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

All study-related information will be stored securely at the study site. All participant 517 information will be stored in locked file cabinets in areas with limited access. All laboratory 518 specimens, reports, data collection, process, and administrative forms will be identified by a coded 519 ID(identification) number only to maintain participant confidentiality. All records that contain 520 names or other personal identifiers, such as locator forms and informed consent forms, will be 521 stored separately from study records identified by code number. All local databases will be secured The trial will be publicised at regional and national conferences. The final results will be 529 presented at scientific meetings and published in a peer-reviewed journal (authorship will be 530 according to the journal's guidelines). In addition, a lay summary of the study results will be 531 circulated to potentially interested parties. 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 public involvement group included a mixture of research experienced and inexperienced people. We 538 will try to work with patient advocacy groups to ensure that plain language summaries of study 539 findings are shared to both participating service users and wider patient groups. And through the 540 communication of participants and researchers, the burden of the intervention will be assessed in a 541 comprehensive and rational way.