Efficacy and Safety of Fixed Dose Combination of Inosine Monophosphate, Agmatine Sulphate, and L-Carnosine (CGXNW) as Add-on Therapy for the Management of Spinal Cord Injury - A Randomized Controlled Clinical Trial.

INTRODUCTION

A prospective, single-center, randomized, controlled, parallel-arm clinical trial involving 120 patients with subacute spinal cord injury (SCI). Participants were randomized (1:1) to receive standard care alone or standard care plus CGXNW for 6 months. Neurological recovery, functional independence, and safety were systematically evaluated.

PURPOSE: To determine whether CGXNW, a multi-target neurorestorative formulation, can improve motor and sensory recovery, functional independence, and quality of life (QOL) when used as an adjunct to conventional therapy in subacute SCI.

OVERVIEW OF LITERATURE: SCI results in long-term neurological deficits with limited restorative pharmacotherapies. Mechanistic targets include excitotoxicity, oxidative stress, and impaired neuroplasticity. Inosine, agmatine, and L-carnosine individually demonstrate neuroprotective and neuroregenerative potential.

MATERIALS AND

METHODS

Eligible subacute SCI patients were allocated into two arms receiving either routine institutional management or adjunct CGXNW for 180 days. Neurological status (international standards for neurological classification of spinal cord injury motor/sensory, ASIA impairment scale), independence (spinal cord independence measure III [SCIM-III] domains), quality-of-life scores, and adverse events were recorded at pre-defined intervals.

RESULTS

The CGXNW group demonstrated significantly greater improvements in motor scores, SCIM-III total scores, and QOL at Day 180 compared to the standard treatment group. Sensory scores showed no significant differences. Only three minor, short-lasting adverse events were seen in the CGXNW group, with no serious events reported.

CONCLUSION

CGXNW as an adjunct to standard care significantly enhances motor function, functional independence, and QOL in subacute SCI, with a favorable safety profile. Larger, multicenter trials are needed to confirm these findings and assess long-term outcomes.