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Sponsors and Collaborators: |
University of Southampton Southampton Complementary Medicine Research Trust PASCOE pharmazeutische Präparate GmbH |
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Information provided by: | University of Southampton |
ClinicalTrials.gov Identifier: | NCT00295490 |
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 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:
These objectives are based on the following hypotheses :
Hypotheses
Condition | Intervention | Phase |
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Osteoarthritis, Knee Osteoarthritis, Hip |
Drug: Harpagophytum procumbens (Devil's claw) |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | A Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Two- Centre Study to Evaluate the Efficacy and Safety of Devil’s Claw in the Treatment of Knee and Hip Osteoarthritis |
Estimated Enrollment: | 264 |
Study Start Date: | December 2004 |
Estimated Study Completion Date: | September 2008 |
Ages Eligible for Study: | 40 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Patients with either a pragmatic diagnosis of osteoarthritis of the knee, with no other known rheumatological condition and who report the following clinical features (based on the ACR classification for knee OA1):
osteoarthritis of the hip, with no other known rheumatological condition and who report the following clinical features (based on the ACR classification for hip OA2):
Exclusion Criteria:
Contact: Sarah Brien, Bsc Msc PhD | 02380241069 | sbb@soton.ac.uk |
Contact: Jane Barnett, Bsc Msc | 02380241049 | J.A.Barnett@soton.ac.uk |
United Kingdom, Hants | |
Wellcome Trust Clinical Research Facility, Southampton General Hospital | Recruiting |
southampton, Hants, United Kingdom, SO16 6YD | |
Principal Investigator: Sarah Brien, Bsc Msc PhD |
Principal Investigator: | George Lewith, MA MD FRCP MRCGP | University of Southampton |
Principal Investigator: | Sarah Brien, Bsc Msc PhD | University of Southampton |
Study ID Numbers: | devilclaw1 |
Study First Received: | February 21, 2006 |
Last Updated: | April 23, 2007 |
ClinicalTrials.gov Identifier: | NCT00295490 |
Health Authority: | United Kingdom: Department of Health |
double blind randomised controlled trial phase II Devil’s Claw osteoarthritis of the knee osteoarthritis of the hip |
Osteoarthritis, Knee Musculoskeletal Diseases Osteoarthritis Joint Diseases |
Arthritis Rheumatic Diseases Osteoarthritis, Hip |