A multicenter, randomized controlled clinical study on the treatment of diabetic nephropathy with Yishenhuashi granules alone and/or in combination with Daglizin tablets

A multicenter, randomized controlled clinical study on the treatment of diabetic nephropathy with Yishenhuashi granules alone and/or in combination with Daglizin tablets - Research on diabetic nephropathy integrated Chinese and Western medicine

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2400086609

Enrollment

Unknown

Registered

2024-07-08

Start date

2024-02-23

Completion date

Unknown

Last updated

2024-07-15

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

Conditions

Diabetic nephropathy

Interventions

Yishenhuashi granule group:Basic treatment + Yishenhuashi granules

Dagliazine group:Basic treatment + daglipzin

Yishenhuashi granules + Dagliazine group:Basic treatment + Yishenhuashi granule basic treatment + Daglipzin

Eligibility

Sex/Gender

All

Age

30 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1) Patients with type 2 diabetic nephropathy. 2) Age 30-70 years old, gender matching. 3) Blood pressure and blood sugar are effectively controlled. 4) The traditional Chinese medicine diagnosis is spleen and kidney qi deficiency or water dampness syndrome. 5) eGFR=[45ml·min-1·(1.73m2) -1]. 6) 24h urinary protein quantification: 0.2 ~ 5.0g. 7) The subject agrees and signs the informed consent.

Exclusion criteria

Exclusion criteria: 1) Diagnosed with type I diabetes. 2) Patients diagnosed with diabetic nephropathy were excluded from renal perforation results. 3) Blood pressure 5.5mmol/L or < 3.5mmol/L. 5) Breastfeeding, pregnancy or planning pregnancy during the study period. 6) Unilateral or bilateral renal artery stenosis. 7) Complicated with serious heart, brain, liver and hematopoietic system diseases, or other serious diseases affecting their survival. 8) Currently participating in another clinical study. 9) Traditional Chinese medicine diagnosis of Yin deficiency fire.

Design outcomes

Primary

Measure	Time frame
Estimating changes in glomerular filtration rate (eGFR);Serum creatinine (SCr) changes;Changes in urinary albumin creatinine ratio (ACR);Changes of urinary protein quantity at 24h;Changes of TCM spleen-kidney qi deficiency syndrome evaluation table of diabetic nephropathy;	—

Secondary

Measure	Time frame
Changes in blood urea nitrogen (BUN);Changes in blood uric acid (UA);Changes of total protein (TP) and albumin (ALB);Changes in hemoglobin (Hb);Changes in the evaluation of edema;	—

Countries

China

Contacts

Public ContactMin Zhang

Beijing Chaoyang Hospital, Capital Medical University

cyyyzm@139.com+86 85231725

Outcome results

None listed

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