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

NCT07657351 | Not Yet Recruiting

• 2 other identifiers: CMUH115-REC3-059CMUBH-TCM-DKD-1
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Diabetic Kidney Disease

Keywords

Traditional Chinese Medicine; Diabetic Kidney Disease; Adjunctive Therapy; Pilot Randomized Controlled Trial

Outcome Measures

Primary Outcomes (1)

• 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\_12weeks - eGFR\_baseline).

  From baseline to 12 weeks of treatment

Study Arms (2)

DKD-1 plus standard therapy

EXPERIMENTAL

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

Standard therapy alone

NO INTERVENTION

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.

Interventions

Chinese herbal formula DKD-1 OTHER

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.

DKD-1 plus standard therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• China Medical University Hospital: lead
• China Medical University Beigang Hospital: collaborator

Study Sites (1)

China Medical University Beigang Hospital

Yunlin, Taiwan, Taiwan

Location

MeSH Terms

Conditions

Diabetic Nephropathies

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases

Study Officials

• Ing-Shiow Lai, MD, PhD

  China Medical University Beigang Hospital

  STUDY DIRECTOR

Central Study Contacts

CHE-JU CHANG, MD

CONTACT

+886-5-7837901; 160076@tool.caaumed.org.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants are randomly assigned in a 1:1 ratio to either the intervention group receiving DKD-1 in addition to standard therapy or the control group receiving standard therapy alone. Both groups are followed simultaneously for 12 weeks.

Study Record Dates

• First Submitted: June 15, 2026
• First Posted: June 18, 2026
• Study Start: June 11, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: June 18, 2026

Record last verified: 2026-06

Locations

TW (1)