A Multi-center, Single-arm, Observational Study to Evaluate the Impact of Centrum Joint & Mobility capsules on Knee Joint Comfort and Mobility in Participants with Primary uni/bilateral Knee Osteoarthritis (OA)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 300
- Locations
- 7
- Primary Endpoint
- Change from Baseline in average Knee Injury and Osteoarthritis Outcome Score (KOOS) for Symptoms and Function-daily living at Week 12
Study Overview
Brief Summary
This will be a prospective study designed to assess the effectiveness of Centrum Joint & Mobility capsules in improving knee joint pain or discomfort, mobility, and functional ability in participants over 35 years of age with primary uni or bilateral knee OA. The study will be conducted at approximately 7-9 sites across India. Participants will be recruited through the investigator’s Outpatient Department (OPD), referrals from healthcare providers, and outreach in clinical settings. Participants with OA who have been prescribed Centrum Joint & Mobility Capsules will be instructed to take one capsule, once daily for three months as advised in the prescription. During baseline assessment, data on participants’ baseline OA symptoms will be collected. To assess changes in knee joint health, mobility, and pain or discomfort over time, the investigator will follow-up with participant at site visits on Weeks 4, 8, and 12, which will include reassessments of knee pain or discomfort, functional ability, joint mobility, scales, and scores, quality of life, and safety. A total of 300 participants will be enrolled into the study to ensure approximately 200 complete the study.
Study Design
- Study Type
- Observational
Eligibility Criteria
- Ages
- 35.00 Year(s) to 99.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Male or female participant over age of 35 years.
- •A participant prescribed with Centrum Joint & Mobility capsules, (1 capsule daily for at least 3 months).
- •Primary unilateral or bilateral knee mild to moderate OA diagnosed based on American College of Rheumatology criteria and the Kellgren-Lawrence grading system.
- •Symptoms of knee OA present for at least 1 month prior to screening.
- •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).
- •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.
- •Willingness to adhere to study protocol and daily supplementation.
- •A signed informed consent.
Exclusion Criteria
- •Patient already on Centrum Joint and Mobility capsules.
- •History or presence of active rheumatic disease (example, rheumatoid arthritis), autoimmune disease like Psoriatic arthritis.
- •Serious systemic diseases (example, severe cardiac, renal, or hepatic conditions).
- •Secondary OA or other joint disorders (example, fibromyalgia, bursitis).
- •Use of joint supplements (example, glucosamine, chondroitin) within the last month.
- •Pregnant or lactating female.
- •Use of systemic or topical corticosteroids or other joint medications outside the study protocol in the last 6 months.
- •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.
- •A participant with a knee skin area pathological condition, such as open skin wounds, infections, inflammations, or exfoliative dermatitis conditions.
- •Participation in other studies (including nonmedicinal studies) involving investigational product(s) within 1 month before screening.
- •An employee of the site or Contract Research Organization (CRO), or sponsor, or a member of the study team.
Outcomes
Primary Outcomes
Change from Baseline in average Knee Injury and Osteoarthritis Outcome Score (KOOS) for Symptoms and Function-daily living at Week 12
Time Frame: Baseline and Week 12
Secondary Outcomes
- Change from Baseline in average KOOS score for Function-Sport and Recreational activities, and quality of life at Week 12(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 8(Baseline, Weeks 4 and 8)
- Change from Baseline in knee pain or discomfort intensity using average VAS scoring at Weeks 4, 8, and 12(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 12(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 12(Baseline, Weeks 4, 8, and 12)
Investigators
Dr Shrirang Limaye
Deoyani Multispeciality Hospital