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

15. juni 2026 opdateret af: 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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

66

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.
Andet: 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.
Ingen indgriben: 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in Estimated Glomerular Filtration Rate (eGFR)
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

China Medical University Hospital

Samarbejdspartnere

China Medical University Beigang Hospital

Efterforskere

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

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

11. juni 2026

Primær færdiggørelse (Anslået)

31. december 2026

Studieafslutning (Anslået)

31. december 2026

Datoer for studieregistrering

Først indsendt

15. juni 2026

Først indsendt, der opfyldte QC-kriterier

15. juni 2026

Først opslået (Faktiske)

18. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

18. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

15. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • CMUH115-REC3-059
  • CMUBH-TCM-DKD-1 (Anden identifikator: China Medical University Beigang Hospital)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

UBESLUTET

IPD-planbeskrivelse

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.

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Kliniske forsøg med Diabetisk nyresygdom

Kliniske forsøg med Chinese herbal formula DKD-1

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