[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100575372":3},{"organization":4,"armGroups":7,"interventions":35,"overallOfficials":46,"centralContacts":50,"locations":56,"responsibleParty":74,"collaborators":10,"id":77,"slug":78,"hasResults":79,"nctId":80,"briefTitle":81,"officialTitle":82,"acronym":10,"eligibilityCriteria":83,"healthyVolunteers":84,"sex":85,"minAge":86,"maxAge":87,"enrollmentInfo":88,"targetDuration":10,"studyType":91,"phases":10,"briefSummary":92,"conditions":93,"keywords":97,"overallStatus":59,"whyStopped":10,"lastUpdateSubmitDate":106,"lastUpdatePostDateStruct":107,"startDateStruct":110,"completionDateStruct":112,"leadSponsor":114,"locationsCount":115},{"fullName":5,"class":6},"Taipei Veterans General Hospital, Taiwan","OTHER_GOV",[8,14,18,23,27,31],{"label":9,"type":10,"description":11,"interventionNames":12},"Group GB20",null,"Group GB20 will received acupuncture at acupoint GB20 twice a week 8 weeks for efficacy evaluation. And we could use the proteomic, exosome-proteomic, , exosome-miRNA, transcriptome, oral microbiota, Schirmer's test, Tear breakup time, 6-GSI, OSDI, TCM pattern, Traditional Chinese Medicine (TCM) tongue diagnosis, TCM pulse diagnosis, and TCM heart rate variability for this purpose.",[13],"Other: acupuncture GB20 or GB20 plus BL2",{"label":15,"type":10,"description":16,"interventionNames":17},"Group GB20 plus BL2","Group GB20 plus BL2 will received acupuncture at acupoint GB20 plus BL2 twice a week 8 weeks for efficacy evaluation. And we could use the proteomic, exosome-proteomic, exosome-miRNA, transcriptome, oral microbiota, Schirmer's test, Tear breakup time, 6-GSI, OSDI, TCM pattern, Traditional Chinese Medicine (TCM) tongue diagnosis, TCM pulse diagnosis, and TCM heart rate variability for this purpose.",[13],{"label":19,"type":10,"description":20,"interventionNames":21},"non AIDDES Healthy Controls (NHC)","ACUDES: Healthy control group will not received any treatment. And we could use the proteomic, exosome-proteomic, exosome-miRNA, transcriptome, oral microbiota, TCM pattern, Traditional Chinese Medicine (TCM) tongue diagnosis, TCM pulse diagnosis, and TCM heart rate variability to find the difference with the comparison between the dry eye syndrome and healthy control.\n\nTBDESJS: Non DES SJS Healthy Controls (NHC) will received Chinese herbal tea TBDESJS 8 weeks on Nourishing Yin and Moistening Dryness the ocular dryness evaluation. And we could use the Schirmer's test, Tear breakup time, Ocular Surface Disease Index (OSDI), EULAR Sjogren's Syndrome Patient Reported Index (ESSPRI), Pittsburgh Sleep Quality Index (PSQI), Ford Insomnia Response to Stress Test (FIRST), cytokine markers, Whole-genome genotyping, TCM pattern, Traditional Chinese Medicine (TCM) tongue diagnosis, TCM pulse diagnosis, and TCM heart rate variability for this purpose.",[13,22],"Drug: Chinese herbal tea TBDESJS",{"label":24,"type":10,"description":25,"interventionNames":26},"Waiting list","Group Waiting list will not received any treatment. at acupoint GB20 plus BL2 twice a week 8 weeks for efficacy evaluation. And we could use the proteomic, exosome-proteomic, exosome-miRNA, transcriptome, oral microbiota, Schirmer's test, Tear breakup time, 6-GSI, OSDI, TCM pattern, Traditional Chinese Medicine (TCM) tongue diagnosis, TCM pulse diagnosis, and TCM heart rate variability for this purpose.",[22],{"label":28,"type":10,"description":29,"interventionNames":30},"Dry eye syndrome (DES)","Dry eye syndrome (DES) will received Chinese herbal tea TBDESJS 8 weeks on Nourishing Yin and Moistening Dryness the ocular dryness evaluation. And we could use the proteomic, exosome-proteomic, exosome-miRNA, transcriptome, Schirmer's test, Tear breakup time, Ocular Surface Disease Index (OSDI), EULAR Sjogren's Syndrome Patient Reported Index (ESSPRI), Pittsburgh Sleep Quality Index (PSQI), Ford Insomnia Response to Stress Test (FIRST), cytokine markers, Whole-genome genotyping, TCM pattern, Traditional Chinese Medicine (TCM) tongue diagnosis, TCM pulse diagnosis, and TCM heart rate variability for this purpose.",[22],{"label":32,"type":10,"description":33,"interventionNames":34},"Sjögren's syndrome (SJS)","Sjögren's syndrome (SJS) will received Chinese herbal tea TBDESJS 8 weeks on Nourishing Yin and Moistening Dryness the ocular dryness evaluation. And we could use the proteomic, exosome-proteomic, exosome-miRNA, transcriptome, Schirmer's test, Tear breakup time, Ocular Surface Disease Index (OSDI), EULAR Sjogren's Syndrome Patient Reported Index (ESSPRI), Pittsburgh Sleep Quality Index (PSQI), Ford Insomnia Response to Stress Test (FIRST), cytokine markers, Whole-genome genotyping, TCM pattern, Traditional Chinese Medicine (TCM) tongue diagnosis, TCM pulse diagnosis, and TCM heart rate variability for this purpose.",[22],[36,41],{"type":37,"name":38,"description":39,"armGroupLabels":40,"otherNames":10},"OTHER","acupuncture GB20 or GB20 plus BL2","acupuncture at acupoint GB20 or GB20 plus BL2 twice a week 8 weeks for efficacy evaluation.",[9,15,19],{"type":42,"name":43,"description":44,"armGroupLabels":45,"otherNames":10},"DRUG","Chinese herbal tea TBDESJS","Chinese herbal tea TBDESJS 8 weeks on Nourishing Yin and Moistening Dryness the ocular dryness evaluation.",[28,32,24,19],[47],{"name":48,"affiliation":5,"role":49},"Ching-Mao Chang, M.D., Ph.D.","PRINCIPAL_INVESTIGATOR",[51],{"name":48,"role":52,"phone":53,"phoneExt":54,"email":55},"CONTACT","8862285757453","333","magicbjp@gmail.com",[57],{"facility":58,"status":59,"city":60,"state":61,"zip":62,"country":61,"countryCode":63,"cosmosGeoPoint":64,"geoPoint":69,"contacts":70},"Ching-Mao","RECRUITING","Taipei","Taiwan","886","TW",{"type":65,"coordinates":66},"Point",[67,68],121.52639,25.05306,{"lat":68,"lon":67},[71,73],{"name":48,"role":52,"phone":72,"phoneExt":54,"email":55},"88628757453",{"name":48,"role":49,"phone":10,"phoneExt":10,"email":10},{"type":49,"investigatorFullName":75,"investigatorTitle":76,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"Ching-Mao Chang","Director of Division of Integrative Medicine, Center for Traditional Medicine","100575372","exosomes-proteomic-for-sjogrens-syndrome-and-dry-eye-syndrome-100575372",false,"NCT06771427","Exosomes Proteomic for Sjogren's Syndrome and Dry Eye Syndrome","Systemic Proteomic Analysis of Plasma Exosomes to Explore the Immunomodulation Reflected to Sjogren's Syndrome and Dry Eye Syndrome","Dry eye syndrome\n\nInclusion Criteria: aged between 20 and 75 years Schirmer's test less than 10 mm\u002F5 min Exclusion Criteria: Pregnancy With eye inflammation or infectious eye disease Accepted operation of eye Sjögren's syndrome\n\nInclusion Criteria: primary or secondary SS aged between 20 and 75 years fulfilled the 2002 American-European Consensus Criteria for SS (AECG) had no abnormal findings of immune, liver, kidney, or blood function evaluations.\n\nExclusion Criteria: a history of alcohol abuse, diabetes mellitus, or major life-threatening condition pregnancy or breastfeeding steroid pulse therapy within three months prior to the commencement of our study.\n\nnon AIDDES Healthy Controls\n\nInclusion Criteria: aged between 20 and 75 years without any Chronic disease Exclusion Criteria: any Sjögren's syndrome or Dry eye syndrome.",true,"ALL","20 Years","75 Years",{"count":89,"type":90},220,"ESTIMATED","OBSERVATIONAL","By analyzing the differential proteins in exosomes, this study aims to understand the pathological mechanisms of SJS and DES, identify potential diagnostic and therapeutic methods, and advance the diagnosis and treatment of these diseases.",[94,95,96],"Dry Eye Syndrome (DES)","Sjogren's Syndrome","Xerophthalmia",[98,99,96,100,101,102,103,104,105],"Dry eye syndrome","Sjögren's syndrome","Chinese herbal tea","Nourishing Yin and Moistening Dryness","Exosome","GB20","BL2","proteomics","2025-01-15",{"date":108,"type":109},"2025-01-17","ACTUAL",{"date":111,"type":109},"2025-01-16",{"date":113,"type":90},"2026-12-31",{"name":5,"class":6},1]