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CTRI Number  CTRI/2025/12/099283 [Registered on: 17/12/2025] Trial Registered Prospectively
Last Modified On: 16/12/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Ozone versus Hyaluronic acid in osteoarthritis of knee: which one is better for your knee? 
Scientific Title of Study   Effectiveness of ultrasound guided intra-articular injections of ozone and hyaluronic acid in improving pain and physical function in patients with primary osteoarthritis of 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  Yambem Hellena Devi 
Designation  Postgraduate trainee 
Affiliation  Regional Institute of Medical Sciences, Imphal, Manipur 
Address  Department of Physical Medicine and Rehabilitation, Regional Institute of Medical Sciences, Imphal, Manipur

Imphal West
MANIPUR
795004
India 
Phone  7005943624  
Fax    
Email  hellenayambem7245@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Nongmaithem Romi Singh 
Designation  Professor 
Affiliation  Regional Institute of Medical Sciences, Imphal, Manipur 
Address  Department of Physical Medicine and Rehabilitation, Regional Institute of Medical Sciences, Imphal, Manipur

Imphal West
MANIPUR
795004
India 
Phone  9436025822  
Fax    
Email  dr.romi.singh@gmail.com  
 
Details of Contact Person
Public Query  
Name  Yambem Hellena Devi 
Designation  Postgraduate trainee 
Affiliation  Regional Institute of Medical Sciences, Imphal, Manipur 
Address  Department of Physical Medicine and Rehabilitation, RIMS, Imphal, Manipur

Imphal West
MANIPUR
795004
India 
Phone  7005943624  
Fax    
Email  hellenayambem7245@gmail.com  
 
Source of Monetary or Material Support  
Department of Physical Medicine and Rehabilitation, Regional Institute of Medical Sciences, Imphal, Manipur 795004 India 
 
Primary Sponsor  
Name  No Primary Sponsor 
Address  Not applicable 
Type of Sponsor  Other [Not applicable] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Yambem Hellena Devi  Regional Institute of Medical Sciences, Imphal  Department of Physical Medicine and Rehabilitation, RIMS, Imphal, Manipur
Imphal West
MANIPUR 		 7005943624

hellenayambem7245@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  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M171||Unilateral primary osteoarthritisof knee,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Hyaluronic acid  High molecular weight hyaluronic acid (8mg) will be given intra-articularly into knee joint under ultrasound guidance. 
Intervention  Ozone  10ml of a mixture of Oxygen-Ozone with concentration of 20mcg/ml will be given intra-articularly into knee joint under ultrasound guidance 
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Age group 40 to 65 years

Patients with primary osteoarthritis of knee fulfilling 2016 ACR (American college
of Rheumatology) revised criteria for early diagnosis of knee OA

Osteoarthritis of knee with Kellgren-Lawrence grade 1,2 and 3

Willingness to participate in the study and comply with treatment and follow up

VAS more than 4 
 
ExclusionCriteria 
Details  Recent knee trauma or knee surgery

Knee infection

Cognitive impairment

Intra-articular injection of steroid/PRP/hyaluronic acid during past 3 months

BMI more than 30
Bleeding disorders

Recent myocardial infarction or stroke

Uncontrolled systemic diseases
 
 
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 
Pain by VAS score  Baseline, 1 month, 3 months and 6 months 
 
Secondary Outcome  
Outcome  TimePoints 
Physical function by WOMAC score  Baseline, 1 month, 3 months,
6 months 
 
Target Sample Size   Total Sample Size="56"
Sample Size from India="56" 
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)   27/12/2025 
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   Osteoarthritis of knee is a chronic degenerative disease with loss of joint surface cartilage leading to pain, stiffness and joint deformity affecting one’s day to day activities. The aim of my study is to compare the effectiveness of ultrasound guided intra-articular injections of ozone and hyaluronic acid in improving pain and physical function in patients with primary osteoarthritis of knee. The VAS and WOMAC will be measured before treatment and at the end of 1 month, 3 months and 6 months post intervention. Data will be analyzed using SPSS 25 version. For descriptive statistics, mean, standard deviation and percentage will be used. For comparing categorical data, Chi-square test will be used. Independent t-test will be used for comparison between the groups and mean changes from baseline within each group will be compared by repeated measures ANOVA test. A p-value < 0.05 will be considered statistically significant. 
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