Evaluating a Nitric Oxide Generator, Nebivolol as a Disease Modifier in Patients With Diabetic Neuropathy.

PHASE2/PHASE3RecruitingINTERVENTIONAL
Enrollment

120

Participants

Timeline

Start Date

November 15, 2024

Primary Completion Date

December 30, 2025

Study Completion Date

March 30, 2026

Conditions
Diabetic Neuropathy Peripheral
Interventions
DRUG

Nebivolol+ Standard care arm

This arm will receive tablet Nebivolol 2.5 mg OD uptitrated at 2 weeks to 5 mg and at 4 weeks if well tolerated to 10 mg/day which the participant will continue upto week 24

DRUG

Epalrestat + Alpha Lipoic Acid +Standard care

This arm will receive tablet Epalrestat -150mg OD+ cap Alpha Lipoic Acid 600mg OD for 24 weeks.

DRUG

Standard care alone

Patients in this arm will receive standard care as judged by their treating physicians which is generally pain modifying treatment.

Trial Locations (2)

560034

RECRUITING

St John's Medical College Hospital, Bangalore

NOT_YET_RECRUITING

St John's Research Institute, Bangalore

All Listed Sponsors
lead

St. John's Research Institute

OTHER