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CTRI Number  CTRI/2022/04/042058 [Registered on: 22/04/2022] Trial Registered Prospectively
Last Modified On: 21/04/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Biological
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparison of platelet rich plasma and triamcinolone in patient of osteoarthritis of knee for pain relief.  
Scientific Title of Study   Comparision of the analgesic effect of intraarticular platelet rich plasma and triamcinolone in patient of osteoarthritis knee - 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  Jankiben Panchal 
Designation  First year resident anaesthesia  
Affiliation  sir t hospital bhavanagar  
Address  303 PG -3 hostel , Sir T Hospital, 4th floor, Department of Anaesthesia, GMC Bhavnagar
303 PG -3 hostel, Sir T Hospital, 4th floor, Department of Anaesthesia, GMC Bhavnagar
Bhavnagar
GUJARAT
364001
India 
Phone  6354517097  
Fax    
Email  panchaljanki222@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Lopa Trivedi 
Designation  Assosciate Professor 
Affiliation  Government Medical College, Bhavnagar 
Address  4th floor, Department of Anaesthesia, GMC Bhavnagar.
4th floor, Department of Anaesthesia, GMC Bhavnagar. 364001
Bhavnagar
GUJARAT
364001
India 
Phone  6354517097  
Fax    
Email  trivedi_lopa@yahoo.in  
 
Details of Contact Person
Public Query  
Name  Jankiben Panchal 
Designation  First year resident anaesthesia  
Affiliation  sir t hospital bhavanagar  
Address  303 PG -3 hostel, Sir T hospital, Department of Anaesthesia, GMC Bhavnagar
303 PG -3 hostel, Sir T hospital, Department of Anaesthesia, GMC Bhavnagar. 364001
Bhavnagar
GUJARAT
364001
India 
Phone  6354517097  
Fax    
Email  panchaljanki222@gmail.com  
 
Source of Monetary or Material Support  
anesthesia department Sir T government hospital bhavnagr 364001 
 
Primary Sponsor  
Name  Government medical college bhavnagr 
Address  Government medical college, SIR T Hospital Bhavnagr Gujarat, 
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 
Jankiben Panchal  Government medical college bhavnagar  anesthesia department pain clinic ,Sir T government hospital bhavnagar 364001
Bhavnagar
GUJARAT 		 6354517097

panchaljanki222@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
ETHICS COMMITTEE BHAVNAGAR   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M179||Osteoarthritis of knee, unspecified, (2) ICD-10 Condition: M179||Osteoarthritis of knee, unspecified, (3) ICD-10 Condition: M171||Unilateral primary osteoarthritisof knee, (4) ICD-10 Condition: M171||Unilateral primary osteoarthritisof knee,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Platelet rich plasma  patients will receive intraarticular injection of 5ml of platelet rich plasma Patient receive one injection PRP and follow up for 3 month  
Comparator Agent  Triamcinolone  patients will receive intraarticular injection of 40mg triamcinolone + 4ml normal saline patient receive one injection and follow up for 3 months  
 
Inclusion Criteria  
Age From  35.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1)Grades I , II, III Knee OA according to criteria of American college of rheumatology
2)History of chronic pain > 3 month duration
3)Swelling of knee > 4 month
4)X-ray diagnosis ( Kellgren Lawrence 1 and 2)

 
 
ExclusionCriteria 
Details  1)Knee joint deformities
2)Acute infection
3)H/o knee surgery
4)H/o diabetes mellitus
5)H/o rheumatoid arthritis, gout
H/o severe cardio vascular disorder, 5)haematological disorders, renal disorder
Immunodeficiency
6)Patients taking anticoagulants
7)Patients with haemoglobin values of <10 and platelets values of <1,50,000/mm3
8)H/o vasovagal shock
9)Pregnant and lactating females
10)H/o corticosteroid consumption within last 3 months
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1)To compare pain decrement by VAS Score ( Visual analogue score).
T2)o compare function and mobility increment and generic health improvement by KOOS score (Knee injury and OA Outcome)(at 6 week)
3)To compare prevention and slowing of the progress of disease by KELLGREN & LAWRENCE Grade (at 3 months ) between two group. 		 1)To compare pain decrement by VAS Score ( Visual analogue score).
T2)o compare function and mobility increment and generic health improvement by KOOS score (Knee injury and OA Outcome)(at 6 week)
3)To compare prevention and slowing of the progress of disease by KELLGREN & LAWRENCE Grade (at 3 months ) between two group. 
 
Secondary Outcome  
Outcome  TimePoints 
1)To compare analgesic requirement during the study period between two group.
2)To compare need of surgical intervention require during study period Between two group.
 		 3 MONTHS 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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)   28/04/2022 
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 Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NONE 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   After taking approval from ethic committee,study will be initiated on patient fulfilling inclusion criteria ,pt will be assessed for pain decrement by VAS Score ,function and  mobility increment and generic health improvement  by  KOOS score (Knee injury and OA Outcome) (at 6 week)&prevention and  slowing of the progress of disease  by KELLGREN & LAWRENCE Grade  (at 3 months ) between two group.  
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