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Monograph: Chaste tree

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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 PLA and on 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: 2010-06-09

NHPID Name

Vitex agnus-castus (USDA 2008)

Proper Name(s)

Vitex agnus-castus L. (Lamiaceae) ( McGuffin et al. 2000 , USDA 1998 )

Common Name(s)

Source Material

Fruit ( Mills and Bone 2005 , Mills and Bone 2000 )

Route Of Administration

Oral ( WHO 2009 , Bradley 2006 , Mills and Bone 2000 )

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): 30 - 2000 Milligrams per day, dried fruit

See Appendix 1 for examples of appropriate dosage preparations, frequencies of use and directions for use, according to cited references

Duration of use

Use for a minimum of 3 month to see beneficial effects  (Bradley 2006, ESCOP 2003, Hoffmann 2003)

Risk Information

Statement(s) to the effect of:

Caution(s) and Warning(s):
  • Consult a health care practitioner if symptoms persist.
  • Consult a health care practitioner if symptoms worsen.
  • Consult a health care practitioner prior to use if you are taking hormone-containing medications such as progesterone preparations, oral contraceptives or hormone replacement therapy.  (Brinker 2010, WHO 2009, Bradley 2006)

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 following monographs: (i) Agnus Castus Fruit published in the European Pharmacopoeia (Ph. Eur. 2007) and British Pharmacopoeia (BP) (ii) Chaste Tree, Powdered Chaste Tree, Powdered Chaste Tree Extract in the U.S. Pharmacopeia (USP 32)

References cited

  • Blumenthal M, Goldberg A, Brinkmann J, editors. 2000. Herbal Medicine: Expanded Commission E Monographs. Boston (MA): Integrative Medicine Communications.
  • BP 2009: British Pharmacopoeia Commission. 2008. British Pharmacopoeia 2009, Volume III. London (GB): The Stationary Office on behalf of the Medicines and Healthcare products Regulatory Agency (MHRA).
  • Bradley PR, editor. 2006. British Herbal Compendium: A Handbook of Scientific Information on Widely Used Plant Drugs, Volume 2. Bournemouth (GB): British Herbal Medicine Association.
  • Brinker F. 2010. Online Updates and Additions to Herb Contraindications and Drug Interactions, 3rd edition. Sandy (OR): Eclectic Medical Publications. [Updated 2010 February 15]; [Accessed 2010 March 04]. Available from: http://www.eclecticherb.com/emp/updatesHCDI.html
  • Bruneton J. 1999. Pharmacognosie, Phytochimie, Plantes Médicinales, 3e édition. Paris (FR) : Technique & Documentation.
  • ESCOP 2003: European Scientific Cooperative on Phytotherapy Scientific Committee. ESCOP Monographs: The Scientific Foundation for Herbal Medicinal Products, 2nd edition. Exeter (GB): European Scientific Cooperative on Phytotherapy in collaboration with Thieme.
  • Grieve M. 1971. A Modern Herbal, Volume 1. New York (NY): Dover Publications; [Reprint of 1931 Harcourt, Brace & Company publication].
  • Guilde des herboristes. 2007. Nomenclature d'herbes médicinales. Rapport d'experts pour la DPSN.
  • 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. Silver Spring (MD): American Herbal Products Association.
  • Mills S, Bone K. 2000. Principles and Practice of Phytotherapy. Toronto (ON): Churchill Livingstone.
  • PasseportSanté.net. 2007. Gattilier. [En ligne]. [Consulté le 12 mai 2010]. Disponible ŕ : http://www.passeportsante.net/fr/Solutions/PlantesSupplements/Fiche.aspx?doc=gattilier_ps
  • Ph. Eur. 2007: European Pharmacopoeia Commission. 2007. European Pharmacopoeia, 6th edition, Supplement 6.2. Strasbourg (FR): Directorate for the Quality of Medicines and HealthCare of the Council of Europe (EDQM).
  • USDA 1998: United States Department of Agriculture, Agricultural Research Service, National Genetic Resources Program. Germplasm Resources Information Network (GRIN) [online database]. Vitex agnus castus L. Beltsville (MD): National Germplasm Resources Laboratory. [Accessed 2010 March 04]. Available from: http://www.ars-grin.gov/cgi-bin/npgs/html/tax_search.pl
  • USDA 2006: United States Department of Agriculture, Agricultural Research Service, National Genetic Resources Program. Germplasm Resources Information Network (GRIN) [online database]. Vitex agnus castus L. Beltsville (MD): National Germplasm Resources Laboratory. [Accessed 2010 March 04]. Available from: http://www.ars-grin.gov/cgi-bin/npgs/html/tax_search.pl
  • USP 2009: United States Pharmacopeial Convention. 2009. The United States Pharmacopeia and the National Formulary (USP 32/NF 27). Rockville (MD): United States Pharmacopeial Convention, Inc.
  • WHO 2009: World Health Organization. WHO Monographs on Selected Medicinal Plants, Volume 4. Geneva (CH): World Health Organization.
  • Wichtl M, editor. 2004. Herbal Drugs and Phytopharmaceuticals: A Handbook for Practice on a Scientific Basis, 3rd edition. Stuttgart (DE): Medpharm GmbH Scientific Publishers.

References reviewed

  • Barnes J, Anderson LA, Philipson JD. 2007. Herbal Medicines, 3rd edition. London (GB): The Pharmaceutical Press.
  • Brinker F. 2001. Herb Contraindications and Drug Interactions, 3rd edition. Sandy (OR): Eclectic Medical Publications.
  • Ellingwood F. 1998. American Materia Medica, Therapeutics and Pharmacognosy. Sandy (OR): Eclectic Medical Publications; [Reprint of 1919 original].
  • Felter HW, Lloyd JU. 1983. King's American Dispensatory, Volume 1, 18th edition. Sandy (OR): Eclectic Medical Publications; [Reprint of 1898 original].
  • Hoffmann D. 2003. Medical Herbalism: The Science and Practice of Herbal Medicine. Rochester (VT): Healing Arts Press.

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

Fruit/berry:

For premenstrual symptoms:

Preparations equivalent to 30-240 mg of dried fruit, per day (ESCOP 2003)

For other use(s) or purpose(s):

Preparations equivalent to 30-40 mg of dried fruit, per day (ESCOP 2003)

Fluid extract:

  • 500-1000 mg dried equivalent, per day (1:1, 70% alcohol, 0.5-1.0 ml) (WHO 2009)
  • 30-40 mg dried equivalent, per day (1:1, 50-70% alcohol, 0.03-0.04 ml) (Blumenthal et al. 2000)

Tincture:

  • 500 mg dried equivalent, per day (1:5, 58% ethanol, 2.5 ml) (WHO 2009)
  • 40-240 mg dried equivalent, per day (Bradley 2006)
  • 500 mg dried equivalent, 3 times per day (1:5, 60%, 2.5 ml) (Hoffmann 2004)
  • 30-40 mg dried equivalent, per day (1:5, 50-70% alcohol, 0.15-0.2 ml) (Blumenthal et al. 2000)
  • 200-1000 mg, per day (1:5, 1-5 ml) (Mills and Bone 2000)
  • 500-2000 mg, per day (1:2, 1-4 ml) (Mills and Bone 2000)

Tablet:

500 mg dried fruit, 1-2 tablets per day (Mills and Bone 2000)

Dried extract:

Preparations equivalent to 40-240 mg of dried fruits, per day (50-70% ethanol) (Bradley 2006)