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Ef?cacy and safety of Yiqi Peiyuan granules for patients with acute kidney injury: a multicenter double-blind placebo-controlled randomized trial

Ef?cacy and safety of Yiqi Peiyuan granules for patients with acute kidney injury: a multicenter double-blind placebo-controlled randomized trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2025000788
Enrollment
Unknown
Registered
2025-04-18
Start date
2025-04-04
Completion date
Unknown
Last updated
2025-04-28

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

Conditions

acute kidney injury

Interventions

Integrated Traditional Chinese and Western Medicine Treatment Group:Yiqi Peiyuan granules and Western Medicine basic treatment

Sponsors

Renji Hospital Af?liated to Shanghai Jiaotong University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1) Diagnosis of AKI based on KDIGO criteria; 2) Patient age between 18 and 75 years old; 3) Etiological diagnosis of renal AKI (such as drug-induced kidney injury infection progression of primary disease etc.); 4) Signed informed consent.

Exclusion criteria

Exclusion criteria: 1) Patients with history of mental illness or those who are mentally confused unable to cooperate severely hypoxic restless and require emergency treatment; 2) Patients known to be allergic to the medication used; 3) Those currently participating in other drug clinical trials or who have taken traditional Chinese medicine compounds within the past week; 4) Those anticipated to require dialysis treatment within 72 hours after enrollment; 5) Patients with comorbid Stage 5 chronic kidney disease; 6) AKI considered to be caused by the use of ACEI/ARB medications; 7) Pregnant women; 8) Other situations where the investigator deems it inappropriate for the patient to participate in the trial

Design outcomes

Secondary

MeasureTime frame
The change in eGFR from baseline.;Incidence of cardiovascular events;The change in creatinine from baseline.;Incidence of dialysis treatment;Change in Traditional Chinese Medicine (TCM) syndrome score from baseline;Metabolomics analysis;

Primary

MeasureTime frame
The change in eGFR from baseline.;

Countries

China

Contacts

Public ContactShan Mou

Renji Hospital Af?liated to Shanghai Jiaotong University School of Medicine

shan_mou@126.com+8613918221242

Outcome results

None listed

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