Treatment of Burning Mouth Syndrome With Integration of Traditional Chinese Medicine and Western Medicine
NCT ID: NCT04189367
Last Updated: 2020-06-16
Study Results
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Basic Information
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UNKNOWN
PHASE3
80 participants
INTERVENTIONAL
2020-06-20
2022-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Western medicine + TCM
1. Meet the conditions of inclusion and exclusion, seek the consent of the patient, and fill out the informed consent.
2. Blood test and physiological assessment, and do the TCM model.
3. Primary type BMS patients receive clonazepam 0.5 mg PO every day before sleep or twice a day for 12 weeks
4. Secondary BMS patients receive nutritional supplements according to the patient's hematic deficiency status for 12 weeks.
5. TCM therapy: one bag of "Qingre Liangkou Ningxin Fang", three times a day for 12 weeks.
Traditional Chinese Medicine
One bag of " Qingre Liangkou Ningxin Fang" at a time, three times a day for 12 weeks.
Western medicine
Western medicine includes:
1. clonazepam 0.5mg every day before sleep or twice a day for 12 weeks
2. Nutritional supplement: vitamin B12, folic acid, iron, zinc, vitamin B complex depending on the hematic deficiency, for 12 weeks
Western medicine
1. Meet the conditions of inclusion and exclusion, seek the consent of the patient, and fill out the informed consent.
2. Blood test and physiological assessment, and do the TCM model.
3. Primary type BMS patients receive clonazepam 0.5 mg PO every day before sleep or twice a day for 12 weeks
4. Secondary BMS patients receive nutritional supplements according to the patient's hematic deficiency status for 12 weeks.
Western medicine
Western medicine includes:
1. clonazepam 0.5mg every day before sleep or twice a day for 12 weeks
2. Nutritional supplement: vitamin B12, folic acid, iron, zinc, vitamin B complex depending on the hematic deficiency, for 12 weeks
Interventions
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Traditional Chinese Medicine
One bag of " Qingre Liangkou Ningxin Fang" at a time, three times a day for 12 weeks.
Western medicine
Western medicine includes:
1. clonazepam 0.5mg every day before sleep or twice a day for 12 weeks
2. Nutritional supplement: vitamin B12, folic acid, iron, zinc, vitamin B complex depending on the hematic deficiency, for 12 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. The clinical diagnosis was primary or secondary type BMS patient
3. ≥ 20-year-old
4. Female
5. Willing to take Traditional Chinese Medicine
Exclusion Criteria
2. Autoimmune disease
3. Poor kidney function
4. Unwilling to take Traditional Chinese Medicine
5. Male
6. Participants who have been treated with TCM or Acupuncture within a month
7. Participants who have been treated with medicine for burning mouth syndrome
20 Years
FEMALE
No
Sponsors
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Ministry of Science and Technology, Taiwan
OTHER_GOV
Chang Gung Memorial Hospital
OTHER
Responsible Party
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MENG LING CHIANG, DDS
Director, Head of Oral Pathology and Oral Diagnosis, Principal Investigator, Assistant Professor
Principal Investigators
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Meng-Ling Chiang, DDS,MS
Role: PRINCIPAL_INVESTIGATOR
Chang Gung Memorial Hospital
Locations
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Chang Gung Memorial Hospital
Taipei, , Taiwan
Countries
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Central Contacts
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Facility Contacts
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References
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Other Identifiers
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NMRPG3J6101
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
IRB201802359A3C601
Identifier Type: -
Identifier Source: org_study_id
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