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Prospective cohort study of Huangkui capsules in the treatment of diabetic kidney disease

Prospective cohort study of Huangkui capsules in the treatment of diabetic kidney disease

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
ITMCTR
Registry ID
ITMCTR2025002127
Enrollment
Unknown
Registered
2025-11-08
Start date
2025-11-30
Completion date
Unknown
Last updated
2025-11-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

diabetic nephropathy

Interventions

exposure group:Huangkui capsules + basic treatment of Western medicine
Non-exposure group:basic treatment of Western medicine

Sponsors

Dongzhimen Hospital of Beijing University of Chinese
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 100 Years

Inclusion criteria

Inclusion criteria: (1) Meet the DKD diagnostic criteria in the 2021 Chinese Guidelines for Clinical Diagnosis and Treatment of Diabetic Kidney Disease; (2) e-GFR=45mL/min (CKD-EPI formula) and no blood purification treatment; (3) Meet any of the following: A. 24-hour urine protein quantification greater than or equal to 0.5g; b. Meet the diagnostic criteria of damp-heat syndrome in the Guiding Principles for Clinical Research of New Traditional Chinese Medicine for the Treatment of Chronic Kidney Disease; (4) Meet the diagnostic criteria of type 2 diabetes in the Chinese Guidelines for the Prevention and Treatment of Type 2 Diabetes (2020 edition); (5) Age over 18 gender not limited; (6) The subject has informed consent and voluntarily signed the informed consent form.

Exclusion criteria

Exclusion criteria: (1) Other secondary nephritis not caused by diabetes such as lupus nephritis allergic purpura nephritis systemic small vessel inflammatory renal damage hypertensive nephropathy gouty nephropathy myeloma nephropathy etc.; (2) Using Huangkui capsules within 1 month before enrollment; (3) Those with allergic constitution or known allergy to the components of this drug; (4) The patient has severe diseases and functional disorders of other organs and life-threatening complications such as severe infection; (5) Patients with acute central nervous system disease severe gastrointestinal disease history of HIV infection history of mental illness history of malignant tumor and other advanced diseases; (6) Pregnant or lactating women; (7) Participating in another clinical study of a drug or device that has not yet reached the primary endpoint; (8) Using glucocorticoids immunosuppressive drugs or leech preparations within 1 month or undergoing the above treatment; (9) Taking other traditional Chinese medicines and decoctions related to kidney disease.

Design outcomes

Primary

MeasureTime frame
Quantitative 24-hour urine protein;

Secondary

MeasureTime frame
The incidence of end event or cardiorenal complications;Blood urea nitrogen;G. F. R;Hyper-sensitive C-reactive protein;Serum cystatin (Cys)-C;Uric acid/creatinine ratio;blood fat;glycosylated hemoglobin;

Countries

china

Contacts

Public Contactyaoxian Liu

Henan University of Traditional Chinese Medicine

lyx123@163.com010-53912475

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Feb 4, 2026