Comparative Efficacy of Trisamagutika versus Kshargutika in the Management of Tundikeri (Chronic Tonsillitis) in Children: A Randomised Controlled Trial Protocol

Introduction: Tonsillitis is more common in children aged 5 to 15 years, and about 200,000 tonsillectomies are performed in India annually. Tonsillitis and Tundikeri can be correlated, as they share similar features. Trisamagutika and Kshargutika have not been assessed for long-term follow-up in the treatment of chronic tonsillitis. Need of the study: Repeated episodes of tonsillitis hamper growth and development and create an economic burden. They can also cause health hazards that lead to tonsillectomy. The immunological role of the tonsils in preventing infections is important to consider before resorting to tonsillectomy. Therefore, it is necessary to search for an alternative, costeffective, feasible and potent therapy with fewer side-effects. Aim: To evaluate the comparative efficacy of Trisamagutika as the standard control medicine versus Kshargutika in children with chronic tonsillitis, based on objective and subjective parameters. Materials and Methods: A randomised, controlled, doubleblind, superiority clinical trial with long-term follow-up to assess recurrence will be conducted at Mahatma Gandhi Ayurved College, Hospital and Research Centre, Wardha Maharashtra, India, from July 2024 to July 2025. Children with chronic tonsillitis meeting the inclusion criteria will be randomly divided into two groups (n=36 per group). Interventions will be administered orally twice daily for 15 days. Assessments will be performed at baseline, and on days 5, 10 and 15, including complete blood count and subjective criteria such as tonsil size by palpation, hyperemia, halitosis, fever and degree of dysphagia. Followup will be conducted monthly for up to one year. Data will be analysed using appropriate parametric and non parametric statistical tests. A 20% reduction in tonsil size and a p-value <0.05 will be considered statistically significant.