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

Jiazhen Yin

Status

Not yet enrolling

Conditions

Chronic Renal Failure/ Kidney Disease

Diabetic Nephropathy Type 2

Treatments

Drug: Jiajian Yishen Xiaozheng Qufeng Granules

Study type

Interventional

Funder types

Other

Identifiers

NCT07459946

MR-33-26-016396

Details and patient eligibility

About

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.

Full 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.

Enrollment

198 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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.

Exclusion criteria

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.