Chronic Urticaria
Conditions
Interventions
High-dose group:Jing Fang mixture oral 4 at a time,use it for 28 days 2 times a day shake well when used
Positive control group:Cetirizine hydrochloride tablets: orally 1 tablet once once a day. use it for 28 days
Low-dose group:Jing Fang mixture oral 3 at a time 2 times a day shake well when used.use it for 28 days
Sponsors
The Affiliated Hospital of Shandong University of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Aged between 18 and 70 years old (both inclusive) regardless of gender. 2. Meeting the diagnostic criteria for chronic spontaneous urticaria. 3. Meeting the TCM syndrome differentiation criteria for the wind-cold syndrome of urticaria. 4. Before randomization the Urticaria Activity Score (UAS7) is between 7 and 28 points (ranging from 0 to 42 points) and the Urticaria Control Test (UCT) score is less than 12 points. 5. Willing to participate in this clinical trial voluntarily understand and sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Those who are known to be allergic to the drugs used in the trial or the ingredients of the formula. 2. Those whose urticaria is induced by definite triggering factors such as foods or medications. 3. Those who have experienced symptoms such as laryngeal edema chest tightness shortness of breath and shock during an acute episode within the past 3 months; those with non-urticarial angioedema allergic asthma anaphylactic shock etc. and are judged by the investigator as not suitable to participate in this study. 4. Those accompanied by other chronic pruritic skin diseases that the investigator deems may affect the judgment of the curative effect such as atopic dermatitis generalized dermatitis generalized eczema bullous pemphigoid and acute eruptive pustulosis. 5. Those who have used H1 receptor antagonists such as diphenhydramine levocetirizine cetirizine loratadine fexofenadine desloratadine montelukast and the drug withdrawal time is less than 5 half-lives. 6. Those who have used H2 receptor antagonists such as cimetidine ranitidine famotidine nizatidine and the drug withdrawal time is less than 3 days. 7. Those who have used immunosuppressants such as cyclosporine A methotrexate cyclophosphamide etc. and the drug withdrawal time is less than 14 days. 8. Those who have withdrawn from using doxepin for less than 8 days. 9. Those who have withdrawn from using omalizumab for less than 30 days. 10. Those who have used systemic hormone therapy such as dexamethasone prednisone etc. and the drug withdrawal time is less than 7 days. 11. Those with severe liver kidney heart brain mental metabolic diseases and autoimmune diseases etc. 12. Those with ALT and AST levels greater than 1.5 times the upper limit of the normal value and Cr level greater than the upper limit of the normal value. 13. Those who have participated in other clinical trials within the past 30 days. 14. Pregnant or lactating women or female subjects of childbearing age who do not agree to adopt medically recognized contraceptive measures (such as oral contraceptives condoms etc.) during the trial period. 15. Those who plan to become pregnant plan to donate/store sperm or eggs within 3 months during and after the trial. 16. According to the investigator's judgment patients who cannot understand and/or comply with the study drugs and operation procedures or those who the investigator deems not suitable to participate in this trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 7-day urticaria activity score; | — |
Secondary
| Measure | Time frame |
|---|---|
| The proportion of subjects with UAS7 = 6 points;Disappearance rate of urticaria symptoms (itching wheals);Chronic Urticaria Quality of Life Questionnaire (CU-Q2OL);The recurrence rate of chronic urticaria in the follow-up period of the subjects;Time of disappearance of urticaria symptoms (itching wheals);The proportion of subjects with UCT < 12 points;Symptom Severity Reduction Index (SSRI);Itching wind-bump single symptom score;Urticaria Control Test (UCT); | — |
Countries
China
Contacts
Public ContactZhao Ying
Shandong University of Traditional Chinese Medicine Affiliated Hospital
Outcome results
None listed