CHASTE TREE - VITEX AGNUS-CASTUS

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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

October 30, 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)	Part(s)	Preparation
Vitex agnus-castus	Chasteberry Chaste tree Vitex	Vitex agnus-castus	Fruit	Dried

References: Proper name: USDA 2018, McGuffin et al. 2000; Common names: USDA 2018, McGuffin et al. 2000, Guilde des herboristes 2007; Source material: Blumenthal 2000, Mills and Bone 2000.

Route of Administration

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

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)

• Used in Herbal Medicine to help relieve premenstrual symptoms (WHO 2009; Bradley 2006; Wichtl 2004; ESCOP 2003; Hoffmann 2003; Blumenthal et al. 2000).
• Used in Herbal Medicine (as a hormone normaliser) to help stabilise menstrual cycle irregularities (WHO 2009; Bradley 2006; Wichtl 2004; ESCOP 2003; Hoffmann 2003; Blumenthal et al. 2000; Mills and Bone 2000).
• Used in Herbal Medicine to help relieve symptoms associated with menopause, such as hot flushes (WHO 2009; Hoffmann 2003).

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

Used in Herbal Medicine (as a hormone normaliser) to help stabilise menstrual cycle irregularities and relieve premenstrual symptoms (WHO 2009; Bradley 2006; Wichtl 2004; ESCOP 2003; Hoffmann 2003; Blumenthal et al. 2000; Mills and Bone 2000).

Dose(s)

Subpopulation(s)

Adults 18 years or older

Quantity(ies)

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

30-2000 milligrams of dried fruit, per day (WHO 2009; Bradley 2006; ESCOP 2003; Hoffmann 2003; Blumenthal et al. 2000; Mills and Bone 2000).

Direction(s) for use

No statement required.

Duration(s) of Use

Use for at least 3 months to see beneficial effects (Bradley 2006; ESCOP 2003; Hoffmann 2003).

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 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 required.

Known adverse reaction(s)

No statement 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

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 (GB): British Herbal Medicine Association.

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

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.

Guilde des herboristes. 2007. Nomenclature d'herbes médicinales. Rapport d'experts pour la DPSN.

Hoffmann D. 2003. Medical Herbalism: The Science and Practice of Herbal Medicine. Rochester (VT): Healing Arts Press.

McGuffin M, Kartesz JT, Leung AY, Tucker AO. 2000. Herbs of Commerce. Silver Spring (MD): American Herbal Products Association.

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

USDA 2018: 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 2018 August 8]. Available from: http://www.ars-grin.gov/cgi-bin/npgs/html/tax_search.pl

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, 3^rd edition. Stuttgart (DE): Medpharm GmbH Scientific Publishers.

References Reviewed

Barnes J, Anderson LA, Philipson JD. 2007. Herbal Medicines, 3^rd edition. London (GB): The Pharmaceutical Press.

Brinker F. 2001. Herb Contraindications and Drug Interactions, 3^rd 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, 18^th 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.