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

calculated and the Fisher's exact test will be used to compare the prevalence of adverse events 463 between the CLD granules, oseltamivir and placebo 28 . All study-related information will be stored securely at the study site. All participant information 489 will be stored in locked file cabinets in areas with limited access. All laboratory specimens, reports, 490 data collection, process, and administrative forms will be identified by a coded ID(identification) 491 number only to maintain participant confidentiality. All records that contain names or other personal 492 identifiers, such as locator forms and informed consent forms, will be stored separately from study 493 records identified by code number. All local databases will be secured with password-protected access 494 systems. Forms, lists, logbooks, appointment books, and any other listings that link participant ID The trial will be publicised at regional and national conferences. The final results will be presented 501 at scientific meetings and published in a peer-reviewed journal (authorship will be according to the 502 journal's guidelines). In addition, a lay summary of the study results will be circulated to potentially 503 interested parties. There had been no direct patient involvement in the design of this protocol. Since there is lack of clinical trials of traditional Chinese herbal medicines (TCHM), not only the 530 effectiveness, but also the safety of TCHM will be investigated in this study 29 . To evaluate the safety, 531 changes in liver and kidney function after treatment will be monitored. 532 In this study, we will divide the patients into cold and heat TCM syndromes to study whether Competing interests 566 The authors declare that they have no competing interests. Table 3 .