The Clinical Research of Traditional Chinese Medicine Compound Formulas

Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-65
SponsorThe Fourth Affiliated Hospital of Zhejiang University School of Medicine

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Shenkangling

    Drug

    Chinese herbal tonics taken orally: Shenkangling, one dose, 2 times a day, 1 time before breakfast and 1 time 30 minutes after dinner.

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: control groupNo intervention 0 interventions
Group B: Shenkangling groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Rate of 24-hour urine protein excretion

Time frame
From enrollment to the end of treatment at 8 weeks
2

Levels of renal function

Biochemical tests for blood creatinine and urea nitrogen

Time frame
From enrollment to the end of treatment at 8 weeks
3

Specific gravity of urine

Time frame
From enrollment to the end of treatment at 8 weeks
4

blood viscosity

By measuring the flow rate of blood in capillaries to evaluate blood viscosity

Time frame
From enrollment to the end of treatment at 8 weeks

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

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