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

NCT07459946 | Not Yet Recruiting

• 1 other identifier: MR-33-26-016396
• Study Type: interventional
• Target: 198
• Locations: 0 countries
• Sites: N/A

Brief 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 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.

Conditions

Diabetic Nephropathy Type 2; Chronic Renal Failure/ Kidney Disease

Keywords

Diabetic Nephropathy Type 2; Randomized Controlled Trial; Multi-omics analysis; Artificial Intelligence (AI) in Diagnosis

Outcome Measures

Primary Outcomes (1)

• UACR/UAER/24-hour urinary protein returns to normal or decreases by 50% compared with before.

  Western medical efficacy evaluation will be conducted at weeks 0, 4, 8, 12, 16, 20, and 24

Study Arms (2)

Experimental group

EXPERIMENTAL

Experimental group basic treatment+Jiajian Yishen Xiaozheng Qufeng Granules

Drug: Jiajian Yishen Xiaozheng Qufeng Granules

Control group

NO INTERVENTION

Basic treatment in the treatment group+simulated traditional Chinese medicine granules

Interventions

Jiajian Yishen Xiaozheng Qufeng Granules DRUG

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).

Experimental group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Meets the clinical diagnostic criteria for diabetic nephropathy;
• Aged 18-75 years, any gender;
• eGFR \>45 ml/min/1.73m²;
• 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.

You may not qualify if:

• 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);
• 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.

Sponsors & Collaborators

• Jiazhen Yin: lead

Central Study Contacts

Caifeng Zhu

CONTACT

+86 189 5807 7658; zhcaifeng@126.com

Jiazhen Yin

CONTACT

+86 138 5814 0006; yinjiazhen@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chief Traditional Chinese Medicine Physician

Study Record Dates

• First Submitted: March 4, 2026
• First Posted: March 10, 2026
• Study Start: March 12, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: March 10, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share