Ayurveda Management of Allergic Rhinitis:Protocol for aRandomized Controlled Trial

Background: Allergic rhinitis (AR) is the inflammation of the membranes lining the nose due to allergen exposure and ischaracterized by sneezing, nasal congestion, itching of the nose, or postnasal discharge. The prevalence varies worldwide, perhapsdue 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 comparingit to a conventional control group. The secondary aims are to determine the mean change in the nasal endoscopy index and themean 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 thetrial and standard control group (including dropouts, 20%), and will be carried out for 24 months. Participants in the trial groupwill receive Ayurvedic treatment, that is, Anu Taila Nasya (6 drops in each nostril for 7 days for 3 consecutive weeks), NaradiyaLaxmivilas Rasa (250 mg twice per day), and Shirishadi Kwath (40 ml twice per day for 45 days). The participants in the controlgroup will receive a fluticasone propionate nasal spray (2 sprays once per day for 45 days). The primary outcome will includethe mean change in the Control of Allergic Rhinitis and Asthma Test score, and the secondary outcomes will include the meanchange in the nasal endoscopy index (assessment of nasal membrane color, pale or hyperemia; rhinorrhea, watery or yellow; andinferior 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 bedisseminated 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/564d2zz8International Registered Report Identifier (IRRID): DERR1-10.2196/56063