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A randomized, double-blind, placebo-controlled clinical and mechanism study on the intervention of the core formula for tonifying qi and enriching essence in the progression of IgA nephropathy

A randomized, double-blind, placebo-controlled clinical and mechanism study on the intervention of the core formula for tonifying qi and enriching essence in the progression of IgA nephropathy

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2025002227
Enrollment
Unknown
Registered
2025-11-17
Start date
2026-01-01
Completion date
Unknown
Last updated
2025-12-08

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

Conditions

IgAN

Interventions

The integrated traditional Chinese and Western medicine treatment group:The Yiqi Peiyuan Formula combined with basic Western medical treatment

Sponsors

Punan Hospital, Pudong New Area, Shanghai
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1) Patients diagnosed with IgA nephropathy through renal biopsy; 2) Patients who have been regularly followed up at the participating research center; 3) 18-75 years old; 4) Within 3 months before the start of the study, no steroid or immunosuppressive agent treatment was used; 5) Within 1 month before the start of the study, standard treatment had been applied: lifestyle improvement + the maximum tolerated dose of ACEI/ARB for the patient + active control of blood pressure, blood sugar and blood lipids; 6) 24-hour urine protein greater than 0.5g/d; 7) Signed the informed consent form.

Exclusion criteria

Exclusion criteria: 1) Expected survival time shorter than 3 months; 2) Known allergy to the test drug; 3) Secondary IgA nephropathy; 4) Unable to follow up regularly; 5) eGFR less than 15 ml/min; 6) Acute renal failure patients; 7) Patients with mental disorders; 8) Pregnant or lactating women; 9) Severe infection, uncontrolled water and electrolyte disorders that cannot be effectively controlled; 10) Patients currently participating in other drug clinical trials or having participated in other clinical trials within the past 3 months.

Design outcomes

Primary

MeasureTime frame
serum creatinine;urea nitrogen;Glomerular Filtration Rate;24-hour urine protein quantification;Urine albumin to creatinine ratio;

Secondary

MeasureTime frame
Traditional Chinese Medicine Syndrome Indicators;

Countries

China

Contacts

Public ContactLumin Tang

Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University

naturetlm@126.com+86 135 6448 7181

Outcome results

None listed

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