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Diabetic Kidney Disease (DKD)Phase 2NCT07907965

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

A Phase 2 study testing Guominkang Granules and Standard Antihypertensive, Antidiabetic, and Lipid-Lowering Regimen in people with Diabetic Kidney Disease (DKD) and Type 2 Diabetes, run by Beijing University of Chinese Medicine at 1 site in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 70 years
What is being tested?
Guominkang Granules and Standard Antihypertensive, Antidiabetic, and Lipid-Lowering Regimen
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
15 participants
Where
1 siteChina
Study dates
20 Oct 2025to 27 Oct 2026
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Clinically diagnosed DKD;
  • Age 18-70 years;
  • eGFR ≥30 mL/min/1.73 m² (CKD-EPI equation);
  • UACR ≥200 mg/g on two or more occasions within 3 months;
  • Stable treatment with ACEI/ARB for ≥3 months;
  • If taking SGLT2 inhibitors or non-steroidal MRAs, stable use for ≥4 weeks and continued throughout the study;
  • If taking other herbal medicines for kidney disease (e.g., Huangkui Capsule), must continue stable use;
  • Willingness to participate and signed informed consent.

Who cannot join

  • eGFR <30 mL/min/1.73 m² or dialysis/transplant;
  • Severe liver dysfunction, active systemic autoimmune diseases (e.g., lupus, Sjögren's), recent chemotherapy/radiotherapy;
  • Cognitive impairment;
  • Pregnancy or breastfeeding;
  • Participation in another clinical trial;
  • Any condition deemed unsuitable by the investigator.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Changzhi Hospital of Traditional Chinese Medicine

    Changzhi, Shanxi

Other trials in China

About this study

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.

Read more

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?

Read the detailed description

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.

Being tested
Guominkang Granules, Standard Antihypertensive, Antidiabetic, and Lipid-Lowering Regimen
Keywords
Traditional Chinese Medicine, Guominkang, Open-label Study, Immune Inflammation
Medical subject headings
Diabetic Nephropathies, Diabetes Mellitus, Type 2, Albuminuria

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Guominkang GranulesDrug

    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 RegimenDrug

    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 groups in NCT07907965
Study groupRoleWhat they receive
Observation GroupOtherStandard 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).
Receives: Drug: Standard Antihypertensive, Antidiabetic, and Lipid-Lowering Regimen
Standard-Dose Guominkang GroupExperimentalParticipants receive standard care plus 1 bag of Guominkang Granules orally once daily for 12 weeks. The drug is administered in addition to existing medications.
Receives: Drug: Guominkang Granules; Drug: Standard Antihypertensive, Antidiabetic, and Lipid-Lowering Regimen
Double-Dose Guominkang GroupExperimentalParticipants receive standard care plus 2 bags of Guominkang Granules orally once daily for 12 weeks. The drug is administered in addition to existing medications.
Receives: Drug: Guominkang Granules; Drug: Standard Antihypertensive, Antidiabetic, and Lipid-Lowering Regimen

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline, Week 2, Week 4, Week 8, Week 12, and Week 16

Secondary outcomes (6)

  1. 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).

    Measured: baseline and week 12

  2. 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.

    Measured: Baseline, Week 4, Week 8, Week 12, and Week 16

  3. 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.

    Measured: Baseline, Week 4, Week 8, Week 12, and Week 16

  4. 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.

    Measured: Baseline, Week 4, Week 8, Week 12, and Week 16

  5. 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.

    Measured: Baseline, Week 4, Week 8, Week 12, and Week 16

  6. 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.

    Measured: Baseline, Week 4, Week 8, Week 12, and Week 16

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Oct 2026
  2. Study start20 Oct 2025
  3. Primary completion27 Feb 2026
  4. Study completion27 Oct 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
15 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07907965
Sponsor's protocol ID
BUCMEC-JG(KY)-2024-42
Status last verified
Oct 2025
First submitted
26 Oct 2026
Last updated
2 Nov 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Hu Q, Chen Y, Deng X, Li Y, Ma X, Zeng J, Zhao Y. Diabetic nephropathy: Focusing on pathological signals, clinical treatment, and dietary regulation. Biomed Pharmacother. 2023 Mar;159:114252. doi: 10.1016/j.biopha.2023.114252. Epub 2023 Jan 13.

    PubMed 36641921

  • American Diabetes Association Professional Practice Committee. 11. Chronic Kidney Disease and Risk Management: Standards of Care in Diabetes-2025. Diabetes Care. 2025 Jan 1;48(1 Suppl 1):S239-S251. doi: 10.2337/dc25-S011.

    PubMed 39651975

  • Bakris GL, Agarwal R, Anker SD, Pitt B, Ruilope LM, Rossing P, Kolkhof P, Nowack C, Schloemer P, Joseph A, Filippatos G; FIDELIO-DKD Investigators. Effect of Finerenone on Chronic Kidney Disease Outcomes in Type 2 Diabetes. N Engl J Med. 2020 Dec 3;383(23):2219-2229. doi: 10.1056/NEJMoa2025845. Epub 2020 Oct 23.

    PubMed 33264825

  • Tang D, Wang C, Gu Z, Li J, Jin L, Li J, Wang Z, Jiang RW. Discovery of anti-allergic components in Guomingkang Formula using sensitive HEMT biochips coupled with in vitro and in vivo validation. Phytomedicine. 2023 Jul;115:154837. doi: 10.1016/j.phymed.2023.154837. Epub 2023 Apr 18.

    PubMed 37126969

  • Tang D, Wang C, Gan Q, Wang Z, Jiang R. Chemical composition-based characterization of the anti-allergic effect of Guominkang Formula on IgE-mediated mast cells activation and passive cutaneous anaphylaxis. Chin J Nat Med. 2022 Dec;20(12):925-936. doi: 10.1016/S1875-5364(22)60225-5.

    PubMed 36549806

  • Ma L, Zheng Y, Wang J, Li Q, Zeng J, Wang Z, Hou T, Zhang Y, Li M, Shen R, Chen X, Qin J, Lei L, Xia Q, Wang Q, Qiao Y, Wu Z. Development of MIF/IL-1beta biosensors for discovery of critical quality attributes and potential allergic rhinitis targets from clinical real-world data by intelligent algorithm coupled with in vitro and vivo mechanism validation. Biosens Bioelectron. 2021 Dec 15;194:113608. doi: 10.1016/j.bios.2021.113608. Epub 2021 Sep 3.

    PubMed 34500224

  • Doumani G, Theofilis P, Vordoni A, Thymis V, Liapis G, Smirloglou D, Kalaitzidis RG. Diabetic Kidney Disease: From Pathophysiology to Regression of Albuminuria and Kidney Damage: Is It Possible? Int J Mol Sci. 2025 Aug 24;26(17):8224. doi: 10.3390/ijms26178224.

    PubMed 40943149

  • Lin YC, Chang YH, Yang SY, Wu KD, Chu TS. Update of pathophysiology and management of diabetic kidney disease. J Formos Med Assoc. 2018 Aug;117(8):662-675. doi: 10.1016/j.jfma.2018.02.007. Epub 2018 Mar 2.

    PubMed 29486908

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Guominkang Granules and Standard Antihypertensive, Antidiabetic, and Lipid-Lowering Regimen in people with Diabetic Kidney Disease (DKD) and Type 2 Diabetes, run by Beijing University of Chinese Medicine at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Urine Albumin-to-Creatinine Ratio (UACR) (time frame: Baseline, Week 2, Week 4, Week 8, Week 12, and Week 16). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07907965, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2026.

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