As an important part in clinical trial design

statistical analysis plan is necessary for full utilization of data and reasonableness and reliability of clinical results. There are many problems in statistical analysis of TCM clinical trials such as missing or incomplete statistical analysis plan

lack of statistical methods

unclear description or improper selection of statistical methods and mismatched comparison type and testing purpose. In order to solve the above problems

statistical analysis plan should be developed according to the characteristics of TCM clinical research such as determining comparison type according to the purpose of trial and establishing assumption based on the primary and secondary outcomes of intervention and the outcome evaluation. Furthermore

statistical analysis plan should include a brief description of clinical trial and the determination of sample size

statistical power

statistical methods and statistical analysis dataset.