Efficacy and safety of Chou-Ling-Dan granules in the treatment of seasonal influenza via combining Western and traditional Chinese medicine: protocol for a multicentre, randomised controlled clinical trial

He, Jiayang; Li, Zhengtu; Huang, Wanyi; Guan, Wenda; Ma, Hongxia; Yang, Zi feng; Wang, Xinhua

The study is designed as a multi-centre, randomised, double-blinded, 27 double-simulation, oseltamivir-and placebo-controlled, parallel-design clinical trial. Eligible subjects 28 (n = 318) will be allocated after satisfying the criteria (Western medicine). Subjects will be randomised 29 to receive CLD granules, oseltamivir, or a placebo for 5 days of treatment and with follow-up after Western medical methods to evaluate the efficacy of Chinese herbal medicines, which is not suit, 126 because of a lack of a mature-traditional Chinese medicine evaluation system. To develop CLD into a 127 targeted drug with less side effects that can be widely used in the prevention and treatment of influenza, 128 an in-depth study needs to be conducted. In this study, a multi-centre, randomised, double-blind, double-simulation approach will be used. 130 It is hoped that the clinical efficacy of CLD for the treatment of influenza will be fully verified at the 131 highest level of clinical trials.