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Clinical study of Dan Zhi Xiaoyao Tablets in the treatment of burning mouth syndrome: a randomized controlled trial

Clinical study of Dan Zhi Xiaoyao Tablets in the treatment of burning mouth syndrome: a randomized controlled trial

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000038189
Enrollment
Unknown
Registered
2020-09-13
Start date
2020-10-01
Completion date
Unknown
Last updated
2020-11-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Burning Mouth Syndrome

Interventions

Sponsors

The Ninth People's Hospital affiliated to Shanghai Jiaotong University Medical College
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

MeasureTime frame
Visual Analogue Scale;

Secondary

MeasureTime frame
Hamilton Depression Scale;Hamilton Anxiety Scale;Oral Health Impact Profile;

Countries

China

Contacts

Public ContactHaiwen Zhou

The Ninth People's Hospital affiliated to Shanghai Jiaotong University Medical College

haiwen39@126.com+86 13916864387

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 7, 2026