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 人开始时间: 待定最近更新:
试验速览
- 阶段
- 未知
- 状态
- 尚未招募
- 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 Study
入排标准
- 年龄范围
- 35(Year) 至 69(Year)（—）
- 性别
- All
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.
- •11)Subjects who have taken physical or herbal therapies (acupuncture, depression, moxibustion, etc.) for degenerative bone disease within 2 weeks of visit.
- •12)Subjects who participate in other intervention trials within two months of visit 1 or plan to participate in other intervention trials after the after the commencement of this study.
- •13)Women who are pregnant, lactating, or planning to become pregnant within three months.
- •14)A person with mental illness or drug addiction or who is under anti-depression treatment.
- •15)A person who is sensitive or allergic to food ingredients.
- •16)A person who has trouble or difficulties participating in the trial as judged by the investigator.
研究者
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