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Prospective, randomized, double-blind, controlled, multi-center clinical study for Hushen Yiqi Granule in the treatment of IgA nephropathy

Prospective, randomized, double-blind, controlled, multi-center clinical study for Hushen Yiqi Granule in the treatment of IgA nephropathy

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR1900002842
Enrollment
Unknown
Registered
2019-12-16
Start date
2020-12-16
Completion date
Unknown
Last updated
2023-02-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

IgA nephropathy

Interventions

experimental group:Hushen Yiqi Granule combined with basic treatment of western medicine

Sponsors

Renji Hospital affiliated to Shanghai Jiaotong University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

MeasureTime frame
;Proteinuria increased by 50% from baseline ;

Secondary

MeasureTime frame
New onset of cardiovascular events requiring hospitalization;New onset of infection requiring hospitalization;Patient enter the ESRD stage ;

Countries

China

Contacts

Public ContactZhaohui Ni
profnizh@126.com+86 18918358557

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Feb 4, 2026