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Drugs and Health Products

Echinacea pallida

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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 are synonyms or that the statements are synonymous. Either term or statement may be selected by the applicant.

Date

July 18, 2017

Proper name(s)

Echinacea pallida (Nutt.) Nutt. (Asteraceae) (USDA 2012; Upton 2010)

Common name(s)

  • Echinacea pallida (Upton 2010; McGuffin et al. 2000)
  • Pale-flowered Echinacea (Upton 2010) / pale-flower Echinacea (McGuffin et al. 2000)
  • Pale echinacea (USDA 2012; ITIS 2010)
  • Pale purple coneflower (ITIS 2010; Upton 2010; McGuffin et al. 2000)

Source material(s)

Root (Blumenthal 2003; Dorn et al. 1997)

Route(s) of administration

Oral

Dosage form(s)

This monograph is not intended to include foods or food-like dosage forms such as bars, chewing gums or beverages.

Dosage forms by age group:

  • Children 2 years: The acceptable dosage forms are limited to emulsion/suspension and solution/drops (Giacoia et al. 2008; EMEA/CHMP 2006).
  • Children 3-5 years: The acceptable dosage forms are limited to chewables, emulsion/ suspension, powders and solution/drops (Giacoia et al. 2008; EMEA/CHMP 2006).
  • Children 6-12 years, Adolescents 13-17 years, and Adults ≥ 18 years: The acceptable dosage forms include, but are not limited to capsules, chewables (e.g., gummies, tablets), liquids, powders, strips or tablets.

Use(s) or Purpose(s)

  • Traditionally used in Herbal Medicine to help relieve cold symptoms (Blumenthal et al. 2000; Moerman 1998).
  • Supportive therapy in the treatment of upper respiratory tract infections (e.g., common colds) (EMA 2009; Dorn et al. 1997).
  • Helps to relieve the symptoms and shorten the duration of upper respiratory tract infections (e.g., common cold) (Dorn et al. 1997).

Note
A claim for traditional use must include the term “ Herbal Medicine ”.

Table 1: Daily dose expressed as quantity dried equivalent of Echinacea pallida root
Subpopulation Quantity dried equivalent (g/day)
Minimum Maximum

Table 1 Footnotes

Table 1 Footnote 1

Children and adolescent doses were calculated as a proportion of the adult dose (JC 2012). The use of Echinacea pallida in children is supported by the following references: Bove 2001; Schilcher 1997.

Return to Table 1 footnote1 referrer

Table 1 Footnote 2

Adult dose supported by the following references: EMA 2009; Blumenthal 2003; Blumenthal et al. 2000; Blumenthal et al. 1998; Dorn et al. 1997.

Return to Table 1 footnote2 referrer

Table 1 Footnote 3

Includes pregnant and breastfeeding women.

Return to Table 1 footnote3 referrer

Children Table 1 Footnote1 2-4 y 0.06 0.5
Children and adolescents Table 1 Footnote1 5-9 y 0.09 0.8
Adolescents Table 1 Footnote1 10-14 y 0.18 1.5
Adolescents and adults Table 1 Footnote1 Table 1 Footnote2 Table 1 Footnote3 ≥ 15 y 0.36 3.0

Directions for use

Start treatment at first signs of common cold (EMA 2009).

Note
Refer to Appendix 1 for examples of dosage preparations and directions for use, according to cited references. The purpose of Appendix 1 is to provide guidance to industry.

Duration of use

For use beyond 8 weeks, consult a health care practitioner (ESCOP 2003; Blumenthal et al. 1998).

Risk information

Caution(s) and warning(s)

  • If symptoms persist or worsen, consult a health care practitioner.
  • If you have a progressive systemic disease such as tuberculosis, collagenosis, multiple sclerosis, AIDS, or HIV infection, consult a health care practitioner prior to use (Brinker 2010; EMA 2009; Brinker 2001; McGuffin et al. 1997).
  • If you have an auto-immune disorder, consult a health care practitioner prior to use (Brinker 2010; McGuffin et al. 1997).
  • If you are taking immunosuppressants, consult a health care practitioner prior to use (Brinker 2010; Mills et al. 2006).

Contraindication(s)

No statement required.

Known adverse reaction(s)

No statement required.

Non-medicinal ingredients

Must be chosen from the current Natural Health Products Ingredients Database (NHPID) 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 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 may comply with the specifications outlined in the pharmacopoeial monographs listed in Table 2 below.
Table 2: Echinacea pallida monographs published in the British (BP), European (Ph.Eur.) and United States (USP) Pharmacopoeias.
Pharmacopeia Monograph
BP Echinacea Pallida Root
Ph.Eur. Pale Coneflower Root: Echinacea pallidae radix
USP Echinacea pallida
Powdered Echinacea pallida
Powdered Echinacea pallida Extract

References cited

  • Blumenthal M, editor. 2003. The ABC Clinical Guide to Herbs. Austin (TX): American Botanical Council.
  • Blumenthal M, Busse WR, Goldberg A, Gruenwald J, Hall T, Riggins CW, Rister RS, editors. 1998. The Complete German Commission E Monographs: Therapeutic Guide to Herbal Medicines. Austin (TX): American Botanical Council.
  • Blumenthal M, Goldberg A, Brinckmann J. 2000. Herbal Medicine: Expanded Commission E Monographs. Newton (MA): Integrative Medicine Communications.
  • Bove M. 2001. An Encyclopedia of Natural Healing for Children and Infants, 2nd edition. New York (NY): McGraw-Hill.
  • BP 2012: British Pharmacopoeia 2012. Volume I. London (GB): The Stationary Office on behalf of the Medicines and Healthcare products Regulatory Agency (MHRA); 2012.
  • Bradley PR, editor. 2006. British Herbal Compendium: A Handbook of Scientific Information on Widely Used Plant Drugs, Volume 2. Bournemouth (GB): British Herbal Medicine Association.
  • Brinker F. 2010.Next link will take you to another Web siteFinal updates and additions for Herb Contraindications and Drug Interactions, 3rd edition. [Internet]. Sandy (OR): Eclectic Medical Publications. [Updated 2010 July 13; Accessed 2013 January 30].
  • Brinker F, editor. 2001. Herb Contraindications & Drug Interactions, 3rd edition. Sandy (OR): Eclectic Medical Publications.
  • Dorn M, Knick E, Lewith G. 1997. Placebo-controlled, double-blind study of Echinacea pallidae radix in upper respiratory tract infections. Complementary Therapies in Medicine 5(1): 40-42.
  • EMA 2009: EMA/HMPC/332350/2008 Community herbal monograph on ECHINACEA PALLIDA (NUTT.) NUTT., RADIX, Final. 16 July 2009. London (GB): European Medicines Agency: Committee on Herbal Medicinal Products (HMPC). [Accessed 2011 March 7]. Available from: Next link will take you to another Web site http://www.ema.europa.eu
  • EMEA/CHMP 2006: European Medicines Agency: Pre-authorization Evaluation of Medicines for Human Use. Committee for Medicinal Products for Human Use. Reflection Paper: Next link will take you to another Web siteFormulations of choice for the paediatric population. Adopted September 2006. EMEA/CHMP/PEG/194810/2005. [Accessed on 2013 June 29].
  • ESCOP 2003: ESCOP Monographs: The Scientific Foundation for Herbal Medicinal Products, 2nd edition. Exeter (GB): European Scientific Cooperative on Phytotherapy and Thieme.
  • Giacoia GP, Taylor-Zapata P, Mattison D. Eunice Kennedy Shriver National Institute of Child Health and Human Development Pediatric Formulation Initiative: selected reports from working groups. Clinical Therapeutics 2008; 30(11):2097-2101.
  • ITIS 2010: Integrated Taxonomic Information System. Taxon Based on Biological Information System [Internet]. Canadian Biodiversity Information Facility, Government of Canada. [Accessed 2011 March 7]. Available from: Next link will take you to another Web site http://www.cbif.gc.ca/pls/itisca/taxaget?p_ifx=cbif
  • JC 2012: Justice Canada. Next link will take you to another Web siteNatural Health Products Regulations [Internet]. Ottawa (ON): Justice Canada.[Current 2012 December 31; Last amended 2008-06-01; Accessed 2013 January 30].
  • 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 JJ, Leung AY, Tucker AO, editors. 2000. Herbs of Commence, 2nd edition. Silver Spring (MD): American Herbal Products Association.
  • Mills E, Dugoua J, Perri D, Koren G. 2006. Herbal Medicines in Pregnancy and Lactation : An Evidence-Based Approach. London (GB): Taylor and Francis Medical.
  • Moerman DE. 1998. Native American Ethnobotany. Portland (OR): Timber Press.
  • Ph.Eur. 2012: European Pharmacopoeia. 7th edition. Strasbourg (FR): Directorate for the Quality of Medicines and HealthCare of the Council of Europe (EDQM); 2012.
  • Schilcher H. 1997. Phytotherapy in Paediatrics: Handbook for Physicians and Pharmacists. Stuttgart (DE): medpharm Scientific Publishers.
  • Upton R, editor. 2010. American Herbal Pharmacopoeia and Therapeutic Compendium: Echinacea pallida Root (Echinacea pallida (Nutt.) Nutt.) – Standards of Analysis, Quality Control, and Therapeutics. Santa Cruz (CA): American Herbal Pharmacopoeia.
  • USDA 2012: United States Department of Agriculture, Agricultural Research Service, National Genetic Resources Program. Germplasm Resources Information Network (GRIN) [Internet]. Beltsville (MD): National Germplasm Resources Laboratory. [Echinacea pallida.: Last updated 2012 March 08; Accessed 2013 January 30]. Available from: Next link will take you to another Web site http://www.ars-grin.gov/cgi-bin/npgs/html/tax_search.pl
  • USP 35: United States Pharmacopeia and the National Formulary (USP 35 - NF 30). Rockville (MD): The United States Pharmacopeial Convention; 2012.

References reviewed

  • Barnes J, Anderson LA, Gibbons S, Phillipson JD. 2005. Echinacea species (Echinacea angustifolia (DC.) Hell., Echinacea pallida (Nutt.) Nutt., Echinacea purpurea (L.) Moench: a review of their chemistry, pharmacology and clinical properties. Journal of Pharmacy and Pharmacology 57(8):929-954.
  • Barnes J, Anderson LA, Phillipson JD. 2007. Herbal Medicines, 3rd edition. London (GB): The Pharmaceutical Press.
  • BHP 1983: British Herbal Pharmacopoeia. Bournemouth (GB): British Herbal Medicine Association.
  • Bielory L. 2004. Complementary and alternative interventions in asthma, allergy, and immunology. Annals of Allergy, Asthma & Immunology 93(1):S45-S54.
  • Boon H, Smith M, editors. 2004. The Complete Natural Medicine Guide to the 50 Most Common Medicinal Herbs, 2nd edition. Toronto (ON): Robert Rose Inc.
  • Bradley PR, editor. 1992. British Herbal Compendium: A Handbook of Scientific Information on Widely Used Plant Drugs, Volume 1. Bournemouth (GB): British Herbal Medicine Association.
  • Chicca A, Pellati F, Adinolfi B, Matthias A, Massarelli I, Benvenuti S, Martinotti E, Bianucci AM, Bone K, Lehmann R, Nieri P. 2008. Cytotoxicity activity of polyacetylenes and polyenes isolated from roots of Echinacea pallida. British Journal of Pharmacology 153(5):879-885.
  • EMEA 2000: Next link will take you to another Web siteThe European Agency for the Evaluation of Medicinal Products. Committee for Veterinary Medicinal Products: Echinacea (use in veterinary homeopathy) Summary Report [Internet]. London (GB): EMEA; 2000.[Accessed 2013 January 30].
  • Gallo M, Sarkar M, Au W, Pietrzak K, Comas B, Smith M, Jaeger TV, Einarson A, Koren G. 2000. Pregnancy outcome following gestational exposure to echinacea: a prospective controlled study. Archives of Internal Medicine 160(20):3141-3143.
  • Huntley A, Coon JT, Ernst E. 2005. The safety of herbal medicinal products derived from echinacea species. Drug Safety 28(5):387-400.
  • Islam J, Carter R. 2005. Use of Echinacea in upper respiratory tract infection. Southern Medical Journal 98(3): 311-318.
  • Melchart D, Linde K, Worku F, Sarkady L, Holzmann M, Jurcic K, Wagner H. 1995. Results of five randomized studies on the immunomodulatory activity of preparations of Echinacea. Journal of Alternative and Complementary Medicine 1(2): 145-160.
  • Miller LG. 1998. Herbal medicinals: selected clinical considerations focusing on known or potential drug-herb interactions. Archives of Internal Medicine 158(20):2200-2211.
  • Mills S. 1985. The Dictionary of Modern Herbalism. Wellingborough (GB): Thorsons Publishers Ltd.
  • Mills S, Bone K. 2005. The Essential Guide to Herbal Safety. St. Louis (MO): Elsevier Churchill Livingstone.
  • Mills S, Bone K. 2000. Principles and Practice of Phytotherapy: Modern Herbal Medicine. Toronto (ON): Churchill Livingstone.
  • Newall CA, Anderson LA, Phillipson JD. 1996. Herbal Medicines: A Guide for Health-Care Professionals. London (GB): The Pharmaceutical Press.
  • Perri D, Dugoua JJ, Mills E, Koren G. 2006. Safety and efficacy of echinacea (Echinacea angustifolia, E. purpurea and E. pallida) during pregnancy and lactation. The Canadian Journal of Clinical Pharmacology 13(3):e262-e267.
  • Speroni E, Govoni P, Guizzardi S, Renzulli C, Guerra MC. 2002. Anti-inflammatory and cicatrizing activity of Echinacea pallida Nutt. root extract. Journal of Ethnopharmacology 79(2): 265-272.
  • WHO 1999: World Health Organization. WHO Monographs on Selected Medicinal Plants: Radix Echinaceae [Internet]. Geneva (CH): World Health Organization; 2007. Available from: http://whqlibdoc.who.int/publications/1999/9241545178.pdf [Accessed 2013 January 30].
  • Wichtl M, editor. 2004. Herbal Drugs and Phytopharmaceuticals: A Handbook for Practice on a Scientific Basis, 3rd edition. Stuttgart (DE): Medpharm GmbH Scientific Publishers.
  • Wiersema JH, León B, editors. 1999. World Economic Plants: A Standard Reference. Boca Raton (FL): CRC Press LLC.

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

For adults only

Dried root:

0.9 - 1 g, 3 times per day (Blumenthal 2003)

Decoction:

1 g dried root, 3 times per day (Blumenthal et al. 2000)

Directions for use:
Place dried root in 150 ml of cold water, bring to a boil and simmer for 10 minutes (Blumenthal et al. 2000). Drink between meals (Blumenthal 2003).

Tincture:

  • 0.9 g dried equivalent, per day (1:5, 50% ethanol) (EMA 2009; Blumenthal et al. 1998)
  • 0.9 g dried equivalent, per day (Dorn et al. 1997)

Dry extract:

(4-8:1), extraction solvent: ethanol 50% (v/v) (EMA 2009)

Posology (EMA 2009):
1) 3 times daily 1 tablet containing 30 mg dry extract (4-8:1)
2) 4 times daily 2 tablets containing 12 mg dry extract (4-8:1)
3) 5 times daily 25 drops containing 100% tincture (1:5)

Duration of use:
The therapy should start at first signs of common cold. If the symptoms persist longer than 10 days during the use of the medicinal product, a doctor or a qualified health care practitioner should be consulted.