Toxicological Studies of Rasasindura, an Ayurvedic Formulation
Department of Rasashstra and Bhaishajya Kalpana, Mahatma Gandhi Ayurved College Hospital and RC, Salod (H), Wardha-442 001, Pharmacology Laboratory, Department of Rasashstra and Bhaishajya Kalpana including Drug Research, Institute of Post Graduate Teaching and Research in Ayurveda, Gujarat Ayurved University, Jamnagar-361 008, India
Department of Rasashstra and Bhaishajya Kalpana, Mahatma Gandhi Ayurved College Hospital and RC, Salod (H), Wardha-442 001, India, E-mail: [email protected]
Rasasindura is a unique, Ayurvedic mercurial preparation widely used by practitioners. Thi investigation is an attempt to perform acute and chronic oral toxicity evaluation of Rasasindura along with an adjuvant Guduchi Ghana (solidified aqueous extract of Tinospora cordifolia Will.) in rats. Oral acute toxicity study of test drug was carried at the limit dose of 2000 mg/kg orally in rats. For chronic toxicity, Rasasindura with adjuvant was administered at therapeutic equivalent dose (45 mg/kg, orally), therapeutic equivalent dose×5 (225 mg/kg, orally), therapeutic equivalent dose×10 (450 mg/kg, orally) for 90 days and an additional recovery group of therapeutic equivalent dose×10 for 30-day observation after the treatment period. Acute toxicity result showed that drug did not produce any signs and symptoms of toxicity or mortality up to an oral dose of 2000 mg/kg in rats. Chronic toxicity results showed that Rasasindura, even at a level as high as therapeutic equivalent dose×10 level, had no significant effect whatsoever on the ponderal and hematological parameters. Although the drug produced mild to moderate adverse changes (in kidney, liver, intestine, and stomach) at therapeutic equivalent dose×10 dose level, equivalent of which are unlikely to be ever employed in a clinical trial. The observed changes were not seen at the lower dose levels as well as in the recovery study. Hence, it is suggested that the Rasasindura, along with the adjuvant prepared as per the customary method, is safe for consumption at the therapeutic dose level.