| CTRI Number |
CTRI/2026/01/101408 [Registered on: 16/01/2026] Trial Registered Prospectively |
| Last Modified On: |
15/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To find out which is better between Dextrose Prolotherapy injection versus Triamcinolone Intraarticular Injection in patients with Osteoarthritis of Knee joint |
|
Scientific Title of Study
|
A RANDOMIZED COMPARATIVE STUDY TO EVALUATE THE EFFECTIVENESS OF DEXTROSE PROLOTHERAPY AND TRIAMCINOLONE INTRAARTICULAR INJECTION ON PAIN AND FUNCTION IN PATIENTS WITH KNEE OSTEOARTHRITIS AT SMS MEDICAL COLLEGE AND HOSPITAL JAIPUR |
| 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 MAHESH KUMAR MEENA |
| Designation |
AASSOCIATE PROFESSOR |
| Affiliation |
Department of physical medicine and rehabilitation |
| Address |
Department of physical medicine and rehabilitation, S.M.S Medical College and Attached
Hospitals, Adarsh Nagar, Jaipur
S.M.S MEDICAL COLLEGE AND ATTACHED HOSPITALS
Jaipur
RAJASTHAN
302004
India |
| Phone |
9828373677 |
| Fax |
|
| Email |
maheshbagdi1970@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR MAHESH KUMAR MEENA |
| Designation |
AASSOCIATE PROFESSOR |
| Affiliation |
Department of physical medicine and rehabilitation |
| Address |
Department of physical medicine and rehabilitation, S.M.S Medical College and Attached
Hospitals, Adarsh Nagar, Jaipur
S.M.S MEDICAL COLLEGE AND ATTACHED HOSPITALS
Jaipur
RAJASTHAN
302004
India |
| Phone |
9828373677 |
| Fax |
|
| Email |
maheshbagdi1970@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr PRASHANT |
| Designation |
Junior resident |
| Affiliation |
Department of physical medicine and rehabilitation |
| Address |
Department of physical medicine and rehabilitation, S.M.S Medical College and Attached
Hospitals, Adarsh Nagar, Jaipur
S.M.S MEDICAL COLLEGE AND ATTACHED HOSPITALS
Jaipur
RAJASTHAN
302094
India |
| Phone |
9461629049 |
| Fax |
|
| Email |
Pravesh1212pk@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of physical medicine and rehabilitation, Sawai Man Singh Medical College and Attached Hospitals, Jaipur |
|
|
Primary Sponsor
|
| Name |
Department of physical medicine and rehabilitation |
| Address |
Sawai Man Singh Medical College and Attached Hospitals, JaipurJLN Marg, Adarsh Nagar, Jaipur |
| 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 prashant |
Sms Mmedical College And Hhospital jaipur |
Department of physical medicine and rehabilitation sms Medical College and hospital jaipur
Jaipur
RAJASTHAN |
9461629049
pravesh1212pk@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Office of ethics committee, SMS Medical college and Attached Hospitals jaipur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
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 |
Dextrose injection |
injection of 3ml solution containing 2ml dextrose 25% and 1ml lidocaine 2%. The dextrose concentration in the final solution is about 16% in affected knee |
| Intervention |
Steroid injection |
3ml solution containing 2ml triamcinolone 20mg/ml and 1ml lidocaine 2% in affected knee |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
1. Those who willing to give informed written consent for participating in the study
2. Adult patients of aged 40-75 years group.
3. Knee osteoarthritis patients with radiologic grading of 2 and 3 according to kellgren lawrence (KL) criteria, in unilateral knee. |
|
| ExclusionCriteria |
| Details |
1. History of any intra-articular injection, knee surgery over the past three months.
2. Systemic comorbidities such as uncontrolled diabetes, rheumatologic disorders etc.
3. Those with a history of allergy to any component of the injectate or with any medical or surgical condition which interferes with the injection technique.
4. Patient is part of any other study. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the comparative effectiveness of Dextrose Prolotherapy injection versus Triamcinolone Intraarticular Injection in patients with Osteoarthritis of Knee joint in terms of: |
Grade 2 and 3 knee osteoarthritis |
|
|
Secondary Outcome
|
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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)
|
27/01/2026 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
27/01/2026 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="4"
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
|
In the study To compare between dextrose prolotherapy injection and Triamcinolone Intraarticular Injection on Pain and Function in Patients with Knee Osteoarthritis |