migraine
Conditions
Interventions
Experimental group:The experimental group was given 4 capsules/time, 3 times a day, for 12 weeks, and the follow-up was continued for 4 weeks after discontinuation.
Control group:The control group received 4 capsules/time of placebo orally, 3 times a day for 12 weeks, and continued follow-up for 4 weeks after discontinuation.
Healthy people group:have no Interventions
migraine with non-stasis obstruction pattern group:have no Interventions
migraine with stasis obstruction pattern group:have no Interventions
Sponsors
Dongzhimen Hospital, Beijing University of Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 50 Years
Inclusion criteria
Inclusion criteria: Cross-sectional study :Inclusion criteria for healthy people (1) Age 18-50 years old (including 18 years old and 50 years old), gender is not limited. (2) No history of migraine, tension-type headache, cluster headache and other primary or secondary headaches with a clear diagnosis, and no family history of migraine. (3) I voluntarily participated in the trial and signed the informed consent form. Cross-sectional study:Inclusion criteria for patients with migraine caused by blood stasis (1) Age 18-50 years old (including 18 years old and 50 years old), gender is not limited. (2) Meet the diagnostic criteria of migraine with typical aura or migraine without aura in the third edition of the International Classification of Headache Disorders (ICHD-3). (3) History of migraine more than 1 year.(4) At least 1 migraine attack per month. (5) Meet the diagnostic criteria for blood stasis and obstruction syndrome in the "Diagnostic Efficacy Criteria for Internal Medicine Syndromes of Traditional Chinese Medicine" (ZY/T001.1-94). (6) I voluntarily participated in the trial and signed the informed consent form. Cross-sectional study:Inclusion criteria for patients with migraine non-stasis obstruction syndrome (1) Age 18-50 years old (including 18 years old and 50 years old), gender is not limited. (2) meet the diagnostic criteria for migraine with typical aura or migraine without aura according to the International Classification of Headache Disorders, Third Edition (ICHD-3).(3) Medical history greater than 1 year. (4) Migraine attacks at least once a month. (5) It does not meet the diagnostic criteria for blood stasis and obstruction syndrome in the "Diagnostic Efficacy Criteria for Internal Medicine Syndromes of Traditional Chinese Medicine" (ZY/T001.1-94). (6) I voluntarily participated in the trial and signed the informed consent form.. Randomized controlled trials inclusion criteria : (1) Age 18-50 years old (including 18 years old and 50 years old), gender is not limited; (2) Migraine with typical aura or migraine without aura in accordance with the International Classification of Headache Disorders, Third Edition (ICHD-3). diagnostic criteria for headache; (3) history of migraine greater than 1 year; (4) at least 1 migraine attack per month; (5) Meet the "Diagnostic Efficacy Criteria for Internal Medicine Syndromes of Traditional Chinese Medicine" (ZY/T001.1-94) in the blood stasis and obstruction pattern of head stroke disease diagnostic criteria;(6) I voluntarily participated in the trial and signed the informed consent form.
Exclusion criteria
Exclusion criteria: Cross-sectional study :Exclusion Criteria for Healthy Persons (1) Those with severe primary diseases such as cardiovascular, cerebrovascular, liver, kidney, hematopoietic system, cognitive dysfunction or history of mental illness. (2) Pregnant and lactating women. (3) alcohol and drug abusers. (4) Those who have bleeding tendency or allergies, and are prone to co-infection. (5) Those who have participated in or are participating in other clinical trials within 1 month before enrollment. Cross-sectional study :Exclusion criteria for migraine caused by blood stasis (1) The number of headache days per month = 15 days, or those who take painkillers >for 10 days per month for headache attacks. (2) Those who have taken migraine prevention drugs (such as calcium antagonists, antiepileptic, anxiety, depression drugs, 5-HT receptor blockers) or acupuncture or interventional treatments within 1 month before enrollment. (3) Those who suffer from other types of headaches (such as tension, cluster headaches) or any other diseases that require regular analgesia at the same time or at different times. (4) Patients with headache caused by organic diseases, such as hypertension, cerebral hemorrhage, cerebral infarction, vascular malformation and other diseases (Note: if intracranial organic diseases cannot be excluded, head CT/MRI examination is required to exclude headache caused by intracranial organic diseases). (5) Patients with serious primary diseases or history of mental illness such as cardiovascular, cerebrovascular, liver, kidney, and hematopoietic system. (6) Those with cognitive dysfunction, unable to read or understand the content of the scale, unable to cooperate with blood drawing, and difficult to complete the efficacy assessment with poor compliance. (7) Pregnant and lactating women, or those who plan to get pregnant within three months. (8) Alcohol and drug abusers. (9) Those who have participated in or are participating in other clinical trials within 1 month before enrollment. Cross-sectional study :Exclusion criteria for migraine non-stasis obstruction syndrome (1) Those who have more =than 15 headache days per month, or take painkillers for > 10 days per month for headache attacks. (2) Those who have taken migraine prevention drugs (such as calcium antagonists, antiepileptic, anxiety, depression drugs, 5-HT receptor blockers) or acupuncture or interventional treatments within 1 month before enrollment. (3) Those who suffer from other types of headaches (such as tension, cluster headaches) or any other diseases that require regular analgesia at the same time or at different times. (4) Patients with headache caused by organic diseases, such as hypertension, cerebral hemorrhage, cerebral infarction, vascular malformation and other diseases (Note: if intracranial organic diseases cannot be excluded, head CT/MRI examination is required to exclude headache caused by intracranial organic diseases). (5) Patients with serious primary diseases or history of mental illness such as cardiovascular, cerebrovascular, liver, kidney, and hematopoietic system. (6) Those with cognitive dysfunction, unable to read or understand the content of the scale, unable to cooperate with blood drawing, and difficult to complete the efficacy assessment with poor compliance. (7) Pregnant and lactating women, or those who plan to get pregnant within three months. (8) Alcohol and drug abusers. (9) Those who have participated in or are participating in other clin
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in migraine attack frequency (number of attacks in 4 weeks) after 12 weeks of medication; | — |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline in migraine attack frequency (number of attacks in 4 weeks) at 4 and 8 weeks and 4 weeks after discontinuation of the drug;Change from baseline in visual analogue scale (VAS) score;Change from baseline in mean duration of migraine attacks;Change from baseline in Headache Impact Scale-6 (HIT-6) score;Change from baseline in head wind and blood stasis pattern score;Change from baseline in migraine stasis obstruction pattern score;Change from baseline in the number of analgesic medications used versus dose over 4 weeks;Blood single-cell transcriptomics;Metabolomics of urine samples;Fecal microbiome;Tongue coating microbiome;Blood proteomics;Blood metabolomics; | — |
Countries
China
Contacts
Public ContactYawei Du
Dongzhimen Hospital, Beijing University of Chinese Medicine
Outcome results
None listed