Safety Evaluation of Vatari Guggulu through Acute and 90-day Repeated Dose Toxicity Study in Experimental Animals

Abstract

Abstract Background: Vatari Guggulu is an Ayurvedic Medicine used in the treatment of Vata disorders. It contains Vatari taila (Castor oil), Shuddha gandhaka (purified Sulphur), Haritaki (Terminalia chebula Retz.), Vibhitaki (Terminalia bellirica [Gaertn.] Roxb.), Amla (Emblica officinalis Gaertn) and guggul (Purified Commiphora mukul Hook). As per the Ayurvedic texts, it is widely used clinically in the treatment of rheumatoid arthritis, hip pain, sciatica, gout, joint pain, and burning sensation. However, there are no systematic toxicity studies were performed to scientifically evaluate the safety of Vatari Guggulu. Objectives: The present study was designed to investigate the safety of Vatari Guggulu in acute and 90-days repeated dose oral toxicity as per Organization for Economic Cooperation and Development guidelines 423 and 408. Materials and Methods: During the acute toxicity, Vatari Guggulu was orally administered at a single limit dose of 2000 mg/kg. The mortality and clinical signs were observed for 14 days. Similarly, the 90-days repeated dose toxicity was studied by administering the Vatari Guggulu at a limit dose of 1000 mg/kg. Results: In the acute toxicity, there were no signs of toxicity, and the LD50 was calculated as >2000 mg/kg. During the 90 days of repeated dose toxicity, the Vatari Guggulu at the dose of 1000 mg/kg did not show any signs of toxicity as compared to the control. The hematological, serum biochemical, and urine analysis profile of the Vatari Guggulu at the dose of 1000 mg/kg did not show any significant difference as compared to the control (P > 0.05). Further, the histopathological data of control and Vatari Guggulu-treated rats were found to be normal. Conclusions: It was concluded that the test drug Vatari Guggulu is found to be safe upto 2000 mg/kg 0in acute toxicity and 1000 mg/kg in 90-days repeated dose oral toxicity study. The NOAEL of Vatari Guggulu is established as 1000 mg/kg/day.