Health Condition 1: M15-M19- Osteoarthritis
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: • Men and women with age of 40 â?? 65 with a diagnosis of arthritis. • Obtaining written Inform consent along with audio, video visual. • Patients with mild to moderate arthritis • Participants who are able to visit the medical institutions throughout the study period
Exclusion criteria
Exclusion criteria: • Patients with Uncontrolled hypertension or diabetes. • Patients with Hepatic or renal impairment • Patients with Current or expected use of anticoagulant • Candidates for imminent joint replacement • Diagnosis of gastric or duodenal ulceration and/or history of significant gastro-duodenal bleeding, within the last 6 months • Participation within 30 days prior to screening in another investigational study • Conditions in the opinion of the investigator make the patient unsuitable to participate in the study. • Any contraindication to blood sampling. • HIV Positive serology • Pregnant (or) Lactating
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| â?¢ Patients Assessment of Osteoarthritis Pain by VAS [Osteoarthritis- Pain Visual analog scale (VAS)] â?¢ Change from Baseline in the WOMAC OA (Western Ontario and McMaster Universities Osteoarthritis) Index-pain subscale score â?¢ WOMAC Osteoarthritis Composite Index & QOL â?¢ Changes in the arthritis impact measurement scale (AIMS 2) â?¢ Change from Baseline in the CGI (Clinical Global Impression) scale score â?¢ Changes in Comprehensive Metabolic Panel (CMP), &Synovial Fluid analysis. Timepoint: â?¢Screening to EOT (Day 120) | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety assessed by Adverse EventsTimepoint: Screening to EOT (Day 120) | — |
Countries
India
Contacts
ICBio Clinical research Pvt Ltd