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A randomized controlled trial evaluating the jiangniaosuan formulation as a treatment for hyperuricemic nephropathy at CKD stages 3-4 patients

Not Applicable
Conditions
hyperuricemic nephropathy at CKD stages 3-4
Registration Number
ITMCTR2100005088
Lead Sponsor
Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Pending
Sex
All
Target Recruitment
Not specified
Inclusion Criteria

1. Meet the diagnostic criteria for uric acid nephropathy and TCM syndromes;
2. Age 18-75 years old, with independent behavior ability, no gender limitation;
3. Glomerular filtration rate: 15ml/min<=eGFRCKD-EPI-ASIA<60ml/min;
4. No renal replacement therapy;
5. Sign the informed consent to enter the clinical research.

Exclusion Criteria

1. Those with allergies or allergic constitution to the test drugs and control drugs;
2. Pregnant or lactating female patients;
3. Patients with abnormal liver function (ALT or AST exceeds the upper limit of normal by 2 times or more);
4. Combined with serious primary diseases such as nervous, cardiovascular, digestive, urinary, endocrine and hematopoietic systems, mental patients;
5. Those who are participating in other clinical drug trials;
6. Those who have received similar treatment within 2 weeks before the trial;
7. Patients with uric acid nephropathy with proteinuria (proteinuria>1g/d) or diabetes or hereditary kidney disease.

Study & Design

Study Type
Interventional study
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
rinary N-acetyl-ß-D-glucosaminidase;Estimated glomerular filtration rate;Urinary ß2-microglobulin;
Secondary Outcome Measures
NameTimeMethod
Chinese medicine clinical symptom score;Urinary microalbumin-creatinine ratio;24-hour urinary protein quantity;Blood urea nitrogen;Serum uric acid;Serum creatinine;24-hour urine uric acid;Urinary retinol binding protein;Kidney B ultrasound;Nitric oxide;
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