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Table 3 Flow diagram for MBYF clinical trial

From: 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

  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
  1. 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
  2. Laboratory examinations*: blood and urine routine, liver and kidney function, glucose