A Phase 2 interventional study of Guominkang Granules and Standard Antihypertensive, Antidiabetic, and Lipid-Lowering Regimen in Diabetic Kidney Disease (DKD), Type 2 Diabetes and Albuminuria, sponsored by Beijing University of Chinese Medicine. Active, not recruiting at 1 site in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-11-02.
Sponsored by Beijing University of Chinese Medicine · Phase 2, Interventional, and Treatment
Among 75 studies in Diabetic Nephropathies with a site in China — 22 open to participants now, 30 under way, none of them phase 3. Diabetic Nephropathies · China.
Among the 75 studies in Diabetic Nephropathies with a site in China, this one is the 49th largest by enrollment of the 52 interventional ones, is one of 7 that started in 2025, is one of 7 in phase 2, reaches primary completion later than 11 of the 29 other live ones, and was the 75th registered.
543 studies on the registry are indexed under Diabetic Nephropathies; 110 are open to participants now.
This study's enrollment of 15 is below the median of 78 across 388 interventional studies indexed under Diabetic Nephropathies.
Browse Diabetic Nephropathies studies →22 of the 75 studies in Diabetic Nephropathies with a site in China are open now, in 1 country. Each count lists the studies.
Of the 50 Diabetic Nephropathies studies recruiting now, 23 (46%) set no upper age limit and 16 (32%) stop at 75 or younger; 5 take children under 18; 8 take healthy volunteers.
This study: 18 Years to 70 Years · all sexes · no healthy volunteers.
The full table on the hub →75 studies; the count open now beside each. This study's row is marked.
First in 2003; this study’s year is marked. 7 started in 2025.
Median enrollment 122 across the 52 interventional studies, 620 across the 22 observational. Of the 29 that completed or were terminated, 6 (21%) have results posted.
15 of 75 have an industry lead sponsor. The 10 most frequent:
Beijing University of Chinese Medicine is the lead sponsor of 32 studies on the registry; 8 are open to participants now.
Beijing University of Chinese Medicine has 1 study filed under Diabetic Nephropathies — fewer than ten, so there is no comparison to draw.
5 of the studies in Diabetic Nephropathies with a site in China that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05888909Chinese PLA General HospitalMultidimensional Accurate Diagnosis and Treatment Technology and Clinical Transformation of Type 2 Diabetes Nephropathy | 2026-11-01 |
| NCT05349955Shanghai Zhongshan HospitalEffects and Safety of Diabetic GUideline Algorithm Implementation Performed by Primary Care Physicians in the Community | 2026-11-30 |
| NCT06843304Chinese PLA General HospitalThe Intelligent Prevention And Control System And Strategy For The Whole Disease Cycle Of Diabetic Nephropathy | 2026-12 |
| NCT06452862Shengjing HospitalMultimodal Magnetic Resonance Imaging in Evaluation of Diabetic Kidney Disease | 2027-06-06 |
| NCT03865914Chinese PLA General HospitalCorrelation Study Between Clinical Phenotype and Pathology of Type 2 Diabetic Nephropathy | 2027-11-30 |
Among the 75 studies in Diabetic Nephropathies with a site in China, from their registry updates:
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?
This is an open-label, prospective pilot clinical trial conducted at Changzhi Hospital of Traditional Chinese Medicine to evaluate the safety and preliminary efficacy of Guominkang Granules, a traditional Chinese herbal formula, in patients with diabetic kidney disease (DKD). Guominkang Granules are an empirical formula developed by Academician Wang Qi, a national TCM master. The formula was originally used for allergic and autoimmune conditions, including IgA nephropathy and antispermatogenic antibody-related infertility. It consists of four herbs: Periostracum Cicadae (Chantui), Ganoderma lucidum (Lingzhi), Fructus Mume (Wumei), and Radix Saposhnikoviae (Fangfeng). Preclinical studies in a DKD mouse model showed that Guominkang significantly reduced urinary albumin excretion from week 2, lowered blood glucose and triglycerides by week 6, and modulated both metabolic and immune-inflammatory pathways based on transcriptomic and pharmacokinetic analyses. These findings support the rationale for exploring its potential role in DKD, where immune-inflammatory mechanisms may contribute substantially to disease progression.
This three-arm pilot trial adopts an open-label design. Allocation will be performed using random trial identification numbers generated in Microsoft Excel. Given the open-label nature, both participants and treating clinicians will be unblinded to group assignment; de-identified data using trial IDs will be used to protect participant privacy.
The intervention phase lasts 12 weeks, followed by a 4-week post-intervention observational period for sustained-effect and safety monitoring. Biospecimens including blood and urine will be collected during scheduled visits for biomarker testing and biobanking.
The sample size was selected to obtain preliminary effect estimates to inform future definitive randomized controlled trials, with reference to previously reported albuminuria-lowering effects of non-steroidal mineralocorticoid receptor antagonists in DKD. As a hypothesis-generating pilot study, this trial is not powered to draw confirmatory efficacy conclusions. Its primary objectives are to assess study feasibility, characterize the safety profile of Guominkang Granules, and identify preliminary efficacy signals to guide the design of larger confirmatory trials. The study will be implemented following institutional review board approval, with pre-specified rules for participant withdrawal and discontinuation to safeguard participant safety and preserve data quality.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Standard Antihypertensive, Antidiabetic, and Lipid-Lowering Regimen： 1. Antihypertensive therapy: ACE inhibitors (ACEI) or angiotensin II receptor blockers (ARB), combined with calcium channel blockers (CCB) and/or diuretics as clinically indicated; 2. Antidiabetic agents: Metformin, sulfonylureas (e.g., glimepiride, gliclazide), alpha-glucosidase inhibitors (e.g., acarbose), thiazolidinediones (e.g., pioglitazone), GLP-1 receptor agonists (e.g., liraglutide), DPP-4 inhibitors (e.g., sitagliptin), and/or SGLT2 inhibitors (e.g., dapagliflozin); 3. Lipid-lowering therapy: Statins (e.g., atorvastatin), fibrates (e.g., fenofibrate), or other agents (e.g., ezetimibe).
Drug: Standard Antihypertensive, Antidiabetic, and Lipid-Lowering Regimen
Participants receive standard care plus 1 bag of Guominkang Granules orally once daily for 12 weeks. The drug is administered in addition to existing medications.
Drug: Guominkang Granules · Drug: Standard Antihypertensive, Antidiabetic, and Lipid-Lowering Regimen
Participants receive standard care plus 2 bags of Guominkang Granules orally once daily for 12 weeks. The drug is administered in addition to existing medications.
Drug: Guominkang Granules · Drug: Standard Antihypertensive, Antidiabetic, and Lipid-Lowering Regimen
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.
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).
Change in Urine Albumin-to-Creatinine Ratio (UACR)
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.
Time frame: Baseline, Week 2, Week 4, Week 8, Week 12, and Week 16
Change in Hemoglobin A1c (HbA1c)
Hemoglobin A1c (HbA1c, %) is measured at baseline and week 12 using standardized assays in a central laboratory. The change from baseline to week 12 is analyzed between groups and within subjects (pre- vs. post-intervention).
Time frame: baseline and week 12
Estimated Glomerular Filtration Rate (eGFR)
Estimated glomerular filtration rate (eGFR, mL/min/1.73m²) is calculated from serum creatinine levels at baseline (pre-treatment), and at weeks 4, 8, 12 (end of treatment), and 16 (4 weeks after treatment discontinuation) using the CKD-EPI equation. Changes in eGFR are assessed between groups and within subjects.
Time frame: Baseline, Week 4, Week 8, Week 12, and Week 16
Change in Fasting Plasma Glucose (FPG)
Fasting plasma glucose (FPG, mmol/L) is measured at baseline to week 16. The change from baseline to week 16 is compared between groups and within individuals using appropriate statistical tests.
Time frame: Baseline, Week 4, Week 8, Week 12, and Week 16
Change in Lipid Profile (Triglycerides, Total Cholesterol, LDL-C, HDL-C)
Serum lipid profile including triglycerides (TG), total cholesterol (TC), low-density lipoprotein cholesterol (LDL-C), and high-density lipoprotein cholesterol (HDL-C) are measured in a central laboratory. Changes from baseline to week 16 are analyzed between groups and within subjects.
Time frame: Baseline, Week 4, Week 8, Week 12, and Week 16
Change in Serum Albumin
Serum albumin (g/L) is measured at baseline, weeks 4, 8, 12, and 16. The primary analysis focuses on the change from baseline to week 16. Between-group and within-subject comparisons are performed.
Time frame: Baseline, Week 4, Week 8, Week 12, and Week 16
Change in Traditional Chinese Medicine Syndrome Score
Assessment will be performed using the Traditional Chinese Medicine Syndrome Scale. The total score ranges from 22 to 88. Higher scores represent more severe TCM syndrome symptoms (worse condition). The total score is obtained by summing individual symptom-item scores. At each scheduled follow-up visit, the therapeutic efficacy index is computed as (Baseline TCM syndrome score - TCM syndrome score at the corresponding visit) / Baseline TCM syndrome score × 100%. Within-subject changes and between-group comparisons of the TCM syndrome score will be assessed from baseline to week 16.
Time frame: Baseline, Week 4, Week 8, Week 12, and Week 16
Plan to share: No
Ran from Oct 2025 to primary completion in Feb 2026, 4 months.
Of 52 phase 2 interventional studies under Diabetic Nephropathies, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 31. This study's 4 months is below that.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is active, not recruiting, as verified in Oct 2025. You cannot join it, but the record below documents what was studied.
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Beijing University of Chinese Medicine