[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100604095":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":32,"centralContacts":36,"locations":43,"responsibleParty":62,"collaborators":41,"id":66,"slug":67,"hasResults":68,"nctId":69,"briefTitle":70,"officialTitle":71,"acronym":41,"eligibilityCriteria":72,"healthyVolunteers":68,"sex":73,"minAge":74,"maxAge":75,"enrollmentInfo":76,"targetDuration":41,"studyType":79,"phases":80,"briefSummary":82,"conditions":83,"keywords":41,"overallStatus":85,"whyStopped":41,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":95},{"fullName":5,"class":6},"China-Japan Friendship Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Yiqi Yangyin Formula","EXPERIMENTAL","The herbal prescription for patients eligible for pSS \"Qi-Yin deficiency syndrome\" , 200 ml twice daily for 12 weeks.",[13],"Drug: Yiqi Yangyin Formula",{"label":15,"type":16,"description":17,"interventionNames":18},"Yiqi Yangyin Formula placebo","PLACEBO_COMPARATOR","The herbal prescription placebo for patients eligible for pSS \"Qi-Yin deficiency syndrome\" , 200 ml twice daily for 12 weeks.",[19],"Drug: Yiqi Yangyin Formula placebo",[21,27],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","Yiqi Yangyin Formula,consists of seven Chinese herbal medicines（Table 1）: Rehmanniae Radix (Sheng Di Huang), Lilium brownii (Bai He), Adenophorae Radix (Nan Sha Shen), Fructus Hordei Germinatus (Sheng Mai Ya), Artemisia annua (Qing Hao), Cimicifuga foetida (Sheng Ma) , and Bupleurum chinense(Chai Hu)",[9],[26],"The treatment group",{"type":22,"name":15,"description":28,"armGroupLabels":29,"otherNames":30},"Yiqi Yangyin Formula placebo,has the same appearance, state, and taste as YQYYF, but contains 5% of the ingredients of Yiqi Yangyin Formula",[15],[31],"The control group",[33],{"name":34,"affiliation":5,"role":35},"Tao Qingwen Tao","STUDY_CHAIR",[37],{"name":38,"role":39,"phone":40,"phoneExt":41,"email":42},"Luo Jing Luo","CONTACT","+8618400664714",null,"luojinggg@sina.com",[44],{"facility":45,"status":41,"city":46,"state":47,"zip":48,"country":49,"countryCode":50,"cosmosGeoPoint":51,"geoPoint":56,"contacts":57},"China-Japan friendship hospital","Beijing","Beijing Municipality","100029","China","CN",{"type":52,"coordinates":53},"Point",[54,55],116.39723,39.9075,{"lat":55,"lon":54},[58],{"name":59,"role":39,"phone":60,"phoneExt":41,"email":61},"Liu Zihan Liu","+86 15290302271","3416309723@qq.com",{"type":63,"investigatorFullName":64,"investigatorTitle":65,"investigatorAffiliation":5,"oldNameTitle":41,"oldOrganization":41},"PRINCIPAL_INVESTIGATOR","Luo Jing","Associate chief physician","100604095","a-study-of-yiqi-yangyin-formula-in-the-treatment-of-primary-sjogrens-syndrome-100604095",false,"NCT07145060","A Study of Yiqi Yangyin Formula in the Treatment of Primary Sjogren's Syndrome","A Randomized Controlled Study of Yiqi Yangyin Formula in the Treatment of Primary Sjogren's Syndrome","Inclusion Criteria:\n\n* Patients aged18-75 years old (including the critical value), gender not limited;\n* Patients meeting the classification criteria of primary Sjogren's syndrome in ACR\u002FEULAR 2016;\n* Patients with dry mouth VAS ≥4 and ESSDAI score \\\u003C 5;\n* Patients with positive autoantibodies (ANA or anti-SSA antibodies or anti-SSB antibodies or RF) and\u002For hyperimmunoglobulinemia or increased erythrocyte sedimentation rate;\n* Patients meeting the syndrome of qi and Yin deficiency in traditional Chinese medicine;\n* The subjects were informed and voluntarily signed the informed consent form.\n\nExclusion Criteria:\n\n* Patients with a history of hypersensitivity or intolerance to any investigational therapeutic drug;\n* Patients diagnosed with secondary Sjogren's syndrome or combined with other connective tissue diseases;\n* Patients with severe lesions in the heart, brain, lungs, liver, kidneys, hematopoietic system, etc., as well as those with malignant tumors or infectious diseases;\n* Patients who are pregnant, preparing for pregnancy or breastfeeding;\n* Patients who have used cholinergic drugs or artificial tears\u002Fsaliva in last 1 week;\n* Patients who have used hydroxychloroquine, total glycosides of Paeonia lactide, Iguratimod, cyclophosphamide, cyclosporine A, tacrolimus, and azathioprine in last 1 month;\n* Patients who have used glucocorticoids, methotrexate or mycophenolate mofetil in last 3 months;\n* Patients who have used Leflunomide in last 6 months;\n* Patients who have used rituximab in last 6 months, or have used other biological agents (such as tofacitinib) other than rituximab in last 3 months;\n* Patients who have participated in or are currently receiving any other experimental drugs or experimental medical devices within the past three months;\n* Other situations that researchers consider ineligible for inclusion (such as cognitive impairment, taking psychotropic drugs).","ALL","18 Years","75 Years",{"count":77,"type":78},105,"ESTIMATED","INTERVENTIONAL",[81],"NA","This project aims to conduct a prospective, randomized, double-blind, controlled clinical study to clarify the efficacy and safety of the YiQi YangYin Formula in treating patients with primary Sjogren's syndrome (pSS) presenting with Qi and Yin deficiency syndrome, with the expectation of providing a scientific basis for the research and development of new traditional Chinese medicine drugs for the effective treatment of pSS.",[84],"Primary Sjögren's Syndrome (pSS)","NOT_YET_RECRUITING","2025-08-20",{"date":88,"type":89},"2025-08-28","ACTUAL",{"date":91,"type":78},"2025-09-01",{"date":93,"type":78},"2028-03-31",{"name":5,"class":6},1]