Chinese herbal formula CKD-1: CKD-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.
Study summary
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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.
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\_week12 - eGFR\_baseline).
Trial sites (1)
Facility
City
Region
Status
China Medical University Beigang Hospital
Yunlin
Taiwan
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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