RHODIOLA - RHODIOLA ROSEA

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Monograph: Rhodiola - Rhodiola rosea (PDF Version - 25 KB)

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

Date

January 27, 2023

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)

Rhodiola rosea

  • Hong jing tian
  • King's-crown
  • Rhodiola
  • Roseroot

Rhodiola rosea



  • Root
  • Root and rhizome


Dry

References: Proper name: USDA 2018, McGuffin et al. 2000; Common names: USDA 2018, McGuffin et al. 2000; Source information: EMA 2012, Winston and Maimes 2007.

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 oral use are indicated in the dosage form drop-down list of the web-based Product Licence Application form for Compendial applications.

Use(s) or Purpose(s)

The following combined use(s) or purpose(s) is/are also acceptable:

(Used in Herbal Medicine) (to) help(s) support cognitive function (such as mental focus and mental stamina) and (as an adaptogen) (to) help(s) (to) temporary relieve symptoms of stress (EMA 2012; Olsson et al. 2009; Winston and Maimes 2007; Pizzorno and Murray 2006; Hoffman 2003).

Dose(s)

Subpopulation(s)

Adults 18 years and older (EMA 2012)

Quantity(ies)

Antioxidant

Methods of preparation: Standardized extracts (Dry extract)

Not to exceed 680 milligrams of extract, per day and 200 milligrams, per single dose (EMA 2012; Darbinyan et al. 2007; Pizzorno and Murray 2006)

Methods of preparation: Non-Standardized Ethanolic Extracts (Dry extract)

Not to exceed 400 milligrams of dry extract and a quantity crude equivalent (QCE) of 2 grams of dried root/root and rhizome, per day; Not to exceed 200 milligrams of dry extract and a QCE of 1 gram of dried root/root and rhizome, per single dose (EMA 2012).

Method of preparation: Tincture

Not to exceed 1.8 grams of dried root/root and rhizome, per day (Winston and Maimes 2007).

Symptoms of Stress, Adaptogen and Cognitive Function

Methods of preparation: Standardized extracts (Dry extract)

144 - 680 milligrams of extract, per day; Not to exceed 200 milligrams per single dose (EMA 2012; Darbinyan et al. 2007; Pizzorno and Murray 2006)

Method of preparation: Tincture

1.2 - 1.8 grams of dried root/root and rhizome, per day (Winston and Maimes 2007).

Symptoms of Stress and Adaptogen

Methods of preparation: Non-Standardized Ethanolic Extracts (Dry extract)

144 - 400 milligrams of dry extract and a Quantity Crude Equivalent (QCE) of 216-2,000 milligrams of dried root/root and rhizome, per day; Not to exceed 200 milligrams of dry extract and a QCE of 1 gram of dried root/root and rhizome, per single dose (EMA 2012).

Direction(s) for use

Avoid taking before bedtime (Iovieno et al. 2011; Pizzorno and Murray 2006; Kelly 2001).

Duration(s) of Use

No statement required.

Risk Information

Caution(s) and warning(s)

Contraindication(s)

Do not use this product if you have bipolar disorder or bipolar spectrum disorder (Iovieno et al. 2011; Winston and Maimes 2007; Brown et al. 2002).

Known adverse reaction(s)

Stop use if you experience irritability or insomnia (Pizzorno and Murray 2006; Kelly 2001).

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

Must be established in accordance with the requirements described in the Natural Health Products Regulations (NHPR).

Specifications

References Cited

References Reviewed