Subchronic toxicological evaluation of EnXtra™ (standardised extract of Alpinia galanga rhizome) in rats
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Devanand Shanmugasundaram
Abstract
Objectives
Alpinia galanga is a commonly used ingredient in Asian food and traditional medicine. But an extract of the rhizome had never been used commercially in food supplements and functional foods. There is some evidence of safety and tolerability in humans for a proprietary A. galanga rhizome extract (EnXtra™) and it is Generally Recognised as Safe (GRAS) in the US already. However, this botanical ingredient has not been evaluated for its subchronic toxicity in rats to confirm its safety in wider food applications.
Methods
Sprague Dawley rats were orally administered the test item for 90 days by following OECD (Test Guideline: 408), with a recovery period of 28 days. Cumulative effects and No Observed Adverse Effect Level (NOAEL) were estimated. EnXtra™ was administered orally at 0, 1,000, 2,000 and 3,000 mg kg−1 body weight (b. wt.) with additional vehicle and high dose recovery groups. Observations included clinical signs, haematology, clinical chemistry, gross pathology and histopathology.
Results
On terminal sacrifice, no treatment-related adverse effects were observed viz., clinical signs, mortality, body weight changes and feed consumption parameters. Haematology, clinical biochemistry and thyroid hormone levels were within the normal range. Further, no treatment-related gross and microscopic pathological lesions were observed across the treatment groups.
Conclusions
Based on the results of the toxicological evaluation, NOAEL of A. galanga rhizome extract (AGRE) was fixed at 3,000 mg kg−1 b. wt. per day and ADI of 1800 mg day−1 in the case of humans.
Funding source: Enovate Biolife, Mumbai, India
Acknowledgments
The author would like to thank Girish Bekkare Chandrashekaraiah (Veterinary College, Hassan, India) for the review of the manuscript.
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Research funding: The study was funded by Enovate Biolife, Mumbai, India.
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Author contributions: Author have accepted responsibility for the entire content of this manuscript and approved its submission.
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Competing interests: Authors state no conflict of interest.
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Informed consent: Not applicable.
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Ethical approval: Study received animal ethical approval from Institutional Animal Ethics Committee (IAEC).
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© 2022 Walter de Gruyter GmbH, Berlin/Boston
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Artikel in diesem Heft
- Frontmatter
- Reviews
- Evidence implementation among complementary medicine practitioners: a meta-summary
- Phytochemical: a treatment option for heavy metal induced neurotoxicity
- The effects of curcumin-containing supplementations on inflammatory markers and lipid profiles in patients with chronic kidney diseases: a systematic review and meta-analysis of randomized controlled trials
- A systematic review on traditional medicinal Animal’s parts and products used for the treatment of respiratory tract disorders in Ethiopia
- Review on nutraceuticals: phase transition from preventive to protective care
- A study of effect of Centella asiatica on oxidative markers in the hippocampus of offsprings born to alcohol-fed pregnant rats and the correlation with their cognitive functions
- Anxiogenic and anxiolytic effects of memantine injected into the ventral hippocampus in male stressed mice
- Research Articles
- Comparison of antithyroid effects and hepatic complications of methimazole with catechin and its nanoencapsulation form in adult male rats
- Almond oil restores blood parameters, liver function, blood and liver antioxidants and DNA, and liver histology more efficiently than olive oil in favism
- Highly efficient microencapsulation of phytonutrients by fractioned cellulose using biopolymer complexation technology
- Ocimum basilicum alleviates blood glucose, lipid profile and iNOS in diabetes gestational rat model
- Blood pressure and blood sugar-lowering effects of purified gambir on diabetic hypertensive Wistar Kyoto rats
- Assessment of anti-inflammatory and antioxidant activity of quercetin–rutin blend (SophorOx™) – an invitro cell based assay
- Subchronic toxicological evaluation of EnXtra™ (standardised extract of Alpinia galanga rhizome) in rats
- Ficus glumosa Del. reduces phenylhydrazine-induced hemolytic anaemia and hepatic damage in Wistar rats
- Screening of anti-cancerous potential of classical Raudra rasa and modified Raudra rasa modified with hiraka bhasma (nanodiamond) through FTIR & LC-MS analysis
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- Biochemical and histopathological evaluation of liver, kidney, and pancreas in normal Sprague Dawley rats administered aqueous extract of beetroot (Beta vulgaris)
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