European Journal of Biomedical and Pharmaceutical Sciences

ACUTE AND LONG TERM TOXICITY STUDIES OF SIDDHA FORMULATION SADHAKUPPAI CHOORANAM

R. Savitha*

ABSTRACT

The polyherbal Siddha formulation Sadhakuppai Chooranam (SKC) has been indicated in classical literature for the management of worm infestations in pediatrics. Though these age old traditional formulations have been clinically beneficial, till now no scientific data exists to confirm its safety and efficacy. Hence the present study was conducted to determine the acute and long term safety profile of Sadhakuppai Chooranam (SKC). Acute toxicity was carried out in 20 Swiss albino mice of both sexes divided into vehicle control group and therapeutic group and the test drug was administered to the groups in a single oral dose (2592mg/kg bwt). Animals were observed for body weight and mortality for 14 days. Long term toxicity study was conducted in 40 Male and Female wistar albino rats of both sexes and was divided into 4 groups(Group I-Vehicle control, Group II- 259 mg, Group III-1296 mg, Group IV-2592 mg). The vehicle control groups received equal volumes of vehicle (i.e water). Administration was by oral gavage once a day for 30 days and the animals were observed for clinical signs, body weight, food and water intake and mortality. The study results showed that both acute and long term toxicity studies did not produce toxic effects when administered 10 times of therapeutic dose and LD50 > 2000mg/kg hence indicating the safety of Sadhakuppai chooranam.

Keywords: Sadhakuppai Chooranam (SKC), Acute toxicity study, Long term toxicity study, Herbal drug, Siddha medicine.