KCT0005308招募中未知
A Multi-center, Randomized, Double-blind, Active-controlled Clinical Trial to Evaluate the Efficacy and Safety of Conjuran®(Polynucleotide) Compared to Hyruan Plus®(Sodium hyaluronate), Synovian®(BDDE cross-linked sodium hyaluronate) in Patients with Knee Osteoarthritis
The Catholic University of Korea, Seoul St. Mary's Hospital0 个研究点目标入组 90 人开始时间: 待定最近更新:
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 发起方
- 入组人数
- 90
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 40(Year) 至 o Limit（—）
- 性别
- All
入选标准
- •(1) Adult over 40 years old
- •(2) Knee osteoarthritis patients of Grade I-III according to Kellgren-Lawrence grading scale (K-L grade)
- •(3) 100mm VAS (visual analogue score) for pain during weight load more than 40mm in at least one joint of the bilateral knee joint
- •(4) Patients who voluntarily submit written consent to participate in clinical trials and are expected to comply with the testing procedures
排除标准
- •(1) Patients with severe trauma or fracture history of the indicator knee joint that may affect clinical trials
- •(2) Those with rheumatoid arthritis or other metabolic arthritis
- •(3) Patients with an infection (osteomyelitis, etc.) around the indicator knee joint
- •(4) Those who have joint replacement surgery or procedures in the indicator knee joint
- •(5) Those who have hip joint osteoarthritis in ipsilateral side of the indicator knee joint
- •(6) Patients with other diseases that may affect the safety and effectiveness evaluation of the indicator knee joint (e.g., patients with severe pain, such as complex site pain syndrome, Paget's disease, intervertebral disc prolapse, and gout, recurrent pseudogout)
- •[However, it is possible to register in the case of degenerative diseases such as spinal stenosis, which are judged by the investigator to not affect the evaluation of the index knee joint.]
- •(7) Patients who received intraarticular hyaluronic acid injections within the previous three months of baseline (before study) or those who received intra-joint steroid injections within one month
- •(8) Those who received anticoagulants or platelet aggregation inhibitors within one week prior to the baseline (before study)
- •Injectable anticoagulants: low molecular weight and non-fractional heparin injections, etc.
- •Oral anticoagulants: Warfarin, Dabigatran, Rivaroxaban, etc.
- •Oral antiplatelets: aspirin, clopidogrel, prasugrel, ticagreler, etc.
- •[However, if you take a low dose of aspirin (300mg / day or less) for the purpose of treatment and management of cardiovascular disease, registration is possible]
- •(9) Patients who received physiotherapy (including herbal therapy, thermal therapy, taping therapy, etc.) in the baseline (before study) within two weeks prior to the indicator knee joint
研究者
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