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Shenan Tongluo decoction in treatment of diabetic kidney disease: Study protocol for a randomized controlled trial

Clinical effect and mechanism of Shenan Tongluo Decoction in treating diabetic kidney disease

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100050187
Enrollment
Unknown
Registered
2021-08-21
Start date
2021-08-10
Completion date
Unknown
Last updated
2022-04-25

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

Conditions

Diabetic Nephropathy

Interventions

experimental group:Shenan Tongluo decoction
control group:Placebo

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. aged 18 to 65 years old; 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. Serious heart, brain, kidney and other complications; 2. Unwilling to cooperate with others (refer to those who cannot cooperate with dietary control or fail to take medicine as prescribed and affect the curative effect) and mental patients; 3. Patients with acute metabolic disorders such as diabetic ketoacidosis or co-infected patients within the past 1 month; 4. Pregnant or lactating women and those who may be allergic to this drug.

Design outcomes

Primary

MeasureTime frame
24h urine protein quantification;

Secondary

MeasureTime frame
Fasting blood glucose ; Postprandial blood glucose;Glycated hemoglobin;Triglycerides;Total cholesterol;High density lipoprotein ;Low-density lipoprotein ;Serum metabonomics test ;Hemodynamic testing;

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