Diabetic Nephropathy Type 2NCT07459946
Research on Innovative Traditional Chinese Medicine Diagnosis and Treatment Technologies for Diabetic Nephropathy Driven by Multi-Omics and Artificial Intelligence
A study testing Jiajian Yishen Xiaozheng Qufeng Granules in people with Diabetic Nephropathy Type 2 and Chronic Renal Failure/ Kidney Disease, run by Jiazhen Yin.
Trial summary
With the help of the 'Traditional Chinese Medicine Specialty Alliance Platform-Multicenter RCT Clinical Research Database,' this platform can be used to conduct scientific research on various aspects of DKD, such as disease prediction, treatment effectiveness evaluation, and recurrence rate analysis, providing… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Diabetic Nephropathy Type 2, Chronic Renal Failure/ Kidney Disease
- What is being tested?
- Jiajian Yishen Xiaozheng Qufeng Granules
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 198 participants
- Where
- No sites listed yet
- Study dates
- 12 Mar 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Meets the clinical diagnostic criteria for diabetic nephropathy;
- Aged 18-75 years, any gender;
- eGFR >45 ml/min/1.73m²;
- 24-hour urine protein <2.0 g/day;
- Exhibits Traditional Chinese Medicine patterns of deficiency, stasis, or rheumatic symptoms;
- Willing to participate in the study, able to attend regular follow-ups, and provide informed consent;
- Has maintained a stable basic treatment plan (including hypoglycemic, antihypertensive, and lipid-lowering therapies) for ≥1 month prior to enrollment; during the first 3 months after enrollment, ARB, finerenone, and SGLT2 inhibitor therapies should generally not be adjusted.
Who cannot join
- Acute kidney injury or renal function impairment caused by other reasons (recent rapid decline in renal function, or kidney damage caused by drugs, infections, etc.);
- Other primary or secondary kidney diseases (such as systemic lupus erythematosus, polycystic kidney disease, etc.);
- Uncontrolled severe complications (such as severe cardiovascular disease, uncontrolled hypertension, severe infections, etc.);
- Critical organ failure (severe diseases of the heart, liver, or lungs);
- Pregnancy or planned pregnancy (women currently pregnant or planning to become pregnant during the study);
- Drug allergy or clear contraindications (allergic to the study drug or its components);
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- Non-cooperative or unable to follow the study protocol (unable or unwilling to comply with study requirements);
- Abnormal coagulation function, or undergoing anticoagulant therapy (such as warfarin, rivaroxaban, etc.) with bleeding risk;
- Currently taking Chinese herbal medicine or patent Chinese medicine with effects of tonifying deficiency, promoting blood circulation, or dispelling wind-dampness.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Research on New Diagnosis and Treatment Technologies for Major Traditional Chinese Medicine Advantage Diseases - Multi-Omics and Artificial Intelligence-Driven Innovative TCM Diagnosis and Treatment Technologies for Diabetic Nephropathy
With the help of the 'Traditional Chinese Medicine Specialty Alliance Platform-Multicenter RCT Clinical Research Database,' this platform can be used to conduct scientific research on various aspects of DKD, such as disease prediction, treatment effectiveness evaluation, and recurrence rate analysis, providing effective means to improve DKD remission rates, delay disease progression, and enhance patients' quality of life. By selecting the Jiade Yishen Xiaozheng Qufang formula and conducting multicenter, prospective, double-blind RCT studies, its clinical value in improving DKD remission rates can be verified. With the support of scientific research, DKD treatment strategies can be optimized, therapeutic efficacy improved, recurrence rates reduced, and disease progression delayed, thereby enhancing patients' quality of life.
Read the detailed description
Cooperative units jointly carry out a prospective randomized placebo-controlled parallel double-blind study, relying on a multi-center clinical research platform, and verify through multi-center, prospective, double-blind RCT studies the clinical value of the Jia Jian Yi Shen Xiao Zheng Qu Feng Formula in improving the remission rate of DKD, in order to optimize the treatment strategy for DKD.
- Being tested
- Jiajian Yishen Xiaozheng Qufeng Granules
- Keywords
- Diabetic Nephropathy Type 2, Randomized Controlled Trial, Multi-omics analysis, Artificial Intelligence (AI) in Diagnosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Jiajian Yishen Xiaozheng Qufeng GranulesDrug
Involving unlisted drugs, vaccines, medical devices, and other products;Unlisted product type: Medicine;Unlisted product name: Jia Jian Yi Shen Xiao Zheng Qu Feng Fang Granules;Unlisted Product Preparation Organization: Jiangyin Tianjiang Pharmaceutical Co., Ltd.;Type of preparation institution for unlisted products: Domestic (within China).
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Experimental group basic treatment+Jiajian Yishen Xiaozheng Qufeng Granules Receives: Drug: Jiajian Yishen Xiaozheng Qufeng Granules |
| Control group | No intervention | Basic treatment in the treatment group+simulated traditional Chinese medicine granules |
What is being measured
The primary outcome is the main question the study is designed to answer.
UACR/UAER/24-hour urinary protein returns to normal or decreases by 50% compared with before.
Measured: Western medical efficacy evaluation will be conducted at weeks 0, 4, 8, 12, 16, 20, and 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2026
- Study start12 Mar 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 Nephropathy Type 2Studies 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
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 198 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiazhen Yin
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jiazhen Yin, Hangzhou Hospital of Traditional Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07459946
- Sponsor's protocol ID
- MR-33-26-016396
- Status last verified
- Mar 2026
- First submitted
- 4 Mar 2026
- Last updated
- 10 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- 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 10 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Research on New Diagnosis and Treatment Technologies for Major Traditional Chinese Medicine Advantage Diseases - Multi-Omics and Artificial Intelligence-Driven Innovative TCM Diagnosis and Treatment Technologies for Diabetic Nephropathy
- ClinicalTrials.gov ID
- NCT07459946
- Acronym / sponsor ID
- MR-33-26-016396
- Keywords
- Diabetic Nephropathy Type 2, Randomized Controlled Trial, Multi-omics analysis, Artificial Intelligence (AI) in Diagnosis
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 198 participants (estimated)
- Lead sponsor
- Jiazhen YinUniversity, hospital or other
- Study start
- 12 Mar 2026 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 10 Mar 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.
With the help of the 'Traditional Chinese Medicine Specialty Alliance Platform-Multicenter RCT Clinical Research Database,' this platform can be used to conduct scientific research on various aspects of DKD, such as disease prediction, treatment effectiveness evaluation, and recurrence rate analysis, providing effective means to improve DKD remission rates, delay disease progression, and enhance patients' quality of life. By selecting the Jiade Yishen Xiaozheng Qufang formula and conducting multicenter, prospective, double-blind RCT studies, its clinical value in improving DKD remission rates can be verified. With the support of scientific research, DKD treatment strategies can be optimized, therapeutic efficacy improved, recurrence rates reduced, and disease progression delayed, thereby enhancing patients' quality of life.
Detailed description
Cooperative units jointly carry out a prospective randomized placebo-controlled parallel double-blind study, relying on a multi-center clinical research platform, and verify through multi-center, prospective, double-blind RCT studies the clinical value of the Jia Jian Yi Shen Xiao Zheng Qu Feng Formula in improving the remission rate of DKD, in order to optimize the treatment strategy for DKD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Drug: Jiajian Yishen Xiaozheng Qufeng GranulesExperimental group basic treatment+Jiajian Yishen Xiaozheng Qufeng Granules |
| Control group | No intervention | –Basic treatment in the treatment group+simulated traditional Chinese medicine granules |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Meets the clinical diagnostic criteria for diabetic nephropathy;
- Aged 18-75 years, any gender;
- eGFR >45 ml/min/1.73m²;
- 24-hour urine protein <2.0 g/day;
- Exhibits Traditional Chinese Medicine patterns of deficiency, stasis, or rheumatic symptoms;
Key exclusion criteria (9 listed)
- Acute kidney injury or renal function impairment caused by other reasons (recent rapid decline in renal function, or kidney damage caused by drugs, infections, etc.);
- Other primary or secondary kidney diseases (such as systemic lupus erythematosus, polycystic kidney disease, etc.);
- Uncontrolled severe complications (such as severe cardiovascular disease, uncontrolled hypertension, severe infections, etc.);
- Critical organ failure (severe diseases of the heart, liver, or lungs);
- Pregnancy or planned pregnancy (women currently pregnant or planning to become pregnant during the study);
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 |
|---|---|---|
| Jiajian Yishen Xiaozheng Qufeng GranulesInvolving unlisted drugs, vaccines, medical devices, and other products;Unlisted product type: Medicine;Unlisted product name: Jia Jian Yi Shen Xiao Zheng Qu Feng Fang Granules;Unlisted Product Preparation Organization: Jiangyin Tianjiang Pharmaceutical Co., Ltd.;Type of preparation institution for unlisted products: Domestic (within China). | Drug | Experimental group |
Primary outcome
UACR/UAER/24-hour urinary protein returns to normal or decreases by 50% compared with before.
Time frame: Western medical efficacy evaluation will be conducted at weeks 0, 4, 8, 12, 16, 20, and 24
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 10 Mar 2026.
- 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.
Questions about this trial
What is this clinical trial studying?
A study testing Jiajian Yishen Xiaozheng Qufeng Granules in people with Diabetic Nephropathy Type 2 and Chronic Renal Failure/ Kidney Disease, run by Jiazhen Yin.
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 9 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 10 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
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 Caifeng Zhu (+86 189 5807 7658, zhcaifeng@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
UACR/UAER/24-hour urinary protein returns to normal or decreases by 50% compared with before. (time frame: Western medical efficacy evaluation will be conducted at weeks 0, 4, 8, 12, 16, 20, and 24). 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 10 Mar 2026.