Health Condition 1: M170- Bilateral primary osteoarthritis of knee
Conditions
Interventions
Intervention1: NIL: NIL
Control Intervention1: NIL: NIL
Sponsors
Abbott Healthcare Pvt Ltd
Eligibility
Inclusion 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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Mean change in functional ability of the patients as assessed by Lower Extremity Functional Scale (LEFS) from baseline at Month 1 and Month 3. 2. Mean change in functional ability of the patients as assessed by 100-mm VAS from baseline at Month 1 and Month 3. Timepoint: Month 1 and Month 3 | — |
Secondary
| Measure | Time frame |
|---|---|
| 3. Mean change in total and subscales (physical health problems, role limitations caused by emotional problems, social functioning, emotional well-being, energy/fatigue, pain, and general health perceptions) of research and development-36 (RAND-36) scale score from baseline at Month 1 and Month 3Timepoint: Month 1 and Month 3;4. Number and percentage of patients requiring rescue medication (such as paracetamol 500 mg, NSAIDs, or intra-articular injection with corticosteroids) at Month 1 and Month 3Timepoint: Month 1 and Month 3;Effectiveness of Rejoint Max a) Mean change in pain intensity at rest as assessed by 100-mm VAS from baseline at Month 1 and Month 3 b) Mean change in pain intensity during walking as assessed by 100-mm VAS from baseline at Month 1 and Month 3 Timepoint: Month 1 and Month 3;Sociodemographic and clinical profileTimepoint: Month 1 and Month 3 | — |
Countries
India
Contacts
Public ContactMs Sneha Nair
Abbott India Ltd.
Outcome results
None listed