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临床试验/CTRI/2023/09/057515
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

发起方
Innovcare LifeSciences Pvt Ltd

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