Status:
NOT_YET_RECRUITING
The Clinical Research of Traditional Chinese Medicine Compound Formulas
Lead Sponsor:
The Fourth Affiliated Hospital of Zhejiang University School of Medicine
Conditions:
Urologic Injuries
Urology
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
Brief Summary
To observe the efficacy and safety of Shenkangling, a traditional Chinese medicine decoction, for renal ischemia-reperfusion injury, and to provide evidence-based medical evidence and ideas for clinic...
Detailed Description
1\. Study Design and Methods 1.1 Research Method A multicenter, open-label study design is employed. 1.2 Source of Participants Clinical observation cases are from patients with ischemia-reperfusion i...
Eligibility Criteria
Inclusion
- Fulfillment of western medical diagnostic criteria requiring renal ischemia-reperfusion surgical operation and renal artery clamping time ≤ 30 min
- Meets the criteria for Chinese medicine identification
- 18 ≤ age ≤ 65
- Voluntary participation with signed informed consent
Exclusion
- Patients with stage 4 or 5 renal insufficiency or patients with acute renal failure
- Those with secondary factors such as systemic lupus erythematosus, drug-induced renal damage, etc. confirmed by examination
- Does not meet the diagnosis of renal ischemia-reperfusion injury
- Cases not within the scope of action of the drug
- Those who have been taking other related therapeutic drugs for a long period of time, e.g., taking Chinese medicines such as Jingui Shenqi Pills by mouth for a long period of time, or those who are unable to stop taking the medicines immediately.
- Advanced deformity, disability, loss of labor force
- Combined heart, brain, liver, hematopoietic system, endocrine system and other serious primary diseases and psychiatric patients
- Pregnant or lactating women
- Critically ill patients
- Other circumstances deemed inappropriate for inclusion in the study
Key Trial Info
Start Date :
October 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2027
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT07153731
Start Date
October 1 2025
End Date
July 1 2027
Last Update
September 4 2025
Active Locations (1)
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1
The Fourth Affiliated Hospital of Zhejiang University School of Medicine
Yiwu, Zhejiang, China, 322000