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A real world study of Yiqi Jianpi Xiaoyu Formula in the treatment of mid-to-late stage IgA nephropathy

Development of in-hospital preparation of traditional Chinese medicine based on phased treatment of IgA nephropathy

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ITMCTR
Registry ID
ITMCTR2025000239
Enrollment
Unknown
Registered
2025-02-10
Start date
2025-06-01
Completion date
Unknown
Last updated
2025-03-03

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

Conditions

IgA nephropathy

Interventions

TCM group:Yiqi Jianpi Xiaoyu Formula
Integrated Traditional Chinese and Western Medicine Group:Yiqi Jianpi Xiaoyu Formula combined with half-dose Compound a-Ketoacid Tablets
Western medicine group:Compound a-Ketoacid Tablets

Sponsors

The Third Affiliated Hospital of Zhejiang Chinese Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: (1) Meetting the diagnostic criteria of CKD stage 3-4 of Western medicine and have not undergone renal replacement therapy;(2) CKD in line with TCM qi deficiency and stasis syndrome;(3) Aged 18~75 years old gender is not limited;(4) Agree to the treatment of this study join the management of chronic diseases and sign the informed consent form;(5) No other drug tests have been carried out in the past 3 months or have been effective drug washout period.

Exclusion criteria

Exclusion criteria: (1) Accompanied by severe organ lesions;(2) Allergy to or contraindication to the use of drugs involved in the study protocol;(3) Renal replacement therapy should be carried out immediately if renal failure or chronic renal failure with acute exacerbation is prepared or has been used for kidney transplantation;(4) hypercalcemia or amino acid metabolism disorder;(5) Pregnant or lactating women;(6) Have a history of mental illness or poor compliance with communication and cognitive dysfunction and cannot cooperate.

Design outcomes

Primary

MeasureTime frame
ALA;Slope of eGFR;PA;

Secondary

MeasureTime frame
Proportion of new cardiovascular events;UACR;SGA score;TCM syndrome score;Percentage of end-stage renal disease occurrence: eGFR <10mL/(min-1.73m²) or renal replacement therapy;

Countries

China

Contacts

Public ContactLu Keda

The Third Affiliated Hospital of Zhejiang Chinese Medical University

lukedaq@126.com13757175879

Outcome results

None listed

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