ISRCTN10096951已完成未知
A randomized, double-blind placebo-controlled, single-joint study to assess the long term (9 months) effect of choline-stabilized orthosilicic acid on symptoms of knee osteoarthritis
Bio Minerals NV0 个研究点目标入组 227 人开始时间: 2020年9月15日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 227
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Provision of written informed consent
- •2. Males and females between the ages of 18 and 75 years old
- •3. Females must use an approved form of birth control or be postmenopausal or be surgically sterile
- •4. OA of the knee as confirmed by radiography (weight-bearing, anteroposterior radiograph of the target knee: Kellgren and Lawrence grade II and III) during the screening visit or by a recent radiograph (<6 months before baseline)
- •5. OA of one or both knees prior to administration of study dietary supplement based on the American College of Rheumatology criteria23:
- •5.1. Knee pain for most days of previous month
- •5.2. Osteophytes at joint margins on radiographs
- •5.3. Age >50 years
- •5.4. Crepitus on active joint motion
- •5.5. Morning stiffness lasting <30 min
- •Criteria 1 and 2 have to be present plus one of the following: 3, 4, 5
- •6. Symptomatic, target knee with OA pain intensity score on a 5-point Likert Scale of moderate (2)” or moderately severe (3)” after withdrawal of analgesic/anti-inflammatory medications. In the case that both knees have a pain score of moderate (2)” or moderately severe (3)”, the knee with the highest pain score is chosen as the target knee
- •7. Participant must continue his/her normal physical activities during the study i.e. there should be no change in physical activity after the screening visit
- •8. WOMAC functional subscale score of > 0
- •9. Physically active: Steinbrocker Class I - III
排除标准
- •1. Participant unable to understand the study procedures and/or not having given written informed consent and/or not wishing to participate in one of the subsequent therapeutic intervention protocols
- •2. Poor general health interfering with compliance or assessment
- •3. Unlikely to co-operate fully in the study
- •4. Participating in another clinical trial in the last 90 days
- •5. Pregnancy or breastfeeding
- •6. Morning stiffness >30 minutes in duration
- •7. Subjects with a swollen or warm joint thought to be secondary to gout, pseudogout or sepsis
- •8. Active rheumatoid arthritis
- •9. Paget’s disease of bone, articular fracture, major dysplasias or congenital abnormality, ochronosis, acromegaly, hemachromatosis, Wilson’s disease and primary osteochondromatosis
- •10. Significant injury to the target joint within 6 months of trial start
- •11. Disease of the spine or lower extremity joints of sufficient degree to affect the assessment of the target joint
- •12. New physical activity i.e. physical activity which was not present prior to the screening visit
- •13. Recent or current alcohol abuse (consumption levels of more than 28 units 25per week) and drug abuse
- •14. Arthroplasty in the target knee and joint surgery of the target knee within 2 years prior to the start of the study
- •15. Participants who have received chondrocyte transplants in any lower extremity joint
- •16. Participants who belong in a high-risk group for HIV
- •17. Clinically significant medical abnormalities which would make the subject unsuitable for the study as judged by the investigator
- •18. Participant has renal failure, documented history of stroke, myocardial infarct or cancer
- •19. Concomitant and previous medication:
- •19.1. Less than 28 days between the topical or systemic treatment with hyaluronic acid, glucosamine sulphate, glucosamine HCl, n-acetyl glucosamine and derivatives thereof such as chondroitin sulphate, glycosaminoglycans and the start of the study
- •19.2. Less than 3 months between the treatment with a slow-acting drug for symptom relief and the start of the study
- •19.3. Participants who have used previous topical and/or systemic treatment with NSAIDs or analgesics, different from paracetamol, such asibuprofen, diclofenac, acetyl salicylic acid, piroxicam and indomethacin in a 14 days period prior to the start of the study
- •19.4. Participants who have used medications with MMP-inhibitory properties (e.g. tetracyclines or structurally related compounds), or took oral (systemic, > 10 days duration) glucocorticoids in a 28 days period prior to start of the study
- •19.5. Participants who have used compounds containing agents claiming to possess disease/structure modifying properties (e.g. diacerhein) in a 28 days period prior to the start of the study
- •19.6. Participants who received intra-articular injections in the target knee of glucocorticoids within 3 months of the start of the study or any other injection (e.g. hyaluronic acid) within 6 months prior to the start of the study
- •19.7. Concomitant and previous supplementation with food supplements containing horsetail extract, bamboo e
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