Contact information
Type
Scientific
Primary contact
Dr Sarah Brien
ORCID ID
Contact details
Complementary Medicine Research Unit
University of Southampton
Aldermoor Health Centre
Aldermoor Close
Southampton
SO16 5ST
United Kingdom
+44 (0)23 8024 1069
sbb@soton.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
NCT00295490
Protocol/serial number
Version 20
Study information
Scientific title
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
Acronym
Study hypothesis
1. Devil's Claw has anti-inflammatory properties (as assessed by the reduction in pain, stiffness and disability aspects on the Western Ontario and McMaster Universities Arthritis Index [WOMAC]) in chronic osteoarthritis (OA) of the knee and/or hip after 16 weeks of treatment, as compared to placebo.
2. A dose response effect exists in the treatment of osteoarthritis of the knee/hip by Devil's Claw.
Ethics approval
Southampton and South West Hampshire, Local Research Ethics Committees, approval: 14/04/2004, ref: LREC 049/04/t
Study design
Randomised double-blind placebo-controlled dose-ranging two-centre study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Osteoarthritis of knee and/or hip
Intervention
Patients randomised to one of four groups:
1. Placebo medication
2. Devil's Claw (240 mg/d extract, equivalent dose of 2.4 - 4.8 mg/d)
3. Devil's Claw (960 mg/d extract, equivalent dose of 9.6 - 19.2 mg/d)
4. Devil's Claw (1920 mg/d extract, equivalent dose of 19.2 - 40.4 mg/d)
Intervention type
Drug
Phase
Not Applicable
Drug names
Devil's Claw (Harpagophytum procumbens)
Primary outcome measure
Reduction in WOMAC total score from baseline to week 16.
Secondary outcome measures
1. Secondary efficacy analysis
2. Change in WOMAC subscales (pain, stiffness, disability) from baseline to end of treatment at week 16
3. Quality of Life assessments (Short Form health survey [SF-36])
4. Changes in the subject's well-being
5. Changes in subject's overall global assessment
6. Changes in attitudes and health beliefs to Complementary/Alternative Medicine (CAM)
7. Group differences between adverse event reporting
Overall trial start date
12/12/2004
Overall trial end date
30/09/2008
Reason abandoned (if study stopped)
Lack of funding/sponsorship
Eligibility
Participant inclusion criteria
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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
264
Participant exclusion criteria
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
Recruitment start date
12/12/2004
Recruitment end date
30/09/2008
Locations
Countries of recruitment
United Kingdom
Trial participating centre
University of Southampton
Southampton
SO16 5ST
United Kingdom
Sponsor information
Organisation
University of Southampton (UK)
Sponsor details
University Road
Highfield
Southampton
SO17 1BJ
United Kingdom
+44 (0)23 8059 8672
info@rso.soton.ac.uk
Sponsor type
University/education
Website
Funders
Funder type
Research organisation
Funder name
Southampton Complementary Medicine Research Trust (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
University of Southampton (UK)
Alternative name(s)
Funding Body Type
private sector organisation
Funding Body Subtype
Universities (academic only)
Location
United Kingdom
Funder name
Pascoe Pharmazeutische Praparate GmbH (Germany)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
See https://clinicaltrials.gov/ct2/show/results/NCT00295490