ArticleToxicology reports2023
Ninety-day repeated dose toxicity of Ashwagandha (Withania somnifera) root extract in Wistar rats.
Article in Toxicology reports, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 15 papers, 1 of them a synthesis that pooled it.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
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Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
15 citing papers in PubMed, 1 synthesis or guideline pooled it.
- A Systematic and Ethnobotanical Review of Ashwagandha's ( Withania Somnifera ) Teratogenic and Abortifacient Potentials.Phytotherapy research : PTR · 2026Pooled it
- Immunomodulatory Properties of Withania somnifera: Regulation of Innate Immune Cells and Clinical Implications.Phytotherapy research : PTR · 2026Review
- Safety Evaluation of an Aqueous Root and Leaf Extract of Ashwagandha ( Withania somnifera ).Phytotherapy research : PTR · 2026Article
- Safety of 12-Months Administration of Ashwagandha ( Withania somnifera ) Standardized Root Extract in Healthy Adults: A Prospective, Observational Study.Phytotherapy research : PTR · 2026Observational
- Ashwagandha: Is It Safe? Part 2: A Preclinical Evidence Review.Phytotherapy research : PTR · 2026Review
- The interplay of Ashwagandha with hormonal dynamics and gut microbiota in women with breast cancer: a tri-axial perspective.Journal of natural medicines · 2026Review
- Phytochemical and Fungal Bioactive Compounds in the "Brain Health Triad": A Narrative Review on Neurostimulating, Neurotrophic, and Neuroprotective Synergy.International journal of molecular sciences · 2026Review
- The Clinical Implications of Ashwagandha (Nutrients · 2026Review
- Ashwagandha (Withania Somnifera): a comprehensive narrative review of its role in enhancing physical performance and health.Nutrition & metabolism · 2026Review
- A review of protective effects ofFrontiers in pharmacology · 2026Review
- Two Sides of the Same Coin for Health: Adaptogenic Botanicals as Nutraceuticals for Nutrition and Pharmaceuticals in Medicine.Pharmaceuticals (Basel, Switzerland) · 2025Review
- A multi-detector analytical approach for characterizing complex botanical extracts: a case study on ashwagandha.Analytical and bioanalytical chemistry · 2025Article
- Reproductive and developmental safety assessment of Ashwagandha (Frontiers in pharmacology · 2025Article
- Comprehensive safety evaluation ofFrontiers in nutrition · 2025Article
- Extraction of Bioactive Compounds FromInternational journal of food science · 2025Review
Corrections and comments
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Authors and funding
4 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Many pharmacological studies have been carried out to describe multiple biological properties of Ashwagandha (Withania somnifera) and the additional safety information on repeated dose toxicity is limited. Therefore, the aim of this study was to obtain safety data for KSM-66 Ashwagandha Root Extract (ARE) through repeated-dose toxicity in Wistar rats according to the Organisation for Economic Co-operation and Development (OECD) test guideline (TG 408). ARE was orally administered to rats at doses of 0, 500, 1000, and 2000 mg/kg body weight/day for 90-day and reversibility of effects of 0 and 2000 mg/kg body weight/day was assessed for 14 days. All the animals from treated, control, recovery control and recovery groups were observed for clinical signs of toxicity once daily, detailed clinical examination every week after dosing and before necropsy day. Mortality/Morbidity was observed twice daily. In addition, observations were noted in the detailed sensory reactivity, functional assessments, body weight, food consumption, ophthalmological examination, hematological parameters, biochemical parameters, organ weights, histopathological findings. The present results show that the no observed adverse effect level (NOAEL) of KSM-66 Ashwagandha Root Extract was considered to be 2000 mg/kg body weight/day in rats after repeated oral administration for 90-day under the present study conditions.
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