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Effectiveness of YishenJianpiHuazhuo formula in the treatment of diabetic nephropathy: a randomized controlled trial

Effectiveness of YishenJianpiHuazhuo formula in the treatment of diabetic nephropathy: a randomized controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400087373
Enrollment
Unknown
Registered
2024-07-25
Start date
2023-02-16
Completion date
Unknown
Last updated
2024-07-29

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

Conditions

diabetic nephropathy

Interventions

treatment group:In the treatment group, patients received both valsartan capsules and the YishenJianpiHuazhuo formula. Valsartan capsules were administered at a daily dosage of 80 mg per dose, taken o
control group:the control group received a combination of valsartan capsules and a placebo. Valsartan capsules were administered at a daily dosage of 80 mg per dose, taken orally once daily. The treat

Sponsors

Changchun University of  Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
20 Years to 80 Years

Inclusion criteria

Inclusion criteria: (1) Between the ages of 20 and 80, regardless of gender; (2) Meets the diagnostic and staging criteria for DN, with stages ranging from DN III to IV; (3) Traditional Chinese medicine syndrome differentiation belongs to spleen and kidney qi deficiency, accompanied by dampness and turbidity; (4) Urinary microalbumin/creatinine>3.39mg/mmol/L, or urinary microalbumin>30mg/L; (5) Those who can complete the entire course of treatment, cooperate with treatment and follow-up; (6) Sign the informed consent form.

Exclusion criteria

Exclusion criteria: (1) Pregnant and lactating women; (2) Difficult to control hypertension and high blood sugar; (3) Patients with acute heart failure, acute renal failure, or the need for emergency hemodialysis; (4) Individuals who have recently merged with acute cardiovascular and cerebrovascular events; (5) Patients with mental disorders and abnormalities who cannot cooperate; (6) Those who have not signed the "Patient Informed Consent Form".

Design outcomes

Primary

MeasureTime frame
Serum creatinine (Scr) level;Blood urea nitrogen (BUN) level;Urinary total protein (UTP) level;Urinary albumin to creatinine ratio (UACR) level;Creatinine clearance;Estimated glomerular filtration rate (eGFR);

Secondary

MeasureTime frame
Fasting blood glucose (FBG) level;Postprandial blood glucose (PBG) level;Fasting insulin (FINS) level;Glycated hemoglobin (HbA1C) level;Total cholesterol (TC) level;Triglycerides (TG) level;High-density lipoprotein cholesterol (HDL-C) level;Low-density lipoprotein cholesterol (LDL-C) level;Malondialdehyde (MDA) level;Superoxide dismutase (SOD) level;Glutathione peroxidase (GSH-Px) level;CD4+ level;CD8+ level;CD4+/CD8+ level;Interleukin-6 (IL-6) level;Interleukin-8 (IL-8) level;Tumor necrosis factor-alpha (TNF-a) level;C-reactive protein (CRP) level;

Countries

China

Contacts

Public ContactHongjiajing

Changchun University of Chinese Medicine

hongjj0607@163.com+86 180 8868 5785

Outcome results

None listed

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