Preclinical Safety Assessment of Furostanol Glycoside-Based Standardized Fenugreek Seed Extract in Laboratory Rats

References

• Abdel-Daim MM, AbdEldaim MA, Hassan AG. Trigonella foenum-graecum ameliorates acrylamide-induced toxicity in rats: roles of oxidative stress, proinflammatory cytokines, and DNA damage. Biochem Cell Biol. 2015;9(3):192–198.
   Google Scholar
• Abdel-Rahman A, Anyangwe N, Carlacci L, Casper S, Danam RP, Enongene E, et al. The safety and regulation of natural products used as foods and food ingredients. Toxicol Sci. 2011;123:333–348.
   Google Scholar
• Ahmad A, Alghamdi SS, Mahmood K, Afzal M. Fenugreek a multipurpose crop: potentialities and improvements. Saudi J Biol Sci. 2015;23:300–310.
   Google Scholar
• 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.
   Google Scholar
• Bailey SA, Zidell RH, Perry RW. Relationships between organ weight and body/brain weight in the rat: what is the best analytical endpoint? Toxicol Pathol. 2004;32:448–466.
   Google Scholar
• Baquer NZ, Kumar P, Taha A, Kale R, Cowsik S, McLean P. Metabolic and molecular action of Trigonella foenum-graecum (fenugreek) and trace metals in experimental diabetic tissues. J Biosci. 2011;36:383–396.
   Google Scholar
• Bauer R. Quality criteria and standardization of phytopharmaceuticals: can acceptable drug standards be achieved? Drug Inf J. 1998;32:101–110.
   Google Scholar
• Bhatia K, Kaur M, Atif F, Ali M, Rehman H, Rahman S, et al. Aqueous extract of Trigonella foenum-graecum L. ameliorates additive urotoxicity of buthioninesulfoximine and cyclophosphamide in mice. Food Chem Toxicol. 2006;44:1744–1750.
   Google Scholar
• Brautbar N, Williams J. Industrial solvents and liver toxicity: risk assessment, risk factors and mechanisms. Int J Hyg Environ Health. 2002;205:479–491.
   Google Scholar
• Center for Drug Evaluation and Research. Guidance for industry: estimating the maximum safe starting dose in initial clinical trials for therapeutics in adult healthy volunteers. US Department of Health and Human Services, Food and Drug Administration, Rockville, MD, 2005.
   Google Scholar
• Kluwe WM. Renal function tests as indicators of kidney injury in subacute toxicity studies. Toxicol Appl Pharmacol. 1981;57:414–424.
   Google Scholar
• Kenny O, Smyth T, Hewage C, Brunton N. Antioxidant properties and quantitative UPLC-MS analysis of phenolic compounds from extracts of fenugreek (Trigonella foenum-graecum) seeds and bitter melon (Momordicacharantia) fruit. Food Chem. 2013;141:4295–4302.
   Google Scholar
• Kunle OF, Egharevba HO, Ahmadu PO. Standardization of herbal medicines – a review. Int J BiodiversConserv. 2012;4:101–112.
   Google Scholar
• Mapanga R, Musabayane C. The renal effects of blood glucose-lowering plant-derived extracts in diabetes mellitus-an overview. Ren Fail. 2010;32:132–138.
   Google Scholar
• Michael B, Yano B, Sellers RS, Perry R, Morton D, Roome N, et al. Evaluation of organ weights for rodent and non-rodent toxicity studies: a review of regulatory guidelines and a survey of current practices. Toxicol Pathol. 2007;35:742–750.
   Google Scholar
• Mortelmans K, Zeiger E. The ames salmonella/microsome mutagenicity assay. Mutat Res. 2000;455:29–60.
   Google Scholar
• Muntner P, Coresh J, Smith JC, Eckfeldt J, Klag MJ. Plasma lipids and risk of developing renal dysfunction: the atherosclerosis risk in communities study. Kidney Int. 2000;58:293–301.
   Google Scholar
• Olaiya CO, Soetan KO. A review of the health benefits of fenugreek (Trigonella foenum-graecum L.): nutritional, biochemical and pharmaceutical perspectives. Am J .Soc Issues Humanit. 2014;3:3–12.
   Google Scholar
• Olorunnisola O, Bradley G, Afolayan A. Acute and sub-chronic toxicity studies of methanolic extract of Tulbaghiaviolacea rhizomes in Wistar rats. Afr J Biotechnol. 2012;11:14934–14940.
   Google Scholar
• Organisation for Economic Co-operation and Development (OECD). OECD guidelines for the testing of chemicals. Paris, France: OECD Publishing, 1993.
   Google Scholar
• Organisation for Economic Co-operation Development (OECD). OECD series on principles of good laboratory practice and compliance monitoring. Paris, France:OECD Publishing, 1995.
   Google Scholar
• Organisation for Economic Co-operation and Development (OECD). Test No. 471: bacterial reverse mutation test. OECD guidelines for the testing of chemicals, section 4: health effects. Paris, France: OECD Publishing, 1997.
   Google Scholar
• Organisation for Economic Co-operation and Development (OECD). OECD guidelines for the testing of chemicals, section 4: health effects. Paris, France: OECD Publishing, 1998.
   Google Scholar
• Organisation for Economic Co-operation and Development (OECD). Test No. 408: repeated dose 90-day oral toxicity study in rodents. OECD guidelines for the testing of chemicals, section 4: health effects. Paris, France: OECD Publishing, 1998.
   Google Scholar
• Organisation for Economic Co-operation and Development (OECD). Test No. 423: acute oral toxicity – acute toxic class method. OECD guidelines for the testing of chemicals, section 4: health effects. Paris, France: OECD Publishing, 2002.
   Google Scholar
• Organisation for Economic Co-operation and Development (OECD). Test No. 473: in vitro mammalian chromosomal aberration test OECD guidelines for the testing of chemicals, section 4: health effects. Paris, France: OECD Publishing, 2014.
   Google Scholar
• Palmer ME, Haller C, McKinney PE, Klein-Schwartz W, Tschirgi A, Smolinske SC, et al. Adverse events associated with dietary supplements: an observational study. Lancet. 2003;361:101–106.
   Google Scholar
• Pang X, Cong Y, Yu H-S, Kang L-P, Feng B, Han B-X, et al. Spirostanolsaponinsderivated from the seeds of Trigonella foenum-graecum by β-glucosidase hydrolysis and their inhibitory effects on rat platelet aggregation. Planta Med. 2012;78:276–285.
   Google Scholar
• Pittler M, Ernst E. Systematic review: hepatotoxic events associated with herbal medicinal products. Aliment Pharmacol Ther. 2003;18:451–471.
   Google Scholar
• Sakr SA, Abo-El-Yazid SM. Effect of fenugreek seed extract on adriamycin-induced hepatotoxicity and oxidative stress in albino rats. Toxicol Ind Health. 2012;28:876–885.
   Google Scholar
• Sakr SA, Mahran HA, Abo-El-Yazid SM. Effect of fenugreek seeds extract on cyclophosphamide-induced histomorphometrical, ultrastructural and biochemical changes in testes of albino mice. Toxicol Ind Health. 2012;28:276–288.
   Google Scholar
• Snehlata HS, Payal DR. Fenugreek (Trigonella foenum-graecum L.): an overview. Int J Curr Pharm Rev Res. 2012;2:169–187.
   Google Scholar
• Steels E, Rao A, Vitetta L. Physiological aspects of male libido enhanced by standardized Trigonella foenum-graecum extract and nineral formulation. Phytother Res. 2011;25:1294–1300.
   Google Scholar
• Ukwuani A, Abubakar M, Hassan S, Agaie B. Toxicological studies of hydromethanolic leaves extract of Grewiacrenata. Int J Pharm Sci Drug Res. 2012;4:245–249.
   Google Scholar
• Ulbricht C, Basch E, Burke D, Cheung L, Ernst E, Giese N, et al. Fenugreek (Trigonella foenum-graecum L. Leguminosae): an evidence-based systematic review by the natural standard research collaboration. J Herbal Pharmacother. 2008;7:143–177.
   Google Scholar
• United Nations. Globally harmonized system of classification and labelling of chemicals (GHS) (5th revised ed.). New York, NY: United Nations, 2013.
   Google Scholar
• Wankhede S, Mohan V, Thakurdesai P. Beneficial effects of fenugreek glycoside supplementation in male subjects during resistance training: A randomized controlled pilot study. J Sport Health Sci. 2016;5(2):176–182.
   Google Scholar
• Winder C, Azzi R, Wagner D. The development of the globally harmonized system (GHS) of classification and labelling of hazardous chemicals. J Hazard Mater. 2005;125:29–44.
   Google Scholar
• Wu K-M, Farrelly J, Birnkrant D, Chen S, Dou J, Atrakchi A, et al. Regulatory toxicology perspectives on the development of botanical drug products in the United States. Am J Ther. 2004;11:213–217.
   Google Scholar
• Wu K-M, Ghantous H, Birnkrant DB. Current regulatory toxicology perspectives on the development of herbal medicines to prescription drug products in the United States. Food Chem Toxicol. 2008;46:2606–2610.
   Google Scholar