[Translation] A randomized, double-blind, placebo and dose-response parallel-controlled, multi-center phase II clinical trial to evaluate the effectiveness and safety of Qianqing Granules in the treatment of common cold (wind-heat and cold syndrome)
本次临床试验以安慰剂为对照,探索不同剂量乾清颗粒治疗普通感冒(风热感冒证)的有效性和安全性。分为Ⅱa期和Ⅱb期,先后开展临床试验。
Ⅱa期临床试验的目的是初步评价乾清颗粒治疗普通感冒(风热感冒证)的有效性和安全性,并对其进行剂量探索。Ⅱb期临床试验是在Ⅱa期临床试验研究结果的基础上,进一步确认乾清颗粒治疗普通感冒(风热感冒证)的有效性和安全性。
[Translation] This clinical trial uses placebo as a control to explore the effectiveness and safety of different doses of Qianqing Granules in the treatment of common cold (wind-heat and cold syndrome). It is divided into Phase IIa and Phase IIb, and clinical trials are carried out successively.
The purpose of the Phase IIa clinical trial is to initially evaluate the effectiveness and safety of Qianqing Granules in the treatment of common colds (wind-heat and cold syndrome), and to conduct dose exploration. The Phase IIb clinical trial is based on the results of the Phase IIa clinical trial to further confirm the effectiveness and safety of Qianqing Granules in treating common colds (wind-heat and cold syndrome).