Trial Evaluating Devil's Claw for the Treatment of Hip and Knee Osteoarthritis

Summary

Osteoarthritis of both the knee and hip joints are common conditions; knee osteoarthritis affects 6% of adults over 30 years of age and osteoarthritis of the hip affects between 3% and 6% of the Caucasian population. Both forms of osteoarthritis are associated with disability. Conventional treatment (analgesics and the use non-steroidal anti-inflammatory, NSAIDS) is prophylactic, aimed at decreasing pain and improving function. However long term use of NSAIDS is associated with a high incidence of adverse events (gastrointestinal tract symptoms). A safer alternative treatment would therefore be beneficial.

Both anecdotal evidence and recent studies have implicated the potential of the herbal remedy Devil's Claw (Harpagophytum procumbens) for the treatment of painful, chronic arthritic type conditions (Ernst and Chrubasik, 2000). Devil's Claw is an extract obtained from the root of the Harpagophytum procumbens plant, a member of the sesame family found in the Kalahari region in South Africa. It has been shown that this herbal remedy has anti-inflammatory and analgesic effects (Baghdikian et al, 1997). Currently Devil's Claw is marketed for use as a supportive treatment of degenerative arthrosis, is not a Medicines Control Agency licensed product and is freely available to the general public in health food stores and pharmacies.

The objectives of this study are to assess the efficacy, optimum dosage and safety of the herbal remedy Devil's Claw (Harpagophytum) in the treatment of osteoarthritis of the knee and/or hip. The primary objective of this study is to investigate the following three principal questions:

1. To compare the efficacy of Devil's Claw with placebo in the treatment of osteoarthritis of the knee and/or hip
2. To determine the optimum dose of Devil's Claw and
3. To evaluate the safety and tolerability of three doses of Devil's Claw in the treatment of osteoarthritis of the knee/hip and to compare them to placebo There are also a number of secondary research objectives that will also be addressed (see later).

These objectives are based on the following hypotheses :

Hypotheses

* Devil's Claw has anti-inflammatory properties (as assessed by the reduction in pain, stiffness and disability aspects on the WOMAC) in chronic osteoarthritis of the knee and/or hip after 16 weeks of treatment, as compared to placebo.
* A dose response effect exists in the treatment of osteoarthritis of the knee/hip by Devil's Claw.

Conditions

• Osteoarthritis, Knee
• Osteoarthritis, Hip

Interventions

DRUG

Devil Claw

Dose ranging study so will elucidate dose Frequency is four times daily

DRUG

Placebo

Placebo has same dosing freq as for active intervention and for same time period

Sponsors & Collaborators

• Pascoe Pharmazeutische Praeparate GmbH

  collaborator INDUSTRY

• University of Southampton

  lead OTHER

Principal Investigators

• George Lewith, MA MD FRCP · University of Southampton

• Sarah Brien, Bsc Msc PhD · University of Southampton

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

40 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2004-12-31

Primary Completion

2007-11-30

Completion

2008-06-30

Countries

• United Kingdom

Study Locations