| CTRI Number |
CTRI/2024/03/063421 [Registered on: 01/03/2024] Trial Registered Prospectively |
| Last Modified On: |
23/02/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Preventive |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Can the addition of Hyaluronic acid to Platelet rich plasma decrease the post procedural pain in intra articular injections for osteoarthritis knee? |
|
Scientific Title of Study
|
A single-centric, patient-blinded randomized parallel group non-inferiority study to compare the effectiveness of post-procedural pain relief between Platelet-Rich Plasma (PRP) alone versus PRP with Hyaluronic Acid Supplementation for intra articular OA Knee injections. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sunaina Mahapatra |
| Designation |
Fellow resident |
| Affiliation |
Daradia the pain clinic |
| Address |
Daradia pain clinic
Room no 1, 1st floor, 327,9/2 DG block Action area 1D, newtown,Kolkata
Kolkata
WEST BENGAL
700156
India |
| Phone |
09438404392 |
| Fax |
|
| Email |
drsunaina91@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Gautam Das |
| Designation |
Director |
| Affiliation |
Daradia the pain clinic |
| Address |
Daradia pain clinic
Room no 1, 1st floor, 327,9/2 DG block Action area 1D, newtown,Kolkata
Kolkata
WEST BENGAL
700156
India |
| Phone |
09163357246 |
| Fax |
|
| Email |
gdas2310@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Gautam Das |
| Designation |
Director |
| Affiliation |
Daradia the pain clinic |
| Address |
Daradia pain clinic
Room no 1, 1st floor, 327,9/2 DG block Action area 1D, newtown,Kolkata
Kolkata
WEST BENGAL
700156
India |
| Phone |
09163357246 |
| Fax |
|
| Email |
gdas2310@gmail.com |
|
|
Source of Monetary or Material Support
|
| Daradia pain clinic,
Room no 1, 1st floor, 327,9/2 DG block Action area 1D, newtown,Kolkata
Pin-700156 |
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NIL |
| Type of Sponsor |
Other [SELF] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sunaina Mahapatra |
Daradia the pain clinic |
Daradia pain clinic
Room no 1, 1st floor, 327,9/2 DG block Action area 1D, newtown,Kolkata
pin-700156
Kolkata
WEST BENGAL |
09438404392
drsunaina91@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| DARADIA ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M179||Osteoarthritis of knee, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Platelet rich plasma
and 90mg Hyaluronic acid |
Site-intra articular knee injection
Frequency-one injection
Drug and Dose- 3ml of platelet rich plasma(PRP) and 90mg of hyaluronic acid in 3ml.
|
| Comparator Agent |
Platelet rich plasma |
Site-intra articular knee injection Frequency-one injection Drug and Dose- 3ml of platelet rich plasma(PRP). |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
History of knee joint pain for atleast 3 months and or joint edema and radiographic evidence of mild to moderate OA Knee of KL grading(1,2,3) |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The mean changes from baseline levels of knee pain as measured using the VAS. |
24 hr,72hr,1week and 6weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| functional changes in the knee (global perceived effect), patient satisfaction with treatment, changes in analgesics, the incidence of adverse effects |
24 hr,72hr,1week and 6weeks |
|
|
Target Sample Size
|
Total Sample Size="106"
Sample Size from India="106"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
15/03/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
We postulate that the combination of Platelet-Rich Plasma (PRP) with Hyaluronic Acid for intra-articular injections in patients of osteoarthritis knee will result in superior post-procedural pain relief compared to PRP alone. |