Table 3 Schedule of enrollment, allocation, visits, and assessments

From: Chinese herbal medicine Tangshen Formula treatment of patients with type 2 diabetic kidney disease with macroalbuminuria: study protocol for a randomized controlled trial

	Study Period
	Enrollment	Allocation	Intervention						Follow-up
Time point (weeks)	−2	0	4	8	12	16	20	24	28	36	48
Eligibility screen	√
Written informed consent	√
Medical history	√
Physical examination		√	√	√	√	√	√	√
Routine blood and urine		√		√		√		√
Electrocardiogram		√		√		√		√
ALT, AST, ALP, GGT, TBIL		√		√		√		√
24 h urinary protein		√	√	√		√		√	√	√	√
Serum Cr, eGFR		√	√	√		√		√	√	√	√
TC, TG, LDL-C, HDL-C		√	√	√		√		√
A1C, CRP		√		√		√		√
Evaluation of TCM syndrome		√	√	√	√	√	√	√	√	√	√
Drug distribution		√	√	√	√	√	√
Retrieval of unused drugs			√	√	√	√	√	√
Adverse events			√	√	√	√	√	√	√	√	√

Abbreviations: A1C hemoglobin A1C, ALP alkaline phosphatase, ALT alanine transaminase, AST aspartate aminotransferase, eGFR estimated glomerular filtration rate, GGT gamma-glutamyl transpeptidase, LDL-C low-density lipoprotein cholesterol, serum Cr serum creatinine, TBIL total bilirubin, TC total cholesterol, TCM traditional Chinese medicine, TG triglycerides, HDL-C high-density lipoprotein cholesterol
√ = Action items

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ISSN: 1745-6215

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