immune-related recurrent oral ulcers
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: a. be between the ages of 18 and 65 (both ends inclusive); b. meet the diagnostic criteria for oral ulcers, such as white or yellow ulcers on the oral mucosa, accompanied by pain and discomfort, etc.; c. a clear correlation between ulcers and immune abnormalities, such as the onset of ulcers is consistent with the appearance or worsening of immune abnormalities; d. have not used intermediate-acting or short-acting hormones for at least 1 week or long-acting hormones for 2 weeks, or if they have been treated with prednisone (dragon) (=10 mg/d) or equivalent hormones and immunodrugs, the dose should be stable for at least 30 days before entering the study and remain unchanged in subsequent treatments; e. voluntarily participate in the study and sign the informed consent form.
Exclusion criteria
Exclusion criteria: a. oral ulcers caused by other non-immune-related causes, such as drug-induced oral ulcers, traumatic oral ulcers, etc.; b. oral ulcers caused by oral cancer or other malignant tumors; c. pregnant women, lactating women, diabetic patients, patients with severe heart, liver and kidney insufficiency, mental illness or cognitive impairment, patients with allergies or allergies to the known ingredients of the study drug, patients with suspected or confirmed alcohol addiction, drug abuse history or other serious diseases; d.those who have participated in other clinical studies within 30 days before screening; e.patients who are unable to cooperate with the study or unwilling to sign the informed consent form
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Classification of oral ulcers;Classification of ulcer pain; | — |
Secondary
| Measure | Time frame |
|---|---|
| Oral PH;Frequency of ulcer recurrence;Quality of life ; | — |
Countries
China
Contacts
Nanjing University of Chinese Medicine/Nanjing Hospital of Traditional Chinese Medicine