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

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ClinicalTrials.gov Identifier: NCT04189367
Recruitment Status : Not yet recruiting
First Posted : December 6, 2019
Last Update Posted : June 16, 2020
Sponsor:
Collaborator:
Ministry of Science and Technology, Taiwan
Information provided by (Responsible Party):
MENG LING CHIANG, DDS, 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.

Condition or disease Intervention/treatment Phase
Burning Mouth Syndrome Drug: Traditional Chinese Medicine Drug: Western medicine Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Estimated Study Start Date : June 20, 2020
Estimated Primary Completion Date : July 2022
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Burns Medicines

Arm Intervention/treatment
Experimental: Western medicine + TCM
  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.
Drug: Traditional Chinese Medicine
One bag of " Qingre Liangkou Ningxin Fang" at a time, three times a day for 12 weeks.
Other Name: TCM

Drug: Western medicine

Western medicine includes:

  1. clonazepam 0.5mg every day before sleep or twice a day for 12 weeks
  2. Nutritional supplement: vitamin B12, folic acid, iron, zinc, vitamin B complex depending on the hematic deficiency, for 12 weeks
Other Name: WM

Active Comparator: 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.
Drug: Western medicine

Western medicine includes:

  1. clonazepam 0.5mg every day before sleep or twice a day for 12 weeks
  2. Nutritional supplement: vitamin B12, folic acid, iron, zinc, vitamin B complex depending on the hematic deficiency, for 12 weeks
Other Name: WM




Primary Outcome Measures :
  1. Global perceived effect (GPE) [ Time Frame: 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.


  2. Numerical Rating Scale (NRS) [ Time Frame: 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.




Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   participant eligibility is based on the different prescriptions of Traditional Chinese Medicine for female and male subjects, not on self-representation of gender identity.
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04189367


Contacts
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Contact: Meng-Ling Chiang, DDS,MS +8867135211 ext 8212 mlingchiang@gmail.com
Contact: Shun-Li Kuo, MD, MS +8863196200 ext 2611 barrington_kuo@hotmail.com

Locations
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Taiwan
Chang Gung Memorial Hospital
Taipei, Taiwan, 105
Contact: Meng Ling Chiang    +8867135211 ext 8212    mlingchiang@gmail.com   
Sponsors and Collaborators
Chang Gung Memorial Hospital
Ministry of Science and Technology, Taiwan
Investigators
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Principal Investigator: Meng-Ling Chiang, DDS,MS Chang Gung Memorial Hospital
Publications of Results:

Other Publications:
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Responsible Party: MENG LING CHIANG, DDS, Director, Head of Oral Pathology and Oral Diagnosis, Principal Investigator, Assistant Professor, Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier: NCT04189367    
Other Study ID Numbers: IRB201802359A3C601
NMRPG3J6101 ( Other Grant/Funding Number: Ministry of Science and Technology, Taiwan )
First Posted: December 6, 2019    Key Record Dates
Last Update Posted: June 16, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by MENG LING CHIANG, DDS, Chang Gung Memorial Hospital:
Burning Mouth Syndrome
Traditional Chinese Medicine
Automatic Tongue Diagnosis System
Body Constitution Questionnaire
Additional relevant MeSH terms:
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Burning Mouth Syndrome
Syndrome
Burns
Disease
Pathologic Processes
Wounds and Injuries
Mouth Diseases
Stomatognathic Diseases