伊朗蜂胶对慢性肾脏病患者肾功能、氧化还原平衡、代谢状态及生活质量的影响：一项正在进行的随机、双盲、安慰剂对照临床试验的研究方案

Effects of Iranian propolis on renal function, prooxidant-antioxidant balance, metabolic status, and quality of life in patients with chronic kidney disease: A study protocol of an ongoing randomized, double-blind, placebo-controlled clinical trial.

作者信息

Anvarifard Paniz, Anbari Maryam, Ostadrahimi Alireza, Ardalan Mohammadreza, Ghoreishi Zohreh

机构信息

Student Research Committee, School of Nutrition and Food Sciences, Tabriz University of Medical Sciences, Tabriz, Iran.

Nutrition Research Center, Tabriz University of Medical Sciences, Tabriz, Iran.

出版信息

Contemp Clin Trials Commun. 2023 Jun 10;34:101159. doi: 10.1016/j.conctc.2023.101159. eCollection 2023 Aug.

DOI:10.1016/j.conctc.2023.101159

PMID:37360969

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10285564/

Abstract

BACKGROUND

Chronic kidney disease (CKD) is a prevalent and progressive disease that is impacted by hyperglycemia, hypertension (HTN), and oxidative stress (OS). Propolis, a natural resinous mixture produced by honeybees from plant materials, has been shown to possess antioxidant, anti-inflammatory, antihyperglycemic, and antihypertensive properties, along with hepato-renal protective effects. This study aims to evaluate the efficacy of propolis supplementation on patients with CKD.

METHODS

This multi-centered, randomized, double-blind, placebo-controlled clinical trial will evaluate the effectiveness of propolis supplementation in 44 eligible patients with CKD. Participants will be randomly allocated to receive either propolis capsule (500 mg, containing 125 mg Iranian alcoholic propolis extract) or placebo, twice daily for three months. The primary outcome is improvement in kidney function parameters of CKD patients, while secondary outcomes include changes in prooxidant-antioxidant balance (PAB), glycemic status, quality of life, and blood pressure (BP). The study will be conducted at Tabriz University of Medical Sciences in Tabriz, Iran.

DISCUSSION

If the results of this study reveal remarkable effectiveness of propolis in improving quality of life and clinical outcomes in patients with CKD, this compound may reach a new milestone as an adjunctive therapy for CKD and it opens a new window for further studies.

TRIAL REGISTRATION

Iranian Registry of Clinical Trials, IRCT20191218045798N1. Prospectively registered on 07 June 2020. Updated on 30 August 2021. https://en.irct.ir/trial/48603.

摘要

背景

慢性肾脏病（CKD）是一种常见的进行性疾病，受高血糖、高血压（HTN）和氧化应激（OS）影响。蜂胶是蜜蜂从植物材料中产生的一种天然树脂混合物，已被证明具有抗氧化、抗炎、抗高血糖和抗高血压特性，以及肝肾保护作用。本研究旨在评估补充蜂胶对CKD患者的疗效。

方法

这项多中心、随机、双盲、安慰剂对照的临床试验将评估补充蜂胶对44例符合条件的CKD患者的有效性。参与者将被随机分配接受蜂胶胶囊（500毫克，含125毫克伊朗酒精蜂胶提取物）或安慰剂，每日两次，共三个月。主要结局是CKD患者肾功能参数的改善，次要结局包括促氧化剂-抗氧化剂平衡（PAB）、血糖状态、生活质量和血压（BP）的变化。该研究将在伊朗大不里士医科大学进行。