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NCT07907965Active, not recruitingPhase 2

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

Source: ClinicalTrials.gov · Last updated 2 Nov 2026

Brief summary (registry, in English)

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?

Status (registry)
Active, not recruiting
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
15 (actual)
First submitted
26 Oct 2026
Start date
20 Oct 2025
Primary completion date
27 Feb 2026
Lead sponsor
Beijing University of Chinese Medicine
NCT number
NCT07907965

What you commit to

  • Study type: Interventional · Phase 2
  • Participants enrolled: 15
  • From 20 Oct 2025 to the primary completion date, 27 Feb 2026
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • Severe liver dysfunction, active systemic autoimmune diseases (e.g., lupus, Sjögren's), recent chemotherapy/radiotherapy;
  • Cognitive impairment;
  • Any condition deemed unsuitable by the investigator.

Lab values

  • eGFR \<30 mL/min/1.73 m² or dialysis/transplant;

Other

  • Pregnancy or breastfeeding;
  • Participation in another clinical trial;

Who the study is looking for

  • 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.

Age in the registry: 18 years to 70 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Changzhi Hospital of Traditional Chinese Medicine
Coordinator of this site? Confirm its status
ChangzhiChinaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.