A comparative study to determine the safety and efficacy of Autologous Human Platelet Lysate (HPL)in treatment of 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)

Status

Active, not recruiting

Phases

Phase 1Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2012/04/002611

Enrollment

Registered

2012-04-27

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Lateral Epicondylitis (Tennis Elbow)

Interventions

Intervention1: Autologous Human platelet Lysate (HPL): Subjects will receive one injection of HPL (5mL) in the lateral epicondyle space Control Intervention1: Corticosteroid: Subjects will receive one

Eligibility

Inclusion criteria

Inclusion criteria: 1. Subjects with clinical diagnosis of tennis elbow within the last 3 months 2. Subjects both male and female, aged 18-60 years (both inclusive) 3. Subjects who are willing to give informed consent and adhere to the study protocol

Exclusion criteria

Exclusion criteria: 1. Subjects aged less than 18 and more than 60 years 2. Subjects with autoimmune diseases 3. Subjects with immuno-compromised system 4. Subjects on Anti-coagulant therapy or blood thinning medicines like Aspirin 5. 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. 6. Subjects who have received treatment with corticosteroid injections within the last 6 months

Design outcomes

Primary

Measure	Time frame
1. Visual Analog Score (VAS) and Patient rated tennis elbow evaluation (PRTEE) score: To evaluate the effect of HPL on Pain Scores. 2. The American Shoulder and Elbow Society score â?? To evaluate the effect of HPL on pain, function, range of motion, strength and patient satisfaction on various numerical scales. 3. All the above questionnaires are externally validated clinical outcome measures that rate elbow pain Timepoint: End of study - 3 Months	—

Measure

Time frame

1. Visual Analog Score (VAS) and Patient rated tennis elbow evaluation (PRTEE) score: To evaluate the effect of HPL on Pain Scores. 2. The American Shoulder and Elbow Society score â?? To evaluate the effect of HPL on pain, function, range of motion, strength and patient satisfaction on various numerical scales. 3. All the above questionnaires are externally validated clinical outcome measures that rate elbow pain Timepoint: End of study - 3 Months

—

Secondary

Measure	Time frame
UltrasonographyTimepoint: End of study - 3 Months	—

Countries

India

Contacts

Public ContactDr Kaushal Shah

Hillway Clinic

narantao@gmail.com0226848368

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026