Health Condition 1: M709- Unspecified soft tissue disorder related to use, overuse and pressure
Conditions
Interventions
Intervention1: 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,
Sponsors
Parth Hospital
Eligibility
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| % 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.Timepoint: 3 Days | — |
Secondary
| Measure | Time frame |
|---|---|
| 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) Timepoint: 3 days | — |
Countries
India
Contacts
Public ContactDr Pratik Vinchhi
Parth Hospital
Outcome results
None listed