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Drugs and Health Products

Rhodiola - Rhodiola rosea

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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 the statements are synonymous. Either term or statement may be selected by the applicant.

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)
  • Roseroot (USDA 2007; McGuffin et al. 2000)

Source material(s)

  • Root (Winston and Maimes 2007)
  • Root and rhizome (EMA 2012)

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

Statement(s) to the effect of

Subpopulation(s)

Adults (≥ 18 years) (EMA 2012)

Quantity(ies)

Symptoms of stress and cognitive function

Standardized extract:
144-680 mg extract per day, not to exceed 200 mg per single dose (EMA 2012; Darbinyan et al. 2007; Pizzorno and Murray 2006)

Potency:

  • 0.8-3% salidroside (Olsson et al. 2009; AU TGA 2008; Winston and Maimes 2007; Pizzorno and Murray 2006; Brown et al. 2002).
  • 1-6% rosavins (Olsson et al. 2009; AU TGA 2008; Winston and Maimes 2007; Pizzorno and Murray 2006; Brown et al. 2002).

Tincture:
1.2-1.8 g dried root/rhizome, per day [1:4; 4.8-7.2 ml] (Winston and Maimes 2007)

Symptoms of stress

Dry non-standardized extract:
144-400 mg dry extract, per day, not to exceed 200 mg per single dose [1.5-5:1, 67-70% ethanol v/v] (EMEA 2012).

Antioxidant

Standardized extract:
Up to 600 mg extract per day, not to exceed 200 mg per single dose (EMA 2012; Pizzorno and Murray 2006).

Potency:

  • 0.8-3% salidroside (Olsson et al. 2009; AU TGA 2008; Winston and Maimes 2007; Pizzorno and Murray 2006; Brown et al. 2002).
  • 1-6% rosavins (Olsson et al. 2009; AU TGA 2008; Winston and Maimes 2007; Pizzorno and Murray 2006; Brown et al. 2002).

Dry non-standardized extract:
Up to 400 mg dry extract, per day, not to exceed 200 mg per single dose [1.5-5:1, 67-70% ethanol v/v] (EMEA 2012).

Tincture:
Up to 1.8 g dried root/rhizome, per day (1:4; up to 7.2 ml) (Winston and Maimes 2007)

Directions for use

Not to be taken immediately before bedtime (Iovieno et al. 2011; Pizzorno and Murray 2006; Kelly 2001).

Duration of use

Statement(s) to the effect of

No statement required.

Risk information

Statement(s) to the effect of

Caution(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 prior to use (EMA 2012).
  • If you are taking antidepressant medication, consult a health care practitioner prior to use (Iovieno et al. 2011; Olsson et al. 2009; Brown et al. 2002).
  • If you are taking hormone replacement therapy (HRT) or birth control pills, consult a health care practitioner prior to use (HC 2013; Brown et al. 2002).

Contraindication(s)

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

Known adverse reaction(s)

If you experience irritability or insomnia, discontinue use (Pizzorno and Murray 2006; Kelly 2001).

Non-medicinal ingredients

Must be chosen from the current NNHPD Natural Health Products Ingredients Database (NHPID ) and must meet the limitations outlined in the database.

Storage conditions

Statement(s) to the effect of

No statement required.

Specifications

References cited

References reviewed

  • 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.Next link will take you to another Web site Final Updates and Additions for Herb Contraindications and Drug Interactions, 3rd edition. Sandy (OR): Eclectic Medical Publications. [Last update 2010 July 13; Accessed 2011 June 23].
  • 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.
  • ITIS Regional 2011: Orrell T, custodian.Next link will take you to another Web site ITIS Regional: The Integrated Taxonomic Information System (version Apr 2011). In: Bisby F, Roskov Y, Culham A, Orrell T, Nicolson D, Paglinawan L, Bailly N, Appeltans W, Kirk P, Bourgoin T, Baillargeon G, Ouvrard D, editors. Species 2000 & ITIS Catalogue of Life, 2012 Annual Checklist. DVD; Reading (GB): Species 2000; 2012. [Rhodiola rosea L. (accepted name), Sedum rosea (L.) Scop. (synonym); Accessed 2012 November 30]
  • 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.