Health Condition 1: null- osteoarthritis.
Conditions
Interventions
Intervention1: Fixed Dose combination of Diclofenac 25 mg + Paracetamol 325 mg: TID for four weeks
Control Intervention1: Aceclofenc 100mg: BD For Four Weeks
Sponsors
Troikaa Pharmaceuticals Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male or females patients aged 45-80 years. 2 Patients with a working diagnosis of osteoarthritis as defined by NICE 2008 guidelines (Appendix-II) 3. At least moderate pain within past 2 weeks
Exclusion criteria
Exclusion criteria: 1. Secondary osteoarthritis related to syphilis, metabolic bone disorder, acute trauma 2. Hypersensitivity to aspirin/ NSAID or any other component of the formulation 3. Any contra-indication to either medication. 4. Clinically active hepatic or peptic ulcer disease 5. H/O alcohol or drug abuse 6. Clinically significant impairment of hepatic and renal functions 7. Corticosteroid use 8. Use of any other analgesic or glucosamine 9. Baseline laboratory values outside the clinically acceptable limits 10. Pregnant women and lactating mothers 11. Women of child bearing age not practicing or not willing to use contraceptive 12. Patients or relatives unwilling to give written informed consent 13. Participation in a clinical study involving an investigational product within past 120 days.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline to final assessment in VAS Score for painTimepoint: At end of second and fourth week of treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Global assessment by Physician and patientsTimepoint: At the end of four weeks of treatment;Improvement in joint symptoms effusion & passive mobilityTimepoint: At the end of second and fourth week of treatment;Need for rescue analgesicTimepoint: At the end of second and fourth week of treatment | — |
Countries
India
Contacts
Public ContactDr Vijaya jaiswal
Troikaa Pharmaceuticals Limited
Outcome results
None listed