Clinical study on reducing the recurrence of chronic spontaneous urticaria with Gubenkangmin prescriptio
- Conditions
- Chronic urticaria
- Registration Number
- ITMCTR2200006796
- Lead Sponsor
- Guangdong Provincial Hosptial of Chinese Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- Not specified
1. Patients who meet the chronic spontaneous urticaria diagnosis creteria and urticaria activity score weekly(UAS7)=16; 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.
(1)those with severe acute attack of urticaria , appearing with chest tightness, asthma, dyspnea,asphyxia or other life-threatening symptoms such as high fever, shivering, pulse speed and so on;
(2)those who are pregnant ,lactating or prepared for pregnancy within the next six months ;
(3)suffering from serious mental disorders;
(4)suffering from other skin disorders which need treatment at the same time;or with severe primary diseases concerned about circulatory system, respiratory system, digestive system, urinary system, endocrine system ,hematopoietic system or with therioma, beyond the control of conventional treatment;or with obvious abnormal medical examination results:such as increase of alanine aminotransferase(ALT) or aspartate aminotransferase(AST)>treble the normal upper limit,increase of creatinine>treble the normal upper limit;
(5)antihistamines or Chinese medicine were used within 1 week before entering the study, steroids hormone(oral medication),immunoglobulin, immunosuppressive drugs ,autohemotherapy were used within 4 weeks ,biologics and steroids hormone(injection) were used within 12 weeks;
(6) allergy to drugs used in this study;
(7) involved in other clinical studies at the same time or in the last 4 weeks.
(8)people whose job require high concentration
(9)Patients should not be enrolled according to the judgment of their physician
Study & Design
- Study Type
- Interventional study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method recurrence rate;
- Secondary Outcome Measures
Name Time Method recurrent times;chronic urticaria quality of life questionnaire;recurrence interval;Urticaria Control Test (UCT);urticaria activity score weekly(UAS7);