Efficacy and safety of Jia Wei Bushen Yiqi formulas as an adjunct therapy to systemic glucocorticoids on acute exacerbation of COPD: study protocol for a randomized, double-blinded, multi-center, placebo-controlled clinical trial

Table 5 Estimation of sample size

Variable	TCM treatment	Systemic glucocorticoid treatment
Primary outcome	CAT score	Time to next exacerbation
Way	2-group,1-sided	2-group non-inferiority
Group A mean	10.30	29
Group B mean	12.95	43.5
Group A standard deviation	6.31	12
Group B standard deviation	5.99	12
Non-inferiority margin		10
Sampling ratio	1	1
Type 1 error	0.05	0.05
Power	0.8	0.8
Sample size	67	88

ISSN: 1745-6215