[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100437778":3},{"organization":4,"armGroups":7,"interventions":25,"overallOfficials":37,"centralContacts":42,"locations":48,"responsibleParty":71,"collaborators":73,"id":76,"slug":77,"hasResults":78,"nctId":79,"briefTitle":80,"officialTitle":80,"acronym":30,"eligibilityCriteria":81,"healthyVolunteers":78,"sex":82,"minAge":83,"maxAge":84,"enrollmentInfo":85,"targetDuration":30,"studyType":88,"phases":89,"briefSummary":91,"conditions":92,"keywords":94,"overallStatus":97,"whyStopped":30,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":102,"completionDateStruct":104,"leadSponsor":106,"locationsCount":107},{"fullName":5,"class":6},"Shanghai Institute of Acupuncture, Moxibustion and Meridian","OTHER",[8,14,20],{"label":9,"type":10,"description":11,"interventionNames":12},"Grain moxibustion","EXPERIMENTAL","Grain moxibustion +standard care",[13],"Device: Grain moxibustion",{"label":15,"type":16,"description":17,"interventionNames":18},"Sham grain moxibustion","SHAM_COMPARATOR","Sham grain moxibustion +standard care",[19],"Device: Sham grain moxibustion",{"label":21,"type":6,"description":22,"interventionNames":23},"Wait-list control","Standard care",[24],"Other: Standard care",[26,31,34],{"type":27,"name":9,"description":28,"armGroupLabels":29,"otherNames":30},"DEVICE","Take Baihui(GV20), apply vaseline on the acupoint, knead moxa villi into grain size, put it on GV20, and ignite it with incense. When the patient feels burning or a little pain, put out moxa with gauze and keep for 10 seconds, so as to ensure enough heat to be penetrated into the acupoint. There are 3 cones for the first six times and 5 cones for the last six times . After the treatment of GV20, the patient will be in prone position. Select bilateral Xinshu(BL15) and Pishu(BL20) and operate the same as that of GV20. 3 times a week, 12 times in all. During the trial, patients with severe sleep disorders will be allowed to take the sedative-hypnotic drug eszopiclone 0.5-2mg orally (Sinopharm approval H31021534, Shanghai Shangyao Xinyi Pharmaceutical Co., Ltd.).",[9],null,{"type":27,"name":15,"description":32,"armGroupLabels":33,"otherNames":30},"Take Baihui(GV20), apply vaseline on the acupoint, knead moxa villi into grain size, put it on GV20, and ignite it with incense. When the moxa burns to half （the patient hasn't feel hot or feel a little hot）, take the moxa away with tweezers. There are 3 cones for the first six times and 5 cones for the last six times . After the treatment of GV20, the patient will be in prone position. Select bilateral Xinshu(BL15) and Pishu(BL20) and operate the same as that of GV20. 3 times a week, 12 times in all. During the trial, patients with severe sleep disorders will be allowed to take the sedative-hypnotic drug eszopiclone 0.5-2mg orally (Sinopharm approval H31021534, Shanghai Shangyao Xinyi Pharmaceutical Co., Ltd.).",[15],{"type":6,"name":22,"description":35,"armGroupLabels":36,"otherNames":30},"Participants in the wait-list control with severe sleep disorders will be allowed to take the sedative-hypnotic drug eszopiclone 0.5-2mg orally (Sinopharm approval H31021534, Shanghai Shangyao Xinyi Pharmaceutical Co., Ltd.). And after waiting for 12 weeks, these patients will be treated with the same grain moxibustion as the grain moxibustion group.",[21],[38],{"name":39,"affiliation":40,"role":41},"Huangan Wu, PhD, MD","Shanghai Institute of Acupuncture and Meridian","STUDY_CHAIR",[43],{"name":44,"role":45,"phone":46,"phoneExt":30,"email":47},"Chunhui Bao, PhD, MD","CONTACT","+8664395973","baochunhui789@126.com",[49,65],{"facility":5,"status":30,"city":50,"state":51,"zip":52,"country":53,"countryCode":54,"cosmosGeoPoint":55,"geoPoint":60,"contacts":61},"Shanghai","Shanghai Municipality","200030","China","CN",{"type":56,"coordinates":57},"Point",[58,59],121.45806,31.22222,{"lat":59,"lon":58},[62],{"name":63,"role":45,"phone":64,"phoneExt":30,"email":47},"Chunhui Bao, PhD,MD","862164395973",{"facility":5,"status":30,"city":50,"state":51,"zip":30,"country":53,"countryCode":54,"cosmosGeoPoint":66,"geoPoint":68,"contacts":69},{"type":56,"coordinates":67},[58,59],{"lat":59,"lon":58},[70],{"name":63,"role":45,"phone":64,"phoneExt":30,"email":47},{"type":72,"investigatorFullName":30,"investigatorTitle":30,"investigatorAffiliation":30,"oldNameTitle":30,"oldOrganization":30},"SPONSOR",[74],{"name":75,"class":6},"Shanghai University of Traditional Chinese Medicine","100437778","grain-moxibustion-treatment-on-insomnia-a-randomized-controlled-trial-100437778",false,"NCT04980703","Grain Moxibustion Treatment on Insomnia: a Randomized Controlled Trial","Inclusion Criteria:\n\n1. Meet the diagnostic criteria of insomnia;\n2. TCM syndrome differentiation belongs to deficiency of both heart and spleen;\n3. Male or female participants aged 18-75;\n4. Participants whose PSQI score is 5-15;\n5. The course of disease is more than 3 months;\n6. Participants who voluntarily agree with the investigation and sign a written informed consent form for the clinical trial.\n\nExclusion Criteria:\n\n1. Participants with mental retardation;\n2. Participants with serious cardiovascular diseases, liver, kidney and hematopoietic system diseases;\n3. Insomnia is caused by nervous system diseases (such as stroke, Parkinson's disease) or mental disorders (including depression or anxiety);\n4. Female participants who is pregnant or lactating;\n5. Participants with diabetes and sensory dysfunction.\n6. Participants with skin diseases of acupoints;\n7. Taking sedative hypnotics (including barbiturates, benzodiazepines, tranquilizers, diphenylmethane, etc) and other insomnia related drugs within 2 weeks before the trial;\n8. Participants with dependence on sleeping drugs;\n9. Participants suffering from malignant tumor, sequelae of severe cerebral apoplexy, organ failure and other major diseases that affect insomnia and therapeutic effect.","ALL","18 Years","75 Years",{"count":86,"type":87},102,"ESTIMATED","INTERVENTIONAL",[90],"NA","This trial intends to observe the clinical efficacy and safety of grain moxibustion at Baihui(GV20), Xinshu(BL15) and Pishu(BL20) in the treatment of insomnia.",[93],"Sleep Initiation and Maintenance Disorders",[95,96],"moxibustion","insomnia","NOT_YET_RECRUITING","2025-05-13",{"date":100,"type":101},"2025-05-14","ACTUAL",{"date":103,"type":87},"2027-07-01",{"date":105,"type":87},"2029-07-31",{"name":5,"class":6},2]