Monograph: Reishi - Ganoderma lucidium

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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" or "Traditional Chinese Medicine"

Date: 2019-02-25

NHPID name

Ganoderma lucidum ( Index Fungorum )

Proper name(s)

Ganoderma lucidum ( CABI 2011 , PPRC 2010 )

Common name(s)

Ganoderma ( PPRC 2010 , Bensky et al. 2004 , McGuffin et al. 2000 )
Ling zhi ( Bensky et al. 2004 , Chen and Chen 2004 , McGuffin et al. 2000 )
Reishi ( PPRC 2010 , Bensky et al. 2004 , McGuffin et al. 2000 )

Source material

Route Of administration

Oral

Dosage form(s)

The acceptable pharmaceutical dosage forms include, but are not limited to capsules, chewables (e.g. gummies, tablets), liquids, powders, strips or tablets.
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:

Source of/Provides antioxidants.
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). (Godfrey et al. 2010, Hobbs 2003, Hoffmann 2003, Leung and Foster 1996)
Source of fungal polysaccharides with immunomodulating properties.
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 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)

Dose(s)

Adults:

Dose(s):

1 Day per day

Directions for use: Take with food/meal to avoid digestive upset.

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

No statement is required

Risk information

Statement(s) to the effect of:

Caution(s) and Warning(s): TCM - relief of cough: Consult a health care practitioner/health care provider/health care professional/doctor/ physician if symptoms persist or worsen. Contraindication(s): No statement is required Known Adverse Reaction(s): Stop use if hypersensitivity/allergy occurs.

Non-medicinal ingredients

Must be chosen from the current Natural health products ingredients database and must meet the limitations outlined in the database.

Storage conditions

Store in a dry place at room temperature (PPRC 2010).

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 medicinal ingredient must comply with the requirements outlined in the Natural Health Products Ingredients Database (NHPID).

References cited

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Appendix 1: Examples of dosage preparations and directions for use

Decoction:

Boil 2-15 g of chopped or powdered reishi mushrooms in approximately 2 L of water. Slowly simmer for 20-60 minutes. When the water is reduced to approximately 2/3 then strain the liquid (Upton 2000).