18. Acute and sub-chronic toxicity of Ich Nieu Khang tablet

Vu Minh Hoan, Nguyen Thi Thanh Tu

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Abstract

This study aimed to evaluate the acute and sub-chronic toxicity of Ich Nieu Khang tablet in experimental animals. The acute toxicity was performed in Swiss mice based on the Litchfield - Wilcoxon method. The sub-chronic toxicity was evaluated in Wistar rats according to the World Health Organization's guidance. The results showed that the highest dose of Ich Nieu Khang tablet (31.5 g/kg b.w./day, equivalent to 41.66 times as high as the maximal recommended human dose) did not show acute oral toxicity in mice and the median lethal dose (LD50) was not determined. Administration of Ich Nieu Khang tablet at these doses: 0.378 g/kg b.w./day (equivalent to clinical dose) and 1.134 g/kg body weight (three times as high as the clinical dose) in 4 weeks did not produce any significant detrimental effect on the body weight, hematological and biochemical parameters, as well as the gross and microscopic images of the rats’ liver and kidney, in comparison to the control group.

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References

1. Wein AJ, Rovner ES. Definition and epidemiology of overactive bladder. Urology. 2002;60(5 Suppl 1): 7-12; discussion 12. doi:10.1016/s0090-4295(02)01784-3.
2. Eapen RS, Radomski SB. Review of the epidemiology of overactive bladder. Res Rep Urol. 2016; 8: 71-76. doi:10.2147/RRU.S102441.
3. Irwin DE, Milsom I, Hunskaar S, et al. Population-based survey of urinary incontinence, overactive bladder, and other lower urinary tract symptoms in five countries: results of the EPIC study. Eur Urol. 2006; 50(6): 1306-1314; discussion 1314-1315. doi:10.1016/j.eururo.2006.09.019.
4. Coyne KS, Sexton CC, Kopp ZS, Ebel-Bitoun C, Milsom I, Chapple C. The impact of overactive bladder on mental health, work productivity and health-related quality of life in the UK and Sweden: results from EpiLUTS. BJU Int. 2011; 108(9): 1459-1471. doi:10.1111/j.1464-410X.2010.10013.x.
5. Fontaine C, Papworth E, Pascoe J, Hashim H. Update on the management of overactive bladder. Ther Adv Urol. 2021; 13:17562872211039034. doi:10.1177/17562872211039034.
6. Zhou J, Jiang C, Wang P, et al. Effects and safety of herbal medicines on patients with overactive bladder: A protocol for a systematic view and meta-analysis. Medicine (Baltimore). 2019; 98(37): e17005. doi:10.1097/MD.0000000000017005.
7. Chughtai B, Kavaler E, Lee R, Te A, Kaplan SA, Lowe F. Use of Herbal Supplements for Overactive Bladder. Rev Urol. 2013; 15(3): 93-96.
8. Cheng M, Qiang Y, Wu Y, et al. Multi-omic approaches provide insights into the molecular mechanisms of Sojae semen germinatum water extract against overactive bladder. Food Res Int Ott Ont. 2024;175:113746. doi:10.1016/j.foodres.2023.113746
9. Nishimura M, Ohkawara T, Sato H, Takeda H, Nishihira J. Pumpkin Seed Oil Extracted From Cucurbita maxima Improves Urinary Disorder in Human Overactive Bladder. J Tradit Complement Med. 2014; 4(1): 72-74. doi:10.4103/2225-4110.124355
10. Research guidelines for evaluating the safety and efficacy of herbal medicines. Accessed December 4, 2023. https://www.who.int/publications/i/item/9290611103.
11. Litchfield J T& Wilcoxon F A. A simplified method of evaluating dose-effect experiments. J. Pharmacol. Exp. Ther. 96: 99-113, 1949.
12. Oecdtg407-2008.pdf. Accessed January 4, 2024. https://ntp.niehs.nih.gov/sites/default/files/iccvam/suppdocs/feddocs/oecd/oecdtg407-2008.pdf
13. Organization WH. Working group on the safety and efficacy of herbal medicine. Rep Reg Off West Pac World Health Organ. Published online 2000.
14. Đỗ trọng (vỏ thân) - Dược Điển Việt Nam. Accessed January 4, 2024. https://duocdienvietnam.com/do-trong-vo-than/.
15. Huang L, Lyu Q, Zheng W, Yang Q, Cao G. Traditional application and modern pharmacological research of Eucommia ulmoides Oliv. Chin Med. 2021; 16(1): 73. doi:10.1186/s13020-021-00482-7.
16. Luo X, Wu J, Li Z, et al. Safety evaluation of Eucommia ulmoides extract. Regul Toxicol Pharmacol. 2020; 118: 104811. doi:10.1016/j.yrtph.2020.104811.
17. Office of Dietary Supplements - Carnitine. Accessed January 4, 2024. https://ods.od.nih.gov/factsheets/Carnitine-HealthProfessional/.
18. Belay B, Esteban-Cruciani N, Walsh CA, Kaskel FJ. The use of levo-carnitine in children with renal disease: a review and a call for future studies. Pediatr Nephrol Berl Ger. 2006; 21(3): 308-317. doi:10.1007/s00467-005-2085-4.
19. Goin-Kochel RP, Scaglia F, Schaaf CP, et al. Side Effects and Behavioral Outcomes Following High-Dose Carnitine Supplementation Among Young Males With Autism Spectrum Disorder: A Pilot Study. Glob Pediatr Health. 2019; 6: 2333794X19830696. doi:10.1177/2333794X19830696.
20. Malaguarnera M, Cauli O. Effects of l-Carnitine in Patients with Autism Spectrum Disorders: Review of Clinical Studies. Molecules. 2019; 24(23): 4262. doi:10.3390/molecules24234262.
21. Šamec D, Loizzo MR, Gortzi O, et al. The potential of pumpkin seed oil as a functional food-A comprehensive review of chemical composition, health benefits, and safety. Compr Rev Food Sci Food Saf. 2022; 21(5): 4422-4446. doi:10.1111/1541-4337.13013.
22. SciELO - Brazil - Extracts from sojae semen germinatum ameliorated carbon tetrachloride-induced liver injury in mice Extracts from sojae semen germinatum ameliorated carbon tetrachloride-induced liver injury in mice. Accessed January 4, 2024. https://www.scielo.br/j/cta/a/S4ck8D5fwcrDHP3yCmJj5tD/?lang=en.