ITMCTR2022000054Not yet recruitingPhase 1
Clinical observation and central mechanism of acupoint catgut embedding in the treatment of chronic spontaneous urticaria based on functional magnetic resonance imaging
Guang 'anmen Hospital0 sitesStarted: TBDLast updated:
Conditions
Trial Snapshot
- Phase
- Phase 1
- Status
- Not yet recruiting
- Sponsor
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional study
Eligibility Criteria
- Ages
- 18 to 60 (—)
- Sex
- All
Inclusion Criteria
- •1. Age between 18 and 60, regardless of gender.
- •2. Meet the diagnostic criteria of chronic spontaneous urticaria: the onset of wind masses every day or intermittently, each duration of no more than 24 hours, the duration of > 6 weeks.
- •3. Despite the use of H1 antihistamines, wind masses and pruritus were present for at least 6 weeks prior to enrollment; At least once a day, mainly wind mass and pruritus, without serious systemic symptoms.
- •4. 7-day urticaria activity score (UAS)=16 points, weekly pruritus score = 8 points.
- •5. Right-handed.
- •6. No history of catgut embedding.
- •7. Sign informed consent, voluntarily and agree to complete all steps of the clinical study.
Exclusion Criteria
- •1. Clear cause of chronic urticaria (such as physical urticaria);
- •2. Glucocorticoid, hydroxychloroquine, methotrexate, cyclosporine, cyclophosphamide, or intravenous immunoglobulin for any indication (daily, or more than 3 consecutive other days) received during the first 30 days of enrollment;
- •3. Received any H2 antihistamine, leukotriene receptor antagonist, omalizumab and other biological agents 7 days before screening and 14 days before randomization;
- •4. Three days before screening, H1 antihistamines exceeded the permitted dose;
- •5. Complicated with serious cardiovascular and cerebrovascular diseases, diabetes, abnormal bone metabolism and other diseases, or 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 with symptoms of urticaria or angioedema, such as urticaria vasculitis, Erythema multiform, cutaneous mastocytosis (pigmentary urticaria) and hereditary or acquired angioedema (e.g., due to deficiency of C1 inhibitor);
- •7. Skin diseases related to chronic pruritus (e.g., atopic dermatitis, bullous pemphigus, herpetic dermatitis, pruritus in old age, etc.) that may affect the evaluation and treatment of the study;
- •8. People allergic to buried wire materials;
- •9. Women with fertility needs, pregnancy and lactation during the study period;
- •10. Contraindicated mri patients;
- •11. Participating in or participating in other clinical trials within the last 3 months;
- •12. Used psychotropic drugs within the past month.
Investigators
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