Chronic urticaria
Conditions
Interventions
Treatment Group:Oral selenium-enriched Cordyceps militaris plus Antihistamine
Sponsors
Dematology Hospital of Southern Medical University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age 18–75 years old, gender is not limited; 2. Diagnosis of chronic urticaria, the course of the disease is more than 6 weeks; 3. TPOAb positive; 4. Regular use of H1 antihistamines at any time before screening>=3 days later, still have itching and wheal symptoms; 5. 7 days before enrollment: UAS7 >6 points (score range 0~42 points), UAS7 itch severity score >=8 points (score range 0~21 points); 6. Complete UAS score records in the 7 days prior to enrollment; 7. Voluntarily sign the informed consent form and be willing to comply with the protocol.
Exclusion criteria
Exclusion criteria: 1.Use of selenium-enriched supplements or medications within 6 months prior to consent; 2.Allergy to selenium-enriched Cordyceps militaris, excipients, or history of severe drug allergy/anaphylaxis; 3.Fungal allergy or residence in high-selenium regions; 4.Inducible urticaria subtypes (e.g., dermatographic, cold, heat, solar, delayed pressure, aquagenic, cholinergic, or contact urticaria) or conditions mimicking urticaria/angioedema (e.g., urticarial vasculitis, mastocytosis, hereditary/acquired angioedema, lymphoma, leukemia); 5.Positive stool parasite test (required for those with chronic GI symptoms, immunosuppression, or endemic area exposure within 6 months, plus eosinophilia >2×ULN); 6.Other chronic pruritic skin diseases (e.g., atopic dermatitis, bullous pemphigoid, dermatitis herpetiformis, senile pruritus) that may confound results; 7.History of CSU with dyspnea due to angioedema in the past 6 months; 8.Active infections requiring treatment (e.g., pneumonia, tuberculosis) at enrollment; 9.Severe organ dysfunction (hepatic/renal/cardiovascular), connective tissue diseases, malignancies, or psychiatric disorders; 10.Concurrent participation in other clinical trials; 11.Infants, children, pregnant or lactating women; 12.Other conditions deemed unsuitable by investigators.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of subjects achieving UAS7 =6 at Week 12; | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in the proportion of subjects with HSS7=0 at Weeks 4, 8, 12, and 16.;Change from baseline in HSS7 at Weeks 4, 8, 12, and 16.;Change in the proportion of subjects with ISS7=3 at Weeks 4, 8, 12, and 16.;Change from baseline in ISS7 at Weeks 4, 8, 12, and 16.;Change in the proportion of subjects with HSS7=3 at Weeks 4, 8, 12, and 16.;Change in the proportion of subjects with ISS7=0 at Weeks 4, 8, 12, and 16.;UAS7 reduction from baseline of = 11 points at Weeks 4, 8, 12, and 16.;Change in the proportion of subjects with UAS7=0 at Weeks 4, 8, 12, and 16.; | — |
Countries
China
Contacts
Public ContactBin Yang
Dematology Hospital of Southern Medical University
Outcome results
None listed