A Study on the Safety and Clinical Efficacy of Guominkang in the Treatment of Diabetic Kidney Disease

Condition(s) studied

Investigational drug(s) / intervention(s)

Guominkang Granules: Guominkang Granules is a traditional Chinese herbal formula composed of multiple herbs, used to regulate immune inflammation and metabolic dysfunction in patients with diabetic kidney disease. In this study, it is administered orally once daily at a dose of either 1 bag or 2 bags for 12 weeks.

Standard Antihypertensive, Antidiabetic, and Lipid-Lowering Regimen: 1. Antihypertensive therapy: Angiotensin-converting enzyme inhibitors (ACEIs) or angiotensin II receptor blockers (ARBs), combined with calcium channel blockers (CCBs) and/or diuretics as clinically indicated. 2. Antidiabetic agents: Metformin; sulfonylureas (e.g., glimepiride, gliclazide, glipizide, gliquidone); alpha-glucosidase inhibitors (e.g., acarbose, voglibose); thiazolidinediones (e.g., rosiglitazone, pioglitazone); glucagon-like peptide-1 (GLP-1) receptor agonists (e.g., exenatide, liraglutide, lixisenatide); dipeptidyl peptidase-4 (DPP-4) inhibitors (e.g., sitagliptin, linagliptin, saxagliptin, alogliptin); and/or sodium-glucose cotransporter-2 (SGLT2) inhibitors (e.g., dapagliflozin, empagliflozin, canagliflozin). 3. Lipid-lowering therapy: Statins (e.g., pravastatin, fluvastatin, simvastatin, atorvastatin); fibrates (e.g., fenofibrate, bezafibrate); and other lipid-modifying agents (e.g., acipimox, gemfibrozil, ezetimibe).

Study summary

We are conducting this clinical trial to find out whether Guominkang-a traditional Chinese herbal formula-is safe and effective for people with diabetic kidney disease (DKD).

DKD is a common complication of diabetes, affecting 20% to 40% of patients. If not well controlled, it can lead to chronic kidney disease or even kidney failure. Current treatments mainly focus on controlling blood sugar and blood pressure, but few therapies directly target immune inflammation, which plays a key role in DKD progression.

In earlier animal studies, Guominkang reduced urine protein and blood sugar in mice with DKD and appeared to work by balancing both metabolism and immune-inflammatory responses.

This pilot study will enroll 18 adults aged 18-70 years with mild-to-moderate kidney damage (CKD stages G1-G3) due to DKD. Participants will be divided into three groups (6 per group):

Observation group: receives standard care only (medications to control blood sugar, blood pressure, and lipids); Standard-dose group: standard care + 1 dose of Guominkang per day; Double-dose group: standard care + 2 doses of Guominkang per day. The treatment lasts 12 weeks, followed by a 4-week follow-up after stopping the study drug.

During the study, you will need to:

Take your assigned medication (or continue standard treatment) as directed; Visit the clinic at weeks 2, 4, 8, 12, and 4 weeks after stopping treatment; Provide blood and urine samples for testing (e.g., urine protein, blood sugar, cholesterol, kidney function).

We hope to answer two main questions:

Can Guominkang reduce urine protein in patients with DKD? Is Guominkang safe-what side effects might occur?

Eligibility

Primary outcome measure(s)

• Change in Urine Albumin-to-Creatinine Ratio (UACR) — Baseline, Week 2, Week 4, Week 8, Week 12, and Week 16
  Urine albumin-to-creatinine ratio (UACR, in mg/g) is measured from spot urine samples collected at six time points: baseline (pre-treatment), and at weeks 2, 4, 8, 12 (end of treatment), and 16 (4 weeks after treatment discontinuation). All samples are analyzed in a central laboratory using standardized assays. The primary analysis focuses on the change in UACR from baseline to week 16. UACR values are compared between groups and within subjects (pre- vs. post-intervention) using appropriate statistical tests.

Trial sites (1)

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