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Drugs and Health Products

AMERICAN GINSENG - PANAX QUINQUEFOLIUS

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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

August 28, 2018

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

Table 1. Proper name(s), Common name(s), Source material(s)
Proper name(s) Common name(s) Source material(s)
Proper name(s) Part(s) Preparation
Panax quinquefolius
  • American ginseng
  • Occidental ginseng
  • Sang
  • Shang
  • Xi yang shen
Panax quinquefolius Root Dried

References: Proper name: USDA 2018; Common names: USDA 2018, McGuffin et al. 2000; Source material: PPRC 2010, Lust 1974, Wren 1956.

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 the age category listed in this monograph and specified route of administration are indicated in the Compendium of Monographs Guidance Document.

Use(s) or Purpose(s)

  • Used in Traditional Chinese Medicine (TCM) for deficiency of qi and yin, internal heat, cough, bloody phlegm, fire in the deficiency syndrome, dysphoria and tiredness, dry and thirsty mouth and throat (PPRC 2010).
  • Used in Herbal Medicine as supportive therapy for the promotion of healthy glucose levels (PPRC 2010; Dascalu et al. 2007; Vuksan et al. 2000a; Vuksan et al. 2000b; Vuksan et al. 2000c).
  • (Traditionally) used in Herbal Medicine to help relieve restlessness and/or nervousness (calmative) (Bartram 1998; Ellingwood 1998).
  • Traditionally used in Herbal Medicine to help relieve nervous dyspepsia/to help digestion in cases of nervousness and/or stress (Bartram 1998; Felter and Lloyd 1983; Wren 1956).
  • Used in Herbal Medicine as an adaptogen to help maintain a healthy immune system (Upton 2012; Godfrey et al. 2010; Assinewe 2001; Bartram 1998).

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)

Glucose levels; Restlessness/Nervousness; Immune System

Methods of preparation: Dry, Powder, Non-Standardised Extracts (Dry extract, Tincture, Fluid extract, Decoction, Infusion)

0.5 - 12 grams dried root, per day (Bartram 1998; Felter and Lloyd 1983; Wren 1956).

TCM

Methods of preparation: Decoction, Decoction concentrate

2.4 - 9 grams dried root, per day (PPRC 2010; Bensky and Gamble 1993).

Direction(s) for use

No statement required.

Duration(s) of Use

No statement required.

Risk Information

Caution(s) and warning(s)

  • Consult a health care practitioner/health care provider/health care professional/doctor/ physician prior to use if you are taking blood thinners or digoxin (Brinker 2010; Elmer et al. 2007; Dasgupta et al. 2005; Yuan et al. 2004).
  • Consult a health care practitioner/health care provider/health care professional/doctor/ physician prior to use if you have diabetes (Brinker 2010; Dascalu et al. 2007; Vuksan et al. 2000a; Vuksan et al. 2000b; Vuksan et al. 2000c).

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.

Storage conditions

No statement required.

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

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  • Dascalu A, Sievenpiper JL, Jenkins AL, Stavro MP, Leiter LA, Arnason JT, Vuksan V. Five batches representative of Ontario-grown American ginseng root produce comparable reductions
  • of postprandial glycemia in healthy individuals. Canadian Journal of Physiology and Pharmacology 2007;85(9):856-864.
  • Dasgupta A, Kang E, Olsen M, Actor JK, Datta P. Interference of Asian, American, and Indian (Ashwagandha) ginseng in serum digoxin measurements by a fluorescence polarization immunoassay can be minimized by using a new enzyme-linked chemiluminescent immunosorbent or turbidimetric assay. Archives of Pathology & Laboratory Medicine 2007;131(4):619-621.
  • Ellingwood F. American Materia Medica, Therapeutics and Pharmacognosy. Sandy (OR): Eclectic Medical Publications; [Reprint of 1919 original]; 1998.
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  • Felter HW, Lloyd JU. King’s American Dispensatory, Volume 1, 18th edition. Sandy (OR): Eclectic Medical Publications; [Reprint of 1898]; 1983.
  • Godfrey A, Saunders PR with Barlow K, Gilbert C, Gowan M, Smith F. Principles and Practices of Naturopathic Botanical Medicine. Volume 1: Botanical Medicine Monographs. Toronto (ON): CCNM Press; 2010.
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  • McGuffin M, Kartesz JT, Leung AY, Tucker AO, editors. Herbs of Commerce, 2nd edition. Silver Spring (MD): American Herbal Products Association; 2000.
  • PPRC 2010: Pharmacopoeia of the People’s Republic of China, Volume 1, English edition 2010. Beijing (CN): The State Pharmacopoeia Commission of the People’s Republic of China.
  • Upton R, editor. American Herbal Pharmacopoeia and Therapeutic Compendium: American ginseng Root (Panax quinquefolius L.) – Standards of Analysis, Quality Control, and Therapeutics. Santa Cruz (CA): American Herbal Pharmacopoeia; 2012.
  • USDA 2018: United States Department of Agriculture, Agricultural Research Service, National Genetic Resources Program. Germplasm Resources Information Network (GRIN) [Online database]. 2005. Panax quinquefolius. Beltsville (MD): National Germplasm Resources Laboratory. [Accessed 2018 June 15]. Available from: http://www.ars-grin.gov/cgi-bin/npgs/html/tax_search.pl
  • Vuksan V, Xu Z, Jenkins AL, Belgan U, Sievenpiper JL, Leiter LA, Josse RG, Stavro
  • MP.American ginseng (Panax quinquefolium L.) improves long-term glycemic control in type 2 diabetes: double-blind placebo controlled crossover trial. Diabetes 2000a;49 (Suppl.1):A95.
  • Vuksan V, Stavro MP, Sievenpiper JL, Beljan-Zdravkovic U, Leiter LA, Josse RG, Xu Z. Similar postprandial glycemic reductions with escalation of dose and administration time of American ginseng in type 2 diabetes. Diabetes Care 2000b;23(9):1221-1226.
  • Vuksan V, Stavro MP, Sievenpiper JL, Koo VY, Wong E, Beljan-Zdravkovic U, Francis T, Jenkins AL, Leiter LA, Josse RG, Xu Z. American ginseng improves glycemia in individuals with normal glucose tolerance: effect of dose and time escalation. Journal of the American College of Nutrition 2000c;19(6):738-744. 
  • Wren RC. Potter’s Cyclopedia of Botanical Drugs and Preparations. London (GB): Potter and Clark; 1956.
  • Yuan CS, Wei G, Dey L, Karrison T, Nahlik L, Maleckar S, Kasza K, Ang-Lee M, Moss J. American ginseng reduces warfarin’s effect in healthy patients. Annals of internal medicine 2004;141(1):23-27.

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