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.
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TaiwanChina Medical University Hospital
Lead sponsor
China Medical University Beigang Hospital
Collaborator