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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.

A randomized, double blind, comparative, parallel-group clinical trial to evaluate the efficacy and safety of a combination of trypsin-chymotrypsin enzymes and diclofenac (TCD) in comparison to diclofenac alone in the management of inflammation due to soft tissue injuries

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2009/091/000813
Enrollment
Unknown
Registered
2009-10-12
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: Trypsin: Chymotrypsin (6:1) 50,000 A.U + Diclofenac Pottasium 50 mg: Three times a day for seven days Control Intervention1: Diclofenac Sodium 50 mg tablets: Three times a day for seve

Sponsors

Elder Pharmaceuticals Ltd., C-9, Dalia Industrial Estate, Veera Desai Road, Off New Link Road, Andheri (W), Mumbai ? 53.
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

MeasureTime frame
Recovery from the injury, assessed by the Global score of the evaluated parameters of inflammation.Timepoint: End of study—

Secondary

MeasureTime frame
Relief of individual symptoms of inflammation assessed by the individual symptom score for pain, swelling and restriction of movement Timepoint: End of study—

Countries

India

Contacts

Public ContactDr. Manas Vyas

Elder Pharmaceuticals Ltd.

drmanas@elderindia.com022-66485326

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026