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Efficacy and Safety of the Chinese Herbal Formula Granules in Chronic Kidney Disease Stage 3: A Prospective, Multi-center, Randomized, Placebo-controlled, Double-blind Clinical Trial

Phase 3
Completed
Conditions
ephrology
Registration Number
ITMCTR1900002601
Lead Sponsor
Affiliated Hospital of Nanjing University of Chinese Medicine
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
All
Target Recruitment
Not specified
Inclusion Criteria

Male and female patients diagnosed as primary CKD aged 18-75 years with estimated glomerular filtration rate (eGFR) >= 30 ml/min/1.73m2 and < 60 ml/min/1.73m2 calculated with the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation and 24-hour proteinuria <=2.0 g/d. Blood pressure was managed <=130/80 mmHg.

Exclusion Criteria

Patients with acute kidney injury, polycystic kidney disease, secondary kidney disease such as diabetic nephropathy were not recruited. Patients were receiving glucocorticoids, immunosuppressants and Tripterygium drug were excluded. Patients with concurrent serious disease, including primary cardiac, cerebral, pulmonary, hepatic, hematological, psychiatric disease, and pregnancy or lactation were also not included.

Study & Design

Study Type
Interventional study
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
24-hour Proteinuria;Urea Nitrogen;Adverse Events;eGFR;Serum Creatine;Serum Creatinine;blood routine examination;
Secondary Outcome Measures
NameTimeMethod
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