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CLINICAL TRIAL article

Front. Allergy
Sec. Rhinology
Volume 5 - 2024 | doi: 10.3389/falgy.2024.1390813

Short-term influence of Immufen™ on mild Allergic Rhinitis: A randomized, double-blind, placebo-controlled study

Provisionally accepted
Mamatha K Mamatha K 1Kanjoormana Aryan Manu Kanjoormana Aryan Manu 2Prathibha Prabhakaran Prathibha Prabhakaran 3Johannah N. Mulakal Johannah N. Mulakal 3Syam Das Syam Das 3Krishnakumar IM Krishnakumar IM 3Sreejith Parameswara Panicker Sreejith Parameswara Panicker 4*
  • 1 Divakar’s Specialty Hospital, Bengaluru, Karnataka, India
  • 2 Amala Cancer Research Centre, Thrissur, Kerala, India
  • 3 Akay Natural Ingredients, Ernakulam, Kerala, India
  • 4 University of Kerala, Thiruvananthapuram, India

The final, formatted version of the article will be published soon.

    Allergic rhinitis (AR) is an IgE-mediated reaction to inhaled allergens and is a prominent health concern affecting approximately 400 million people worldwide. Comprehensive understanding of AR's pathophysiology is imperative for developing novel therapies, especially considering its frequent comorbidity 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 symptoms include nasal congestion, nasal itching, rhinorrhea, and sneezing which significantly impact the quality of life, social interactions, and workplace productivity entailing substantial economic costs. This randomized, double-blind, placebocontrolled, 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) compared to a bioavailable curcumin (CGM) and placebo in alleviating AR symptoms and enhancing the quality of life in individuals with mild AR. Participants received 400 mg of either placebo, CGM, or CQAB twice/day for 28 days, and subjective measures were recorded at the baseline and at the end of study. CQAB supplementation demonstrated a significant (P < 0.05) improvement in Total Nasal Symptom Score (TNSS) compared to placebo and CGM. Furthermore, CQAB administration led to improved sleep quality (P < 0.05) as assessed by the BIS questionnaire, increased vigor, and reduced fatigue and overall mood disturbance (POMS-SF) compared to both placebo and CGM, indicating the potential of CQAB as a dietary supplement to alleviate AR-related discomforts.

    Keywords: allergic rhinitis, Ashwagandha, CurQfen, FenuMAT, Immunity, sleep issues, TNSs, BIS

    Received: 12 Mar 2024; Accepted: 26 Aug 2024.

    Copyright: © 2024 K, Manu, Prabhakaran, Mulakal, Das, IM and Parameswara Panicker. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.

    * Correspondence: Sreejith Parameswara Panicker, University of Kerala, Thiruvananthapuram, India

    Disclaimer: All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article or claim that may be made by its manufacturer is not guaranteed or endorsed by the publisher.