Evaluation of Comparative Efficacy of Polyherbal Steam Inhalation versus Dhoopana (Polyherbal nasal fumigation) in Children with Pratishyaya (Rhinitis): A Randomized Controlled Clinical Trial (Preprint)

BACKGROUND Rhinitis is a condition characterized by inflammation of the nasal mucosa. It causes obstruction and congestion in the nasal cavity. Clinically, it resembles with Pratishyaya (Rhinitis) in Ayurveda which is caused by accumulation and downward movement of the Tridoshas (three elements named Vata, Pitta and Kapha) in the nasal cavity. Rhinitis is one of the most common diseases among children. There is no role of antibiotics in rhinitis. Nasal decongestants also not found effective in its proper management. In Ayurveda, Nasal fumigation (Dhoopana) is mentioned in the treatment protocol of Pratishyaya. But there is no any previous study found regarding its efficacy. Efficacy of the herbs Tulsi, Vasa, Nirgundi and Nilgiri is already proven as steam inhalation in respiratory tract infections. So, in this study Dhoopana (Nasal fumigation) of a polyherbal formulation containing Tulsi, Nirgundi, Vasa and Nilgiri will be compared with the steam inhalation containing Arka of Tulsi, Nirgundi, Vasa and Nilgiri in Pratishyaya in children. OBJECTIVE Evaluation of the Efficacy of Polyherbal Steam Inhalation as a standard control against Polyherbal Nasal Fumigation (Dhoopana) in children lying in age group 7-14 years with Rhinitis (Pratishyaya): -A Randomized Controlled Clinical Trial. METHODS After doing drug analysis, a total of 84 participants fulfilling the inclusion criteria will be selected and are distributed in two groups having 42 each. In group I (Intervention group) Polyherbal nasal fumigation (Dhoopana) in group C (Control group), Polyherbal steam inhalation will be given twice daily till 7 days. Assessment will be done on day 3rd, 5th, 7th and after the intervention; follow up will be taken on 7th, 14th day and 28th day. RESULTS Results will be drawn from the observations of subjective and objective parameters. CONCLUSIONS Conclusion of the study will be drawn based on statistical data calculated from the collected data. CLINICALTRIAL CTRI No. - CTRI/2023/03/050876 (clinical trial registry India) Dated –20/03/2023