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A Prospective, Multicentric, Open Label, Randomised, Bio-Interventional Phase I/II Pilot Study To Evaluate The Safety And Efficacy Of Autologous Human Platelet Lysate (HPL) For The Treatment Of Lateral Epicondylitis (Tennis Elbow)
This is a multicentre, open label, randomized, pilot study to evaluate safety and efficacy of human Platelet Lysate (HPL) in subjects with Lateral Epicondylitis (Tennis Elbow). The study is being conducted in 2 centers in India. The primary end points are Visual Analog Score (VAS) and Patient rated tennis elbow evaluation (PRTEE) score. The secondary endpoint is improvement in ultrasonography form randomization to End of study.
Details
| Lead sponsor | Kasiak Research Pvt. Ltd. |
|---|---|
| Phase | Phase 1/Phase 2 |
| Status | UNKNOWN |
| Enrolment | 20 |
| Start date | 2012-03 |
| Completion | 2012-11 |
Conditions
- Lateral Epicondylitis (Tennis Elbow)
Interventions
- Autologous Human Platelet Lysate
- Corticosteroid
Primary outcomes
- Change in Visual Analog Score (VAS) — Day 0, Month 1, Month 2, End of Study - Month 3
Countries
India