Ignite Creation Date:
2025-12-25 @ 12:00 AM
Ignite Modification Date:
2026-01-10 @ 11:56 PM
Study NCT ID:
NCT02855658
Status:
UNKNOWN
Last Update Posted:
2016-08-04
First Post:
2016-07-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Modulation of Immunity-related Gene Expression Under the Chinese Herbal Formula SS-1 Treatment for Sjögren's Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012859', 'term': "Sjogren's Syndrome"}], 'ancestors': [{'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': 'D015352', 'term': 'Dry Eye Syndromes'}, {'id': 'D007766', 'term': 'Lacrimal Apparatus Diseases'}, {'id': 'D005128', 'term': 'Eye 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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C506361', 'term': 'sang ju yin'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 90}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2014-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-08', 'completionDateStruct': {'date': '2017-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-08-01', 'studyFirstSubmitDate': '2016-07-13', 'studyFirstSubmitQcDate': '2016-08-01', 'lastUpdatePostDateStruct': {'date': '2016-08-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-08-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Adverse effect (AE) and Adverse drug reaction(ADR)', 'timeFrame': '7 months', 'description': 'Monitor the Adverse effect (AE) and Adverse drug reaction(ADR) during the SS-1 trial.'}, {'measure': 'Liver, Kidney and Blood function monitor', 'timeFrame': '7 months', 'description': 'Monitor the Liver, Kidney and Blood function monitor (RBC, WBC, Hb, Platelet, AST, ALT, BUN, Cre) of patient during the SS-1 trial, and the different units are listed below: WBC (1000/uL), RBC (million/uL), Hb (g/dL), Platelet (1000/uL), AST (U/L), ALT (U/L), BUN (mg/dL), Serum Creatinine (mg/dL).'}, {'measure': 'Traditional Chinese medicine (TCM) tongue diagnosis', 'timeFrame': '7 months', 'description': 'To evaluate the effect of the SS-1 on the TCM tongue diagnosis before and after treatment.'}], 'primaryOutcomes': [{'measure': 'Ocular surface disease index (OSDI)', 'timeFrame': '7 months', 'description': 'OSDI is an questionnaire of dry eye.'}, {'measure': "EULAR Sjogren's syndrome patient reported index (ESSPRI)", 'timeFrame': '7 months', 'description': 'ESSPRI is an questionnaire of dry, pain and fatigue.'}, {'measure': "Sjogren's syndrome symptoms Questionnaire", 'timeFrame': '7 months', 'description': "Sjogren's syndrome symptoms Questionnaire is an questionnaire of dry month."}, {'measure': "Schirmer's test", 'timeFrame': '7 months', 'description': "Schirmer's test is an objective detection of dry eye, which this test use paper strips inserted into the eye for 5 minutes to measure the production of tears."}, {'measure': 'Salivary scintigraphy', 'timeFrame': '7 months', 'description': "Salivary scintigraphy is an objective detection of dry month, which is used to detect the salivary flow in parotid gland of Sjogren's syndrome."}], 'secondaryOutcomes': [{'measure': 'Oxidative stress and antioxidant capacity', 'timeFrame': '7 months', 'description': 'To evaluate the effect of the SS-1 on the oxidative stress and antioxidant capacity. The "relative ratio" is the unit of these biomarkers for oxidative stress and antioxidant capacity'}, {'measure': 'Quality of life (SF-36)', 'timeFrame': '7 months'}, {'measure': 'Regulatory effect on cytokine', 'timeFrame': '7 months', 'description': 'To evaluate the effect of the SS-1 on the cytokine. The "pg/ml" is the unit of these biomarkers for oxidative stress and antioxidant capacity'}, {'measure': 'Nanostring nCounter immune Panel', 'timeFrame': '7 months', 'description': 'To evaluate the effect of the SS-1 on the immunity-related gene expression. Nanostring nCounter immune Panel is a tool for detecting the immunity-related gene expression.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ["Sjögren's syndrome", 'Gan-Lu-Yin', 'Sang-Ju-Yin', 'Xuefu-Zhuyu-Decoction', 'Oxidative stress', 'Immune regulation', 'Gene modulation', 'SS-1'], 'conditions': ["Sjögren's Syndrome"]}, 'referencesModule': {'references': [{'pmid': '25923413', 'type': 'RESULT', 'citation': "Chang CM, Chu HT, Wei YH, Chen FP, Wang S, Wu PC, Yen HR, Chen TJ, Chang HH. The Core Pattern Analysis on Chinese Herbal Medicine for Sjogren's syndrome: A Nationwide Population-Based Study. Sci Rep. 2015 Apr 29;5:9541. doi: 10.1038/srep09541."}], 'seeAlsoLinks': [{'url': 'https://clinicaltrials.gov/ct2/show/study/NCT02110446', 'label': "NCT02110446: Evaluation of the Efficacy and the Mechanism of Chinese Herbal Formula SS-1 for Sjögren's Syndrome (SS-1)"}]}, 'descriptionModule': {'briefSummary': "To evaluate the modulation of immunity-related gene expression for the Sjögren's syndrome under Chinese herbal medicine (SS-1) treatment.", 'detailedDescription': "Objective: To evaluate the modulation of immunity-related gene expression for the Sjögren's syndrome under Chinese herbal medicine (SS-1) treatment.\n\nMethod:\n\nThe evidence of the regulation of oxidative-related cytokines and the antioxidant capacity could be provided from the previous randomized, double-blinded, placebo-controlled, cross-over design, two-center clinical trial for evaluating the effect of Chinese herbal medicine (SS-1) for the Sjögren's syndrome patients. However, the clinical trail could not find out the modulation of immunity-related gene expression for SS-1 treatment, and it did set up a healthy control group for SS-1 comparison. This study want to establish a healthy control group for evaluating the normal range of oxidative stress and cytokines, which this work could be used to compare with the 72 SS-1 subjects in previous study. And This study also want to analyze the 770 immunity-related gene expression for the Sjögren's syndrome under the SS-1 treatment: (1) The best 20 (at least) efficacy SJS subjects who were evaluated before and after SS-1 treatments. (2) The 10 (at least) healthy control subjects. The findings could provide the evidence on the modulation of immunity-related gene expression for clinical manifestation, oxidative stress and cytokine in Sjögren's syndrome patients.\n\nExpected Results:\n\n1. Establish the normal range of oxidative stress and cytokines for healthy control group.\n2. To evaluate the regulatory effect on oxidative stress and cytokine secretion between SS-1 group and healthy control group.\n3. To evaluate the immunity-related gene expression for the Sjögren's syndrome under the SS-1 treatment.\n4. To evaluate the immunity-related gene expression among the best efficacy SJS subjects and healthy control subjects.\n5. To evaluate the immunity-related gene expression with the characteristic of TCM tongue diagnosis.\n6. To analyze the correlation among clinical manifestations, Sjögren's syndrome -related clinical questionnaires and immunity-related gene expression."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Primary or Secondary Sjögren's syndrome patient\n* Age from 20 to 75 year old, male or female patient\n* Fit the criteria of 2002 year American-European classification\n* If the subject took Cyclosporine, Cevimeline, Pilocarpine, Rituximab or other biological agent before enter into our study, the subject need to stop these drugs for one month\n* If the subject took Gan-Lu-Yin, Sang- Ju-Yin or Xuefu-Zhuyu-Decoction before enter into our study, the subject need to stop these drugs for one month\n* Secondary Sjögren's syndrome patient:\n\n * Stable treatment: Steroid (≦10mg/d) and fixed hydroxychloroquine dose before 3 months enrolled\n * No abnormal change of immunology, liver, kidney, and blood function\n * No major life threatened condition\n\nExclusion Criteria:\n\n* Alcohol abuse, DM (Glucose PC\\>200mg/dL) and major life threatened condition\n* Pregnancy or breast feeding\n* Abnormal liver and kidney function\n* Forbid steroid pulse therapy before 3 months enrolled into our study, and forbid the Chinese herbal medicine except SS-1"}, 'identificationModule': {'nctId': 'NCT02855658', 'briefTitle': "Modulation of Immunity-related Gene Expression Under the Chinese Herbal Formula SS-1 Treatment for Sjögren's Syndrome", 'organization': {'class': 'OTHER', 'fullName': 'China Medical University Hospital'}, 'officialTitle': "Modulation of Immunity-related Gene Expression Under the Chinese Herbal Formula SS-1 Treatment for Sjögren's Syndrome", 'orgStudyIdInfo': {'id': 'CMUH105-REC3-025'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'SS-1', 'description': 'SS-1 is composed of the powder of Gan-Lu-Yin, Sang-Ju-Yin and Xuefu-Zhuyu-Decoction with the ratio of 2:1:1. Patients take 6 gram of experiment medicine three times per day.', 'interventionNames': ['Drug: SS-1']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'The placebo is composed of corn starch, pigment and minimal dose of 1% SS-1. Patients take 6 gram of experiment medicine three times per day.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'SS-1', 'type': 'DRUG', 'otherNames': ['Gan-Lu-Yin, Sang-Ju-Yin and Xuefu-Zhuyu-Decoction'], 'description': 'The patients will be divided into two groups (A and B) at random and all of them keep the routine treatment in the rheumatology OPD. Group A patients will receive 12 weeks SS-1 treatment first, and then stop the SS-1 for 4 weeks for wash-out phase, and then receive 12 weeks placebo treatment. Group B patients receive 12 weeks placebo first, and then stop the placebo treatment for 4 weeks for wash-out phase, and then receive 12 weeks SS-1 treatment. SS-1 is composed of 3 traditional Chinese herbal formula: Gan-Lu-Yin, Sang-Ju-Yin and Xuefu-Zhuyu-Decoction with the ratio of 2:1:1. The placebo is composed with corn starch, pigment and minimal dose of 1% SS-1. Patients in both groups take 6 gram of SS-1/Placebo three times per day.', 'armGroupLabels': ['SS-1']}, {'name': 'Placebo', 'type': 'DRUG', 'otherNames': ['1% SS-1'], 'description': 'The placebo is composed of corn starch, pigment and minimal dose of 1% SS-1. Patients take 6 gram of experiment medicine three times per day.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '333', 'city': 'Gueishan Township', 'state': 'Taiwan', 'status': 'RECRUITING', 'country': 'Taiwan', 'contacts': [{'name': 'Kuang-Hui Yu, M.D.', 'role': 'CONTACT', 'email': 'goutyu@gmail.com'}, {'name': 'Shue-Fen Luo, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Jr-Rung Lin, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Yau-Huei Wei, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Ching-Mao Chang, M.D., Ph.D.', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Kuang-Hui Yu, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Taoyuan Chang Gung Memorial Hospital'}, {'zip': '404', 'city': 'Taichung', 'status': 'RECRUITING', 'country': 'Taiwan', 'contacts': [{'name': 'Hen-Hong Chang, M.D., Ph.D.', 'role': 'CONTACT', 'email': 'tcmchh55@gmail.com', 'phone': '+886-4-22053366', 'phoneExt': '3501'}, {'name': 'Ching-Mao Chang, M.D.', 'role': 'CONTACT', 'phone': '886'}, {'name': 'Hen-Hong Chang, M.D., Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'China Medical University Hospital', 'geoPoint': {'lat': 24.1469, 'lon': 120.6839}}], 'centralContacts': [{'name': 'Hen-Hong Chang, M.D., Ph.D.', 'role': 'CONTACT', 'email': 'tcmchh55@gmail.com', 'phone': '+886-3196200', 'phoneExt': '2677'}, {'name': 'Ching-Mao Chang, M.D.', 'role': 'CONTACT', 'email': 'magicbjp@gmail.com', 'phone': '+886-919074951'}], 'overallOfficials': [{'name': 'Hen-Hong Chang, M.D., Ph.D.', 'role': 'STUDY_CHAIR', 'affiliation': 'China Medical University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'China Medical University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Chang Gung Memorial Hospital', 'class': 'OTHER'}, {'name': 'China Medical University, China', 'class': 'OTHER'}, {'name': 'National Research Program for Biopharmaceuticals, Taiwan', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}