Clinical observation and mechanism exploration of Guben Xiaozhen recipe in the treatment of chronic spontaneous urticaria

Not Applicable

• Conditions: chronic urticaria

• Registration Number: ITMCTR2200006862
• Lead Sponsor: Guangdong Provincial Hospital of Chinese Medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 6 March 2023

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: Not specified

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

(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.

Study & Design

• Study Type: Interventional study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Weekly Urticaria Activity Score(UAS7);

Secondary Outcome Measures

Name	Time	Method
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;