Actively Recruiting
Evaluating a Nitric Oxide Generator, Nebivolol as a Disease Modifier in Patients With Diabetic Neuropathy.
Led by St. John's Research Institute · Updated on 2025-02-04
120
Participants Needed
2
Research Sites
71 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The goal of this clinical trial is to test in patients with diabetic neuropathy, * Can Nevibolol at a dose of 2.5 mg- 10 mg compared with standard pain modulating treatment conserve the mean nerve action potential amplitude (sural and tibial nerves) at 24 weeks follow- up. * Can Nevibolol at a dose of 2.5 mg- 10 mg compared with a combination of Alpha Lipoic Acid (600 mg/day)+EPALRESTAT (150 mg/day) conserve the mean nerve action potential amplitude (sural and tibial nerves) at 24 weeks follow- up * All potential participants will undergo screening- about 10 ml of blood will be drawn to perform the following assesments at screening- HbA1c, FBS,Vit B12, TSH, fT4. * Baseline assessments conducting a nerve conduction study, quality of life assesment using Eq-5D-5L and NRS pain score. * 20% of patients (24 patients) will undergo Sudoscan, Corneal confocal microscopy and a skin biopsy for assessing IENFD (Intra Epidermal Nerve Fibre Density). * 15th day, 1 month and 3rd month followup for evaluating patients status and medication adherance. * 6th month followup for evaluating patients status and medication adherance. Researchers will compare Nebivolol against combination of Epalrestat+Alpha Lipoic Acid against standard pain modulating treatment to evaluate their diseaes modifying effect as reflected by nerve conduction study parameters.
CONDITIONS
Official Title
Evaluating a Nitric Oxide Generator, Nebivolol as a Disease Modifier in Patients With Diabetic Neuropathy.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged 18 years or older diagnosed with diabetes within the last 5 years
- HbA1c less than 9% with stable blood sugar control for the past 3 months
- Evidence of neuropathy by abnormal nerve conduction studies and either diabetic neuropathy symptoms or disability scores
You will not qualify if you...
- Presence of heart conditions contraindicating Nebivolol, such as sick-sinus syndrome, resting heart rate below 50, second or third degree heart blocks, severe asthma or COPD, and acute heart failure
- Need for non-dihydropyridine calcium channel blockers
- Requirement for other beta-blockers as judged by treating physician
- Patients who have had or are awaiting major lower limb amputations
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
St John's Medical College Hospital
Bangalore, Karnataka, India, 560034
Actively Recruiting
2
St John's Research Institute
Bangalore, Karntakaka, India, 560034
Not Yet Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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