Effect of Chinese Herbal Medicine on Renal Function in Diabetic Kidney Disease

This study is a prospective, single-blind (data analyst-blinded), randomized controlled pilot trial evaluating a traditional Chinese medicine formula (DKD-1) as adjunctive therapy in patients with Diabetic Kidney Disease. DKD is a progressive condition with limited treatment options to slow renal deterioration and manage glycemic control. Traditional Chinese medicine is widely used as a complementary approach, but clinical evidence remains limited. After providing informed consent, eligible participants will be screened according to inclusion and exclusion criteria and randomly assigned in a 1:1 ratio to receive either standard therapy alone or standard therapy plus daily oral DKD-1 (14.5 g) for 12 weeks. Baseline and post-intervention assessments include estimated glomerular filtration rate (eGFR), serum creatinine, urine albumin-to-creatinine ratio (UACR), glycated hemoglobin (HbA1c), quality of life (KDQOL-SF™ 1.3), and TCM tongue diagnosis. Adverse events will be monitored throughout the study. This trial is designed to provide preliminary clinical evidence on the potential role of DKD-1 in improving renal function, glycemic control, and quality of life, supporting future larger-scale randomized controlled trials.

Inclusion criteria

• Adults aged ≥18 years.
• Patients diagnosed with type 2 diabetes mellitus and stage 3-4 chronic kidney disease (CKD), confirmed by a nephrologist and classified as ICD-10-CM codes E11.21-E11.29 combined with N18.3-N18.4, consistent with diabetic kidney disease (DKD) definitions.
• Ability to understand the study procedures and provide written informed consent.
• Willingness to comply with study procedures and follow-up visits.

Exclusion criteria

• Acute kidney injury or major kidney-related surgery within 3 months prior to enrollment.
• Participation in another clinical trial within 3 months that may significantly affect renal function.
• Alanine aminotransferase (ALT) levels greater than 3 times the upper limit of normal.
• Pregnancy or breastfeeding.
• History of malignancy currently receiving chemotherapy, radiotherapy, or other systemic anticancer treatment.
• End-stage disease as defined under palliative care regulations.
• Known allergy to any components of the DKD-1 herbal formula, including Astragalus membranaceus, Salvia miltiorrhiza, Chinese yam, Poria cocos, Moutan cortex, Schisandra chinensis, or Smilax glabra.