NCT04481841

Head Yuanshi Dian Therapy in Burning Mouth Syndrome

Status unknown EARLY_PHASE1 Last updated 19 July 2021

What this trial tests

EARLY_PHASE1 trial testing oryzanol + vitamin B2 (riboflavin) + vitamin E in Burning Mouth Syndrome in 290 participants. Status unknown.

Timeline

27 July 2020

Primary endpoint
1 February 2022

1 May 2022

Quick facts

Lead sponsor	Second Affiliated Hospital, School of Medicine, Zhejiang University
Phase	EARLY_PHASE1
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	290
Start date	27 July 2020
Primary completion	1 February 2022
Estimated completion	1 May 2022
Sites	3 locations across China

Drugs / interventions tested

• oryzanol + vitamin B2 (riboflavin) + vitamin E — full drug profile →

Conditions studied

• Burning Mouth Syndrome — all drugs for Burning Mouth Syndrome →
• Oral Mucosa Disease — all drugs for Oral Mucosa Disease →

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Who can join

Adults 25 to 90, any sex, with Burning Mouth Syndrome or Oral Mucosa Disease. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.