None listed
Conditions
Brief summary
The purpose of the study is to determin the safety, efficacy and potential modes of action of BSP-201 in adults with osteoarthritis of the knees and/or hips. It will be a randomised, double-blind (both subjects and investigators are blinded), placebo-controlled, parallel study.
Interventions
2250mg/day Sheabutter extract (BSP-201) capsules over a 15 week period
Sponsors
BSP Pharma A/S (this is the full name of company)
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
X-ray and clinical evidence of osteoarthritis of the knees and/or hipsTotal WOMAC score of 30 or more at baseline.Good general health.Adequate venous access.
Exclusion criteria
A history of trauma with the affected joint.Gout, rheumatoid arthritis or other inflammatory joint condition.Allergy to Sheabutter.Use of anti-arthritic agents before baseline (3 weeks for anti-inflammatory agents inlcuding aspirin, 4 weeks for corticosteroids and 6 weeks for complementary medicines).Liver function tests greater than 2 times the upper limit of normal at baseline.History of alcohol or substance abuse.Females who are pregnant, lactating, planning to become pregnant or unwilling to use birth control during the study.Participants unwilling or unable to comply with the study protocol.Participants who have participated another clincial trial in the last 30 days.History of serious or unstable cardiac, renal, hypertensive, pulmonary, endocrine, neurologic or neuropsychiatric disorder.
Outcome results
None listed