| CTRI Number |
CTRI/2026/01/100407 [Registered on: 06/01/2026] Trial Registered Prospectively |
| Last Modified On: |
05/01/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparison of two injection treatments with conventional management in treatment of knee pain |
|
Scientific Title of Study
|
Platelet rich plasma (PRP) vs Prolotherapy in knee osteoarthritis: A single-center 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 |
Dachepalli Satya Sreekar |
| Designation |
Senior Resident |
| Affiliation |
All India Institute of Medical Sciences, Bibinagar |
| Address |
AIIMS, Bibinagar
Hyderabad Metropolitan Region,
Bibinagar,
Dist. Yadadri Bhuvanagiri
Nalgonda
TELANGANA
508126
India |
| Phone |
7306980044 |
| Fax |
|
| Email |
sreekardachepalli@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dachepalli Satya Sreekar |
| Designation |
Senior Resident |
| Affiliation |
All India Institute of Medical Sciences, Bibinagar |
| Address |
AIIMS, Bibinagar
Hyderabad Metropolitan Region,
Bibinagar,
Dist. Yadadri Bhuvanagiri
TELANGANA
508126
India |
| Phone |
7306980044 |
| Fax |
|
| Email |
sreekardachepalli@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dachepalli Satya Sreekar |
| Designation |
Senior Resident |
| Affiliation |
All India Institute of Medical Sciences, Bibinagar |
| Address |
AIIMS, Bibinagar
Hyderabad Metropolitan Region,
Bibinagar,
Dist. Yadadri Bhuvanagiri
TELANGANA
508126
India |
| Phone |
7306980044 |
| Fax |
|
| Email |
sreekardachepalli@gmail.com |
|
|
Source of Monetary or Material Support
|
| AIIMS Bibinagar
Bibinagar,
Hyderabad Metropolitan Region,
Dist. Yadadri Bhuvanagiri,
Telangana - 508126 |
|
|
Primary Sponsor
|
| Name |
AIIMS Bibinagar |
| Address |
Bibinagar,
Hyderabad Metropolitan Region,
Dist. Yadadri Bhuvanagiri,
Telangana - 508126 |
| 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 Dachepalli Satya Sreekar |
AIIMS Bibinagar |
Bibinagar,
Hyderabad Metropolitan Region,
Dist. Yadadri Bhuvanagiri,
Telangana - 508126
Nalgonda
TELANGANA |
7306980044
sreekardachepalli@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, AIIMS Bibinagar |
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 |
Conservative treatment |
Conservative management with Non-steroidal anti-inflammatory drugs and exercise is prescribed |
| Intervention |
Dextrose prolotherapy |
25% Dextrose is diluted with Bupivacaine and injected into tender points periarticularly around the knee |
| Intervention |
Platelet Rich Plasma (PRP) |
Intraarticular PRP injection is done using landmark guided technique |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Knee osteoarthritis diagnosed according to American College of Rheumatology criteria
2. Kellegren-Lawerence grades 2 and 3 on x-ray imaging
3. Knee pain for more than 3 months not responding to conservative management |
|
| ExclusionCriteria |
| Details |
1. Presence of knee effusion
2. Local infection at the injection site
3. Evidence of systemic infection
4. Previous diagnosis of inflammatory arthropathy |
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Visual Analog Scale |
Before the first injection
2 weeks, 6 weeks and 3 months after the first injection |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Western Ontario and McMaster Universities Osteoarthritis index |
Before the first injection
2 weeks, 6 weeks and 3 months after the first injection |
|
|
Target Sample Size
|
Total Sample Size="210"
Sample Size from India="210"
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)
|
16/01/2026 |
| 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="0"
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 significantly affects the quality of life and functional ability of individuals. The use of
intra-articular Platelet Rich Plasma (PRP) injections has gained considerable
attention as a therapeutic option for knee OA. Prolotherapy, an
injection-based treatment involving the administration of a proliferative
agent, such as dextrose, has been investigated as a non-surgical intervention
for knee OA. This trial aims to compare the outcomes of these two
procedures on pain and function with conservative management.
|