Actively Recruiting
The Effect of Vinpocetine on the Clinical Outcome of Patients With Diabetic Nephropathy
Led by Ain Shams University · Updated on 2024-07-11
64
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating the effect of vinpocetine on clinical outcomes in patients with diabetic nephropathy, a serious kidney complication affecting about half of people with type 2 diabetes. This condition involves kidney damage caused by complex factors like high blood sugar, inflammation, and oxidative stress. Current treatments do not always stop the disease from worsening to kidney failure, so this study explores vinpocetine, a drug with antioxidant and anti-inflammatory properties, as a potential new option. The trial is a randomized controlled study sponsored by Ain Shams University. Participants will be randomly assigned to receive either vinpocetine capsules, 30 mg twice daily with meals, or matching placebo capsules, also taken twice daily with meals. Both treatments will be taken for 3 months alongside their usual standard therapy, which includes anti-hypertensive and anti-diabetic medications. The study will measure changes in kidney function and other health markers before and after the treatment period. During the study, researchers will assess various health outcomes including albuminuria levels, kidney function tests (such as serum creatinine and blood urea nitrogen), blood sugar control (including HbA1c and glucose levels), lipid profiles, body mass index, endothelial function, and quality of life. These measurements will be taken at the start and after 12 weeks. Participants will be monitored for safety and treatment adherence throughout the trial, which aims to better understand vinpocetine's impact on diabetic kidney disease.
CONDITIONS
Brief Title
Clinical Outcome of Vinpocetine in Diabetic Nephropathy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Diagnosed with type II diabetes and chronic kidney disease stage 3 (eGFR 30-59 ml/min) or stage 4 (eGFR 15-29 ml/min)
- Albumin to creatinine ratio between 30 and 300 micrograms per milligram
- Stable use of standard therapy for at least 3 months before joining the study
You will not qualify if you...
- Kidney donor or recipient
- Active cancer
- Pregnant or breastfeeding
- Known allergy or intolerance to vinpocetine
- Participation in other interventional clinical trials
- Poor liver function with ALT or AST levels three times above normal
- Severe other medical conditions
- Currently taking warfarin medication
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 3 months
Participants receive Vinpocetine or placebo capsules twice daily with meals, alongside standard therapy, to evaluate effects on diabetic nephropathy.
Visits at baseline and after 12 weeks for sample collection and assessments
Trial Site Locations
Total: 2 locations
1
Ain Shams University Hospital
Cairo, Abbasseia, Egypt, 11588
Not Yet Recruiting
2
Ain Shams Hospitals
Cairo, Abbasseya, Egypt, 11588
Actively Recruiting
Research Team
T
Tamer El Said
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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