[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100555336":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":33,"centralContacts":37,"locations":43,"responsibleParty":69,"collaborators":25,"id":71,"slug":72,"hasResults":73,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":25,"eligibilityCriteria":77,"healthyVolunteers":73,"sex":78,"minAge":79,"maxAge":80,"enrollmentInfo":81,"targetDuration":25,"studyType":84,"phases":85,"briefSummary":87,"conditions":88,"keywords":25,"overallStatus":46,"whyStopped":25,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":102},{"fullName":5,"class":6},"Children's Hospital of Fudan University","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Traditional Chinese Medicine+acupuncture","EXPERIMENTAL","Subjects in this group will be treated with traditional Chinese medicine and intradermal acupuncture point stimulation for 6 months.",[13,14],"Other: intradermal needles","Drug: Ziyinxiehuo Granules of traditional Chinese Medicine",{"label":16,"type":17,"description":18,"interventionNames":19},"Traditional Chinese Medicine","ACTIVE_COMPARATOR","Subjects in this group will be treated withTraditional Chinese Medicine for 6 months.",[14],[21,26],{"type":6,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"intradermal needles","Disposable intradermal needles will be used for acupoint stimulation and Tai Chong, Taixi, Sanyinjiao, Hegu as well as Yanglingquan are chosen for acupuncture point. Acupuncture point pressure will last for 10 minutes each time, three times per day, and the intradermal needles will be changed every 2 days.",[9],null,{"type":27,"name":28,"description":29,"armGroupLabels":30,"otherNames":31},"DRUG","Ziyinxiehuo Granules of traditional Chinese Medicine","Ziyinxiehuo Granules of traditional Chinese Medicine which includes shengdi 15g, xuanshen 9g, zexie 9g, zhimu9g, huangbai 9g, zhiguiban 9g, maiya 15g, tiandong 9g, zhigancao 9g,and will be administered after dissolved, 1package every time, 2 times per day after a meal.",[16,9],[32],"traditional Chinese Medicine for nourishing Yin and purging fire",[34],{"name":35,"affiliation":5,"role":36},"Sun Yanyan, Master","PRINCIPAL_INVESTIGATOR",[38],{"name":39,"role":40,"phone":41,"phoneExt":25,"email":42},"Han Xinghui, Master","CONTACT","021-64931219","1055952886@qq.com",[44,62],{"facility":45,"status":46,"city":47,"state":48,"zip":49,"country":50,"countryCode":51,"cosmosGeoPoint":52,"geoPoint":57,"contacts":58},"Children's Hospital of Fudan university","RECRUITING","Shanghai","Shanghai Municipality","201102","China","CN",{"type":53,"coordinates":54},"Point",[55,56],121.45806,31.22222,{"lat":56,"lon":55},[59],{"name":35,"role":40,"phone":60,"phoneExt":25,"email":61},"02164931219","sunyanyan09@fudan.edu.cn",{"facility":5,"status":46,"city":47,"state":25,"zip":49,"country":50,"countryCode":51,"cosmosGeoPoint":63,"geoPoint":65,"contacts":66},{"type":53,"coordinates":64},[55,56],{"lat":56,"lon":55},[67],{"name":68,"role":40,"phone":60,"phoneExt":25,"email":61},"Sun Yanyan, master",{"type":70,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","100555336","phase-3-a-trial-of-chinese-traditional-medicine-combining-with-intradermal-acupuncture-for-treating-precocious-puberty-100555336",false,"NCT06510764","A Trial of Chinese Traditional Medicine Combining With Intradermal Acupuncture for Treating Precocious Puberty","A Randomized Controlled Trial of Ziyin-Xiehuo Chinese Medicine Herbs Combined With Intradermal Acupuncture for the Treatment of Girl's Idiopathic Precocious Puberty With Yin Deficiency and Fire Hyperactivity","Inclusion Criteria:\n\n* Girls are diagnosed as Idiopathic precocious puberty, and their age of onset ≤7.5years;\n* Tanner stages of breast in female patients ≤ Tanner III stage, diameters of mammillary nucleus ≤ 3cm; •B-type ultrasonography: the volume of uterus≥ 3ml, the volume of ovary≥1.5ml, the diameter of follicle≥4mm;\n* Bone age: compared the chronological age, the bone age is less than 1 year and the bone age \\\u003C10 years old;\n* No GnRH analogs or Sex hormones were administrated in the past; and All above are needed at the same time.\n\nExclusion Criteria:\n\n* Precocity caused by the central nervous system organic diseases;\n* Precocious precocity caused by congenital hypothyroidism, congenital adrenal hyperplasia, adrenal tumor and ovarian or testicular neoplasms as well as McCune-Albright syndrome, etc;\n* Precocious precocity with a family history of diseases such as tumor, leukemia, diabetes, systemic lupus erythematous;\n* Pseudo sexual precocity and partial precocious puberty.","FEMALE","4 Years","9 Years",{"count":82,"type":83},170,"ESTIMATED","INTERVENTIONAL",[86],"PHASE3","A randomized controlled study will be conducted to evaluate the therapeutic effect of traditional Chinese medicine and acupoints stimulation on children with idiopathic precocious puberty.",[89,90,91,92],"Precocious Puberty","Treatment","Alternative Medicine","Acupuncture","2026-03-13",{"date":95,"type":96},"2026-03-16","ACTUAL",{"date":98,"type":96},"2024-09-15",{"date":100,"type":83},"2027-07-01",{"name":5,"class":6},2]