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Evaluation of Clinical Efficacy and Mechanism Study of Wenyang Xiaozheng Decoction in the Treatment of Diabetic Nephropathy Based on the Three-Differentiation Model

Evaluation of Clinical Efficacy and Mechanism Study of Wenyang Xiaozheng Decoction in the Treatment of Diabetic Nephropathy Based on the Three-Differentiation Model

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2025001414
Enrollment
Unknown
Registered
2025-07-16
Start date
2024-10-18
Completion date
Unknown
Last updated
2025-07-21

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

Conditions

Diabetic Kidney Disease

Interventions

Experimental group:basic treatment + warming yang and eliminating symptoms
Control group (basic treatment):Control group (basic treatment)

Sponsors

Ningbo Municipal Hospital of Traditional Chinese Medicine Affiliated to Zhejiang Chinese Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria Diabetic nephropathy was included in the criteria (1) Western medicine diagnosis is consistent with diabetic nephropathy; (2) TCM constitution conforms to: 1) Yang deficiency or blood stasis 2) Yang deficiency combined with blood stasis 3) Yang deficiency + blood stasis tendency, or blood stasis + Yang deficiency tendency; (3) TCM diagnosis is consistent with yang deficiency and blood stasis; (4) Age between 18 and 75; (5) The subject agrees and signs the informed consent. Inclusion criteria for healthy subjects (1) Participants who are not participating in the trial for therapeutic benefit, have good health status and do not have diseases related to this study; (2) The patient's age is between 18 and 75 years old; (3) Subjects with relatively complete physical examination data shall agree and sign the informed consent for entering clinical research.

Exclusion criteria

Exclusion criteria: Exclusion criteria (1) Patients with serious diseases of important organs, such as moderate to severe liver dysfunction (transaminase more than 3 times higher than normal), malignant tumor, severe anemia (HB less than 60g/L), and cardiovascular stent operation in the past 3 months; (2) Those who are taking hormones or immunosuppressants; (3) Allergy to the known ingredients of the test drug, or severe allergic constitution; (4) Pregnant or lactating women; (5) Patients with eGFR<25ml/min or who have entered dialysis; (6) Exclude patients with mental illness (7) Other situations in which the investigator judged poor compliance or deemed it unsuitable to participate in the trial.

Design outcomes

Primary

MeasureTime frame
Glomerular filtration rate (eGFR);renal function;Proteinuria/creatinine;

Secondary

MeasureTime frame
blood fat;Evaluation of curative effect of TCM syndromes;routine urine test;routine blood test;Occurrence of cardiovascular and cerebrovascular events;blood sugar;electrolytic;length of hospital stay;Judgment of TCM Constitution;all-cause mortality;

Countries

china

Contacts

Public Contactlin xiaomeng

Ningbo Municipal Hospital of Traditional Chinese Medicine Affiliated to Zhejiang Chinese Medical University

linxiaomeng521@163.com13567924194

Outcome results

None listed

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