Melatonin in Stroke

The registry criteria, word for word

What the trial wants to find out

Acute ischemic stroke (AIS) is a leading cause of mortality and disability worldwide, placing a substantial burden on healthcare systems and society.1 Despite intensive advancements in the stroke care, incomplete neurological recovery after stroke is quite common, with many survivors experiencing persistent motor, cognitive, or sensory deficits.2 These long-term impairments significantly affect the quality of life and highlight the need for additional neurorestorative therapies.3,4 The pathophysiology of ischemic stroke involves a complex cascade of events including excitotoxicity, oxidative stress, inflammation, and apoptosis, which contribute to neuronal injury and limit functional recovery.5,6 Current treatment strategies primarily focus on revascularization and supportive care, with limited options available to actively promote neuroprotection and regeneration.7,8 Melatonin, an endogenous neurohormone hormone primarily involved in regulating sleep-wake cycles, has been shown to possess several potential therapeutic properties, including antioxidant, anti-inflammatory, and neuroprotective effects.9 These properties have led to investigate the use of melatonin as an adjunctive treatment for various conditions, including stroke.10,11 However, its potential benefit in recovery of neurological status in patients with acute ischemic stroke remains understudied.12 Pre-clinical studies have demonstrated that melatonin can attenuate ischemia-induced brain injury, reduce infarct size, and improve functional outcomes.13 There is a compelling need to explore novel therapeutic interventions that can target neurological recovery in stroke patients. Exogenous melatonin administration offers a promising avenue for this intervention.14, 15 Preliminary studies have shown that melatonin may protect against acute ischemic stroke by suppressing both inflammatory and oxidative stresses.16 The purpose of this study is to evaluate the effects of exogenous melatonin supplementation on the neurological and functional recovery in patients with acute ischemic stroke, potentially leading to improved clinical outcomes. By addressing this research gap, the study seeks to provide valuable insights into the potential role of melatonin as a therapeutic agent in the management of acute ischemic stroke.

The 2 groups in the trial

• melatonin groupTreatment being tested

  Treatment: Melatonin

• control groupPlacebo, for comparison

  Treatment: Placebo