BURDOCK - ARCTIUM LAPPA - Oral

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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

January 27, 2023

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

Table 1. Proper name(s), Common name(s), Source information
Proper name(s)	Common name(s)	Source information
Proper name(s)	Common name(s)	Source material(s)	Part(s)	Preparation
Arctium lappa	Burdock Burr seed Cocklebur Edible burdock Gobo Goboshi Great Burdock Great Burdocks Greater Burdock Hardock Harebur Lappa Niu bang zi	Arctium lappa	Root	Dry

References: Proper name: USDA 2018; Common names: Brinker 2010, McGuffin et al. 2000, BHP 1996; Source information: BHP 1996, Grieve 1971.

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 oral use are indicated in the dosage form drop-down list of the web-based Product Licence Application form for Compendial applications.

Use(s) or Purpose(s)

Traditionally used in Herbal Medicine as a diuretic (Wichtl 2004; Bradley 1992; Wren 1907).
Traditionally used in Herbal Medicine to induce sweating (diaphoretic) (Bradley 1992; Wren 1907).
Traditionally used in Herbal Medicine as an alterative to help remove accumulated waste products via the kidneys, skin and mucus membranes (Hoffmann 2003; Wren 1907).
Traditionally used in Herbal Medicine to help alleviate the pain associated with rheumatism (Wichtl 2004; Bradley 1992; Grieve 1971).

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

Traditionally used in Herbal Medicine as a diuretic, to induce sweating (diaphoretic) and as an alterative to help remove accumulated waste products via the kidneys, skin and mucus membranes (Wichtl 2004; Hoffmann 2003; Bradley 1992; 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-Standardized Extracts (Dry extract, Tincture, Fluid extract, Decoction, Infusion)

1.2-18 grams of dried root, per day (Hoffmann 2003; Bradley 1992; BHP 1983).

Direction(s) for use

No statement required.

Duration(s) of Use

Diuretic

For occasional use only (Berardi et al. 2002; CPHA 2002).

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 breastfeeding.
Consult a health care practitioner/health care provider/health care professional/doctor/physician prior to use if you have diabetes (Brinker 2010; Barnes et al. 2007).

Contraindication(s)

Do not use this product if you are pregnant (Brinker 2010).

Known adverse reaction(s)

Stop use if hypersensitivity/allergy occurs (Brinker 2010).

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

Must be established in accordance with the requirements described in the Natural Health Products Regulations (NHPR).

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

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

Berardi RR, DeSimone EM, Newton GD, Oszko MA, Popovich NG, Rollins CJ, Shimp LA, Tietze KJ, editors. Handbook of Nonprescription Drugs: An Interactive Approach to Self-Care, 13th edition. Washington (DC): American Pharmaceutical Association; 2002.

BHP 1996: British Herbal Pharmacopoeia. Bournemouth (UK): The British Herbal Medicine Association; 1996.

BHP 1983: British Herbal Pharmacopoeia. Cowling (UK): British Herbal Medical Association; 1983.

Bradley PR, editor. British Herbal Compendium: A Handbook of Scientific Information on Widely Used Plant Drugs, Volume 1. Bournemouth (UK): British Herbal Medicine Association; 1992.

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

CPhA 2002: Canadian Pharmacists Association. Patient Self-Care. Helping Patients Make Therapeutic Choices. Ottawa (ON): Canadian Pharmacists Association; 2002.

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.

McGuffin M, Kartesz JT, Leung AY, Tucker AO, editors. Herbs of Commerce, 2^nd edition. Silver Spring (MD): American Herbal Products Association; 2000.

USDA 2018: United States Department of Agriculture, Agricultural Research Service, National Genetic Resources Program. Germplasm Resources Information Network (GRIN). Arctium lappa L. National Germplasm Resources Laboratory, Beltsville (MD). [Accessed 2018 August 8]. Available from: http://www.ars-grin.gov/cgi-bin/npgs/html/tax_search.pl

Wichtl M, editor. Herbal Drugs and Phytopharmaceuticals: A Handbook for Practice on a Scientific Basis, 3^rd edition. Stuttgart (D): Medpharm GmbH Scientific Publishers; 2004.

Wren RC. Potter's Cyclopedia of Botanical Drugs and Preparations. London (UK): Potter and Clark; 1907.

References Reviewed

Barnes J, Anderson LA, Phillipson JD. Herbal Medicines: A Guide for Healthcare Professionals, 2^nd edition. London (UK): Pharmaceutical Press; 2002.

Bisset NG, Wichtl M, editors. Herbal Drugs and Phytopharmaceuticals: A Handbook for Practice on a Scientific Basis, 2^nd edition. Stuttgart (D): Medpharm GmbH Scientific Publishers; 2001.

Gruenwald J, Brendler T, Jaenicke C, editors. PDR for Herbal Medicines, 1st edition. Montvale (NJ): Medical Economics Company; 1998.

Mills S, Bone K. The Essential Guide to Herbal Safety. St. Louis (MO): Elsevier Churchill Livingstone; 2005.

Peirce A. The American Pharmaceutical Association Practical Guide to Natural Medicines. New York (NY): William Morrow and Company, Inc; 1999.