Toxicological study of Balacaturbhadrika churna

Balacaturbhadrika churna has an important place in pediatric practice in Ayurveda. Millennia of use of this formulation bears testimony to its safety when used for prolonged duration in children. This prompted us to initiate a long-term, acute oral toxicity evaluation of Balacaturbhadrika churna in rats. The study was carried out by administering Balacaturbhadrika churna orally once only in a dose up to 2000 mg/kg. For long-term toxicity, Balacaturbhadrika churna was administered in doses of 450 and 900 mg/kg orally for 45 consecutive days. The effects of the drug on ponderal changes, hematological, biochemical and histological parameters were noted. The acute toxicity experiment showed that the drug did not produce any signs and symptoms of toxicity (or mortality) up to the dose of 2000 mg/kg. Long-term toxicity results showed that, even at higher dose of 900 mg/kg, Balacaturbhadrika churna did not affect the parameters studied, to a significant extent. The doses employed for these toxicity studies were several times higher than normal clinical doses of Balacaturbhadrika churna, hence the observed changes will probably not become apparent at therapeutic dose level.