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

ISRCTN ISRCTN57843703
DOI https://doi.org/10.1186/ISRCTN57843703
ClinicalTrials.gov number NCT00295490
Secondary identifying numbers Version 20
Submission date
13/11/2006
Registration date
13/12/2006
Last edited
05/08/2021
Recruitment status
Stopped
Overall study status
Stopped
Condition category
Musculoskeletal Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Sarah Brien
Scientific

Complementary Medicine Research Unit
University of Southampton
Aldermoor Health Centre
Aldermoor Close
Southampton
SO16 5ST
United Kingdom

Phone +44 (0)23 8024 1069
Email sbb@soton.ac.uk

Study information

Study designRandomised double-blind placebo-controlled dose-ranging two-centre study
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleA 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
Study objectives1. 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(s)Southampton and South West Hampshire, Local Research Ethics Committees, approval: 14/04/2004, ref: LREC 049/04/t
Health condition(s) or problem(s) studiedOsteoarthritis of knee and/or hip
InterventionPatients 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 typeDrug
Pharmaceutical study type(s)
PhaseNot Applicable
Drug / device / biological / vaccine name(s)Devil's Claw (Harpagophytum procumbens)
Primary outcome measureReduction in WOMAC total score from baseline to week 16.
Secondary outcome measures1. 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 study start date12/12/2004
Completion date30/09/2008
Reason abandoned (if study stopped)Lack of funding/sponsorship

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants264
Key inclusion criteria1. 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
Key exclusion criteria1. 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
Date of first enrolment12/12/2004
Date of final enrolment30/09/2008

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

University of Southampton
Southampton
SO16 5ST
United Kingdom

Sponsor information

University of Southampton (UK)
University/education

University Road
Highfield
Southampton
SO17 1BJ
England
United Kingdom

Phone +44 (0)23 8059 8672
Email info@rso.soton.ac.uk
Website http://www.soton.ac.uk/
ROR logo "ROR" https://ror.org/01ryk1543

Funders

Funder type

Research organisation

Southampton Complementary Medicine Research Trust (UK)

No information available

University of Southampton (UK)
Government organisation / Universities (academic only)
Alternative name(s)
University of Southampton UK
Location
United Kingdom
Pascoe Pharmazeutische Praparate GmbH (Germany)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Basic results 09/09/2011 No No

Editorial Notes

05/08/2021: Internal review.
20/07/2021: Internal review.
21/03/2016: added link to results - basic reporting.

Please note that this trial was stopped on 04/06/2007 due to lack of funding.