Knee osteoarthritis is a common condition that causes knee pain, stiffness, reduced mobility, and difficulty performing daily activities. Many patients seek non-surgical treatment options to help manage their symptoms and improve their quality of life.
This study aims to evaluate the effectiveness and safety of Mobithron® Xtra, an oral health supplement containing hyaluronic acid, undenatured type II collagen, and Boswellia serrata extract, in adults with primary knee osteoarthritis. Participants will take Mobithron® Xtra once daily for 3 months as part of their routine care.
The study will observe changes in knee pain, stiffness, physical function, treatment satisfaction, and overall perception of improvement using validated patient-reported outcome measures, including the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), Visual Analogue Scale (VAS), Treatment Satisfaction Questionnaire for Medication (TSQM), and Patient Global Impression of Change (PGIC).
This is a prospective, multicentre observational study involving patients receiving treatment in participating general practitioner clinics throughout Malaysia. No experimental procedures will be performed, and participants will continue to receive standard clinical care. Safety will be monitored throughout the study by documenting any adverse events reported by participants.
The findings from this study may provide valuable real-world evidence regarding the role of Mobithron® Xtra in improving symptoms and quality of life among patients with primary knee osteoarthritis.
Adults ≥40 years with primary knee osteoarthritis (OA)
Radiographic diagnosis of primary knee OA (Grade 2 or 3 on Kellgren-Lawrence scale)
Stable physiotherapy regimen for ≥3 months (if applicable).
Baseline VAS score ≥ 5
Secondary OA (such as post-traumatic and inflammatory arthritis)
Grade IV Primary OA
Patients on analgesia (e.g., paracetamol, NSAIDs)
Patients on Mobithron (P/Advance/Xtra) or glucosamine products
Prospective, multi-centred, observational cohort study, whereby patients fulfilling inclusion and exclusion criteria will be recruited prospectively at general practitioner clinics located throughout Malaysia.
Cohort
Prospective
Not listed
Effectiveness of Mobithron® Xtra as measured by the WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index)
The WOMAC is a validated patient-reported outcome measure assessing pain, stiffness, and physical function in individuals with osteoarthritis. The total WOMAC score ranges from 0 to 96 points, with higher scores indicating worse pain, stiffness, and functional impairment (worse outcome) and lower scores indicating better clinical status (better outcome). Effectiveness will be assessed by comparing the change in WOMAC total score from baseline to the end of treatment at 3 months
Effectiveness of Mobithron® Xtra in reducing pain and symptoms of knee OA, as measured by VAS score
The Visual Analog Scale (VAS) for Pain is a patient-reported measure of pain intensity. Participants rate their pain on a scale ranging from 0 to 10, where 0 represents no pain and 10 represents the worst imaginable pain. Higher scores indicate greater pain severity (worse outcome), while lower scores indicate less pain severity (better outcome). Effectiveness will be assessed by comparing the change in VAS pain scores from baseline to the end of treatment at 3 months.
Assess treatment satisfaction using Treatment Satisfaction Questionnaire for Medication (TSQM) v1.4
This section evaluates the effectiveness, side effects, and convenience of the medication taken by the patients, and is evaluated on the likert scale from 1 to 7. A lower score indicates a worse outcome whereas a higher score indicates a better outcome.
Evaluate patients' global impression of change (PGIC)
The Patient Global Impression of Change (PGIC) is a patient-reported measure that assesses participants' perception of overall change in their condition since starting treatment. Participants rate their overall condition using a 7-point ordinal scale: 1. Very much improved, 2. Much improved, 3. Minimally improved, 4. No change, 5. Minimally worse, 6. Much worse, or 7. Very much worse. Higher levels of improvement indicate a better outcome, while worsening categories indicate a poorer outcome.
Identify progressive trends in range of motion improvement from baseline to Month 3
Knee range of motion (ROM) will be assessed using a goniometer and recorded in degrees (°). Measurements will be obtained at baseline and at each follow-up visit through Month 3. Effectiveness will be evaluated by assessing the change in ROM over time and identifying progressive trends in knee mobility improvement. Higher ROM values indicate greater joint mobility and a better outcome.
Evaluate the safety profile of Mobithron® Xtra
Number of participants experiencing treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), and adverse drug reactions (ADRs). The events will be escalated to the research team and recorded in the standardised Adverse Drug Reaction form. All data collected will be monitored continuously throughout the study period.
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University of Malaya
Lead sponsor
BREGO Life Sciences Sdn Bhd
Collaborator
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