Diabetic Kidney Disease (DKD)NCT07034807
YiqiJiangzhuoHuoxueTongluo Method to Delay the Occurrence of End-stage Renal Disease in Diabetic Kidney Disease--Study2
A study testing the traditional Chinese medicine prescription ' Shenzhuo Decoction ' and basic treatment in people with Diabetic Kidney Disease (DKD), run by Liu Hongfang at 5 sites in China.
Trial summary
Using the practical randomized controlled trial designed by Zelen, the subjects were randomly divided into the experimental group and the control group. The experimental group was given the traditional Chinese medicine prescription ' Shenzhuo Decoction ' ( composed of Astragalus membranaceus, Salvia miltiorrhiza… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Diabetic Kidney Disease (DKD)
- What is being tested?
- the traditional Chinese medicine prescription ' Shenzhuo Decoction ' and basic treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 228 participants
- Where
- 5 sitesChina
- Study dates
- 1 Aug 2025to 31 Jul 2028
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1 In line with the diagnostic criteria of Western medicine type 2 DKD ;
- 2 18-80 years old, regardless of gender ;
- 3 30ml / min / 1.73m2 ≤ eGFR < 60ml / min / 1.73m2 ( eGFR was calculated according to CKD-EPI formula ) ;
- 4 In line with the diagnostic criteria of qi deficiency and collateral stasis syndrome in traditional Chinese medicine ;
- 5 hbA1c between 7-10 % ;
- 6 uACR ≥ 300mg / g
- 7 blood pressure ≤ 150 / 90mmHg ;
- 8 signed the informed consent ;
Who cannot join
- 1 Patients who are currently receiving other traditional Chinese medicines and Chinese patent medicines with DKD therapeutic effects ;
- 2 combined with other clear renal diseases, such as polycystic kidney disease, glomerulonephritis, renal tumors ;
- 3 Patients with acute or chronic infection who needed treatment were judged by the researchers not suitable for inclusion in the study ;
- 4 Patients who participated in any other research drug study and / or received or had received another research drug or intervention treatment ( within one month before signing the informed consent form ) ;
- 5 patients who were allergic or contraindicated to the planned use of drugs ;
- 6 There are serious acute or chronic diseases that the major researchers believe may pose an excessive risk to the subjects, including : patients with cardiovascular, cerebrovascular, lung, blood, digestive tract, liver, kidney, neuropsychiatric or infectious diseases ;
Show all 11Show fewer
- 7 Patients with a history of immunodeficiency, including patients with other acquired, congenital immunodeficiency diseases, or patients with a history of organ transplantation or planned organ transplantation ;
- 8 Women with positive pregnancy screening test or lactating or planning to get pregnant in the next 24 months. Female or male patients who were reluctant to use contraception throughout the study period ;
- 9 patients with a history of malignant tumors within 5 years ;
- 10 patients with type 1 diabetes ;
- 11 patients with maintenance dialysis > 2 weeks and / or expected maintenance dialysis > 8 weeks before treatment and patients who were judged by any researcher not suitable for inclusion in the trial.
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
China5 sites
Dongzhimen Hospital
Beijing, Beijing Municipality
Qingqing Liu, +8615811362511, 125982343@qq.com
Guang'anmen Hospital，China Academy of Chinese Medical Sciencescancel
Beijing, Beijing Municipality
Shen Li, +8613681116668, Lishen58173@163.com
The Affiliated Hospital to ChangChun University of Chinese Medicinecancel
Changchun, Jilin
Jia Mi, +8613630558296, mijia8201@126.com
The First Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong
Wei Chen, +8613924150966, chenwei99@mail.sysu.edu.cn
Tianjin Medical University Chu Hsien-I Memorial Hospital
Tianjin, Tianjin Municipality
Baocheng Chang, +8618622051556, changbc1970@126.com
About this study
Official title: Evidence-based Evaluation of Yiqi Jiangzhuo Huoxue Tongluo Method in Delaying the Occurrence of End-stage Renal Disease in Diabetic Kidney Disease--Study 2
Using the practical randomized controlled trial designed by Zelen, the subjects were randomly divided into the experimental group and the control group. The experimental group was given the traditional Chinese medicine prescription ' Shenzhuo Decoction ' ( composed of Astragalus membranaceus, Salvia miltiorrhiza, Leech, Raw Rhubarb, Epimedium, Motherwort ) + basic treatment ( including nutrition, lifestyle, hypoglycemic, hypotensive, lipid-lowering, control of other risk factors, etc. ), the control group was given basic treatment, a total of 1 year of drug intervention, followed up for 1 year.
- Conditions
- Diabetic Kidney Disease (DKD)
- Being tested
- the traditional Chinese medicine prescription ' Shenzhuo Decoction ', basic treatment
- Medical subject headings
- Diabetic Nephropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
the traditional Chinese medicine prescription ' Shenzhuo Decoction 'Drug
Also called Chinese medicine
The traditional Chinese medicine prescription ' Shenzhuo Decoction ' is composed of Astragalus membranaceus, Salvia miltiorrhiza, Leech, Raw Rhubarb, Epimedium, Motherwort. It is a traditional Chinese medicine prescription for the treatment of diabetic kidney disease, which was founded by Tong Xiaolin, an academician of the Chinese Academy of Sciences.
basic treatmentCombination product
Also called control group
Basic treatment includes six aspects : nutrition, lifestyle, hypoglycemic, hypotensive, lipid-lowering, and control of other risk factors, which are implemented in accordance with clinical standard treatment specifications.
| Study group | Role | What they receive |
|---|---|---|
| Shenzhuo Decoction | Experimental | The experimental group was given the traditional Chinese medicine prescription ' Shenzhuo Decoction ' ( composed of Astragalus membranaceus, Salvia miltiorrhiza, Leech, Raw Rhubarb, Epimedium, Motherwort ) + basic treatment ( including nutrition, lifestyle, hypoglycemic, hypotensive, lipid-lowering, control of other risk factors, etc. ) Receives: Drug: the traditional Chinese medicine prescription ' Shenzhuo Decoction '; Combination Product: basic treatment |
| basic treatment | Active comparator | the control group was given basic treatment, a total of 1 year of drug intervention（including nutrition, lifestyle, hypoglycemic, hypotensive, lipid-lowering, control of other risk factors, etc.） Receives: Combination Product: basic treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glomerular filtration rate ( eGFR ) decline slope
Measured: At the time of enrollment, 6 months ± 1 week, 12 months ± 1 week, 18 months ± 1 week, 24 months ± 1 week after enrollment.
Secondary outcomes (5)
The incidence of renal composite outcome
Defined as the occurrence of end-stage renal disease [ dialysis, transplantation or glomerular filtration rate ( eGFR ) < 15ml / ( min · 1.73m2 ) ], eGFR decreased by more than 50 %, death caused by renal causes
Measured: Introduction period ( 1 month before enrollment ), enrollment, 6 months ± 1 week, 12 months ± 1 week, 18 months ± 1 week, 24 months ± 1 week after enrollment.
Urinary albumin creatinine ratio (UACR )
Measured: Introduction period ( 1 month before enrollment ), enrollment, 6 months ± 1 week, 12 months ± 1 week, 18 months ± 1 week, 24 months ± 1 week after enrollment.
Changes in 24-hour urinary protein levels
Measured: Introduction period ( 1 month before enrollment ), enrollment, 6 months ± 1 week, 12 months ± 1 week, 18 months ± 1 week, 24 months ± 1 week after enrollment.
Estimate the change value of glomerular filtration rate ( eGFR ) level, slope
Measured: Introduction period ( 1 month before enrollment ), enrollment, 6 months ± 1 week, 12 months ± 1 week, 18 months ± 1 week, 24 months ± 1 week after enrollment.
Changes of Traditional Chinese Medicine syndrome integrals
The symptoms of the patients were scored with the Traditional Chinese Medicine syndrome scale to better judge the changes of the symptoms of the patients.The highest score was 114 points, and the lowest score was 0 points. The higher the score, the worse the patient 's health.
Measured: Introduction period ( 1 month before enrollment ), enrollment, 6 months ± 1 week, 12 months ± 1 week, 18 months ± 1 week, 24 months ± 1 week after enrollment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2025
- Study start1 Aug 2025 (estimated)
- Primary completion31 Jul 2028 (estimated)
- Study completion31 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Kidney Disease (DKD)Studies of the same condition, open and under way.
- 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
- the practical randomized controlled trial designed by Zelen
- Masking
- None (open label)
- Enrolment
- 228 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Liu Hongfang
- Sponsor type
- University, hospital or other
- Collaborators
- Guang'anmen Hospital，China Academy of Chinese Medical Sciencescancel, First Affiliated Hospital, Sun Yat-Sen University, Tianjin Medical University, Affiliated Hospital of Changchun University of Chinese Medicine, EFONG PHARMRCEUTICRL
- Responsible party
- Sponsor-investigator, Liu Hongfang, Dongzhimen Hospital, Beijing
- Investigators
- HongFang Liu, Study director, Dongzhimen Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07034807
- Sponsor's protocol ID
- 2023ZD0509303-2
- Status last verified
- Jun 2025
- First submitted
- 8 Apr 2025
- Last updated
- 24 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evidence-based Evaluation of Yiqi Jiangzhuo Huoxue Tongluo Method in Delaying the Occurrence of End-stage Renal Disease in Diabetic Kidney Disease--Study 2
- ClinicalTrials.gov ID
- NCT07034807
- Acronym / sponsor ID
- 2023ZD0509303-2
- Conditions
- Diabetic Kidney Disease (DKD)
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 228 participants (estimated)
- Lead sponsor
- Liu HongfangUniversity, hospital or other
- Collaborators
- Guang'anmen Hospital，China Academy of Chinese Medical Sciencescancel, First Affiliated Hospital, Sun Yat-Sen University, Tianjin Medical University, Affiliated Hospital of Changchun University of Chinese Medicine, EFONG PHARMRCEUTICRL
- Study start
- 1 Aug 2025 (estimated)
- Primary completion
- 31 Jul 2028 (estimated)
- Study completion
- 31 Jul 2028 (estimated)
- First posted
- 24 Jun 2025 (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.
Using the practical randomized controlled trial designed by Zelen, the subjects were randomly divided into the experimental group and the control group. The experimental group was given the traditional Chinese medicine prescription ' Shenzhuo Decoction ' ( composed of Astragalus membranaceus, Salvia miltiorrhiza, Leech, Raw Rhubarb, Epimedium, Motherwort ) + basic treatment ( including nutrition, lifestyle, hypoglycemic, hypotensive, lipid-lowering, control of other risk factors, etc. ), the control group was given basic treatment, a total of 1 year of drug intervention, followed up for 1 year.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- the practical randomized controlled trial designed by Zelen
| Arm | Type | Receives |
|---|---|---|
| Shenzhuo Decoction | Experimental | Drug: the traditional Chinese medicine prescription ' Shenzhuo Decoction ', Combination Product: basic treatmentThe experimental group was given the traditional Chinese medicine prescription ' Shenzhuo Decoction ' ( composed of Astragalus membranaceus, Salvia miltiorrhiza, Leech, Raw Rhubarb, Epimedium, Motherwort ) + basic treatment ( including nutrition, lifestyle, hypoglycemic, hypotensive, lipid-lowering, control of other risk factors, etc. ) |
| basic treatment | Active comparator | Combination Product: basic treatmentthe control group was given basic treatment, a total of 1 year of drug intervention（including nutrition, lifestyle, hypoglycemic, hypotensive, lipid-lowering, control of other risk factors, etc.） |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 1 In line with the diagnostic criteria of Western medicine type 2 DKD ;
- 2 18-80 years old, regardless of gender ;
- 3 30ml / min / 1.73m2 ≤ eGFR < 60ml / min / 1.73m2 ( eGFR was calculated according to CKD-EPI formula ) ;
- 4 In line with the diagnostic criteria of qi deficiency and collateral stasis syndrome in traditional Chinese medicine ;
- 5 hbA1c between 7-10 % ;
Key exclusion criteria (11 listed)
- 1 Patients who are currently receiving other traditional Chinese medicines and Chinese patent medicines with DKD therapeutic effects ;
- 2 combined with other clear renal diseases, such as polycystic kidney disease, glomerulonephritis, renal tumors ;
- 3 Patients with acute or chronic infection who needed treatment were judged by the researchers not suitable for inclusion in the study ;
- 4 Patients who participated in any other research drug study and / or received or had received another research drug or intervention treatment ( within one month before signing the informed consent form ) ;
- 5 patients who were allergic or contraindicated to the planned use of drugs ;
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 |
|---|---|---|
| the traditional Chinese medicine prescription ' Shenzhuo Decoction 'Also: Chinese medicineThe traditional Chinese medicine prescription ' Shenzhuo Decoction ' is composed of Astragalus membranaceus, Salvia miltiorrhiza, Leech, Raw Rhubarb, Epimedium, Motherwort. It is a traditional Chinese medicine prescription for the treatment of diabetic kidney disease, which was founded by Tong Xiaolin, an academician of the Chinese Academy of Sciences. | Drug | Shenzhuo Decoction |
| basic treatmentAlso: control groupBasic treatment includes six aspects : nutrition, lifestyle, hypoglycemic, hypotensive, lipid-lowering, and control of other risk factors, which are implemented in accordance with clinical standard treatment specifications. | Combination product | Shenzhuo Decoction, basic treatment |
Primary outcome
Glomerular filtration rate ( eGFR ) decline slope
Time frame: At the time of enrollment, 6 months ± 1 week, 12 months ± 1 week, 18 months ± 1 week, 24 months ± 1 week after enrollment.
5 secondary outcomes
The incidence of renal composite outcome
Time frame: Introduction period ( 1 month before enrollment ), enrollment, 6 months ± 1 week, 12 months ± 1 week, 18 months ± 1 week, 24 months ± 1 week after enrollment.
Urinary albumin creatinine ratio (UACR )
Time frame: Introduction period ( 1 month before enrollment ), enrollment, 6 months ± 1 week, 12 months ± 1 week, 18 months ± 1 week, 24 months ± 1 week after enrollment.
Changes in 24-hour urinary protein levels
Time frame: Introduction period ( 1 month before enrollment ), enrollment, 6 months ± 1 week, 12 months ± 1 week, 18 months ± 1 week, 24 months ± 1 week after enrollment.
Estimate the change value of glomerular filtration rate ( eGFR ) level, slope
Time frame: Introduction period ( 1 month before enrollment ), enrollment, 6 months ± 1 week, 12 months ± 1 week, 18 months ± 1 week, 24 months ± 1 week after enrollment.
Changes of Traditional Chinese Medicine syndrome integrals
Time frame: Introduction period ( 1 month before enrollment ), enrollment, 6 months ± 1 week, 12 months ± 1 week, 18 months ± 1 week, 24 months ± 1 week after enrollment.
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 24 Jun 2025.
- Individual participant dataSharing planned: No
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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.
HongFang Liu study director
Dongzhimen Hospital
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing the traditional Chinese medicine prescription ' Shenzhuo Decoction ' and basic treatment in people with Diabetic Kidney Disease (DKD), run by Liu Hongfang at 5 sites in China.
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 8 inclusion and 11 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 24 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in China. 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 Qingqing Liu (+8615811362511, 125982343@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glomerular filtration rate ( eGFR ) decline slope (time frame: At the time of enrollment, 6 months ± 1 week, 12 months ± 1 week, 18 months ± 1 week, 24 months ± 1 week after enrollment.). 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 24 Jun 2025.