Effects of propolis and melatonin on oxidative stress, inflammation, and clinical status in patients with primary sepsis: Study protocol and review on previous studies.

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.