Research on Innovative Traditional Chinese Medicine Diagnosis and Treatment Technologies for Diabetic Nephropathy Driven by Multi-Omics and Artificial Intelligence

March 4, 2026 updated by: Jiazhen Yin

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
198

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Meets the clinical diagnostic criteria for diabetic nephropathy;
  2. Aged 18-75 years, any gender;
  3. eGFR >45 ml/min/1.73m²;
  4. 24-hour urine protein <2.0 g/day;
  5. Exhibits Traditional Chinese Medicine patterns of deficiency, stasis, or rheumatic symptoms;
  6. Willing to participate in the study, able to attend regular follow-ups, and provide informed consent;
  7. 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.

Exclusion Criteria:

  1. 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.);
  2. Other primary or secondary kidney diseases (such as systemic lupus erythematosus, polycystic kidney disease, etc.);
  3. Uncontrolled severe complications (such as severe cardiovascular disease, uncontrolled hypertension, severe infections, etc.);
  4. Critical organ failure (severe diseases of the heart, liver, or lungs);
  5. Pregnancy or planned pregnancy (women currently pregnant or planning to become pregnant during the study);
  6. Drug allergy or clear contraindications (allergic to the study drug or its components);
  7. Non-cooperative or unable to follow the study protocol (unable or unwilling to comply with study requirements);
  8. Abnormal coagulation function, or undergoing anticoagulant therapy (such as warfarin, rivaroxaban, etc.) with bleeding risk;
  9. Currently taking Chinese herbal medicine or patent Chinese medicine with effects of tonifying deficiency, promoting blood circulation, or dispelling wind-dampness.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Experimental group
Experimental group basic treatment+Jiajian Yishen Xiaozheng Qufeng Granules
Drug: Jiajian Yishen Xiaozheng Qufeng Granules
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).
No Intervention: Control group
Basic treatment in the treatment group+simulated traditional Chinese medicine granules

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
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
Western medical efficacy evaluation will be conducted at weeks 0, 4, 8, 12, 16, 20, and 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Jiazhen Yin

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 12, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 4, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 4, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 10, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 10, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 4, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • MR-33-26-016396

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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