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 (NCT)	NCT00295490
Protocol serial number	Version 20
Sponsor	University of Southampton (UK)
Funders	Southampton Complementary Medicine Research Trust (UK), University of Southampton (UK), Pascoe Pharmazeutische Praparate GmbH (Germany)

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

Primary study design	Interventional
Study design	Randomised double-blind placebo-controlled dose-ranging two-centre study
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
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
Study objectives	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(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) studied	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 / device / biological / vaccine name(s)	Devil's Claw (Harpagophytum procumbens)
Primary outcome measure(s)	Reduction in WOMAC total score from baseline to week 16.
Key secondary outcome measure(s)	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
Completion date	30/09/2008
Reason abandoned (if study stopped)	Lack of funding/sponsorship

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	264
Key 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
Key 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
Date of first enrolment	12/12/2004
Date of final enrolment	30/09/2008

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

University of Southampton

Southampton
SO16 5ST
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not 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
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

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.