| CTRI Number |
CTRI/2025/12/099447 [Registered on: 18/12/2025] Trial Registered Prospectively |
| Last Modified On: |
18/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Biological |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Does adding ozone to platelet therapy give better relief in knee arthritis |
|
Scientific Title of Study
|
Effectiveness of ultrasound guided intra-articular injection of platelet rich plasma with ozone in comparison with platelet rich plasma in improving knee function and quality of life in patients with osteoarthritis of the knee: A randomized controlled trial |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Songku manyu |
| Designation |
Postgraduate trainee |
| Affiliation |
Regional Institute of Medical Sciences |
| Address |
Department of Physical Medicine and Rehabilitation, Regional Institute of Medical Sciences, Imphal , Manipur , Imphal west
Imphal West
MANIPUR
795004
India |
| Phone |
6909424808 |
| Fax |
|
| Email |
songkumanyu1003@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Longjam Nilachandra Singh |
| Designation |
Professor |
| Affiliation |
Regional Institute of Medical Sciences |
| Address |
Department of Physical Medicine and Rehabilitation, OPD Complex, Regional Institute of Medical Sciences
Imphal
Manipur
Imphal West
MANIPUR
795004
India |
| Phone |
7005019045 |
| Fax |
|
| Email |
drnilalong@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Longjam Nilachandra Singh |
| Designation |
Professor |
| Affiliation |
Regional Institute of Medical Sciences |
| Address |
Department of Physical Medicine and Rehabilitation, OPD Complex, Regional Institute of Medical Sciences
Imphal
Manipur
Imphal West
MANIPUR
795004
India |
| Phone |
7005019045 |
| Fax |
|
| Email |
drnilalong@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Physical Medicine and Rehabilitation, Regional Institute of Medical Sciences, Imphal, Manipur, India 795004 |
|
|
Primary Sponsor
|
| Name |
Dr Songku Manyu |
| Address |
Regional Institute of Medical Sciences, Lamphelpat, Imphal, Manipur, India 795004 |
| 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 Songku Manyu |
Regional Institute of Medical Sciences, Imphal |
Department of Physical Medicine and Rehabilitation, OPD Complex
Imphal West
MANIPUR |
6909424808
songkumanyu1003@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Research ethics board RIMS |
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 |
| Comparator Agent |
Platelet rich plasma |
PRP(4ml) will be given intra-articular as a one time dose and observed in follow up. Only one dose of injection PRP will be given to each patient during the study. |
| Intervention |
Platelet rich plasma with ozone |
Platelet rich plasma(4ml) with ozone(10ml) will be given intra-articularly. Passive flexion-extension movement of the knee will be done to distribute ozone throughout the joint. Only one dose of injection PRP with ozone shall be given to each patient during the study. |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Person with knee osteoarthritis as per 2016 revised ACR criteria for early diagnosis of osteoarthritis
Age group 40-70 years
Duration of symptoms more than e months
Knee OA graded 2 to 3 according to KL grading
Willingness to participate in the study and comply with treatment and follow up |
|
| ExclusionCriteria |
| Details |
Bleeding disorder
Local or systemic infections
Trauma
Uncontrolled diabetes and hypertension/ systemic disease
Recent myocardial infarction or stroke
Intra-articular steroid injection during 3 months
Ongoing pregnancy |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| WOMAC index |
Baseline, 1week, 4week, 12week, 24week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| SF-36 health survey instrument |
Baseline, 1week, 4week, 12week, 24week |
|
|
Target Sample Size
|
Total Sample Size="64"
Sample Size from India="64"
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
|
N/A |
|
Date of First Enrollment (India)
|
29/12/2025 |
| 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
|
Knee osteoarthritis is a progressive chronic degenerative musculoskeletal disease of the knee joint which is the commonest rheumatological condition causing pain, functional impairment, chronic disabilities , and diminished quality of life. Diagnosis will be made by the 2016 ACR criteria for early diagnosis of knee osteoarthritis. Non operative treatment includes lifestyle modification, muscle strengthening excercise, physical therapy, NSAIDs, platelet rich plasma(PRP), normal saline, and ozone therapy. Treatment should aim to relieve pain, improve function, limit disabilities, and improve quality of life. PRP is an Otho-biologicals that has anti-inflammatory, immunomodulatory, anti-edemic and anti-oxidative effects whereas ozone has anti-inflammatory, analgesics effects and rapid healing process, both results in improvement in knee function and quality of life with fewer adverse effects. Both have recently gained popularity in the treatment of knee osteoarthritis. Due to confined number of studies available there is enduring need to study the combine effects of platelet rich plasma with ozone therapy. This study is a randomized controlled trial which shall be conducted in the Department of Physical Medicine and Rehabilitation to determine the effectiveness of ultrasound guided intra-articular injection of PRP with ozone in comparison with PRP in the treatment of patients with grade 2 and 3 osteoarthritis of the knee osteoarthritis of the knee. A sample size of 64 patients of grade 2 and 3 osteoarthritis of knee attending PMR OPD, RIMS with knee pain will be chosen and randomized. Outcomes will be measured using SF-36 and WOMAC at baseline, and post-intervention at 1st, 4th, 12th and 24th weeks. For statiscal analysis, the Chi-square test, independent t-test, and repeated measure ANOVA will be used and a p-value<0.05 will be taken as significant. |