ITMCTR2100004564
Recruiting
未知
Antiprmechanisms of central nervous system by multimodal magnetic resonance imaging in mind-oriented acupuncture therapy for treating chronic spontaneous urticaria
Guang'anmen Hospital, China Academy of Chinese Medicine Sciences0 sitesTBD
Conditionschronic spontaneous urticaria
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- chronic spontaneous urticaria
- Sponsor
- Guang'anmen Hospital, China Academy of Chinese Medicine Sciences
- Status
- Recruiting
- Last Updated
- 3 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
- •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.
Outcomes
Primary Outcomes
Not specified
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