Efficacy and safety of Chinese herbal medicine Piminxiao Capsule for the treatment of chronic spontaneous urticaria (CSU) with wind-heat or wind-heat complicated by dampness: a multi-center randomized controlled trial
- Conditions
- chronic spontaneous urticaria
- Registration Number
- ITMCTR2200005831
- Lead Sponsor
- Jiangsu Province Hispital of Chinese Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- Not specified
Participants are included if they are aged between 18 and 60 years; clinically diagnosed with CSU, and belonging to wind-heat or wind-heat complicated by dampness according to TCM; and give written informed consent. For the diagnostic criteria of CSU, we will refer to The EAACI/GA2LEN/EDF/WAO Guideline for the definition, classification, diagnosis and management of urticaria. For the TCM diagnostic criteria, we will refer to Expert Consensus on TCM Treatment of Urticaria.
1. Patients with obvious predisposing factors can be found (such as cold urticaria, stress urticaria, etc. ).
2. Patients with other diseases with urticaria or vascular edema as skin manifestations, such as hereditary vascular edema, acquired vascular edema.
3. Interventions of glucocorticoid, hydroxychloroquine, methotrexate, cyclophosphamide, cyclosporine or intravenous immunoglobulin in the previous 1 month.
4. Interventions of histamine H2 receptor antagonist or leukotriene receptor antagonist in the previous 1 week.
5. Patients who took off-label dosage levocetirizine hydrochloride or used other histamine H1 receptor antagonists in the last two weeks
6. Patients allergic to the drugs used in this study.
7. Patients with serious primary diseases of the liver or kidney systems.
8. Patients with pregnancy or lactation.
9. Other conditions that researchers believe are unsuitable for clinical trials.
Study & Design
- Study Type
- Interventional study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method rticaria activity score, UAS;
- Secondary Outcome Measures
Name Time Method Chronic Urticaria Quality of Life Questionnaire, CU-Q2oL;TCM symptom scale score;Itch severity score, ISS;Urticaria control test, UCT;