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CTRI Number  CTRI/2025/12/098365 [Registered on: 03/12/2025] Trial Registered Prospectively
Last Modified On: 23/11/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   “A study comparing injection-based treatment (hyaluronic acid) and routine physiotherapy exercises on knee pain and inflammation in patients with knee osteoarthritis. 
Scientific Title of Study   Comparison of Effect on Serum Inflammatory Markers Following Viscosupplementation Versus Conventional Management in Knee Osteoarthritis 
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 Ishita 
Designation  PG Resident 
Affiliation  VMMC and Safdarjung hospital  
Address 
Room No. 27, Department of Physical Medicine and Rehabilitation, Vardhman Mahavir Medical College and Safdarjung Hospital, Ring Roada
South
DELHI
110029
India 
Phone  9899675868  
Fax    
Email  ishitaladha3@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Ajay Gupta 
Designation  Director Professor& Head of Department  
Affiliation  Vardhman Mahavir Medical College and Safdarjung hospital  
Address  Room No. 27, Department of Physical Medicine and Rehabilitation, Vardhman Mahavir Medical College and Safdarjung Hospital, Ring Roada

South
DELHI
110029
India 
Phone  9899675868  
Fax    
Email  dragupta2013@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Ishita 
Designation  PG Resident 
Affiliation  VMMC and Safdarjung hospital  
Address  Room No. 27, Department of Physical Medicine and Rehabilitation, Vardhman Mahavir Medical College and Safdarjung Hospital, Ring Roada

South
DELHI
110029
India 
Phone  9899675868  
Fax    
Email  ishitaladha3@gmail.com  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  Vardhman Mahavir Medical College and Safdarjung Hospital 
Address  Department of Physical Medicine and Rehabilitation, Ring Road (Near AIIMS), New Delhi – 110029, Delhi, India. 
Type of Sponsor  Government medical college 
 
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 Ishita Ladha  VMCC and Safdarjung Hospital  H693+H6W NH 48 near AIIMS Hospital Ansari Nagar West New Delhi Delhi 110029
New Delhi
DELHI 		 09899675868

ishitaladha3@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ethics committee of VMMC and safdarjung Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  • Patients of either gender, diagnosed with primary OA knee of tibio- femoral joint as defined by ACR clinical and radiographic criteria. 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Conventional Management (Non-viscosupplementation)  Participants in the comparator arm will receive conventional management comprising isometric quadriceps and hamstrings strengthening exercises, physical modalities (such as deep heat therapy), topical analgesics, and paracetamol 1000 mg SOS.” 
Intervention  Intra-articular High Molecular Weight Hyaluronic Acid (HMW-HA)  Participants in the intervention arm will receive a single intra-articular injection of High Molecular Weight Hyaluronic Acid (90 mg/3 mL) into the affected knee under aseptic precautions, along with isometric quadriceps and hamstrings strengthening exercises for 4 weeks 
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Adults of either gender with primary tibiofemoral knee osteoarthritis fulfilling ACR clinical and radiographic criteria, radiographic Kellgren Lawrence grade II or III, and body mass index less than 40, who are willing to provide written informed consent. 
 
ExclusionCriteria 
Details  History of bleeding disorders; any acute injury or recent surgery within the past three months; use of anti-inflammatory drugs for more than seven days in the past four weeks or within five days before starting the trial; current use of corticosteroids or immunosuppressive drugs; presence of any acute co-existing illness; prior hyaluronic acid injection or unwillingness to receive hyaluronic acid; any overlying skin infection; venous or lymphatic stasis. 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
   
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="118"
Sample Size from India="118" 
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)   10/01/2026 
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="0"
Months="3"
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 the knee is a common degenerative joint disorder associated with cartilage degradation and low grade inflammation leading to pain and functional limitation. Intra articular hyaluronic acid injection, also known as viscosupplementation, is used to improve joint lubrication and has shown potential anti inflammatory effects. This randomized comparative trial aims to compare the effect of viscosupplementation versus conventional management on serum inflammatory markers interleukin 6 and tumor necrosis factor alpha as well as functional outcomes in patients with primary knee osteoarthritis. A total of 118 participants fulfilling American College of Rheumatology clinical and radiographic criteria for grade II or III knee osteoarthritis will be randomly assigned into two groups. The study group will receive a single intra articular injection of high molecular weight hyaluronic acid along with exercise therapy, while the control group will receive exercise therapy and physical modalities only. Serum interleukin 6, tumor necrosis factor alpha, Knee Injury and Osteoarthritis Outcome Score, and physical performance tests will be assessed at baseline and after four weeks of intervention to evaluate changes in inflammatory markers and physical function. 
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