A phase IV, randomized, multicentre, prospective, open-label, comparative, post-marketing study to evaluate safety & efficacy of combination of Diclofenac, Paracetamol, Trypsin and Chymotrypsin versus combination of Diclofenac and Paracetamol in patients with soft tissue injury.

Cachet Pharmaceutical Pvt Ltd0 sites220 target enrollmentTBD

Overview

No summary available.

Registry

who.int

Start Date

TBD

End Date

December 8, 2021

Last Updated

3 years ago

Study Type

Interventional

Sponsor

Cachet Pharmaceutical Pvt Ltd

•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

•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. CrohnÃ¢â?¬•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.