| Objective:To study the clinical efficacy security and side effect of shuanjinlian Oral Liquid in treating Common Cold(CC) of fen-re syndrome.Methods: This is a double blind ,randomized,controlled,multicenter trial..240 cases were included, There were 238 cases in intention-to-treat(ITT), and 237 cases in per-protocol popotation(PP). The study group (ITT:n=119. PP:n=119) received shuanjinlian Oral Liquid and the controll group (ITT:n=119. PP:n=118) were given shuanhuanglian Oral Liquid.Results: The value of synthesis curative effecy:in ITT,the total effective percentage in the study group was 73.95%,and 59.67% in the control group ,in PP ,the numbers were 74.58% and 59.66%, they showed obvious statistical difference (ITT: CMH=6.0690 P=0.0138 ; PP: CMH=5.9039 P=0.0151) shuanjinlian Oral Liquid could markedly alleviate body temperature of patients (P<0.01), there was no significant electrocardiogram difference(P>0.05)between two groups before treatment. Conclusion: shuanjinlian Oral Liquid is effective and safety in the treatment of common cold , the conclusion is awaiting to be confirmed by the third period clinical trail. |