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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Prospective, Open, Multicenter, Clinical Study of Huangqi Guizhi Wuwu Decoction in Treating Diabetic Nephropathy (Stage CKD2-4)

Conditions
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Diabetic Nephropathies

Intervention / Treatment
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* Drug: Huangqi Guizhi Wuwu decoction
* Drug: Dapagliflozin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients diagnosed as diabetic nephropathy TCM syndrome differentiation is Qi deficiency and blood stasis type 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: Exposure to immunosuppressors, glucocorticoid，without a one weeks washout period Urinary tract infection (leukocytes in urinary sediment > 5 / HP) Serum potassium > 5.5 mmol/L Serum albumin < 30g/L Pregnant or lactating women, and participants (including males) who were unable or unwilling to take adequate contraception during the study period Having comorbidities that affect the progression of diabetic nephropathy (including but not limited to Malignant tumors, Systemic autoimmune diseases, Liver cirrhosis) Participating in another clinical trial Investigators do not think it suitable for a participant to join this study

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Huangqi Guizhi Wuwu decoction group<br>Huangqi Guizhi Wuwu decoction | Drug: Huangqi Guizhi Wuwu decoction<br>* Huangqi Guizhi Wuwu decoction, 100ml at a time, 2 times a day. Oral administration.<br>|
| Active Comparator: Dapagliflozin group<br>Dapagliflozin | Drug: Dapagliflozin<br>* Dapagliflozin, 10mg at a time, once a day. Oral administration.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetic nephropathy,Huangqi Guizhi Wuwu Decoction (CKD2-4)