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Status unknownNCT01668862Updated Aug 20, 2012

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

A Phase 1/2 interventional study of Autologous Human Platelet Lysate and Corticosteroid in Lateral Epicondylitis (Tennis Elbow), sponsored by Kasiak Research Pvt. Ltd.. Status unknown at 1 site in India. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2012-08-20.

Sponsored by Kasiak Research Pvt. Ltd. · Phase 1/2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jul 2012), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 1/2
Study type
Interventional
Enrollment
20
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
01

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.

02

Conditions studied

  • Lateral Epicondylitis (Tennis Elbow)

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03

In context

Tennis Elbow

284 studies on the registry are indexed under Tennis Elbow; 60 are open to participants now.

This study's planned enrollment of 20 is below the median of 50 across 253 interventional studies indexed under Tennis Elbow.

Browse Tennis Elbow studies →

Lead sponsor

Kasiak Research Pvt. Ltd. is the lead sponsor of 8 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
20 participants (estimated)

Study arms

  • Other
    Study arm A

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

    Biological: Autologous Human Platelet Lysate

  • Other
    Control Arm B

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

    Drug: Corticosteroid

Interventions

  • BiologicalAutologous Human Platelet Lysate

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

  • DrugCorticosteroid

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

06

What researchers measure

Primary outcomes

  1. Change in Visual Analog Score (VAS)

    Time frame: Day 0, Month 1, Month 2, End of Study - Month 3

Secondary outcomes

  1. Change in Ultrasonography of the lateral epicondyle region from Baseline to End of study at Month 3

    Time frame: Day 0, End of study - Month 3

Other outcomes

  1. Patient rated tennis elbow evaluation (PRTEE Score)

    Time frame: Day 0, Month 1, Month 2, End of study-Month 3

  2. The American Shoulder and Elbow Society score

    Time frame: Dya 0, Month 1, Month 2, End of study-Month 3

07

Study locations

1 of 1 sites recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 20, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01668862
Lead sponsor
Kasiak Research Pvt. Ltd.
Responsible party
Sponsor
First posted
Aug 20, 2012
Start date
Mar 2012
Primary completion
Oct 2012 (estimated)
Completion
Nov 2012 (estimated)
Last update
Aug 20, 2012

Study contacts

Kaushal Shah, Phd
Contact
kaushal.shah@kasiakresearch.com
+91-22-41173472
Anant Joshi, Dr.
principal investigator · ASMI
Nicolas Antao, Dr.
principal investigator · Hillway Clinic
Gauresh Palekar, Dr.
principal investigator · Surya Orthopedic Clinic

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jul 2012. You cannot join it, but the record below documents what was studied.

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