Antipyretic effect of amrittottar kashay ghan vati in the management of febrile children preclinical and clinical trial

Abstract

Aim of study: The study aimed to evaluate the antipyretic effect of Amrittottar Kashay Ghan Vati in febrile children and compare its efficacy with Paracetamol. Materials and Methods: Pilot study Pilot study was carried out in 31 patients to assess the safety and efficacy .In subjective parameters Significant antipyretic activity of Amrittottar Kashay Ghan Vati was noted 80% of the individual with dose of 2 tablets (500mg each) in TDS. Statistically non-significant results were observed in reduction of fever but significant results were observed in spike and duration of fever. Analytical study- The analytical study involved the preparation of Amrittottar Kashay Ghan Vati with all SOP and analysis of Amrittottar Kashay Ghan Vati, including phytochemical analysis, HPTLC, GCMS, and antimicrobial activity. Experimental study- The Brewer s yeast induced pyrexia method was adopted and antipyretic effect of Amrittottar Kashay Ghan Vati was evaluated by measuring rectal temperature along with fever markers like IL6 and TNF alpha. Clinical study- A clinical study was conducted with 112 febrile children, divided into two groups: one treated with Amrittottar Kashay Ghan Vati (250 mg to 500 mg thrice daily) and the other with Paracetamol (10-15 mg/kg/dose every 6 hours) for 3 to 5 days. Patients were assessed based on body temperature, CBC, CRP, urine analysis, and subjective parameters such as Agnimandya, Angamarda, Swedavarodh, Pindikodwestan, and Shirashoola. Results and Discussion: In subjective parameters Significant antipyretic activity of Amrittottar Kashay Ghan Vati was noted 80% of the individual with dose of 2 tablets (500mg each) in TDS. Statistically non-significant results were observed in reduction of fever but significant results were observed in spike and duration of fever. The phytochemical analysis of Amrittottar Kashay Ghan Vati revealed the presence of various bioactive compounds like terpenoids, steroids, alkaloids, and flavonoids, among others.