A randomised, 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
- Conditions
- Osteoarthritis of knee and/or hipMusculoskeletal DiseasesArthritis
- Registration Number
- ISRCTN57843703
- Lead Sponsor
- niversity of Southampton (UK)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Stopped
- Sex
- All
- Target Recruitment
- 264
1. Patients with either a pragmatic diagnosis of:
1.1. Osteoarthritis of the knee, with no other known rheumatological condition and who report the following clinical features (based on the American College of Rheumatology [ACR] classification for knee OA1):
1.1.1. Knee pain on most days of the previous month
1.1.2. Morning stiffness of less than 30 minutes duration
1.1.3. Stiffness in resting the joint, and
1.1.4. Aged over 40 years
1.2. 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 three features:
1.2.1. Erythrocyte sedimentation rate (ESR) less than 20 mm/hour
1.2.2. Radiographic femoral or acetabular osteophytes
1.2.3. Radiographic joint space narrowing (superior, axial and/or medial), and
1.2.4. Aged over 45 years of age
The diagnosis of osteoarthritis will be confirmed by X-ray.
2. 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 zero to grade four where grades zero and one represent doubtful osteoarthritic changes and therefore a doubtful diagnosis)
3. 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)
4. Only those patients who record baseline pain scores on the WOMAC scale of at least 20 mm on the Visual Analogue Scale (VAS) for a minimum of six out of seven days monitored during the period from Clinic Visit one (screening) and Clinic Visit two (baseline)
5. Ability to comply with the requirements of the study and to give informed consent
6. For women of child-bearing potential: negative pregnancy test
1. Participation in an investigational trial within 30 days prior to enrolment
2. Previous treatment with Devil's Claw within 90 days prior to enrolment
3. Patients awaiting a replacement knee or hip joint
4. Patients with other conditions that cause pain
5. Patients with congenital dislocation of the hip
6. Patients who have had operations on their hip due to previous trauma
7. Patients with severe co-morbidities - including severe cardiac or pulmonary disease and cancer
8. 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
9. Patients taking corticosteroid medication
10. Known allergies against any of the ingredients of the treatments
11. Patients who would be unable to complete the self assessment forms, or to attend for X-ray and clinical examination
12. Patients with other known rheumatic disease such as rheumatoid arthritis
13. Patients with the diagnosis gout
14. Patients who report a red or hot swollen joint (which is unlikely to be due to OA), and would require further rheumatological assessment
15. 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
16. Patients who are pregnant, trying to become pregnant or breastfeeding
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method