Pahlavani Naseh, Sedaghat Alireza, Bagheri Moghaddam Ahmad, Mazloumi Kiapey Seyedeh Shabnam, Gholizadeh Navashenaq Jamshid, Jarahi Lida, Reazvani Reza, Norouzy Abdolreza, Nematy Mohsen, Safarian Mohammad, Ghayour-Mobarhan Majid
Student Research Committee, Faculty of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran.
Cardiac Anesthesia Research Center, Mashhad University of Medical Sciences, Mashhad, Iran.
Clin Nutr ESPEN. 2019 Oct;33:125-131. doi: 10.1016/j.clnesp.2019.06.007. Epub 2019 Jul 5.
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.
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.
Iranian Registry of Clinical Trials: IRCT20181025041460N1. Registered on 6 November 2018.
以往的研究在实验研究中探讨了蜂胶和褪黑素的抗炎、抗感染及减轻氧化应激的作用。然而，目前尚无研究探讨蜂胶和褪黑素对原发性脓毒症患者的影响。本研究旨在评估蜂胶和褪黑素作为药物制剂对原发性脓毒症患者的潜在作用。
方法/设计：本研究将在伊玛目礼萨医院作为一项随机对照临床试验进行。将招募患有原发性脓毒症的患者，分为四组，每组人数相等。治疗药物为蜂胶、褪黑素和安慰剂。将评估以下主要和次要结局指标：急性生理与慢性健康状况评分系统II（APACHE II）评分、序贯器官衰竭评估（SOFA）评分、营养风险及预后评估（NUTRIC）评分、炎症因子和氧化应激标志物。
我们描述了一项临床试验设计方案，该方案旨在评估同时给予蜂胶和褪黑素对原发性脓毒症患者的影响。本研究的结果，无论阳性或阴性，都应为指导当前和未来关于将蜂胶和褪黑素作为原发性脓毒症患者辅助治疗的政策提供证据方面的重大改变。
伊朗临床试验注册中心：IRCT20181025041460N1。于2018年11月6日注册。
