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Monograph: 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: (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 pallida (USDA 2008)

Proper Name(s)

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

Common Name(s)

Source Material

Root ( Blumenthal et al. 2003 , Dorn et al. 1997 )

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): 0.06 - 0.5 Grams per day, dried root
Directions For Use: Start treatment at first signs of common cold (EMA 2009)

Children and adolescents 5 - 9 years:

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

Dose(s): 0.09 - 0.8 Grams per day, dried root
Directions For Use: Start treatment at first signs of common cold (EMA 2009)

Adolescents 10 - 14 years:

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

Dose(s): 0.18 - 1.5 Grams per day, dried root
Directions For Use: Start treatment at first signs of common cold (EMA 2009)

Adults and adolescents 15 and over:

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

Dose(s): 0.36 - 3 Grams per day, dried root
Directions For Use: Start treatment at first signs of common cold (EMA 2009)


  • Adult dose supported by the following references: EMEA 2009; Blumenthal 2003; Blumenthal et al. 2000; Blumenthal et al. 1998; Dorn et al. 1997.
  • Adults includes pregnant and breastfeeding women.
  • Children and adolescent doses were calculated as a proportion of the adult dose (JC 2012).
  • 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.
  • The use of Echinacea pallida in children is supported by the following references: Bove 2001; Schilcher 1997.

Duration of use

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

Risk Information

Statement(s) to the effect of:

Caution(s) and Warning(s):

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).
  • 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 may comply with the specifications outlined in the following pharmacopoeial monographs: 'Echinacea Pallida Root' of the British Pharmacopoeia(BP), 'Pale Coneflower Root: Echinacea pallidae radix' of the European Pharmacopoeia(Ph Eur) as well as 'Echinacea pallida', 'Powdered Echinacea pallida' and 'Powdered Echinacea pallida Extract' of the United States (USP) Pharmacopoeias.

References cited

  • Blumenthal M, Busse W, Goldberg A, Gruenwald J, Hall T, Riggins C, Rister R, editors. The Complete German Commission E Monographs: Therapeutic Guide to Herbal Medicines. Austin (TX): American Botanical Council; 1998.
  • Blumenthal M, Goldberg A, Brinckmann J, editors. Herbal Medicine: Expanded Commission E Monographs. Boston (MA): Integrative Medicine Communications; 2000.
  • Blumenthal M, Hall T, Goldberg A, Kunz T, Kinda K, editors. 2003. The ABC Clinical Guide to Herbs. Austin (TX): American Botanical Council
  • Bove M. An Encyclopedia of Natural Healing for Children and Infants. New Canaan (CT): Keats Publishing, Incorporated; 1996
  • 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. British Herbal Compendium: A Handbook of Scientific Information on Widely Used Plant Drugs, Volume 2. Bournemouth (UK): British Herbal Medicine Association; 2006.
  • Brinker F. 2001. Herb Contraindications and Drug Interactions, 3rd edition. Sandy (OR): Eclectic Medical Publications.
  • Brinker F. 2010. Final updates and additions for Herb Contraindications and Drug Interactions, 3rd edition. [internet]. Sandy (OR): Eclectic Medical Publications. [Updated 2010 July 13; Accessed 2011 March 7]. Available from: http://www.eclecticherb.com/emp/updateshcdi.html
  • 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: http://www.ema.europa.eu
  • ESCOP 2003: ESCOP Monographs: The Scientific Foundation for Herbal Medicinal Products, 2nd edition. Exeter (UK): European Scientific Cooperative on Phytotherapy and Thieme; 2003.
  • 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: http://www.cbif.gc.ca/pls/itisca/taxaget?p_ifx=cbif
  • 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].
  • 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.
  • Mills E, Dugoua J, Perri D, Koren G. Herbal Medicines in Pregnancy and Lactation: An Evidence-Based Approach. London (UK): Taylor and Francis Medical; 2006.
  • 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. Phytotherapy in Paediatrics: Handbook for Physicians and Pharmacists. Stuttgart (D): Medpharm Scientific Publishers; 1997.
  • 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 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
  • 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. The Journal of Pharmacy and Pharmacology 57(8):929-954.
  • Barnes J, Anderson LA, Philipson JD. 2007. Herbal Medicines, 3rd edition. London (GB): Pharmaceutical Press.
  • BHP 1983: British Herbal Pharmacopoeia. Cowling (GB): British Herbal Medical Association; 1983.
  • Bielory L. 2004. Complementary and alternative interventions in asthma, allergy, and immunology. Annals of Allergy, Asthma & Immunology 93(1):S45-S54.
  • Boon H, Smith MJ. 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: The European Agency for the Evaluation of Medicinal Products. Committee for Veterinary Medicinal Products: Echinacea (use in veterinary homeopathy) Summary Report [online]. London (UK): EMEA; 2000. Available from: http://www.emea.europa.eu/pdfs/vet/mrls/068799en.pdf [Accessed 26 June 2008].
  • 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, 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.
  • Mills S. The Dictionary of Modern Herbalsim. Wellingborough (UK): Thorsons Publishers Ltd; 1985.
  • Newall CA, Anderson LA, Phillipson JD. 1996. Herbal Medicines: A Guide for Health-Care Professionals. London (UK): 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. 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, Volume 1. Geneva (CH): World Health Organization; 1999.
  • Wichtl M, editor. Herbal Drugs and Phytopharmaceuticals: A Handbook for Practice on a Scientific Basis, 3rd edition. Stuttgart (D): Medpharm GmbH Scientific Publishers; 2004.
  • Wiersema J, León B. 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.