Prospective, randomized, double-blind, controlled, multi-center clinical study for Hushen Yiqi Granule in the treatment of IgA nephropathy
- Conditions
- IgA nephropathy
- Registration Number
- ITMCTR1900002842
- Lead Sponsor
- Renji Hospital affiliated to Shanghai Jiaotong University School of Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- Not specified
1. Pathological diagnosis of patients with IgA nephropathy;
2. 24-hour urine protein quantitation >= 1.0g (two tests, interval > 7 days), or CKD 2-4;
3. Aged 18-80 years;
4. Sign the informed consent form.
1. Combine life-threatening complications such as severe infections, new malignant tumors, severe water-electrolyte disorders, severe heart, brain, liver, hematopoietic system, and gastrointestinal tract such as vital organ diseases or dysfunctions;
2. Those who are known to be allergic to the drugs used;
3. Patients with mental illness;
4. Pregnant or lactating women;
5. Being accepted by other clinical trials;
6. Patients with secondary IgA nephropathy;
7. Patients with IgA nephropathy who present with progressive nephritis;
8. Other persons who have no capacity for civil conduct and limit their capacity for civil conduct.
Study & Design
- Study Type
- Interventional study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method ;Proteinuria increased by 50% from baseline ;
- Secondary Outcome Measures
Name Time Method ew onset of cardiovascular events requiring hospitalization;New onset of infection requiring hospitalization;Patient enter the ESRD stage ;