A clinical trial to study the effects of a combination of trypsin-chymotrypsin enzymes and diclofenac in comparison to diclofenac alone in patients with soft tissue injuries.
- Registration Number
- CTRI/2009/091/000813
- Lead Sponsor
- Elder Pharmaceuticals Ltd.,C-9, Dalia Industrial Estate, Veera Desai Road, Off New Link Road,Andheri (W), Mumbai ? 53.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 0
1)Adult patients aged between 18 and 65 years with soft tissue injuries like sprains, strains, stress injuries, ecchymosis, hematomas and lacerations seen within 24 hours of the injury
2)Patients aged between 18 and 65 years.
3)Patients who have given their written informed consent
4)Patients of childbearing years who are using appropriate contraceptive methods for 3 weeks prior to the study and throughout the duration of the study.
The following patients may also be included:
1. Clean Lacerated Wounds (non infected) requiring suturing.
2.Patients with healed fractures more than 3 months old
1)Any long standing/ chronic inflammatory condition like Rheumatoid Arthritis, Osteoarthritis or Spondylitis where the patient has been on long term NSAIDs, Anti-Inflammatory drugs or Analgesics.
2)Infected wounds, Tissue abscesses and Cellulitis
3)Patients with Fracture if less than 3 months old.
4)Post operative cases
5)Patients who have Diabetes/ Raised Blood Sugar
6)Pregnant or breast-feeding women.
7)Patients who are simultaneously participating in another clinical trial with an unlicensed drug or who have done so within a one month period.
8)Patients with a known hypersensitivity to TC or Diclofenac
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method