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

NCT01668862 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2012-08-20

No results posted yet for this study

Summary

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.

Conditions

  • Lateral Epicondylitis (Tennis Elbow)

Interventions

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

Sponsors & Collaborators

  • Kasiak Research Pvt. Ltd.

    lead INDUSTRY

Principal Investigators

  • Anant Joshi, Dr. · ASMI

  • Nicolas Antao, Dr. · Hillway Clinic

  • Gauresh Palekar, Dr. · Surya Orthopedic Clinic

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-03-31
Primary Completion
2012-10-31
Completion
2012-11-30

Countries

  • India

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01668862 on ClinicalTrials.gov