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

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

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2200006839
Enrollment
Unknown
Registered
2022-11-30
Start date
2022-12-01
Completion date
Unknown
Last updated
2023-03-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic spontaneous urticarial

Interventions

Sponsors

Guang 'anmen Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
Urticaria activity scores over 7days;

Secondary

MeasureTime frame
Self-Rating Anxiety Scale;Insomnia Severity Index;chronic urticaria quality of life questionnaire;urticaria control test;Self-Rating Depression Scale;

Countries

China

Contacts

Public ContactCui Bingnan

Guang'anmen Hospital

cbn1998@163.com+86 15010459211

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Feb 4, 2026