Effectiveness and safety of addition binahong extract 2.5 on saline nasal irrigation for allergic rhinitis patients: protocol for randomized controlled trial investigator-blinded

Background: Saline nasal irrigation is effective, inexpensive and safe treatment for allergic rhinitis (AR). Binahong leaves extract 2.5 showed anti-allergy effect by suppress immunoglobulin E and prospect as therapeutic agent for allergic treatment. The aim of this study is to investigate the short-term effectiveness and safety outcomes of binahong extract 2.5 addition for nasal saline irrigation treatment in adult patients with AR. Methods: In this open label, parallel randomized controlled trial, 80 participants will be randomly assigned in a ratio 1:1 to the nasal saline irrigation adding with binahong extract 2.5 group or control group nasal saline irrigation. All participants will receive nasal irrigation using 300 mL solution in nasal wash bottle, twice daily for 2 weeks and 4 weeks follow-up. The primary outcomes is changes in the messenger RNA (mRNA) expression of interleukin (IL)-4, IL-6, IL-13, and tumor necrosis factor (TNF)-α. Secondary outcomes include changes in score for the 22-item Sinonasal Outcome Test (SNOT-22), mini Rhinoconjunctivitis Quality of Life Questionnaire (mini-RQLQ), mucociliary transport time (MCT) and nasal patency using peak nasal inspiration flow (PNIF). Any side effects of the treatment will be recorded. Discussion: The results of this study will determine the effectiveness and safety of binahong extract 2.5 addition for nasal saline irrigation treatment in adult patients with AR. This study will be the first to explore the effect of binahong extract 2.5 on the biomolecular inflammation mediator using mRNA expression of IL-4, IL-6, IL-13, and TNF-α combine with symptoms, quality of life and nasal physiology. Trial Registration: This clinical trial protocol is registered at the ClinicalTrials.gov (NCT05960526). © Journal of Xiangya Medicine. All rights reserved.