Clinical trial: Trial Evaluating Devil's Claw for the Treatment of Hip and Knee Osteoarthritis (NCT00295490)

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
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 40 Years old.


Patient description (medical language): A 66-year-old woman comes to the office due to joint pain in the hands and periodic morning stiffness that lasts less than 15 minutes.  The pain is moderately severe and worsens with daily activity. The patient used Tylenol with minimal relief.  Past medical history is notable for hypertension and hypercholesteremia.  Physical examination shows firm nodules over the distal interphalangeal joints, bilaterally. The patient has pain in her knees as well. The knees are stiff in the morning for less than 30 minutes and become worse with climbing stairs. She has some sensation of bone friction during activity. X-ray shows narrowing of the joint space, subchondral bone sclerosis and osteophyte formation along the joints.

Patient description (patient's own words): I'm a 66-year-old woman and I went to my doctor's office because of a bloody joint pain in my hands that has been lasting for a while. The pain comes and go in the morning usually. I feel like a stiffness that last less than 15 minutes. The pain is moderately severe but it gets worse when I'm using my hands. I used Tylenol which helped a little. Apart from that, I suffer from hypertension and high cholesterol. The doctor made me notice that I have bumps around both of my hand joints. I also suffer from my knees and they are also stiff in the morning for around 30 min. It's even worse when I climb up the stairs! I also feel like my bones are rubbing against each other when I'm moving. The X-ray showed that I have narrow joint space, I have sclerosis, and abnormal growths of bone along my joints.

Does the patient match the trial criteria? Entailment