Ignite Creation Date:
2025-12-25 @ 1:16 AM
Ignite Modification Date:
2026-02-26 @ 12:04 PM
Study NCT ID:
NCT06780293
Status:
RECRUITING
Last Update Posted:
2025-04-09
First Post:
2025-01-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Laser Acupuncture on Dry Eye and Sjögren's Syndrome-related Dry Eye Symptoms (LADESJS)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015352', 'term': 'Dry Eye Syndromes'}, {'id': 'D012859', 'term': "Sjogren's Syndrome"}], 'ancestors': [{'id': 'D007766', 'term': 'Lacrimal Apparatus Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D001172', 'term': 'Arthritis, Rheumatoid'}, {'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D014987', 'term': 'Xerostomia'}, {'id': 'D012466', 'term': 'Salivary Gland Diseases'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'The randomization process will be conducted by a statistical expert using permuted block randomization to generate a "Clinical Trial Randomized Allocation Table." The allocation details will be sealed in envelopes to ensure blinding. Additionally, individual decoding envelopes will be prepared for each participant to allow emergency unblinding without compromising the trial\'s integrity. The randomization table and grouping details will be securely stored by the statistical expert and the principal investigator, while the individual decoding envelopes will be kept exclusively by the principal investigator.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '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).'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 140}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-02-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-07', 'studyFirstSubmitDate': '2025-01-13', 'studyFirstSubmitQcDate': '2025-01-13', 'lastUpdatePostDateStruct': {'date': '2025-04-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-01-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-04-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Numerical Rating Scale (NRS)', 'timeFrame': 'one year', 'description': 'Numerical Rating Scale (NRS) is a tool for evaluating pain among the Dry eye syndrome (DES).'}, {'measure': "Schirmer's test", 'timeFrame': 'one year', 'description': "Schirmer's test is a tool for evaluating aqueous tear production among the Dry eye syndrome (DES)."}, {'measure': 'Ocular Surface Disease Index (OSDI)', 'timeFrame': 'one year', 'description': 'Ocular Surface Disease Index (OSDI) is a tool to rate the severity of dry eye disease among the Dry eye syndrome (DES).'}], 'secondaryOutcomes': [{'measure': "EULAR Sjögren's Syndrome Patient Reported Index (ESSPRI)", 'timeFrame': 'one year', 'description': "EULAR Sjögren's Syndrome Patient Reported Index (ESSPRI) is a tool for evaluating the symptoms of SJS among the Dry eye syndrome (DES)."}, {'measure': 'Traditional Chinese Medicine (TCM) tongue diagnosis', 'timeFrame': 'one year', 'description': 'Traditional Chinese Medicine (TCM) tongue diagnosis is a tool for detecting tongue expression among the Dry eye syndrome (DES).'}, {'measure': 'Traditional Chinese Medicine (TCM) pulse diagnosis', 'timeFrame': 'one year', 'description': 'Traditional Chinese Medicine (TCM) pulse diagnosis is a tool for detecting tongue expression pulse pattern among the Dry eye syndrome (DES).'}, {'measure': 'Traditional Chinese Medicine (TCM) constitution questionnaire', 'timeFrame': 'one year', 'description': 'Traditional Chinese Medicine (TCM) constitution questionnaire is a tool for detecting the constitution among the Dry eye syndrome (DES).'}, {'measure': 'Traditional Chinese Medicine (TCM) heart rate variability analysis', 'timeFrame': 'one year', 'description': 'Traditional Chinese Medicine (TCM) heart rate variability analysis is a tool for detecting ratio between High-frequency (HF) activity and low-frequency (LF) activity among the Dry eye syndrome (DES).'}, {'measure': 'Nailfold microcirculation assessment', 'timeFrame': 'one year', 'description': 'Nailfold microcirculation assessment is a tool for detecting the status of nailfold microcirculation among the Dry eye syndrome (DES).'}, {'measure': 'Iris examination', 'timeFrame': 'one year', 'description': 'Iris examination is a tool for detecting the status of iris among the Dry eye syndrome (DES).'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Dry eye syndrome', "Sjögren's syndrome", 'Laser Acupuncture', 'Fengchi (GB20)', 'Zanzhu (BL2)', 'Hegu (LI4)', 'Quchi (LI11)'], 'conditions': ['Dry Eye Syndrome (DES)', 'Laser Acupuncture', "Sjögren's Syndrome (SS)"]}, 'descriptionModule': {'briefSummary': '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."', 'detailedDescription': 'Method: 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."\n\nExpected Results:\n\n1. Assess the therapeutic differences between Sham+LA and LA+LA groups in the SJS-DES population.\n2. Assess the therapeutic differences between Sham+LA and LA+LA groups in the Non-SJS-DES population.\n3. Evaluate the therapeutic differences between the SJS-DES and Non-SJS-DES populations.\n\nKeywords: Dry eye syndrome, Sjögren\'s syndrome, Laser Acupuncture, GB20, BL2, LI4, LI11'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "• Dry eye syndrome\n\nInclusion Criteria:\n\n1. aged between 20 and 75 years\n2. Schirmer's test less than 10 mm/5 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."}, 'identificationModule': {'nctId': 'NCT06780293', 'acronym': 'LADESJS', 'briefTitle': "Laser Acupuncture on Dry Eye and Sjögren's Syndrome-related Dry Eye Symptoms (LADESJS)", 'organization': {'class': 'OTHER_GOV', 'fullName': 'Taipei Veterans General Hospital, Taiwan'}, 'officialTitle': "Exploring the Long-term Therapeutic Effects of Laser Acupuncture on Dry Eye and Sjögren's Syndrome-related Dry Eye Symptoms", 'orgStudyIdInfo': {'id': '2024-11-008C'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'LA+LA group of SJS-DES', 'description': "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.", 'interventionNames': ['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']}, {'type': 'SHAM_COMPARATOR', 'label': 'Sham+LA group of SJS-DES', 'description': "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.", 'interventionNames': ['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', 'Other: Sham Laser Acupuncture']}, {'type': 'EXPERIMENTAL', 'label': 'LA+LA group of Non-SJS-DES', 'description': "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.", 'interventionNames': ['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']}, {'type': 'SHAM_COMPARATOR', 'label': 'Sham+LA group of Non-SJS-DES', 'description': "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.", 'interventionNames': ['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', 'Other: Sham Laser Acupuncture']}, {'type': 'OTHER', 'label': 'Waiting list', 'description': "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.", 'interventionNames': ['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']}], 'interventions': [{'name': 'Laser acupuncture (LA)', 'type': 'OTHER', 'description': '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.', 'armGroupLabels': ['LA+LA group of Non-SJS-DES', 'LA+LA group of SJS-DES', 'Sham+LA group of Non-SJS-DES', 'Sham+LA group of SJS-DES']}, {'name': 'Numerical Rating Scale (NRS)', 'type': 'DIAGNOSTIC_TEST', 'description': '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).', 'armGroupLabels': ['LA+LA group of Non-SJS-DES', 'LA+LA group of SJS-DES', 'Sham+LA group of Non-SJS-DES', 'Sham+LA group of SJS-DES', 'Waiting list']}, {'name': "Schirmer's test", 'type': 'DIAGNOSTIC_TEST', 'description': "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.", 'armGroupLabels': ['LA+LA group of Non-SJS-DES', 'LA+LA group of SJS-DES', 'Sham+LA group of Non-SJS-DES', 'Sham+LA group of SJS-DES', 'Waiting list']}, {'name': 'Ocular Surface Disease Index (OSDI)', 'type': 'DIAGNOSTIC_TEST', 'description': '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.', 'armGroupLabels': ['LA+LA group of Non-SJS-DES', 'LA+LA group of SJS-DES', 'Sham+LA group of Non-SJS-DES', 'Sham+LA group of SJS-DES', 'Waiting list']}, {'name': "EULAR Sjögren's Syndrome Patient Reported Index (ESSPRI)", 'type': 'DIAGNOSTIC_TEST', 'description': '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.', 'armGroupLabels': ['LA+LA group of Non-SJS-DES', 'LA+LA group of SJS-DES', 'Sham+LA group of Non-SJS-DES', 'Sham+LA group of SJS-DES', 'Waiting list']}, {'name': 'Traditional Chinese Medicine (TCM) tongue diagnosis', 'type': 'DIAGNOSTIC_TEST', 'description': '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.', 'armGroupLabels': ['LA+LA group of Non-SJS-DES', 'LA+LA group of SJS-DES', 'Sham+LA group of Non-SJS-DES', 'Sham+LA group of SJS-DES', 'Waiting list']}, {'name': 'Traditional Chinese Medicine (TCM) pulse diagnosis', 'type': 'DIAGNOSTIC_TEST', 'description': '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.', 'armGroupLabels': ['LA+LA group of Non-SJS-DES', 'LA+LA group of SJS-DES', 'Sham+LA group of Non-SJS-DES', 'Sham+LA group of SJS-DES', 'Waiting list']}, {'name': 'Traditional Chinese Medicine (TCM) constitution questionnaire', 'type': 'DIAGNOSTIC_TEST', 'description': '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.', 'armGroupLabels': ['LA+LA group of Non-SJS-DES', 'LA+LA group of SJS-DES', 'Sham+LA group of Non-SJS-DES', 'Sham+LA group of SJS-DES', 'Waiting list']}, {'name': 'Traditional Chinese Medicine (TCM) heart rate variability analysis', 'type': 'DIAGNOSTIC_TEST', 'description': '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.', 'armGroupLabels': ['LA+LA group of Non-SJS-DES', 'LA+LA group of SJS-DES', 'Sham+LA group of Non-SJS-DES', 'Sham+LA group of SJS-DES', 'Waiting list']}, {'name': 'nailfold microcirculation assessment', 'type': 'DIAGNOSTIC_TEST', 'description': '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.', 'armGroupLabels': ['LA+LA group of Non-SJS-DES', 'LA+LA group of SJS-DES', 'Sham+LA group of Non-SJS-DES', 'Sham+LA group of SJS-DES', 'Waiting list']}, {'name': 'iris examination', 'type': 'DIAGNOSTIC_TEST', 'description': '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.', 'armGroupLabels': ['LA+LA group of Non-SJS-DES', 'LA+LA group of SJS-DES', 'Sham+LA group of Non-SJS-DES', 'Sham+LA group of SJS-DES', 'Waiting list']}, {'name': 'Sham Laser Acupuncture', 'type': 'OTHER', 'description': '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.', 'armGroupLabels': ['Sham+LA group of Non-SJS-DES', 'Sham+LA group of SJS-DES']}]}, 'contactsLocationsModule': {'locations': [{'zip': '886', 'city': 'Taipei', 'state': 'Taiwan', 'status': 'RECRUITING', 'country': 'Taiwan', 'contacts': [{'name': 'Ching-Mao Chang, M.D., Ph.D.', 'role': 'CONTACT', 'email': 'magicbjp@gmail.com', 'phone': '88628757453', 'phoneExt': '333'}, {'name': 'Ching-Mao Chang, M.D., Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Ching-Mao Chang', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}], 'centralContacts': [{'name': 'Ching-Mao Chang, M.D., Ph.D.', 'role': 'CONTACT', 'email': 'magicbjp@gmail.com', 'phone': '886-28757453, 333'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'The decision to share individual participant data (IPD) is currently undecided due to ongoing discussions regarding data management, privacy concerns, and compliance with institutional and regulatory requirements. Additional considerations include the establishment of appropriate data-sharing agreements, ensuring participant confidentiality, and defining the scope and method of data access. Once these factors are thoroughly evaluated and addressed, a final decision regarding IPD sharing will be made in accordance with ethical guidelines and applicable regulations.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Taipei Veterans General Hospital, Taiwan', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director of Division of Integrative Medicine, Center for Traditional Medicine', 'investigatorFullName': 'Ching-Mao Chang', 'investigatorAffiliation': 'Taipei Veterans General Hospital, Taiwan'}}}}