| CTRI Number |
CTRI/2025/11/097338 [Registered on: 13/11/2025] Trial Registered Prospectively |
| Last Modified On: |
12/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Biological
Yoga & Naturopathy |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A comparative study of Yoga-enhanced Platelet-Rich Plasma and Conventional Platelet-Rich Plasma therapy in improving growth factor levels and knee function in early osteoarthritis. |
|
Scientific Title of Study
|
Y-PRP Trial : Yoga enhanced PRP vs Conventional PRP- Growth factor assessment and functional outcomes in early knee osteoarthritis |
| 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 Sandeep Patel |
| Designation |
Associate Professor |
| Affiliation |
PGIMER |
| Address |
Department of Orthopaedic Surgery
PGIMER
Sec 12 Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9901440404 |
| Fax |
|
| Email |
sandeepdrpatel@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
A Ramachandra Dora |
| Designation |
Junior Resident |
| Affiliation |
PGIMER |
| Address |
Department of Orthopaedic Surgery
PGIMER
Sec 12 Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9437374275 |
| Fax |
|
| Email |
rjintu001@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
A Ramachandra Dora |
| Designation |
Junior Resident |
| Affiliation |
PGIMER |
| Address |
Department of Orthopaedic Surgery
PGIMER
Sec 12 Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9437374275 |
| Fax |
|
| Email |
rjintu001@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
CCRYN |
| Address |
CCRYN
6th floor research block b
PGIMER
Sector 12
Chandigarh 160012 |
| Type of Sponsor |
Research institution |
|
|
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 Suresh Kumar |
PGIMER Chandigarh |
Department of Orthopaedic Surgery
Counter no 15
PGIMER Chandigarh
Chandigarh
CHANDIGARH |
01722755266
iecpgi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| PGIMER CHANDIGARH |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M170||Bilateral primary osteoarthritis of knee, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Intra articular injection of PRP in knees |
The injection will be given on the same day of preparation preferably within 30 minutes of preparation. The patients will be made to lie down supine with the knee in full extension. Under sterile conditions, the PRP injection will be given with an 18 gauge needle into the suprapatellar pouch through a superolateral approach. The patients will be instructed to flex and extend the knee repeatedly at least ten times, and then discharged after 30 minutes of observation. |
| Comparator Agent |
Intra articular injection of PRP in knees after doing yoga |
The injection will be given on the same day of preparation preferably within 30 minutes of preparation. The patients will be made to lie down supine with the knee in full extension. Under sterile conditions, the PRP injection will be given with an 18 gauge needle into the suprapatellar pouch through a superolateral approach. The patients will be instructed to flex and extend the knee repeatedly at least ten times, and then discharged after 30 minutes of observation. |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Symptomatic Primary OA Knee OA classified as Grade 1 & 2 who have responded to conservative treatment for 6 months
|
|
| ExclusionCriteria |
| Details |
Secondary OA
Grade 3& 4 OA
immunocompromised status or uncontrolled diabetes
bronchial Asthma or known cardiac disease
Symptomatic OA affecting joint other than knees
Recent 6 month intra articular steroids
anti coagulation therapy
active or previous infections
unwilling to follow exercise protocol/ not consenting for intervention |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study the effect of specific yoga protocol on the cell count & growth factor yield of PRP |
Check whether PRP has better Growth Factor post yoga therapy |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare functional outcomes in terms of WOMAC, VAS, DASS 21 score between conventional & yoga enhanced PRP |
At 6 weeks, 3 months & 6 months |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
30/11/2025 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Patients presenting with symptoms of knee pain, crepitus, and/or stiffness will be assessed and recruited in the Orthopaedics OPD in PGIMER. A detailed history, general health check-up and a clinical examination of the knee will be performed for each subject to make a differential diagnosis. This examination will include a general physical examination, knee examination, and x-ray of both knees to confirm the diagnosis of OA. The x-rays will be taken in two orthogonal views: a standing anteroposterior and a 30-60° accurate lateral view, through a digital radiographic machine and print on a standard x-ray film will be taken for analysis and grading of OA. Patients with symptomatic KL grade 1 or 2 knee OA fulfilling the inclusion criteria will be recruited for the study after taking written informed consent. All patients will be assessed for pain, stiffness, and functional status using a validated score for knee OA i.e. Western Ontario and McMaster Universities Arthritis Index Questionnaire (WOMAC) score29. Pain in the affected knee joint will be assessed using the Visual Analog Scale(VAS)30. Psychological Scoring will also be done using DASS 2131 Scale to rule out any distress or anxiety-related factors which may affect patient satisfaction after the injection.
|