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Monograph: Echinacea purpurea

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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: (i) Text in parentheses is additional optional information which can be included on the PLA and product label at the applicant's discretion. (ii) The solidus (/) indicates that the terms and/or the statements are synonymous. Either term or statement may be selected by the applicant. (iii) A claim for traditional use must include the term " Herbal Medicine"

Date: 2013-07-10

NHPID Name

Echinacea purpurea (USDA 2008)

Proper Name(s)

Echinacea purpurea L. Moench (Asteraceae) ( USDA 2012 )

Common Name(s)

Source Material


Route Of Administration

Oral

Dosage Form(s)

  • The acceptable pharmaceutical dosage forms include, but are not limited to chewables (e.g. gummies, tablets), caplets, capsules, strips, lozenges, powders or liquids where the dose is measured in drops, teaspoons or tablespoons.
  • This monograph is not intended to include foods or food-like dosage forms such as bars, chewing gums or beverages.

Use(s) or Purpose(s)

Statement(s) to the effect of:

Dose(s)

Children 2 - 4 years:

Preparation: Dry, Powder, Decoction & Infusion + All Non-Standardised Extracts

Dose(s): Herb top: 0.4 - 1 Grams per day, dried herb tops
Directions For Use: Take at the first sign of infection (Goel et al. 2004, Schulten et al. 2001, Brinkeborn et al. 1999, Hoheisel et al. 1997)

Dose(s): Herb top and root: 0.5 - 0.9 Grams per day, dried herb tops and root
Directions For Use: Take at the first sign of infection (Goel et al. 2004, Schulten et al. 2001, Brinkeborn et al. 1999, Hoheisel et al. 1997)

Dose(s): Root: 0.15 - 0.8 Grams per day, dried root
Directions For Use: Take at the first sign of infection (Goel et al. 2004, Schulten et al. 2001, Brinkeborn et al. 1999, Hoheisel et al. 1997)

Preparation: Non-standardised juices

Dose(s): Herb top: 0.7 - 1.7 Millilitres per day, herb tops
Directions For Use: Take at the first sign of infection (Goel et al. 2004, Schulten et al. 2001, Brinkeborn et al. 1999, Hoheisel et al. 1997)

Children and adolescents 5 - 9 years:

Preparation: Dry, Powder, Decoction & Infusion + All Non-Standardised Extracts

Dose(s): Herb top: 0.6 - 1.5 Grams per day, dried herb tops
Directions For Use: Take at the first sign of infection (Goel et al. 2004, Schulten et al. 2001, Brinkeborn et al. 1999, Hoheisel et al. 1997)

Dose(s): Herb top and root: 0.8 - 1.4 Grams per day, dried herb tops and root
Directions For Use: Take at the first sign of infection (Goel et al. 2004, Schulten et al. 2001, Brinkeborn et al. 1999, Hoheisel et al. 1997)

Dose(s): Root: 0.23 - 1.1 Grams per day, dried root
Directions For Use: Take at the first sign of infection (Goel et al. 2004, Schulten et al. 2001, Brinkeborn et al. 1999, Hoheisel et al. 1997)

Preparation: Non-standardised juices

Dose(s): Herb top: 1 - 2.5 Millilitres per day, herb tops
Directions For Use: Take at the first sign of infection (Goel et al. 2004, Schulten et al. 2001, Brinkeborn et al. 1999, Hoheisel et al. 1997)

Adolescents 10 - 14 years:

Preparation: Dry, Powder, Decoction & Infusion + All Non-Standardised Extracts

Dose(s): Herb top: 1.3 - 3 Grams per day, dried herb tops
Directions For Use: Take at the first sign of infection (Goel et al. 2004, Schulten et al. 2001, Brinkeborn et al. 1999, Hoheisel et al. 1997)

Dose(s): Herb top and root: 1.5 - 2.8 Grams per day, dried herb tops and root
Directions For Use: Take at the first sign of infection (Goel et al. 2004, Schulten et al. 2001, Brinkeborn et al. 1999, Hoheisel et al. 1997)

Dose(s): Root: 0.45 - 2.3 Grams per day, dried root
Directions For Use: Take at the first sign of infection (Goel et al. 2004, Schulten et al. 2001, Brinkeborn et al. 1999, Hoheisel et al. 1997)

Preparation: Non-standardised juices

Dose(s): Herb top: 2 - 5 Millilitres per day, herb tops
Directions For Use: Take at the first sign of infection (Goel et al. 2004, Schulten et al. 2001, Brinkeborn et al. 1999, Hoheisel et al. 1997)

Adults and adolescents 15 and over:

Preparation: Dry, Powder, Decoction & Infusion + All Non-Standardised Extracts

Dose(s): Herb top: 2.5 - 6 Grams per day, dried herb tops
Directions For Use: Take at the first sign of infection (Goel et al. 2004, Schulten et al. 2001, Brinkeborn et al. 1999, Hoheisel et al. 1997)

Dose(s): Herb top and root: 3 - 5.5 Grams per day, dried herb tops and root
Directions For Use: Take at the first sign of infection (Goel et al. 2004, Schulten et al. 2001, Brinkeborn et al. 1999, Hoheisel et al. 1997)

Dose(s): Root: 0.9 - 4.5 Grams per day, dried root
Directions For Use: Take at the first sign of infection (Goel et al. 2004, Schulten et al. 2001, Brinkeborn et al. 1999, Hoheisel et al. 1997)

Preparation: Non-standardised juices

Dose(s): Herb top: 3.9 - 10 Millilitres per day, herb tops
Directions For Use: Take at the first sign of infection (Goel et al. 2004, Schulten et al. 2001, Brinkeborn et al. 1999, Hoheisel et al. 1997)


  • Adults includes pregnant and breastfeeding women.
  • Children and adolescent doses were calculated as a proportion of the adult dose (JC 2012).
  • 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.
  • The following references support adult doses: (i) herb tops - Mills and Bone 2000, (ii) juice from herb tops - Schulten et al. 2001; Hoheisel et al. 1997, (iii) root - Mills and Bone 2000; Braunig et al. 1992, and (iv) both herb tops and root - Mills and Bone 2000.
  • The use of Echinacea purpurea in children is supported by the following references: McIntyre 2005; Bove 2001; Schilcher 1997

Duration of use

For use beyond 8 weeks, consult a health care practitioner  (ESCOP 2003, Blumenthal et al. 2000)

Risk Information

Statement(s) to the effect of:

Caution(s) and Warning(s):
  • If symptoms persist or worsen, consult a health care practitioner.
  • If you are taking immunosuppressants, consult a health care practitioner prior to use  (Brinker 2010, Mills and Bone 2005)
  • If you have an autoimmune disorder, consult a health care practitioner prior to use  (Brinker 2010, McGuffin et al. 1997)
  • If you have a progressive systemic disease such as tuberculosis, collagenosis, multiple sclerosis, AIDS and/or HIV infection, consult a health care practitioner prior to use  (Brinker 2010, McGuffin et al. 1997)

Contraindication(s):
No statement is required

Known Adverse Reaction(s):
Echinacea purpurea - Herb top:
Rare cases of severe allergic reactions have been known to occur; use caution if you are allergic to plants of the Daisy family.  (MHRA 2012, EMA 2010, Kligler 2003, WHO 1999)

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).
  • The medicinal ingredient may comply with the specifications outlined in the following pharmacopoeial monographs: 'Purple Coneflower Herb' and 'Purple Coneflower Root' of the European (Ph.Eur) Pharmacopoeia as well as 'Echinacea purpurea Aerial Parts', 'Echincea purpurea Root', 'Powdered Echinacea purpurea' and 'Powdered Echinacea purpurea Extract' of the United States (USP) Pharmacopoeia.
  • The medicinal ingredient must comply with the requirements outlined in the Natural Health Products Ingredients Database (NHPID).

References cited

  • Barnes J, Anderson LA, Philipson JD. 2007. Herbal Medicines, 3rd edition. London (GB): Pharmaceutical Press.
  • Blumenthal M, Goldberg A, Brinckmann J, editors. Herbal Medicine: Expanded Commission E Monographs. Boston (MA): Integrative Medicine Communications; 2000.
  • Bove M. An Encyclopedia of Natural Healing for Children and Infants. New Canaan (CT): Keats Publishing, Incorporated; 1996
  • Brinkeborn RM, Shah DV, Degenring FH. 1999. Echinaforce and other Echinacea fresh plant preparations in the treatment of the common cold. A randomized, placebo controlled, double-blind clinical trial. Phytomedicine 6(1):1-6.
  • Brinker F. 2001. Herb Contraindications and Drug Interactions, 3rd edition. Sandy (OR): Eclectic Medical Publications.
  • Brinker F. 2010. Online Updates and Additions to Herb Contraindications and Drug Interactions, 3rd edition. Sandy (OR): Eclectic Medical Publications. [Updated 2010 July 13; Accessed 2013 January 30]. Available from: http://www.eclecticherb.com/emp/updatesHCDI.html
  • Bräunig B, Dorn M, Limburg, Knick E, Bausendorf. 1992. Echinaceae purpureae radix: zur Stärkung der körpereigenen Abwehr bei grippalen Infekten. Zeitschrift für Phytotherapie 13:7-13.
  • EMA 2010: European Medicines Agency (GB). EMA/HMPC/577784/2008. Community herbal monograph on Echinacea purpurea (L.) Moench., radix. Draft. [2010 March 11; Accessed 2013 January 30]. Available from: http://www.ema.europa.eu/docs/en_GB/document_library/Herbal_-_Community_herbal_monograph/2011/01/WC500101497.pdf
  • ESCOP 2003: ESCOP Monographs: The Scientific Foundation for Herbal Medicinal Products, 2nd edition. Exeter (UK): European Scientific Cooperative on Phytotherapy and Thieme; 2003.
  • Goel V, Lovlin R, Barton R, Lyon MR, Bauer, Lee TDG, Basu TK. 2004. Efficacy of a standardized echinacea preparation (Echinilin¿) for the treatment of the common cold: a randomized, double-blind, placebo-controlled trial. Journal of Clinical Pharmacy and Therapeutics 29(1):75-83.
  • Grieve M. 1971. A Modern Herbal, Volume 1. New York (NY): Dover Publications [Reprint of 1931 Harcourt, Brace & Company publication].
  • Hoffmann D. 2003. Medical Herbalism: The Science and Practice of Herbal Medicine. Rochester (VT): Healing Arts Press.
  • Hoheisel O, Sandberg M, Bertram S, Bulitta M, Schäfer M. 1997. Echinagard treatment shortens the course of the common cold: a double-blind, placebo-controlled clinical trial. European Journal of Clinical Research 9:261-268.
  • JC 2012: Justice Canada. Natural Health Products Regulations [Internet]. Ottawa (ON): Justice Canada. Available from: http://laws-lois.justice.gc.ca/eng/regulations/SOR-2003-196/index.html [Current 2012 December 31, Last amended 2008-06-01; Accessed 2013 January 30].
  • Kligler B. 2003. Echinacea. American Family Physician 67(1):77-80. [Accessed 2013 January 30]. Available from: http://www.aafp.org/afp/2003/0101/p77.html
  • McGuffin M, Hobbs C, Upton R, Goldberg A, editors. 1997. American Herbal Products Association's Botanical Safety Handbook. Boca Raton (FL): CRC Press.
  • McGuffin M, Kartesz JT, Leung AY, Tucker AO, editors. 2000. Herbs of Commerce, 2nd edition. Austin(TX): American Herbal Products Association.
  • McIntyre A. Herbal Treatment of Children - Western and Ayurvedic Perspectives. Toronto (ON): Elsevier Limited; 2005.
  • MHRA 2012: Medicines and Healthcare products Regulatory Agency (GB). Press release: Echinacea herbal products should not be used in children under 12 years old. [Press release 2012 August 20; Accessed 2013 January 31]. Available from: http://www.mhra.gov.uk/NewsCentre/Pressreleases/CON180627
  • Mills S, Bone K. 2000. Principles and Practice of Phytotherapy. Toronto (ON): Churchill Livingstone.
  • Mills S, Bone K. 2005. The Essential Guide to Herbal Safety. St. Louis (MO): Elsevier Churchill Livingstone.
  • Moerman DE . 1998. Native American Ethnobotany. Portland (OR): Timber Press.
  • Remington JP, Woods HC, editors. The Dispensatory of the United States of America [Internet] 20th edition; 1918. Abridged; botanicals only. Scanned by Michael Moore, director, Southwest School of Botanical Medicine, Bisbee (AZ). [Accessed 2012 April 19]. Available from: http://www.swsbm.com/Dispensatory/USD-1918-complete.pdf
  • Schilcher H. Phytotherapy in Paediatrics: Handbook for Physicians and Pharmacists. Stuttgart (D): Medpharm Scientific Publishers; 1997.
  • Schulten B, Bulitta M, Ballering-Brühl B, Köster U, Schäfer M. 2001. Efficacy of Echinacea purpurea in patients with a common cold. A placebo-controlled, randomised, double-blind clinical trial. Arzneimittelforschung 51(7):563-8.
  • USDA 2012: United States Department of Agriculture, Agricultural Research Service, National Genetic Resources Program. Germplasm Resources Information Network (GRIN) [Internet]. Echinacea purpurea (L.) Moench. Beltsville (MD): National Germplasm Resources Laboratory. Available from: http://www.ars-grin.gov/cgi-bin/npgs/html/tax_search.pl [Last updated 2012 March 08; Accessed 2013 January 30].
  • WHO 1999: World Health Organization. WHO Monographs on Selected Medicinal Plants, Volume 1. Geneva (CH): World Health Organization; 1999.

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Appendix 1: Examples of appropriate dosage preparations, frequencies of use and directions for use (for adults only)

Aerial parts:

Dried aerial parts:

2.5 - 6 g, per day (Mills and Bone 2000)

Pressed juice:

  • 5 ml, 2 times per day (22% alcohol) (Schulten et al. 2001)
  • 1.3 ml (20 drops), per dose (22% alcohol) (Hoheisel et al. 1997)
  • Directions for use: Take each dose in a half glass of water every two hours for the first day, followed by three times per day until symptoms disappear [not to exceed 10 ml, per day] (Hoheisel et al. 1997)

Root:

Dried root:

1.5 - 4.5 g, per day (Mills and Bone 2000)

Tincture:

  • 1.5 - 4.5 g dried equivalent, per day (1:2, 3 - 9 ml) (Mills and Bone 2000)
  • 1.5 - 4.5 g dried equivalent, per day (1:5, 7.5-22.5 ml) (Mills and Bone 2000)
  • 0.9g dried equivalent, per day (1:5, 55% ethanol) (Braunig et al. 1992)

Preparations containing aerial parts and root:

Fluid extract:

3 - 5.5 g dried equivalent, per day (1:1, 3 - 5.5 ml) (Mills and Bone 2000)