Melatonin for Clinical Improvement in Patients with Ischemic Stroke: A Randomized Clinical Trial

Abstract

Background: Ischemic stroke is the most frequent form of stroke, which imposes considerable cost and causes disabilities for the patients. Melatonin is proven to have anti-oxidant along with anti-inflammatory effects. Objectives: The present study aimed to examine the effects of melatonin on clinical features of acute stroke in Iranian patients. Methods: This randomized clinical trial was conducted on 58 patients who were admitted to Valiasr Hospital and Neurology Center in Arak, Iran, from April 2016 to April 2017. Inclusion criteria were: age ≥ 50 years and diagnosis of acute ischemic stroke. All participants were asked to fill out informed consent forms before entering the study. Through simple randomization, an expert nurse divided cases into two groups of 29 people: Group 1 as the intervention group: ASA 80mg/day + Plavix 75 mg/day + melatonin 3 mg (every night one pill for two months), Group 2 as the control group: ASA 80 mg/day + Plavix 75 mg/day + placebo (every night one pill for two months). Canadian Neurological Stroke Scale (CNSS) was recorded for all cases before and after treatment. Results: Mean age, sex, circulation, cardiovascular accident incidence time, and symptoms were not significantly different between the two groups. Mean of the CNSS was significantly higher after the treatment in both groups. It improved significantly more in the intervention group than in the control group. Conclusion: Findings of the present study showed that CNSS improved more in the intervention group than in the control group. Therefore, melatonin administration in patients with ischemic stroke will result in better clinical improvements.