CTRI/2020/10/028725已完成不适用
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 Ltd2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2020年10月30日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Improvement from baseline to the end of the supplementation period in VAS (Visual Analogue Scale)
研究概览
简要总结
This is a randomized, double-blind, placebo-controlled 2 arm clinical study to evaluate the efficacy and tolerability of 5-LOXIN in subjects with mild osteoarthritis of knee.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 40.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
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) ≥ 3 times the upper limit of normal.
- •Subject with Creatinine ≥ 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.
结局指标
主要结局
Improvement from baseline to the end of the supplementation period in VAS (Visual Analogue Scale)
时间窗: Screening, Day 14, Day 28 and Day 56
次要结局
- Change from baseline to the end of the study in WOMAC
- Change from baseline to the end of the study in Bio-markers(Day 1 and Day 56)
- Change from baseline to the end of the study in Improvement in osteoarthritis by Subject Global Assessment (SGA) and Physician Global Assessment (PGA)(Day 14, Day 28 and Day 56)
研究者
研究点 (2)
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