Ayurveda Management of Allergic Rhinitis: Protocol for a Randomized Controlled Trial (2025)

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Ayurveda Management of Allergic Rhinitis: Protocol for a Randomized Controlled Trial (1)

Author(s):

Shweta Mata , MS, PhD 1 , ,

Shivshankar Rajput , MS, PhD 1 ,

Isha Preet Tuli , MS 2 ,

Pallavi Mundada , MD 3 ,

Bharti Gupta , MD, PhD 1 ,

Narayanam Srikanth , MD, PhD 3 ,

Rabinarayanan Acharya , MD, PhD 3

Editor(s):

Amaryllis Mavragani

Other contributor(s):

Muhammad Faisal Nadeem (Reviewer),

Yongning Wu (Reviewer)

Publication date (Electronic): 25 September 2024

Journal: JMIR Research Protocols

Publisher: JMIR Publications

Keywords: allergic rhinitis, AR, Anu Taila Nasya, fluticasone propionate nasal spray, Naradiya Laxmivilas Rasa, randomized controlled trial, Shrishadi Kwath

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      Abstract

      Background

      Allergic rhinitis (AR) is the inflammation of the membranes lining the nose due to allergen exposure and is characterized by sneezing, nasal congestion, itching of the nose, or postnasal discharge. The prevalence varies worldwide, perhaps due to the geographic and aeroallergen differences, with 10% to 30% of the world’s population experiencing AR. In this study, Anu Taila Nasya, Naradiya Laxmivilas Rasa, and Shirishadi Kwath will be compared to a fluticasone nasal spray.

      Objective

      The primary aim is to assess the efficacy of Ayurvedic management for AR (or vataja pratishyaya) by comparing it to a conventional control group. The secondary aims are to determine the mean change in the nasal endoscopy index and the mean change in the laboratory tests.

      Methods

      This ongoing study is an open-label randomized controlled interventional trial, with a sample size of 90 both in the trial and standard control group (including dropouts, 20%), and will be carried out for 24 months. Participants in the trial group will receive Ayurvedic treatment, that is, Anu Taila Nasya (6 drops in each nostril for 7 days for 3 consecutive weeks), Naradiya Laxmivilas Rasa (250 mg twice per day), and Shirishadi Kwath (40 ml twice per day for 45 days). The participants in the control group will receive a fluticasone propionate nasal spray (2 sprays once per day for 45 days). The primary outcome will include the mean change in the Control of Allergic Rhinitis and Asthma Test score, and the secondary outcomes will include the mean change in the nasal endoscopy index (assessment of nasal membrane color, pale or hyperemia; rhinorrhea, watery or yellow; and inferior turbinate swelling, hypertrophy) and the mean change in the laboratory tests.

      Results

      As of May 2024, 72 patients have been enrolled in both groups. Data analysis should be completed by February 2025. The study will be reported following standard guidelines for reporting randomized controlled trials. Clinical results will be disseminated through conferences and peer-reviewed publication in a relevant journal.

      Conclusions

      The Ayurvedic approach could be an evidence-based therapeutic tactic for the management of AR.

      Trial Registration

      Clinical Trials Registry India CTRI/2023/06/053395; https://tinyurl.com/564d2zz8

      International Registered Report Identifier (IRRID)

      DERR1-10.2196/56063

      Related collections

      JMIR: Research Protocols

      Most cited references24

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      Allergic Rhinitis and its Impact on Asthma (ARIA) 2008 update (in collaboration with the World Health Organization, GA(2)LEN and AllerGen).

      J. Bousquet, N Khaltaev, A A Cruz (2008)

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        The diagnosis and management of rhinitis: an updated practice parameter.

        Dana V Wallace, Mark Dykewicz, David I Bernstein (2008)

        0 comments Cited 230 times – based on 0 reviews Review now

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          Allergic rhinitis: Definition, epidemiology, pathophysiology, detection, and diagnosis

          David Skoner (2001)

          Allergic rhinitis (AR) is a heterogeneous disorder that despite its high prevalence is often undiagnosed. It is characterized by one or more symptoms including sneezing, itching, nasal congestion, and rhinorrhea. Many causative agents have been linked to AR including pollens, molds, dust mites, and animal dander. Seasonal allergic rhinitis (SAR) is fairly easy to identify because of the rapid and reproducible onset and offset of symptoms in association with pollen exposure. Perennial AR is often more difficult to detect than SAR because of the overlap with sinusitis, respiratory infections, and vasomotor rhinitis. SAR can result in hyperresponsiveness to allergens such as cigarette smoke, once pollen season is over. Perennial AR is defined as occurring during approximately 9 months of the year. AR affects an estimated 20 to 40 million people in the United States alone, and the incidence is increasing; an estimated 20% of cases are SAR; 40% of cases are perennial rhinitis; and 40% of cases are mixed. The pathophysiology of SAR is complex. There is a strong genetic component to the allergic response, which is driven through mucosal infiltration and action on plasma cells, mast cells, and eosinophils. The allergic response occurs in two phases, which are considered the "early" and "late" phase responses. Early phase response occurs within minutes of exposure to the allergen and tends to produce sneezing, itching, and clear rhinorrhea; late phase response occurs 4 to 8 hours after allergen exposure and is characterized by congestion, fatigue, malaise, irritability, and possibly neurocognitive deficits. The key to diagnosis of AR is awareness of signs and symptoms. IgE antibody tests to detect specific allergens are the standard method used today; however, in addition, diagnosis must be confirmed with a positive history and demonstration that the symptoms are the result of IgE-mediated inflammation.

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            Author and article information

            Contributors

            Shweta Mata:

            ORCID: https://orcid.org/0000-0002-7427-3955

            Central Ayurveda Research InstituteCentral Council for Research in Ayurvedic SciencesMinistry of AyushRoad no. 66 Punjabi Bagh WestNew Delhi, 110026India91 08866014946drshwetamataccras@gmail.com

            Journal

            Journal ID (nlm-ta): JMIR Res Protoc

            Journal ID (iso-abbrev): JMIR Res Protoc

            Journal ID (publisher-id): ResProt

            Title: JMIR Research Protocols

            Publisher: JMIR Publications (Toronto, Canada )

            ISSN (Electronic): 1929-0748

            Publication date Collection: 2024

            Publication date (Electronic): 25 September 2024

            Volume: 13

            Electronic Location Identifier: e56063

            Affiliations

            [1 ] Central Ayurveda Research Institute Central Council for Research in Ayurvedic Sciences Ministry of Ayush New Delhi India

            [2 ] Vardhman Mahavir Medical College Safdarjung Hospital New Delhi India

            [3 ] Central Council for Research in Ayurvedic Sciences Ministry of Ayush New Delhi India

            Author notes

            Corresponding Author: Shweta Mata drshwetamataccras@ 123456gmail.com

            Author information
            Article

            Publisher ID: v13i1e56063

            DOI: 10.2196/56063

            PMC ID: 11464932

            PubMed ID: 39321461

            SO-VID: fc1f7764-dd79-4c66-adc6-7d462f5ad741

            Copyright © ©Shweta Mata, Shivshankar Rajput, Isha Preet Tuli, Pallavi Mundada, Bharti Gupta, Narayanam Srikanth, Rabinarayanan Acharya. Originally published in JMIR Research Protocols (https://www.researchprotocols.org), 25.09.2024.

            License:

            This is an open-access article distributed under the terms of the Creative Commons Attribution License ( https://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work, first published in JMIR Research Protocols, is properly cited. The complete bibliographic information, a link to the original publication on https://www.researchprotocols.org, as well as this copyright and license information must be included.

            History

            Date received : 15 February 2024

            Date revision requested : 6 June 2024

            Date revision received : 17 June 2024

            Date accepted : 22 July 2024

            Categories

            Subject: Protocol

            Subject: Protocol


            Keywords: allergic rhinitis,ar,anu taila nasya,fluticasone propionate nasal spray,naradiya laxmivilas rasa,randomized controlled trial,shrishadi kwath

            Data availability:

            Keywords: allergic rhinitis, ar, anu taila nasya, fluticasone propionate nasal spray, naradiya laxmivilas rasa, randomized controlled trial, shrishadi kwath

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            Ayurveda Management of Allergic Rhinitis: Protocol for a Randomized Controlled Trial (2025)
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