CTRI/2020/10/028725已完成未知
A randomized, double-blind, placebo-controlled clinical trial to evaluate the efficacy and tolerability of 5-LOXIN in subjects with mild osteoarthritis of knee
Ju Yeong NS Co Ltd0 个研究点目标入组 100 人开始时间: 待定最近更新:
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 100
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
入选标准
- •Subjects who signed an informed consent form voluntarily to participate in the study
- •Both gender, between 40 and 70 years.
- •VAS (Visual Analogue Scale) 30 to 70 mm.
- •K/L grade of knee I, II on X-ray
排除标准
- •Subject with other than degenerative arthritis [osteoarthritis] determined by investigator.
- •Subject whose joint space is decreased by less than 2mm.
- •Subject with severe arthritis accompanied by bone spurs around joint, irregular articular surface, chondrogenesis, and bone cyst.
- •Subject with clinically significant cardiovascular, immunization, infective, or neoplastic diseases.
- •Subject being treated for gastritis or gastric ulcer.
- •Subject with uncontrolled hypertension (over 140/95mmHg measured at screening).
- •Subject with uncontrolled diabetes mellitus (more than 125mg/dl of fasting glucose measured at screening).
- •Subject with AST (GOT) and ALT (GPT) ââ?°Â¥ 3 times the upper limit of normal.
- •Subject with Creatinine ââ?°Â¥ 2 times the upper limit of normal.
- •Subject who is pregnant or planning to become pregnant within 3 months or who is lactating.
- •Subjects took intra articular injections including hyaluronic acid or subjects had corticosteroid therapy in last 3 months.
- •Subject administered medication including NSAIDs or health functional foods related to arthritis within 30 days of screening.
- •Subject with mental disorders such as schizophrenia, depressive disorder and drug intoxication /Subject with severe mental illness.
- •Subject planning to participate in the other clinical trial or subject participated in any clinical trial within 3 month.
- •Inappropriate subject decided by the investigator.
- •Subject who has septic arthritis, inflammatory joint disease, palindromic pseudogout, paget disease, joint fracture, ochronosis, acromegaly, hematochromatosis, Wilson disease, primary Osteochondrosis, genetic disorder (ex, hyperkinesia), collagen abnormality.
研究者
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