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

Not yet recruiting

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Estimated)

198

Phase

  • 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 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

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
Intervention / Treatment
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

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

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)

March 12, 2026

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

March 4, 2026

First Submitted That Met QC Criteria

March 4, 2026

First Posted (Actual)

March 10, 2026

Study Record Updates

Last Update Posted (Actual)

March 10, 2026

Last Update Submitted That Met QC Criteria

March 4, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID 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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