Huangqi Guizhi Wuwu Decoction in CKD Stage 2-4 Diabetic Nephropathy

• Status: Recruiting
• Trial end date: 2022-12-31
• Target enrollment: 0
• Participant gender: All

Summary

This is a prospective, open, multicenter clinical trial.The objective of this study is to evaluate the efficacy and safety of Huangqi Guizhi Wuwu Decoction in patients with CKD stage 2-4 diabetic nephropathy.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The First Affiliated Hospital of Dalian Medical University
• Treatments: Dapagliflozin

Criteria

Inclusion Criteria:

1. Patients diagnosed as diabetic nephropathy

2. TCM syndrome differentiation is Qi deficiency and blood stasis type

3. Male or female, 18≤age≤75 4.25mL/（min.1.73m2）≤ eGFR<90mL/（min.1.73m2） 5.24-hour urine protein ration ≤3.5g/24h

6.The participants must be capable of understanding and comply with the protocol and sign a written informed consent document

Exclusion Criteria:

1. Exposure to immunosuppressors, glucocorticoid，without a one weeks washout period

2. Urinary tract infection (leukocytes in urinary sediment > 5 / HP)

3. Serum potassium > 5.5 mmol/L

4. Serum albumin < 30g/L

5. Pregnant or lactating women, and participants (including males) who were unable or unwilling to take adequate contraception during the study period

6. Having comorbidities that affect the progression of diabetic nephropathy (including but not limited to Malignant tumors, Systemic autoimmune diseases, Liver cirrhosis)

7. Participating in another clinical trial

8. Investigators do not think it suitable for a participant to join this study