| CTRI Number |
CTRI/2025/09/095003 [Registered on: 17/09/2025] Trial Registered Prospectively |
| Last Modified On: |
09/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Biological |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To know if Platelet rich plasma therapy is effective in intra articular cartilage growth,improve functions and relief pain in patients with moderate osteoarthritis knee. |
|
Scientific Title of Study
|
Effectiveness of autologous platelet rich plasma in grade 2 and grade 3 osteoarthritis knee in terms of controlling pain, improving functions and structural outcome - A prospective interventional study. |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Mohd Abdul Aziz |
| Designation |
Postgraduate |
| Affiliation |
Esic medical College and hospital |
| Address |
Department of physical medicine and rehabilitation,esic medical College and hospital, sanathnagar, hyderabad, telangana
Hyderabad
TELANGANA
500038
India |
| Phone |
8328569028 |
| Fax |
|
| Email |
maaziz868@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Gudise Sambi Reddy |
| Designation |
Professor |
| Affiliation |
Esic medical College and hospital |
| Address |
Department of physical medicine and rehabilitation, esic medical College and hospital, sanathnagar, hyderabad, telangana
Hyderabad
TELANGANA
500038
India |
| Phone |
9848260927 |
| Fax |
|
| Email |
sambireddy57@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Gudise Sambi Reddy |
| Designation |
Professor |
| Affiliation |
Esic medical College and hospital |
| Address |
Department of physical medicine and rehabilitation, esic medical College and hospital, sanathnagar, hyderabad, telangana
Hyderabad
TELANGANA
500038
India |
| Phone |
9848260927 |
| Fax |
|
| Email |
sambireddy57@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Department of physical medicine and rehabilitation, esic medical College and hospital, sanathnagar, hyderabad ,telangana, India pincode-500038. |
|
|
Primary Sponsor
|
| Name |
dr Mohd Abdul Aziz |
| Address |
Postgraduate student, department of physical medicine and rehabilitation, esic medical College and hospital, sanathnagar ,hyderabad, telangana,india, pincode 500038 |
| Type of Sponsor |
Other [Principal investigator ] |
|
|
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 Mohd Abdul Aziz |
Esic medical College and hospital,sanathnagar, hyderabad |
Room no: 5
Department of physical medicine and rehabilitation, esic medical College and hospital, sanathnagar, hyderabad, telangana
Hyderabad
TELANGANA |
8328569028
maaziz868@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee, ESIC medical College & hospital and ESIC super speciality hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M170||Bilateral primary osteoarthritis of knee, (2) ICD-10 Condition: M171||Unilateral primary osteoarthritisof knee, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
AUTOLOGOUS PRP THERAPY IN GRADE 2 AND GRADE 3 OA KNEE |
3 to 5ml PRP (obtained from 30ml of blood through centrifuge) is given in to the affected knee joint(grade 2 and grade 3 OA knee), weekly once for 4 weeks and its effectiveness is recorded in terms of pain relief, cartilage growth and functional improvement in knee joint. post 4 sessions of PRP therapy patient is followed up every month for 3 months to assess the outcome of the therapy. Pain is measured with VAS score, functional improvement is assessed with the help of WOMAC score and cartilage growth is assessed with the help of MRI prior starting the treatment and 3 months post last PRP session. |
| Comparator Agent |
N/A |
N/A |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients who are willing for follow up, confirmed cases of osteoarthritis knee, kellgren Lawrence radiological grade 2 and grade 3 osteoarthritis knee |
|
| ExclusionCriteria |
| Details |
Patients with grade 1 and grade 4 osteoarthritis knee,patients with heart diseases using antiplatelets and anti-coagulation medications , secondary osteoarthritis knee, sepsis , platelets disorders or diseases , any intervention in last 3 months , any immunodeficiency, autoimmune, collagen vascular diseases , any contraindications for MRI , any contraindications to platelets rich plasma therapy. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement in terms of pain control, functional improvement, and cartilage growth. |
after baseline evaluation patients are given PRP injections into the affected knee joint every week for 4 weeks,then they are followed up every month for 3 months. At follow up patients are asked about subjective improvement and assessed for functional improvement and at the end of 3 months post last dose of PRP INJECTION structural outcome is evaluated with the help of MRI. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="23"
Sample Size from India="23"
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 3 |
|
Date of First Enrollment (India)
|
28/09/2025 |
| 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="1"
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
|
This is prospective interventional single arm study to know the effectiveness of autologous platelet rich plasma therapy in grade 2 and grade 3 osteoarthritis knee in terms of controlling the pain, improving functions and structural outcome. Eligible candidates undergo radiographic screening,blood screening. candidates are explained about the whole protocol and consent is taken for the same. baseline assesment is done with VAS, 6MWT, WOMAC SCORES and MRI SCANS. Four doses of PLATELET RICH PLASMA is given into the affected knee joint each one week apart. VAS, 6MWT, WOMAC SCORES are assessed at 4 weeks,8 weeks and 12 weeks after last dose of prp therapy. Structural outcome in knee joint is assessed with MRI sequences at the end of 12 weeks.
The main objective of this study is to quantify the effect of platelets rich plasma therapy on structural improvement of articular cartilage of knee joint using MRI sequencing in addition to pain relief, functional outcome. |