FENUGREEK - TRIGONELLA FOENUM-GRAECUM - Oral

Help on accessing alternative formats, such as Portable Document Format (PDF), Microsoft Word and PowerPoint (PPT) files, can be obtained in the alternate format help section.

(PDF Version - 70 KB)

This monograph is intended to serve as a guide to industry for the preparation of Product Licence Applications (PLAs) and labels for natural health product market authorization. It is not intended to be a comprehensive review of the medicinal ingredient.

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 and/or statements are synonymous. Either term or statement may be selected by the applicant.

Date

August 28, 2018

Proper name(s), Common name(s), Source material(s)

Table 1. Proper name(s), Common name(s), Source material(s)
Proper name(s)	Common name(s)	Source material(s)
Proper name(s)	Common name(s)	Proper name(s)	Part(s)	Preparation
Trigonella foenum-graecum	Common fenugreek Fenugreek Greek-clover Greek hay Hu lu ba	Trigonella foenum-graecum	Seed	Dried

References: Proper name: USDA 2018; Common names: McGuffin et al. 2000; Source material: Bradley 2006, Blumenthal et al. 2000.

Route of Administration

Oral

Dosage Form(s)

This monograph excludes foods or food-like dosage forms as indicated in the Compendium of Monographs Guidance Document.

Acceptable dosage forms for the age category listed in this monograph and specified route of administration are indicated in the Compendium of Monographs Guidance Document.

Use(s) or Purpose(s)

(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).
(Traditionally) used in Herbal Medicine to help relieve dyspepsia and gastritis (Bradley 2006; Blumenthal et al. 2000; Mills 1985; Grieve 1971; 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 (anticatarrhal) (Wichtl 2004; Williamson 2003; Felter and Lloyd 1983).
(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).
(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).

The following combined use(s) or purpose(s) is/are also acceptable:

Used in Herbal Medicine to help stimulate the appetite, as a digestive tonic to aid digestion, to help relieve dyspepsia and gastritis, and as a mild laxative (Bradley 2006; Mills and Bone 2005; Blumenthal et al. 2000; Khory and Katrak 1999; Williamson et al. 1988; Mills 1985; Felter and Lloyd 1983; Grieve 1971; Wren 1907).

Note

Claims for traditional use must include the term "Herbal Medicine", "Traditional Chinese Medicine", or "Ayurveda".

Dose(s)

Subpopulation(s)

Adults 18 years and older

Quantity(ies)

Methods of preparation: Dry, Powder, Non-Standardised Extracts (Dry extract, Tincture, Fluid Extract, Decoction, Infusion)

2 - 30 grams of dried seeds, per day (Bradley 2006; Mills and Bone 2005; API 2001; Blumenthal et al. 2000; Mills 1985; Felter and Lloyd 1983; Grieve 1971; Wren 1907).

Direction(s) for use

No statement required.

Duration(s) of Use

No statement required.

Risk Information

Caution(s) and warning(s)

Consult a health care practitioner/health care provider/health care professional/doctor/ physician if symptoms persist or worsen.
Consult a health care practitioner/health care provider/health care professional/doctor/ physician if you are pregnant or have diabetes (Brinker 2010; Mills et al. 2006; Mills and Bone 2005; Hoffman 2003; Blumenthal et al. 2000; McGuffin et al. 1997).

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 (NHPID) and must meet the limitations outlined in the database.

Storage conditions

No statement required.

Specifications

The finished product specifications must be established in accordance with the requirements described in the Natural and Non-prescription Health Products Directorate (NNHPD) Quality of Natural Health Products Guide.
The medicinal ingredient must comply with the requirements outlined in the NHPID.

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 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.

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. Herb Contraindications and Drug Interactions, 4^th edition. Sandy (OR): Eclectic Medical Publications; 2010.

Felter HW, Lloyd JU. 1983. King’s American Dispensatory, Volume 1, 18^th 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.

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

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

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.

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

USDA 2018: 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 2018 June 14]. Available from: https://npgsweb.ars-grin.gov/gringlobal/taxonomydetail.aspx?id=40421

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. 2002. Herbal Medicines: A Guide for Healthcare Professionals, 2^nd edition. London (UK): The Pharmaceutical Press.

Barnes J, Anderson LA, Philipson JD. 2007. Herbal Medicines: A Guide for Healthcare Professionals, 3^rd 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. 1998. PDR for Herbal Medicines, 2^nd edition. Montvale (NJ): Medical Economics Company.

Gruenwald J, Brendler T, Jaenicke C, editors. 2004. PDR for Herbal Medicines, 3^rd edition. Montvale (NJ): Thompson PDR.

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.

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.