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

Condition(s) studied

Investigational drug(s) / intervention(s)

Chinese herbal formula DKD-1: DKD-1 is a traditional Chinese herbal formula administered orally at a total daily dose of 14.5 g for 12 weeks. The formula consists of Astragalus membranaceus (3.0 g), Salvia miltiorrhiza (2.5 g), Chinese yam (2.5 g), Poria cocos (2.0 g), Moutan cortex (1.5 g), Schisandra chinensis (1.0 g), and Smilax glabra (2.0 g). It is used as an adjunct to standard care in patients with diabetic kidney disease.

Study summary

This study is a randomized controlled pilot trial designed to evaluate the effects and safety of a traditional Chinese medicine formula (DKD-1) as an add-on therapy to standard treatment in patients with Diabetic Kidney Disease (DKD). Eligible participants will be randomly assigned to receive either standard care alone or standard care combined with DKD-1 for 12 weeks. Kidney function, glycemic control, proteinuria, quality of life, and traditional Chinese medicine tongue features will be assessed before and after the intervention. The study aims to provide preliminary evidence on whether DKD-1 can improve renal function, glycemic control, and quality of life in this patient population.

Eligibility

Primary outcome measure(s)

• Change in Estimated Glomerular Filtration Rate (eGFR) — From baseline to 12 weeks of treatment
  Change in estimated glomerular filtration rate (eGFR) from baseline to week 12. eGFR is calculated using standard clinical laboratory methods. The primary endpoint is defined as the difference between eGFR at week 12 and baseline (ΔeGFR = eGFR\_12weeks - eGFR\_baseline).

Trial sites (1)

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