MedTrace Logo

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

NCT04981613 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2025-08-12

No results posted yet for this study

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.

Conditions

  • Diabetic Nephropathy

Interventions

DRUG

Kunxian capsule

Kunxian capsule (2# tid or 2# bid) + irbesartan tablet (150mg qd or 300mg qd) for 48 weeks

Sponsors & Collaborators

  • First Affiliated Hospital Xi'an Jiaotong University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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

Countries

  • China

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04981613 on ClinicalTrials.gov