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

June 15, 2026 updated by: China Medical University Hospital

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

66

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Taiwan
    • Taiwan
      • Yunlin, Taiwan, Taiwan
        • China Medical University Beigang Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CKD-1 plus standard therapy
Participants receive CKD-1 (13.5 g/day) orally in addition to standard care for 12 weeks. Standard care includes guideline-based management of blood pressure and kidney protection therapy, which remains stable during the study period.
Other: 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.
No Intervention: Standard therapy alone
Participants receive standard care alone for 12 weeks. Standard care includes guideline-based management of blood pressure and kidney protection therapy, maintained without addition of Chinese herbal medicine during the study period.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Estimated Glomerular Filtration Rate (eGFR)
Time Frame: 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).
From baseline to 12 weeks of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

China Medical University Hospital

Collaborators

China Medical University Beigang Hospital

Investigators

  • Study Director: Ing-Shiow Lai, MD, PhD, China Medical University Beigang Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 11, 2026

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

June 15, 2026

First Submitted That Met QC Criteria

June 15, 2026

First Posted (Actual)

June 18, 2026

Study Record Updates

Last Update Posted (Actual)

June 18, 2026

Last Update Submitted That Met QC Criteria

June 15, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • CMUH115-REC3-058
  • CMUBH-TCM-CKD-1 (Other Identifier: China Medical University Beigang Hospital)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

The data sharing plan is currently undecided. A final decision regarding the sharing of individual participant data will be made upon the completion of the study and prior to the publication of the primary results.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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