Health Condition 1: M798- Other specified soft tissue disorders
Conditions
Interventions
Intervention1: FDC of 50000 armour unit of Trypsin - Chymotrypsin activity (6:1) Enzyme and Diclofenac 50 mg Oral Tablet: 3 times a day orally at an interval of approximately 8 hours, for 7 days
Contr
Sponsors
Torrent Pharamceutical Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male or female patients of age between 18 and 65 years. 2. Patients with minor traumatic inflammatory soft tissues injuries like sprains, strains, hematomas (Sub-dermal type only), contusion, abrasions, lacerations, acute sports injuries (excluding suspected fractures), seen within 24 hours of the injury at screening. (Refer appendix 18.1 for terms) 3. Patients with moderate to severe pain (Numeric Pain Rating Scale of more than or equal to 4 on scale of 0 to 10) and swelling (Swelling score more than or equal to 2) 4. Patients willing to give written informed consent and to comply with study procedures
Exclusion criteria
Exclusion criteria: 1. Any long standing/chronic inflammatory condition like rheumatoid arthritis, osteoarthritis or spondylitis where the patient had been on long term (i.e., past 3 months or more) anti-inflammatory drugs including non-steroidal anti-inflammatory drugs, corticosteroids or analgesics. 2. Patients with infected wounds, tissue abscesses and cellulitis. 3. Patients who are known case of diabetes mellitus. 4. Patients with a known hypersensitivity to any ingredient of study drugs. 5. Patients with injuries (such as sprains/strains) requiring immobilization for more than 48 hours, orthopaedic or surgical intervention. 6. Patients with multiple soft tissue injuries, fractures, ruptured ligaments or complicated wound requiring surgical intervention. 7. Patients with active or history of recurrent peptic ulcer/gastro-intestinal bleeding or perforation. 8. Patients known to have established congestive heart failure, ischemic heart disease, peripheral arterial disease, cerebrovascular disease, renal and liver disease or any clinically significant disease as per investigator discretion. 9. Patients who are known seropositive cases of HIV, Hepatatis B or Hepatitis C. 10. Patients with clinically significant abnormality in ECG at screening. 11. Patients with localized skin disease (e.g. eczema, psoriasis etc.) at the site of injury that may interfere in evaluation of the injury. 12. Patients who had participated in any clinical trial within one month prior to enrolment. 13. Pregnant or breast-feeding women. 14. Female patients who are of childbearing potential and who have neither used a medically acceptable contraceptive method (like hormonal agents, barrier methods or intrauterine device or) nor surgically sterilized within 3 weeks prior to screening visit and not willing to use any of the contraceptive methods or abstinence from sex during the study period. 15. Patients who have taken prohibited medications (other NSAIDs, opioid analgesics and systemic corticosteroids) in last 7 days.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Median Time to achieve clinically significant reduction of 2 points for swelling score (4 points scale) from baseline 0 - Absent, 1 - Mild, 2 - Moderate, 3- Severe Time points: 0, 2, 24, 48, 72, 120, 168hr 2. Mean change in swelling score at 72 hr (4 points scale) from baseline 0 - Absent, 1 - Mild, 2 - Moderate, 3- SevereTimepoint: For primary efficacy parameter 1.) [Median Time to achieve clinically significant reduction of 2 points for swelling score (4 points scale) from baseline] Time points: 0, 2, 24, 48, 72, 120, 168 hr For Primary Efficacy Parameter 2.) [Mean change in swelling score at 72 hr (4 points scale) from baseline] - Time Point - 0, 2, 24, 48, 72 hr | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The sum of pain difference (SPID) over 72 hr between the treatment groupsTimepoint: 2, 24, 48 and 72hr;Investigatorâ??s global assessment (IGA; 5-point scale)Timepoint: 168 hr;Mean change from baseline to end of study in pain intensity assessed by Numeric Pain Rating Scale (NPRS) (11 Point Scale) between the treatment groupsTimepoint: 0, 2, 24, 48, 72, 120, 168 hr;Patient Global Impression of Change (PGIC) 7-point scaleTimepoint: 168 hr;Percentage of patients requiring rescue medicationTimepoint: 168 hr | — |
Countries
India
Contacts
Public ContactDr Sushil Kumar Anand
Torrent Pharmaceuticals Ltd, Torrent Research Centre
Outcome results
None listed