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
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Global perceived effect (GPE)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Participants who signed the informed consent
- •The clinical diagnosis was primary or secondary type BMS patient
- •≥ 20-year-old
- •Willing to take Traditional Chinese Medicine
排除标准
- •History of an angiotensin-converting enzyme inhibitor (ACEI) taking
- •Autoimmune disease
- •Poor kidney function
- •Unwilling to take Traditional Chinese Medicine
- •Participants who have been treated with TCM or Acupuncture within a month
- •Participants who have been treated with medicine for burning mouth syndrome
研究组 & 干预措施
Western medicine + TCM
- Meet the conditions of inclusion and exclusion, seek the consent of the patient, and fill out the informed consent.
- Blood test and physiological assessment, and do the TCM model.
- Primary type BMS patients receive clonazepam 0.5 mg PO every day before sleep or twice a day for 12 weeks
- Secondary BMS patients receive nutritional supplements according to the patient's hematic deficiency status for 12 weeks.
- TCM therapy: one bag of "Qingre Liangkou Ningxin Fang", three times a day for 12 weeks.
干预措施: Traditional Chinese Medicine (Drug)
Western medicine + TCM
- Meet the conditions of inclusion and exclusion, seek the consent of the patient, and fill out the informed consent.
- Blood test and physiological assessment, and do the TCM model.
- Primary type BMS patients receive clonazepam 0.5 mg PO every day before sleep or twice a day for 12 weeks
- Secondary BMS patients receive nutritional supplements according to the patient's hematic deficiency status for 12 weeks.
- TCM therapy: one bag of "Qingre Liangkou Ningxin Fang", three times a day for 12 weeks.
干预措施: Western medicine (Drug)
Western medicine
- Meet the conditions of inclusion and exclusion, seek the consent of the patient, and fill out the informed consent.
- Blood test and physiological assessment, and do the TCM model.
- Primary type BMS patients receive clonazepam 0.5 mg PO every day before sleep or twice a day for 12 weeks
- Secondary BMS patients receive nutritional supplements according to the patient's hematic deficiency status for 12 weeks.
干预措施: Western medicine (Drug)
结局指标
主要结局
Global perceived effect (GPE)
时间窗: 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)
时间窗: 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.
次要结局
未报告次要终点
研究者
MENG LING CHIANG, DDS
Director, Head of Oral Pathology and Oral Diagnosis, Principal Investigator, Assistant Professor
Chang Gung Memorial Hospital