Naseh Pahlavani1, Alireza Sedaghat2, Ahmad Bagheri Moghaddam3, Seyedeh Shabnam Mazloumi Kiapey4, Jamshid Gholizadeh Navashenaq5, Lida Jarahi6, Reza Reazvani4, Abdolreza Norouzy7, Mohsen Nematy4, Mohammad Safarian8, Majid Ghayour-Mobarhan9. 1. Student Research Committee, Faculty of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran. 2. Cardiac Anesthesia Research Center, Mashhad University of Medical Sciences, Mashhad, Iran. 3. Department of Internal Medicine and Critical Care, Faculty of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran. 4. Department of Nutrition, Faculty of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran. 5. Immunology Research Center, Faculty of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran. 6. Department of Community Medicine, Faculty of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran. 7. Department of Clinical Nutrition, School of Nutritional Sciences and Dietetics, Tehran University of Medical Sciences, Tehran, Iran. 8. Department of Nutrition, Faculty of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran. Electronic address: SafarianM@mums.ac.ir. 9. Metabolic Syndrome Research Center, Mashhad University of Medical Sciences, Mashhad, Iran; Cardiovascular Research Center, Mashhad University of Medical Sciences, Mashhad, Iran. Electronic address: ghayourm@mums.ac.ir.
Abstract
BACKGROUND: Previous studies have explored the anti-inflammatory, anti-infection and oxidative stress reduction effects of propolis and melatonin in experimental studies. However, there are no studies at present exploring the effects of propolis and melatonin in patients with primary sepsis. The present study aims to evaluate the potential effects of propolis and melatonin as a pharmaceutical agent in patients with primary sepsis. METHODS/ DESIGN: The study will be conducted as a randomized controlled clinical trial at the Imamreza hospital. Patients with primary sepsis, in four equal groups, will be recruited for the study. The treatment drugs are propolis and melatonin and the placebo. The following primary and secondary outcome measures will be evaluated: APACHE II Score, SOFA score, NUTRIC score, inflammatory factors, and oxidative stress markers. DISCUSSION: We describe the protocol for a clinical trial design evaluating the effects of simultaneous administration of propolis and melatonin in patients with primary sepsis. The result of the present study, positive or negative, should provide a step change in the evidence guiding current and future policies regarding the use of propolis and melatonin as an auxiliary treatment in patients with primary sepsis. TRIAL REGISTRATION: Iranian Registry of Clinical Trials: IRCT20181025041460N1. Registered on 6 November 2018.
RCT Entities:
BACKGROUND: Previous studies have explored the anti-inflammatory, anti-infection and oxidative stress reduction effects of propolis and melatonin in experimental studies. However, there are no studies at present exploring the effects of propolis and melatonin in patients with primary sepsis. The present study aims to evaluate the potential effects of propolis and melatonin as a pharmaceutical agent in patients with primary sepsis. METHODS/ DESIGN: The study will be conducted as a randomized controlled clinical trial at the Imamreza hospital. Patients with primary sepsis, in four equal groups, will be recruited for the study. The treatment drugs are propolis and melatonin and the placebo. The following primary and secondary outcome measures will be evaluated: APACHE II Score, SOFA score, NUTRIC score, inflammatory factors, and oxidative stress markers. DISCUSSION: We describe the protocol for a clinical trial design evaluating the effects of simultaneous administration of propolis and melatonin in patients with primary sepsis. The result of the present study, positive or negative, should provide a step change in the evidence guiding current and future policies regarding the use of propolis and melatonin as an auxiliary treatment in patients with primary sepsis. TRIAL REGISTRATION: Iranian Registry of Clinical Trials: IRCT20181025041460N1. Registered on 6 November 2018.