Chronic Spontaneous Urticaria
Conditions
Interventions
Treatment Group:Treatment with oral Cetirizine plus umbilical Qi-Gui Formula patch
Control group:Treatment with oral Cetirizine
Sponsors
Longhua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1.Meet the following diagnostic criteria of traditional Chinese medicine and Western medicine 2.Aged 18–70 years, no gender restriction 3.The patient and their family agree to and cooperate with the observation and treatment, and have signed the informed consent form Diagnostic Criteria Western Medicine Diagnostic Criteria: With reference to the [Chinese Guidelines for the Diagnosis and Treatment of Refractory Chronic Spontaneous Urticaria (2025 Edition) [J]. Chinese Journal of Dermatology, 2025, e20240674. doi:10.35541/cjd.20240674.] for the diagnosis of chronic spontaneous urticaria: characterized by recurrent episodes of wheals and pruritus, with or without angioedema, each episode resolving within 24 hours, recurring for more than 6 weeks, with at least two episodes per week, and without identifiable triggers prior to onset. Traditional Chinese Medicine (TCM) Syndrome Diagnostic Criteria: With reference to the relevant diagnostic criteria in the [Expert Consensus on TCM Treatment of Urticaria (2017 Edition) by the Dermatology Branch of the China Association of Chinese Medicine [J]. Chinese Journal of Dermatovenereology of Integrated Traditional and Western Medicine, 2017, 16(3): 2.]: sudden appearance of edematous patches on the skin accompanied by pruritus; patches vary in size and shape, with clear borders, no fixed location, pruritus appearing and disappearing intermittently, abrupt onset and resolution, recurrent episodes, prolonged and refractory course, lasting more than 6 weeks. TCM Syndrome Diagnosis: Syndrome of Qi and Blood Deficiency: Main symptoms: Wheals pale red in color or similar to skin tone, recurrent episodes, persisting for months or even years without resolution, or worsening after exertion. Accompanying symptoms: Dizziness, palpitations, fatigue and lack of strength, pale lips, pale tongue with thin white coating, thin pulse.
Exclusion criteria
Exclusion criteria: 1. Administration of glucocorticoids and immunosuppressants in any form (oral, intravenous drip, or other routes), or injection of biologics such as omalizumab, within 4 weeks prior to the start of the study. 2. Participation in any other clinical trials within 4 weeks prior to the start of the study. 3. Presence of severe primary diseases affecting major organs such as the heart, liver, kidneys, or spleen. 4. Inability to adequately communicate or complete scale assessments, or individuals diagnosed with mental or psychological disorders. 5. Women who are pregnant or breastfeeding.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Urticaria Activity Score for 7 Days; | — |
Secondary
| Measure | Time frame |
|---|---|
| Dermatology Life Quality Index;Traditional Chinese Medicine Syndrome Evaluation Scale;Pittsburg Sleep Quality Index; | — |
Countries
CHINA
Contacts
Public ContactSong Yu
Shanghai University of Traditional Chinese Medicine affiliated LongHua Hospital
Outcome results
None listed