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CTRI Number  CTRI/2025/04/085875 [Registered on: 29/04/2025] Trial Registered Prospectively
Last Modified On: 01/05/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Other (Specify) [ozone]  
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Intra-articular (Knee)injection of Ozone as a treatment for pain in patients with rheumatoid arthritis  
Scientific Title of Study   Comparing The Efficacy Of Intra-Articular Ozone Injection Vs Intra-Articular Corticosteroid Injection In Knee Synovitis In Rheumatoid Arthritis. 
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 Deshik Nekkalapudi 
Designation  Post Graduate Trainee 
Affiliation  AIIMS Bhubaneswar 
Address  Department of Physical Medicine and Rehabilitation, AIIMS Bhubaneswar, Sijua, Patrapada

Khordha
ORISSA
751019
India 
Phone  8105000443  
Fax    
Email  deshiknekkalapudi@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Jagannatha Sahoo 
Designation  Professor and Head of Department 
Affiliation  AIIMS Bhubaneswar 
Address  Department of Physical Medicine and Rehabilitation, AIIMS Bhubaneswar, Sijua, Patrapada

Khordha
ORISSA
751019
India 
Phone  9437081814  
Fax    
Email  pmr_jagannath@aiimsbhubaneswar.edu.in  
 
Details of Contact Person
Public Query  
Name  Dr Deshik Nekkalapudi 
Designation  Junior Resident 
Affiliation  AIIMS Bhubaneswar 
Address  Department of Physical Medicine and Rehabilitation, AIIMS Bhubaneswar, Sijua, Patrapada

Khordha
ORISSA
751019
India 
Phone  8105000443  
Fax    
Email  deshiknekkalapudi@gmail.com  
 
Source of Monetary or Material Support  
AIIMS Bhubaneswar, Sijua Patrapada, Khordha 751019 
 
Primary Sponsor  
Name  AIIMS Bhubaneswar 
Address  Department of Physical Medicine & Rehabilitation AIIMS Bhubaneswar Sijua, Patrapada 
Type of Sponsor  Research institution and hospital 
 
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 Deshik Nekkalapudi  AIIMS Bhubaneswar  Room 4, Department of Physical Medicine and Rehabilitation, AIIMS Bhubaneswar
Khordha
ORISSA 		 8105000443

deshiknekkalapudi@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
AIIMS Institutional Ethics Committee   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M059||Rheumatoid arthritis with rheumatoid factor, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Methyl Prednisalone  Patients in this group will be injected 2ml of Methyl Prednisalone Acetate(Depopred) 40 mg/ml mixed with 8 ml of normal saline intraarticularly in the knee once 
Intervention  Ozone  Patients in this group will be injected with 10 ml ozone oxygen(O3 O2) with 40 ug/ml concentration (made by generator) intraarticularly in the knee a total of three times, once weekly 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  1. Patients age greater than 18 years, fulfilling the clinical criteria of rheumatoid arthritis defined by ACR EULAR diagnostic criteria greater or equal to 6/10
2. Increased knee pain and stiffness for at last 3 months.
3. Pain intensity on Visual Analog Scale greater than or equal to 4 out of
10 at knee joint.
4. RA diagnosed and patient has taken DMARDs for
more than 6 months, with no alteration in dosage for the last 3 months. 
 
ExclusionCriteria 
Details  1. Diabetes mellitus
2. Pregnancy
3. Previous arthroplasty
4. Intra articular or peri articular injection in the past three months
5. Body mass index more than 40.
6. Any disease flare in the last 3 months
7. Any local lesion in the injection site.
8. Coagulation disorder, Allergic reaction to local anesthetic, ozone, and steroid in the past
9. Switch to any other treatment modality during the 12 weeks of follow up in the post
injection period.
10. Any patient on systemic Biological DMARDs 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Centralized 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare the improvement in pain in the intervened knee (measured by VAS 100mm scale)
following intra-articular injection of ozone therapy against intra-articular injection of
corticosteroid in rheumatoid arthritis patients with synovitis of knee 		 at 2, 6 and 12 weeks post intervention 
 
Secondary Outcome  
Outcome  TimePoints 
Improvement in quality of life and functional improvement   at 2, 6 and 12 weeks post intervention 
measure decrease in synovial hypertrophy in injected knee  at 2, 6 and 12 weeks post intervention 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
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)   16/06/2025 
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 - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [deshiknekkalapudi@gmail.com].

  6. For how long will this data be available start date provided 01-01-2027 and end date provided 31-12-2030?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary
Modification(s)  
This study is a randomized double blinded control trial to compare the efficacy and advantage of offering intra articular ozone injection instead of intra articular corticosteroid injection in improving pain and knee synovitis in patients with rheumatoid arthritis The primary outcome will be the decrease in pain (as VAS score) at 2, 6 and 12 weeks post final injection. The secondary outcomes will be improvement in quality of life via EuroQOL and RAPS scale and decrease in synovial hypertrophy as per EULAR-OMERACT criteria.m
 
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