| CTRI Number |
CTRI/2012/04/002611 [Registered on: 27/04/2012] Trial Registered Retrospectively |
| Last Modified On: |
10/04/2013 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Biological |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A comparative study to determine the safety and efficacy of Autologous Human Platelet Lysate (HPL)in treatment of Lateral Epicondylitis (Tennis Elbow) |
|
Scientific Title of Study
|
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) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| KRPL/HPL-TE/11-12/003 |
Other |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Anant Joshi |
| Designation |
Specialist In Orthopaedics |
| Affiliation |
Dr Anant Joshi’s Clinic |
| Address |
Dr Anant Joshi’s Clinic
Shop # 168A Savitri Sadan
Dr. Ambedkar Road
Dadar East
Mumbai
MAHARASHTRA
400014
India |
| Phone |
022-24143240 |
| Fax |
|
| Email |
asminst@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nicholas A Antao |
| Designation |
Consultant Orthopaedic, Arthroscopic, Sports Medicine and Joint Replacement Surgeon |
| Affiliation |
Hillway Clinic |
| Address |
Hillway Clinic
23 Opp Police Station
Near To Abhyudaya Bank
Hill Rd Bandra (W)
Mumbai
MAHARASHTRA
400050
India |
| Phone |
0226848368 |
| Fax |
|
| Email |
narantao@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kaushal Shah |
| Designation |
Head Clinical Research |
| Affiliation |
KASIAK RESEARCH PRIVATE LIMITED |
| Address |
KASIAK RESEARCH PRIVATE LIMITED
1st Floor Building No.1
Dil Complex
Near Tatwagyan Vidyapeeth
Ghodbunder Road
Thane
MAHARASHTRA
400610
India |
| Phone |
02241173472 |
| Fax |
|
| Email |
kaushal.shah@kasiakresearch.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
KASIAK RESEARCH PRIVATE LIMITED |
| Address |
1st Floor Building No.1
Dil Complex
Near Tatwagyan Vidyapeeth
Ghodbunder Road
Thane (West) 400610
|
| Type of Sponsor |
Other [Biotechnology company] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Anant Joshi |
Dr Anant Joshi’s Clinic |
Shop # 168A Savitri Sadan
Dr. Ambedkar Road Dadar East
Mumbai
MAHARASHTRA |
02224143240
asminst@yahoo.com |
| Dr Nicholas A Antao |
Hillway Clinic |
23 Opp Police Station
Near To Abhyudaya Bank
Hill Rd
Bandra (W)
Mumbai
MAHARASHTRA |
02226431872
narantao@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Clinical Ethics Forum (CEF); Mumbai |
Approved |
| Clinical Ethics Forum; Mumbai |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Lateral Epicondylitis (Tennis Elbow), |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Autologous Human platelet Lysate (HPL) |
Subjects will receive one injection of HPL (5mL) in the lateral epicondyle space |
| Comparator Agent |
Corticosteroid |
Subjects will receive one injection of corticosteroid in the lateral epicondyle space |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
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
|
|
| ExclusionCriteria |
| Details |
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
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
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 – 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
|
End of study - 3 Months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Ultrasonography |
End of study - 3 Months |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
Phase 1/ Phase 2 |
|
Date of First Enrollment (India)
|
20/03/2012 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
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. |