ORIGINAL RESEARCH article
Front. Pharmacol.
Sec. Ethnopharmacology
Volume 16 - 2025 | doi: 10.3389/fphar.2025.1572025
Reproductive and Developmental Safety Assessment of Ashwagandha (Withania somnifera) Root Extract in Wistar Rats
Provisionally accepted
- Sri Ramachandra Institute of Higher Education and Research, Chennai, India
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Introduction: Ashwagandha (Withania somnifera L. Dunal), a popular botanical drug in Ayurveda, has a wide range of therapeutic applications. However, safety data for effects on reproduction and embryonic development in animal models is scarce. This randomized controlled study investigated the effects on body weight, reproductive organ weight, and thyroid hormone levels in pups of Wistar rats (10M/13F per group) who received oral aqueous Ashwagandha Root extract (500, 1000, or 2000 mg/kg/day body weight) or carboxymethylcellulose (control) for 4 weeks.Methods: Animals were housed in polypropylene cages with males and females together during the preexposure and pre-mating periods. During the mating phase, one male and one female were kept together until confirmation of pregnancy. Pregnant females were housed individually during the post-mating period and lactating phase, while male rats were returned to their group cages. The procedure used was based on OECD Guideline 421 (OECD, 2016).The no observed adverse effect level (NOAEL) in adult rats was 2000 mg/kg. The mean body weights of pups and parental animals were similar (p > 0.05) in the treatment and control arms. Also, the weight of reproductive organs in parental male and female rats was similar (p > 0.05) in all groups.Discussion: The parameters such as T4 and TSH levels, body weight, and weight of reproductive organs in adult Wistar rats and pups, were within range even at the maximum dosage. No evidence of toxicity at various stages of development and reproduction with aqueous extract was observed when administered orally. Rats' ability to reproduce and develop was unaffected by standardized ashwagandha root extract.
Keywords: Ashwagandha Root Extract, developmental toxicity, reproductive toxicity, Wistar Rats, Safety
Received: 12 Feb 2025; Accepted: 28 May 2025.
Copyright: © 2025 V., K., V., P., R. and Tamrakar. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
* Correspondence: Gayathri V., Sri Ramachandra Institute of Higher Education and Research, Chennai, India
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