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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Huangqi Guizhi Wuwu decoction group | Experimental | Huangqi Guizhi Wuwu decoction |
|
| Dapagliflozin group | Active Comparator | Dapagliflozin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Huangqi Guizhi Wuwu decoction | Drug | Huangqi Guizhi Wuwu decoction, 100ml at a time, 2 times a day. Oral administration. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Rate of change in Estimated Glomerular Filtration Rate (eGFR) compared to baseline | Events based on eGFR measure compared to baseline calculated using the CKD-EPI formula. | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in 24-hour urine protein ration from baseline. | 24-hour urinary protein quantification is being assessed once every 4 weeks for a total of 4 times during the whole study. | Start of treatment until the end of the treatment for 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Composite endpoint incidence | The incidence of endpoint events：①eGFR decreased by 15% from baseline；② The incidence of doubling the quantitative change of 24-hour urinary protein (measured twice continuously). | Start of treatment until the end of the treatment for 12 weeks |
| Incidence of adverse reactions |
Inclusion Criteria:
6.The participants must be capable of understanding and comply with the protocol and sign a written informed consent document
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Dalian medical university | Recruiting | Dalian | Liaoning | 116011 | China |
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| ID | Term |
|---|---|
| D003928 | Diabetic Nephropathies |
| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| ID | Term |
|---|---|
| C529054 | dapagliflozin |
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| Dapagliflozin | Drug | Dapagliflozin, 10mg at a time, once a day. Oral administration. |
|
The proportion of patients with adverse reactions to the total population |
| Start of treatment until the end of the treatment for 12 weeks |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D048909 | Diabetes Complications |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |