Health Condition 1: M959- Acquired deformity of musculoskeletal system, unspecified
Conditions
Interventions
Intervention1: Ligashot (Aflapin 100 mg
Collagen Peptide 150 mg
Glucosamine Sulphate 250 mg
Chondroitin 200 mg): taken orally once daily at night for 3 months
Control Intervention1: NA: NA
Sponsors
Innovcare LifeSciences Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 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 (VAS) 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 the study.
Exclusion criteria
Exclusion criteria: 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 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. Traumatic brain injury (TBI) that limits their ability to participate in their post-operative care; 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Change from baseline to 16 weeks in pain intensity measured by Pain VAS Scale. 2. Time to return to pre-injury level of activity. 3. Multiple Ligament Quality of Life (MLQoL) Questionnaire. 4. Change in ESR and CRP 5. Global rating change 6. MRI assessment Timepoint: Day 0 and week 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| To demonstrate safety and tolerability of study product by Clinical AEs, including laboratory abnormalities (If any) Safety and tolerability evaluation criteria: Adverse events and serious adverse events during the study periodTimepoint: Day 0, Week 4, Week 8 , Week 12 | — |
Countries
India
Contacts
Public ContactDr Gayathri Sivakumar
Thirumalai medical Centre, ki3
Outcome results
None listed