Primary headache and insomnia
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Inclusion criteria for migraine: (1) Patients who agree to participate in the clinical trial and sign informed consent (2) Patients aged 18-65 with onset age =50 met the diagnostic criteria of migraine in the International Headache Society Classification iii (ICHD-3) (2) The history of headache =1 year and the frequency of headache = 2 times within 3 months (4) Three months before entering the initiation period, the frequency of migraine attacks =2 times (5) Subjects can accurately identify migraine and understand the study instructions, and can independently complete the headache diary Inclusion criteria for tension-type headache: (1) Patients who agree to participate in the clinical trial and sign informed consent (2) 18-65 years of age, with the first episode =50 years of age, meeting the diagnostic criteria of tension headache according to the International Headache Society Classification Iii (ICHD-3) (3) After meeting the conditions in (2), headache history =1 year and headache attack frequency = 2 times within 4 weeks (4) The frequency of tension-type headache =2 times in 3 months before the initiation period; (5) Subjects can accurately identify tension-type headache, understand the study instructions, and independently complete the headache diary Insomnia inclusion criteria: (1) Patients who agree to participate in the clinical trial and sign informed consent (2) 18-65 years of age, with the first episode =50 years of age, meeting the diagnostic criteria for insomnia in the International Classification of Sleep Disorders (ICSD-3) (3) Three months before entering the initiation period, the number of insomnia attacks =3 times; (4) Subjects can accurately identify insomnia and understand the researcher's instructions, and can independently complete the sleep diary records
Exclusion criteria
Exclusion criteria: If you suffer from migraines, please read the following carefully to make sure that you do not have any of the following conditions: (1) Headache is a type other than migraine; (2) patients with other types of headache, including secondary headache; (3) patients with thrombocytopenia, glaucoma, peripheral vascular disease or Raynaud's syndrome; (4) Participants in other clinical trials, including pharmacotherapy and alternative therapy (such as acupuncture, massage, percutaneous electrical stimulation, etc.) during the study period and within 3 months prior to the study; (5) patients who underwent facial surgery in the sphenopalatine ganglion region due to plastic surgery, correction, treatment or trauma; (6) Patients with liver and kidney function impairment: ALT and AST were 1.5 times higher than the upper limit of normal value, Cr was more than the upper limit of normal value, and TBIL was more than 2 times higher than the upper limit of normal value; (7) patients complicated with other serious cardiovascular and cerebrovascular diseases and hematopoietic diseases;Patients with malignant tumors; (8) Patients who have recently undergone major surgery or trauma are not eligible to participate in this study; (9) patients with schizophrenia, major depression (HAMD >24 points), alcohol dependence, and history of drug abuse; (10) patients with severe ear diseases; (11) women who are pregnant or breast-feeding, and those who plan to have children during the trial or within 3 months after stopping the medication; (12) Persons with allergic constitution or previous allergy to multiple drugs, or allergic to the ingredients in the drug under study; (13) Patients who had been treated with ear acupuncture for other diseases within 2 months prior to the trial; (14) Taking painkillers for more than 10 days/month; (15) those who had taken prophylactic drugs within 1 month before the trial; (16) Patients considered unsuitable for the study by other researchers. If you are a tension-type headache sufferer, please read the following text carefully to make sure that you do not have the following conditions: (1) Headache is a type other than tension headache; (2) patients with other types of headache, including secondary headache; (3) patients with thrombocytopenia, glaucoma, peripheral vascular disease or Raynaud's syndrome; (4) Participants in other clinical trials, including pharmacotherapy and alternative therapy (such as acupuncture, massage, percutaneous electrical stimulation, etc.) during the study period and within 3 months prior to the study; (5) patients who underwent facial surgery in the sphenopalatine ganglion region due to plastic surgery, correction, treatment or trauma; (6) Patients with liver and kidney function impairment: ALT and AST were 1.5 times higher than the upper limit of normal value, Cr was more than the upper limit of normal value, and TBIL was more than 2 times higher than the upper limit of normal value; (7) patients complicated with other serious cardiovascular and cerebrovascular diseases and hematopoietic diseases;Patients with malignant tumors; (8) Patients who have recently undergone major surgery or trauma are not eligible to participate in this study; (9) patients with schizophrenia, major depression (HAMD >24 points), alcohol dependence, and history of drug abuse; (10) patients with severe ear diseases; (11) women who are pregnant or breast-feeding, and those who plan to have children du
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Brain functional magnetic resonance examination; | — |
Secondary
| Measure | Time frame |
|---|---|
| headache diary;scale;Multi-dimensional thermal imaging;electroencephalogram;insomnia diary; | — |
Countries
China