chronic urticaria
Conditions
Interventions
test group:Gubenxiaozhenfang granules for oral administration
placebo group:Oral particle simulant
Sponsors
Guangdong Provincial Hospital of Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: (1)Clinical diagnosis of patients with chronic spontaneous urticaria, the degree of disease is moderate to severe (16=UAS7=42). (2)Male and female aged 18 to 65 years old. (3)Patients with syndrome pattern of Wei qi deficiency. (4)To be able to and willing to provide signed informed consent.
Exclusion criteria
Exclusion criteria: (1) he occurrence of chronic urticaria is severe, such as the appearance of chest stuffy, wheezing, breathing difficulties, and the choking of the laryngeal mucosa. Accompanied by high fever, cold war,tachycardia, etc. (2) Pregnant,lactating women or pregnancy is planned in half a year. (3) Patients with psychiatric disorders; (4) Patients with other skin diseases that require treatment currently, with history of primary cardiovascular, respiratory, digestive, urinary, endocrinologic and hematologic diseases, which can't be controlled through ordinary treatments.patients with malignant tumor. Patients with clinical test results listed below: AST or ALT 3 times more than normal upper limit; Creatinine 3 times more than normal upper limit;Or any other abnormal laboratory test results, assessed by investigators, that are not suitable for this clinical study. (5) Topical treatments with antihistamines or chinese medicine within 1 week; Oral hormones and other immunosuppressive drugs, immunoglobulins and autohemotherapy within 4 weeks; biological therapy or inject glucocorticoid drugs within 12 weeks. (6) Allergic to this drug ingredient. (7) Participating other clinical trials.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Weekly Urticaria Activity Score(UAS7); | — |
Secondary
| Measure | Time frame |
|---|---|
| chronic urticaria quality of life questionnaire(CU-Q2oL);Proportion of improvement in UAS7 score with minimal clinically important difference (MID);Weekly itch score;Urticaria Control Test (UCT);Recurrence rate;Dermatology Life Quality Index(DLQI);Time to first relapse;Ointment dosage;Weekly hive score; | — |
Countries
China
Contacts
Public ContactChuanjian Lu
Guangdong Provincial Hospital of Chinese Medicine
Outcome results
None listed