| 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
|
|
|
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
|
|
|
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 |