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Clinical evidence-based evaluation study on the treatment of acute renal failure with qi deficiency and blood stasis by hushenxiaoyuxiezhuo decoction

Clinical evidence-based evaluation study on the treatment of acute renal failure with qi deficiency and blood stasis by hushenxiaoyuxiezhuo decoction

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2025001533
Enrollment
Unknown
Registered
2025-08-05
Start date
2025-08-15
Completion date
Unknown
Last updated
2025-08-18

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

Conditions

Acute Kidney Injury

Interventions

Experimental group:(1) Kidney protection and stasis and turbidity drink: raw astragalus, cooked rhubarb, angelica, baiji, peach kernel, plantain, leeches, etc. Course of administration: 4 weeks, once
Control group:(1) Placebo of traditional Chinese medicine granules: Ingredients are made of 10% of the original drug ingredients plus dextrin. Course of administration: 4 weeks, 1 bag each time, 2 tim

Sponsors

the First Affiliated Hospital of Zhejiang Chinese Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1) Age 18-75 years old; 2) The patient meets the diagnosis of AKI as assessed by a specialist of intermediate rank or above in the Department of Nephrology; 3) If the diagnosis of malignant tumor is clearly diagnosed by clinicopathology the life expectancy is = 6 months; 4) If treated with ICIs (treatment regimen follows the 2024 CSCO Guidelines for the Clinical Application of Immune Checkpoint Inhibitors either alone or in combination not in combination with cisplatin) meets the ICIs-AKI staging of G1-G3 of the ICI nephrotoxicity staging in the Chinese Society of Clinical Oncology (CSCO) Guidelines for Management of Toxicity Associated with Immunocheckpoint Inhibitors 2023 and meets the randomized stratification. 5) The patient or the patient's authorized person gave informed consent and signed the informed consent form.

Exclusion criteria

Exclusion criteria: 1) Clear diagnosis of obstructive acute kidney injury; 2) The presence of uncorrectable hyperkalemia heart failure etc. is consistent with emergency hemodialysis; 3) The presence of uncontrollable complex diseases including symptomatic congestive heart failure uncontrollable hypertension unstable angina active peptic ulcer or bleeding disorders; 4) Accompanied by an infectious disease such as tuberculosis or a history of mental illness; 5) Women who are pregnant or preparing for pregnancy or breastfeeding; 6) Those who are participating in other interventional clinical trials or have participated in other clinical trials within 12 weeks; 7) Patients with a history of allergy or contraindication to the drugs used in this study.

Design outcomes

Primary

MeasureTime frame
eGFR;

Secondary

MeasureTime frame
Ratio of Scr to baseline Scr;FBG;PLT;Scr;Chinese medicine evidence score;Urine protein characterization;24h Upro;TG;Chinese Medicine Cognitive Score;TC;ECG;BUN;Urine micro-protein/urine creatinine;urine CXCL9;WBC;Hb;HCT;

Countries

China

Contacts

Public ContactXiangfu Gao

the First Affiliated Hospital of Zhejiang Chinese Medical University

gaoxf6016@126.com135 0571 6016

Outcome results

None listed

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