Evaluate the efficacy and safety of Ligashot inLigament injury (Knee sprain, Ankle sprain, Shoulder dislocation,Post-operative recovery) patients of Grade 1 and 2.
试验速览
- 阶段
- Phase 3 4
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- 1. Change from baseline to 16 weeks in pain intensity measured by Pain VAS Scale.
研究概览
简要总结
The Subjects who fulfilled the inclusion and exclusion criteria will be enrolled in the study. 30 Participants will be randomized into single group. Dosing will be done twice daily orally for 12 weeks. Subjects will be asked to visit clinical facility/ institution for their follow up at the end of week 4, week 8 and week 12 and any other additional visits if needed
Primary and Secondary Outcome
-
VAS Scale
-
Time to return to Pre-Injury level of activity
-
Patient Reported Physical Function- Activity Limitation Scale of Multiple Ligament Quality of Life (MLQoL) Questionnaire
-
Hs-C Reactive Protein
-
ESR
-
Global Rating of Change
-
Activity Limitation Scale of Multiple Ligament
-
MRI Scan
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •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.
- •Pain defined by a level of greater than or equal to 30 mm on a 100 mm Visual Analogue Scale (VAS)
- •Patient should have not participated in any other clinical trial during the past 3 months.
- •Participants, who are willing to give written, signed and dated informed consent to participate in the study.
排除标准
- •Prior knee ligament surgery of the involved knee;
- •Torn or avulsed patellar or quadriceps tendon;
- •Periarticular or long bone fracture that is anticipated to preclude weight-bearing after surgery;
- •Require use of an external fixator for greater than 10 days;
- •Planned staged surgical treatment;
- •Unable to weight bear on the contralateral uninjured leg;
- •Surgical procedures that precludes early weight-bearing or range of motion.
- •Any condition that would preclude the ability to comply with post-operative guidelines
- •Moderate to severe renal impairment
- •Pregnant or lactating
- •History of hypersensitivity to any of the test products.
- •Any condition decided as unfit for study by clinical investigator.
结局指标
主要结局
1. Change from baseline to 16 weeks in pain intensity measured by Pain VAS Scale.
时间窗: Day 0 and week 12
5. Global rating change
时间窗: Day 0 and week 12
3. Multiple Ligament
时间窗: Day 0 and week 12
Quality of Life (MLQoL) Questionnaire.
时间窗: Day 0 and week 12
4. Change in ESR and CRP
时间窗: Day 0 and week 12
6. MRI assessment
时间窗: Day 0 and week 12
2. Time to return to pre-injury level of activity.
时间窗: Day 0 and week 12
次要结局
- To demonstrate safety and tolerability of study product by Clinical AEs,(including laboratory abnormalities (If any))