Randomised placebo controlled trial on the safety and efficacy of BSP-201 in osteoarthritis
Randomised placebo controlled trial on the safety and efficacy to reduce pain, stiffness and physical disfunction of a Sheabutter Extract (BSP-201) in osteoarthritis
BSP Pharma A/S (this is the full name of company)
128 participants
May 5, 2006
Interventional
Conditions
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.
Eligibility
Inclusion Criteria1
- 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 Criteria1
- 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.
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Interventions
2250mg/day Sheabutter extract (BSP-201) capsules over a 15 week period
Locations(1)
View Full Details on ANZCTR
For the most up-to-date information, visit the official listing.
ACTRN12606000162516