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Devil's Claw - HARPAGOPHYTUM

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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

August 16, 2017

Proper name(s)

  • Harpagophytum procumbens (Burch.) DC. ex Meisn. (Pedaliaceae) (USDA 2017)
  • Harpagophytum zeyheri Decne. (Pedaliaceae) (USDA 2017)

Common name(s)

Devil's claw (McGuffin et al. 2000)

Source material(s)

Secondary root tubers (ESCOP 2003; Blumenthal et al. 2000; Bradley 1992)

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)

  • (Traditionally) used in Herbal Medicine as a bitter to help stimulate appetite (EMA 2016; ESCOP 2003; Blumenthal et al. 2000; Bradley 1992).
  • (Traditionally) used in Herbal Medicine to help relieve digestive disturbances such as dyspepsia (EMA 2016; ESCOP 2003; Blumenthal et al. 2000; Bradley 1992).
  • Used in Herbal Medicine to help relieve joint pain associated with osteoarthritis (EMA 2016; Mills and Bone 2005; ESCOP 2003; Hoffmann 2003).

Dose(s)

Subpopulation(s):

Adults (≥ 18 years)

Quantity(ies):

Preparation: Dry, powder, dry extract, liquid extract, fluid extract, tincture, decoction, infusion

For stimulation of appetite:
0.6 - 1.5 g dried secondary root tubers, per day (EMA 2016; Blumenthal et al. 2000; Bradley 1992)

For relief of digestive disturbances:
0.6 - 4.5 g dried secondary root tubers, per day (EMA 2016; Blumenthal et al. 2000; Bradley 1992)

For the relief of joint pain associated with osteoarthritis:
0.6 - 7.5 g dried secondary root tubers, per day (EMA 2016; Mills and Bone 2005; ESCOP 2003; Hoffmann 2003; Bradley 1992)

See Appendix 1 for examples of appropriate dosage preparations, frequencies of use and directions for use, according to cited references. The purpose of Appendix 1 is to provide guidance to industry.

Duration of use

For the relief of joint pain associated with osteoarthritis:
Use for a minimum of 2-3 months to see beneficial effects (ESCOP 2003).

Risk information

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.

Contraindication(s)

No statement required.

Known adverse reaction(s)

No statement required.

Non-medicinal ingredients

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

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.

References cited

  • Blumenthal M, Goldberg A, Brinkmann J, editors. Herbal Medicine: Expanded Commission E Monographs. Boston (MA): Integrative Medicine Communications; 2000.
  • Bradley PR, editor. British Herbal Compendium: A Handbook of Scientific Information on Widely Used Plant Drugs, Volume 1. Bournemouth (UK): British Herbal Medicine Association; 1992.
  • EMA 2016: EMA/CHMP/627057/2015 European Union herbal monograph on Harpagophytum procumbens DC. and/or Harpagophytum zeyheri Decne., radix Final. 12 July 2016. London (GB): European Medicines Agency: Committee on Herbal Medicinal Products (CHMP). [Accessed 2017 January 5]. Available from: Next link will take you to another Web site http://www.ema.europa.eu
  • ESCOP 2003: ESCOP Monographs: The Scientific Foundation for Herbal Medicinal Products, 2nd edition. Exeter (UK): European Scientific Cooperative on Phytotherapy and Thieme.
  • Hoffmann D. Medical Herbalism. Rochester (VT): Healing Arts Press; 2003.
  • McGuffin M, Kartesz JT, Leung AY, Tucker AO, editors. Herbs of Commerce, 2nd edition. Silver Spring (MD): American Herbal Products Association; 2000
  • Mills S, Bone K. The Essential Guide to Herbal Safety. St. Louis (MO): Elsevier Churchill Livingstone; 2005.
  • USDA 2017: United States Department of Agriculture, Agricultural Research Service, National Genetic Resources Program. Germplasm Resources Information Network (GRIN). National Germplasm Resources Laboratory, Beltsville (MD). [Accessed 2017 May 29]. Available from: Next link will take you to another Web site http://www.ars-grin.gov/cgi-bin/npgs/html/tax_search.pl

References reviewed

  • Brien S, Lewith GT, McGregor G. Devil's claws ((Harpagophytum procumbens) as a treatment for osteoarthritis: A review of efficacy and safety. The Journal of Alternative and Complimentary Medicine 2006;12(10):981-993.
  • Brinker F. Online Updates and Additions to Herb Contraindications and Drug Interactions, 3rd edition. Sandy (OR): Eclectic Medical Publications; 2008. [Accessed 2008 May 9]. Available from: Next link will take you to another Web site http://www.eclecticherb.com/emp/updatesHCDI.html
  • Chantre P, Cappelaere A, Leblan D, Guedon D, Vandermander J, Fournie B. Efficacy and tolerance of Harpagophytum procumbens versus diacerhein in treatment of osteoarthritis. Phytomedicine 2000;7(3):177-83.
  • Chrubasik JE, Roufogalis BD, Chrubasik S. Evidence of effectiveness of herbal antiinflammatory drugs in the treatment of painful osteoarthritis and chronic low back pain. Phytotherapy Research: PTR 2007;21(7):675-683.
  • Chrubasik S, Chrubasik C, Kunzel O, Black A. Patient-perceived benefit during one year of treatment with Doloteffin. Phytomedicine 2007;14(6):371-376.
  • Chrubasik S, Conradt C, Black A. The quality of clinical trials with Harpagophytum procumbens. Phytomedicine 2003;10(6-7):613-623.
  • Chrubasik S, Conradt C, Roufogalis BD. Effectiveness of Harpagophytum extracts and clinical efficacy. Phytotherapy Research: PTR 2004;18(2):187-189.
  • Chrubasik S, Model A, Black A, Pollak S. A randomized double-blind pilot study comparing Doloteffin and Vioxx in the treatment of low back pain. Rheumatology 2003:42(1):141-148.
  • Chrubasik S, Thanner J, Kunzel O, Conradt C, Black A, Pollak S. Comparison of outcome measures during treatment with the proprietary Harpagophytum extract Doloteffin in patients with pain in the lower back, knee or hip. Phytomedicine 2002;9(3):181-194.
  • Gagnier JJ, vanTulder M, Berman B, Bombardier C. Herbal medicine for low back pain: a Cochrane review. Spine 2008;32(1):82-92.
  • Grant L, McBean DE, Fyfe L, Warnock AM. A review of the biological and potential actions of Harpagophytum procumbens. Phytotherapy Research: PTR 2007;21(3):199-209.
  • Gregory PJ, Sperry M, Friedman Wilson A. Dietary supplements for osteoarthritis. American Family Physician 2008;77(2):177-184.
  • Laudahn D, Walper A. Efficacy and tolerance of Harpagophytum extract LI 174 in patients with chronic non-radicular back pain. Phytotherapy Research 2001;15(7):621-4.
  • Leblan D, Chantre P, Fournié B. Harpagophytum procumbens in the treatment of knee and hip osteoarthritis. Four-month results of a prospective, multicenter, double-blind trial versus diacerhein. Joint, bone, spine : revue du rhumatisme 2000;67(5):462-7.
  • McGuffin M, Hobbs C, Upton R, Goldberg A, editors. American Herbal Products Association's Botanical Safety Handbook. Boca Raton (FL): CRC Press; 1997
  • Mills S, Bone K. Principles and Practice of Phytotherapy. Toronto (ON): Churchill Livingstone; 2000.

Appendix 1: Examples of appropriate dosage preparations, frequencies of use and directions for use

For stimulation of appetite:

Dried secondary root tuber:

1.5 g, per day (Blumenthal et al. 2000)

Decoction:

0.5 g dried secondary root tubers, 3 times per day (Blumenthal et al. 2000; Bradley 1992)

Directions for use: Place dried secondary root tubers in 150 ml of water, bring to a boil, and simmer (Blumenthal et al. 2000).

Fluidextract:

0.5 g dried equivalent, 3 times per day (1:1, 0.5 ml) (Blumenthal et al. 2000)

Tincture:

0.2 g dried equivalent, 3 times per day (1:5, 25% alcohol, 1 ml) (Bradley 1992)

For relief of digestive disturbances:

Dried secondary root tuber:

4.5 g, per day (Blumenthal et al. 2000)

Infusion:

1.5 g dried secondary root tubers, 3 times per day (Blumenthal et al. 2000)

Directions for use: Pour 300 ml of boiling water over 4.5 g dried secondary root tubers and steep for 8 hours. Drink 100 ml, 3 times per day (Blumenthal et al. 2000).

Decoction:

  • 1.5 g dried secondary root tubers, 3 times per day (Blumenthal et al. 2000)
  • 0.5 g dried secondary root tubers, 3 times per day (Bradley 1992)
  • Directions for use: Place dried secondary root tubers in 150 ml of water, bring to a boil, and simmer (Blumenthal et al. 2000).

Fluidextract:

1.5 g dried equivalent, 3 times per day (1:1, 1.5 ml) (Blumenthal et al. 2000)

Tincture:

0.2 g dried equivalent, 3 times per day (1:5, 25% alcohol, 1 ml) (Bradley 1992)

For the relief of joint pain associated with osteoarthritis:

Dried secondary root tuber:

  • 1.5-6 g, per day (Mills and Bone 2005)
  • 2-5 g, per day (ESCOP 2003)
  • 4.5 g, per day (Blumenthal et al. 2000)

Infusion:

1.5 g dried secondary root tubers, 3 times per day (Blumenthal et al. 2000)

Directions for use: Pour 300 ml of boiling water on 4.5 g dried secondary root tubers and steep for 8 hours. Drink 100 ml, 3 times per day (Blumenthal et al. 2000).

Decoction:

  • 1.5-6 g dried secondary root tubers, per day (Mills and Bone 2005)
  • 1.5 g dried secondary root tubers, 3 times per day (Blumenthal et al. 2000)
  • 1.5-2.5 g dried secondary root tubers, 3 times per day (Bradley 1992)
  • Directions for use: Place dried secondary root tubers in 150 ml of water, bring to a boil, and simmer (Blumenthal et al. 2000).

Fluidextract:

  • 1.5 g dried equivalent, 3 times per day (1:1, 1.5 ml) (Blumenthal et al. 2000)
  • 1-2 g dried equivalent, 3 times per day (1:1, 25% ethanol, 1-2 ml) (Bradley 1992)

Tincture:

0.2-0.4 g dried equivalent, 3 times per day (1:5, 40% alcohol, 1-2 ml) (Hoffmann 2003)