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: 2018-10-30

NHPID name

Vitex agnus-castus ( Germplasm Resources Information Network Taxonomy )

Proper name(s)

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

Common name(s)

Source material

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

Route Of administration

Oral

Dosage form(s)

Use(s) or purpose(s)

Statement(s) to the effect of:

Dose(s)

Adults:

Dose(s):

1 Day per day

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 at least 3 months to see beneficial effects.

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

References cited

References reviewed

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:

Tincture:

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)