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Drugs and Health Products

PANAX GINSENG

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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 information

Table 1. Proper name(s), Common name(s), Source information
Proper name(s) Common name(s) Source information
Source material(s) Part(s) Preparation(s)
Panax ginseng
  • Asian ginseng
  • Chinese ginseng
  • Hong shen
  • Korean ginseng
  • Korean red ginseng
  • Oriental ginseng
  • Panax ginseng
  • Red ginseng
  • Ren shen
Panax ginseng
  • Root
  • Rootlet
Dried

References: USDA 2018; McGuffin et al. 2000; Common names: USDA 2018, PPRC 2010, USP 32 2008, Vuksan et al. 2008, Reay et al. 2006, Kim et al. 2005, Sünram-Lea et al. 2005, McGuffin et al. 2000, WHO 1999; Source information: PPRC 2010, Ph. Eur 2008, USP 32 2008, Vuksan et al. 2008, Sievenpiper et al. 2006, ESCOP 2003, WHO 1999, Bradley 1992, BHP 1983, Wren 1907.

Route of Administration

Oral

Dosage Form(s)

This monograph excludes foods or food-like dosage forms listed 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 Herbal Medicine as) supportive therapy for the promotion of healthy glucose levels (Vuksan et al. 2008; Sievenpiper et al. 2006; Williamson 2003; Tetsutani et al. 2000; WHO 1999; Sotaniemi et al. 1995).
  • (Used in Herbal Medicine to) help(s) support cognitive function and/or reduce mental fatigue (in cases of mental stress) (Reay et al. 2006; Reay et al. 2005; Sünram-Lea et al. 2005; Kennedy et al. 2004; ESCOP 2003; Kennedy et al. 2002; Scholey and Kennedy 2002; Kennedy et al. 2001; Sorensen and Sonne 1996; Bradley 1992; D'Angelo et al. 1986; BHP 1983).
  • Helps support cognition (Reay et al. 2006; Reay et al. 2005; Sünram-Lea et al. 2005; Kennedy et al. 2004; ESCOP 2003; Kennedy et al. 2002; Scholey and Kennedy 2002; Kennedy et al. 2001; Sorensen and Sonne 1996; Bradley 1992; D'Angelo et al. 1986; BHP 1983).
  • (Used in Herbal Medicine to) help(s) enhance physical capacity/performance (in cases of physical stress) (Kim et al. 2005; ESCOP 2003; Gross et al. 2002; WHO 1999; Gross et al. 1995; Sotaniemi et al. 1995; Schepdael 1993).
  • Used in Herbal Medicine as an adaptogen to help increase energy and resistance to stress (e.g. in case of mental and physical fatigue related to stress) (Winston and Maimes 2007, Bone 2003, Hoffman 2003, Blumenthal et al. 2000, WHO 1999, Bradley 1992).
  • Used in Traditional Chinese Medicine (TCM) to reinforce qi, benefit the spleen and lung, relieve symptoms of thirst due to impairment of body fluids and internal heat (PPRC 2010; Bensky et al. 2004, Chen and Chen 2004).

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; Cognitive function/cognition; Mental stress; Physical stress; Adaptogen

Methods of preparation: Standardized extracts (Dry extract)

200 - 600 milligrams of extract, per day; standardized to 4 - 7% total ginsenosides; Not to exceed 9 grams of dried root/rootlet, per day (Vuksan et al. 2008; Reay et al. 2006; Sievenpiper et al. 2006; Reay et al. 2005; Sünram-Lea et al. 2005; Kennedy et al. 2004; ESCOP 2003; Kennedy et al. 2002; Scholey and Kennedy 2002; Engels et al. 2001; Kennedy et al. 2001; Scaglione et al. 2001; Blumenthal et al. 2000; Tetsutani et al. 2000; McGuffin et al. 1997; Engels et al. 1996; Scaglione et al. 1996; Gross et al. 1995; Scaglione et al. 1994; Scaglione et al. 1990; Petkov and Mosharrof 1987; D'Angelo et al. 1986; Soldati and Sticher 1980).

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

0.5 - 9 grams dried root/rootlets, per day (Vuksan et al. 2008; Reay et al. 2006; Sievenpiper et al. 2006; Reay et al. 2005; Sunram-Lea et al. 2005; Kennedy et al. 2004; ESCOP 2003; Kennedy et al. 2002; Scholey and Kennedy 2002; Engels et al. 2001; Kennedy et al. 2001; Scaglione et al. 2001; Blumenthal et al. 2000; McGuffin et al. 1997; Engels et al. 1996; Scaglione et al. 1996; Gross et al. 1995; Scaglione et al. 1994; Scaglione et al. 1990; Petkov and Mosharrof 1987; D'Angelo et al. 1986; Soldati and Sticher 1980).

Traditional Chinese Medicine

Methods of preparation: Decoction, decoction concentrate

3 - 10 grams dried root, per day (PPRC 2010; Bensky et al. 2004, Chen and Chen 2004)

Methods of preparation: Powder

0.5 - 4 grams dried root, per day (PPRC 2010, Bensky et al. 2004, Chen and Chen 2004)

Direction(s) for use

No statement required.

Duration(s) of use

Consult a health care practitioner/health care provider/health care professional/doctor/physician for use beyond 3 months (Mills and Bone 2005; Blumenthal et al. 2000; McGuffin et al. 1997; Bradley 1992).

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 pregnant, breastfeeding or have diabetes (Brinker 2010; Vuksan et al. 2008; Seely et al. 2008; Sievenpiper et al. 2006; ESCOP 2003; Tetsutani et al. 2000; Sotaniemi et al. 1995; Chin 1991).
  • Consult a health care practitioner/health care provider/health care professional/doctor/physician prior to use if you are taking antidepressant medication, blood thinners or digoxin (Brinker 2010; Lee et al. 2008a; Dasgupta and Reyes 2005; Janetzki and Morreale 1997; Gonzalez-Seijo et al. 1995; Shader and Greenblatt 1988; Jones and Runikis 1987; Shader and Greenblatt 1985).

Contraindication(s)

Traditional Chinese Medicine

Do not use this product in cases of yin deficiency with heat signs, heat excess, or in the absence of significant qi deficiency (Bensky et al. 2004).

Known adverse reaction(s)

Stop use if you experience insomnia, anxiety or headaches (Lee et al. 2008b; Vuksan et al 2008; de Andrade et al. 2007; Sievenpiper et al. 2006; Coon and Ernst 2002; Ellis and Reddy 2002; Scaglione et al. 2001; Siegel 1979).

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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