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

NCT00295490 | Terminated Phase 2 Results

• 1 other identifier: devilclaw1
• Study Type: interventional
• Target: 67
• Locations: 1 country
• Sites: 1

Brief 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:

• 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

Keywords

double blind randomised controlled trial; phase II; Devil's Claw; osteoarthritis of the knee; osteoarthritis of the hip

Outcome Measures

Primary Outcomes (1)

• Western Ontario and Mc Master University OA Index (WOMAC)

  WOMAC is a disease specific outcome measure for osteoarthritis. It has three subscales assessing pain (5 questions), stiffness (2 questions) and function (15 questions). together the subscales give an overall total score ranging from 0 (worst) to 100 (best; an increase in total score indicates an improvement in health. THe outcome was measured at baseline, week 8 and week 16. In this study the primary outcome was the reduction in WOMAC total score from baseline to the end of treatment at week 16.

  Baseline, week 8 and week 16

Secondary Outcomes (7)

• Pain Subscale on Western Ontario and Mc Master University OA Index

  Baseline, week 8 and week 16

• Disability Subscale on The Western Ontario and Mc Master University OA Index

  baseline, 8 and 16 weeks

• Stiffness Subscale on the The Western Ontario and Mc Master University OA Index

  Baseline, week 8 and week 16

• Short Form-36 (SF-36)

  Baseline, week 8 and week 16

• Patient Global Assessment

  Baseline, week 8 and week 16

Study Arms (4)

240mg Devil claw

EXPERIMENTAL

Sub clinical dose if the 3 doses employed

Drug: Devil Claw

960mg Devil Claw

EXPERIMENTAL

Active dose

Drug: Devil Claw

1920 mg Devil claw

EXPERIMENTAL

Active dose

Drug: Devil Claw

Placebo

PLACEBO COMPARATOR

Comparator for all active intervention arms

Drug: Placebo

Interventions

Devil Claw DRUG

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

Also known as: Harpagophytum procumbens

1920 mg Devil claw; 240mg Devil claw; 960mg Devil Claw

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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):
• knee pain on most days of the previous month
• morning stiffness of less than 30 minutes duration
• "stiffness" in resting the joint and and are aged over 40 years
• 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):
• hip pain on most days of the previous month and at least two of the following 3 features:
• ESR \< 20mm/hour
• Radiographic femoral or acetabular osteophytes
• Radiographic joint space narrowing (superior, axial and/or medial)
• And are aged over 45 years of age
• The diagnosis of osteoarthritis will be confirmed by X-ray. Only patients who have grade 2 to 4 of the Kellgren and Lawrence scale will be recruited. (The Kellgren and Lawrence scale ranges from grade 0 to grade 4 where grades 0 and 1 represent doubtful osteoarthritic changes and therefore a doubtful diagnosis.)
• Patients who have been on stable medication (conventional or complementary, including nutritional medicine) for the past three months, but are still getting symptoms (incomplete responders)
• Only those patients who record baseline pain scores on the WOMAC scale of at least 20 mm on the VAS for a minimum of 6 out of 7 days monitored during the period from Clinic Visit 1 (screening) and Clinic Visit 2 (baseline)
• Ability to comply with the requirements of the study and to give informed consent
• For women of child-bearing potential: negative pregnancy test

You may not qualify if:

• Participation in an investigational trial within 30 days prior to enrollment
• Previous treatment with Devil' s Claw within 90 days prior to enrollment
• Patients awaiting a replacement knee or hip joint
• Patients with other conditions that cause pain
• Patients with congenital dislocation of the hip
• Patients who have had operations on their hip due to previous trauma
• Patients with severe co-morbidities - including severe cardiac or pulmonary disease and cancer
• Dementia, psychoses, or other significant impairment of mental status that would prohibit sufficient comprehension, provision of informed consent and to allow undertaking of the necessary self-care or toxicity reporting
• Patients taking corticosteroid medication
• Known allergies against any of the ingredients of the treatments
• Patients who would be unable to complete the self assessment forms, or to attend for X-ray and clinical examination
• Patients with other known rheumatic disease such as rheumatoid arthritis
• Patients with the diagnosis gout
• Patients who report a red or hot swollen joint (which is unlikely to be due to OA), and would require further rheumatological assessment
• Patients with conditions known to be contraindicated to the study medication i.e. patients with gastric or duodenal ulcers; gallstones; patients taking drugs for arrhythmias; patients with heart failure

Sponsors & Collaborators

• University of Southampton: lead
• Pascoe Pharmazeutische Praeparate GmbH: collaborator

Study Sites (1)

Wellcome Trust Clinical Research Facility, Southampton General Hospital

Southampton, Hants, SO16 6YD, United Kingdom

Location

MeSH Terms

Conditions

Osteoarthritis, Knee; Osteoarthritis, Hip

Interventions

Harpagophytum extract LI 174

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Results Point of Contact

• Title: Dr Sarah Brien
• Organization: University of Southampton

sbb@southampton.ac.uk

07870642667

Study Officials

• George Lewith, MA MD FRCP

  University of Southampton

  PRINCIPAL INVESTIGATOR

• Sarah Brien, Bsc Msc PhD

  University of Southampton

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Research Fellow

Study Record Dates

• First Submitted: February 21, 2006
• First Posted: February 23, 2006
• Study Start: December 1, 2004
• Primary Completion: November 1, 2007
• Study Completion: June 1, 2008
• Last Updated: September 12, 2011
• Results First Posted: September 9, 2011

Record last verified: 2011-09

Locations

GB (1)