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)0 个研究点目标入组 128 人开始时间: 2006年5月8日最近更新: 2020年1月13日

适应症

试验速览

暂无简介。

•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.

•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.

发起方

BSP Pharma A/S (this is the full name of company)