovascular, cerebrovascular, liver, kidney, hematopoietic system and other serious primary diseases; (5) mental patients; (6) Allergic to the drug; (7) Pregnant or lactating women; Healthy Control group: (1) Patients with serious primary diseases such as heart and cerebrovascular diseases, liver and kidney dysfunction, hematopoietic system diseases, malignant tumors, or infection or injury of any part within the past 1 month; (2) Participants were participating in other clinical intervention researchers, or taking other therapeutic or preventive drugs or health supplements in the month before enrollment. Including, but not limited to, history of contraceptive use; History of antioxidant use, such as vitamin E, vitamin C, or n-acetylcysteine; History of xanthine oxidase inhibitors, such as allopurinol or folate; Anti-inflammatory drugs; Glucocorticoid hormones; (3) Patients who abuse or are dependent on alcohol, drugs or other substances; (4) Pregnant or lactating women.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Days of migraine attacks; | — |
Secondary
| Measure | Time frame |
|---|---|
| Number of migraine attacks;Halving of migraine attack days;Number of days with moderate/severe migraine attacks;Duration of migraine attacks;The number and quantity of analgesics used;Migraine Patient-Reported Outcome Evaluation Scale (PRO Scale); | — |
Countries
China
Contacts
Public ContactCao Kegang
Dongzhimen Hospital Beijing University of Chinese Medicine
Outcome results
None listed