Chronic urticaria
Conditions
Interventions
Control Group:Omalizumab + Antihistamines (as needed) + Placebo Capsule
Treatment Group:Omalizumab + Antihistamines (as needed) + Selenium Nanoparticle Capsules
Sponsors
Dematology Hospital of Southern Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18-75 years, regardless of gender. 2. Diagnosed with chronic spontaneous urticaria for more than 6 weeks. 3. Presence of pruritus and wheals despite regular use of H1-antihistamines for at least 3 consecutive days prior to screening. 4. A weekly Urticaria Activity Score (UAS7) of >=6 (score range 0-42) as assessed by the patient in the 7 days prior to enrollment. 5. Scheduled to receive omalizumab treatment for at least 3 months. 6. 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 omalizumab; or a history of anaphylactic shock. 3.Thyroid ultrasound indicating thyroid nodules classified as level 4 or higher. 4.Inducible urticaria with a clear trigger, including but not limited to: cold, heat, solar, delayed pressure, aquagenic, cholinergic, or contact urticaria; and any diseases that might present with urticaria and/or angioedema symptoms, including: urticarial vasculitis, urticaria pigmentosa, erythema multiforme, mastocytosis, hereditary or acquired angioedema, lymphoma, leukemia, etc. 5.Other chronic pruritic skin conditions that, in the investigator's assessment, may interfere with the interpretation of study results (e.g., atopic dermatitis, bullous pemphigoid, dermatitis herpetiformis, senile pruritus, etc.). 6.Patients with chronic spontaneous urticaria who have experienced dyspnea due to angioedema within the past 6 months. 7.Drug Washout Period: Biological agents for CSU (e.g., omalizumab): 4-month washout. Regular systemic corticosteroid use (daily or every other day for =5 consecutive days): 30-day washout. Use of immunosuppressants (e.g., hydroxychloroquine, methotrexate, cyclosporine, cyclophosphamide, tacrolimus, mycophenolate mofetil, tripterygium glycosides, etc.): 30-day washout. 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.Patients with severe organic diseases (e.g., hepatic, renal, cardiovascular, cerebrovascular), connective tissue diseases, malignant tumors, or psychiatric disorders. 11.Current participation in other clinical trials. 12.Pregnant or lactating women. 13.Any other condition considered by the investigator to make the patient unsuitable for study participation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean number of days of antihistamine use per week at Month 4.; | — |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of subjects achieving HSS7 <=3 at Months 1, 2, and 3.;Change from baseline in the Weekly Hive Severity Score (HSS7) at Months 1, 2, and 3.;Change from baseline in the Weekly Itch Severity Score (ISS7) at Months 1, 2, and 3.;Time to first use of rescue antihistamine.;Proportion of subjects achieving HSS7=0 at Months 1, 2, and 3.;Change from baseline in thyroid antibody (TPOAb, TGAb) titers at Months 1 and 3.;Proportion of subjects achieving ISS7 <=3 at Months 1, 2, and 3.;Change from baseline in the weekly peak pruritus Visual Analog Scale (VAS) score at Months 1, 2, and 3.;Proportion of subjects achieving UAS7=0 at Months 1, 2, and 3.;Mean number of days of antihistamine use per week at Months 1, 2, and 3.;Change from baseline in the Weekly Urticaria Activity Score (UAS7) at Months 1, 2, and 3.;Mean number of days of rescue antihistamine use per week at Months 1, 2, and 3.;Proportion of subjects achieving ISS7=0 at Months 1, 2, and 3.; | — |
Countries
China
Contacts
Public Contactchenyangxia
Dematology Hospital of Southern Medical University
Outcome results
None listed