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CTRI Number  CTRI/2023/07/055477 [Registered on: 21/07/2023] Trial Registered Prospectively
Last Modified On: 26/08/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Biological 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Effectiveness of Injections into the knee joint like Platelet Rich Plasma with (Hyaluronic Acid) Gel in comparison with Botulinum Toxin type A (Derived from Bacteria) with (Hyaluronic Acid) Gel in reducing Knee pain and improving function of Knee in cases of degenerative disease of Knee. 
Scientific Title of Study   Effectiveness of Intra- Articular Platelet Rich Plasma with Hyaluronic Acid in comparison with Intra- Articular Botulinum Toxin Type-A with Hyaluronic Acid in improving pain and functional limitation in Osteoarthritis of Knee: A Randomized Clinical 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  Dr Shubha V Hegde 
Designation  MBBS, MD, DNB, Fellow in Pain Medicine 
Affiliation  Alleviate Pain Management Hospital 
Address  Alleviate Pain Management Hospital, Department of Pain Medicine, 2nd floor, Santoshimaa Enclave, T. Dasarahalli, Bengaluru, Karnataka.

Bangalore
KARNATAKA
560057
India 
Phone  8197809917  
Fax    
Email  hegdeshubha93@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Khaja Javed Khan 
Designation  Consultant Pain physician and Fellowship Programme Head 
Affiliation  Alleviate Pain Management Hospital 
Address  Alleviate Pain Management Hospital, Department of Pain Medicine, 2nd floor, Santoshimaa Enclave, T. Dasarahalli, Bengaluru, Karnataka

Bangalore
KARNATAKA
560057
India 
Phone  9008497791  
Fax    
Email  khaja.javed.khan@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Shubha V Hegde 
Designation  MBBS, MD, DNB, Fellow in Pain Medicine 
Affiliation  Alleviate Pain Management Hospital 
Address  Alleviate Pain Management Hospital, Department of Pain medicine, 2nd floor, Santoshimaa Enclave, T. Dasarahalli, Bengaluru, Karnataka.

Bangalore
KARNATAKA
560057
India 
Phone  8197809917  
Fax    
Email  hegdeshubha93@gmail.com  
 
Source of Monetary or Material Support  
Alleviate Pain Management Hospital,2nd floor, Santoshimaa Enclave, T. Dasarahalli, Bengaluru,Karnataka- 560057 
 
Primary Sponsor  
Name  Dr Shubha V Hegde 
Address  Alleviate Pain Management Hospital, Santoshimaa Enclave, T. Dasarhalli, Bengaluru. 
Type of Sponsor  Other [Self] 
 
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 Shubha V Hegde  Alleviate Pain Management Hospital.  Department of Pain Medicine, 2nd floor, BALC Computer Education Institute 8th mile, Santoshimaa Enclave,39/2, Tumkur Road above Adhishwar electroworl, TDasarhalli, Bengaluru.
Bangalore
KARNATAKA 		 8197809917

hegdeshubha93@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
AEC Independent Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Bilateral Knee Osteoarthritis. 
Patients  (1) ICD-10 Condition: M170||Bilateral primary osteoarthritis of knee,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Botulinum Toxin type A and Hyaluronic Acid  Route of administration: Knee Intra- articular Dose: 100 units of Botulinum Toxin type A and 60mg of Hyaluronic Acid. Frequency: Once. Duration of Intervention: 30 minutes.  
Comparator Agent  Platelet Rich Plasma and Hyaluronic Acid  Route: Intra- articular Dose :4-5ml containing 8-10 lakh/cumm of Platelet Rich Plasma and Hyaluronic Acid- 60mg. Frequency: Once. 
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  1.Bilateral Knee Osteoarthritis Grade 3 and 4.
2.Knee pain> 3 months.
3.Morning stiffness < 30 minutes.  
 
ExclusionCriteria 
Details  1.Patient’s unwillingness to participate.
2.History of other diseases affecting knee joint like Rheumatoid Arthritis, Gout, Neuromuscular diseases.
3.Previous intra-articular injections.
4.History of knee joint surgery.
5.Acute Trauma.
6.Contraindications to intra-articular injection e.g., sepsis, intra-articular infections, intra-articular fracture, or uncontrolled coagulopathy. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
1.To evaluate the efficacy of intra- articular Platelet rich plasma with Hyaluronic Acid (PRP with HA) in comparison with intra- articular Botulinum Toxin A with Hyaluronic Acid on knee pain.

2.To evaluate the effect of intra- articular PRP with HA in comparison with intra- articular Botulinum Toxin A with Hyaluronic Acid on functional limitation of Knee.

3.To assess the effect of patient factors post procedure, on knee pain & functional limitation . 		 Pre- Procedural, Immediate post procedure, 2weeks, 4 weeks, 12 weeks and 24 weeks.
 
 
Secondary Outcome  
Outcome  TimePoints 
To assess the effect of patient factors post procedure, on knee pain & functional limitation .  Baseline, At the end of 24 weeks. 
 
Target Sample Size   Total Sample Size="54"
Sample Size from India="54" 
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 3 
Date of First Enrollment (India)   28/07/2023 
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="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details
Modification(s)  		 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

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response (Others) -  Journal

  6. For how long will this data be available start date provided 11-01-2023 and end date provided 11-01-2032?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary
Modification(s)  

Intra-articular injections like PRP, HA and Botox help in alleviating Knee pain, improving functionality of the joint and simultaneously improving quality of life of the  patients with knee osteoarthritis, we intended to compare the efficacy of intra-articular PRP with HA (because of their synergistic effect) and Botox and HA in reducing the knee pain and functional limitation of the knee and also to assess the effect of  patient factors post procedure like, weight reduction and regular physiotherapy on knee pain and functional limitation of the knee . Hence the need for the study.

 
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