KCT0008424招募中Unknown
Efficacy, Safety and Economic Evaluation of Dokhwalgisaeng-tang for Degenerative Knee Osteoarthritis : A multicenter, randomized, Assessor-blind, parallel clinical trial
Kyung Hee University Oriental Medicine Hospital at Gangdong0 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
- Unknown
- 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
入排标准
- 年龄范围
- 40(Year) 至 70(Year)（—）
- 性别
- All
入选标准
- •1. Adults aged from 40 to 70
- •2. Patients suffering knee pain from knee osteoarthritis for more than 3 months.
- •3. Patients diagnosed with knee osteoarthritis according to ACR criteria and at the same time, whose target lesion is Kellgren-Lawrence grade ?~? in simple X-ray.
- •4. Patients with a total score of 30 or higher on KOWAC which is done at the screening visit.
- •5. Patients who can agree to discontinue any existing treatment and can cooperate.
- •6. Patients voluntarily agreed to participate in the study
- •7. Patients with unilateral osteoarthritis or bilateral osteoarthritis whose target lesion can be designated to one side according to the following standard: If both knees meet the selection/exclusion criteria, target lesions are designated according to the criteria below.
- •? Designate the one with the higher Kellgren-Lawrence grade as the target lesion.
- •? If the Kellgren-Lawrence grade is the same, the one with the higher pain felt by the subject during the screening interview is designated as the target lesion.
- •? If all criteria of ?~? are the same, designate the right knee as the target lesion.
排除标准
- •1. Patients with a history of knee joint trauma within the last 6 months.
- •2. Patients with a history of knee joint surgery or a plan for surgery during the clinical study period
- •3. Patients with a history of any intra-articular injection treatment within the last 3 months
- •4. Patients who are suspected of the following disease through physical or diagnostic medical examination: Rheumatoid arthritis, autoimmune disease, septic arthritis, inflammatory joint disease, gout, recurrent pseudogout, Paget's disease, joint fracture, ochronosis, acromegaly, hemochromatosis, Wilson's disease, primary osteochondrosis, genetic diseases (e.g. hyperkinesia), collagen gene abnormalities, etc.
- •5. Patients with musculoskeletal disorders which the researcher judged would affect this study. (e.g. hip or spine problems)
- •6. Patients receiving treatment for mental disorders such as depression and schizophrenia
- •7. Patients with liver disease (AST or ALT > 2 times the normal range)
- •8. Patients with renal disease (creatinine clearance < 30mL/min)
- •9. Patients with other diseases that may interfere with treatment, such as serious gastrointestinal or cardiovascular diseases, uncontrolled hypertension or diabetes, serious kidney or liver diseases, or hemorrhagic diseases
- •10. Patients with concomitant diseases or hypersensitivity reactions for whom the prescription of non-steroidal anti-inflammatory drugs is contraindicated.
- •11. Pregnant or lactating women
- •12. Patients whom the researcher judged not suitable for herbal medicine treatment
- •13. Patients who have participated in another clinical trial within 4 weeks of the start of the clinical trial or are currently participating in another clinical trial
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