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Drugs and Health Products

Monograph: Heal-all - Oral

This monograph is intended to serve as a guide to industry for the preparation of Product Licence Applications 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. Note: (i) Text in parentheses is additional optional information which can be included on the Product Licence Application and product labels at the applicant's discretion. (ii) Claims for traditional use must include the term "Herbal Medicine".

Date: 2009-02-27

NHPID Name

Prunella vulgaris (USDA 2008)

Proper Name(s)

Prunella vulgaris L. (Lamiaceae) ( USDA 2008 )

Common Name(s)

Source Material


Route Of Administration

Oral

Dosage Form(s)

Those suited to the allowable route(s) of administration. This monograph is not intended to include 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): 0.75 - 32 Grams per day, dried shoots and leaves

See Appendix 1 for examples of appropriate dosage preparations and frequencies of use, according to cited references. The purpose of Appendix 1 is to provide guidance to industry.

Duration of use

No statement is required

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.

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).

References cited

  • Bartram T. Bartram's Encyclopedia of Herbal Medicine: The Definitive Guide to the Herbal Treatments of Diseases. New York (NY): Marlowe & Company; 1998.
  • Chevallier A. 1996. The Encyclopaedia of Medicinal Plants. New York (NY): Dorling Kindersley.
  • Culpeper N. Complete Herbal. Ware (UK):Wordsworth Editions Limited; 1995. [Reprint of 1653 original].
  • Felter HW, Lloyd JU. King's American Dispensatory, Volume 1, 18th edition. Sandy (OR): Eclectic Medical Publications; 1983 [Reprint of 1898 original].
  • Grieve M. 1971. A Modern Herbal, Volume 1. New York (NY): Dover Publications [Reprint of 1931 Harcourt, Brace & Company publication].
  • Hoffmann D. The Complete Illustrated Holistic Herbal. Rockport (MA): Element Books Inc.; 1996.
  • Lust J. The Herb Book. New York (NY): Bantam Books Incorporated, published by arrangement with Benedict Lust Publications; 1987.
  • McGuffin M, Kartesz JT, Leung AY, Tucker AO, editors. 2000. Herbs of Commerce, 2nd edition. Austin(TX): American Herbal Products Association.
  • Meyer JE. The Herbalist. Glenwood (IL): Meyerbooks; 1993.
  • Meyrick W. The New Family Herbal; or, Domestic Physician: enumerating, with accurate descriptions, all the known vegetables which are any way remarkable for medical efficacy; with an account of their virtues in the several diseases incident to the human frame. Birmingham (UK): Knott and Lloyd; 1790.
  • USDA 2008: ARS, National Genetic Resources Program. Germplasm Resources Information Network (GRIN). National Germplasm Resources Laboratory, Beltsville (MD). [Accessed 2008-01-21]. Available at http://www.ars-grin.gov/cgi-bin/npgs/html/tax_search.pl
  • Williamson EM. Potter's Herbal Cyclopaedia: The Authoritative Reference work on Plants with a Known Medical Use. Saffron Walden (UK): The C.W. Daniel Company Limited; 2003.
  • Wren RC. 1907. Potter's Cyclopedia of Botanical Drugs and Preparations. London (GB): Potter and Clark.

References reviewed

  • Bensky D, Gamble A. Chinese Herbal Medicine: Materia Medica. Revised Edition. Seattle (WA): Eastland Press, Incorporated; 1993.
  • Duke JA, Bogenschutz-Godwin MJ, DuCellier J, Duke PK. 2002. Handbook of Medicinal Herbs, 2nd edition. Boca Raton (FL): CRC Press.
  • Fauci AS, Braunwald E, Isselbacher KJ, Wilson JD, Martin JB, Kasper DI, Hauser SL and Longo DL, editors. Harrison's Principles of Internal Medicine, 14th edition. Toronto (ON): McGraw-Hill Health Professions Division; 1998.
  • Fetrow CW, Avila JR. Professional's Handbook of Complementary and Alternative Medicines, 3rd edition. Philadelphia (PA): Lippincott Williams and Wilkins; 2004.
  • Gerard J. The Herbal or General History of Plants. The Complete 1633 Edition as Revised and Enlarged by Thomas Johnson. NY (NY): Dover Publications; 1975.
  • Hoffmann D. 2003. Medical Herbalism: The Science and Practice of Herbal Medicine. Rochester (VT): Healing Arts Press.
  • McGuffin M, Hobbs C, Upton R, Goldberg A, editors. 1997. American Herbal Products Association's Botanical Safety Handbook. Boca Raton (FL): CRC Press.
  • Sherman JA. The Complete Botanical Prescriber, 3rd edition. Corvallis (OR): self-published; 1993.
  • Shou-zhong Y, translator. The Divine Farmer's Materia Medica - A translation of the Shen Nong Ben Cao Jing. Boulder (CO): Blue Poppy Press; 2004.
  • Wiersema J, León B. 1999. World Economic Plants: A Standard Reference. Boca Raton (FL): CRC Press LLC.
  • Williamson EM, Evans FJ, Wren RC. Potter's New Cyclopaedia of Botanical Drugs and Preparations. Saffron Walden (GB): C.W. Daniel Company Limited; 1988.
  • Wiseman N and Ye F. A Practical Dictionary of Chinese Medicine. 2nd edition. Brookline (MA): Paradigm Publications; 1999.
  • Yeung H. Handbook of Chinese Herbal Formulas. Rosemeade (CA): Institute of Chinese Medicine; 1998.

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

ORAL:

Infusion:

  • 4 g dried shoots and young leaves, 7-8 times per day (Grieve 1971[1931]; Wren 1907)
  • Directions for use:Pour 475 ml (1 pint) of boiling water over 30 g dried shoots and young leaves (Grieve 1971 [1931]; Wren 1907) and infuse. Take in doses of a wineglassful (Felter and Lloyd 1983 [1898])). 60 ml = 2 ounces = 1 wineglassful (Felter and Lloyd 1983 [1898])).

Tincture:

  • 1 g dried equivalent, 2 to 3 times per day (1:5, 40% alcohol, 5 ml) (Chevallier 1996)
  • 0.25 - 0.5 g, 3 times per day (1:4, 30% alcohol, 1-2 ml) (Hoffmann 1996)