Clinical study on SuHuang ZhiKe capsule in treating 140 cases of cough variant asthma

Objective: To preliminary evaluate the clinical efficacy and safety of SuHuang ZhiKe capsule for the treatment of cough variant asthma.Methods: A parallel-group randomized non-inferiority and double-blind mutlicenter clinical trial with positive control was carried out in phaseⅡ with 140 cases.The treatment group including 70 cases received capsule SuHuang ZhiKe in a dosage of 0.45g×3 tid.by oral.The control group including 70 cases took another capsule in the same way.The course of treatment was 14 days.Results: The total cough efficacy rates were 86.2% in treatment group and 71.6% in control group(P0.05).The total TCM syndrome efficacy rates were 96.9% in treatment group and 80.6% in control group(P0.01).After 14-day treatment,the results of the safety evaluation showed that some patients were abnormal in blood test,urine test,stool test, liver function test and kidney function test.Meanwhile,adverse events occurred in 1 case which belonged to the control group.Conclusion: Capsule SuHuang ZhiKe is effective and safe for the treatment of CVA with syndrome of wind evil invading lungs.