KCT0004925
尚未招募
未知
A 12 week, randomized, double-blind, placebo-controlled clinical trial for the evaluation of the efficacy and safety of HT083 on mild Osteoarthritis
The Catholic University of Korea, Uijeongbu St. Mary’s Hospital0 个研究点目标入组 100 人待定
概览
- 阶段
- 未知
- 干预措施
- 未指定
- 疾病 / 适应症
- 未指定
- 发起方
- The Catholic University of Korea, Uijeongbu St. Mary’s Hospital
- 入组人数
- 100
- 状态
- 尚未招募
- 最后更新
- 6年前
概览
简要总结
暂无简介。
研究者
入排标准
入选标准
- •1\)Male or female adults aged between 35 and 70 years of age.
- •2\)Subjects with a visual analog scale (VAS) score of more than 30 mm
- •3\)Subjects with Kellgren and Lawrence grade I or II determined by X\-ray
- •4\)Subjects who agree to participate in the clinical trial voluntarily and sign the informed consent form (ICF)
排除标准
- •1\)A person who has arthritis other than osteoarthritis.
- •2\)A person whose joint space is less than 2 mm.
- •3\)A person with moderate osteoarthritis accompanied by osteoporosis, irregular joint surface, subchondral osteocytes of the joint and so on.
- •4\)Those who have clinically significant cardiovascular, autoimmune, infectious or neoplastic diseases in addition to joint pain.
- •5\)Hypertension patients with more than 160mmHg systolic blood pressure or more than 100mmHg diastolic blood pressure.
- •6\)Diabetic patients whose fasting blood glucose level is above 180 mg / dl).
- •7\)TSH lower than 0\.1µIU/ml or upper than 10 µIU/ml
- •8\)A person who has AST (GOT) or ALT (GPT) level 3 times higher than the normal upper limit.
- •9\)Abnormal creatinine level (more than twice the normal upper limit).
- •10\)Those who have taken arthritis medicines or dietary supplements for joint health within 2 weeks of visit.
结局指标
主要结局
未指定
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