| CTRI Number |
CTRI/2025/10/096086 [Registered on: 15/10/2025] Trial Registered Prospectively |
| Last Modified On: |
14/10/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Non-randomized, Multiple Arm Trial |
|
Public Title of Study
|
Efficacy of intra-articular ozone, steroid and dextrose in improving the symptoms of osteoarthritis knee |
|
Scientific Title of Study
|
The comparative effectiveness of intraarticular steroid, ozone and prolotherapy in improving functionality, quality of life, pain and articular cartilage thickness in patients suffering from moderate knee osteoarthritis: A prospective observational 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 |
Lt Col Dr Mohit Kataruka |
| Designation |
Assosciate Professor |
| Affiliation |
AIIMS Kalyani |
| Address |
Room 115, First Floor, OPD Building, AIIMS Kalyani.
Nadia
WEST BENGAL
741245
India |
| Phone |
8729912916 |
| Fax |
|
| Email |
mohit.pmr@aiimskalyani.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Souvik Bhattacharjee |
| Designation |
Senior Resident |
| Affiliation |
AIIMS Kalyani |
| Address |
Room 117, First Floor, OPD Building, AIIMS Kalyani
Nadia
WEST BENGAL
741245
India |
| Phone |
7044544347 |
| Fax |
|
| Email |
souvik.vicky@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Souvik Bhattacharjee |
| Designation |
Senior Resident |
| Affiliation |
AIIMS Kalyani |
| Address |
Room 117, First Floor, OPD Building, AIIMS Kalyani.
Nadia
WEST BENGAL
741245
India |
| Phone |
7044544347 |
| Fax |
|
| Email |
souvik.vicky@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
AIIMS Kalyani |
| Address |
NH-34 Connector, Basantapur, Saguna, Kalyani, Nadia, 741245 |
| Type of Sponsor |
Government medical college |
|
|
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 Souvik Bhattacharjee |
AIIMS kalynai |
Department of Physical Medicine and Rehabilitation, First floor, Room No. 117.
Nadia
WEST BENGAL |
7044544347
souvik.vicky@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee All India Institute of Medical Sciences, Kalyani |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M171||Unilateral primary osteoarthritisof knee, (2) ICD-10 Condition: M171||Unilateral primary osteoarthritisof knee, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Dextrose-prolotherapy and ozone |
Group B (Prolotherapy Group): will receive 3 doses of 10 ml of 25 % dextrose, in a 2-week interval
Group C (Ozone Group): will receive 3 doses of 10 ml ozone (30µg/ml), in a 2-week interval |
| Comparator Agent |
Steroid |
Group A (Steroid Group) will receiveaSingle dose of Methyl prednisolone injection (40 mg). |
|
|
Inclusion Criteria
|
| Age From |
45.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Clinically diagnosed as an OA knee according to the American College of Rheumatology (ACR) criteria
2. Radiographic Kellgren-Lawrence grades2 and 3
3. Knee pain with pain intensity of more or equal to 4 of 10 on a visual analoguescale,most days for at least 3 months, refractory to conservative treatments
|
|
| ExclusionCriteria |
| Details |
1. Severe neurological or psychiatric diseases
2. History of any steroid injection within 3 months
3. Previous knee surgeries (unicompartmental or total arthroplasty, debridement arthroscopy, osteotomies)
4. Persons using anticoagulants or with bleeding disorders
5. Persons with uncontrolled diabetes and hypertension
6. Any history of allergy or superficial skin infection.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Visual analog scale |
At baseline, after 1month, after 4 month and after 6 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Western Ontario and McMaster Universities Osteoarthritis Index |
1 months, 4 months and 6 months |
| Oxford knee score |
1 months, 4 months, 6 months |
|
|
Target Sample Size
|
Total Sample Size="63"
Sample Size from India="63"
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 4 |
|
Date of First Enrollment (India)
|
03/11/2025 |
| 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="3"
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
|
Knee osteoarthritis is a chronic degenerative condition characterised by articular cartilage degeneration, subchondral sclerosis in middle-aged and elderly people. It causes functional limitations to the patient and hampers their day-to-day activities immensely. The worldwide prevalence of OA knee is around 3.8% , affecting more than 25% of people above 45 years. The treatment approach is divided into surgical and conservative treatment. Because of the cost and post-surgical complications, and limitations, many of the people suffering from OA of the knee accept conservative management. Along with the pharmacological management, intra-articular injection therapy is one of the most common procedures for alleviating the symptoms of OA knee. Among the recommended intra-articular injections,corticosteroids, dextrose, hyaluronic acid (HA), platelet-rich plasma and ozone are used.Inrecent years, some studies have also documented the effectiveness of intraarticular mesenchymal stem cells, bone marrow aspirate and stromal vascular fraction. |