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Mechanisms of Renal Immune-Mediated Injury in Diabetic Nephropathy and Integrated Traditional Chinese-Western Medicine Approaches: A Multicenter, Randomized Controlled Clinical Trial of Yishen Huashi Granules Alone or in Combination with Dapagliflozin for Diabetic Nephropathy

Mechanisms of Renal Immune-Mediated Injury in Diabetic Nephropathy and Integrated Traditional Chinese-Western Medicine Approaches: A Multicenter, Randomized Controlled Clinical Trial of Yishen Huashi Granules Alone or in Combination with Dapagliflozin for Diabetic Nephropathy

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500102454
Enrollment
Unknown
Registered
2025-05-15
Start date
2025-06-01
Completion date
Unknown
Last updated
2025-05-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetic Nephropathy

Interventions

Yishen Huashi Granules Group (Group A):Yishen Huashi Granules Group (Group A): Standard treatment + Yishen Huashi Granules, Yishen Huashi Granules, 1 sachet (6g) orally three times daily.
Dapagliflozin Group (Group B):Dapagliflozin Group (Group B): Standard Treatment + Dapagliflozin, Dapagliflozin, 10 mg once daily, taken orally after breakfast.
Yishen Huashi Granules + Dapagliflozin Group (Group C):Yishen Huashi Granules + Dapagliflozin Group (Group C): Standard Treatment + Yishen Huashi Granules + Dapagliflozin, Yishen Huashi Granules, 1 sa

Sponsors

Beijing Chao-Yang Hospital, Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
30 Years to 75 Years

Inclusion criteria

Inclusion criteria: ?1. Clinically diagnosed with Type 2 Diabetic Nephropathy (T2DN); ?2. Age 30-75 years, gender-matched; ?3. Blood pressure and blood glucose under effective control (e.g., systolic BP =45 mL/min/1.73 m²; ?6. Urinary albumin-to-creatinine ratio (UACR) 200–5000 mg/g; ?7. Written informed consent obtained from participants.

Exclusion criteria

Exclusion criteria: 1. Confirmed diagnosis of Type 1 Diabetes Mellitus (T1DM); 2. Diabetic nephropathy excluded by renal biopsy; 3. Blood pressure 5.5 mmol/L or <3.5 mmol/L; 5. Lactation, current pregnancy, or planned pregnancy during the study period; 6. Unilateral or bilateral renal artery stenosis (RAS); 7. Severe comorbidities affecting cardiovascular, cerebrovascular, hepatic, hematopoietic systems, or other life-threatening conditions; 8. Current participation in another clinical trial; 9. TCM diagnosis of Yin Deficiency with Fire Effulgence.

Design outcomes

Primary

MeasureTime frame
Changes in estimated glomerular filtration rate (eGFR);Changes in serum creatinine (SCr);Changes in urinary albumin-to-creatinine ratio (UACR);Changes in TCM Spleen-Kidney Qi Deficiency Syndrome Score Scale for Diabetic Nephropathy;—

Secondary

MeasureTime frame
Changes in blood urea nitrogen (BUN);Changes in serum uric acid (UA);—

Countries

China

Contacts

Public ContactMin Zhang

Beijing Chao-Yang Hospital, Capital Medical University

cyyyzm@139.com+86 135 2293 6133

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026