Recurrent Aphthous Ulcer
Conditions
Interventions
experimental group:Compound Sophora Gargle, 25 mL each time, gargled three times daily, used 30 minutes after breakfast, lunch, and dinner. Each gargling duration is at least 3 minutes, swallow after
Control Group:Take Thalidomide at bedtime, once daily, 25 mg (1 tablet) each time
Sponsors
Shanghai Ninth People's Hospital, College of Stomatology, Shanghai Jiaotong University School of Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1.Diagnosed with RAU of Spleen-Stomach Damp-Heat Pattern according to TCM syndrome differentiation criteria + Western medical diagnostic criteria; 2.Aged 18-70 years (inclusive), any gender; 3.At least 2 episodes of RAU history, with a disease duration of over 1 year; Oral ulcer episodes occurring more than once per month; 4.Patient voluntarily participates and signs the informed consent form.
Exclusion criteria
Exclusion criteria: 1.Patients with pregnancy plans during the medication period or within six months after discontinuation; individuals who need to engage in work requiring high concentration, such as driving or working at heights, during the medication period; patients with severe systemic diseases or tumors. 2. Patients allergic to the study drugs or with allergic constitutions. 3. Use of oral analgesics within 24 hours; use of transdermal analgesic patches or intramuscular long-acting analgesics within 1 week; use of antibiotics or anti-inflammatory drugs within 1 month; systemic use of glucocorticoids or immunosuppressants within 3 months. 4. Any mental illness or other conditions that may legally be deemed as limiting capacity for civil conduct. 5. Laboratory test results during the screening period judged by the investigator as clinically significant abnormalities:Blood Routine: WBC 10.0 × 10^9/L; HGB 450 × 10^9/L.Liver Function: ALT and/or AST > 1.5 × ULN (ULN reference value: 40 U/L).Renal Function: Cr > 104 µmol/L (male) or > 84 µmol/L (female); BUN > 7.1 mmol/L.Electrolytes: K+ 5.5 mmol/L; Na+ 145 mmol/L; Cl- 108 mmol/L.Glucose: FPG 6.1 mmol/L.Coagulation: PT prolonged > 3 seconds (compared to normal control); APTT prolonged > 10 seconds (compared to normal control); TT prolonged > 3 seconds (compared to normal control). 6. Patients with other confirmed oral mucosal diseases or autoimmune diseases. This response is AI-generated, for reference only.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ulcer healing days; | — |
Secondary
| Measure | Time frame |
|---|---|
| TCM Symptom Score;Clinical Efficacy;Pain Score ;Pain Duration;Oral Microbiota Profiling;Measurement of Serum Inflammatory Factors;Measurement of T-Cell Subset Levels;Recurrence Rate During the 3-Month Follow-up Period; | — |
Countries
China
Contacts
Public ContactLan Wu
Shanghai Ninth People's Hospital, College of Stomatology, Shanghai Jiaotong University
Outcome results
None listed