Trial Evaluating Devil's Claw for the Treatment of Hip and Knee Osteoarthritis
Status:
Terminated
Trial end date:
2008-06-01
Target enrollment:
Participant gender:
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.