Karimi Elham, Khorvash Fariborz, Arab Arman, Sepidarkish Mahdi, Saadatnia Mohammad, Amani Reza
Department of Clinical Nutrition, School of Nutrition and Food Sciences, Isfahan University of Medical Sciences, Isfahan, Iran.
Research Development Center, Arash Women's Hospital, Tehran University of Medical Sciences, Tehran, Iran.
BMC Nutr. 2023 Feb 16;9(1):32. doi: 10.1186/s40795-023-00690-4.
Stroke is a debilitating disease that affects over 15 million people worldwide each year, resulting in the death of one-third of those people and severe disability in two-thirds of survivors. Previous studies reported various health benefits of Royal jelly in the context of its anti-inflammatory properties. We will aim to investigate the effects of royal jelly supplementation on oxidative stress, inflammatory mediators, mental health, cognitive function, quality of life, and clinical outcomes of patients with ischemic stroke.
The present study will be a triple-blind randomized placebo trial. Patients who meet our eligibility criteria will be assigned to the intervention or the control groups to receive allocated intervention for 12 weeks. Individuals of the intervention group will consume 1000 mg of Royal jelly dragee daily after breakfast. Subjects of the control group will receive a placebo dragee identical to the Royal jelly dragee. The severity of the stroke, cognitive function, mental health, quality of life, clinical outcomes, and biochemical measures will be assessed at baseline and post-intervention.
The current study is designed to investigate the effectiveness and safety of royal jelly supplementation in a randomized, parallel, two-arms, single-center, triple-blind, placebo-controlled manner. This study will provide evidence as a phase III clinical trial.
IRCT20180818040827N4, registered on 16 October 2021. https://www.irct.ir/trial/59275.
中风是一种使人衰弱的疾病，每年影响全球超过1500万人，导致其中三分之一的人死亡，三分之二的幸存者严重残疾。先前的研究报道了蜂王浆在抗炎特性方面的各种健康益处。我们旨在研究补充蜂王浆对缺血性中风患者的氧化应激、炎症介质、心理健康、认知功能、生活质量和临床结局的影响。
本研究将是一项三盲随机安慰剂试验。符合我们纳入标准的患者将被分配到干预组或对照组，接受分配的干预措施，为期12周。干预组的个体将在早餐后每天服用1000毫克蜂王浆糖衣丸。对照组的受试者将接受与蜂王浆糖衣丸相同的安慰剂糖衣丸。将在基线和干预后评估中风的严重程度、认知功能、心理健康、生活质量、临床结局和生化指标。
本研究旨在以随机、平行、双臂、单中心、三盲、安慰剂对照的方式研究补充蜂王浆的有效性和安全性。本研究将作为一项III期临床试验提供证据。
IRCT20180818040827N4，于2021年10月16日注册。https://www.irct.ir/trial/59275 。
