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

Phase 1

• Conditions: Lateral Epicondylitis (Tennis Elbow)
• Interventions: Drug: Corticosteroid; Biological: Autologous Human Platelet Lysate

• Registration Number: NCT01668862
• Lead Sponsor: Kasiak Research Pvt. Ltd.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-03
• Status Verified: 2012-07
• Study First Submitted: 2012-07-17
• Study First Submitted QC: 2012-08-16
• Last Update Submitted: 2012-08-16
• Study First Posted: 2012-08-20
• Last Update Posted: 2012-08-20
• Primary Completion: 2012-10
• Study Completion: 2012-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control Arm B	Corticosteroid	Subjects will receive one injection of Corticosteroid in the lateral epicondyle space
Study arm A	Autologous Human Platelet Lysate	Subjects will receive one injection of Autologous Human Platelet lysate in the lateral epicondyle space

Primary Outcome Measures

Name	Time	Method
Change in Visual Analog Score (VAS)	Day 0, Month 1, Month 2, End of Study - Month 3

Secondary Outcome Measures

Name	Time	Method
Change in Ultrasonography of the lateral epicondyle region from Baseline to End of study at Month 3	Day 0, End of study - Month 3

Trial Locations

Locations (1)

Kasiak Research Pvt Ltd; 🇮🇳 Thane, Maharashtra, India