Gubenkangmin Granules for chronic spontaneous urticaria: a randomised double-blind, placebo-controlled clinical trial

Not Applicable

• Conditions: Chronic urticaria

• Registration Number: ITMCTR1900002367
• 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: 20 February 2023

Recruitment & Eligibility

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

Inclusion Criteria

1. Patients who meet the chronic spontaneous urticaria diagnosis creteria;
2. Male and female aged 18 to 65 years old;
3. Patients with syndrome pattern of Wei qi deficiency;
4. UAS7=7;
5. To be able to and willing to provide signed informed consent.

Exclusion Criteria

1. The 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 or participated within 3 months;
8. Workers engaged in highly concentrated attention (driving machines, cars, ships, high-altitude work, mechanical assignments, and precision instruments);
9. Patients who are unfit to enter the group according to doctor's judgment.

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Weekly Urticaria Activity Score;

Secondary Outcome Measures

Name	Time	Method
The use of western medicine;Time to first relapse;Propotion of a reduction of weekly UAS to 40% of baseline;Weekly itch score;Weekly hive score;Dermatology Quality Life Index;Relapse rate;