Health Condition 1: M179- Osteoarthritis of knee, unspecified
Conditions
Interventions
Intervention1: Tablet Polmacoxib: Tablet Polmacoxib 2 mg once daily for 6 weeks
Control Intervention1: Standard of care: Tablet diclofenac 50 mg BD for 6 weeks
Sponsors
Dr Elavarasi R
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients with newly diagnosed or Treatment naive Primary Osteoarthritis based on ACR clinical classification criteria. 2. WOMAC OA index score of 49 to 79 baseline 3. Patients willing to provide informed written consent. 4. Subjects capable and willing to comply with study procedures
Exclusion criteria
Exclusion criteria: 1)Patients with secondary osteoarthritis. 2)Patients with Cardiovascular disease, uncontrolled hypertension, gastrointestinal bleeding and chronic illness of liver, kidney. 3)Patients using any other analgesic or Acetaminophen except study medication. 4)Use of Anticoagulants within 2 weeks of screening. 5)Use of Corticosteroids, Herbal medicines, Glucosamines, Chondroitin sulphates. 6)Hypersensitivity to NSAIDs.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The efficacy of Polmacoxib will be assessed by Modified Western Ontario McMaster Universities(WOMAC) -OA pain,stiffness,physical function subscale and index during Day 1 of therapy and 4th week, 8th week of treatment.Timepoint: Reduction of WOMAC OA index score from patients initial score ,after completion of treatment with tablet polmacoxib for 6 weeks . | — |
Secondary
| Measure | Time frame |
|---|---|
| The safety of Polmacoxib will be assessed by incidence of Treatment Emergent Adverse Effects during treatment and follow up.Timepoint: Treatment Emergent Adverse Effects from initiation of therapy,4th week,8th week of treatment will be assessed. | — |
Countries
India
Contacts
Public ContactDr Elavarasi R
Chengalpattu Medical College
Outcome results
None listed