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

N/ANot Yet RecruitingNCT07657338

China Medical University Hospital66 enrolled

Overview

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.

This study is a prospective, single-blind (data analyst-blinded), randomized controlled pilot trial evaluating a traditional Chinese medicine formula (CKD-1) as adjunctive therapy in patients with stage 3-4 non-diabetic chronic kidney disease. Chronic kidney disease is a progressive condition with limited treatment options to slow renal deterioration. Traditional Chinese medicine is widely used as a complementary approach, but clinical evidence remains limited. This trial is designed to provide preliminary clinical evidence on the potential role of CKD-1 in improving renal outcomes and supporting future large-scale randomized controlled trials.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Non-diabetic Chronic Kidney Disease

Interventions

Chinese herbal formula CKD-1OTHER

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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).

Time frame: From baseline to 12 weeks of treatment