CTRI/2023/09/057515已完成Unknown
A case study to evaluate the efficacy and safety of Collashot C2 Plus inosteoarthritis patients - NI
Innovcare LifeSciences Pvt Ltd0 个研究点目标入组 30 人开始时间: 待定最近更新:
试验速览
- 阶段
- Unknown
- 状态
- 已完成
- 发起方
- 入组人数
- 30
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
入选标准
- •1. Have osteoarthritis (OA) of the knee joint based on American College of Rheumatology (ACR)
- •criteria and confirmed with X-rays and ACR functional class of III and with grade 3 or 4 as per
- •Kellgren and Lawrence classification system.
- •2. Have been on stable dose of prescription Nonsteroidal Anti- Inflammatory Drugs (NSAIDS), or
- •acetaminophen of at least 2000 mg per day for at least 20 days in the past month.
- •3. Pain defined by a level of greater than or equal to 30 mm on a 100 mm Visual Analogue Scale
- •4. Patient should have not participated in any other clinical trial during the past 3 months.
- •5. Participants, who are willing to give written, signed and dated informed consent to participate in
排除标准
- •1. Arthritis of the knee from other causes
- •2. Uncontrolled hypertension or diabetes
- •3. Have OA pain that requires treatment with potent opioids, systemic corticosteroids, intra-
- •articular injections, duloxetine, or venlafaxine
- •4. Moderate to severe renal impairment
- •5. Pregnant or lactating
- •6. Received any other investigational medicine within 7 days prior to screening which can
- •interfere with investigational product activity
- •7. Suffering from any illness which will interfere with present study as decided by clinical
- •investigator
- •8. History of hypersensitivity to any of the test products.
- •9. Any condition decided as unfit for study by clinical investigator
研究者
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