Clinical trial NCT04189367: Treatment of Burning Mouth Syndrome With Integration of Traditional Chinese Medicine and Western Medicine
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Burning Mouth Syndrome
Keywords: Burning Mouth Syndrome
Traditional Chinese Medicine
Automatic Tongue Diagnosis System
Body Constitution Questionnaire
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
Collaborators: name: Ministry of Science and Technology, Taiwan
First posted: 2019-12-06
Enrollment: 80
Sex: FEMALE
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

1. Participants who signed the informed consent
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:

1. History of an angiotensin-converting enzyme inhibitor (ACEI) taking
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

Primary outcomes:
measure: Global perceived effect (GPE)
timeFrame: after treatment 1 week, 3 weeks, 6 weeks, 9weeks, 12weeks
measure: Numerical Rating Scale (NRS)
timeFrame: baseline, after treatment 1 week, 3 weeks, 6 weeks, 9weeks, 12weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Chang Gung Memorial Hospital
Study officials:
affiliation: Chang Gung Memorial Hospital
name: Meng-Ling Chiang, DDS,MS
role: PRINCIPAL_INVESTIGATOR
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