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

June 11, 2020 updated by: MENG LING CHIANG, DDS, Chang Gung Memorial Hospital

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

80

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Taiwan
      • Taipei, Taiwan, 105
        • Chang Gung Memorial Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • 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 Names:
  • WM

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
after treatment 1 week, 3 weeks, 6 weeks, 9weeks, 12weeks
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.
baseline, after treatment 1 week, 3 weeks, 6 weeks, 9weeks, 12weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chang Gung Memorial Hospital

Collaborators

Ministry of Science and Technology, Taiwan

Investigators

  • Principal Investigator: Meng-Ling Chiang, DDS,MS, Chang Gung Memorial Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

June 20, 2020

Primary Completion (Anticipated)

July 1, 2022

Study Completion (Anticipated)

December 1, 2022

Study Registration Dates

First Submitted

December 3, 2019

First Submitted That Met QC Criteria

December 5, 2019

First Posted (Actual)

December 6, 2019

Study Record Updates

Last Update Posted (Actual)

June 16, 2020

Last Update Submitted That Met QC Criteria

June 11, 2020

Last Verified

June 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB201802359A3C601
  • NMRPG3J6101 (Other Grant/Funding Number: Ministry of Science and Technology, Taiwan)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Burning Mouth Syndrome

Clinical Trials on Traditional Chinese Medicine

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Spain

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe