This study is to compare the beneficial effects of polmacoxib with existing therapy in the pain management of osteoarthitis along with the safety profile in South Indian population.
Phase 4
- Conditions
- Health Condition 1: M179- Osteoarthritis of knee, unspecified
- Registration Number
- CTRI/2024/01/061489
- Lead Sponsor
- Dr Elavarasi R
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
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
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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.