Effect of Ligashot inLigament injury

Phase 3

Completed

Brief Summary: 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

1) VAS Scale

2) Time to return to Pre-Injury level of activity

3) Patient Reported Physical Function- Activity Limitation Scale of Multiple Ligament Quality of Life (MLQoL) Questionnaire

4) Hs-C Reactive Protein

5) ESR

6) Global Rating of Change

7) Activity Limitation Scale of Multiple Ligament

8) MRI Scan

Recruitment & Eligibility

Inclusion Criteria

Male or female patients aged more than 18 years with grade 1 and 2 Ligament injury of knee, ankle or shoulder â€“ 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) 3.
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.

Exclusion Criteria

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 surgery; 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.
Surgical procedures that precludes early weight-bearing or range of motion.
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.
Any condition decided as unfit for study by clinical investigator.

Primary Outcome Measures

Name	Time	Method
1. Change from baseline to 16 weeks in pain intensity measured by Pain VAS Scale.	Day 0 and week 12
5. Global rating change	Day 0 and week 12
3. Multiple Ligament	Day 0 and week 12
Quality of Life (MLQoL) Questionnaire.	Day 0 and week 12
4. Change in ESR and CRP	Day 0 and week 12
6. MRI assessment	Day 0 and week 12
2. Time to return to pre-injury level of activity.	Day 0 and week 12

Secondary Outcome Measures

Name	Time	Method
To demonstrate safety and tolerability of study product by Clinical AEs,	including laboratory abnormalities (If any)

Locations (1): Thirumalai Medical Centre
🇮🇳
Chennai, TAMIL NADU, India
Thirumalai Medical Centre
🇮🇳Chennai, TAMIL NADU, India
Dr M Sakthi Balan
Principal investigator
9443627722
saheerose@gmail.com