ISRCTN88583133已完成未知
A Randomized, Double-blind Placebo-controlled, Single-joint Study to Assess the Effect of Choline-Stabilized Orthosilicic Acid (ch-OSA) on symptoms of Knee Osteoarthritis
Bio Minerals NV0 个研究点目标入组 166 人开始时间: 2015年10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
- 166
研究概览
简要总结
2017 results in https://pubmed.ncbi.nlm.nih.gov/28056936/ (added 10/12/2020)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Aged between 50 and 75 years
- •2. Females must be either postmenopausal, surgically sterile or use an approved form of birth control.
- •3. OA of the knee as confirmed by radiography (weight-bearing, antero-posterior 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)
- •4. Primary (idiopathic) OA of one or both knees for at least 12 weeks prior to administration of study dietary supplement based on the American College of Rheumatology criteria. In addition to pain in the knee, at least 3 of the following 6 characteristics has to be present:
- •4.1. Over 50 years of age
- •4.2. Less than 30 minutes of morning stiffness
- •4.3. Crepitus on active motion
- •4.4. Bony tenderness
- •4.5. Bony enlargement
- •4.6. No palpable warmth of synovium
- •5. 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.
- •6. Pain in target knee due to OA during load (e.g. standing, weight-bearing) or movement must exceed pain from other joints, or pain experienced due to other non-articular medical conditions
- •7. Subject must continue his/her normal physical activities during the study i.e. there should be not change in physical activity after the screening visit
- •8. WOMAC functional sub-scale score greater than 0
排除标准
- •1. Subject 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, pseudo gout or sepsis
- •8. Secondary OA of the target knee including Paget’s disease of bone, articular fracture, major dysplasias or congenital abnormality, ochronosis, acromegaly, hemachromatosis, Wilson’s disease and primary osteochondromatosis
- •9. Significant injury to the target joint within 6 months of trial start
- •10. Disease of spine or lower extremity joints of sufficient degree to affect assessment of the target joint
- •11. New physical activity i.e. physical activity which was not present prior to the screening visit
- •12. Recent or current alcohol abuse (consumption levels of more than 28 units per week) and drug abuse
- •13. Arthroplasty in the target knee and joint surgery of the target knee within 2 years prior to the start of the study
- •14. Subjects who have received chondrocyte transplants in any lower extremity joint
- •15. Subjects who belong in a high risk group for HIV
- •16. Clinically significant medical abnormalities which would make the subject unsuitable for the study as judged by the investigator
- •17. Subject has renal failure, documented history of stroke, myocardial infarct or cancer
- •18. Concomitant and previous medication:
- •18.1. 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
- •18.2. Less than 3 months between the treatment with a slow acting drug for symptom relief and start of the study
- •18.3. Subjects who have used previous topical and/or systemic treatment with NSAID’s or analgetica, different from paracetamol, such as ibuprofen, diclofenac, acetyl salicylic acid, piroxicam and indomethacin in a 14 days period prior to the start of the study
- •18.4. Subjects 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
- •18.5. Subjects who have used compounds containing agents claiming to possess disease/structure modifying properties (e.g. diacerhein) in a 28 days period prior to start of the study
- •18.6. Subjects who received intra-articular injections in a 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
- •18.7. Concomitant and previous supplementation with food supplements containing horsetail extract, bamboo extract, silicic acid or silanol derivatives withi
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