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Table 2 Eligibility criteria

From: Chinese herbal medicine Shenzhuo Formula treatment in patients with macroalbuminuria secondary to diabetic kidney disease: study protocol for a randomized controlled trial

Inclusion criteria

Exclusion criteria

• Diabetic kidney disease (DKD) diagnostic criteria:

•Type 1 diabetes

(a) Type-2 diabetes over 10 years with microalbuminuria

• Taking potassium-sparing diuretics

(b) Diabetic retinopathy with microalbuminuria

• Severe anemia, Hb < 60 g/L

(c) Macroalbuminuria: 24-h urinary protein (24-h UP) 0.5–3 g

• Albumin < 35 g/L

•Chinese syndrome differentiation of qi deficiency and with blood stasis

• Severe cardiovascular and cerebrovascular diseases

• Age between 18 and 80 years

• Other primary or secondary renal diseases (e.g., IgA nephropathy, membranous nephropathy, or lupus nephritis)

• Willingness to provide signed informed consent

• Pregnant or lactating women, women intending to become pregnant and women not using appropriate contraceptive methods

• HbA1C ≤ 8.0%

• Allergy to components of agents used in the study

• Serum creatinine < 133 μmol/L (1.5 mg/dL)

• Severe mental disorder

• Controlled hypertension (blood pressure ≤ 140/90 mmHg)

• Recent participation in other clinical trials recently

 

• Other unstable elements such as malignancy, or migration

 

• Liver dysfunction (ALT or AST 2.5 times higher than normal levels)