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Manajit Bora ¹, Barnali M Sinha ², Manish Kumar Gautam ³, Sudesh N Gaidhani ⁴, Sachchidanand N Upadhyay ², Shrirang B Jamadagni ⁵, Amit Kumar Dixit ²

Affiliations
1 Central Ayurveda Research Institute, under CCRAS, Ministry of AYUSH, Government of India, Guwahati – 781028, Assam, IN
2 Central Ayurveda Research Institute, under CCRAS, Ministry of AYUSH, Government of India, Kolkata – 700091, West Bengal, IN
3 Faculty of Pharmaceutical Sciences, Assam Down Town University, Panikhaiti, Guwahati-781026, Assam, IN
4 National Ayurveda Research Institute for Panchakarma, under CCRAS, Ministry of AYUSH, Government of India, Cheruthuruthy, Kerala – 679531, IN
5 Regional Ayurveda Research Institute, under CCRAS, Ministry of AYUSH, Government of India, Kothrud, Pune – 411038, Maharashtra, IN

Abstract

The present study was undertaken to evaluate the Maximum Tolerated Dose and No Observed Adverse Effect Level of Trayodashang guggulu (TG), an Ayurvedic classical formulation, in Wistar rats. TG was administered orally to Wistar rats in as single dose (2000 mg/kg body weight) in an acute toxicity study. Ninety days repeated dose oral toxicity (subchronic) study was carried out by using three dose levels (250, 500 and 1000 mg/kg body weight) administered orally daily for 90 consecutive days and derived from 28 days dose range-finding study. In acute and subchronic toxicity studies, animals were observed for general clinical signs, mortality, weekly body weight changes, weekly feed intake, weekly water intake, blood biochemical investigation, haematological parameters, and gross pathological and histological investigations. In an acute toxicity study, the dose level of 2000 mg/kg of TG was found to be safe when given at a single dose. In the dose rangefinding study and subchronic toxicity study TG was found to be safe at all tested dose levels. No significant changes in food and water consumption, haematological and blood biochemical parameters were noticed at any dose level in both studies. No major changes were noticed during histopathological evaluation in ninety days repeated dose oral toxicity study. The study concluded that the Maximum Tolerated Dose of TG was found at 2000 mg/kg body weight and the No Observed Adverse Effect Level was found at 1000 mg/kg in Wistar rats.

Keywords

Acute Toxicity, Dose Range Finding Study, Sub-chronic Toxicity Study, Toxicity Study, Trayodashang guggulu

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