Mamatha K, Manu Kanjoormana Aryan, Prathibha Prabhakaran, Johannah Natinga Mulakal, Syam Das S, Krishnakumar Im, Sreejith Parameswara Panicker
{"title":"Short-term influence of Immufen™ on mild allergic rhinitis: a randomized, double-blind, placebo-controlled study.","authors":"Mamatha K, Manu Kanjoormana Aryan, Prathibha Prabhakaran, Johannah Natinga Mulakal, Syam Das S, Krishnakumar Im, Sreejith Parameswara Panicker","doi":"10.3389/falgy.2024.1390813","DOIUrl":null,"url":null,"abstract":"<p><strong>Introduction: </strong>Allergic rhinitis (AR) is an IgE-mediated reaction to inhaled allergens, and is a prominent health concern affecting approximately 400 million people worldwide. A comprehensive understanding of AR's pathophysiology is imperative for developing novel therapies, especially considering its frequent co-morbidity with asthma and conjunctivitis. The escalating prevalence of AR is correlated with increased urbanization and environmental pollutants, recognized as prominent contributing factors. Dysregulation in immune networks, Th1/Th2 cytokine imbalance, activation of mast cells and eosinophils are implicated in AR progression. Classic AR symptoms include nasal congestion, nasal itching, rhinorrhea, and sneezing which significantly impact the quality of life, social interactions, and workplace productivity.</p><p><strong>Methods: </strong>This randomized, double-blind, placebo-controlled, three-arm, three-sequence study was aimed to assess the efficacy of supplementation of a co-delivery form of turmeric extract with ashwagandha extract (CQAB) in comparison with a bioavailable curcumin (CGM) and placebo in alleviating AR symptoms and enhancing the quality of life in individuals with mild AR. Participants received either placebo, CGM, or CQAB twice/day for 28 days, and subjective measures were recorded at the baseline and at the end of study.</p><p><strong>Results: </strong>CQAB supplementation demonstrated a significant (<i>P</i> < 0.05) improvement in Total Nasal Symptom Score (TNSS) compared to placebo and CGM. Furthermore, CQAB administration resulted in enhanced sleep quality (<i>P</i> < 0.05) as evaluated by the BIS questionnaire, heightened energy levels, and decreased fatigue and overall mood disturbance (POMS-SF) compared to both placebo and CGM.</p><p><strong>Conclusion: </strong>The results suggests that CQAB has the potential to be used as a dietary supplement in alleviating AR discomforts.</p><p><strong>Clinical trial registration: </strong>https://ctri.nic.in/Clinicaltrials/login.php; Identifier CTRI/2021/01/030355.</p>","PeriodicalId":73062,"journal":{"name":"Frontiers in allergy","volume":null,"pages":null},"PeriodicalIF":3.3000,"publicationDate":"2024-10-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11513368/pdf/","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Frontiers in allergy","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.3389/falgy.2024.1390813","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2024/1/1 0:00:00","PubModel":"eCollection","JCR":"Q2","JCRName":"ALLERGY","Score":null,"Total":0}
引用次数: 0
Abstract
Introduction: Allergic rhinitis (AR) is an IgE-mediated reaction to inhaled allergens, and is a prominent health concern affecting approximately 400 million people worldwide. A comprehensive understanding of AR's pathophysiology is imperative for developing novel therapies, especially considering its frequent co-morbidity with asthma and conjunctivitis. The escalating prevalence of AR is correlated with increased urbanization and environmental pollutants, recognized as prominent contributing factors. Dysregulation in immune networks, Th1/Th2 cytokine imbalance, activation of mast cells and eosinophils are implicated in AR progression. Classic AR symptoms include nasal congestion, nasal itching, rhinorrhea, and sneezing which significantly impact the quality of life, social interactions, and workplace productivity.
Methods: This randomized, double-blind, placebo-controlled, three-arm, three-sequence study was aimed to assess the efficacy of supplementation of a co-delivery form of turmeric extract with ashwagandha extract (CQAB) in comparison with a bioavailable curcumin (CGM) and placebo in alleviating AR symptoms and enhancing the quality of life in individuals with mild AR. Participants received either placebo, CGM, or CQAB twice/day for 28 days, and subjective measures were recorded at the baseline and at the end of study.
Results: CQAB supplementation demonstrated a significant (P < 0.05) improvement in Total Nasal Symptom Score (TNSS) compared to placebo and CGM. Furthermore, CQAB administration resulted in enhanced sleep quality (P < 0.05) as evaluated by the BIS questionnaire, heightened energy levels, and decreased fatigue and overall mood disturbance (POMS-SF) compared to both placebo and CGM.
Conclusion: The results suggests that CQAB has the potential to be used as a dietary supplement in alleviating AR discomforts.
简介过敏性鼻炎(AR)是由 IgE 介导的对吸入过敏原的反应,是影响全球约 4 亿人健康的一个突出问题。全面了解过敏性鼻炎的病理生理学是开发新型疗法的当务之急,特别是考虑到过敏性鼻炎经常与哮喘和结膜炎并发。AR 发病率的上升与城市化和环境污染的加剧有关,而城市化和环境污染被认为是主要的致病因素。免疫网络失调、Th1/Th2 细胞因子失衡、肥大细胞和嗜酸性粒细胞活化都与 AR 的发展有关。典型的 AR 症状包括鼻塞、鼻痒、鼻出血和打喷嚏,严重影响生活质量、社会交往和工作效率:这项随机、双盲、安慰剂对照、三臂、三序列研究旨在评估姜黄提取物与水飞蓟提取物联合给药形式(CQAB)与生物可利用姜黄素(CGM)和安慰剂相比,在减轻轻度 AR 患者的 AR 症状和提高其生活质量方面的疗效。研究人员在28天内每天两次服用安慰剂、姜黄素或CQAB,并在基线和研究结束时记录主观测量结果:结果:补充 CQAB 有显著效果(P P 结论):结果表明,CQAB具有作为膳食补充剂缓解AR不适的潜力。临床试验注册:https://ctri.nic.in/Clinicaltrials/login.php;标识符为CTRI/2021/01/030355。