| CTRI Number |
CTRI/2025/11/097728 [Registered on: 20/11/2025] Trial Registered Prospectively |
| Last Modified On: |
20/11/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Treatment of knee joint osteoarthritis |
|
Scientific Title of Study
|
Intra articular triamcinolone vs oral methotrexate in knee osteoarthritis:an open labelled randomized control trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sashwat Swayang SiddhaTarenia |
| Designation |
Post doctoral trainee |
| Affiliation |
IPGMER AND SSKM |
| Address |
Rajarhat new town street 257 near db community market
dept.of clinical immunology and rheumatology ,ipgmer and sskm,AJC BOSE ROAD
Kolkata
WEST BENGAL
700156
India |
| Phone |
9903520159 |
| Fax |
|
| Email |
sashwattarenia98@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr.biswadip ghosh |
| Designation |
Professor ,dept of clinical immunology and rheumatology |
| Affiliation |
IPGMER AND SSKM |
| Address |
howrah west bengal
dept.of clinical immunology andrheumatology,Ipgmer and sskm,kolkata
Kolkata
WEST BENGAL
700156
India |
| Phone |
9903520159 |
| Fax |
|
| Email |
sashwattarenia98@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Sashwat Swayang SiddhaTarenia |
| Designation |
Post doctoral trainee |
| Affiliation |
IPGMER AND SSKM |
| Address |
Rajarhat new town street 257 near db community market
dept.of clinical immunology and rheumatology ,ipgmer and sskm,AJC BOSE ROAD
Kolkata
WEST BENGAL
700156
India |
| Phone |
9903520159 |
| Fax |
|
| Email |
sashwattarenia98@gmail.com |
|
|
Source of Monetary or Material Support
|
| IPGMER AND SSKM,kolkata ,west bengal |
|
|
Primary Sponsor
|
| Name |
IPGMER AND SSKM |
| Address |
AJC BOSE ROAD |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Sashwat Tarenia |
IPGMER AND SSKM |
AJC BOSE ROAD
Kolkata
WEST BENGAL |
9903520159
sashwattarenia98@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IPGMER Research oversight committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M170||Bilateral primary osteoarthritis of knee, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
IACS |
intra articular injection |
| Intervention |
oral methotrexate |
15mg once a week |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
a Age 40 to 75 years
b Satisfying ACR criteria for classification and reporting of osteoarthritis of knee joint 1986
c Symptomatic for at least 6 months
d Radiographic Kellgren Lawrence grade II definite osteophyte and unimpaired joint space or grade III moderate multiple osteophytes definite narrowing of joint space some sclerosis and possible deformity of bone contour
e Visual analog score for knee pain at least 40 or more on the scale of 0 to 100
f Failure to control osteoarthritis symptoms with conventional therapy defined as persistence of pain of severity 40 or more on VAS scale of 0 to 100 despite conventional treatment defined as one of the following medications taken daily during the preceding 3 month acetaminophen 2 to 4 gram per day maximum tolerated and recommended dose of an NSAID or acetaminophen codeine combination
g Evidence of inflammation any two of the following presence of effusion in the knee joint as detected from bulge sign or patellar tap evidence of synovial inflammation on MRI knee joints or raised CRP
h BMI less than 30 kg per meter square |
|
| ExclusionCriteria |
| Details |
b Seropositivity for RF anti CCP or ANA
c History of trauma in the knees sufficient to reduce the mobility of the patient for at least 7 days in the past 1 year
d Taking any other therapy for osteoarthritis except topical or systemic NSAIDS including any conventional DMARD
e History of intraarticular glucocorticoid in knee joint in last 3 months
f History of oral inhaled or intranasal glucocorticoid within one month
g History of intraarticular hyaluronic acid in the knee within six months
h Arthroscopic or open surgery of knee
i History of knee replacement
j Known hypersensitivity to corticosteroid
k Patients with chronic inflammatory rheumatic disease Rheumatoid arthritis spondyloarthropathy psoriatic arthritis gout chondrocalcinosis or other autoimmune disease
l Serum creatinine more than 15 mg per dL and deranged LFT
m Patients with any history suggestive of multiple sclerosis or CNS demyelinating disease
n Persons with uncontrolled diabetes mellitus unstable ischemic heart disease congestive heart failure active inflammatory bowel disease recent stroke chronic leg ulcer active hepatitis B and C infection positive HIV status history of infection requiring treatment with IV antibiotics in last 6 months
o History of tuberculosis in last 2 years
p Unwilling to give consent and unwilling to follow up |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
A) Improvement in WOMAC pain subscale score (0-100) at 12 weeks and ICOAP score
B) To compare between oral methotrexate and IACS in terms of efficacy of pain relief.
|
A) Improvement in WOMAC pain subscale score (0-100) at 12 weeks and ICOAP score
B) To compare between oral methotrexate and IACS in terms of efficacy of pain relief.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
A) Improvement bone marrow lesions on MRI (Based on semiquantitative score) at 12 weeks.
B) Comparison of bone marrow lesions on MRI between the 2 arms
|
A) Improvement bone marrow lesions on MRI (Based on semiquantitative score) at 12 weeks.
B) Comparison of bone marrow lesions on MRI between the 2 arms
|
|
|
Target Sample Size
|
Total Sample Size="74"
Sample Size from India="74"
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)
|
01/12/2025 |
| 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)
|
Open to Recruitment |
| 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
|
This is an open labeled RCT to compare between the efficacy of methotrexate and IACS in osteoarthritis .OA is a both degenerative and inflammatory.As it is difficult to control pain and inflammation in OA,we are performing this RCT to analyze the response to treatment |