Randomized Double-blind and Multi-center Clinical Trial ofLianhua Jizhi Tablets in Treatment of Acute Trachitis and Bronchitis with Syndrome of Phlegm-Heat Obstructing Lung / 中国中医药信息杂志

ABSTRACT

Objective To evaluated the effectiveness and safety ofLianhua Jizhi Tablets for acute trachitis and bronchitis with syndrome of phlegm-heat obstructing.Methods A randomized double-blind, placebo-controlled and multi-center clinical trial design was selected. Totally 240 cases were randomly divided into experimental group and control group, 120 cases in each group, of which 237 cases were included in the analysis of FAS. Experimental group was givenLianhua Jizhi Tablets, while control group was given placebo, 12 tablets/day, 7 days for a course. Curative effect of acute trachitis and bronchitis, TCM syndrome and disappearance of cough, cough and sputum symptom scores and area under the curve (AUC) were observed. The safety was evaluated. Results The cure rates of disease in experimental group and control group were 66.67% (78/117) and 29.17% (35/120), respectively;cure rates of TCM syndrome in experimental group and the control group were 68.38% (80/117) and 27.50% (33/120), respectively;there was statistically significant difference in area under the curve of cough and sputum symptom score between the two groups (P<0.01). Disappearance rates (cure) of daytime cough in experimental group and control group were 52.99% (62/117) and 13.33% (16/120), respectively;disappearance rates (cure) of nocturnal cough in experimental group and control group were 76.52% (88/115) and 31.90% (37/116), respectively;there were no side effects in experimental group.ConclusionLianhua Jizhi Tablets can significantly relieve clinic symptoms in the treatment of acute trachitis and bronchitis, and have good clinical efficacy and safety.