Rhodiola roseola – Health Canada Product Monograph
SOURCE- HEALTH CANADA: Compendium of Medicinal Ingredients Nomenclature
Drugs and natural health products
Product Monograph: Rhodiola roseola
The purpose of this monograph is to serve as a guide for industry in the preparation of licence applications (MMDLs) and labels for the purpose of obtaining a product market authorization. It is not intended to be an in-depth study of the medicinal ingredient.
Note
- Parentheses contain optional pieces of information; they do not need to be included in the DLMM or on the product label.
- The forward slash (/) indicates that the terms or statements are synonymous. The applicant may use any of the terms or statements indicated.
Date
October 24, 2013
Proper name(s)
Rhodiola rosea L. (crassulaceae) (USDA 2007; McGuffin et al. 2000)
(Synonym: Sedum rosea (L.) Scop. (USDA 2007; McGuffin et al. 2000)))
Common name(s)
- Rhodiola (McGuffin et al. 2000)
- Rose orpin (health passport 2011)
Original material(s)
- Racine (Winston and Maimes 2007)
- Root and rhizome (EMA 2012)
Route(s) of administration
Oral
Dosage form(s)
- Acceptable dosage forms include, but are not limited to, strips, capsules, tablets, chewable dosage forms (e.g., tablets, gummies), liquids or powders.
- Foods or food-like dosage forms such as bars, chewing gum or beverages are excluded from this monograph.
Recommended use(s) or purpose(s)
Statement(s) specifying the following
- (Used in herbal medicine/herbalism) (as an adaptogen) (for) temporarily assisting in the relief of stress symptoms (such as intellectual fatigue and feeling weak) (EMA 2012; Olsson et al. 2009; Winston and Maimes 2007; Pizzorno and Murray 2006; Hoffman 2003)
- (Used in herbal medicine/herbalism for) helps(r) maintain cognitive functions (such as concentration and intellectual vigor) (Olsson et al. 2009; Winston and Maimes 2007).
- Provides antioxidants (Skarpanska-Stejnborn et al. 2009; Winston and Maimes 2007; Kim et al. 2006).
Dose(s)
Subpopulation(s)
Adults (≥ 18 years)(EMA 2012)
Quantity(ies)
Stress symptoms and cognitive function
Standardized extract:
144 to 680 mg of rhodiola extract per day, not to exceed 200 mg per single dose (EMA 2012; Darbinyan et al. 2007; Pizzorno and Murray 2006)
Activity:
- 0.8-3% salidroside (Olsson et al. 2009; AT THE 2008 TGA; Winston and Maimes 2007; Pizzorno and Murray 2006; Brown et al. 2002).
- 1-6% rosavin (Olsson et al. 2009; AT THE 2008 TGA; Winston and Maimes 2007; Pizzorno and Murray 2006; Brown et al. 2002).
Dye:
1.2-1.8 g dried root/rhizome, daily (1:4; 4.8-7.2 ml) (Winston and Maimes 2007)
Symptoms of stress
Unsized dry extract:
144 to 400 mg dry extract, daily, not more than 200 mg per single dose [1.5-5:1, 67-70% ethanol v/v] (EMEA 2012)
Antioxidant
Standardized extract:
Up to 600 mg of rhodiola extract per day, not to exceed 200 mg per single dose (EMA 2012; Pizzorno and Murray 2006).
Activity:
- 0.8-3% salidroside (Olsson et al. 2009; AT THE 2008 TGA; Winston and Maimes 2007; Pizzorno and Murray 2006; Brown et al. 2002).
- 1-6% rosavin (Olsson et al. 2009; AT THE 2008 TGA; Winston and Maimes 2007; Pizzorno and Murray 2006; Brown et al. 2002).
Unsized dry extract:
144 to 400 mg dry extract, daily, not more than 200 mg per single dose [1.5-5:1, 67-70% ethanol v/v] (EMEA 2012)
Dye:
Up to 1.8 g rhizome/dried root per day (1:4; up to 7.2 ml) (Winston and Maimes 2007)
Instructions for use
Do not take immediately before bedtime (Iovieno et al. 2011; Pizzorno and Murray 2006; Kelly 2001).
Duration(s) of use
Statement not required.
Risk statement(s)
Statement(s) specifying the following
Precaution(s) and warning(s)
- If symptoms persist or worsen, consult a health care practitioner.
- If you are pregnant or breastfeeding, consult a health care practitioner (EMA 2012).
- If you are taking an antidepressant, consult a health care practitioner (Iovieno et al. 2011; Olsson et al. 2009; Brown et al. 2002).
- If you are taking hormone replacement therapy or taking oral contraceptives, consult a health care practitioner before using them (HC 2013; Brown et al. 2002).
Contraindication(s)
Do not use 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)
If you suffer from irritability or insomnia, stop taking the product (Pizzorno and Murray 2006; Kelly 2001).
Non-medicinal ingredients
Must be selected from NNHPD (NHPD) and comply with the restrictions set out in this database.
Storage conditions the current version of the Natural Health Product Ingredients Database
Statement not required.
Specifications
- Finished product specifications must be established in accordance with the requirements outlined in the NNHPD Natural Health Product Quality Reference Guide.
- The medicinal ingredient must comply with the requirements set out in the NHPID Natural Health Product Ingredients Database
- Brown RP, Gerbarg PL, Ramazanov Z. Rhodiola rosea:A Phytomedicinal Overview. HerbalGram 2002;56:40-52.
- Darbinyan V, Aslanyan G, Amroyan E, Gabrielyan E, Malmstrom C, Panossian A. Clinical trial of Rhodiola rosea L. extract SHR-5 in the treatment of mild to moderate depression. Nordic journal of psychiatry 2007;61(5):343-348.
- Iovieno, N., Dalton, ED., Fava, M., Mischoulon, D. Second-tier natural antidepressants: review and critique. Journal of Affective Disorders 2011; 130(3): 343-357
- Kelly GS. Rhodiola rosea:A Possible Plant Adaptogen. Alternative Medicine Review 2001; 6(3): 293-302
- Kim SH, Hyun SH, Choung SY. Antioxidant effects of Cinnamomi cassiae and Rhodiola rosea extracts in liver of diabetic mice. Biofactors 2006;26(3): 209-219
- McGuffin M, Kartesz JT, Leung AY, Tucker AO, editors. Herbs of Commerce. 2nd edition. Silver Spring (MD): American Herbal Products Association; 2000.
- Health Passport 2011: Rhodiola. Montreal (QC): Totalmedia Inc.; 2011. [Consulté le 12 avril 2013] .
- Pizzorno JE, Murray MT, editors. Textbook of Natural Medicine. Third edition, volume 1. St. Louis (MI): Churchill Livingstone Elsevier; 2006.
- e (MD). [Arnica montana L. Updated on 29 May 2007; Accessed April 12, 2013].
- Winston D, Maimes S. Adaptogens: Herbs for Strength, Stamina, and Stress Relief. Rochester (VT): Healing Arts Press, 2007.
References consulted
- Abidov M, Grachev S, Seifulla RD, Ziegenfuss TN. Extract of Rhodiola rosea radix reduces the level of C-reactive protein and creatinine kinase in the blood. Bulletin of Experimental Biology and Medicine 2004;138:63-64.
- Blomkvist J, Taube A, Larhammar D. Perspective on roseroot (Rhodiola rosea) studies. Planta Medica 2009;75:1187-1190.
- Brinker F. Herb Contraindications and Drug Interactions, 3rd edition. Sandy (OR): Eclectic Medical Publications; 2001.
- Bystritsky A, Kerwin L, Feusner JD. A pilot study of Rhodiola rosea (Rhodax®) for Generalized Anxiety Disorder (GAD). The Journal of Alternative and Complementary Medicine 2008;14:175-180.
- Darbinyan V, Kteyan A, Panossian A, Gabrielian E, Wikman G, Wagner H. Rhodiola rosea in stress induced fatigue – a double blind cross-over study of a standardized extract SHR-5 with a repeated low-dose regimen on the mental performance of healthy physicians during night duty. Phytomedicine 2000;7:365-371.
- De Bock K, Eijnde BO, Ramaekers M, Hespel P. Acute Rhodiola Rosea Intake Can Improve Endurance Exercise Performance. International Journal of Sport Nutrition and Exercise Metabolism 2004;14:298-307.
- Edward D, Heufelder A, Zimmermann Z. Therapeutic Effects and Safety of Rhodiola rosea Extract WS® 1375 in Subjects with Life-stress Symptoms – Results of an Open-label Study. Phytotherapy Research 2012;26:1220-1225.
- Hung SK, Perry R, Ernst E. The effectiveness and efficacy of Rhodiola rosea L: A systematic review of randomized clinical trials. Phytomedicine 2011;18:235-244.
- Ishaque S, Shamseer L, Bukutu C, Vohra S. Rhodiola rosea for physical and mental fatigue: a systematic review. Complementary & Alternative Medicine 2012;12:70-78.
- Noreen EE, Buckley JG, Lewis SL, Brandauer J, Stuempfle KJ. The effects of an acute dose of Rhodiola rosea on endurance exercise performance. Journal of Strength and Conditioning Association 2013;27(3):839-847.
- Panossian A, Wilkman G, Sarris J. Rosenroot (Rhodiola rosea): Traditional use, chemical composition, pharmacology and clinical efficacy. Phytomedicine 2010;17:481-493.
- Parisi A, Tranchita E. Duranti G, Ciminelli E, Quaranta I, Ceci R, Cerulli C, Borrione P, Sabatini S. Effects of chronic Rhodiola rosea supplementation on sport performance and antioxidant capacity in trained male : preliminary results. The Journal of Sports Medicine and Physical Fitness 2010;50:57-63.
- Peschel W, Prieto JM, Karkour C, Williamson EM. Effect of provenance, plant part and processing on extract profiles from cultivated European Rhodiola rosea L. for medicinal use. Phytochemistry 2013;86:92-102.
- Shevtsov VA, Zholus BI, Shervarly VI, Vol’skij VB, Korovin YP, Khristich MP, Roslyakova NA, Wikman G. A randomized trial of two different doses of a SHR-5 Rhodiola rosea extract versus placebo and control of capacity for mental work. Phytomedicine 2003;10:95-105.
- Skarpanska-Stejnborn A, Pilaczynska-Szczesniak L, Basta P, Deskur-Smielecka E. The influence of supplementation with Rhodiola rosea L. extract on selected redox parameters in professional rowers. International Journal of Sport Nutrition and Exercise Metabolism 2009; 19(2): 186-199
- Spasov AA, Wikman GK, Mandrikow VB, Mironova IA, Neumoin VV. A double-blind, placebo-controlled pilot study of the stimulating and adaptogenic effect of Rhodiola rosea SHR-5 extract on the fatigue of students caused by stress during an examination period with a repeated low-dose regimen. Phytomedicine 2000;7:85-89.
- Walker TB, Altobelli SA, Caprihan A, Robergs RA. Failure of Rhodiola rosea to alter skeletan muscle phosphate kinetics in trained men. Metabolism 2007:56(8):1111-1117.