Effect of Chinese Herbal Medicine on Kidney Function in Non-Diabetic CKD

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.

Inclusion Criteria: * 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. 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 affect renal function. * Alanine aminotransferase (ALT) levels greater than 3 times the upper limit of normal. * Pregnancy or breastfeeding. * History of diabetes mellitus. * Malignancy currently receiving chemotherapy, radiotherapy, or other systemic anticancer treatment. * End-stage disease defined under palliative care regulations. * Known allergy to any components of the CKD-1 herbal formula, including Astragalus membranaceus, Salvia miltiorrhiza, Poria cocos, Moutan cortex, Scutellaria baicalensis, Lonicera japonica, or Alisma orientale.