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CTRI Number  CTRI/2023/10/058367 [Registered on: 05/10/2023] Trial Registered Prospectively
Last Modified On: 23/09/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Biological
Stem Cell Therapy
Preventive 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Role of platelet rich plasma in Osteoarthritis knee  
Scientific Title of Study   A randomized control trial evaluating role of cellular therapy in osteoarthritis of knee 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Prashanth Balusani  
Designation  Junior Resident  
Affiliation  Jawaharlal Nehru Medical College,wardha 
Address  Orthopedic department, Jawaharlal Nehru Medical College,Sawangi Meghe,Wardha

Wardha
MAHARASHTRA
442001
India 
Phone  9986570353  
Fax    
Email  babbulu321@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Sandeep Shrivastava 
Designation  Professor 
Affiliation  Jawaharlal Nehru Medical College,wardha 
Address  Orthopedic department, Jawaharlal Nehru Medical College,Sawangi Meghe,Wardha

Wardha
MAHARASHTRA
442001
India 
Phone  9765404068  
Fax    
Email  drsandeepshrivastava@gmail.com  
 
Details of Contact Person
Public Query  
Name  Sandeep Shrivastava 
Designation  Professor 
Affiliation  Jawaharlal Nehru Medical College,wardha 
Address  Orthopedic department, Jawaharlal Nehru Medical College,Sawangi Meghe,Wardha

Wardha
MAHARASHTRA
442001
India 
Phone  9765404068  
Fax    
Email  drsandeepshrivastava@gmail.com  
 
Source of Monetary or Material Support  
Jawaharlal Nehru Medical,Sawangi Meghe wardha 442001 
 
Primary Sponsor  
Name  Jnmc 
Address  Sawangi Meghe,Wardha 
Type of Sponsor  Private 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 
Prashanth Balusani  Jawaharlal Nehru Medical College   Department of Orthopaedics , Jawaharlal Nehru Medical College, Sawangi Meghe , Wardha Wardha MAHARASHTRA
Wardha
MAHARASHTRA 		 9986570353

babbulu321@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Datta Meghe Institute of medical sciences INSTITUTIONAL ETHICS COMMITTEE  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,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  patient treated with Bone marrow aspirate concentrate   patients managed with Bone marrow aspirate concentrate at 1 month ,3 months , 6 months.  
Comparator Agent  Patients treated with platelet rich plasma  patients managed with platelet rich plasma at 1 month ,3 months , 6 months. 
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  All patients with Grade 1 and grade 2 osteoarthritis knee 
 
ExclusionCriteria 
Details  Co morbid conditions like sickle cell anaemia , blood dyscrasias. 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Alternation 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Platelet rich plasma & bone marrow aspirate concentrate will heal faster in grade 1 and grade 2 osteoarthritis   Platelet rich plasma & bone marrow aspirate concentrate will heal faster in grade 1 and grade 2 osteoarthritis  
 
Secondary Outcome  
Outcome  TimePoints 
healing osteoarthritis knee with PRP & BMAC  serial USG knee was done at 1 month,3 months & 6 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   Phase 2 
Date of First Enrollment (India)   10/10/2023 
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="2"
Months="1"
Days="1" 
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 - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report
    Response -  Analytic Code
    Response - None of the above

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [babbulu321@gmail.com].

  6. For how long will this data be available start date provided 20-08-2023 and end date provided 01-06-2027?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   Osteoarthritis is a degenerative disease of the joints which involves cartilage. Osteoarthitis of the knees is the most common joint disease. It is chronic progressive degenerative disease. It affects 30% of the people having age more than 50 years. Various studies have shown that osteoarthritis leads to a major burden on the economy of many developing countries.1,2,3 There have been various non-operative and operative modalities used in the treatment of osteoarthritis of knees. But early osteoarthritis is mostly treated with non-operative modalities. These modalities range from Oral analgesics i.e. Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) are most commonly used to intra-articular PRP injections and BMAC injections. All these modalities have their own plus points and drawbaks. NSAIDs are cheaper and more easily available than the others. They have short term good effect but on prolonged usage lead to systemic side effects. Various oral supplements like Glucosamine and Chondrotin sulfate are  shown to have good results in treatment of osteoarthtitis of knees on prolonged use but these cannot be considered as ideal treatment for the same. Intra-articular injections of steroids are shown to have good short term effects but like NSAIDs on prolonged usage are known to cause systemic side effects as well as adverse effects on local cartilage. Intra-articular injections of viscosupplements particularly Hyaluronic acid is another modality. Various studies have shown promising effects in early osteoarthtitis of knees.  
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