HORSE CHESTNUT - AESCULUS HIPPOCASTANUM

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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

December 18,2018

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
Aesculus hippocastanum	Common horse chestnut Horse-chestnut	Aesculus hippocastanum	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 (Bradley 2006; ESCOP 2003)

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 any age category listed in this monograph and the 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 treat haemorrhoids (Bradley 2006; Mills and Bone 2005; Hoffmann 2003; Felter and Lloyd 1983; Grieve 1971).
• Used in Herbal Medicine to help treat chronic venous insufficiency and associated symptoms (Bradley 2006; Mills and Bone 2005; ESCOP 2003; Blumenthal et al. 2000).
• Used in Herbal Medicine to help treat varicose veins (Bradley 2006; ESCOP 2003; Hoffmann 2003; Blumenthal et al. 2000).

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)

0.3 - 5 grams of dried seed, per day (Mills and Bone 2005; Hoffmann 2003; Blumenthal et al. 2000; Grieve 1971).

Methods of preparation: Standardized extracts (Dry extract, Tincture, Fluid extract, Decoction, Infusion)

50 - 150 milligrams of aescin, per day (Bradley 2006; Mills and Bone 2005; ESCOP 2003; Hoffmann 2003; Blumenthal et al. 2000).

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 prior to use if you are pregnant or breastfeeding (Brinker 2010; Mills and Bone 2005).

Contraindication(s)

No statement required.

Known adverse reaction(s)

Some people may experience headache, dizziness, gastric irritation, or itchiness (Bradley 2006; Mills and Bone 2005; ESCOP 2003).

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.
• The medicinal ingredient must conform to one of the following criteria:
  1. the horse chestnut seed has been adequately processed, such that the outer capsule (pericarp) has been completely removed and discarded, to ensure that the finished product does not contain esculin or
  2. the horse chestnut seed complies with the specifications outlined in the Horse Chestnut, Powdered Horse Chestnut, or Powdered Horse Chestnut Extract Monographs published in the US Pharmacopoeia.

References Cited

• Blumenthal M, Goldberg A, Brinkmann J, editors. Herbal Medicine: Expanded Commission E Monographs. Boston (MA): Integrative Medicine Communications; 2000.
• Bradley PR, editor. British Herbal Compendium: A Handbook of Scientific Information on Widely Used Plant Drugs, Volume 2. Bournemouth (UK): British Herbal Medicine Association; 2006.
• Brinker F. Herb Contraindications and Drug Interactions, 4^th edition. Sandy (OR): Eclectic Medical Publications; 2010.
• ESCOP 2003: ESCOP Monographs: The Scientific Foundation for Herbal Medicinal Products, 2^nd edition. Exeter (UK): European Scientific Cooperative on Phytotherapy and Thieme; 2003.
• Felter HW, Lloyd JU. King's American Dispensatory, Volume 2, 18^th edition. Sandy (OR): Eclectic Medical Publications; 1983 [Reprint of 1898 original].
• Grieve M. A Modern Herbal, Volume 1. New York (NY): Dover Publications; 1971 [Reprint of 1931 Harcourt, Brace & Company publication].
• Hoffmann D. Medical Herbalism. Rochester (VT): Healing Arts Press; 2003.
• Mills S, Bone K. The Essential Guide to Herbal Safety. St. Louis (MO): Elsevier Churchill Livingstone; 2005.
• McGuffin M, Kartesz JT, Leung AY, Tucker AO, editors. Herbs of Commerce, 2nd edition. Silver Spring (MD): The American Herbal Products Association; 2000.
• USDA 2018: United States Department of Agriculture, Agricultural Research Service, National Genetic Resources Program. Germplasm Resources Information Network (GRIN). Aesculus hippocastanum L. National Germplasm Resources Laboratory, Beltsville (MD). [Accessed 2018 September 28]. Available from: https://npgsweb.ars-grin.gov/gringlobal/taxonomydetail.aspx?id=1628

References Reviewed

• Brinker F. Herb Contraindications and Drug Interactions, 3rd edition. Sandy (OR): Eclectic Medical Publications; 2001.
• Felter HW. The Eclectic Materia Medica, Pharmacology and Therapeutics. Sandy (OR): Eclectic Medical Publications; 1983 [Reprint of 1922 original].