CTRI/2020/03/023852
Not yet recruiting
Phase 4
A Prospective, Observational, Multicenter Study to Determine the Effectiveness and Safety of Glucosamine and Undenatured Collagen Type II Combination (Rejoint Max®) in Indian Patients with Osteoarthritis of Knee
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Health Condition 1: M170- Bilateral primary osteoarthritis of knee
- Sponsor
- Abbott Healthcare Pvt Ltd
- Status
- Not yet recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\.Male and female patient \>40 years of age, with primary knee OA (bilateral) of the knee as per the American College of Rheumatology criteria and Kellgren\-Lawrence system.
- •2\.Patient who have been recommended Rejoint Max as per physician discretion without any additional NSAIDs.
- •3\.Patients presenting with symptoms of OA of knee, expressed continuously or intermittently over the last 6\-months prior to screening
- •4\.Patients with pain VAS \> 40/100 mm
Exclusion Criteria
- •1\.Patients with history or presence of active rheumatic disease
- •2\.Patients with serious concomitant systemic diseases, peripheral or central neurological disorder, severe cardiac/renal/hepatic condition, severe inflammation of joints, hematologic disease joint deformities, secondary OA, fibromyalgia, bursitis, and tendonitis
- •3\.Patients on oral treatment with glucosamine/chondroitin/other natural health products within the last month
- •4\.Pregnant and lactating females
- •5\.Patients with any medical condition judged by investigators that warrant exclusion
Outcomes
Primary Outcomes
Not specified
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