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Efficacy and safety of a formula for strengthening the spleen resolving dampness and removing blood stasis in the treatment of diabetic nephropathy

Efficacy and safety of a formula for strengthening the spleen resolving dampness and removing blood stasis in the treatment of diabetic nephropathy

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2025000582
Enrollment
Unknown
Registered
2025-03-24
Start date
2024-09-20
Completion date
Unknown
Last updated
2025-04-07

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

Conditions

Diabetic kidney disease

Interventions

control group:The standardized Western medicine treatment of lowering sugar, blood pressure, lipids, and urinary protein was used, with the addition of the granule simulant of Strengthening the Spleen
test group:Western medicine standardized treatment of lowering glucose blood pressure lipids and urinary protein was used with the addition of granules of Strengthening the Spleen Resolving Dampness a

Sponsors

Guangdong Hospital of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1) Any gender age =18 years and =75 years; 2) Meet the clinical diagnostic criteria for type 2 diabetes mellitus; 3) Meet the clinical diagnostic criteria for DKD stage III; 4)Conforms to the TCM evidence of dampness turbidity and blood stasis; 5) Those who sign the informed consent form; 6) Willing to obey the doctor's treatment plan and cooperate with the follow-up.

Exclusion criteria

Exclusion criteria: 1) pregnant or lactating; 2) psychiatric patients can not understand the nature scope and possible results of the study or can not comply with medical advice; 3) diabetic ketoacidosis hyperglycemic hyperosmolar syndrome diabetic lactic acidosis and other acute complications; 4) hematuria urinary obvious abnormal tubular pattern systemic or urinary tract infections urinary stones the combination of other renal diseases and renal vascular disease severe cardiac and hepatic insufficiency Connective tissue diseases malignant tumors stress heart attack angina pectoris cerebral infarction within the past 6 months; 5) history of nephrotoxic drugs within 1 month; 6) sudden onset of edema and normal renal function; 7) intractable hypertension; 8) is or will be participating in other clinical trials needing to intervene in the treatment of patients; 9) allergic or known to be intolerant to the study drug patients.

Design outcomes

Primary

MeasureTime frame
Urine microalbumin creatinine ratio;

Secondary

MeasureTime frame
cholesterol;2-hour postprandial blood glucose;creatinine;Estimated glomerular filtration rate;fasting blood glucose;blood urea nitrogen;glycosylated hemoglobin;triglyceride;Chinese Medicine Score;

Countries

China

Contacts

Public ContactFan Guanjie

Guangdong Hospital of Traditional Chinese Medicine

13925119990@139.com+86 139 2511 9990

Outcome results

None listed

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