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Two Weeks Dose Range Finding Study of KSM-66 Ashwagandha Root Extract by Oral Route in Wistar Rats – A Toxicity Study
Dr. P. Kalaivani, Dr. R. Siva, Dr. V. Gayathri
DOI : 10.5281/zenodo.10807262
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Ashwagandha (Withania Somnifera) is widely used as an adaptogenic medicinal herbin Ayurveda, the Indian system of Medicine. This study assessedpotential toxic effects associated with repeated oral administration of Ashwagandha root extract (ARE) for two weeks in Wistar rats. Twenty male and female Wistar rats were assigned to four groups viz., control, ARE (500/1000/2000 mg/kg body weight per day). Animals were observed for mortality/morbidity, clinical signs of toxicity (daily cage side observation), clinical examination (gait, mobility, arousal level, respiration, clonic/tonic movement, stereotype, bizarre behaviour, defecation, urine pools, vocalization, and rearing) prior to dosing and before necropsy day, body weight (weekly), and feed consumption. After 14 days, the animals were euthanized (CO2) and subjected to detailed gross necropsy (examination of external orifices, cranial, thoracic, and abdominal cavities, and their contents). Organs (liver, kidney, heart, spleen, brain, adrenal, thymus, ovaries, uterus with cervix, testes, and epididymis) were removed and weighed. No clinical signs of toxicity were observed with Ashwagandhatreated groups, and it had nosignificant (p>0.05) effect on body weight and feed consumption by animals compared to control. No differences (p>0.05) were observed between ARE treated animals and control with respect to the absolute and relative organ weightand gross pathological findings. Ashwagandha root extract was found to be well tolerated in doses up to 2000 mg/kg body weight administered orally for 14 days in Wistar rats.

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