Head Yuanshi Dian Therapy in Burning Mouth Syndrome

NCT04481841 | Unknown Early Phase 1

• 1 other identifier: 2019-281
• Study Type: interventional
• Target: 290
• Locations: 1 country
• Sites: 3

Brief Summary

Burning mouth syndrome is one of the most common oral mucosal diseases in clinic. It is a chronic pain syndrome with extensive burning pain of oral mucosa as its main symptoms. There are no pathological changes in oral mucosa and no characteristic histopathological changes. Patients often have accompanying symptoms such as depression and xerostomia. Although the patient does not have obvious oral lesions, the pain symptoms are more serious and the mental pressure is greater. BMS, as a complex clinical syndrome associated with multiple factors, mainly occurs in people aged 27-87, with an average age of 61. BMS is rare among people under 30 years old. BMS is predominant in women, the ratio of male to female is 1:5 to 1:7, the incidence is 0.7%-15%, and increases with age. Up to 90% of female patients are in perimenopausal period. Symptoms occur from 3 years before menopause to 12 years after menopause. The causes of BMS are complex, and the treatment is difficult, easy to relapse and protracted. Studies have confirmed that the occurrence and development of BMS are directly related to mental factors. Therefore, psychosocial factors are the most important pathogenic factors of BMS. If we intervene in these factors, it is hopeful to improve the curative effect of BMS. Traditional psychotherapy methods include drug treatment, psychotherapy, surgical treatment, traditional Chinese medicine treatment, etc. Drug treatment is mainly based on different types of mental and psychological diseases, choose different pharmacological effects of drugs, so as to effectively control the disease. However, these drugs are prone to adverse reactions such as sleepiness, weight gain, headache, physical weakness, etc. The basic principle of psychotherapy is to let patients fully expose symptoms, listen to their complaints patiently, carry out explanatory psychotherapy according to their medical history or take other psychological training, so as to relieve patients' mental stress and alleviate symptoms. But this method has a long course of treatment and needs the cooperation of the patients' family members; the basic principle of surgical treatment is to resect the corresponding areas of the brain or adopt endoscopy and micro-current to treat them, but the risks and injuries caused by the operation are greater, and the adverse reactions after the operation are larger; the treatment of traditional Chinese medicine needs a long course of treatment, and the treatment of some patients. The effect is not stable enough. The causes of BMS are complex, there is no objective disease in clinic, and the patients suffer from abnormal pain, but the treatment methods are not uniform, and the curative effect is not good, which makes the patients unable to get effective treatment in the early stage of the disease, and easy to relapse, resulting in the aggravation and development of BMS into intractable sensory abnormalities, and protracted! Literature reports confirm that the tri-drug of oryzanol-riboflavin-vitamin E (oryzanol-riboflavin-vitamin E) is a classic treatment for BMS and has been included in the classic book in China, Pharmacotherapy for oral mucosal disease . However, its long-term clinical application has found that its efficacy is unstable, and clinical symptoms after drug withdrawal. The symptoms are prone to recurrence or even aggravation. Therefore, it is necessary to use the classical program on the basis of a combination of interventions to promote the efficacy of stable and safe. Over the past two years, the investigators has treated nearly 100 cases of BMS with head yuanshi dian therapy, and achieved satisfactory results. It can obviously relieve burning pain of BMS oral mucosa, promote saliva secretion, improve dry mouth and bitter mouth, and improve sleep to a certain extent. However, due to the limited number of cases treated, the classification of BMS is not meticulous enough, and there are still vague areas in the classification of BMS, which affects the rigorous evaluation of the therapeutic effect of BMS. Therefore, the investigators propose a hypothesis: can the head yuanshi dian therapy be used as the main adjuvant therapy for BMS? By consulting Pubmed, OVID, CNKI, Wanfang and other major databases at home and abroad, the investigators found that there is no relevant report at home and abroad. In view of this, the investigators intend to design this randomized positive controlled clinical trial, using conventional valley-nucleus-E triple drug therapy as the positive control group, to observe the efficacy and safety of head yuanshi dian therapy for BMS, in order to find a safe and effective green non-invasive therapy, effectively alleviate or eliminate oral mucosal pain, dry mouth, etc.

Conditions

Burning Mouth Syndrome; Oral Mucosa Disease

Keywords

Burning Mouth Syndrome; Effect and Safety; Primary Point Push

Outcome Measures

Primary Outcomes (4)

• Pain index

  The basic method is to use a swimming scale about 10 cm long, with 10 scales on one side, and the two ends are "0" and "10" ends respectively. 0 indicates no pain and 10 points represents the most severe pain that is unbearable.

  one year

• Depressive mood index

  one year

• Pittsburgh sleep quality index

  one year

• Kupperman Climacteric Score

  one year

Study Arms (2)

experimental group

EXPERIMENTAL

On the basis of classical "Gu-Nucleus-E" triple drug therapy, the experimental group was treated with head yuanshi dian therapy twice a day for 1 months as a course of treatment.

Drug: oryzanol + vitamin B2 (riboflavin) + vitamin E

control group

ACTIVE COMPARATOR

oryzanol + vitamin B2 (riboflavin) + vitamin E, oryzanol tablets, oral, 10 mg/time, 3 times/day; vitamin B2 tablets, oral, 10 mg/time, 3 times/day; vitamin E pills, oral, 100 mg/time, 1 time/day, 1 months as a course of treatment.

Drug: oryzanol + vitamin B2 (riboflavin) + vitamin E

Interventions

oryzanol + vitamin B2 (riboflavin) + vitamin E DRUG

1:Control group Specific medicines and usage, course of treatment are as follows: oryzanol + vitamin B2 (riboflavin) + vitamin E, oryzanol tablets, oral, 10 mg/time, 3 times/day; vitamin B2 tablets, oral, 10 mg/time, 3 times/day; vitamin E pills, oral, 100 mg/time, 1 time/day, 1 months as a course of treatment. 2.Therapeutic regimen of experimental group On the basis of classical "Gu-Nucleus-E" triple drug therapy, the experimental group was treated with head yuanshi dian therapy twice a day for 1 months as a course of treatment.

Also known as: head yuanshi dian therapy

control group; experimental group

Eligibility Criteria

• Age: 25 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Persons aged 25-90;
• By inquiring the medical history in detail, BMS can be diagnosed if the clinical symptoms and signs do not conform to the clinical characteristics, and the medical history is more than 4 months.
• Burning pain and/or dry mouth in tongue or other parts of oral mucosa were the main clinical symptoms.
• Those with normal blood routine, blood sugar, liver and kidney function, urine routine, abdominal ultrasonography, chest X-ray and other basic physical examination items;
• Those who voluntarily participate in the experiment and sign the informed consent.

You may not qualify if:

• There are local stimulating factors that can cause burning pain in the mouth;
• Patients with other serious oral mucosal diseases;
• Complicated with serious systemic diseases;
• Patients with mental disorders who take drugs routinely;
• Abnormal levels of sex hormones;
• Sjogren's syndrome.
• Possible drug-related xerostomia.
• Pregnant or lactating women;
• The patients'cognitive level was low and they could not understand and fill in the questionnaire correctly.
• Those who fail to comply with the doctor's advice or return to the doctor on time;
• Those who participated in clinical trials within 3 months.

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead
• Zhejiang Provincial Hospital of TCM: collaborator
• Guiyang Hospital of Stomatology: collaborator

Study Sites (3)

Guiyang Hospital of Stomatology

Guiyang, Guizhou, 550002, China

NOT YET RECRUITING

Zhejiang Provincal Hospital of TCM

Hangzhou, Zhejiang, 310003, China

NOT YET RECRUITING

Department of Oral Medicine, the Second Affiliated Hospital, School of Medicine Zhejiang University

Hangzhou, Zhejiang, 310009, China

RECRUITING

MeSH Terms

Conditions

Burning Mouth Syndrome

Interventions

gamma-oryzanol; Riboflavin; Vitamin E

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Flavins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 3-Ring; Coenzymes; Enzymes and Coenzymes; Pigments, Biological; Biological Factors; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring

Study Officials

• Weilian Sun

  Second Affiliated Hospital, School of Medicine, Zhejiang University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Weilian Sun, PhD

CONTACT

13757119563; weiliansun@zju.edu.cn

Weilian Sun

CONTACT

13757119563; weiliansun@zju.edu.cn

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Each of the three centers has a researcher responsible for the treatment and interpretation of the subjects. The head of the research center trained the researcher to unify the standards. Three researchers were not involved in the evaluation of efficacy. Another researcher was responsible for recording pain and emotional nature and degree score, pain index, pain multi-dimensional characteristics score, depression index, Pittsburgh sleep quality index, Kupperman menopause score, dry mouth subjective symptoms questionnaire, saliva flow, and recording laboratory results, and collecting records. Data, analysis of efficacy, the researchers do not know the specific grouping, in order to minimize the subjective impact of the researchers on the test results.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 1:1 randomized controlled clinical trial were used. Random numbers generated by SPSS21.0 will be placed in sequentially coded, sealed, opaque envelopes. When the qualifications of the subjects were determined by the researchers, the envelopes were opened sequentially and the subjects were assigned to groups. The odd number represented the experimental group and the even number represented the control group.

Study Record Dates

• First Submitted: November 15, 2019
• First Posted: July 22, 2020
• Study Start: July 27, 2020
• Primary Completion: February 1, 2022
• Study Completion: May 1, 2022
• Last Updated: July 19, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (3)