KCT0007219已完成未知
Clinical study on efficacy and safety of Perilla Frutescens extract against knee joint pain: a randomized, double-blind, placebo-controlled, single-center trial.
Daejeon Korean Medicine Hospital of Daejeon University0 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
- 20(Year) 至 75(Year)（—）
- 性别
- All
入选标准
- •1) Male and female adults aged 20-75 years at the time of the screening test.
- •2) Adults complain of mild knee pain, as VAS score same or less than 50mm (without recent any type of joint injury or similar episode; 0 and 100 indicate ‘no pain’ and ‘unbearable pain’, respectively).
- •3) People who voluntarily participate in the trial with written consent.
排除标准
- •1)A person who is currently taking arthritis-related medications.
- •2)A person is accompanied by osteoporosis around the joint, irregular joint surface, and subchondral osteocytes of the joint and is moderate to severe arthritis as identified on plain radiographs (moderate to severe arthritis as identified on plain radiographs: Kellgren-Lawrence (K-L) grade = 3 on plain radiographs).
- •3)A person who has a medical history of knee arthroplasty surgery.
- •4)A person who has been diagnosed with other musculoskeletal disorders other than knee joint pain and is being treated for pain.
- •5)A person who is taking products containing PFE or has a history of a significant overreaction (including allergic reaction).
- •6)A woman who is pregnant or breastfeeding
- •7)A person who has an important heart, kidney, liver, and other organ disease or is expected to affect the evaluation of abnormal reactions after participating in the human application test or interfere with the completion of the human application test.
- •8)A person who is treating gastritis and stomach ulcers.
- •9)A person with a history of significant medical treatment/surgery that may affect the human application test.
- •10)A person with a history of gastrointestinal disorders (e.g., Crohn's disease) or gastrointestinal surgery (excluding simple appendectomy or hernia surgery) that may affect the absorption of human-applied test products.
- •11)A person who has consumed drugs, herbal medicines, and healthy functional foods that may affect joint health within 2 weeks (glucosamine, NAG, mucopolysaccharide - protein, MSM, green leaf mussel oil, Scutellaria baicalensis, rose hip powder, fatty acid compound (FAC), Boswellia extract, ginseng extract, Achyranthes japonica Nakai, etc.).
- •12)A person with mental illness such as schizophrenia, drug addiction, etc., and being treated for depression.
- •13)A person who has therapeutic history due to alcoholism or drug abuse.
- •14)A person who has participated in another human body application test within two months prior to screening.
- •15)A person who exhibits the following results in a laboratory inspection.
- •? AST, ALT> 3 times the upper limit of the reference range
- •? Serum Creatine> Twice the upper limit of the reference range
- •16)A person who has been determined unfit to participate in the study due to other reasons, including the results of the diagnostic examination medical examination.
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