Trial Evaluating Devil's Claw for the Treatment of Hip and Knee Osteoarthritis
Osteoarthritis, Knee, Osteoarthritis, Hip
About this trial
This is an interventional treatment trial for Osteoarthritis, Knee focused on measuring double blind randomised controlled trial, phase II, Devil's Claw, osteoarthritis of the knee, osteoarthritis of the hip
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
Sites / Locations
- Wellcome Trust Clinical Research Facility, Southampton General Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
Experimental
Experimental
Placebo Comparator
240mg Devil claw
960mg Devil Claw
1920 mg Devil claw
Placebo
Sub clinical dose if the 3 doses employed
Active dose
Active dose
Comparator for all active intervention arms