chronic spontaneous urticaria
Conditions
Interventions
Sponsors
Guang'anmen Hospital, China Academy of Chinese Medicine Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1. The age is between 18-60 years old, regardless of gender. 2. Accord with the diagnostic criteria of chronic spontaneous urticaria: wheal attacks every day or intermittently, each time lasting no more than 24 hours, lasting more than 6 weeks. 3. Despite the use of H1 antihistamines, wheezing and itching occurred at least 6 consecutive weeks before enrollment. 4. Urticaria activity score (UAS) >= 16 on 7 days, pruritus score >= 8 on each week. 5. The diary card of patients was complete one week before randomization. 6. Sign the informed consent, voluntarily and agree to complete each step of this clinical study.
Exclusion criteria
Exclusion criteria: 1. Exclusion criteria included chronic urticaria with definite cause (such as physical urticaria). 2. Systemic glucocorticoid, hydroxychloroquine, methotrexate, cyclosporine, cyclophosphamide, or intravenous immunoglobulin therapy for any indication (daily, or three consecutive alternate days) 30 days before enrollment. 3. 7 days before screening, 14 days before randomization, received any H2 antihistamines, leukotriene receptor antagonists, omazumab treatment. 4. Three days before screening, H1 antihistamines exceeded the permitted dose. 5. Patients with cardiovascular and cerebrovascular diseases, diabetes mellitus, abnormal bone metabolism, liver and kidney diseases, hematopoietic system and other serious primary diseases; patients with systemic lupus erythematosus and other serious autoimmune diseases. 6. Diseases other than chronic urticaria have symptoms of urticaria or angioedema, such as urticaria vasculitis, erythema multiforme, cutaneous mast cell hyperplasia (pigmented urticaria) and hereditary or acquired angioedema (e.g. due to lack of C1 inhibitors). 7. Parasite infection. 8. Chronic pruritus related skin diseases (such as atopic dermatitis, bullous pemphigus, herpetic dermatitis, senile pruritus, etc.) that may affect the evaluation and treatment results of the study. 9. Pregnant and lactating women with reproductive needs during the study period. 10. Patients with MRI contraindications. 11. Have participated in or participated in other clinical trials in the last three months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| UAS7; | — |
Secondary
| Measure | Time frame |
|---|---|
| Chronic urticaria quality of life questionnaire;Urticaria Control Test; | — |
Countries
China
Contacts
Public ContactWang Yu-Ming
Guang'anmen Hospital, China Academy of Chinese Medicine Sciences
Outcome results
None listed