Fenugreek

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Archived Monograph - January 2008

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: Text in parentheses is additional optional information which can be included on the PLA and product label 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.

Date: June 24, 2009

Proper name(s): Trigonella foenum-graecum L. (Fabaceae) (USDA 2000)

Common name(s): Fenugreek (McGuffin et al. 2000)

Source material(s): Seed (Bradley 2006; Blumenthal et al. 2000)

Route(s) of administration:

• Oral
• Topical

Dosage form(s):

• Those suited to topical administration.
• Those pharmaceutical dosage forms suited to oral administration, including but not limited to chewables (eg. gummies, tablets), caplets, capsules, strips, lozenges, powders or liquids where the dose is measured in drops, teaspoons or tablespoons, are acceptable. 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): Statements to the effect of:

Oral:

• (Traditionally) used in Herbal Medicine to help stimulate the appetite (Bradley 2006; Mills and Bone 2005; Blumenthal et al. 2000; Khory and Katrak 1999).
• (Traditionally) used in Herbal Medicine as a digestive tonic to aid digestion (Williamson et al. 1988; Mills 1985; Felter and Lloyd 1983 [1898]).
• (Traditionally) used in Herbal Medicine to help relieve dyspepsia and gastritis (Bradley 2006; Blumenthal et al. 2000; Mills 1985; Grieve 1971 [1931]; Wren 1907).
• Used in Herbal Medicine as a mild laxative (Bradley 2006; Williamson 2003; Mills 1993).
• Traditionally used in Herbal Medicine as an expectorant to help relieve excess mucous of the upper respiratory passages (anti-catarrhal) (Wichtl 2004; Williamson 2003; Felter and Lloyd 1983 [1898]).
• (Traditionally) used in Herbal Medicine as a nutritive tonic (Bradley 2006; Mills and Bone 2005; Blumenthal et al. 2000; Khory and Katrak 1999; Grieve 1971 [1931]).
• (Traditionally) used in Herbal Medicine as a galactogogue/lactogogue to help promote milk production/secretion (Bradley 2006; Mills and Bone 2005; Williamson 2002).
• (Traditionally) used in Herbal Medicine as supportive therapy for the promotion of healthy glucose levels (Bradley 2006; Mills and Bone 2005; Williamson 2002; API 2001; Al-Habori and Raman 1998; Sharma and Raghuram 1990).
• Used in Herbal Medicine to help reduce elevated blood lipid levels/hyperlipidemia (Mills and Bone 2005; Hoffman 2003; Al-Habori and Raman 1998; Sharma and Raghuram 1990).

Topical: (Traditionally) used in Herbal Medicine to help heal minor skin wounds, burns, irritations and local inflammations (Bradley 2006; Blumenthal et al. 2000; Meyer 1993; Mills 1985; Felter and Lloyd 1983 [1898]; Wren 1907).

Note: Claims for traditional use must include the term "Herbal Medicine".

Dose(s):

Oral: Preparations equivalent to 2-30 g seeds, per day (Bradley 2006; Mills and Bone 2005; API 2001; Blumenthal et al. 2000; Mills 1985; Felter and Lloyd 1983 [1898]; Grieve 1971 [1931]; Wren 1907)

Topical: Preparations equivalent to 50 g powdered seed (Bradley 2006; Blumenthal et al. 2000)

Directions for use:

• Apply to affected area as needed, or
• Add to hot bath (Blumenthal et al. 2000).

See Appendix 1 for examples of dosage preparations, frequencies of use and directions for 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:

Cautions and warnings:

Oral:

• Consult a health care practitioner if symptoms persist or worsen.
• Consult a health care practitioner prior to use if you are pregnant (Mills et al. 2006; Hoffman 2003; Blumenthal et al. 2000; Brinker 2001; McGuffin et al. 1997).
• Consult a health care practitioner prior to use if you have diabetes (Brinker 2009; Mills and Bone 2005).

Topical: Consult a health care practitioner if symptoms persist or worsen.

Contraindications: No statement is required.

Known adverse reactions: No statement is required.

Non-medicinal Ingredients: Must be chosen from the current NHPD Natural Health Products Ingredients Database and must meet the limitations outlined in the list.

Specifications:

• The finished product must comply with the minimum specifications outlined in the current NHPD Compendium of Monographs
• 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, 1^st 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, Brinkmann J, editors. 2000. Herbal Medicine: Expanded Commission E Monographs. Boston (MA): Integrative Medicine Communications.

BP 2008: British Pharmacopoeia Commission. 2007. British Pharmacopoeia 2008, Volume 1. London (UK): The Stationary Office.

Bradley PR, editor. 2006. British Herbal Compendium: A Handbook of Scientific Information on Widely Used Plant Drugs, Volume 2. Bournemouth (UK): British Herbal Medicine Association.

Brinker F. 2001. Herb Contraindications and Drug Interactions, 3^rd edition. Sandy (OR): Eclectic Medical Publications.

Brinker F. 2009. Online Updates and Additions to Herb Contraindications and Drug Interactions, 3^rd edition. Sandy (OR): Eclectic Medical Publications. [Accessed 2009 June 24]. Available from: http://www.eclecticherb.com/emp/updatesHCDI.html

Felter HW, Lloyd JU. 1983. King's American Dispensatory, Volume 1, 18th edition. Sandy (OR): Eclectic Medical Publications; [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. 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, 2^nd edition. Silver Spring (MD): American Herbal Products Association.

Meyer JE. 1993. The Herbalist. Glenwood (IL): Meyerbooks.

Mills S. 1993. The Essential Book of Herbal Medicine. Toronto (ON): Arkana.

Mills S. 1985. The Dictionary of Modern Herbalism. Wellingborough (UK): Thorsons Publishers Ltd.

Mills S, Bone K. 2005. The Essential Guide to Herbal Safety. St. Louis (MO): Elsevier Churchill Livingstone.

Mills E, Duguoa J, Perri D, Koren G. 2006. Herbal Medicines in Pregnancy and Lactation. An Evidence-Based Approach. New York (NY): Taylor and Francis.

Ph. Eur. 2008: European Pharmacopoeia Commission. 2007. European Pharmacopoeia, 6^th edition, Volume 2. Strasbourg (FR): Directorate for the Quality of Medicines and HealthCare of the Council of Europe (EDQM).

Sharma RD and Raghuram TC. 1990. Hypoglycaemic effect of fenugreek seeds in non-insulin dependant diabetic subjects. Nutrition Research 10(7):731-739.

USDA 2000: United States Department of Agriculture, Agricultural Research Service, National Genetic Resources Program. Germplasm Resources Information Network (GRIN) [online database]. Trigonella foenum-graecum L. Beltsville (MD): National Germplasm Resources Laboratory. [Accessed 2009 February 03]. Available from: http://www.ars-grin.gov/cgi-bin/npgs/html/tax_search.pl

Wichtl M, editor. 2004. Herbal Drugs and Phytopharmaceuticals: A Handbook for Practice on a Scientific Basis, 3^rd edition. Stuttgart (DE): Medpharm GmbH Scientific Publishers.

Williamson EM. 2003. Potter's Herbal Cyclopaedia: The Authoritative Reference work on Plants with a Known Medical Use. Saffron Walden (UK): The C.W. Daniel Company Limited.

Williamson EM, editor. 2002. Major Herbs of Ayurveda. London (UK): Churchill Livingstone.

Williamson EM, Evans FJ, Wren RC. 1988. Potter's New Cyclopaedia of Botanical Drugs and Preparations. Saffron Walden (RU): C.W. Daniel Company Limited.

Wren RC. 1907. Potter's Cyclopedia of Botanical Drugs and Preparations. London (UK): Potter and Clark.

References reviewed:

API 1999: The Ayurvedic Pharmacopoeia of India, 1^st edition, Part I, Volume II. Delhi (IN): The Controller of Publications; [Reprint of 1990 publication]..

Barnes J, Anderson LA, Philipson JD. 2007. Herbal Medicines: A Guide for Healthcare Professionals, 3^rd edition. London (UK): The Pharmaceutical Press.

Barnes J, Anderson LA, Philipson JD. 2002. Herbal Medicines: A Guide for Healthcare Professionals, 2^nd edition. London (UK): The Pharmaceutical Press.

Bartram T. 1998. Bartram's Encyclopedia of Herbal Medicine. London (UK): Robinson Publishing Ltd.

BHP 1996: British Herbal Medicine Association (BHMA) Scientific Committee. 1996. British Herbal Pharmacopoeia 1996. Bournemouth (UK): British Herbal Medicine Association.

Bisset NG, Wichtl M. 2001. Herbal Drugs and Phytopharmaceuticals, 2^nd edition. Stuttgart (DE): Medpharm GmbH Scientific Publishers.

Bordia A, Verma SK, Srivastava KC. 1997. 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 56(5):379-384.

Bradley PR, editor. 1992. British Herbal Compendium: A Handbook of Scientific Information on Widely Used Plant Drugs, Volume 1. Bournemouth (UK): 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. 1983. The Eclectic Materia Medica, Pharmacology and Therapeutics. Sandy (OR): Eclectic Medical Publications [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. 2004. PDR for Herbal Medicines, 3^rd edition. Montvale (NJ): Thompson PDR.

Gruenwald J, Brendler T, Jaenicke C, editors. 1998. PDR for Herbal Medicines, 2^nd edition. Montvale (NJ): Medical Economics Company.

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. 2001. Pseudo-maple syrup urine disease due to maternal prenatal ingestion of fenugreek. Journal of Paediatrics and Child Health 37(4):403-404.

Mills S, Bone K. 2000. Principles and Practice of Phytotherapy. Toronto (ON): Churchill Livingstone.

PasseportSanté.net 2008: Fenugrec [online]. Montreal (QC): Totalmédia inc. [Accessed 2009 February 03]. Available from: http://www.passeportsante.net/fr/Solutions/PlantesSupplements/Fiche.aspx?doc=fenugrec_ps

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. 1986. Effect of fenugreek seeds and leaves on blood glucose and serum insulin responses in human subjects. Nutrition Research 6(12):1353-1364.

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 Research 10(4):332-334.

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. 1999. Peculiar odor of traditional food and maple syrup urine disease. Pediatrics International 41(1):108-109.

Appendix 1: Examples of 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)
• 2 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 (~ 6 tsp) seed, per day ((Felter and Lloyd 1983 [1898]; Grieve 1971 [1931]; Wren 1907)

Directions for use: Place seeds in 475 ml (~ 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).

Topical:

Powdered seed: 50 g (Bradley 2006; Blumenthal et al. 2000)

Directions for use:

• Add powdered seed to 250 ml (1 cup) of water and boil for 5 minutes (Bradley 2006). Apply to affected area as needed.
• Add powdered seed to 1 L hot water and make a semi-solid paste. Apply to affected area as needed (Blumenthal et al. 2000).
• Mix 50 g powdered seed with 250 ml (1 cup) water. Add to hot bath (Blumenthal et al. 2000).