Diabetic Kidney DiseaseNCT07657351
Effect of Chinese Herbal Medicine on Renal Function in Diabetic Kidney Disease
A study testing Chinese herbal formula DKD-1 in people with Diabetic Kidney Disease, run by China Medical University Hospital at 1 site in Taiwan.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Kidney Disease
- What is being tested?
- Chinese herbal formula DKD-1
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteTaiwan
- Study dates
- 11 Jun 2026to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site
China Medical University Beigang Hospital
Yunlin, Taiwan
CHE-JU CHANG, MD, +886-5-7837901 ext. 1229, 160076@tool.caaumed.org.tw
About this study
Official title: 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.
Read the 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.
- Conditions
- Diabetic Kidney Disease
- Being tested
- Chinese herbal formula DKD-1
- Keywords
- Traditional Chinese Medicine, Diabetic Kidney Disease, Adjunctive Therapy, Pilot Randomized Controlled Trial
- Medical subject headings
- Diabetic Nephropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chinese herbal formula DKD-1Other
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: From baseline to 12 weeks of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2026
- Study start11 Jun 2026 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Kidney DiseaseStudies of the same condition, open and under way.
- More trials run by China Medical University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- China Medical University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- China Medical University Beigang Hospital
- Responsible party
- Sponsor
- Investigators
- Ing-Shiow Lai, MD, PhD, Study director, China Medical University Beigang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07657351
- Sponsor's protocol ID
- CMUH115-REC3-059
- Other IDs
- CMUBH-TCM-DKD-1
- Status last verified
- Jun 2026
- First submitted
- 15 Jun 2026
- Last updated
- 18 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: 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.
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Chinese Herbal Medicine as an Adjunctive Therapy on Renal Function in Patients With Diabetic Kidney Disease: A Pilot Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07657351
- Acronym / sponsor ID
- CMUH115-REC3-059
- Conditions
- Diabetic Kidney Disease
- Keywords
- Traditional Chinese Medicine, Diabetic Kidney Disease, Adjunctive Therapy, Pilot Randomized Controlled Trial
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- China Medical University HospitalUniversity, hospital or other
- Collaborators
- China Medical University Beigang Hospital
- Study start
- 11 Jun 2026 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 18 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| DKD-1 plus standard therapy | Experimental | Other: Chinese herbal formula DKD-1Participants 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Chinese herbal formula DKD-1DKD-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. | Other | DKD-1 plus standard therapy |
Primary outcome
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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2026.
- Individual participant dataSharing planned: Undecided. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ing-Shiow Lai, MD, PhD study director
China Medical University Beigang Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Chinese herbal formula DKD-1 in people with Diabetic Kidney Disease, run by China Medical University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 18 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact CHE-JU CHANG, MD (+886-5-7837901 ext. 1229, 160076@tool.caaumed.org.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Estimated Glomerular Filtration Rate (eGFR) (time frame: From baseline to 12 weeks of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2026.