A Prospective, Interventional, Randomized, Double-blinded, Placebo-controlled Clinical Study to Evaluate the Efficacy and Safety of ImmunoSEB as Immunomodulator in Acute Allergic Rhinitis

In the current clinical trial, ImmunoSEB, a proprietary blend of systemic hydrolase enzymes (e.g., lysozyme, amyloglucosidase, catalase, peptizyme, serrapeptase, amylase, lactoferrin and papain) is used to evaluate their ability to induce immune system by modulating a series of inflammatory markers and immune cells in allergic rhinitis. ImmunoSEB was previously reported as biological response modifiers that has antibacterial, antimicrobial and immunomodulatory properties (Chitnis and Rathi, 2020). The present study highlights the efficacy and safety of ImmunoSEB to demonstrate immunomodulatory effect in acute allergic rhinitis.

在本次临床试验中，专有复方系统性水解酶制剂ImmunoSEB（成分包括溶菌酶、淀粉葡萄糖苷酶、过氧化氢酶、肽酶、舍雷肽酶、淀粉酶、乳铁蛋白及木瓜蛋白酶）被用于评估其通过调节变应性鼻炎患者体内的一系列炎症标志物与免疫细胞，以激活免疫系统的能力。此前已有研究表明，ImmunoSEB作为生物反应调节剂，具备抗菌、抗微生物及免疫调节特性（Chitnis与Rathi，2020）。本研究着重探讨了ImmunoSEB在急性变应性鼻炎中发挥免疫调节作用的有效性与安全性。