[Translation] A randomized, blinded, positive drug (original dosage form) and placebo-controlled, multicenter phase III clinical trial on the efficacy and safety of Cuitang granules in the treatment of common cold
以普通感冒24h解热率为主要疗效指标,与原剂型催汤丸以及安慰剂对照,在Ⅱb期临床试验基础上,进一步评价催汤丸工艺改进及改变剂型后,催汤颗粒治疗普通感冒的有效性与安全性,最终为药物注册申请获得批准提供充分依据。
[Translation] Taking the 24-hour antipyretic rate of the common cold as the main efficacy indicator, compared with the original dosage form of Cuitang Pills and placebo, on the basis of the Phase IIb clinical trial, the effectiveness and safety of Cuitang Granules in treating the common cold were further evaluated after the process improvement and dosage form change of Cuitang Pills, ultimately providing sufficient basis for the approval of the drug registration application.