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Clinical effect and mechanism of Shen'an decoction in the treatment of diabetic kidney disease: a randomized controlled clinical study protocol

Clinical effect and mechanism of Shen'an decoction in the treatment of diabetic kidney disease: a randomized controlled clinical study protocol

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100049394
Enrollment
Unknown
Registered
2021-08-01
Start date
2021-08-21
Completion date
Unknown
Last updated
2022-04-19

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

Conditions

Diabetic Nephropathy

Interventions

Sponsors

Changchun University of Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1.At the same time, it meets the diagnostic criteria and syndrome differentiation criteria of Chinese medicine, and the diagnostic criteria of Western medicine for diabetic nephropathy; 2.The gender is not limited, and the aged 18 to 65 years; 3.HbA1c<=7%, for patients with severe complications such as recurrent hypoglycemia, severe microvascular or macrovascular complications, or patients who cannot meet the standard requirements after adequate treatment, HbA1c<=8%. 4.Control blood pressure below 130/80mmHg; 5.The patient knows and voluntarily participates in the trial study and signs the consent form, and has good compliance.

Exclusion criteria

Exclusion criteria: 1.Patients with mental illness who cannot cooperate with treatment and cannot follow the doctor's instructions to receive treatment on time; 2.Patients with recent acute complications and co-infection; 3.Women who are pregnant or breastfeeding or who are about to conceive; 4.People who are prone to allergies or are allergic to test drugs; 5.Patients who have undergone hemodialysis and kidney transplantation; 6.Patients with acute metabolic dysfunction complications such as diabetic ketoacidosis and hyperosmolar coma in the past month; 7.Suffer from other primary or secondary kidney diseases, or other diseases that can cause increased urine protein.

Design outcomes

Primary

MeasureTime frame
Urine protein was quantified at 24h;

Secondary

MeasureTime frame
Fasting blood-glucose;2h postprandial blood glucose;Glycosylated hemoglobin;Serum creatinine;Glomerular filtration rate;Serum metabolomics;Total cholesterol;Triglycerides;Low-density lipoprotein;High-density lipoprotein;Traditional Chinese medicine symptom scores;

Countries

China

Contacts

Public ContactLiu Le

Changchun University of Chinese Medicine

707993226@qq.com+86 15567763962

Outcome results

None listed

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