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

Phase 3

• Conditions: Burning Mouth Syndrome
• Interventions: Drug: Traditional Chinese Medicine; Drug: Western medicine

• Registration Number: NCT04189367
• Lead Sponsor: Chang Gung Memorial Hospital

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.

Study Timeline

• Study First Submitted: 2019-12-03
• Study First Submitted QC: 2019-12-05
• Study First Posted: 2019-12-06
• Status Verified: 2020-06
• Last Update Submitted: 2020-06-11
• Last Update Posted: 2020-06-16
• Study Start: 2020-06-20
• Primary Completion: 2022-07
• Study Completion: 2022-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Western medicine + TCM	Traditional Chinese 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. 5. TCM therapy: one bag of "Qingre Liangkou Ningxin Fang", three times a day for 12 weeks.
Western medicine + TCM	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. 5. TCM therapy: one bag of "Qingre Liangkou Ningxin Fang", three times a day for 12 weeks.
Western medicine	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.

Primary Outcome Measures

Name	Time	Method
Global perceived effect (GPE)	after treatment 1 week, 3 weeks, 6 weeks, 9weeks, 12weeks	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 ≥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.
Numerical Rating Scale (NRS)	baseline, after treatment 1 week, 3 weeks, 6 weeks, 9weeks, 12weeks	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 ≤ 1 after treatment; (2) NRS change from baseline ≥ 50% after treatment.

Trial Locations

Locations (1)

Chang Gung Memorial Hospital; 🇨🇳 Taipei, Taiwan