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

hermore, this trial is a confirmatory study on the treatment of influenza by CLD Granules. 349 The patients will be randomly assigned in three groups: positive group, test group and placebo 350 group. In this trial, the number of sample cases was estimated based on the test hypothesis that the 351 test group was superior to the placebo group and the test group was not inferior to the positive 352 control group. 353 The main index of treatment effectiveness is the period of time until subsidence of symptoms 354 (hours). It has been reported that the average period of time for remission of these symptoms in the 355 placebo group was about 5 days (120 hours) 26 . This trial requires that the average time for 356 symptomatic remission of the test group should be at least 12 hours shorter than the placebo group, 357 it means the Permissible Error (δ) of the superiority trial is 12 hours. In order to be considered 358 clinically significant, the mean time for symptomatic remission in the positive group must less than 359 12 hours compared with the placebo group, which means the Permissible Error (δ) of the superiority 360 trial is within 12 hours. The calculation data is as follows: through local advertising. And each participant will receive financial compensation after they 371 finishing the entire treatment. For patients who drop out, payments will be pro-rated for the length 372 of time they stayed in the study, but payment will not be made until the study would have been 373 completed.