migraine
Conditions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1) Complying with the criteria of the International Classification of Migraine Disorders (with aura or without aura), 3rd edition; 2) The age of the first migraine attack was <= 50 years old; 3) A history of migraine for at least 12 months; 4) At least 6 attacks,during the 3 months pre-introduction period; 5) 2-4 attacks during 2 weeks introduction period; 6) Less than 7 Migraine days during 2 weeks preintroduction period; 7) Aged 16 to 65 year; 8) Subjects were able to accurately identify migraine and understand the investigator's instructions and were able to independently complete the headache-diary record; 9) Participants signed consent forms for this trial.
Exclusion criteria
Exclusion criteria: 1. Hemorrhagic stroke; 2. Pulmonary hypertension; 3. Right ventricular cardiomyopathy; 4. Pulmonary valve stenosis, pulmonary artery stenosis or right ventricular outflow tract stenosis; 5. Moderate to severe tricuspid regurgitation caused by various causes; 6. The headache can't match the criteria of paroxysmal migraine; 7. Combined with other types of headache, including consequential headache patients; 8. Patients with thrombocytopenia, glaucoma, peripheral vascular disease, or Raynaud's syndrome; 9. Participate in this trial and participate in other clinical trials within the first 3 months of participation, including participation in drug therapy and alternative therapies (eg acupuncture, massage, percutaneous electrical stimulation, etc.); 10. Patients undergoing facial surgery of the sphenopalatine ganglion region due to plastic surgery, correction, treatment, or trauma; 11. Combined with liver and kidney function damage: ALT >= 3 x ULN; AST >= 3 x ULN 3; Cr >= ULN; TBIL>= 2 x ULN; 12. Patients with other serious cardiovascular and hematopoietic diseases and hematopoietic diseases; patients with malignant tumors; 13. Patients who have recently undergone major surgery or trauma are not eligible to participate in this study; 14. Patients with schizophrenia, major depression (HAMD scale >24), alcohol dependence, history of drug abuse; 15. Pregnancy and breastfeeding women and those who have a birth plan within 3 months of the trial or after the stop of medication; 16. Allergies or encounter a wide range of drug allergies, or to study the ingredients of the medication for allergic persons; 17. Take painkillers >10 days/month; 18. Other patients who should not be involved in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cessation of headache;The frequency of headache attacks per month decreased by 50%;he number of headache days attacks per month decreased by 50%; | — |
Secondary
| Measure | Time frame |
|---|---|
| Headache Impact Test-6;reduction in migraine headache attacks;reduction in migraine headache days; | — |
Countries
China
Contacts
Department of Cardiology, Zhejiang Provincial People's Hospital