Trial | NCT01668862  Report issue

Title

A Study to Determine Safety & Efficacy of Autologous Human Platelet Lysate in Lateral Epicondylitis (Tennis Elbow)
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)

  • Phase

    Phase 1/Phase 2

  • Study Type

    Interventional

  • Status

    Unknown status

  • Study Participants

    20
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.
Study Started
Mar 31
2012
Primary Completion
Oct 31
2012
Anticipated
Study Completion
Nov 30
2012
Anticipated
Last Update
Aug 20
2012
Estimate

Biological Autologous Human Platelet Lysate

Subjects will receive one injection of Autologous Human Platelet Lysate in the lateral epicondyle space

Drug Corticosteroid

Subjects will receive one injection of Corticosteroid in the lateral epicondyle space

Study arm A Other

Subjects will receive one injection of Autologous Human Platelet lysate in the lateral epicondyle space

Control Arm B Other

Subjects will receive one injection of Corticosteroid in the lateral epicondyle space

Criteria 

Inclusion Criteria:

Subjects with clinical diagnosis of tennis elbow within the last 3 months
Subjects both male and female, aged 18-60 years (both inclusive)
Subjects who are willing to give informed consent and adhere to the study protocol

Exclusion Criteria:

Subjects aged less than 18 and more than 60 years
Subjects with autoimmune diseases
Subjects with immuno-compromised system
Subjects on Anti-coagulant therapy or blood thinning medicines like Aspirin
Subjects taking concomitant therapy that might interfere with the study results in investigators opinion or who had concomitant other injury of the tennis elbow tendons.
Subjects who have received treatment with corticosteroid injections within the last 6 months
No Results Posted