Ignite Creation Date:
2025-12-25 @ 12:43 AM
Ignite Modification Date:
2026-02-23 @ 4:31 AM
Study NCT ID:
NCT04189367
Status:
UNKNOWN
Last Update Posted:
2020-06-16
First Post:
2019-12-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Treatment of Burning Mouth Syndrome With Integration of Traditional Chinese Medicine and Western Medicine
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002054', 'term': 'Burning Mouth Syndrome'}], 'ancestors': [{'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008516', 'term': 'Medicine, Chinese Traditional'}], 'ancestors': [{'id': 'D008518', 'term': 'Medicine, East Asian Traditional'}, {'id': 'D008519', 'term': 'Medicine, Traditional'}, {'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2020-06-20', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-06', 'completionDateStruct': {'date': '2022-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-06-11', 'studyFirstSubmitDate': '2019-12-03', 'studyFirstSubmitQcDate': '2019-12-05', 'lastUpdatePostDateStruct': {'date': '2020-06-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-12-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Global perceived effect (GPE)', 'timeFrame': 'after treatment 1 week, 3 weeks, 6 weeks, 9weeks, 12weeks', 'description': 'GPE is defined as symptoms improvement change compared to baseline, 1=worse; 2=no difference; 3=mild improvement; 4=much improvement; 5=totally improvement.\n\nThe responder is defined to be the subject occurring at least one of the defined effective events: (1) GPE ≥2 after treatment for burning sensation; (2) GPE ≥2 after treatment for sleep; (3) GPE ≥2 after treatment for dry mouth; (4) GPE ≥2 after treatment for taste change. (5) GPE ≥2 after treatment for her other uncomfortable.'}, {'measure': 'Numerical Rating Scale (NRS)', 'timeFrame': 'baseline, after treatment 1 week, 3 weeks, 6 weeks, 9weeks, 12weeks', 'description': 'NRS is defined as 0=no pain, scale from 1 to 10 (mild to very severe).\n\nThe responder is defined to be the subject occurring at least one of the defined effective events: (1) NRS ≤ 1 after treatment; (2) NRS change from baseline ≥ 50% after treatment.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Burning Mouth Syndrome', 'Traditional Chinese Medicine', 'Automatic Tongue Diagnosis System', 'Body Constitution Questionnaire'], 'conditions': ['Burning Mouth Syndrome']}, 'referencesModule': {'references': [{'pmid': '11871678', 'type': 'BACKGROUND', 'citation': 'Grushka M, Epstein JB, Gorsky M. Burning mouth syndrome. Am Fam Physician. 2002 Feb 15;65(4):615-20.'}, {'pmid': '23771276', 'type': 'BACKGROUND', 'citation': 'Headache Classification Committee of the International Headache Society (IHS). The International Classification of Headache Disorders, 3rd edition (beta version). Cephalalgia. 2013 Jul;33(9):629-808. doi: 10.1177/0333102413485658. No abstract available.'}, {'pmid': '29257770', 'type': 'BACKGROUND', 'citation': 'Jaaskelainen SK. Is burning mouth syndrome a neuropathic pain condition? Pain. 2018 Mar;159(3):610-613. doi: 10.1097/j.pain.0000000000001090.'}, {'pmid': '28247977', 'type': 'BACKGROUND', 'citation': 'Liu YF, Kim Y, Yoo T, Han P, Inman JC. Burning mouth syndrome: a systematic review of treatments. Oral Dis. 2018 Apr;24(3):325-334. doi: 10.1111/odi.12660. Epub 2017 Mar 30.'}, {'pmid': '27855478', 'type': 'BACKGROUND', 'citation': 'McMillan R, Forssell H, Buchanan JA, Glenny AM, Weldon JC, Zakrzewska JM. Interventions for treating burning mouth syndrome. Cochrane Database Syst Rev. 2016 Nov 18;11(11):CD002779. doi: 10.1002/14651858.CD002779.pub3.'}, {'pmid': '21217613', 'type': 'BACKGROUND', 'citation': 'Minguez-Sanz MP, Salort-Llorca C, Silvestre-Donat FJ. Etiology of burning mouth syndrome: a review and update. Med Oral Patol Oral Cir Bucal. 2011 Mar 1;16(2):e144-8. doi: 10.4317/medoral.16.e144.'}, {'pmid': '15674897', 'type': 'BACKGROUND', 'citation': 'Zakrzewska JM, Forssell H, Glenny AM. Interventions for the treatment of burning mouth syndrome. Cochrane Database Syst Rev. 2005 Jan 25;(1):CD002779. doi: 10.1002/14651858.CD002779.pub2.'}, {'pmid': '29156085', 'type': 'RESULT', 'citation': 'Adamo D, Sardella A, Varoni E, Lajolo C, Biasotto M, Ottaviani G, Vescovi P, Simonazzi T, Pentenero M, Ardore M, Spadari F, Bombeccari G, Montebugnoli L, Gissi DB, Campisi G, Panzarella V, Carbone M, Valpreda L, Giuliani M, Aria M, Lo Muzio L, Mignogna MD. The association between burning mouth syndrome and sleep disturbance: A case-control multicentre study. Oral Dis. 2018 May;24(4):638-649. doi: 10.1111/odi.12807. Epub 2018 Mar 13.'}, {'pmid': '19175713', 'type': 'RESULT', 'citation': 'Cavalcanti DR, da Silveira FR. Alpha lipoic acid in burning mouth syndrome--a randomized double-blind placebo-controlled trial. J Oral Pathol Med. 2009 Mar;38(3):254-61. doi: 10.1111/j.1600-0714.2008.00735.x. Epub 2009 Jan 23.'}, {'pmid': '27974236', 'type': 'RESULT', 'citation': 'Chang CM, Wu PC, Chiang JH, Wei YH, Chen FP, Chen TJ, Pan TL, Yen HR, Chang HH. Integrative therapy decreases the risk of lupus nephritis in patients with systemic lupus erythematosus: A population-based retrospective cohort study. J Ethnopharmacol. 2017 Jan 20;196:201-212. doi: 10.1016/j.jep.2016.12.016. Epub 2016 Dec 12.'}, {'pmid': '24389028', 'type': 'RESULT', 'citation': 'Chang YY, Tsai YT, Lai JN, Yeh CH, Lin SK. The traditional Chinese medicine prescription patterns for migraine patients in Taiwan: a population-based study. J Ethnopharmacol. 2014 Feb 12;151(3):1209-1217. doi: 10.1016/j.jep.2013.12.040. Epub 2014 Jan 2.'}, {'pmid': '21824510', 'type': 'RESULT', 'citation': 'Chen HY, Lin YH, Wu JC, Chen YC, Yang SH, Chen JL, Chen TJ. Prescription patterns of Chinese herbal products for menopausal syndrome: analysis of a nationwide prescription database. J Ethnopharmacol. 2011 Oct 11;137(3):1261-6. doi: 10.1016/j.jep.2011.07.053. Epub 2011 Aug 2.'}, {'pmid': '24969368', 'type': 'RESULT', 'citation': 'Chen HY, Huang BS, Lin YH, Su IH, Yang SH, Chen JL, Huang JW, Chen YC. Identifying Chinese herbal medicine for premenstrual syndrome: implications from a nationwide database. BMC Complement Altern Med. 2014 Jun 27;14:206. doi: 10.1186/1472-6882-14-206.'}, {'pmid': '19295226', 'type': 'RESULT', 'citation': 'Chen LL, Lin JS, Lin JD, Chang CH, Kuo HW, Liang WM, Su YC. 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Core outcome measures for chronic pain clinical trials: IMMPACT recommendations. Pain. 2005 Jan;113(1-2):9-19. doi: 10.1016/j.pain.2004.09.012. No abstract available.'}, {'pmid': '11002408', 'type': 'RESULT', 'citation': 'Femiano F, Gombos F, Scully C, Busciolano M, De Luca P. Burning mouth syndrome (BMS): controlled open trial of the efficacy of alpha-lipoic acid (thioctic acid) on symptomatology. Oral Dis. 2000 Sep;6(5):274-7. doi: 10.1111/j.1601-0825.2000.tb00138.x.'}, {'pmid': '9830647', 'type': 'RESULT', 'citation': 'Grushka M, Epstein J, Mott A. An open-label, dose escalation pilot study of the effect of clonazepam in burning mouth syndrome. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 1998 Nov;86(5):557-61. doi: 10.1016/s1079-2104(98)90345-6.'}, {'pmid': '22344742', 'type': 'RESULT', 'citation': 'Heckmann SM, Kirchner E, Grushka M, Wichmann MG, Hummel T. A double-blind study on clonazepam in patients with burning mouth syndrome. Laryngoscope. 2012 Apr;122(4):813-6. doi: 10.1002/lary.22490. Epub 2012 Feb 16.'}, {'pmid': '22044166', 'type': 'RESULT', 'citation': 'Hens MJ, Alonso-Ferreira V, Villaverde-Hueso A, Abaitua I, Posada de la Paz M. Cost-effectiveness analysis of burning mouth syndrome therapy. Community Dent Oral Epidemiol. 2012 Apr;40(2):185-92. doi: 10.1111/j.1600-0528.2011.00645.x. Epub 2011 Nov 1.'}, {'pmid': '22765925', 'type': 'RESULT', 'citation': 'Hidaka T, Yonezawa R, Saito S. Kami-shoyo-san, Kampo (Japanese traditional medicine), is effective for climacteric syndrome, especially in hormone-replacement-therapy-resistant patients who strongly complain of psychological symptoms. J Obstet Gynaecol Res. 2013 Jan;39(1):223-8. doi: 10.1111/j.1447-0756.2012.01936.x. Epub 2012 Jul 6.'}, {'pmid': '25178949', 'type': 'RESULT', 'citation': 'Hsu PC, Tsai YT, Lai JN, Wu CT, Lin SK, Huang CY. Integrating traditional Chinese medicine healthcare into diabetes care by reducing the risk of developing kidney failure among type 2 diabetic patients: a population-based case control study. J Ethnopharmacol. 2014 Oct 28;156:358-64. doi: 10.1016/j.jep.2014.08.029. Epub 2014 Aug 29.'}, {'pmid': '26293497', 'type': 'RESULT', 'citation': 'Imura H, Shimada M, Yamazaki Y, Sugimoto K. Characteristic changes of saliva and taste in burning mouth syndrome patients. J Oral Pathol Med. 2016 Mar;45(3):231-6. doi: 10.1111/jop.12350. Epub 2015 Aug 21.'}, {'pmid': '28606830', 'type': 'RESULT', 'citation': 'Kuten-Shorrer M, Treister NS, Stock S, Kelley JM, Ji YD, Woo SB, Lerman MA, Palmason S, Sonis ST, Villa A. Safety and tolerability of topical clonazepam solution for management of oral dysesthesia. Oral Surg Oral Med Oral Pathol Oral Radiol. 2017 Aug;124(2):146-151. doi: 10.1016/j.oooo.2017.05.470. Epub 2017 May 11.'}, {'pmid': '27340102', 'type': 'RESULT', 'citation': 'Lien AS, Jiang YD, Mou CH, Sun MF, Gau BS, Yen HR. Integrative traditional Chinese medicine therapy reduces the risk of diabetic ketoacidosis in patients with type 1 diabetes mellitus. J Ethnopharmacol. 2016 Sep 15;191:324-330. doi: 10.1016/j.jep.2016.06.051. Epub 2016 Jun 20.'}, {'pmid': '26817897', 'type': 'RESULT', 'citation': 'Lee AL, Chen BC, Mou CH, Sun MF, Yen HR. Association of Traditional Chinese Medicine Therapy and the Risk of Vascular Complications in Patients With Type II Diabetes Mellitus: A Nationwide, Retrospective, Taiwanese-Registry, Cohort Study. Medicine (Baltimore). 2016 Jan;95(3):e2536. doi: 10.1097/MD.0000000000002536.'}, {'pmid': '23128097', 'type': 'RESULT', 'citation': 'Lin JD, Chen LL, Lin JS, Chang CH, Huang YC, Su YC. BCQ-: a body constitution questionnaire to assess Yin-Xu. Part I: establishment of a provisional version through a Delphi process. 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BMC Complement Altern Med. 2017 Aug 29;17(1):427. doi: 10.1186/s12906-017-1939-1.'}, {'pmid': '22924055', 'type': 'RESULT', 'citation': 'Lo LC, Chen YF, Chen WJ, Cheng TL, Chiang JY. The Study on the Agreement between Automatic Tongue Diagnosis System and Traditional Chinese Medicine Practitioners. Evid Based Complement Alternat Med. 2012;2012:505063. doi: 10.1155/2012/505063. Epub 2012 Aug 8.'}, {'pmid': '24716178', 'type': 'RESULT', 'citation': 'Lo LC, Cheng TL, Chiang JY, Damdinsuren N. Breast cancer index: a perspective on tongue diagnosis in traditional chinese medicine. J Tradit Complement Med. 2013 Jul;3(3):194-203. doi: 10.4103/2225-4110.114901.'}, {'pmid': '26365451', 'type': 'RESULT', 'citation': 'Lo LC, Cheng TL, Chen YJ, Natsagdorj S, Chiang JY. TCM tongue diagnosis index of early-stage breast cancer. Complement Ther Med. 2015 Oct;23(5):705-13. doi: 10.1016/j.ctim.2015.07.001. 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Epub 2013 Jan 9.'}, {'pmid': '30439807', 'type': 'RESULT', 'citation': 'Sikora M, Verzak Z, Matijevic M, Vcev A, Siber S, Music L, Carek A. Anxiety and Depression Scores in Patients with Burning Mouth Syndrome. Psychiatr Danub. 2018 Dec;30(4):466-470. doi: 10.24869/psyd.2018.466.'}, {'pmid': '19142042', 'type': 'RESULT', 'citation': 'Su YC, Chen LL, Lin JD, Lin JS, Huang YC, Lai JS. BCQ+: a body constitution questionnaire to assess Yang-Xu. Part I: establishment of a first final version through a Delphi process. Forsch Komplementmed. 2008 Dec;15(6):327-34. doi: 10.1159/000175938. Epub 2008 Dec 5.'}, {'pmid': '21120510', 'type': 'RESULT', 'citation': 'Terauchi M, Hiramitsu S, Akiyoshi M, Owa Y, Kato K, Obayashi S, Matsushima E, Kubota T. Effects of three Kampo formulae: Tokishakuyakusan (TJ-23), Kamishoyosan (TJ-24), and Keishibukuryogan (TJ-25) on Japanese peri- and postmenopausal women with sleep disturbances. Arch Gynecol Obstet. 2011 Oct;284(4):913-21. doi: 10.1007/s00404-010-1779-4. Epub 2010 Dec 1.'}, {'pmid': '25091464', 'type': 'RESULT', 'citation': 'Tsai DS, Chang YS, Li TC, Peng WH. Prescription pattern of Chinese herbal products for hypertension in Taiwan: a population-based study. J Ethnopharmacol. 2014 Sep 29;155(3):1534-40. doi: 10.1016/j.jep.2014.07.047. Epub 2014 Aug 1.'}, {'pmid': '19905906', 'type': 'RESULT', 'citation': 'Yang YH, Chen PC, Wang JD, Lee CH, Lai JN. Prescription pattern of traditional Chinese medicine for climacteric women in Taiwan. Climacteric. 2009 Dec;12(6):541-7. doi: 10.3109/13697130903060081.'}, {'pmid': '24905866', 'type': 'RESULT', 'citation': 'Yu MC, Lin SK, Lai JN, Wei JC, Cheng CY. The traditional Chinese medicine prescription patterns of Sjogren׳s patients in Taiwan: a population-based study. J Ethnopharmacol. 2014 Aug 8;155(1):435-42. doi: 10.1016/j.jep.2014.05.049. Epub 2014 Jun 4.'}]}, 'descriptionModule': {'briefSummary': 'This study is an open-label randomized controlled trial of the efficacy of the integration of Traditional Chinese medicine (TCM) and western medicine based on TCM syndrome differentiation. The hypothesis is (1) TCM model can identify the primary and secondary type burning mouth syndrome (BMS); (2) TCM model can identify BMS after treatment with western medicine; (3) There is a positive effect of TCM in treating BMS.', 'detailedDescription': "BMS patients will be classified into the primary type and secondary type according to the patients' clinical histories and laboratory examinations. The secondary BMS only includes nutritional deficiency, such as Vitamin B12, folate, iron, zinc. At first, the primary BMS patients are treated with 0.5\\~1 mg clonazepam every day before sleep for 8 weeks. The secondary BMS patients are treated with vitamin B12, folate, iron and zinc according to the patient's nutritional deficiency status. Patients with no improvement or little improvement after the first stage of Western medicine management will be arranged to receive traditional Chinese medicine (TCM) therapy. All patients will receive the TCM model, including TCM doctor, automatic tongue diagnostic system (ATDS), and body constitutional questionnaire (BCQ), evaluations.\n\nThe results of this study are expected to understand whether adjuvant TCM treatment of BMS can improve treatment efficacy. The investigators will understand whether the constitution pattern may be a predictive indicator of efficacy for western BMS. The investigators will find a diagnostic indicator for the TCM model and apply it to the assessment of the prognosis of BMS patients."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'genderBased': True, 'genderDescription': 'participant eligibility is based on the different prescriptions of Traditional Chinese Medicine for female and male subjects, not on self-representation of gender identity.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Participants who signed the informed consent\n2. The clinical diagnosis was primary or secondary type BMS patient\n3. ≥ 20-year-old\n4. Female\n5. Willing to take Traditional Chinese Medicine\n\nExclusion Criteria:\n\n1. History of an angiotensin-converting enzyme inhibitor (ACEI) taking\n2. Autoimmune disease\n3. Poor kidney function\n4. Unwilling to take Traditional Chinese Medicine\n5. Male\n6. Participants who have been treated with TCM or Acupuncture within a month\n7. Participants who have been treated with medicine for burning mouth syndrome'}, 'identificationModule': {'nctId': 'NCT04189367', 'briefTitle': 'Treatment of Burning Mouth Syndrome With Integration of Traditional Chinese Medicine and Western Medicine', 'organization': {'class': 'OTHER', 'fullName': 'Chang Gung Memorial Hospital'}, 'officialTitle': 'A Prospective Study on the Treatment of Burning Mouth Syndrome With Integration of Traditional Chinese Medicine(TCM) and Western Medicine Based on TCM Syndrome Differentiation', 'orgStudyIdInfo': {'id': 'IRB201802359A3C601'}, 'secondaryIdInfos': [{'id': 'NMRPG3J6101', 'type': 'OTHER_GRANT', 'domain': 'Ministry of Science and Technology, Taiwan'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Western medicine + TCM', 'description': '1. Meet the conditions of inclusion and exclusion, seek the consent of the patient, and fill out the informed consent.\n2. Blood test and physiological assessment, and do the TCM model.\n3. Primary type BMS patients receive clonazepam 0.5 mg PO every day before sleep or twice a day for 12 weeks\n4. Secondary BMS patients receive nutritional supplements according to the patient\'s hematic deficiency status for 12 weeks.\n5. TCM therapy: one bag of "Qingre Liangkou Ningxin Fang", three times a day for 12 weeks.', 'interventionNames': ['Drug: Traditional Chinese Medicine', 'Drug: Western medicine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Western medicine', 'description': "1. Meet the conditions of inclusion and exclusion, seek the consent of the patient, and fill out the informed consent.\n2. Blood test and physiological assessment, and do the TCM model.\n3. Primary type BMS patients receive clonazepam 0.5 mg PO every day before sleep or twice a day for 12 weeks\n4. Secondary BMS patients receive nutritional supplements according to the patient's hematic deficiency status for 12 weeks.", 'interventionNames': ['Drug: Western medicine']}], 'interventions': [{'name': 'Traditional Chinese Medicine', 'type': 'DRUG', 'otherNames': ['TCM'], 'description': 'One bag of " Qingre Liangkou Ningxin Fang" at a time, three times a day for 12 weeks.', 'armGroupLabels': ['Western medicine + TCM']}, {'name': 'Western medicine', 'type': 'DRUG', 'otherNames': ['WM'], 'description': 'Western medicine includes:\n\n1. clonazepam 0.5mg every day before sleep or twice a day for 12 weeks\n2. Nutritional supplement: vitamin B12, folic acid, iron, zinc, vitamin B complex depending on the hematic deficiency, for 12 weeks', 'armGroupLabels': ['Western medicine', 'Western medicine + TCM']}]}, 'contactsLocationsModule': {'locations': [{'zip': '105', 'city': 'Taipei', 'country': 'Taiwan', 'contacts': [{'name': 'Meng Ling Chiang', 'role': 'CONTACT', 'email': 'mlingchiang@gmail.com', 'phone': '+8867135211', 'phoneExt': '8212'}], 'facility': 'Chang Gung Memorial Hospital', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}], 'centralContacts': [{'name': 'Meng-Ling Chiang, DDS,MS', 'role': 'CONTACT', 'email': 'mlingchiang@gmail.com', 'phone': '+8867135211', 'phoneExt': '8212'}, {'name': 'Shun-Li Kuo, MD, MS', 'role': 'CONTACT', 'email': 'barrington_kuo@hotmail.com', 'phone': '+8863196200', 'phoneExt': '2611'}], 'overallOfficials': [{'name': 'Meng-Ling Chiang, DDS,MS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Chang Gung Memorial Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chang Gung Memorial Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Ministry of Science and Technology, Taiwan', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director, Head of Oral Pathology and Oral Diagnosis, Principal Investigator, Assistant Professor', 'investigatorFullName': 'MENG LING CHIANG, DDS', 'investigatorAffiliation': 'Chang Gung Memorial Hospital'}}}}