JMIR Publications

ABSTRACT

Background:

Allergic rhinitis (AR) is the inflammation of the membranes lining the nose, consequent to an allergen exposure, characterized by sneezing, nasal congestion, itching of the nose, and/or postnasal discharge. The prevalence varies worldwide, perhaps due to the geographic and aeroallergen differences, with 10% and 30% of the world’s population suffering from AR. In the present study, Anu Taila Nasya, Naradiya Laxmivilas Rasa (NLR), and Shrishadi kwath are planned to be compared with the contemporary fluticasone nasal spray in control group medicine.

Objective:

The Primary Objective is to assess the efficacy of Ayurvedic management in Allergic Rhinitis (Vataja Pratishyaya) by comparing it with a conventional control group. The Secondary Objectives are 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 mean change in the Laboratory investigations.

Methods:

This ongoing study is an open-label Randomised Controlled Interventional trial, with a sample size of 90 both in the trial and standard control group (Including 20% dropouts) and will be carried out within the duration of 24 months. Participants in the trial group will receive Ayurvedic treatment, i.e., Anu Taila Nasya 6 drops in each nostril for 7 days in three consecutive weeks, NLR of 250 mg twice a day, and Shrishadi kwath 40 ml twice a day for 45 Days. The participants in the standard control group will receive Fluticasone propionate Nasal Spray 2 puffs once a day for 45 days. The primary outcome will include the mean change in the CARAT (Control of Allergic Rhinitis and Asthma Test) Score, and the secondary outcome 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 investigations.

Results:

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

Conclusions:

The Ayurvedic approach may provide an evidence-based therapeutic tactic for the management of Allergic Rhinitis. Clinical Trial: Clinical Trial Registry (CTRI/2023/06/053395)