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

NCT04189367 | Unknown Phase 3

• 2 other identifiers: IRB201802359A3C601NMRPG3J6101
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Burning Mouth Syndrome

Keywords

Burning Mouth Syndrome; Traditional Chinese Medicine; Automatic Tongue Diagnosis System; Body Constitution Questionnaire

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (2)

Western medicine + TCM

EXPERIMENTAL

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; Drug: Western medicine

Western medicine

ACTIVE COMPARATOR

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

Interventions

Traditional Chinese Medicine DRUG

One bag of " Qingre Liangkou Ningxin Fang" at a time, three times a day for 12 weeks.

Also known as: TCM

Western medicine + TCM

Western medicine DRUG

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

Also known as: WM

Western medicine; Western medicine + TCM

Eligibility Criteria

• Age: 20 Years+
• Gender Eligibility Details: participant eligibility is based on the different prescriptions of Traditional Chinese Medicine for female and male subjects, not on self-representation of gender identity.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants who signed the informed consent
• The clinical diagnosis was primary or secondary type BMS patient
• ≥ 20-year-old
• Female
• Willing to take Traditional Chinese Medicine

You may not qualify if:

• History of an angiotensin-converting enzyme inhibitor (ACEI) taking
• Autoimmune disease
• Poor kidney function
• Unwilling to take Traditional Chinese Medicine
• Male
• Participants who have been treated with TCM or Acupuncture within a month
• Participants who have been treated with medicine for burning mouth syndrome

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead
• Ministry of Science and Technology, Taiwan: collaborator

Study Sites (1)

Chang Gung Memorial Hospital

Taipei, 105, Taiwan

Location

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MeSH Terms

Conditions

Burning Mouth Syndrome

Interventions

Medicine, Chinese Traditional

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Medicine, East Asian Traditional; Medicine, Traditional; Complementary Therapies; Therapeutics

Study Officials

• Meng-Ling Chiang, DDS,MS

  Chang Gung Memorial Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Meng-Ling Chiang, DDS,MS

CONTACT

+8867135211; mlingchiang@gmail.com

Shun-Li Kuo, MD, MS

CONTACT

+8863196200; barrington_kuo@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Head of Oral Pathology and Oral Diagnosis, Principal Investigator, Assistant Professor

Study Record Dates

• First Submitted: December 3, 2019
• First Posted: December 6, 2019
• Study Start: June 20, 2020
• Primary Completion: July 1, 2022
• Study Completion: December 1, 2022
• Last Updated: June 16, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)