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

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.

Keywords

• Propolis
• Chronic kidney disease
• Protocol study
• Randomized controlled trial