Chronic urticaria
Conditions
Interventions
Trial Group:Nanoseelenium capsules: 3 tablets daily (100 µg/tablet), oral, once daily for 12 weeks
routine treatment: as needed, one or more antihistamines (e.g., loratadine 10 mg, cetirizine 10 mg, ebastine 10 mg) and one rescue medication
Placebo Group:Placebo capsules: 3 tablets daily, oral, once daily for 12 weeks
Sponsors
Dematology Hospital of Southern Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
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.Presence of pruritus and wheals despite regular use of H1-antihistamine treatment for >=3 days at any time prior to screening. 4.A UAS7 (Urticaria Activity Score over 7 days) >=6 points (score range: 0–42) during the 7 days prior to enrollment. 5.Voluntarily signed informed consent and willingness to comply with the study protocol.
Exclusion criteria
Exclusion criteria: 1.Use of selenium-raising health products or medications within 6 months prior to signing informed consent, or a history of residency in Enshi City, Hubei Province. 2.Allergy to selenium-containing drugs or foods, as well as to vitamin C, shiitake mushrooms, lactose, edible starch; or history of severe drug allergies or anaphylactic shock. 3.Thyroid ultrasound indicating thyroid nodules of grade 4 or higher. 4.Inducible urticaria with clearly identified triggers, including but not limited to: cold-, heat-, solar-, delayed pressure-, water-, cholinergic-, or contact-induced urticaria; or any disease that may present with urticaria and/or angioedema symptoms, including: urticarial vasculitis, pigmentary urticaria, erythema multiforme, mastocytosis, hereditary or acquired angioedema, lymphoma, leukemia, etc. 5.Other chronic pruritic skin diseases that may interfere with the evaluation of study outcomes, as assessed by the investigator (e.g., atopic dermatitis, bullous pemphigoid, dermatitis herpetiformis, senile pruritus, etc.). 6.Patients with chronic spontaneous urticaria who experienced dyspnea due to angioedema within the past 6 months. 7.Medication washout period requirements: Biological agents for CSU (e.g., omalizumab): 4 months; Regular systemic glucocorticoid use (daily or every other day for >= 5 consecutive days): 30 days; Use of immunosuppressants (including but not limited to hydroxychloroquine, methotrexate, cyclosporine, cyclophosphamide, tacrolimus, mycophenolate mofetil, tripterygium glycosides, etc.): 30 days. 8.Patients with parasitic infections, severe gastrointestinal symptoms, or immunosuppression. 9.Acute active infectious diseases requiring treatment at the time of enrollment, including but not limited to pulmonary infections, tuberculosis, etc. 10.Severe organic diseases (e.g., hepatic, renal, cardiovascular, or cerebrovascular disorders), connective tissue diseases, malignant tumors, psychiatric disorders, etc. 11.Current participation in other clinical trials.Pregnant or lactating women. 12.Any other condition considered by the investigator to make the patient unsuitable for study participation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percent change from baseline in the number of symptomatic days; | — |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of subjects with HSS7=3;Proportion of subjects with ISS7=3;Proportion of subjects with ISS7=0;Change from baseline in HSS7;Time to first use of rescue medication.;Proportion of subjects with UAS7=0;Proportion of subjects with HSS7=0;Proportion of subjects with UAS7 = 6;Proportion of subjects with a reduction from baseline in UAS7 of =11 points;Change from baseline in weekly peak pruritus VAS;Change from baseline in ISS7;Change from baseline in the number of rescue medication uses; | — |
Countries
China
Contacts
Public ContactChen Yangxia
Dematology Hospital of Southern Medical University
Outcome results
None listed