Acute and Sub-Acute Oral Toxicity Assessment of Mixed Extract of Trigonella Foenum-Graecum Seeds and Withania Somnifera Root in Rats

Authors

  • Mohammed Sadeg A. Al-Awar Department of Biology, Faculty of Applied Science, Amran University, Yemen.

DOI:

https://doi.org/10.35516/jjps.v15i4.673

Keywords:

Trigonella Foenum-graecum, Withania Somnifera, rats, safety, toxicity

Abstract

This study aimed at assessing the safety of a mixed extract of Trigonella Foenum-graecum seeds and Withania Somnifera root (TFWS), which effectively relieves male menopausal symptoms. To this end, male and female Sprague-Dawley rats were divided into the following groups and repeatedly administered TFWS orally for 90 days: control, low-dose (500 mg/kg/day), intermediate-dose (1,000 mg/kg/day), and high-dose (2,000 mg/kg/day) groups. The animals were monitored for general symptoms; their body weights and electrolyte levels were measured; urinalysis, blood chemistry, biochemistry tests, and histopathological tests were performed to assess the toxicity of TFWS. The no-observed-adverse-effect level of TFWS was 2,000 mg/kg/day for all male and female rats. While in the TFWS-administered and control groups, most parameters were within the normal range; some rats in the high-dose group showed changes not induced by the test substance but which may be specific to an individual animal or may occur naturally. Thus, based on our findings, we consider that TFWS may be a safe, non-toxic substance for alleviating male menopausal symptoms.

Author Biography

Mohammed Sadeg A. Al-Awar, Department of Biology, Faculty of Applied Science, Amran University, Yemen.

Department of Biology, Faculty of Applied Science, Amran University, Yemen.

Department of Medical Laboratory, College of Medical Science, Al-Razi University, Yemen.

References

Harman SM, Metter EJ, Tobin JD, Pearson J, Blackman MR, Baltimore Longitudinal Study of Aging: Longitudinal effects of aging on serum total and free testosterone levels in healthy men. J Clin Endocrinol Metab 2001;86:724–731.

Zmuda JM, Cauley JA, Kriska A, Glynn NW, Gutai JP, Kuller LH: Longitudinal relation between endogenous testosterone and cardiovascular disease risk factors in middle-aged men. A 13-year follow-up of former Multiple Risk Factor Intervention Trial participants. Am J Epidemiol 1997;146:609–617.

Al-Zeidaneen S, Jaber, D. Women's opinions, beliefs, and practices towards using different medicinal plants for postpartum health problems care. Jordan Journal of Pharmaceutical Sciences. 2021; 14(3): 309-322.‏

Singh P: Andropause: Current concepts. Indian J Endocrinol Metab 2013;17:S621–629.

Bhasin S, Cunningham GR, Hayes FJ, Matsumoto AM, Snyder PJ, Swerdloff RS, Montori VM; Task Force, Endocrine Society. Testosterone therapy in men with androgen deficiency syndromes: an Endocrine Society clinical practice guideline. J Clin Endocrinol Metab 2010;95:2536–2559.

Debaggio, Thomas; Tucker, Arthur O. (2009). The Encyclopedia of Herbs. ISBN 9781604691344. Retrieved 10 May 2021.

Ibraheem H.M. The plant life of Jabal al-Nabi Shuaib, Bani Matar District, Sana'a Governorate, Republic of Yemen. Ph.D. Thesis, Department of Biology, Faculty of Science, Sana'a University, Yemen. 2013.

Duru M, Erdoğan Z, Duru A, Küçükgül A, Düzgüner V, Kaya DA, Şahin A: Effect of seed powder of a herbal legume fenugreek (Trigonella foenum-graceum L.) on growth performance, body components, digestive parts, and blood parameters of broiler chicks. Pakistan J Zool 2013;45:1007–1014.

Kattuoa M, Issa R, Beitawi S. Commonly used herbal remedies for the treatment of Primary Dysmenorrhea and Heavy Menstrual Bleeding by herbalists in Amman, Jordan: A cross-sectional survey. Jordan Journal of pharmaceutical sciences. 2020; 13(4):467-483.

Kassem A, Al-Aghbari A, AL-Habori M, Al-Mamary M: Evaluation of the potential antifertility effect of fenugreek seeds in male and female rabbits. Contraception 2006;73:301–306.

Aswar U, Bodhankar SL, Mohan V, Thakurdesai PA: Effect of furostanol glycosides from Trigonella foenum-graecum on the reproductive system of male albino rats. Phytother Res 2010;24:1482–1488.

Steels E, Rao A, Vitetta L: Physiological aspects of male libido enhanced by standardized Trigonella foenum-graecum extract and mineral formulation. Phytother Res 2011;25:1294–1300.

Wilborn C, Taylor L, Poole C, Foster C, Willoughby D, Kreider R: Effects of a purported aromatase and 5α-reductase inhibitor on hormone profiles in college-age men. Int J Sport Nutr Exerc Metab 2010;20:457–465.

Chandrasekhar K., Kapoor J., Anishetty S. A prospective, randomized double-blind, placebo-controlled study of safety and efficacy of a high-concentration full-spectrum extract of Ashwagandha root in reducing stress and anxiety in adults. Indian Journal of Psychological Medicine. 2012;34(3):255–262.

5. Archana R., Namasivayam A. Antistressor effect of Withania somnifera . Journal of Ethnopharmacology. 1998;64(1):91–93.

Öberg K., Fugl-Meyer K. S. On Swedish women's distressing sexual dysfunctions: some concomitant conditions and life satisfaction. Journal of Sexual Medicine. 2005;2(2):169–180.

Singh N., (Mrs.) Nath R., (Miss) Lata A., Singh S. P., Kohli R. P., Bhargava K. P. Withania somnifera (Ashwagandha), a rejuvenating herbal drug which enhances survival during stress (an Adaptogen) Pharmaceutical Biology. 1982;20(1):29–35.

Mahdi A. A., Shukla K. K., Ahmad M. K., et al. Withania somnifera improves semen quality in stress-related male fertility. Evidence-Based Complementary and Alternative Medicine. 2011;2011:9.

Ambiye V. R., Langade D., Dongre S., Aptikar P., Kulkarni M., Dongre A. Clinical evaluation of the spermatogenic activity of the root extract of Ashwagandha (Withania somnifera) in oligospermic males: a pilot study. Evidence-Based Complementary and Alternative Medicine. 2013;2013:6.

Gulati S., Madan V. K., Singh S., Singh I. Chemical and Phytochemical Composition of Ashwagandha (Withania somnifera L.) Roots. Asian J. Chemi, 2017, 29(8): 1683-1686.

Akbari S., Abdurahman N. H., Yunus R. M., Alara O. R., Abayomi O. O. Extraction, characterization and antioxidant activity of fenugreek (Trigonella-Foenum Graecum) seed. Materials Sci. for Energy Technol, 2019, 2 349–355.

Al-Ashban R. M., Abou-Shaaban R.R., Shah A. H. Toxicity studies on Trigonella foenum-graecum L. seeds used in spices and as a traditional remedy for diabetes. Oriental Pharmacy and Experimental Medicine, 2010 10(2): 66-78.

Al-Awar M. S. Anti-diabetic Activities of Zizyphus Spina-Christi Seeds Embryos Extract on General Characteristics of Diabetes, Carbohydrate Metabolism Enzymes and Lipids Profile in Rats. Jordan Journal of Pharmaceutical Sciences, 2019. 12 (2): 91-107.

Mercer C. H. Sexual behaviour. Medicine. 2014;42(6):291–293.

Berman J. R., Berman L. A., Werbin T. J., Goldstein I. Female sexual dysfunction: anatomy, physiology, evaluation and treatment options. Current Opinion in Urology. 1999;9(6):563–568.

Meston C. M., Rellini A. H., Telch M. J. Short- and long-term effects of Ginkgo biloba extract on sexual dysfunction in women. Archives of Sexual Behavior. 2008;37(4):530–547.

Lee KS, Lee EK, Kim SY, Kim TH, Kim HP: Effect of a mixed extract of fenugreek seeds and Lespedeza cuneata on testosterone deficiency syndrome. Korean J Food Sci Technol 2015;47:492–498.

Dongre S., Langade D. and Bhattacharyya S. Clinical Study Efficacy and Safety of Ashwagandha (Withania somnifera) Root Extract in Improving Sexual Function in Women: A Pilot Study. BioMed Res Int, 2015 ., 284154.1-9.

Parasuraman S: Toxicological screening. J Pharmacol Pharmacother 2011;2:74–79.

Seo DS, Kwon M, Sung HJ, Park CB: Acute oral or dermal and repeated dose 90-day oral toxicity of tetrasodium pyrophosphate in Sprague Dawley (SD) rats. Environ Health Toxicol 2011;26:e2011014.

Downloads

Published

2022-12-25

How to Cite

Al-Awar, M. S. A. . . (2022). Acute and Sub-Acute Oral Toxicity Assessment of Mixed Extract of Trigonella Foenum-Graecum Seeds and Withania Somnifera Root in Rats. Jordan Journal of Pharmaceutical Sciences, 15(4), 493–506. https://doi.org/10.35516/jjps.v15i4.673

Issue

Section

Articles