Randomized double-blind placebo-controlled clinical observation and central mechanism of acupoint catgut embedding in the treatment of chronic spontaneous urticaria

Phase 1

• Conditions: Chronic spontaneous urticarial

• Registration Number: ITMCTR2200006839
• Lead Sponsor: Guang 'anmen Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 6 March 2023

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

(1)Age between 18 and 60, regardless of gender;(2)Meet the diagnostic criteria of chronic spontaneous urticaria;(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)No history of catgut embedding;(6)Sign informed consent, volunteer to participate in this 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.

Study & Design

• Study Type: Interventional study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
rticaria activity scores over 7days;

Secondary Outcome Measures

Name	Time	Method
Self-Rating Anxiety Scale;Insomnia Severity Index;chronic urticaria quality of life questionnaire;urticaria control test;Self-Rating Depression Scale;