ITMCTR2200005600尚未招募1 期
Study on the mechanism and standard of ear acupuncture in treating primary headache and insomnia
The First Medical Center of the PLA General Hospital0 个研究点开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional study
入排标准
- 年龄范围
- 18 至 65（—）
- 性别
- All
入选标准
- •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
排除标准
- •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
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