[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100576054":3},{"organization":4,"armGroups":7,"interventions":43,"overallOfficials":48,"centralContacts":94,"locations":100,"responsibleParty":120,"collaborators":48,"id":122,"slug":123,"hasResults":124,"nctId":125,"briefTitle":126,"officialTitle":127,"acronym":128,"eligibilityCriteria":129,"healthyVolunteers":124,"sex":130,"minAge":131,"maxAge":132,"enrollmentInfo":133,"targetDuration":48,"studyType":136,"phases":137,"briefSummary":139,"conditions":140,"keywords":144,"overallStatus":103,"whyStopped":48,"lastUpdateSubmitDate":151,"lastUpdatePostDateStruct":152,"startDateStruct":155,"completionDateStruct":157,"leadSponsor":159,"locationsCount":160},{"fullName":5,"class":6},"Taipei Veterans General Hospital, Taiwan","OTHER_GOV",[8,24,30,34,38],{"label":9,"type":10,"description":11,"interventionNames":12},"LA+LA group of SJS-DES","EXPERIMENTAL","LA+LA group of SJS-DES will receive laser acupuncture at acupoint GB20, BL2, LI4 and LI11 twice a week 8 weeks for efficacy evaluation. And we could use the Numerical Rating Scale (NRS), Schirmer's test, Ocular Surface Disease Index (OSDI), EULAR Sjögren's Syndrome Patient Reported Index (ESSPRI), Traditional Chinese Medicine (TCM) tongue diagnosis, TCM pulse diagnosis, TCM constitution questionnaire, TCM heart rate variability analysis, nailfold microcirculation assessment, and iris examination for this purpose.",[13,14,15,16,17,18,19,20,21,22,23],"Other: Laser acupuncture (LA)","Diagnostic Test: Numerical Rating Scale (NRS)","Diagnostic Test: Schirmer's test","Diagnostic Test: Ocular Surface Disease Index (OSDI)","Diagnostic Test: EULAR Sjögren's Syndrome Patient Reported Index (ESSPRI)","Diagnostic Test: Traditional Chinese Medicine (TCM) tongue diagnosis","Diagnostic Test: Traditional Chinese Medicine (TCM) pulse diagnosis","Diagnostic Test: Traditional Chinese Medicine (TCM) constitution questionnaire","Diagnostic Test: Traditional Chinese Medicine (TCM) heart rate variability analysis","Diagnostic Test: nailfold microcirculation assessment","Diagnostic Test: iris examination",{"label":25,"type":26,"description":27,"interventionNames":28},"Sham+LA group of SJS-DES","SHAM_COMPARATOR","Sham+LA group of SJS-DES will receive sham acupuncture twice a week 4 weeks and then laser acupuncture at acupoint GB20, BL2, LI4 and LI11 twice a week 4 weeks for efficacy evaluation. And we could use the Numerical Rating Scale (NRS), Schirmer's test, Ocular Surface Disease Index (OSDI), EULAR Sjögren's Syndrome Patient Reported Index (ESSPRI), Traditional Chinese Medicine (TCM) tongue diagnosis, TCM pulse diagnosis, TCM constitution questionnaire, TCM heart rate variability analysis, nailfold microcirculation assessment, and iris examination for this purpose.",[13,14,15,16,17,18,19,20,21,22,23,29],"Other: Sham Laser Acupuncture",{"label":31,"type":10,"description":32,"interventionNames":33},"LA+LA group of Non-SJS-DES","LA+LA group of Non-SJS-DES will receive laser acupuncture at acupoint GB20, BL2, LI4 and LI11 twice a week 8 weeks for efficacy evaluation. And we could use the Numerical Rating Scale (NRS), Schirmer's test, Ocular Surface Disease Index (OSDI), EULAR Sjögren's Syndrome Patient Reported Index (ESSPRI), Traditional Chinese Medicine (TCM) tongue diagnosis, TCM pulse diagnosis, TCM constitution questionnaire, TCM heart rate variability analysis, nailfold microcirculation assessment, and iris examination for this purpose.",[13,14,15,16,17,18,19,20,21,22,23],{"label":35,"type":26,"description":36,"interventionNames":37},"Sham+LA group of Non-SJS-DES","Sham+LA group of Non-SJS-DES will receive sham acupuncture twice a week 4 weeks and then laser acupuncture at acupoint GB20, BL2, LI4 and LI11 twice a week 4 weeks for efficacy evaluation. And we could use the Numerical Rating Scale (NRS), Schirmer's test, Ocular Surface Disease Index (OSDI), EULAR Sjögren's Syndrome Patient Reported Index (ESSPRI), Traditional Chinese Medicine (TCM) tongue diagnosis, TCM pulse diagnosis, TCM constitution questionnaire, TCM heart rate variability analysis, nailfold microcirculation assessment, and iris examination for this purpose.",[13,14,15,16,17,18,19,20,21,22,23,29],{"label":39,"type":40,"description":41,"interventionNames":42},"Waiting list","OTHER","Group Waiting list will not receive any treatment at acupoint GB20, BL2, LI4 and LI11 twice a week 8 weeks for efficacy evaluation. And we could use the Numerical Rating Scale (NRS), Schirmer's test, Ocular Surface Disease Index (OSDI), EULAR Sjögren's Syndrome Patient Reported Index (ESSPRI), Traditional Chinese Medicine (TCM) tongue diagnosis, TCM pulse diagnosis, TCM constitution questionnaire, TCM heart rate variability analysis, nailfold microcirculation assessment, and iris examination for this purpose.",[14,15,16,17,18,19,20,21,22,23],[44,49,54,58,62,66,70,74,78,82,86,90],{"type":40,"name":45,"description":46,"armGroupLabels":47,"otherNames":48},"Laser acupuncture (LA)","The RJ-Laser acupuncture device (Reimers \\& Janssen GmbH, Waldkirch, Germany) is used with a laser wavelength of 810 nm (infrared). The Bahr frequency B3 is set at 2398 Hz, with an energy output of 400 mW, operating in intermittent pulse mode. Each acupoint is irradiated for 15 seconds. A total of 8 bilateral acupoints are treated per session, with a total treatment time of approximately 120 seconds.",[31,9,35,25],null,{"type":50,"name":51,"description":52,"armGroupLabels":53,"otherNames":48},"DIAGNOSTIC_TEST","Numerical Rating Scale (NRS)","LA+LA group of SJS-DES, Sham+LA group of SJS-DES, LA+LA group of Non-SJS-DES, Sham+LA group of Non-SJS-DES and Waiting list will take the Numerical Rating Scale (NRS).",[31,9,35,25,39],{"type":50,"name":55,"description":56,"armGroupLabels":57,"otherNames":48},"Schirmer's test","LA+LA group of SJS-DES, Sham+LA group of SJS-DES, LA+LA group of Non-SJS-DES, Sham+LA group of Non-SJS-DES and Waiting list will take the Schirmer's test.",[31,9,35,25,39],{"type":50,"name":59,"description":60,"armGroupLabels":61,"otherNames":48},"Ocular Surface Disease Index (OSDI)","LA+LA group of SJS-DES, Sham+LA group of SJS-DES, LA+LA group of Non-SJS-DES, Sham+LA group of Non-SJS-DES and Waiting list will take the OSDI test.",[31,9,35,25,39],{"type":50,"name":63,"description":64,"armGroupLabels":65,"otherNames":48},"EULAR Sjögren's Syndrome Patient Reported Index (ESSPRI)","LA+LA group of SJS-DES, Sham+LA group of SJS-DES, LA+LA group of Non-SJS-DES, Sham+LA group of Non-SJS-DES and Waiting list will take the ESSPRI.",[31,9,35,25,39],{"type":50,"name":67,"description":68,"armGroupLabels":69,"otherNames":48},"Traditional Chinese Medicine (TCM) tongue diagnosis","LA+LA group of SJS-DES, Sham+LA group of SJS-DES, LA+LA group of Non-SJS-DES, Sham+LA group of Non-SJS-DES and Waiting list will take the Traditional Chinese Medicine (TCM) tongue diagnosis.",[31,9,35,25,39],{"type":50,"name":71,"description":72,"armGroupLabels":73,"otherNames":48},"Traditional Chinese Medicine (TCM) pulse diagnosis","LA+LA group of SJS-DES, Sham+LA group of SJS-DES, LA+LA group of Non-SJS-DES, Sham+LA group of Non-SJS-DES and Waiting list will take the Traditional Chinese Medicine (TCM) pulse diagnosis.",[31,9,35,25,39],{"type":50,"name":75,"description":76,"armGroupLabels":77,"otherNames":48},"Traditional Chinese Medicine (TCM) constitution questionnaire","LA+LA group of SJS-DES, Sham+LA group of SJS-DES, LA+LA group of Non-SJS-DES, Sham+LA group of Non-SJS-DES and Waiting list will take the Traditional Chinese Medicine (TCM) constitution questionnaire.",[31,9,35,25,39],{"type":50,"name":79,"description":80,"armGroupLabels":81,"otherNames":48},"Traditional Chinese Medicine (TCM) heart rate variability analysis","LA+LA group of SJS-DES, Sham+LA group of SJS-DES, LA+LA group of Non-SJS-DES, Sham+LA group of Non-SJS-DES and Waiting list will take the Traditional Chinese Medicine (TCM) heart rate variability analysis.",[31,9,35,25,39],{"type":50,"name":83,"description":84,"armGroupLabels":85,"otherNames":48},"nailfold microcirculation assessment","LA+LA group of SJS-DES, Sham+LA group of SJS-DES, LA+LA group of Non-SJS-DES, Sham+LA group of Non-SJS-DES and Waiting list will take the nailfold microcirculation assessment.",[31,9,35,25,39],{"type":50,"name":87,"description":88,"armGroupLabels":89,"otherNames":48},"iris examination","LA+LA group of SJS-DES, Sham+LA group of SJS-DES, LA+LA group of Non-SJS-DES, Sham+LA group of Non-SJS-DES and Waiting list will take the iris examination.",[31,9,35,25,39],{"type":40,"name":91,"description":92,"armGroupLabels":93,"otherNames":48},"Sham Laser Acupuncture","The RJ-Laser acupuncture device (Reimers \\& Janssen GmbH, Waldkirch, Germany) is used with a laser wavelength of 810 nm (infrared). The Bahr frequency B3 is set at 2398 Hz, with an energy output of 400 mW, operating in intermittent pulse mode. Each acupoint is irradiated for 15 seconds. A total of 8 bilateral acupoints are treated per session, with a total treatment time of approximately 120 seconds.\n\nThe sham laser acupuncture procedure follows the same process as the true laser acupuncture protocol, including the positioning, cleaning of acupoints, and wearing of protective goggles. However, no laser emission is delivered during the treatment. This ensures a consistent experience for the patient while maintaining the blinding integrity of the study.",[35,25],[95],{"name":96,"role":97,"phone":98,"phoneExt":48,"email":99},"Ching-Mao Chang, M.D., Ph.D.","CONTACT","886-28757453, 333","magicbjp@gmail.com",[101],{"facility":102,"status":103,"city":104,"state":105,"zip":106,"country":105,"countryCode":107,"cosmosGeoPoint":108,"geoPoint":113,"contacts":114},"Ching-Mao Chang","RECRUITING","Taipei","Taiwan","886","TW",{"type":109,"coordinates":110},"Point",[111,112],121.52639,25.05306,{"lat":112,"lon":111},[115,118],{"name":96,"role":97,"phone":116,"phoneExt":117,"email":99},"88628757453","333",{"name":96,"role":119,"phone":48,"phoneExt":48,"email":48},"PRINCIPAL_INVESTIGATOR",{"type":119,"investigatorFullName":102,"investigatorTitle":121,"investigatorAffiliation":5,"oldNameTitle":48,"oldOrganization":48},"Director of Division of Integrative Medicine, Center for Traditional Medicine","100576054","phase-2-laser-acupuncture-on-dry-eye-and-sjgrens-syndrome-related-dry-eye-symptoms-ladesjs-100576054",false,"NCT06780293","Laser Acupuncture on Dry Eye and Sjögren's Syndrome-related Dry Eye Symptoms (LADESJS)","Exploring the Long-term Therapeutic Effects of Laser Acupuncture on Dry Eye and Sjögren's Syndrome-related Dry Eye Symptoms","LADESJS","• Dry eye syndrome\n\nInclusion Criteria:\n\n1. aged between 20 and 75 years\n2. Schirmer's test less than 10 mm\u002F5 min\n\nExclusion Criteria:\n\n1. Pregnancy\n2. With eye inflammation or infectious eye disease\n3. Accepted operation of eye\n\n   * Sjögren's syndrome\n\nInclusion Criteria:\n\n1. primary or secondary SS\n2. aged between 20 and 75 years\n3. fulfilled the 2002 American-European Consensus Criteria for SS (AECG)\n4. had no abnormal findings of immune, liver, kidney, or blood function evaluations.\n\nExclusion Criteria:\n\n1. a history of alcohol abuse, diabetes mellitus, or major life-threatening condition\n2. pregnancy or breastfeeding\n3. steroid pulse therapy within three months prior to the commencement of our study.","ALL","20 Years","75 Years",{"count":134,"type":135},140,"ESTIMATED","INTERVENTIONAL",[138],"PHASE2","This randomized, double-blind, placebo-controlled clinical trial aims to evaluate the efficacy of adding laser acupuncture at Fengchi (GB20), Zanzhu (BL2), Hegu (LI4), and Quchi (LI11) acupoints to standard care for the treatment of dry eye symptoms in both Sjögren's Syndrome-related dry eye (SJS-DES) and non-Sjögren's Syndrome-related dry eye (Non-SJS-DES) populations. A total of 140 dry eye patients will be recruited and divided into two groups: 70 participants with SJS-DES and 70 with Non-SJS-DES. Participants will be randomly assigned into three groups: Sham+LA group (60 participants receiving 4 weeks of placebo laser acupuncture followed by 4 weeks of active laser acupuncture), LA+LA group (60 participants receiving 4 weeks of active laser acupuncture followed by another 4 weeks of active laser acupuncture), and a Waiting List group (20 participants receiving no laser acupuncture treatment). Each session will target the Fengchi (GB20), Zanzhu (BL2), Hegu (LI4), and Quchi (LI11) acupoints bilaterally, performed twice a week. The total study period is 8 weeks, and the treatment efficacy will be assessed at the end of the 8-week treatment. The Waiting List group (20 participants) will not receive any laser acupuncture treatment during this period. Efficacy will be evaluated using the Numerical Rating Scale (NRS), Schirmer's test, Ocular Surface Disease Index (OSDI), EULAR Sjögren's Syndrome Patient Reported Index (ESSPRI), Traditional Chinese Medicine (TCM) tongue diagnosis, TCM pulse diagnosis, TCM constitution questionnaire, TCM heart rate variability analysis, nailfold microcirculation assessment, and iris examination. This study aims to investigate the impact of laser acupuncture on dry eye symptom improvement and the potential markers that differentiate between SJS-DES and Non-SJS-DES patients. The goal is to develop a comprehensive integrated care model for early screening, diagnosis, and personalized treatment plans for Dry Eye Syndrome and Sjögren's Syndrome, achieving the ultimate objective of \"Holistic Health Care.\"",[141,142,143],"Dry Eye Syndrome (DES)","Laser Acupuncture","Sjögren's Syndrome (SS)",[145,146,142,147,148,149,150],"Dry eye syndrome","Sjögren's syndrome","Fengchi (GB20)","Zanzhu (BL2)","Hegu (LI4)","Quchi (LI11)","2025-04-07",{"date":153,"type":154},"2025-04-09","ACTUAL",{"date":156,"type":154},"2025-02-03",{"date":158,"type":135},"2026-12-31",{"name":5,"class":6},1]