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Based on the "Yi Zé Ba Fa" thought to guide the optimization of Traditional Chinese Medicine treatment for diabetic kidney disease: A clinical study

Based on the "Yi Zé Ba Fa" thought to guide the optimization of Traditional Chinese Medicine treatment for diabetic kidney disease: A clinical study

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2026000715
Enrollment
Unknown
Registered
2026-03-24
Start date
2025-10-23
Completion date
Unknown
Last updated
2026-03-30

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

Conditions

Diabetic kidney disease

Interventions

Treatment group:Yangtonifying Nephrotonifying Granules
Treatment group:Yin Nourishing Kidney Soothing Granules
Traditional Chinese Medicine control group:Jinshuibao Granules
Western medicine control group:Valsartan Capsules

Sponsors

Affiliated Hospital of Changchun University of Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: (1) Patients with both Qi and Yin deficiency, toxin damaging the kidney network, and Liver-Kidney Yin deficiency, toxin damaging the kidney network should be in the microalbuminuria stage; patients with Spleen-Kidney Yang deficiency, toxin damaging the kidney network should be in the clinical proteinuria stage; (2) Adult patients aged =18 years and =70 years; (3) Patients whose blood sugar metabolism is stable after basic treatment for diabetic kidney disease: fasting blood glucose between 4-7 mmol/L (including both endpoints), postprandial 2-hour blood glucose not exceeding 10 mmol/L (including 10 mmol/L); glycated hemoglobin not exceeding 7% (including 7%); (4) Patients who can accept dietary and exercise therapy for diabetic kidney disease; (5) Patients who can voluntarily sign the informed consent form and comply with medical advice.

Exclusion criteria

Exclusion criteria: (1) Those who have experienced acute complications of diabetes such as lactic acidosis, ketosis acidosis, hyperosmolar coma, or infections within the past 6 months; (2) Those with elevated UAER due to intense physical activity, other primary diseases (chronic inflammation, gout, lupus erythematosus, kidney disease, etc.), or bacterial infections; (3) Those who are taking other medications (excluding traditional Chinese medicine) to reduce urinary protein; (4) Those whose syndrome does not match the criteria required for this study; (5) Those whose age is not within the range of 18 to 70 years, or who have mental impairments, psychiatric disorders, or are pregnant or breastfeeding women; (6) Those with severe diseases in the cardiovascular, cerebrovascular, kidney, or liver systems; (7) Those who have participated in other clinical drug trials within the past 3 months; (8) Those deemed to have poor compliance, making them prone to dropping out of the study.

Design outcomes

Primary

MeasureTime frame
Urinary creatinine/urinary protein;TCM Syndrome Score;

Secondary

MeasureTime frame
Fasting Blood Glucose;glycated hemoglobin;Postprandial 2-hour blood glucose;Renal Hemodynamic Alterations;The serum inflammatory factor (NF-?B);Total Cholesterol;Low-Density Lipoprotein;

Countries

China

Contacts

Public ContactHe Ze

Affiliated Hospital of Changchun University of Chinese Medicine

zjchz201371@aliyun.com15948000533

Outcome results

None listed

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