A case study to evaluate the efficacy and safety of Tendoshot Pro in Tendon Injury (Knee Sprain, Ankle Sprain (Achilles Heel), Shoulder Dislocation, Post-Operative Recovery, Plantar fasciitis) Patients of Grade 2
试验速览
- 阶段
- 3 期
- 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 (0-100 mm)
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 facility for their followup up to end of week 4, Week 8 and Week 12 and any other additional visits if needed.
Primary Outcome
-
Change from baseline to weeks in pain intensity measured by pain VAS Scale
-
Time to return to Pre- Injury level of activity
-
Patient-Reported Physical Function- Activity Limitation scale of Multiple Ligament (MLQoL) Questionnaire
-
Activity Limitation Scale of the Multiple Ligament Qulaity of Life Scale
-
Change from Baseline to 3month a)Hs-C Reactive Protein b)ESR
-
Global Rating of Change (GRC)
-
Changes from baseline to 3 months in Quality of Life Questionnaires
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Male or female patients aged more than 18 years with grade 1 and 2 Tendon 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/ankle /shoulder surgery;
- •Torn or avulsed 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;
- •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 (0-100 mm)
时间窗: Baseline and 12 weeks
2.Time to Return to Pre-Injury Level of Activity
时间窗: Baseline and 12 weeks
3.Change from baseline to 12 weeks in ESR and CRP levels
时间窗: Baseline and 12 weeks
4. quality of life
时间窗: Baseline and 12 weeks
5. Global rating of change
时间窗: Baseline and 12 weeks
次要结局
- To demonstrate safety and tolerability of study product by Clinical(AEs, including laboratory abnormalities (If any))
研究者
Dr Sakthi Balan
Ki3 Private Limited