Chronic spontaneous urticaria
Conditions
Interventions
Experimental Group:Sanhuang Xiaozhen Decoction
Sponsors
Changzhou Hospital of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: (1) Meets the Western medicine diagnostic criteria for chronic spontaneous urticaria; (2) Identified as Wind-Heat Syndrome in traditional Chinese medicine; (3) Age between 18 and 70 years old (inclusive), with no gender restrictions; (4) Retrospective evaluation within 7 days prior to enrollment, with UAS7 score (range 0-42) satisfying 7 = UAS7 score < 28; (5) Voluntarily participates in this clinical trial and signs the informed consent form.
Exclusion criteria
Exclusion criteria: (1) Clearly defined underlying causes of chronic urticaria other than CSU, including acute, solar, cholinergic, heat, cold, aquagenic, delayed pressure, or contact urticaria; (2) Any of the following diseases that may present with urticaria and/or angioedema symptoms: urticarial vasculitis, Schnitzler syndrome, and other autoinflammatory syndromes; adult Still's disease, and other autoimmune diseases; neutrophilic urticarial dermatoses; subacute cutaneous lupus erythematosus; acute febrile neutrophilic dermatosis; pigmentary urticaria; erythema multiforme; mastocytosis; hereditary or acquired angioedema; lymphoma; leukemia; or generalized cancer; (3) Any chronic pruritic dermatosis other than CSU that may affect the evaluation of efficacy (e.g., atopic dermatitis, bullous pemphigoid, dermatitis herpetiformis, and senile pruritus); (4) Concomitant severe cardiovascular, digestive, endocrine, nervous system diseases, or other conditions that, in the investigator's judgment, may affect the evaluation of efficacy and safety or compliance after enrollment; (5) Liver function tests (ALT, AST) with any value exceeding 1.5 times the upper limit of normal reference values, or serum creatinine (Scr) exceeding the upper limit of normal reference values; (6) Use of oral, intravenous, or other forms of glucocorticoids and immunosuppressive drugs within 1 month prior to enrollment; (7) Use of drugs for urticaria, other than emergency medications (loratadine), within 1 week prior to enrollment, or use of loratadine for more than 3 days, or use of preparations (decoctions, granules, traditional Chinese medicine formulations, etc.) prohibited during the study period; (8) Pregnant or breastfeeding women, women planning pregnancy, or those unable to adopt effective contraceptive measures; (9) Concomitant severe intellectual or mental disorders; (10) History of alcohol or substance abuse within 1 year prior to the trial; (11) History of allergy to the components or excipients of the investigational drug or emergency medications; (12) Participation in any interventional clinical trial within 30 days prior to screening.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Urticaria Activity Score over 7 days; | — |
Secondary
| Measure | Time frame |
|---|---|
| 7-day Itching Severity Rating;7-day urticaria wheal severity score;Urticaria Control Test (UCT) Score;Change from baseline in serum total IgE levels;Clinical Efficacy Evaluation;The change in Traditional Chinese Medicine (TCM) syndrome score from baseline and the efficacy of TCM syndrome.;Changes in health-related quality of life (HRQoL) assessment scale scores compared to baseline in patients with chronic urticaria.;Usage of emergency medications during treatment.;Clinical Efficacy During the Follow-up Period; | — |
Countries
China
Contacts
Public ContactWu Kejia
Changzhou Hospital of Traditional Chinese Medicine
Outcome results
None listed