Title:- Evaluation of comparative efficacy of Trisamagutika versus Kshargutika in management of Tundikeri (chronic tonsillitis) in children: A Randomized Controlled Clinical Study (Preprint)

BACKGROUND • Tonsillitis is more common in children between 5 to 15 years ( more in 4 to 8 years.).There are 7,455,494 cases of tonsillitis and 2,00,000 tonsillectomies are performed in India per year. The incidence of this disease is about 7% of all visits to the paediatrician. Tundikeri is one of the Urdhwajatrugat Roga (diseases of Head and neck) mentioned by Acharya Sushrut, Vagbhata. Tonsillitis and Tundikeri can be correlated as both have the same features. Any infection in a growing child affects the immune system Repeated attacks of tonsillitis hampers routine growth and development also. Lastly, a radical cure for recurrent attacks is Tonsillectomy. Kshargutika from Charaksamhita is one of the formulations to treat kanthgat roga. The present study will be conducted to explore the efficacy of Kshargutika versus the efficacy of Trisamagutika in the management of chronic tonsilitis in children. OBJECTIVE 1. To evaluate the comparative efficacy of Trisamagutika as standard control medicine versus Kshargutika in children with chronic tonsillitis on objective & Subjective parameters 2. To assess recurrence in terms of proportion in the reference of the control group ( Trisamagutika) and trial group(Kshargutika). METHODS Children with chronic Tonsillitis fulfilling inclusion criteria shall be randomly divided into two groups; 36 patients in each group. One group (P) will be given Trisamagutika and the other group (Q) will be given Kshargutika for 15 days orally B.D. Assessment will be done at 0,5,10 &15 th day. Followup will be taken every month for up to 1 year RESULTS Results will be drawn on the observations of subjective parameters. CONCLUSIONS The conclusion of the study will be drawn based on statistical data calculated from the collected data. CLINICALTRIAL - CTRI No.- CTRI/2023/08/056542 Dated- 16/08/2023