KCT0002693已完成未知
A 8-week, randomized, double-blind, placebo-controlled, multi-center therapeutic exploratory clinical trial to evaluate the efficacy and safety of ChondroT on Knee-osteoarthritis
Dongshin University Mokpo Oriental Hospital0 个研究点目标入组 72 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
- 72
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. Subjects who are subject to clinical diagnosis of ACR Clinical Classification Criteria for Osteoarthritis of the knee
- •a. Pain in the knee
- •b. And over 3 of the following
- •1) over 50 and under 80 years of age
- •2) Less than 30 minutes of morning stiffness
- •3) Crepitus on active motion
- •4) Bony tenderness
- •5) Bony enlargement
- •6) No palpable warmth of synovium
- •2. A daily mean Pain VAS(100mm Pain visual analog scale) = 40 ,during the past 1 week (0-100)
排除标准
- •1. Subjects who have had steroids shot around his knee in three months
- •2. Subjects who have received a mucosal supplement injection (hylane, sodium hyaluronate, hyalulonan, etc.) in the joint in the last 6 months
- •3. Subjectsl who had an aspiration of synovium within the past 6 months
- •4. Oriental medicine treatment of acupuncture, moxibustion, cupping therapy, herbal medicine, etc. for the past 4 weeks
- •5. Subjects who is on a diet Health Functional Foods including glucosamine to improve joint/cartilage health
- •6. An inflammatory disease, tumor, trauma, rheumatoid arthritis, autoimmune disease, severe bowel and inner degeneration of knee joints, secondary arthritis, hip disease, or other forms of inflammatory arthritis
- •7. Subjects had operation of knee
- •8. Subjects who uses local painkillers (pas, spray, etc.) on the knee joint within 3 days of randomization.
- •9. Subects who are allergic to the base and components for clinical testing medicine.
- •10. Subjects with renal function disorder (more than twice the normal limit of Serum creatinine)
- •11. Subjects who has received physical and local treatment, such as physical therapy, in the past two weeks
- •12. Subjects who has gastrointestinal conditions (e.g., Crohn's Disease) or gastrointestinal operations that could affect the absorption of test products (except for simple appendicitis or hernia)
- •13. Subjects participating in other clinical trials within two months to visiting the screening
- •14. Subjects with liver function disorder (exceeds the normal limit by more than three times)
- •15. Subjects with connective tissue (collagen) disease
- •16. Subjects with medical conditions such as multiple sclerosis
- •17. Taking immunosuppressant, cortico-steroid, cyclosporine, and osteoarthritis medications
- •18. Have been treated with antipsychotics within two months prior to screening
- •19. A history of drug or alcohol abuse
- •20. pregnant or nursing woman
- •21. Any fertile women who are likely to have a pregnancy that does not permit the implementation of appropriate contraceptives (excluding infertile women).
- •22. The research manager has determined that it is unsuitable for clinical testing
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