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CTRI Number  CTRI/2024/09/073371 [Registered on: 04/09/2024] Trial Registered Prospectively
Last Modified On: 04/09/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   To study the effect of Dynapar QPS in the treatment of swelling/pain after injury. 
Scientific Title of Study   A single-centre, randomized, open-label, active controlled, investigator initiated clinical trial evaluating the efficacy and safety of Dynapar QPS for the treatment of post-traumatic swelling / inflammation 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
PH/2024-25/001 Version 1.0, Dated 03 Jul 2024  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Pratik Vinchhi 
Designation  Orthopedic Surgeon 
Affiliation  Parth Hospital 
Address  Parth Hospital E 405/4, 407-411, OPD No 1, Department of Orthopedics Galaxy Arcade Galaxy Cinema Road Naroda

Ahmadabad
GUJARAT
382330
India 
Phone  9909032354  
Fax    
Email  pratikvinchhi.cr@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Pratik Vinchhi 
Designation  Orthopedic Surgeon 
Affiliation  Parth Hospital 
Address  Parth Hospital E 405/4, 407-411, OPD No 1, Department of Orthopedics, Galaxy Arcade Galaxy Cinema Road Naroda


GUJARAT
382330
India 
Phone  9909032354  
Fax    
Email  pratikvinchhi.cr@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Pratik Vinchhi 
Designation  Orthopedic Surgeon 
Affiliation  Parth Hospital 
Address  Parth Hospital E 405/4, 407-411, OPD no 1, Department of Orthopedics, Galaxy Arcade Galaxy Cinema Road Naroda


GUJARAT
382330
India 
Phone  9909032354  
Fax    
Email  pratikvinchhi.cr@gmail.com  
 
Source of Monetary or Material Support  
Parth Hospial E 405/4, 407-411, OPD No 1, Department of Orthopedics, Galaxy Arcade Galaxy Cinema Road Naroda 382330, Gujarat, India  
 
Primary Sponsor  
Name  Parth Hospital 
Address  Parth Hospital E 405/4 407-411 Galaxy Arcade Galaxy Cinema Road, Naroda, Ahmedabad 382330, Gujarat, India 
Type of Sponsor  Research institution and hospital 
 
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 Pratik Vinchhi  Parth Hospital  E 405/4 407-411, OPD No 1, Department of Orthopedics, Galaxy Arcade Galaxy Cinema Road Naroda 382330
Ahmadabad
GUJARAT 
9909032354

pratikvinchhi.cr@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Parth Hospital Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M709||Unspecified soft tissue disorder related to use, overuse and pressure,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Diclofenac Diethylamine (Dynapar QPS) 4.64% w/v   On the affected area, 4 pump strokes should be applied 4 times a day at regular intervals. After applying the required number of sprays, spread the solution gently with fingertip over the affected area. The same procedure will be followed 4 times a day till pain and swelling subsides or advised by investigator. Care should be taken that the application site is left open till the solution dries and the solution does not get absorbed into the clothing. 
Comparator Agent  Marketed product of Diclofenac Diethylamine 1.16% w/w Topical Gel  Diclofenac gel 1.16% w/w will be applied as a 3 – 4 cm strip around the affected area 4 times daily at regular intervals. After applying the required quantity of gel, spread the gel gently with fingertip over the affected area. The same procedure will be followed 3-4 times a day till pain and swelling subsides or advised by investigator. Care should be taken that the application site is left open till the gel dries and the gel does not get absorbed into the clothing 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  1. Patients of either gender in the age group of 18 years and above
2. Patients presenting with any type of fresh impact injuries (blunt, traumatic soft tissue injuries and contusions) with localised swelling / inflammation.
3. Patients willing to give written informed consent prior to participation in the study
4. Able to understand the study procedures and the use of the pain scales and to communicate meaningfully with the study observer and staff.
5. The female subjects who are of non-childbearing potential or of childbearing potential, who are non-pregnant.
 
 
ExclusionCriteria 
Details  1. Patients with known hypersensitivity or contraindication to study drugs or any of the excipients.
2. Patient presenting with a fracture, infection, open wound or wound requiring hospitalization or a surgical procedure.
3. Patient receiving any digestive enzymes (like Trypsin / Chymotrypsin / Serratiopeptidase) or any other topical preparation.
4. Patient requiring antibiotics or corticosteroids.
5. Pregnant and/or lactating women.
6. Patient has participated in another clinical study (investigational or marketed product) within 30 days prior to screening.
7. Patients, for any reason not considered to be suitable candidate by the investigator.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
% change in swelling at various time points from baseline is the main outcome/s in this study which is used to determine the effects of the both intervention/s (Diclofenac Diethylamine (Dynapar QPS) 4.64% w/v Topical Solution manufactured by Troikaa Pharmaceuticals Ltd. versus Marketed product of Diclofenac Diethylamine 1.16% w/w Topical Gel). Moreover this is an exploratory trial hence data from 50 patients will be enough to estimate difference between two interventions.  3 Days 
 
Secondary Outcome  
Outcome  TimePoints 
1. Pain intensity difference on VAS (PID vas) from baseline at 15 min, 30 min, 45 min, 1 hour, 3 hour and 6 hour after first dose and at 1 hour after each subsequent doses (from Day 0 to Day 3) from baseline.
2. Time to first rescue
3. Number and percentage of patients requiring rescue medication at each time point after repeated dose (During the 24 hours after the first dose)
 
3 days 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
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   Post Marketing Surveillance 
Date of First Enrollment (India)   16/09/2024 
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  

Pain, swelling, and inflammation are common symptoms that can occur after a non-surgical post-traumatic event or blunt trauma. These symptoms are a natural part of the body’s healing process and are typically seen within the first 24 hours after the injury. During this initial stage of inflammation, it is important to manage these symptoms to promote healing and provide relief to the patient.

 

Post-traumatic swelling and inflammation are common symptoms following injuries or trauma. Several topical formulations of diclofenac have been studied for their effectiveness in treating these symptoms. These formulations include solutions, emulsion gels, controlled-release pellets, and polymeric film coatings. These formulations have shown promising results in controlled drug release, providing sustained relief from swelling and inflammation. The effectiveness of topical formulations of diclofenac in treating post-traumatic swelling and inflammation in humans has been studied. Based on the available research, topical formulations of diclofenac have shown to be effective in reducing post-traumatic swelling and inflammation in humans. Comparative pharmacokinetics and bioavailability study of percutaneous absorption of diclofenac from two topical formulations containing drug as a solution or as an emulsion gel. Additionally, comparative studies have shown that topical diclofenac has a similar short-term effect in reducing pain and improving function compared to oral forms of the drug for symptoms of osteoarthritis in a single knee.

 

Non-surgical trauma, such as sprains, strains, and bruises, often results in pain, swelling, and inflammation. Dynapar QPS is a novel topical formulation of diclofenac diethylamine, a nonsteroidal anti-inflammatory drug that can be applied directly to the affected area. It works by inhibiting the production of prostaglandins, which are responsible for inflammation and pain. Using topical diclofenac in non-surgical trauma can help alleviate pain, reduce swelling, and decrease inflammation, providing localized relief without the need for oral medications or invasive procedures. Dynapar QPS that can be applied directly to the affected area and is known to have analgesic and anti-inflammatory properties. It is also well-tolerated and safe for topical use, with minimal risk of systemic side effects. Additionally, topical diclofenac has been extensively studied and proven to be effective in managing various types of acute and chronic pain, including musculoskeletal pain, joint pain, and soft tissue injuries. Overall, topical diclofenac is a safe and effective option for managing pain, swelling, and inflammation in non-surgical trauma cases. Using topical diclofenac in non-surgical trauma can provide targeted relief of pain, swelling, and inflammation without the need for oral medications or invasive procedures. It is a convenient and practical option for patients who prefer topical treatments or those who may have contraindications to systemic medications. Additionally, topical diclofenac has been shown to have a faster onset of action compared to oral medications, providing quicker relief to patients.

 

This study has been designed to observe the effectiveness of Dynapar QPS over the marketed product of Diclofenac Diethylamine 1.16% w/w Topical Gel in the treatment of post traumatic swelling / inflammation

 
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