Effect of Chinese Herbal Medicine on Renal Function in Diabetic Kidney Disease

June 15, 2026 updated by: China Medical University Hospital

Effects of Chinese Herbal Medicine as an Adjunctive Therapy on Renal Function in Patients With Diabetic 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 (DKD-1) as an add-on therapy to standard treatment in patients with Diabetic Kidney Disease (DKD). Eligible participants will be randomly assigned to receive either standard care alone or standard care combined with DKD-1 for 12 weeks. Kidney function, glycemic control, proteinuria, quality of life, and traditional Chinese medicine tongue features will be assessed before and after the intervention. The study aims to provide preliminary evidence on whether DKD-1 can improve renal function, glycemic control, 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 (DKD-1) as adjunctive therapy in patients with Diabetic Kidney Disease. DKD is a progressive condition with limited treatment options to slow renal deterioration and manage glycemic control. Traditional Chinese medicine is widely used as a complementary approach, but clinical evidence remains limited. After providing informed consent, eligible participants will be screened according to inclusion and exclusion criteria and randomly assigned in a 1:1 ratio to receive either standard therapy alone or standard therapy plus daily oral DKD-1 (14.5 g) for 12 weeks. Baseline and post-intervention assessments include estimated glomerular filtration rate (eGFR), serum creatinine, urine albumin-to-creatinine ratio (UACR), glycated hemoglobin (HbA1c), quality of life (KDQOL-SF™ 1.3), and TCM tongue diagnosis. Adverse events will be monitored throughout the study. This trial is designed to provide preliminary clinical evidence on the potential role of DKD-1 in improving renal function, glycemic control, and quality of life, supporting future larger-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 type 2 diabetes mellitus and stage 3-4 chronic kidney disease (CKD), confirmed by a nephrologist and classified as ICD-10-CM codes E11.21-E11.29 combined with N18.3-N18.4, consistent with diabetic kidney disease (DKD) definitions.
  • 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 significantly affect renal function.
  • Alanine aminotransferase (ALT) levels greater than 3 times the upper limit of normal.
  • Pregnancy or breastfeeding.
  • History of malignancy currently receiving chemotherapy, radiotherapy, or other systemic anticancer treatment.
  • End-stage disease as defined under palliative care regulations.
  • Known allergy to any components of the DKD-1 herbal formula, including Astragalus membranaceus, Salvia miltiorrhiza, Chinese yam, Poria cocos, Moutan cortex, Schisandra chinensis, or Smilax glabra.

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: DKD-1 plus standard therapy
Participants receive DKD-1 (14.5 g/day) orally in addition to standard care for 12 weeks. Standard care includes guideline-based management of blood glucose, blood pressure, and kidney protection therapy, which remains stable throughout the study period. DKD-1 consists of Astragalus 3.0 g, Salvia miltiorrhiza 2.5 g, Chinese yam 2.5 g, Poria 2.0 g, Moutan cortex 1.5 g, Schisandra 1.0 g, and Smilax glabra 2.0 g as concentrated herbal granules. Participants in the control group receive standard care alone without DKD-1 supplementation.
Other: Chinese herbal formula DKD-1
DKD-1 is a traditional Chinese herbal formula administered orally at a total daily dose of 14.5 g for 12 weeks. The formula consists of Astragalus membranaceus (3.0 g), Salvia miltiorrhiza (2.5 g), Chinese yam (2.5 g), Poria cocos (2.0 g), Moutan cortex (1.5 g), Schisandra chinensis (1.0 g), and Smilax glabra (2.0 g). It is used as an adjunct to standard care in patients with diabetic kidney disease.
No Intervention: Standard therapy alone
Participants receive standard care alone for 12 weeks. Standard care includes guideline-based management of blood glucose, blood pressure, and kidney protection therapy, maintained without addition of DKD-1 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_12weeks - 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

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CMUH115-REC3-059
  • CMUBH-TCM-DKD-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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