migraine
Conditions
Interventions
Test group:When the patient has migraine, first clean the nasal cavity, press the index finger on one side of the nostril, insert the nozzle into the other side of the nostril, press the spray bottle
Control group:When the patient has migraine, first clean the nasal cavity, press one side of the nostril with the index finger, insert the nozzle into the other side of the nostril, press the spray bo
Sponsors
The First Affiliated Hospital of Guangzhou Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. The age at the time of signing the informed consent is = 18 years old and<65 years old, male and female are not limited; 2. The diagnosis conforms to the trial version of the International Classification of Headache Diseases (ICHD - ?) released by the International Headache Association( ß)) The degree of migraine without aura diagnostic criteria is moderate or severe; 3. The age of the first migraine attack of the patient should be less than 50 years old, and meet the requirements of 5 or more migraine attacks or migraine history = 1 year; 4. The patient has moderate or severe migraine attacks = 6 times and = 1 time per month within 3 months before enrollment, and has a headache interval of at least 48 hours; 5. Patients who have the ability to distinguish migraine from other types of headache when headache occurs; 6. Screening female patients who did not have unprotected sex 15 days before screening, and patients who did not have family planning during the trial and within 6 months after the end of the trial (regardless of gender); 7. Patients who have the ability to observe the curative effect and adverse events and record headache logs; Before starting any detailed procedure of this study, the patient has the ability to understand and sign the written informed consent approved by the Ethics Committee.
Exclusion criteria
Exclusion criteria: 1. The average headache time of the patient in the 3 months before the test is = 15 days per month; 2. Patients who take painkillers for a long time or use painkillers excessively (taking painkillers for more than 10 days each month for 3 consecutive months); 3. Abnormal renal function: creatinine value>upper limit of normal value; 4. Patients with a history of severe liver disease or patients with obvious abnormal liver function: alanine aminotransferase (ALT)/aspartate aminotransferase (AST) = 1.5 times the upper limit of normal value or total bilirubin (TBIL) = 1.5 times the upper limit of normal value; 5. History of major mental and neurological diseases such as depression and epilepsy; 6. Patients taking central sedatives for a long time, such as barbiturates and benzodiazepines, including diazepam and lorazepam; 7. Patients with serious cardiovascular diseases, such as those who have undergone coronary artery bypass surgery, or have a history of one of the following diseases, including but not limited to patients with ischemic heart disease, such as angina pectoris (including Platt's variant angina pectoris), myocardial infarction, history of arrhythmia (such as preexcitation syndrome) or any symptoms and signs related to the disease, or patients who have had a significant ECG abnormal change; 8. Patients with severe cerebrovascular diseases, including but not limited to cerebral ischemia and cerebral hemorrhage; 9. Have serious peripheral vascular diseases, such as Raynaud's syndrome; 10. For patients who cannot effectively control blood pressure after drug treatment, systolic blood pressure (SBP) > 140mmHg or diastolic blood pressure (DBP) > 90mmHg; 11. Have taken ergot or ergot derivatives (such as dihydroergot or ergometrine) or other 5-HT1 receptor agonists within 7 days before randomization; 12. Patients with sinusitis; 13. Regularly take drugs to prevent headache attack for more than 2 weeks before randomization, including but not limited to flunarizine, topiramate and Chinese patent drugs with similar effects; 14. For patients with alcohol abuse and drug abuse, the standard of alcohol abuse is: the average alcohol consumption per week is more than 28 units (one unit of alcohol is equivalent to 250 mL of beer, 125 mL of wine, or 20 mL of spirits or alcoholism); The drugs abused include two categories: one is narcotic drugs, such as heroin, cannabis and cannabis resin, opiates and morphine preparations, codeine, etc; The other is psychotropic drugs, such as various hallucinogens and tetrahydrocannabinol, central stimulants, barbiturates, benzodiazepines, etc; 15. Patients with family planning during pregnancy, lactation or during the study period, including women of childbearing age with positive pregnancy test results; 16. Patients who have participated in any other clinical trial within 3 months before participating in this trial and have plans to participate in other drug clinical trials; The patient may not be able to complete the test due to the reason of the patient, or the researcher thinks it is not suitable for the patient to participate in the test.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| NRS Scale;Complete relief rate of headache;Proportion of subjects with effective medication; | — |
Countries
China
Contacts
Public ContactPingyi Xu
The First Affiliated Hospital of Guangzhou Medical University
Outcome results
None listed