Health Condition 1: M170- Bilateral primary osteoarthritis of knee Health Condition 2: M171- Unilateral primary osteoarthritisof knee
Conditions
Interventions
Intervention1: Centrum Joint & Mobility Capsule: Participants with OA who have been prescribed Centrum Joint & Mobility Capsules will be instructed to consume the capsule as advised in the prescriptio
Sponsors
Haleon
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male or female participant over age of 35 years. 2. A participant prescribed with Centrum Joint & Mobility capsules, (1 capsule daily for at least 3 months). 3. Primary unilateral or bilateral knee mild to moderate OA diagnosed based on American College of Rheumatology criteria and the Kellgren-Lawrence grading system. 4. Symptoms of knee OA present for at least 1 month prior to screening. 5. Knee pain or discomfort visual analog scale (VAS) score more than or equal to 40 millimeter (mm) and less than or equal to 70 mm in the affected knee(s). 6. Participant taking a homemade remedy or over the counter (OTC) medicine, or on a regular dose of Nonsteroidal Anti-Inflammatory Drugs (NSAID) or paracetamol for up to 6 months, or even a participant not on any medication for OA will be included. 7. Willingness to adhere to study protocol and daily supplementation. 8. A signed informed consent.
Exclusion criteria
Exclusion criteria: 1. Patient already on Centrum Joint and Mobility capsules. 2. History or presence of active rheumatic disease (example, rheumatoid arthritis), autoimmune disease like Psoriatic arthritis. 3. Serious systemic diseases (example, severe cardiac, renal, or hepatic conditions). 4. Secondary OA or other joint disorders (example, fibromyalgia, bursitis). 5. Use of joint supplements (example, glucosamine, chondroitin) within the last month. 6. Pregnant or lactating female. 7. Use of systemic or topical corticosteroids or other joint medications outside the study protocol in the last 6 months. 8. A participant who has been administered local steroids or other NSAIDs injections or other injectables (hyaluronic acid) to the affected knee(s) within the last 6 months. 9. A participant with a recent history of major knee injury or surgery. 10. A participant with a knee skin area pathological condition, such as open skin wounds, infections, inflammations, or exfoliative dermatitis conditions. 11. Participation in other studies (including nonmedicinal studies) involving investigational product(s) within 1 month before screening. 12. An employee of the site or Contract Research Organization (CRO), or sponsor, or a member of the study team.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from Baseline in average Knee Injury and Osteoarthritis Outcome Score (KOOS) for Symptoms and Function-daily living at Week 12Timepoint: Baseline and Week 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| Change from Baseline in average KOOS score for Function-Sport and Recreational activities, and quality of life at Week 12Timepoint: Baseline and Week 12;Change from Baseline in average KOOS score for Symptoms, Function-daily living, Function-Sport and recreational activities, Quality of Life at Weeks 4 and 8Timepoint: Baseline, Weeks 4 and 8;Change from Baseline in knee pain or discomfort intensity using average VAS scoring at Weeks 4, 8, and 12Timepoint: Baseline, Weeks 4, 8, and 12;Change from Baseline in Leg strength as measured by average score from 30-second chair stand test at Weeks 4,8, and 12Timepoint: Baseline, Weeks 4,8, and 12;Change from Baseline in health-related quality of life average scores assessed by RAND-36, focusing on physical, emotional, and social well-being at Weeks 4, 8, and 12Timepoint: Baseline, Weeks 4, 8, and 12 | — |
Countries
India
Contacts
Public ContactDr Atul Sharma
Haleon India
Outcome results
None listed