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

Based on this diary, the investigator will evaluate the subject's adherence to the interventions to the Data entry and management is the responsibility of the assigned data manager who will 318 establish the database and the verification procedure. Then, two specialised trained keyboard 319 operators will input and confirm the data. After checking the CRF, identified entry errors will be 320 corrected until the input data is exactly as the same as the CRF. Any queries on the CRF will be 321 communicated to the researchers through the data query form. These data query forms must be 322 processed, signed and dated timely by the researcher. Resolved data questions must be returned to 323 the data manager, who revises and verifies the data according to the feedback, and correspondingly 324 updates the database, then the necessary data question form can be queried again. statisticians and data manager must be provided. Additionally, revisions will be performed in the 330 statistical analysis. Primary outcome 343 The primary outcome is the time to alleviate influenza-like symptoms: fever; stuffy nose; 344 running nose; sore throat; cough; myalgia; fatigue; headaches; chills and sweating, which will be 345 measured in hours. Alleviation means that the influenza-like symptoms score is ≤1 (mild) and the 346 state is stable for more than 24h Error! Reference source not found..