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January 23, 2026Phytotherapy Research

Biosafety Assessment of Shagandha, Standardized Extract From the Roots of Withania somnifera

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Authors

AMAnju MajeedSami Labs (India)SMShaheen MajeedAPAnjali PandeyGalgotias University

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Implication

Assesses safety outcomes of Shagandha in rodents, suggesting it is non-toxic and non-mutagenic.

Key Points

  • The study aims to evaluate the safety of Shagandha, a standardized extract from Ashwagandha roots, focusing on its potential toxicological effects.
  • Conducted GLP studies for acute, subacute, and subchronic toxicity.
  • Performed bacterial reverse mutation assay and mammalian erythrocyte micronucleus test.
  • Analyzed with USP method using HPLC to quantify withanolides.
  • No significant toxicological changes were observed in clinical signs, body weight, or reproductive parameters.
  • Shagandha did not show any genotoxic effects in both in vitro and in vivo testing.
  • The extract was found to be safe for oral administration in rodents.

Cite This Study

Majeed et al. (2026) studied this question.

synapsesocial.com/papers/69730f18c8125b09b0d1ee71https://doi.org/10.1002/ptr.70156
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Also Consider

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  5. 5A Standardized Withania somnifera (Linn.) Root Extract with Piperine Alleviates the Symptoms of Anxiety and Depression by Increasing Serotonin Levels: A Double-Blind, Randomized, Placebo-Controlled Study2023 · 24 citations