Safety and Efficacy of Arthronat in subjects with painful Osteoarthritis
Phase 2
Completed
- Conditions
- Health Condition 1: null- Osteoarthritis
- Registration Number
- CTRI/2011/07/001886
- Lead Sponsor
- Rowtasha
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 80
Inclusion Criteria
A previously diagnosed (atleast 3 months prior to the screening visit) case of osteoarthritis of hip, knees based on the ACR Clinical Classification criteria for osteoarthritis
A previously diagnosed (atleast 3 months prior to screening visit) case on shoulders, neck and wrists based on the clinical and radiographic findings.
Exclusion Criteria
Subject with history of disease which may involve the index joint including but not
limited to rheumatoid arthritis
Any inflammatory joint disease
Metabolic bone disease (gout, pseudo gout etc)
Bone tumours
Joint infections (reactive arthritis, septic arthritis)
Avascular necrosis (especially of neck of femur)
Neuropathic disorders etc.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in the pain scores as evaluated by Visual Analogue Scale (VAS) at end of 1 <br/ ><br>week as compared to Baseline (Day 0 / Visit 2) <br/ ><br> <br/ ><br>Improvement (change) in mobility at the end of Week 1 as compared to Baseline (day <br/ ><br>0 / Visit 2) evaluated by change in the WOMAC sub-scales of Stiffness and Physical <br/ ><br>function.Timepoint: 1 Week
- Secondary Outcome Measures
Name Time Method Change in the pain scores as evaluated by VAS at end of 2, 3 and 4 weeks as compared to Baseline (Day 0 / Visit 2)Timepoint: week 2, 3 and 4