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

Burning Mouth Syndrome Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04189367
• Other study ID #: IRB201802359A3C601
• Secondary ID: NMRPG3J6101
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: June 20, 2020
• Est. completion date: December 2022

Study information

• Verified date: June 2020
• Source: Chang Gung Memorial Hospital
• Contact: Meng-Ling Chiang, DDS,MS
• Phone: +8867135211
• Email: mlingchiang[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. completion date: December 2022
• Est. primary completion date: July 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Burning Mouth Syndrome
• Burns
• Syndrome

Intervention

Drug:
• 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: clonazepam 0.5mg every day before sleep or twice a day for 12 weeks Nutritional supplement: vitamin B12, folic acid, iron, zinc, vitamin B complex depending on the hematic deficiency, for 12 weeks

Locations

Country	Name	City	State
Taiwan	Chang Gung Memorial Hospital	Taipei

Sponsors (2)

Lead Sponsor	Collaborator
Chang Gung Memorial Hospital	Ministry of Science and Technology, Taiwan

Country where clinical trial is conducted

Taiwan, 

References & Publications (45)

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* Note: There are 45 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Global perceived effect (GPE)	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.	after treatment 1 week, 3 weeks, 6 weeks, 9weeks, 12weeks
Primary	Numerical Rating Scale (NRS)	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.	baseline, after treatment 1 week, 3 weeks, 6 weeks, 9weeks, 12weeks

External Links

•   International Association for the Study of Pain (IASP), orofacial pain, updated 2016, burning mouth syndrome.