Trial Evaluating Devil's Claw for the Treatment of Hip and Knee Osteoarthritis
Condition: Osteoarthritis, Knee; Osteoarthritis, Hip
MeSH terms: Osteoarthritis; Osteoarthritis, Knee; Osteoarthritis, Hip
Intervention: Devil Claw; Placebo
Intervention description: Dose ranging study so will elucidate dose Frequency is four times daily; Placebo has same dosing freq as for active intervention and for same time period
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 67.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No
Keywords: double blind randomised controlled trial; phase II; Devil's Claw; osteoarthritis of the knee; osteoarthritis of the hip

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.
    

Eligibility criteria:

        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):

               -  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

        Exclusion Criteria:

          -  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

          -  Patients who are pregnant, trying to become pregnant or breastfeeding