Chinese herbal medicine Tangshen Formula treatment for type 2 diabetic kidney disease in the early stage: study protocol for a randomized controlled trial

Table 1 Measurement items and point of data capture

Visit project	Screening period/baseline	Visits 1–2, 4–5	Visit 3	Visit 6
Visiting time	–7 to 0 days	Medication 4, 8, 16, 20 weeks ±7 days	Medication 12 weeks ±7 days	Medication 24 weeks ±7 days
Collect basic medical history
Sign informed consent	×
Fill in general information	×
Medical history and treatment history	×
Determine inclusion and exclusion criteria	×
Vital signs	×	×	×	×
Physical examination	×	×	×	×
Comorbidity and medication records	×	×	×	×
Monitoring and inspection
Urine pregnancy test	×
Glycosylated hemoglobin, blood lipids	×		×	×
Fasting blood sugar and blood pressure	×	×	×	×
Effectiveness observation
Urinary microalbumin–creatinine ratio	×	×	×	×
Urinary microalbumin excretion rate	×	×	×	×
Serum creatinine	×	×	×	×
Glomerular rate filtration	×	×	×	×
24-h urinary microalbumin and 24-h urinary microalbumin quantification	×		×	×
Physico-chemical examination
Routine blood test and routine urine test	×		×	×
Stool routine examination	×		×	×
Vital signs	×	×	×	×
ECG, liver and kidney function	×		×	×
Adverse event		×	×	×
Other work
Random grouping	×
Distribute drug and patient journal cards	×	×	×
Recovery drugs, quantity statistics		×	×	×
Recycle patient’s diary card		×	×	×
End of study summary				×

ISSN: 1745-6215