Data collected from baseline to follow-up visits
| Study period | |||||||||
Enrolment | Allocation | Intervention | Postintervention | |||||||
D-1 | D0 | D1 | D2 | D3 | D4 | D5 | D6 | Discharge | 30 days after discharge | |
Enrolment | ||||||||||
Consent form | √ | |||||||||
Basic information | √ | |||||||||
Inclusion and exclusion criteria | √ | |||||||||
Allocation | √ | |||||||||
Intervention: | ||||||||||
XJXBCQ+budesonide (All)+WST | √ | √ | √ | √ | √ | |||||
XJXBCQ+budesonide (half) +WST | √ | √ | √ | √ | √ | |||||
XJXBCQ placebo +budesonide (All)+WST | √ | √ | √ | √ | √ | |||||
Outcome measure | ||||||||||
Clinical symptoms score | √ | √ | √ | √ | √ | √ | √ | √ | ||
TCM syndrome score | √ | √ | √ | √ | √ | √ | √ | √ | ||
Blood gas analysis (PH, PaO2, PaCO2) | √ | √ | ||||||||
Serum inflammatory markers (PCT, CRP, IL-6, TNF-α) | √ | √ | √ | |||||||
Induced sputum and stool sample | √ | √ | ||||||||
Safety assessments: | ||||||||||
Adverse events recorded | √ | √ | √ | √ | √ | √ | √ | √ | √ | |
Physical examination | √ | √ | √ | √ | √ | √ | √ | √ | ||
Blood and urine routine | √ | √ | ||||||||
Liver function (AST, ALT, Tbil, ALP, GGT) | √ | √ | ||||||||
Kidney function (Scr, BUN, eGFR) | √ | √ | ||||||||
ECG | √ | √ |
ALP, alkaline phosphatase; ALT, alanine aminotransferase; AST, aspartate aminotransferase; BUN, blood urea nitrogen; CRP, C reactive protein; eGFR, estimated glomerular filtration rate; GGT, Gamma glutamyl transferase; IL-6, interleukin-6; Paco2, alveolar carbon dioxide tension (or pressure); Pao2, arterial oxygen tension (or pressure); Scr, serum creatinine; Tbil, total bilirubin; TCM, traditional Chinese medicine; TNF-α, tumour necrosis factor-α; WST, western standard therapy.