Effects of Chinese Herbal Medicine as an Adjunctive Therapy on Renal Function in Patients With Non-Diabetic Chronic Kidney Disease: A Pilot Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Enrollment
- 66
- Locations
- 1
Study Overview
Brief 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.
Detailed Description
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Masking Description
Although this study is open-label, the data analysts performing statistical analyses and interpreting the results will remain blinded to group allocation throughout the study to minimize analysis and interpretation bias.
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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.
- •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.