Efficacy and safety of modified Bushen Yiqi formulas (MBYF) as an add-on to formoterol and budesonide in the management of COPD: study protocol for a multicentre, double-blind, placebo-controlled, parallel-group, randomized clinical trial: FB-MBYF Trial

Table 3 Flow diagram for MBYF clinical trial

	Enrollment	Allocation	Post-allocation
Timepoint	− 7 days	0 ± 3 days	60 ± 3 days	120 ± 3 days	180 ± 3 days	240 ± 3 days	300 ± 3 days	360 ± 3 days
Enrolment:
Eligibility screen	X
Informed consent	X
Background information	X
Interventions
MBYF or placebo
Budesonid and Formoteraol
Safety outcomes
ECG		X			X			X
Chest X-ray or CT		X			X			X
Laboratory examinations*		X			X			X
AEs		X			X			X
Primary outcomes
The frequency、time and severity of AECOPD		X	X	X	X	X	X	X
CAT score		X			X			X
Pulmonary function test		X						X
Secondary outcomes
mMRC dyspnea scale		X			X			X
6MWT		X			X			X
BODE index		X			X			X
Quantitative score of TCM syndrome		X			X			X
Inflammation indexes and HPA axis function		X						X
Other test
Genotypes		X						X

MBYF modified Bushen Yiqi formulas, AECOPD acute exacerbation of COPD, CT computed tomography, AE adverse event, ECG electrocardiogram, CAT COPD assessment test, mMRC Modified Medical Research Council, 6MWT Six minutes of walking test, BODE B: body mass index (BMI), D: Degree of airflow obstruction, E: Evaluation of dyspnea, D: Dynamic ability, TCM traditional Chinese medicine, HPA hypothalamic-pituitary-adrenaline axis
Laboratory examinations*: blood and urine routine, liver and kidney function, glucose

ISSN: 1745-6215