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

The First Affiliated Hospital of Dalian Medical University

Status: Enrolling

Conditions: Diabetic Nephropathies

Treatments: Drug: Huangqi Guizhi Wuwu decoction; Drug: Dapagliflozin

Study type: Interventional

Funder types: Other

Identifiers

NCT05418465

PJ-KS-KY-2021-228(X2)

Details and patient eligibility

About

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.

Full description

The incidence rate of chronic kidney disease is 10.8% in China. The incidence rate of diabetic nephropathy has increased year by year, and now it has become the first cause of uremia. Therefore, the treatment of diabetic nephropathy can delay the progression of renal function and is of great value and significance in reducing uremia. Huangqi Guizhi Wuwu decoction is a traditional Chinese medicine decoction. Previous studies have shown that it is effective in the treatment of diabetic nephropathy. In this study, there were 2 hospitals participating in. We planned to enroll 100 participants, who will be divided into the Huangqi Guizhi Wuwu decoction group (experimental group) and the Dapagliflozin group (control group). All participants will take medication for 12 weeks, and investigators will follow up participates at weeks 0, 2,4, 6, 8,12.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Huangqi Guizhi Wuwu decoction group

Experimental group

Description:

Huangqi Guizhi Wuwu decoction

Treatment:

Drug: Huangqi Guizhi Wuwu decoction

Dapagliflozin group

Active Comparator group

Description:

Dapagliflozin

Treatment:

Drug: Dapagliflozin