Harpagophyti radix

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The European Union herbal monograph adopted by the HMPC and supporting documents can be found under the 'All documents' tab.


Summary for the public

This is a summary of the scientific conclusions reached by the Committee on Herbal Medicinal Products (HMPC) on the medicinal uses of devil’s claw root. The HMPC conclusions are taken into account by EU Member States when evaluating applications for the licensing of herbal medicines containing devil’s claw root.

This summary is not intended to provide practical advice on how to use medicines containing devil’s claw root. For practical information about using devil’s claw root medicines, patients should read the package leaflet that comes with the medicine or contact their doctor or pharmacist.

What is devil’s claw root?

Devil’s claw root is the common name for the tuberous secondary root of the plants Harpagophytum procumbens DC. and Harpagophytum zeyheri Decne.

The HMPC conclusions cover devil’s claw root preparations obtained by comminuting (reducing into tiny pieces) the roots or by drying and powdering them. They also cover liquid, soft and dry extracts. Extracts are obtained by using a technique to extract compounds by putting the plant material in a solvent (such as ethanol or water) to dissolve compounds and form a liquid extract. For soft and dry extracts, the solvent is then partially or completely evaporated.

Herbal medicines containing these devil’s claw root preparations are usually available as herbal tea to be drunk and in liquid or solid forms to be taken by mouth.

Devil’s claw root preparations may also be found in combination with other herbal substances in some herbal medicines. These combinations are not covered in this summary.

What are the HMPC conclusions on its medicinal uses?

The HMPC concluded that, on the basis of its long-standing use, these devil’s claw root preparations can be used for the relief of minor joint pain. They can also be used for the relief of mild digestive disorders such as bloating or flatulence and for temporary loss of appetite.

Devil’s claw root medicines should only be used in adults. The patient should consult a doctor or a qualified healthcare practitioner if symptoms worsen during use of the medicine or if joint pain symptoms last for more than 4 weeks or digestive disorders last for more than 2 weeks.

Detailed instructions on how to take devil’s claw root medicines and who can use them can be found in the package leaflet that comes with the medicine.

What evidence supports the use of devil’s claw root medicines?

The HMPC conclusions on the use of these devil’s claw root medicines for joint pain, digestive disorders and loss of appetite are based on their ‘traditional use’. This means that, although there is insufficient evidence from clinical trials, the effectiveness of these herbal medicines is plausible and there is evidence that they have been used safely in this way for at least 30 years (including at least 15 years within the EU). Moreover, the intended use does not require medical supervision.

In its assessment, the HMPC also considered clinical studies involving the use of devil’s claw medicines for short term treatment of joint pain related to arthritis (inflammation of the joints). Although an effect in treating joint pain was observed, since the studies were inconsistent in design with the majority being non-controlled with no placebo group firm conclusions could not be drawn. Therefore, the HMPC conclusions on the use of these devil’s claw root medicines are based on their long-standing use.

For detailed information on the studies assessed by the HMPC, see the HMPC assessment report.

What are the risks associated with devil’s claw root medicines?

Side effects have been reported with devil’s claw root medicines and include stomach and gut symptoms (diarrhoea, nausea, vomiting, abdominal pain), headache, vertigo (a spinning sensation) and hypersensitivity (allergic) reactions (rash, hives and face swelling).

Further information on the risks associated with these devil’s claw root medicines, including the appropriate precautions for their safe use, can be found in the monograph under the tab ‘All documents’.

How are devil’s claw root medicines approved in the EU?

Any applications for the licensing of medicines containing devil’s claw root have to be submitted to the national authorities responsible for medicinal products, which will assess the application for the herbal medicine and take into account the scientific conclusions of the HMPC.

Information on the use and licensing of devil’s claw root medicines in EU Member States should be obtained from the relevant national authorities.

Other information about devil’s claw root medicines

Further information on the HMPC assessment of devil’s claw root medicines, including details of the Committee’s conclusions, can be found under the tab ‘All documents’.

For more information about treatment with devil’s claw root medicines, read the package leaflet that comes with the medicine or contact your doctor or pharmacist.

Name Language First published Last updated
Devil’s claw root: Summary for the public (English only) 2016-12-02  

Summary

Product details for Harpagophyti radix
Latin name of herbal substanceHarpagophyti radix
Botanical name of plantHarpagophytum procumbens DC.; Harpagophytum zeyheri Decne
English common name of herbal substanceDevil’s Claw Root
StatusF: Assessment finalised
Date added to the inventory23/11/2005
Date added to priority list23/11/2005
Outcome of European assessment

European Union herbal monograph

Additional information

Consultation

Documentation

Key documents

Name Language First published Last updated
Final European Union herbal monograph on Harpagophytum procumbens DC. and/or Harpagophytum zeyheri Decne., radix (English only) 2016-11-14  
Opinion of the HMPC on a European Union herbal monograph on Harpagophytum procumbens DC. and/or Harpagophytum zeyheri Decne., radix (English only) 2016-11-14  
Final list of references supporting the assessment of Harpagophytum procumbens DC. and/or Harpagophytum zeyheri Decne., radix (English only) 2016-11-14  
Final assessment report on Harpagophytum procumbens DC. and/or Harpagophytum zeyheri Decne., radix (English only) 2016-11-14  
Overview of comments on European Union herbal monograph on Harpagophytum procumbens DC. and /or Harpagophytum zeyheri Decne., radix (EMA/HMPC/627057/2015) (English only) 2016-11-14  
Superseded community herbal monograph on Harpagophytum procumbens DC. and/or Harpagophytum zeyheri Decne, radix (English only) 2008-11-06 2016-11-14
Superseded opinion of the Committee on Herbal Medicinal products on a community herbal monograph on Harpagophytum procumbens DC. and/or Harpagophytum zeyheri Decne, radix (English only) 2008-11-06 2016-11-14
Superseded list of references for assessment of: Harpagophyti radix Harpagophytum procumbens DC.; Harpagophytum zeyheri Decne (devil's claw root) (English only) 2009-03-12 2016-11-14
Superseded assessment report on Harpagophytum procumbens DC. and/or Harpagophytum zeyheri Decne, radix (English only) 2009-03-12 2016-11-14
Superseded overview of comments received on 'Community herbal monograph on Harpagophytum procumbens DC. and/or Harpagophytum zeyheri Decne, radix' (EMEA/HMPC/251323/2006) (English only) 2008-11-06 2016-11-14

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