CTRI/2023/09/057919已完成3 期
Evaluate the efficacy and safety of Ligashot inLigament injury (Knee sprain, Ankle sprain, Shoulder dislocation,Post-operative recovery) patients of Grade 1 and 2. - 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
- 3 期
- 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. Male or female patients aged more than 18 years with grade 1 and 2 Ligament injury of knee,
- •ankle or shoulder – with or without dislocation.
- •2. Pain defined by a level of greater than or equal to 30 mm on a 100 mm Visual Analogue Scale
- •3. Patient should have not participated in any other clinical trial during the past 3 months.
- •4. Participants, who are willing to give written, signed and dated informed consent to participate in
排除标准
- •1. Prior knee ligament surgery of the involved knee;
- •2. Torn or avulsed patellar or quadriceps tendon;
- •3. Periarticular or long bone fracture that is anticipated to preclude weight-bearing after
- •4. Require use of an external fixator for greater than 10 days;
- •5. Planned staged surgical treatment;
- •6. Unable to weight bear on the contralateral uninjured leg;
- •7. Traumatic brain injury (TBI) that limits their ability to participate in their post-operative
- •8. Surgical procedures that precludes early weight-bearing or range of motion.
- •9. Any condition that would preclude the ability to comply with post-operative guidelines
- •10. Moderate to severe renal impairment
- •11. Pregnant or lactating
- •12. History of hypersensitivity to any of the test products.
- •13. Any condition decided as unfit for study by clinical investigator
研究者
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