Health Condition 1: S869- Injury of unspecified muscle and tendon at lower leg level
Conditions
Interventions
Intervention1: Tendoshot Pro: 1 tablet twice daily orally after food for 12 weeks
Control Intervention1: Not applicable: Not applicable
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 Tendon 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/ankle /shoulder surgery; 2. Torn or avulsed 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. Any condition that would preclude the ability to comply with post-operative guidelines 9. Moderate to severe renal impairment 10. Pregnant or lactating 11. History of hypersensitivity to any of the test products. 12. 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 (0-100 mm) 2.Time to Return to Pre-Injury Level of Activity 3.Change from baseline to 12 weeks in ESR and CRP levels 4. quality of life 5. Global rating of change Timepoint: Baseline and 12 weeks | — |
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: Baseline and 12 weeks | — |
Countries
India
Contacts
Public ContactDr Gayathri Sivakumar
Ki3 Private Limited
Outcome results
None listed