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A randomized, double-blind, placebo parallel-controlled, multi-center clinical trial to investigate the efficacy and safety of Bushen Xiaoyu Xiezhuo Formula in the treatment of diabetic kidney disease with kidney deficiency and stasis type

A randomized, double-blind, placebo parallel-controlled, multi-center clinical trial to investigate the efficacy and safety of Bushen Xiaoyu Xiezhuo Formula in the treatment of diabetic kidney disease with kidney deficiency and stasis type

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400080840
Enrollment
Unknown
Registered
2024-02-08
Start date
2024-03-01
Completion date
Unknown
Last updated
2024-02-11

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

Conditions

diabetic kidney disease

Interventions

treatment group:Bushen Xiaoyu Xiezhuofang granules, 2 times a day, 2 bags each time, taken with boiling water
control group:Bushen Xiaoyu Xiezhuo granules mimics, 2 times a day, 2 bags each time, taken with boiling water

Sponsors

The First Affiliated Hospital of Zhejiang Chinese Medicine University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: (1) Consistent with the diagnosis of diabetic nephropathy (DKD); (2) The 24-hour urine protein was quantified at 0.5~3.5g; (3) CKD stage 2-3 (eGFR 30-89ml/min, estimated by CKD-EPI formula); (4) With hypertension (blood pressure can be controlled = 130-140/80-90mmHg with medication) or without hypertension; ?HbA1c<8.0% ; (6) TCM syndrome differentiation is kidney deficiency and stasis syndrome; (7) Have taken ACE inhibitors/ARB drugs for 2 weeks or more, and have taken irbesartan tablets for 2 weeks or more after the introduction period, with a daily dosage of 150-300mg; (8) Age 18~70 years old, gender is not limited; (9) Those who voluntarily sign the informed consent form.

Exclusion criteria

Exclusion criteria: (1) Blood pressure > 180/90mmHg or 5.5mmol/L or <3.5mmol/L after clinical treatment; (3) Patients whose serum creatinine has doubled in the past six months (4) History of unilateral or bilateral renal artery stenosis; (5) Other serious diabetic complications and serious macrovascular events in the past six months, such as cerebral hemorrhage, large-scale cerebral infarction, and acute myocardial infarction; (6) Patients with various infectious diseases in the past 4 weeks; (7) Combined with primary and other secondary kidney diseases; (8) Combined with other serious diseases, such as hematologic diseases, malignant tumors, etc.; (9) Serious psychological or psychiatric abnormalities; (10) Pregnant or lactating women; (11) Patients with a history of allergy to the components in this study drug; (12) Subjects who are participating in clinical trials of other drugs. Note: If any of the above conditions are met, this study is excluded.

Design outcomes

Primary

MeasureTime frame
24-hour urine protein quantification;Urine albumin-creatinine ratio;serum creatinine;blood urea nitrogen;blood uric acid;

Secondary

MeasureTime frame
TCM Syndrome Points;serum albumin;total triglycerides;total cholesterol;Low-density lipoprotein;High-density lipoprotein;high-sensitivity C-reactive protein;tumor necrosis factor alpha;Monocyte Chemoattractant Protein-1;interleukin 6;Transforming growth factor beta;Connective tissue growth factor;Platelet-derived growth factor;

Countries

China

Contacts

Public ContactChen Hongbo

The First Affiliated Hospital of Zhejiang Chinese Medicine University

chenhb521@126.com+86 138 5808 9008

Outcome results

None listed

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