This study is a randomized controlled pilot trial designed to evaluate the effects and safety of a traditional Chinese medicine formula (CKD-1) as an add-on therapy to standard treatment in patients with stage 3-4 non-diabetic chronic kidney disease. Eligible participants will be randomly assigned to receive either standard care alone or standard care combined with CKD-1 for 12 weeks. Kidney function, urine protein levels, and quality of life will be assessed before and after the intervention. The study aims to provide preliminary evidence on whether CKD-1 can improve renal function and quality of life in this patient population.
Adults aged ≥18 years.
Patients diagnosed with stage 3-4 chronic kidney disease (CKD), confirmed by a nephrologist and classified as ICD-10-CM codes N18.3-N18.4.
Ability to understand the study procedures and provide written informed consent.
Willingness to comply with study procedures and follow-up visits.
Acute kidney injury or major kidney-related surgery within 3 months prior to enrollment.
Participation in another clinical trial within 3 months that may affect renal function.
Alanine aminotransferase (ALT) levels greater than 3 times the upper limit of normal.
Pregnancy or breastfeeding.
Parallel
Chinese herbal formula CKD-1
Other interventionCKD-1 is a traditional Chinese herbal formula administered orally at a total daily dose of 13.5 g for 12 weeks. The formula consists of Astragalus membranaceus (3.0 g), Salvia miltiorrhiza (2.5 g), Poria cocos (2.0 g), Moutan cortex (1.5 g), Scutellaria baicalensis (1.5 g), Lonicera japonica (1.5 g), and Alisma orientale (1.5 g). It is used as an adjunct to standard care in patients with stage 3-4 non-diabetic chronic kidney disease.
Change in Estimated Glomerular Filtration Rate (eGFR)
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\_week12 - eGFR\_baseline).
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China Medical University Hospital
Lead sponsor
China Medical University Beigang Hospital
Collaborator
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