REISHI - GANODERMA LUCIDUM
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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
February 25, 2019
Proper name(s), Common name(s), Source material(s)
Proper name(s) | Common name(s) | Source material(s) | ||
---|---|---|---|---|
Proper name(s) | Part(s) | Preparation | ||
Ganoderma lucidum |
|
Ganoderma lucidum |
|
Dried |
References: Proper name: CABI 2018, PPRC 2010; Common names: PPRC 2010, Bensky et al. 2004, Chen and Chen 2004, McGuffin et al. 2000; Source materials: Godfrey et al. 2010, PPRC 2010, Leung and Foster 2003, Yarnell et al. 2003, Wasser 2002, Upton 2000, Flynn et Roest 1995.
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 any age category listed in this monograph for the specified route of administration are listed in the Compendium of Monographs Guidance Document.
Use(s) or Purpose(s)
Fruiting body
- Used in Traditional Chinese Medicine (TCM) to dispel phlegm, stop cough and arrest wheezing (PPRC 2010; Bensky et al. 2004; Chen and Chen 2004).
- Used in Traditional Chinese Medicine (TCM) to nourish the Heart and strengthen qi and blood to treat Heart and Spleen deficiencies that manifest in insomnia, forgetfulness, fatigue, listlessness and poor appetite (PPRC 2010; Bensky et al. 2004; Chen and Chen 2004).
- Used in Traditional Chinese Medicine (TCM) to strengthen the body and tonify qi (PPRC 2010; Bensky et al. 2004; Chen and Chen 2004).
The following combined use(s) or purpose(s) is/are also acceptable:
Used in Traditional Chinese Medicine (TCM) to strengthen the body, qi and blood to treat Heart and Spleen deficiencies that manifest in insomnia, forgetfulness, fatigue, listlessness and poor appetite (PPRC 2010; Bensky et al. 2004; Chen and Chen 2004).
Fruiting body; Cultured mycelium; Mycelium
- Source of/Provides antioxidants (Wachtel-Galor et al. 2011; Godfrey et al. 2010; Wicks et al. 2007).
- Source of fungal polysaccharides with immunomodulating properties (Chan et al. 2009; Wasser 2002).
- Used in Herbal Medicine as a liver tonic (Godfrey et al. 2010; Yarnell et al. 2003; Saunders 2000; Huang 1999; Peirce 1999; Belanger 1997; Hsu et al. 1986).
- Used in Herbal Medicine to support the immune system (Wachtel-Galor et al. 2011; Godfrey et al. 2010; Ko and Leung 2007; Lin 2005; Chen and Chen 2004; Wachtel-Galor et al. 2004; Hoffmann 2003; Yarnell et al. 2003; Wasser 2002; Peirce 1999; Belanger 1997; Hsu et al. 1986).
- Used in Herbal Medicine as an adaptogen to help increase energy and resistance to stress (in case of mental and physical fatigue related to stress) (Godfrey et al. 2010; Hobbs 2003; Hoffmann 2003; Leung and Foster 1996).
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)
Antioxidant; Source of Polysaccharides
Methods of preparation: Dry, Powder, Non-Standardized Ethanolic Extracts (Dry extract, Tincture, Fluid extract)
Not to exceed 6 grams of dried Reishi, per day (Godfrey et al. 2010)
Methods of preparation: Standardized Ethanolic Extracts (Dry extract, Tincture, Fluid extract)
Not to exceed 6 grams of dried Reishi, per day and 40 % polysaccharides (Godfrey et al. 2010)
Method of preparation: Decoction
Not to exceed 15 grams of dried Reishi, per day (Wachtel-Galor et al. 2011)
Method of preparation: Decoction standardized
Not to exceed 15 grams of dried Reishi, per day and 40 % polysaccharides (Wachtel-Galor et al. 2011)
Liver tonic; Adaptogen; Traditional Chinese Medicine - Cough - Heart - Tonify qi
Method of preparation: Dry, Powder, Non-Standardized Ethanolic Extracts (Dry extract, Tincture, Fluid extract)
1.5 - 6 grams of dried Reishi, per day (Bensky et al. 2004; Chen and Chen 2004; Hobbs 2003; Upton 2000; Huang 1999).
Methods of preparation: Standardized Ethanolic Extracts (Dry extract, Tincture, Fluid extract)
1.5 - 6 grams of dried Reishi, per day and not to exceed 40 % polysaccharides (Bensky et al. 2004; Chen and Chen 2004; Hobbs 2003; Upton 2000; Huang 1999).
Method of preparation: Decoction
3 - 15 grams of dried Reishi, per day (Godfrey et al. 2010; PPRC 2010; Bensky et al. 2004; Chen and Chen 2004).
Method of preparation: Decoction standardized
3 - 15 grams of dried Reishi, per day and not to exceed 40 % polysaccharides (Godfrey et al. 2010; PPRC 2010; Bensky et al. 2004; Chen and Chen 2004).Immune Support
Method of preparation: Tincture, Fluid extract
1.5 - 6 grams of dried reishi, per day (Godfrey et al. 2010)
Method of preparation: Tincture standardized, Fluid extract standardized
1.5 - 6 grams of dried reishi, per day and not to exceed 40 % polysaccharides (Godfrey et al. 2010)
Method of preparation: Decoction
3 - 15 grams of dried reishi, per day (Wachtel-Galor et al. 2011; Wasser 2002).
Method of preparation: Decoction standardized
3 - 15 grams of dried reishi, per day and not to exceed 40 % polysaccharides (Wachtel-Galor et al. 2011; Wasser 2002).
Notes
- Non-extracted powder preparations are not acceptable to support the recommended use "Used in Herbal Medicine to support the immune system".
- For standardized extracts, as evidence mainly supports the quantity crude equivalent of Reishi, both the quantity crude equivalent and the maximum concentration of the potency constituent must be met.
Direction(s) for use
Take with food/meal to avoid digestive upset (Flynn and Roest 1995).
Duration(s) of Use
No statement required.
Risk Information
Caution(s) and warning(s)
Traditional Chinese Medicine - Cough
Consult a health care practitioner/health care provider/health care professional/doctor/ physician if symptoms persist or worsen.
Contraindication(s)
No statement required.
Known adverse reaction(s)
Stop use if hypersensitivity/allergy occurs (derMarderosian and Beutler 2008; Bensky et al. 2004; Gao et al. 2003, 2002).
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.
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