KCT0005507已完成未知
Randomized, double-blind, and controlled clinical study for improvement of articular cartilage via the analysis of effect of low molecular weight collagen peptide
Pusan National University Korean Medicine Hospital0 个研究点目标入组 80 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
- 80
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
- 40(Year) 至 75(Year)（—）
- 性别
- All
入选标准
- •1. Adult aged 40 years or older and under 75 years old
- •2. Persons with grade I or II Kellgren-Lawrence grading scale of one or both knee joints in simple radiographic examination
- •3. Persons with a knee arthritis pain score of 30 ? or more evaluated with a visual analog scale (VAS-100 ?)
- •4. Applicants who are capable of normal physical activity and have consented in writing to the test agreement
排除标准
- •1. Those who are currently being treated for clinically significant acute or chronic cardio-cerebrovascular, immune system, respiratory system, hepatobiliary system, kidney and urinary system, nervous system, musculoskeletal disease, mental, infectious and blood, neoplastic disease
- •2. Those who have undergone artificial knee replacement surgery or plan to receive it during the human application test period.
- •3. Those who have been diagnosed with inflammatory arthritis such as rheumatoid arthritis or lupus arthritis, or who have been diagnosed with secondary osteoarthritis due to systemic diseases.
- •4. People with gout or recurrent pseudo gout
- •5. Those with infection or severe inflammation of the knee joint such as septic arthritis
- •6. Those who had a fracture of the leg within the last 3 months
- •7. Those with a history of clinically significant hypersensitivity reactions to collagen components
- •8. Patients with uncontrolled hypertension (measured after 10 minutes of rest for subjects with blood pressure of 160/100 ?Hg or more)
- •9. Creatinine is more than twice the normal upper limit of the laboratory
- •10. Those whose AST (GOT) and ALT (GPT) are more than 2.5 times the normal upper limit of the laboratory
- •11. Persons who received the following drugs before the first consumption of food for human application test
- •-Those who received hyaluronic acid or steroid administration to the knee joint within 1 month from the time of screening test
- •-Those who have systemically used steroids within 1 month from the time of screening test (except topical application and inhalation)
- •-Those who took drugs that affect knee joint pain, such as NSAID, glucosamine, and chondroitin sulfate, within 1 month before the first ingestion of the human test food
- •12. Persons who cannot stop drugs or health functional foods that affect knee pain during the test period from 1 month before the first intake of human test food
- •13. Those who have participated in or plan to participate in other clinical trials within the last 1 month
- •14. Those who are judged to interfere with the test due to excessive alcohol consumption
- •15. Pregnant or nursing mothers who plan to become pregnant during this human application test
- •16. Those with a body mass index (BMI) of 30 ?/? or more
- •17. A person who judges that the tester is unsuitable for other reasons
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