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

Phase 1

Study type

Interventional

Source

ITMCTR

Registry ID

ITMCTR2100005191

Enrollment

Unknown

Registered

2021-08-21

Start date

2021-08-10

Completion date

Unknown

Last updated

2023-02-20

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

Conditions

Diabetic Nephropathy

Interventions

The control group:The placebo

The treatment group:SATL

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 age range of the included patients is 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) In line with the diagnostic criteria of diabetic nephropathy of Western medicine and the diagnostic criteria of Traditional Chinese medicine and syndrome differentiation criteria. (2) Gender was not limited, and the included patients ranged from 18 to 65 years old; (3) HbA1c=7% : for patients with serious complications such as recurrent hypoglycemia, severe microvascular or macrovascular complications, or those who still fail to meet the standard after adequate treatment, HbA1c=8% (4) Blood pressure should be controlled below 130/80mmHg; (5) Patients are informed and voluntarily participate in the study and sign the consent form, with good compliance.

Design outcomes

Primary

Measure	Time frame
24h urine protein quantification ;	—

Secondary

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

Countries

China

Contacts

Public ContactLe Liu

Changchun University of Chinese Medicine

707993226@qq.com15567763962

Outcome results

None listed

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