Double-Blind Randomized Controlled Trial Evaluating the Antipyretic Efficacy of Panchatikta Kashaya Rectal Suppository in Children Aged 1–5 Years: Study Protocol
DOI:
https://doi.org/10.70066/jahm.v14i3.2650Keywords:
Amrutottaram Kashaya Guda varti, GRASP Fever chart. Jwara Santapa, Panchatikta Kashaya Gudavarti, Rectal suppository, Study Protocol.Abstract
Background: Fever is a frequent pediatric presentation and, though physiologically protective, may cause adverse outcomes if inadequately treated. Conventional antipyretics are limited by tolerability and challenges in oral administration in young children. Ayurveda describes fever as Jwara, arising from impaired Agni (digestive fire), Ama (metabolic toxin) accumulation, and Dosha (humor) imbalance, for which Tikta-rasa (bitter taste) predominant formulations are indicated in early stages. Panchatikta Kashaya, described in Chakradatta Jwara Cikitsa, possesses antipyretic potential but has poor palatability. Rectal delivery, as Gudavarti (rectal suppository), offers improved absorption and compliance. This double-blind randomized controlled trial evaluates the antipyretic efficacy of Panchatikta Kashaya Gudavarti in children aged 1-5 years with mild to moderate fever, compared with Amrutottaram Kashaya Gudavarti. Objective: To compare and assess the antipyretic efficacy of a single administration of Panchatikta Kashaya Gudavarti with Amrutottaram Kashaya Gudavarti (rectal suppositories) in children aged 1-5 years. Methods: The ongoing study is a prospective, double-blind, randomized controlled, superiority, single-center, efficacy trial of a total 50 participants diagnosed with Jwara (Fever). The trial group will receive single administration of Panchatikta Kashaya Gudavarti, rectal suppository of 2 grams, and the antipyretic effect will be assessed 15 minutes, 30 minutes, 1 hour, 2 hours, and 3 hours post-administration based on the reduction in temperature. Control group participants will similarly receive Amrutottaram Kashaya Gudavarti of 2 grams, and will be assessed for reduction in temperature in the same way. The primary outcome is the reduction in temperature and other features of fever on GRASP fever chart and graded clinical parameters of Jwara. The secondary outcome measure is to note the comparative efficacy of Panchatikta Kashaya Gudavarti with Amrutottaram Kashaya Gudavarti. Conclusion: The study is expected to demonstrate the safety and efficacy of the Ayurvedic intervention Panchatikta Kashaya Gudavarti (rectal suppository) in reducing mild to moderate fever.
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