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| ID | Type | Description | Link |
|---|---|---|---|
| NMRPG3J6101 | Other Grant/Funding Number | Ministry of Science and Technology, Taiwan |
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| Name | Class |
|---|---|
| Ministry of Science and Technology, Taiwan | OTHER_GOV |
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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.
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.
The 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Western medicine + TCM | Experimental |
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| Western medicine | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Traditional Chinese Medicine | Drug | One bag of " Qingre Liangkou Ningxin Fang" at a time, three times a day for 12 weeks. |
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| Measure | Description | Time Frame |
|---|---|---|
| Global perceived effect (GPE) | GPE is defined as symptoms improvement change compared to baseline, 1=worse; 2=no difference; 3=mild improvement; 4=much improvement; 5=totally improvement. The responder is defined to be the subject occurring at least one of the defined effective events: (1) GPE ā„2 after treatment for burning sensation; (2) GPE ā„2 after treatment for sleep; (3) GPE ā„2 after treatment for dry mouth; (4) GPE ā„2 after treatment for taste change. (5) GPE ā„2 after treatment for her other uncomfortable. | after treatment 1 week, 3 weeks, 6 weeks, 9weeks, 12weeks |
| Numerical Rating Scale (NRS) | NRS is defined as 0=no pain, scale from 1 to 10 (mild to very severe). The responder is defined to be the subject occurring at least one of the defined effective events: (1) NRS ā¤ 1 after treatment; (2) NRS change from baseline ā„ 50% after treatment. | baseline, after treatment 1 week, 3 weeks, 6 weeks, 9weeks, 12weeks |
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Inclusion Criteria:
Exclusion Criteria:
participant eligibility is based on the different prescriptions of Traditional Chinese Medicine for female and male subjects, not on self-representation of gender identity.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Meng-Ling Chiang, DDS,MS | Contact | +8867135211 | 8212 | mlingchiang@gmail.com |
| Shun-Li Kuo, MD, MS | Contact | +8863196200 | 2611 | barrington_kuo@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Meng-Ling Chiang, DDS,MS | Chang Gung Memorial Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chang Gung Memorial Hospital | Taipei | 105 | Taiwan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 11871678 | Background | Grushka M, Epstein JB, Gorsky M. Burning mouth syndrome. Am Fam Physician. 2002 Feb 15;65(4):615-20. | |
| 23771276 | Background | 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. |
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| ID | Term |
|---|---|
| D002054 | Burning Mouth Syndrome |
| ID | Term |
|---|---|
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
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| ID | Term |
|---|---|
| D008516 | Medicine, Chinese Traditional |
| ID | Term |
|---|---|
| D008518 | Medicine, East Asian Traditional |
| D008519 | Medicine, Traditional |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
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| Western medicine | Drug | Western medicine includes:
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