KCT0003968尚未招募未知
A 8-week, investigator-initiated clinical trial to evaluate the efficacy and safety of gold Mae-sun therapy on patients with degenerative knee osteoarthritis
Wonkwang University, Gwangju Medical Center0 个研究点目标入组 30 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
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
- 50(Year) 至 80(Year)（—）
- 性别
- All
入选标准
- •1. 50 to 80 years old
- •2. A person who diagnosed primary osteoarthritis on American college of rheumatology criteria
- •a. A person who currently has pain in on or both knees
- •b. Person who over at least three of the following sis criteria
- •1) Age: 50 to 80 years old
- •2) A person who knee joints are not more than 30 minutes stiffness in the morning
- •3) Crepitus of knee joint
- •4) Bony tenderness
- •5) Bony enlargement
- •6) No palpable warmth
- •3. A person who 100mm VAS(visual analogue scale) pain is more than average 40 points per day (for a week)
- •4. Those who have heard the full explanation of this human application test, fully understand it, and have voluntarily decided to participate and have agreed in writing to comply with the precautions.
排除标准
- •1. A person who had a steriod injecionin the joint cavity(within the last 3 months).
- •2. A person who received an viscosupplement(hylan, sodium hyaluronate, hyalulonan etc.) injection in the joint cavity(within the last 6 months).
- •3. A person who eliminated to expel joint fluid from joint cavity(within the last 6 months).
- •4. Those with past history or current history such as inflammoatory disease, tumor, rheumarthritis, autoimmune dieases and degeneratio of knee(serious valgus, varus ets.)
- •5. those who particiapate in other osteoarthritis clinical studies(3 months before screening)
- •6. Subjects with connective tissue(collagen) disease
- •7. Subjects with multiple sclerosis disease
- •8. A person taking immunosuppressant, corticosteroid, cyclosporin
- •9. A person who experienced to antisychotics treatment(within 3 months before screening test)
- •10. those who have a history of drug or alcohol abuse
- •11. Female patients who are pregnant or breastfeeding
- •12. Diagnostic test A person who is determined by the Principal inspector to be ineligible for research due to medical examination results or other reasons
研究者
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