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research-article
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
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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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. 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. 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. 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. Abstract
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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)
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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
Author notes
Corresponding Author: Shweta Mata drshwetamataccras@ 123456gmail.com
Author information
Shweta Mata https://orcid.org/0000-0002-7427-3955
Shivshankar Rajput https://orcid.org/0000-0003-1083-2292
Isha Preet Tuli https://orcid.org/0000-0001-5601-6157
Pallavi Mundada https://orcid.org/0000-0003-3326-2165
Bharti Gupta https://orcid.org/0000-0003-1245-8986
Narayanam Srikanth https://orcid.org/0000-0002-3976-4978
Rabinarayanan Acharya https://orcid.org/0000-0003-4413-1937
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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