Chronic Renal Failure/ Kidney Disease, Diabetic Nephropathy Type 2
Conditions
Keywords
Diabetic Nephropathy Type 2, Randomized Controlled Trial, Multi-omics analysis, Artificial Intelligence (AI) in Diagnosis
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.
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.
Interventions
DRUGJiajian 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).
Sponsors
Jiazhen Yin
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 |
Contacts
CONTACTCaifeng Zhu
CONTACTJiazhen Yin
Outcome results
None listed