RecruitingPhase 2Phase 3NCT06441591

Clinical Outcome of Vinpocetine in Diabetic Nephropathy

The Effect of Vinpocetine on the Clinical Outcome of Patients With Diabetic Nephropathy


Sponsor

Ain Shams University

Enrollment

64 participants

Start Date

Jul 10, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

The goal of this controlled, randomized, clinical trial is to evaluate the effect of vinpocetine on clinical outcomes on the diabetic nephropathy patients. The following will be evaluated; anthropometrics, kidney functions, glucose panel, lipid panel, ICAM-1, quality of life. Participants will receive either vinpocetine or placebo, twice daily for 3 months.


Eligibility

Min Age: 18 Years

Inclusion Criteria4

  • Age ≥ 18 years,
  • Type II diabetic patients with CKD stage 3 (eGFR = 30 - 59 ml/min) or stage 4 (eGFR 15-29 ml/min),
  • Albumin/Creatinine ratio (ACR): 30 - 300 μg /mg (microalbuminuria),
  • Stable standard therapy for at least three months prior to inclusion in the study.

Exclusion Criteria8

  • Kidney donor or recipient,
  • Active malignancy,
  • Pregnancy or breastfeeding,
  • Known intolerance or hypersensitivity to VPN,
  • Participation in other interventional trials,
  • Patients with inadequate liver function (ALT and AST three times greater than the upper normal limits),
  • Patients with severe comorbidities
  • Patients receiving warfarin

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Interventions

DRUGVinpocetine

Vinca derivative of apovincamine, phosphodiestrase 1 inhibitor, sodium-gated voltage channel

DRUGStandard Therapy

Anti-hypertensive and anti-diabetic medications according to the the institution's protocol

OTHERPlacebo

Starch-filled capsules, matching those of the intervention


Locations(2)

Ain Shams University Hospital

Cairo, Abbasseia, Egypt

Ain Shams Hospitals

Cairo, Abbasseya, Egypt

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NCT06441591


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