drugset / Trial / NCT04981613

Study on the Efficacy and Safety of a Novel Tripterygium Wilfordii Preparation in Reducing Proteinuria in Patients With Diabetic Nephropathy

NCT04981613

RandomizedParallel-groupSingle-blindTreatment

Summary

The investigators designed a randomized parallel controlled clinical study, selected 98 cases of diabetic nephropathy patients with urinary protein \> 1g, randomly assigned into the Kunxian capsule + irbesartan group or irbesartan group, 48 weeks of treatment and follow-up, reduced levels of urinary protein and effective relief time, remission rate as the main end point, estimated glomerular filtration rate (eGFR) drop rate slope for secondary end points, safety events were also collected. To evaluate the efficacy and safety of Kunxian capsule combined with irbesartan in treatment of diabetic nephropathy compared with irbesartan alone.

Timeline

Start
2021-07-28
Primary completion
2024-08-28
Completion
2024-08-28

Drugs

EvaluationDrugModalityDoseRoute
Subject Kunxian capsule Unknown
Background Irbesartan Small molecule 150 mg
Background Irbesartan Small molecule 300 mg