Study on the mechanism and standard of ear acupuncture in treating primary headache and insomnia

Phase 1

Conditions: Primary headache and insomnia

Registration Number: ITMCTR2200005600

Lead Sponsor: The First Medical Center of the PLA General Hospital

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: All

Target Recruitment: Not specified

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

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