urticaria
Conditions
Interventions
Experiemntal group:JingFang Mixture+Cetirizine hydrochloride tablet simulant
Control group:JingFang Mixture simulant+Cetirizine hydrochloride tablet
Sponsors
Beijing Hospital of Traditional Chinese Medicine, Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Age 18~70 years old (including border), male or female; 2. Meet the diagnostic criteria for urticaria; 3. Duration of illness >= 3 days; 4. UAS scored > 7 points overall; 5. Voluntarily participate in this clinical trial, understand and sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Pregnant and lactating women; 2. Patients with obvious TCM fever, such as fever, thirst and cold drinks; or red-faced, upset, constipation, short urine, etc.; 3. Patients with obvious deficiency of qi and blood in Chinese medicine, such as dizziness, panic, fatigue, lip color white, insomnia, etc.; 4. Exogenous factors such as foods and drugs with a history of allergies appear after recent exposure symptomatic; 5. Urticaria with laryngeal edema, non-urticarial angioedema, allergic asthma, anaphylactic shock, etc. and those who are judged by the investigator to be unsuitable to participate in this research; 6. Associated with other skin diseases (atopic dermatitis, eczema, bullous pemphigoid, acute exanthematous impetigo); 7. Discontinuation time of H1 receptor antagonists such as diphenhydramine and levocetirizine < 3 days, cetirizine, loratadine, fexofenadine discontinuation time< 5 days, desloratadine < 8 days, etc.; 8. Use of H2 receptor antagonists such as cimetidine, ranitidine, famotidine, and roxatidine discontinuation time< 3 days, etc.; 9. Use other treatments for urticaria, such as montelukast, cyclosporine A discontinuation time< 2 days, doxepin discontinuation time< 8 days, etc., omalizumab discontinuation time < 3 months, etc.; 10. Discontinuation time of steroid hormones and immunosuppressants< 30 days; 11. Severe liver, kidney, heart, brain, psychiatric, metabolic diseases and autoimmune diseases; 12. Known hypersensitivity to investigational drugs or formulation components or hydroxyzine or piperazine derivatives or those with lactose intolerance; 13. Participants in other clinical trials within 30 days; 14. According to the judgment of the investigator, the patient cannot understand and/or follow the study drug or procedure, or those deemed unsuitable by the investigator to participate in the trial.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| vital signs;physical examination;blood routine examination;urine routines examination;liver function;renal function;adverse events;12-lead ECG ; | — |
Primary
| Measure | Time frame |
|---|---|
| Urticaria activity score within 7 days;Proportion of participants in UAS<7;Time to disappear of hives (itching, wheals) within 14 days of taking the drug;;Disappearance rate of urticaria symptoms (itching, wheals) after 7 and 14 days of medication;;Dermatological Quality of Life Index (DLQI);Symptom Score Decline Index (SSRI); | — |
Countries
China
Contacts
Public ContactZhou Dongmei
Beijing Hospital of Traditional Chinese Medicine Affiliated to Capital Medical University
Outcome results
None listed