KCT0007997招募中未知
A 12-week, randomized, double-blind, placebo-controlled,multi-center, phase IIb 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 160 人开始时间: 待定最近更新:
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 发起方
- 入组人数
- 160
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 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 year 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. Those with a daily average pain of 100mm(10mm pai Visual Analogue Scale) of 40mm or more during rest for the past week at the of visit 1 and visit 2
- •3. A person who has a Kellgren&Lawrence grade level of 2-3 through radiography(X-ray) at visit 1
- •4. Voluntarily agreed to participate and signed the consent form after hearing a clear explanation of the purpose and characteristics of this clinical trial
排除标准
- •1. A person who has undergone surgery on the knee due to degenerative Knee arthritis or other trauma
- •2. A post-traumatic degenerative Knee arthritis patient
- •3. Those sho have received intra-articular mucosal (viscosupplement; hylan, sodium hyalurinate, hyalulonan) supplement injection within 6 months of
- •4. A person who discharges joint fluid through intra-articular injection within 3 monts of Screening
- •5. A person who has received injection treatment such as prolotherapy or steroids in the cavity and around the knee sithin 3 months of screening
- •6. A persom who has received anti-psychotic treatment within three months of screening
- •7. A person who has received herbal treatment such as acupuncture, moxibustion, cupping, and herbal medicine within 4 weeks of screening
- •8. A person who has received non-drug topical treatment, such as physical therapy, within 4 weeks of screening
- •9. A person who is taking a health functional food that improves joint/cartilage health, including osteoarthritis treatment and glucosamine, within 4 weels of screening
- •10. A person who uses a local painkiller(pass, spray, etc.) at the knee joint within 7 days of random assignment
- •11. A person who has history or history of inflammatory diseases, tumors, trauma, rheumatoid arthritis, autoimmune diseases, severe external and internal degeneration of knee joints, inflammatory arthritis, hip diseases, or other inflammatory arthritis
- •12. Patients with psychiatric disorders, immune system disorders, and those on medication
- •13. Those who take adrenocortical hormone drugs, immunosuppressants, corticosteroids, cyclosorine, or other nonsteroidal anti-inflammatory analgesics for other diseases
- •14. A person whose ALT(GPT) or AST(GOT) is three times or more than the normal upper limit of the enforcement agency
- •15. A person whose Creatinine is more than twice the normal upper limit of the implementing agency
- •16.A person who has a history of gastrointestinal diseases(e.g.,Crohn's diseases) or gastrointestinal surgery (excluding simple appendectomy or hernia surgery) that may affect the absorption of the product
- •17. A person with multiple sclerosis, connective tissue(teacher's) diseases
- •18. People with skin allergies, skin ulcers, and skin infection
- •19. A person who has history of drug or alcohol abuse
- •20. A person who has a history of notifying the main and components of a clinical trial drug or remedy
- •21.Patients with peptic ulcers, severe blood problems, severe liver problems, severe kidney problems, severe heart failure, and aspirin asthma
- •22. A person who is pregnant or has a plan of pregnancy during this clinical trial
- •23. A person who has participated in another clinical trial within 2 months of screening criteria or plans to participate in another clinical trial during the trial period (However, if he/she has participated in a non-material observation study, he/she may participate at the discretion of the test director)
- •24. A person who has determined that the tester is unfit to participate in a clinical trial due to other reasons
研究者
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