Efficacy and Safety of Chuan Huang Fang Combining Reduced Glutathione in Treating Acute Kidney Injury (Grades 1–2) on Chronic Kidney Disease (Stages 2–4): Study Protocol for a Multicenter Randomized Controlled Clinical Trial

Table 3

SPIRIT table: measured items and time points.

Items	Baseline	Treatment
	0 week	1 week	2 weeks
General	×
Informed consent	×
Inclusion and exclusion criteria	×
General information	×
General physical examination	×
Urine HCG (only women)	×
Medical and drug use history	×
Concomitant disease and treatment	×
Combined medication	×	×	×
Randomization	×
Intervention
RG group
CHF group
RG + CHF group
Effectiveness observation
Renal functions (Scr, BUN, eGFR)	×		×
AKI biomarkers (NGAL, IL-18, γ-GT)	×		×
TCM symptoms	×		×
Mechanism observation
Inflammatory indicators (IL-6, TNF-α)	×		×
Oxidative stress indicators (HO-1, MDA, SOD)	×		×
Safety observation
Electrocardiogram	×		×
Blood routine	×		×
Urine routine	×		×
Fecal routine and occult blood test	×		×
Serum potassium	×		×
Hemoglobin	×		×
Adverse events		×	×
Drug management
Drug distribution	×	×	×
Drug recycling		×	×
Drug count		×	×
Research conclusion			×