The Clinical Research of Traditional Chinese Medicine Compound Formulas
Observation on the Clinical Efficacy of Shenkangling in the Treatment of Renal Ischemia-reperfusion Injury (Kidney Deficiency and Blood Stasis Syndrome)
1 other identifier
interventional
100
1 country
1
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 clinical therapeutic use.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Oct 2025
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 11, 2025
CompletedFirst Posted
Study publicly available on registry
September 4, 2025
CompletedStudy Start
First participant enrolled
October 1, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2027
ExpectedSeptember 4, 2025
September 1, 2025
Same day
May 11, 2025
September 3, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (12)
Rate of 24-hour urine protein excretion
From enrollment to the end of treatment at 8 weeks
Levels of renal function
Biochemical tests for blood creatinine and urea nitrogen
From enrollment to the end of treatment at 8 weeks
Specific gravity of urine
From enrollment to the end of treatment at 8 weeks
blood viscosity
By measuring the flow rate of blood in capillaries to evaluate blood viscosity
From enrollment to the end of treatment at 8 weeks
Levels of renal fibrosis（CⅣ、PCⅢ、CTGF、TIMP-1）
From enrollment to the end of treatment at 8 weeks
Levels of electrolytes
Mainly includes the following indicators: Potassium ion, Sodium ion, Chloride ion, Calcium ions.
From enrollment to the end of treatment at 8 weeks
Levels of urobilinogen
From enrollment to the end of treatment at 8 weeks
Occult blood in urine
From enrollment to the end of treatment at 8 weeks
White blood cell count of urine
From enrollment to the end of treatment at 8 weeks
Red blood cell count of urine
From enrollment to the end of treatment at 8 weeks
Levels of urine NAG enzyme
From enrollment to the end of treatment at 8 weeks
Levels of urine β2-microglobulin
From enrollment to the end of treatment at 8 weeks
Study Arms (2)
control group
NO INTERVENTIONNo treatment
Shenkangling group
EXPERIMENTALShenkangling
Interventions
Chinese herbal tonics taken orally: Shenkangling, one dose, 2 times a day, 1 time before breakfast and 1 time 30 minutes after dinner.
Eligibility Criteria
You may qualify if:
- 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
- ≤ age ≤ 65
- Voluntary participation with signed informed consent
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The Fourth Affiliated Hospital of Zhejiang University School of Medicine
Yiwu, Zhejiang, 322000, China
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 11, 2025
First Posted
September 4, 2025
Study Start
October 1, 2025
Primary Completion
October 1, 2025
Study Completion (Estimated)
July 1, 2027
Last Updated
September 4, 2025
Record last verified: 2025-09
Data Sharing
- IPD Sharing
- Will not share