Health Condition 1: M799- Soft tissue disorder, unspecified
Conditions
Interventions
Intervention1: Combination of Diclofenac, Paracetamol, Trypsin and Chymotrypsin: All patients in the study will receive combination of Diclofenac, Paracetamol, Trypsin and Chymotrypsin tablets 1 table
Sponsors
Cachet Pharmaceutical Pvt Ltd
Alkem Laboratories Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male or female patients between 18-65 years of age. 2. Patients with soft tissues injuries associated with inflammation & swelling like sprains, strains, hematomas (Sub-dermal type only), contusion, acute sports injuries (excluding suspected fractures), seen within 24 hours of the injury at screening. 3. Patients with pain VAS score between 4 - 6 4. Patients with ankle injury not requiring interventional treatment 5. Patients willing to give written informed consent and willing to comply with trial protocol
Exclusion criteria
Exclusion criteria: 1. Patients previously hypersensitive to diclofenac, paracetamol, trypsin or chymotrypsin 2. Patients with significant gastrointestinal complications, such as but not limited to the following conditions: a. Gastrointestinal ulcer b. Gastrointestinal bleeding c. Crohnââ?¬•s disease or ulcerative colitis. 3. Any long standing/chronic inflammatory condition like rheumatoid arthritis, osteoarthritis or spondylitis where the patient had been on long term anti-inflammatory drugs including nonsteroidal anti-inflammatory drugs, corticosteroids or analgesics. 4. Patients with wounds, tissue abscesses and cellulitis. 5. Patients with injuries (such as sprains/strains) requiring immobilization for more than 48 hours, orthopaedic or surgical intervention. 6. Patients known to have established congestive heart failure, cerebrovascular disease, renal and liver disease or any clinically significant disease as per investigator discretion. 7. Patient with any abnormal renal and hepatic function. 8. Patients who are known seropositive cases of HIV, Hepatitis B or Hepatitis C. 9. Patients with localized skin disease (e.g. eczema, psoriasis etc.) at the site of injury that may interfere in evaluation of the injury. 10. Patients who had participated in any clinical trial within one month prior to enrolment. 11. Patients who have taken prohibited medications (other NSAIDs, opioid analgesics and systemic corticosteroids) in last 7 days. 12. Pregnant and lactating women or the women of child bearing age who are not practicing effective method of contraception.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary objective of this study is to evaluate the efficacy of combination of Diclofenac, Paracetamol, Trypsin and Chymotrypsin versus combination of Diclofenac and Paracetamol in terms of percentage reduction in swelling from baseline to End of treatment.Timepoint: Patients completing treatment from baseline to EOT i.e. day 6 to day 8 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. To evaluate change in VAS score from baseline to EOT 2. To evaluate rate of pain relief during the study.(reduction in VAS score from baseline) 3. Use of any rescue medication 4. To evaluate the safety and tolerability.Timepoint: Patients completing treatment from baseline to EOT i.e. day 6 to day 8 | — |
Countries
India
Contacts
Public ContactDr Vinayaka Shahavi
Alkem Laboratoroes Limited
Outcome results
None listed