Clinical study of Dan Zhi Xiaoyao Tablets in the treatment of burning mouth syndrome: a randomized controlled trial
- Conditions
- Burning Mouth Syndrome
- Registration Number
- ITMCTR2000004110
- Lead Sponsor
- The Ninth People's Hospital affiliated to Shanghai Jiaotong University Medical College
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- Not specified
1. Above 18 years old, below 75 years old.
2. Gender is not limited.
3. Meet the diagnostic criteria of BMS defined by the International Association for The Study of Pain:A. The symptoms lasted for more than 2 h per day for more than 3 months in total, and the pain was characterized by burning sensation and dry oral mucosa.B. Normal appearance of oral mucosa and normal clinical examination.C. There is no more suitable diagnosis in the Third edition of the International Classification of Headache Diseases.
4. In line with the syndrome of qi depression and fire clamps deficiency: irritable, or from night sweat, or headache, acerbity eyes, or cheeks, dry mouth, or irregular menstruation, lower abdomen pain, or urination pain, red tongue, thin yellow coating on the tongue, pulse string or deficiency.
5. Did not receive any treatment for BMS in 1 month.
6. VAS score (visual simulation score) is greater than or equal to 2.
7. Willing to sign written informed consent after full explanation.
1. Other oral mucous membrane diseases.
2. Systemic diseases, such as diabetes, anemia, nutritional deficiencies (vitamins, folic acid, Fe, Zn, etc.), thyroid dysfunction, allergy to food or dental materials, autoimmune diseases, mental diseases, Sjogren's syndrome, etc.
3. Bad oral habits such as biting cheek, tongue, etc.
4. There are local stimulation factors, such as sharp tooth tip, bad repair, chemical and physical injury.
Study & Design
- Study Type
- Interventional study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Visual Analogue Scale;
- Secondary Outcome Measures
Name Time Method Oral Health Impact Profile;Hamilton Anxiety Scale;Hamilton Depression Scale;