Evaluation of Comparative Efficacy of Polyherbal Steam Inhalation Versus Polyherbal Nasal Fumigation (Dhoopana) in Children With Rhinitis (Pratishyaya): Protocol for an Open-Label Randomized Controlled Trial.

Abstract

Background: Rhinitis is a condition characterized by inflammation of the nasal mucosa. It causes obstruction and congestion in the nasal cavity. Clinically, it resembles pratishyaya (rhinitis) in Ayurveda, which is caused by accumulation and downward movement of the tridoshas (3 elements, named vata, pitta, and kapha) in the nasal cavity. Rhinitis is one of the most common diseases among children. There is no role for antibiotics in rhinitis, and nasal decongestants have also not been found to be effective in its management. In Ayurveda, dhoopana (nasal fumigation) is mentioned in the pratishyaya treatment protocol. However, we have found no previous study regarding its efficacy. The efficacy of tulsi, vasa, nirgundi, and nilgiri is already proven when they are used for steam inhalation in respiratory tract infections. Therefore, in this study, a dhoopana of a polyherbal formulation containing tulsi, vasa, nirgundi, and nilgiri will be compared with the inhalation of steam containing arka (a liquid obtained by distillation) of tulsi, vasa, nirgundi, and nilgiri leaves in children with pratishyaya.

Objective: We aim to evaluate the efficacy of polyherbal steam inhalation as a standard control against dhoopana in children aged 7 to 14 years with pratishyaya.

Methods: A total of 70 participants fulfilling the inclusion criteria were selected and distributed into 2 groups of 35 each. The intervention group received dhoopana and the control group received polyherbal steam inhalation, both twice daily for 7 days. The primary outcome measure was the change in Total Nasal Symptom Score and a modified cold spatula test. At the same time, the association between prakriti (body constitution) and the prevalence of pratishyaya in children was analyzed as a secondary outcome. Assessments were performed on days 3, 5, and 7, with a follow-up time of 28 days. Appropriate descriptive and inferential statistics will be used for data analysis.

Results: As of November 2024, we have completed our enrollment of 70 patients, with 35 patients in each group. Data analysis will be completed by February 2025, and we expect results to be published in March 2025.

Conclusions: We anticipate that polyherbal nasal fumigation will be found to be equally as effective as polyherbal steam inhalation in the management of acute rhinitis in the pediatric population. This study may provide a standardized, herbal, safe, and cost-effective treatment for rhinitis in children in the form of dhoopana.

International registered report identifier (irrid): DERR1-10.2196/58197.