| CTRI Number |
CTRI/2021/05/033302 [Registered on: 03/05/2021] Trial Registered Prospectively |
| Last Modified On: |
25/11/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Biological |
| Study Design |
Randomized, Parallel Group Trial |
Public Title of Study
Modification(s)
|
Knee Osteoarthritis study |
|
Scientific Title of Study
|
An open label comparative study to evaluate safety and effectiveness of intraarticular
injection of Autologous Growth Factor Concentrate (AGFC) versus
Hyaluronic acid (HA) in Knee Osteoarthritis |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| W-ONXT-401 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
|
| Designation |
|
| Affiliation |
|
| Address |
|
| Phone |
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| Fax |
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| Email |
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Details of Contact Person
Scientific Query
|
| Name |
Dr Ashima Bhatia |
| Designation |
Senior Vice President-Global Clinical Development |
| Affiliation |
Wockhardt ltd |
| Address |
Wockhardt Towers, Ist west wing, VP room,
Bandra Kurla Complex
Mumbai (Suburban)
MAHARASHTRA
400051
India |
| Phone |
02226534444 |
| Fax |
|
| Email |
abhatia@wockhardt.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ashima Bhatia |
| Designation |
Senior Vice President-Global Clinical Development |
| Affiliation |
Wockhardt ltd |
| Address |
Wockhardt Towers, Ist West Wing, VP Room,
Bandra Kurla Complex
Mumbai (Suburban)
MAHARASHTRA
400051
India |
| Phone |
02226534444 |
| Fax |
|
| Email |
abhatia@wockhardt.com |
|
|
Source of Monetary or Material Support
|
| Wockhardt Regenerative Private Limited |
|
|
Primary Sponsor
|
| Name |
Wockhardt Regenerative Private Limited |
| Address |
G-Block, Plot C-2, Bandra-Kurla Complex, Bandra(E), Mumbai- 400051 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
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Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 6 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Ravi Malhotra |
Deep Hospital |
Deep Hospital, 481, Model Town Rd, Pritm Nagar, Model Town, Ludhiana, Punjab 141002
Ludhiana
PUNJAB |
8556872627
ravmalh@gmail.com |
| Dr Rajesh Dhadiwal |
Dhadiwal Hospital |
Trambakeshwar Rd, Opp. New CBS, Matoshree Nagar, Nashik, Maharashtra 422002"
Nashik
MAHARASHTRA |
9823040106
dhadiwalhospital@gmail.com |
| Dr Amit Kale |
Dr.D.Y.Patil Medical College, Hospital and Research Centre, Pimpri, Pune- |
Medical College, Hospital and Research Centre, Pimpri, P
Pune
MAHARASHTRA |
9423585027
dramitkale@rediffmail.com |
| Dr Chirag Borana |
Masina Hospital Trust |
Masina Hospital Trust, Sant Savta Mali Marg, Near Gloria Church
Mumbai
MAHARASHTRA |
9326864008
drchiragb@gmail.com |
| Dr Vrajesh Shah |
Viroc Hospital |
Arya Kanya Road, opposite Lohana Samaj Seva Mandal, Karelibagh
Vadodara
GUJARAT |
9227473101
drvrs74@gmail.com |
| Dr Brijesh Kidiyoor |
Yashoda Hospitals |
Yashoda Hospitals
SP Road, Secunderabad, Hyderabad, Telangana – 500003
Hyderabad
TELANGANA |
8374907947
drbrijeshkidiyoor@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 6 |
| Name of Committee |
Approval Status |
| Anand Institutional Ethics Committee |
Approved |
| Institutional Ethics Committee Deep Hospital |
Approved |
| Institutional Ethics Committee Yashoda Academy of Medical Education and Research |
Approved |
| Institutional Ethics Committee, Dr. D. Y. Patil Vidyapeeth |
Approved |
| Masina Hospital Ethics Committee |
Approved |
| Shree Institutional Ethics Committee (SIEC) |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M171||Unilateral primary osteoarthritisof knee, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Autologous Growth Factor Concentrate intra-articular
injection |
Autologous Growth Factor Concentrate intra-articular
injection given in the affected knee joint at Baseline, Month 1 and Month 2.
Dosage – 2 ml per injection. |
| Comparator Agent |
Hyaluronic Acid (molecular weight of 0.5-1.5 million
Dalton) injection intra-articular injection |
Hyaluronic Acid (molecular weight of 0.5-1.5 million
Dalton) injection intra-articular injection given in the affected knee joint at
Baseline, Month 1 and Month 2.
Dosage – 2 ml per injection. |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
1. Confirmed osteoarthritis of the knee joint on radiological assessment
(Grade I, II & III on Kellgren-Lawrence Grading Scale) and
2. Visual Analogue Scale (VAS) pain score of 4 or more (on numeric
rating scale) since past 2 weeks in spite of taking NSAIDs |
|
| ExclusionCriteria |
| Details |
1. Grade IV on Kellgren-Lawrence Grading Scale
2. Past surgery or fracture on knee joint
3. Knee instability |
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Change from baseline of Western Ontario and McMaster
Universities Osteoarthritis Index score (WOMAC) |
Baseline and Month 11] |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Change from baseline of VAS pain numeric rating scale |
Baseline, Month 1, Month 2, Month 5, Month 8, and Month
11 |
| Change from baseline of WOMAC score |
Baseline,
Month 5 and Month 8 |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "100"
Final Enrollment numbers achieved (India)="100" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
04/05/2021 |
| Date of Study Completion (India) |
31/08/2023 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="2"
Months="5"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
None |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
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Brief Summary
|
To evaluate Safety and Effectiveness of intra-articular injection of Autologous Growth Factor Concentrate (AGFC) versus Hyaluronic acid (HA) in Knee Osteoarthritis. |