[Translation] A randomized, double-blind, placebo-controlled, positive drug-controlled, multicenter phase III clinical trial of Xiangpuzhengqi soft capsules in the treatment of colds (dampness-induced superficial damage syndrome)
以感冒的疾病缓解时间为主要疗效指标,进一步评价香朴正气软胶囊治疗感冒(湿邪伤表证)的疗效。
以中医证候及单项症状消失率为次要疗效指标,以进一步评价香朴正气软胶囊治疗感冒(湿邪伤表证)的疗效。
通过临床不良事件观察,以进一步评价香朴正气软胶囊的安全性。
[Translation] The time of disease remission of cold was used as the main efficacy index to further evaluate the efficacy of Xiangpuzhengqi soft capsule in treating cold (symptoms of dampness damaging the exterior).
The disappearance rate of TCM syndrome and single symptom was used as the secondary efficacy index to further evaluate the efficacy of Xiangpuzhengqi soft capsule in treating cold (symptoms of dampness damaging the exterior).
The safety of Xiangpuzhengqi soft capsule was further evaluated through clinical adverse event observation.