Treatment of Burning Mouth Syndrome With Integration of Traditional Chinese Medicine and Western Medicine

Chang Gung Medical Foundation

Status and phase: Unknown; Phase 3

Conditions: Burning Mouth Syndrome

Treatments: Drug: Western medicine; Drug: Traditional Chinese Medicine

Study type: Interventional

Funder types: Other

Identifiers

NCT04189367

IRB201802359A3C601

NMRPG3J6101 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 estimated patients

Sex: Female

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 2 patient groups

Western medicine + TCM

Experimental group

Description:

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.

Treatment:

Drug: Western medicine

Drug: Traditional Chinese Medicine

Western medicine

Active Comparator group

Description:

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.

Treatment:

Drug: Western medicine