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Drugs and Health Products

Monograph: Fenugreek - Oral

This monograph is intended to serve as a guide to industry for the preparation of Product Licence Applications (PLA) and labels for natural health product market authorization. It is not intended to be a comprehensive review of the medicinal ingredient. It is a referenced document to be used as a labelling standard. Notes: (i) Text in parentheses is additional optional information which can be included on the PLA and product labels at the applicant's discretion. The solidus (/) indicates that the terms are synonyms or that the statements are synonymous. Either term or statement may be selected by the applicant. (ii) Claims for traditional use must include the term "Herbal Medicine".

Date: 2009-06-24

NHPID Name

Trigonella foenum-graecum (USDA 2008)

Proper Name(s)

Trigonella foenum-graecum L. (Fabaceae) ( USDA 2008 )

Common Name(s)

Fenugreek ( McGuffin et al. 2000 )

Source Material

Seed ( Bradley 2006 , Blumenthal et al. 2000 )

Route Of Administration

Oral

Dosage Form(s)

  • The acceptable pharmaceutical dosage forms include, but are not limited to capsules, chewables (e.g. gummies, tablets), liquids, powders, strips or tablets.
  • This monograph is not intended to include foods or food-like dosage forms such as bars, chewing gums or beverages.

Use(s) or Purpose(s)

Statement(s) to the effect of:

Dose(s)

Adults:

Preparation: Dry, Powder, Decoction & Infusion + All Non-Standardised Extracts

Dose(s): 2 - 30 Grams per day, seeds

See Appendix 1 for examples of appropriate dosage preparations and frequencies of use, according to cited references. The purpose of Appendix 1 is to provide guidance to industry.

Duration of use

No statement is required

Risk Information

Statement(s) to the effect of:

Caution(s) and Warning(s):

Contraindication(s):
No statement is required

Known Adverse Reaction(s):
No statement is required

Non-medicinal ingredients

Must be chosen from the current Natural Health Products Ingredients Database and must meet the limitations outlined in the database.

Specifications

  • The finished product specifications must be established in accordance with the requirements described in the NHPD Quality of Natural Health Products Guide.
  • The medicinal ingredient must comply with the requirements outlined in the Natural Health Products Ingredient Database (NHPID).
  • The medicinal ingredient may comply with the specifications outlined in the Fenugreek monograph published in the British Pharmacopoeia (BP) or the European Pharmacopoeia (Ph.Eur.).

References cited

  • Al-Habori M, Raman A. 1998. Anti-diabetic and hypocholesterolaemic effects of fenugreek. Phytotherapy Research 12(4):233-242.
  • API 2001: The Ayurvedic Pharmacopoeia of India, 1st edition, Part I, Volume I. Delhi (IN): Government of India, Ministry of Health and Family Welfare, Department of Indian Systems of Medicine & Homoeopathy.
  • Blumenthal M, Goldberg A, Brinckmann J, editors. Herbal Medicine: Expanded Commission E Monographs. Boston (MA): Integrative Medicine Communications; 2000.
  • BP 2008: British Pharmacopoeia, Volume 1. Londron (UK): British Pharmacopoeia Commission. The Stationary Office.
  • Bradley PR, editor. British Herbal Compendium: A Handbook of Scientific Information on Widely Used Plant Drugs, Volume 2. Bournemouth (UK): British Herbal Medicine Association; 2006.
  • Brinker F. 2001. Herb Contraindications and Drug Interactions, 3rd edition. Sandy (OR): Eclectic Medical Publications.
  • Brinker F. Online Updates and Additions to Herb Contraindications and Drug Interactions, 3rd edition. Sandy (OR): Eclectic Medical Publications; 2010. [Accessed 2015 June 4]. Available from: http://www.eclecticherb.com/emp/updatesHCDI.html
  • European Pharmacopoeia, 6th edition. Strasbourg (France): Directorate for the Quality of Medicines and HealthCare of the Council of Europe (EDQM).; 2008
  • Felter HW, Lloyd JU. King's American Dispensatory, Volume 1, 18th edition. Sandy (OR): Eclectic Medical Publications; 1983 [Reprint of 1898 original].
  • Grieve M. 1971. A Modern Herbal, Volume 1. New York (NY): Dover Publications [Reprint of 1931 Harcourt, Brace & Company publication].
  • Hoffmann D. 2003. Medical Herbalism: The Science and Practice of Herbal Medicine. Rochester (VT): Healing Arts Press.
  • Khory RN, Katrak NN.1999 [1903]. Materia Medica of India and Their Therapeutics. Delhi (IN): Komal Prakashan; [Reprint of 1903 publication].
  • McGuffin M, Hobbs C, Upton R, Goldberg A, editors. 1997. American Herbal Products Association's Botanical Safety Handbook. Boca Raton (FL): CRC Press.
  • McGuffin M, Kartesz JT, Leung AY, Tucker AO, editors. 2000. Herbs of Commerce, 2nd edition. Austin(TX): American Herbal Products Association.
  • Meyer JE. The Herbalist. Glenwood (IL): Meyerbooks; 1993.
  • Mills E, Dugoua J, Perri D, Koren G. Herbal Medicines in Pregnancy and Lactation: An Evidence-Based Approach. London (UK): Taylor and Francis Medical; 2006.
  • Mills S, Bone K. 2005. The Essential Guide to Herbal Safety. St. Louis (MO): Elsevier Churchill Livingstone.
  • Mills S. The Dictionary of Modern Herbalsim. Wellingborough (UK): Thorsons Publishers Ltd; 1985.
  • Mills S. The Essential Book of Herbal Medicine. Toronto (ON): Arkana; 1993.
  • Sharma RD and Raghuram TC. 1990. Hypoglycaemic effect of fenugreek seeds in non-insulin dependant diabetic subjects. Nutrition Research 10(7):731-739.
  • USDA 2008: ARS, National Genetic Resources Program. Germplasm Resources Information Network (GRIN). National Germplasm Resources Laboratory, Beltsville (MD). [Accessed 2008-01-21]. Available at http://www.ars-grin.gov/cgi-bin/npgs/html/tax_search.pl
  • Wichtl M, editor. Herbal Drugs and Phytopharmaceuticals: A Handbook for Practice on a Scientific Basis, 3rd edition. Stuttgart (D): Medpharm GmbH Scientific Publishers; 2004.
  • Williamson EM, editor. 2002. Major Herbs of Ayurveda. London (UK): Churchill Livingstone.
  • Williamson EM, Evans FJ, Wren RC. Potter's New Cyclopaedia of Botanical Drugs and Preparations. Saffron Walden (GB): C.W. Daniel Company Limited; 1988.
  • Williamson EM. Potter's Herbal Cyclopaedia: The Authoritative Reference work on Plants with a Known Medical Use. Saffron Walden (UK): The C.W. Daniel Company Limited; 2003.
  • Wren RC. 1907. Potter's Cyclopedia of Botanical Drugs and Preparations. London (GB): Potter and Clark.

References reviewed

  • API 1999: The Ayurvedic Pharmacopoeia of India, Part I, Volume II, 1st edition. Delhi (India): The Controller of Publications; 1999.
  • Barnes J, Anderson LA, Philipson JD. 2002. Herbal Medicines: A Guide for Healthcare Professionals, 2nd edition. London (GB): The Pharmaceutical Press.
  • Barnes J, Anderson LA, Philipson JD. 2007. Herbal Medicines, 3rd edition. London (GB): Pharmaceutical Press.
  • Bartram T. Bartram's Encyclopedia of Herbal Medicine: The Definitive Guide to the Herbal Treatments of Diseases. New York (NY): Marlowe & Company; 1998.
  • BHP 1996: British Herbal Pharmacopoeia. Bournemouth (UK): British Herbal Medical Association; 1996.
  • Bisset NG, Wichtl M, editors. Herbal Drugs and Phytopharmaceuticals: A Handbook for Practice on a Scientific Basis, 2nd edition. Stuttgart (D): Medpharm GmbH Scientific Publishers; 2001.
  • Bordia A, Verma SK, Srivastava KC. Effect of ginger (Zingiber officinale Rosc.) and fenugreek (Trigonella foenumgraecum L.) on blood lipids, blood sugar and platelet aggregation in patients with coronary artery disease. Prostaglandins, Leukotrienes and Essential Fatty Acids 1997;56(5):379-84.
  • Bradley PR, editor. 1992. British Herbal Compendium: A Handbook of Scientific Information on Widely Used Plant Drugs, Volume 1. Bournemouth (GB): British Herbal Medicine Association.
  • Choudhary D, Chandra D, Choudhary S, Kale RK. 2001. Modulation of glyoxalase, glutathione S-transferase and antioxidant enzymes in the liver, spleen and erythrocytes of mice by dietary administration of fenugreek seeds. Food and Chemical Toxicology 39(10):989-997.
  • Ellingwood F. 1983. American Materia Medica, Therapeutics and Pharmacognosy. Sandy (OR): Eclectic Medical Publications [Reprint of 1919 original].
  • Felter HW. The Eclectic Materia Medica, Pharmacology and Therapeutics. Sandy (OR): Eclectic Medical Publications; 1983 [Reprint of 1922 original].
  • Genet S, Kale RK, Baquer NZ. 2002. Alterations in antioxidant enzymes and oxidative damage in experimental diabetic rat tissues: Effect of vanadate and fenugreek (Trigonella foenum graecum). Molecular and Cellular Biochemistry 236(1-2):7-12.
  • Gruenwald J, Brendler T, Jaenicke C, editors. PDR for Herbal Medicines, 2nd edition. Montvale (NJ): Medical Economics Co.; 1998.
  • Gruenwald J, Brendler T, Jaenicke C, editors. PDR for Herbal Medicines, 3rd edition. Montvale (NJ): Thompson PDR; 2004.
  • Gupta A, Gupta R, Lal B. 2001. Effect of Trigonella foenum-graecum (fenugreek) seeds on glycaemic control and insulin resistance in type 2 diabetes mellitus: a double blind placebo controlled study. The Journal of the Associated Physicians of India 49:1057-1061.
  • Kaviarasan S, Vijayalakshmi K, Anuradha CV. 2004. Polyphenol-rich extract of fenugreek seeds protect erythrocytes from oxidative damage. Plant Foods for Human Nutrition 59(4):143-147.
  • Korman SH, Cohen E., Preminger A. Pseudo-maple syrup urine disease due to maternal prenatal ingestion of fenugreek. Journal of Paediatrics and Child Health 2001;37(4):403-404.
  • Mills S, Bone K. 2000. Principles and Practice of Phytotherapy. Toronto (ON): Churchill Livingstone.
  • PasseportSanté.net 2007 Montréal (QC): PasseportSanté.net, Totalmédia Inc.; 2008. Disponible en ligne à : http://www.passeportsante.net/fr/Solutions/PlantesSupplements/Index.aspx
  • Ravikumar P, Anuradha CV. 1999. Effect of fenugreek seeds on blood lipid peroxidation and antioxidants in diabetic rats. Phytotherapy Research 13(3):197-201.
  • Sharma RD and Raghuram TC. 1991. Short Communication: Hypolipidaemic effect of fenugreek seeds: A clinical study. Phytotherapy Research 5(3):145-147.
  • Sharma RD, Raghuram TC, Rao NS. 1990. Effect of Fenugreek seeds on blood glucose and serum lipids in Type I diabetes. European Journal of Clinical Nutrition 44(4):301-306.
  • Sharma RD, Sarkar A, Hazra DK, Misra B, Singh JB, Maheshwara BB, Sharma SK. 1996. Short Communication: Hypolipidaemic Effect of Fenugreek Seeds: a Chronic Study in Non-insulin Dependant Diabetic Patients. Phytotherapy Research10(4):332-334.
  • Sharma RD. 1986. Effect of fenugreek seeds and leaves on blood glucose and serum insulin responses in human subjects. Nutrition Research 6(12):1353-1364.
  • Srinivasan K. 2006. Fenugreek (Trigonella foenum-graceum): a review of health beneficial physiological effects. Food Reviews International 22(2):203-224.
  • Thirunavukkarasu V, Anuradha CV, Viswanathan P. 2003. Protective effect of fenugreek (Trigonella foenum graecum) seeds in experimental ethanol toxicity. Phytotherapy Research 17(7):737-743.
  • Yalçin SS., Tekinalp G, Ozalp I. Peculiar odor of traditional food and maple syrup urine disease. Pediatrics International 1999;41(1):108-109.

Appendix 1: Examples of appropriate dosage preparations, frequencies of use and directions for use

ORAL:

For reducing blood lipid levels:

Seed:

  • 2 g crushed seed, 1 to 3 times per day (Bradley 2006)
  • 25 g dried seed, per day (Mills and Bone 2005)

For support of healthy glucose levels:

Seeds:

  • 25 g of powdered seed, per day (Bradley 2006)
  • 25 g dried seed, per day (Mills and Bone 2005)
  • 3 - 6 g, in powder form, per day (API 2001)

For all other claims:

Seed:

  • 2 g crushed seed, 1 to 3 times per day (Bradley 2006)
  • 2 g dried seed, per day (Mills and Bone 2005)
  • 6 g cut or crushed seed, per day (Blumenthal et al. 2000)
  • 1 - 6 g dried seed, 3 times per day (Mills 1985)

Directions for use:

Take with adequate fluid before a meal (Bradley 2006)

Decoction:

30 g (approx. 6 tsp) seed, per day ((Felter and Lloyd 1983 [1898]; Grieve 1971 [1931]; Wren 1907)

Directions for use:

Place seeds in 475 ml (approx. 2 cups) water, bring to a boil and simmer, covered, for 15 minutes. Let cool, strain and rinse with enough water to make the preparation measure 475 ml (Felter and Lloyd 1983 [1898]).

Fluid extract:

  • 2 g dried equivalent, per day (1:1, 2 ml) (Mills and Bone 2005)
  • 6 g dried equivalent, per day (1:1, 6 ml) (Blumenthal et al. 2000)
  • 1 to 6 g dried equivalent, 3 times per day (1:1, 1-6 ml) (Mills 1985)

Tincture:

  • 2 g dried equivalent, per day (1:5, 10 ml) (Mills and Bone 2005)
  • 6 g dried equivalent, per day (1:5, 30 ml) (Blumenthal et al. 2000)
  • 1 to 6 g dried equivalent, 3 times per day (Mills 1985)

Maceration:

0.5 g cut or crushed seed, several times (up to 12) per day (Blumenthal et al. 2000)

Directions for use:

Place cut or crushed seed in 150 ml cold water, let stand for 3 hours, strain. Drink several times (up to 12) per day (Blumenthal et al. 2000).