Diabetic Kidney Disease (DKD)NCT07032116
YiqiJiangzhuoHuoxueTongluo Method to Delay the Occurrence of End-stage Renal Disease in Diabetic Kidney Disease--Study1
An observational study of Diabetic Kidney Disease (DKD), run by Liu Hongfang at 5 sites in China.
Trial summary
In order to reduce the clinical demand for kidney dialysis rate of Diabetic Kidney Disease（DKD） patients, a bidirectional cohort study of 4472 patients with DKD (Qi deficiency and collateral stasis syndrome) was carried out based on a preliminary DKD cohort of 13,000 patients. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Diabetic Kidney Disease (DKD)
- Type of treatment
- Pill or oral medicine
- How many people
- 4,472 participants
- Where
- 5 sitesChina
- Study dates
- 1 Aug 2025to 31 Jul 2028
- Phase
- Observational
- 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
Study population: Diabetic kidney disease patients, in line with the inclusion criteria, do not meet the exclusion criteria
Who may be able to join
- 1 in line with Western medicine diagnostic criteria for type 2 diabetic kidney disease ;
- 2 18-80 years old, regardless of gender ;
- 3 eGFR > 15ml / ( min · 1.73m2 ) ; the eGFR was calculated according to the chronic kidney disease epidemiology collaboration equation ( CKD-EPI ).
- 4 In line with the diagnostic criteria of qi deficiency and collateral stasis syndrome in traditional Chinese medicine ;
- 5glycosylated hemoglobin ( HbA1c ) between 7-10 % ;
- 6 blood pressure ≤ 160 / 100mmHg ;
- 7 to sign the informed consent ;
Who cannot join
- 1 combined with other clear renal diseases, such as polycystic kidney disease, glomerulonephritis, renal tumor, etc. ;
- 2 patients with a history of recurrent genitourinary tract infection ;
- 3 combined with cardiovascular and cerebrovascular, digestive, respiratory, urinary, immune system serious diseases or mental diseases ;
- 4 currently in pregnancy, lactation, or pregnancy plan women ;
- 5 Patients with type 1 diabetes.
- 6 Tumor patients undergoing radiotherapy, chemotherapy or targeted therapy.
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 of BeijingUniversity of Chinese Medicine
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 1
In order to reduce the clinical demand for kidney dialysis rate of Diabetic Kidney Disease（DKD） patients, a bidirectional cohort study of 4472 patients with DKD (Qi deficiency and collateral stasis syndrome) was carried out based on a preliminary DKD cohort of 13,000 patients. The exposure factor was supplementing and reducing the kidney turbidity-Huoxue Tongluo method represented by the addition and subversion of Shenzhuo prescription, and the incidence of end-stage renal disease was the main therapeutic index. Follow-up was conducted for 2 years
- Conditions
- Diabetic Kidney Disease (DKD)
- Medical subject headings
- Diabetic Nephropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Exposed group | People receiving exposure factors:In addition to the basic treatment and non-Yiqi Jiangzhuo Huoxue Tongluo Chinese patent medicine(except for Niaoduqing Granules, Shenshuaining Tablets/Capsules,Qizhi Capsules,Qizhi Yishen Capsules and other Chinese patent medicine),the exposure factors were treated with Shenqi Decoction(composed of Astragalus,Salvia miltiorrhiza,Leech,Rhubarb,Epimedium,Motherwort)as the representative of Yiqi Jiangzhuo Huoxue Tongluo Chinese medicine prescription treatment,and did not receive other traditional Chinese medicine treatment measures for urinary protein or renal insufficiency.The definition of basic treatment is:standardized diet,exercise,hypoglycemic,antihypertensive,lipid-lowering and other basic treatment measures,appropriate doses of angiotensin converting enzyme inhibitors(ACEI)/angiotensin receptor blockers(ARB),sodium-glucose co-transporter 2 inhibitors(SGLT2i),salt hormone receptor antagonists(MRA) and other drugs with clear renal protective effect | |
| Non-exposed group | Diabetic kidney disease patients who did not receive exposure factors. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of end-stage renal disease
dialysis, transplantation or glomerular filtration rate ( eGFR ) < 15ml / ( min · 1.73m2 )
Measured: Review period, enrollment, enrollment two months, enrollment half a year, enrollment 1 year, enrollment 1 and a half years, enrollment two years
Secondary outcomes (5)
Incidence of renal composite outcome indicators
End-stage renal disease [ dialysis, transplantation or glomerular filtration rate ( eGFR ) < 15ml / ( min · 1.73m2 ) ], eGFR decreased by more than 50 %, renal causes of death were defined.
Measured: Review period, enrollment, enrollment two months, enrollment half a year, enrollment 1 year, enrollment 1 and a half years, enrollment two years
Changes of urinary protein creatinine ratio
Changes of urinary protein creatinine ratio
Measured: Review period, enrollment, enrollment two months, enrollment half a year, enrollment 1 year, enrollment 1 and a half years, enrollment two years
Changes of 24-hour urinary protein level
Changes of 24-hour urinary protein level
Measured: Review period, enrollment, enrollment two months, enrollment half a year, enrollment 1 year, enrollment 1 and a half years, enrollment two years
Estimate the change value of glomerular filtration rate ( eGFR ) level, slope
Estimate the change value of glomerular filtration rate ( eGFR ) level, slope
Measured: Review period, enrollment, enrollment two months, enrollment half a year, enrollment 1 year, enrollment 1 and a half years, enrollment two years
Chinese medicine syndrome scores
The TCM（Traditional Chinese Medicine） symptoms of the patients were scored by the TCM syndrome scale in order to judge the improvement of their symptoms.The highest score was 114 points, and the lowest score was 0 points. The higher the score, the worse the patient 's health.
Measured: Review period, enrollment, enrollment two months, enrollment half a year, enrollment 1 year, enrollment 1 and a half years, enrollment two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 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
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 4,472 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Liu Hongfang
- Sponsor type
- University, hospital or other
- Collaborators
- Guang'anmen Hospital of China Academy of Chinese Medical Sciences, First Affiliated Hospital, Sun Yat-Sen University, Tianjin Medical University, Changchun University of Chinese Medicine, EFONG PHARMRCEUTICRL, Xinxiang Central Hospital of Henan province, Xiamen Hospital of Traditional Chinese Medicine, Affiliated Hospital of Liaoning University of Traditional Chinese Medicine, Beijing Tiantan Hospital, Cangzhou Hospital of Integrated Traditional Chinese and Western Medicine, Hubei Zhongshan Hospital Affiliated to Wuhan University
- Responsible party
- Sponsor-investigator, Liu Hongfang, Dongzhimen Hospital, Beijing
- Investigators
- HongFang Liu, Study director, Dongzhimen Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07032116
- Sponsor's protocol ID
- 2023ZD0509303-1
- Status last verified
- Jun 2025
- First submitted
- 8 Apr 2025
- Last updated
- 22 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 22 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 1
- ClinicalTrials.gov ID
- NCT07032116
- Acronym / sponsor ID
- 2023ZD0509303-1
- Conditions
- Diabetic Kidney Disease (DKD)
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 4,472 participants (estimated)
- Lead sponsor
- Liu HongfangUniversity, hospital or other
- Collaborators
- Guang'anmen Hospital of China Academy of Chinese Medical Sciences, First Affiliated Hospital, Sun Yat-Sen University, Tianjin Medical University, Changchun University of Chinese Medicine, EFONG PHARMRCEUTICRL, Xinxiang Central Hospital of Henan province, Xiamen Hospital of Traditional Chinese Medicine, Affiliated Hospital of Liaoning University of Traditional Chinese Medicine, Beijing Tiantan Hospital, Cangzhou Hospital of Integrated Traditional Chinese and Western Medicine, Hubei Zhongshan Hospital Affiliated to Wuhan University
- Study start
- 1 Aug 2025 (estimated)
- Primary completion
- 31 Jul 2028 (estimated)
- Study completion
- 31 Jul 2028 (estimated)
- First posted
- 22 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.
In order to reduce the clinical demand for kidney dialysis rate of Diabetic Kidney Disease（DKD） patients, a bidirectional cohort study of 4472 patients with DKD (Qi deficiency and collateral stasis syndrome) was carried out based on a preliminary DKD cohort of 13,000 patients. The exposure factor was supplementing and reducing the kidney turbidity-Huoxue Tongluo method represented by the addition and subversion of Shenzhuo prescription, and the incidence of end-stage renal disease was the main therapeutic index. Follow-up was conducted for 2 years
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exposed group | – | –People receiving exposure factors:In addition to the basic treatment and non-Yiqi Jiangzhuo Huoxue Tongluo Chinese patent medicine(except for Niaoduqing Granules, Shenshuaining Tablets/Capsules,Qizhi Capsules,Qizhi Yishen Capsules and other Chinese patent medicine),the exposure factors were treated with Shenqi Decoction(composed of Astragalus,Salvia miltiorrhiza,Leech,Rhubarb,Epimedium,Motherwort)as the representative of Yiqi Jiangzhuo Huoxue Tongluo Chinese medicine prescription treatment,and did not receive other traditional Chinese medicine treatment measures for urinary protein or renal insufficiency.The definition of basic treatment is:standardized diet,exercise,hypoglycemic,antihypertensive,lipid-lowering and other basic treatment measures,appropriate doses of angiotensin converting enzyme inhibitors(ACEI)/angiotensin receptor blockers(ARB),sodium-glucose co-transporter 2 inhibitors(SGLT2i),salt hormone receptor antagonists(MRA) and other drugs with clear renal protective effect |
| Non-exposed group | – | –Diabetic kidney disease patients who did not receive exposure factors. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Diabetic kidney disease patients, in line with the inclusion criteria, do not meet the exclusion criteria
Key inclusion criteria (7 listed)
- 1 in line with Western medicine diagnostic criteria for type 2 diabetic kidney disease ;
- 2 18-80 years old, regardless of gender ;
- 3 eGFR > 15ml / ( min · 1.73m2 ) ; the eGFR was calculated according to the chronic kidney disease epidemiology collaboration equation ( CKD-EPI ).
- 4 In line with the diagnostic criteria of qi deficiency and collateral stasis syndrome in traditional Chinese medicine ;
- 5glycosylated hemoglobin ( HbA1c ) between 7-10 % ;
Key exclusion criteria (6 listed)
- 1 combined with other clear renal diseases, such as polycystic kidney disease, glomerulonephritis, renal tumor, etc. ;
- 2 patients with a history of recurrent genitourinary tract infection ;
- 3 combined with cardiovascular and cerebrovascular, digestive, respiratory, urinary, immune system serious diseases or mental diseases ;
- 4 currently in pregnancy, lactation, or pregnancy plan women ;
- 5 Patients with type 1 diabetes.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The incidence of end-stage renal disease
Time frame: Review period, enrollment, enrollment two months, enrollment half a year, enrollment 1 year, enrollment 1 and a half years, enrollment two years
dialysis, transplantation or glomerular filtration rate ( eGFR ) < 15ml / ( min · 1.73m2 )
5 secondary outcomes
Incidence of renal composite outcome indicators
Time frame: Review period, enrollment, enrollment two months, enrollment half a year, enrollment 1 year, enrollment 1 and a half years, enrollment two years
Changes of urinary protein creatinine ratio
Time frame: Review period, enrollment, enrollment two months, enrollment half a year, enrollment 1 year, enrollment 1 and a half years, enrollment two years
Changes of 24-hour urinary protein level
Time frame: Review period, enrollment, enrollment two months, enrollment half a year, enrollment 1 year, enrollment 1 and a half years, enrollment two years
Estimate the change value of glomerular filtration rate ( eGFR ) level, slope
Time frame: Review period, enrollment, enrollment two months, enrollment half a year, enrollment 1 year, enrollment 1 and a half years, enrollment two years
Chinese medicine syndrome scores
Time frame: Review period, enrollment, enrollment two months, enrollment half a year, enrollment 1 year, enrollment 1 and a half years, enrollment two years
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 22 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?
An observational study of 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 7 inclusion and 6 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 22 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?
The incidence of end-stage renal disease (time frame: Review period, enrollment, enrollment two months, enrollment half a year, enrollment 1 year, enrollment 1 and a half years, enrollment two years). 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 22 Jun 2025.